case study related to ethics

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• 30 Apr 2024

When Managers Set Unrealistic Expectations, Employees Cut Ethical Corners

Corporate misconduct has grown in the past 30 years, with losses often totaling billions of dollars. What businesses may not realize is that misconduct often results from managers who set unrealistic expectations, leading decent people to take unethical shortcuts, says Lynn S. Paine.

• 23 Apr 2024
• Cold Call Podcast

Amazon in Seattle: The Role of Business in Causing and Solving a Housing Crisis

In 2020, Amazon partnered with a nonprofit called Mary’s Place and used some of its own resources to build a shelter for women and families experiencing homelessness on its campus in Seattle. Yet critics argued that Amazon’s apparent charity was misplaced and that the company was actually making the problem worse. Paul Healy and Debora Spar explore the role business plays in addressing unhoused communities in the case “Hitting Home: Amazon and Mary’s Place.”

• 15 Apr 2024

Struggling With a Big Management Decision? Start by Asking What Really Matters

Leaders must face hard choices, from cutting a budget to adopting a strategy to grow. To make the right call, they should start by following their own “true moral compass,” says Joseph Badaracco.

• 26 Mar 2024

How Do Great Leaders Overcome Adversity?

In the spring of 2021, Raymond Jefferson (MBA 2000) applied for a job in President Joseph Biden’s administration. Ten years earlier, false allegations were used to force him to resign from his prior US government position as assistant secretary of labor for veterans’ employment and training in the Department of Labor. Two employees had accused him of ethical violations in hiring and procurement decisions, including pressuring subordinates into extending contracts to his alleged personal associates. The Deputy Secretary of Labor gave Jefferson four hours to resign or be terminated. Jefferson filed a federal lawsuit against the US government to clear his name, which he pursued for eight years at the expense of his entire life savings. Why, after such a traumatic and debilitating experience, would Jefferson want to pursue a career in government again? Harvard Business School Senior Lecturer Anthony Mayo explores Jefferson’s personal and professional journey from upstate New York to West Point to the Obama administration, how he faced adversity at several junctures in his life, and how resilience and vulnerability shaped his leadership style in the case, "Raymond Jefferson: Trial by Fire."

• 02 Jan 2024

Should Businesses Take a Stand on Societal Issues?

Should businesses take a stand for or against particular societal issues? And how should leaders determine when and how to engage on these sensitive matters? Harvard Business School Senior Lecturer Hubert Joly, who led the electronics retailer Best Buy for almost a decade, discusses examples of corporate leaders who had to determine whether and how to engage with humanitarian crises, geopolitical conflict, racial justice, climate change, and more in the case, “Deciding When to Engage on Societal Issues.”

• 12 Dec 2023

Can Sustainability Drive Innovation at Ferrari?

When Ferrari, the Italian luxury sports car manufacturer, committed to achieving carbon neutrality and to electrifying a large part of its car fleet, investors and employees applauded the new strategy. But among the company’s suppliers, the reaction was mixed. Many were nervous about how this shift would affect their bottom lines. Professor Raffaella Sadun and Ferrari CEO Benedetto Vigna discuss how Ferrari collaborated with suppliers to work toward achieving the company’s goal. They also explore how sustainability can be a catalyst for innovation in the case, “Ferrari: Shifting to Carbon Neutrality.” This episode was recorded live December 4, 2023 in front of a remote studio audience in the Live Online Classroom at Harvard Business School.

• 11 Dec 2023
• Research & Ideas

Doing Well by Doing Good? One Industry’s Struggle to Balance Values and Profits

Few companies wrestle with their moral mission and financial goals like those in journalism. Research by Lakshmi Ramarajan explores how a disrupted industry upholds its values even as the bottom line is at stake.

• 27 Nov 2023

Voting Democrat or Republican? The Critical Childhood Influence That's Tough to Shake

Candidates might fixate on red, blue, or swing states, but the neighborhoods where voters spend their teen years play a key role in shaping their political outlook, says research by Vincent Pons. What do the findings mean for the upcoming US elections?

• 21 Nov 2023

The Beauty Industry: Products for a Healthy Glow or a Compact for Harm?

Many cosmetics and skincare companies present an image of social consciousness and transformative potential, while profiting from insecurity and excluding broad swaths of people. Geoffrey Jones examines the unsightly reality of the beauty industry.

• 09 Nov 2023

What Will It Take to Confront the Invisible Mental Health Crisis in Business?

The pressure to do more, to be more, is fueling its own silent epidemic. Lauren Cohen discusses the common misperceptions that get in the way of supporting employees' well-being, drawing on case studies about people who have been deeply affected by mental illness.

• 07 Nov 2023

How Should Meta Be Governed for the Good of Society?

Julie Owono is executive director of Internet Sans Frontières and a member of the Oversight Board, an outside entity with the authority to make binding decisions on tricky moderation questions for Meta’s companies, including Facebook and Instagram. Harvard Business School visiting professor Jesse Shapiro and Owono break down how the Board governs Meta’s social and political power to ensure that it’s used responsibly, and discuss the Board’s impact, as an alternative to government regulation, in the case, “Independent Governance of Meta’s Social Spaces: The Oversight Board.”

• 24 Oct 2023

From P.T. Barnum to Mary Kay: Lessons From 5 Leaders Who Changed the World

What do Steve Jobs and Sarah Breedlove have in common? Through a series of case studies, Robert Simons explores the unique qualities of visionary leaders and what today's managers can learn from their journeys.

• 03 Oct 2023
• Research Event

Build the Life You Want: Arthur Brooks and Oprah Winfrey Share Happiness Tips

"Happiness is not a destination. It's a direction." In this video, Arthur C. Brooks and Oprah Winfrey reflect on mistakes, emotions, and contentment, sharing lessons from their new book.

• 12 Sep 2023

Successful, But Still Feel Empty? A Happiness Scholar and Oprah Have Advice for You

So many executives spend decades reaching the pinnacles of their careers only to find themselves unfulfilled at the top. In the book Build the Life You Want, Arthur Brooks and Oprah Winfrey offer high achievers a guide to becoming better leaders—of their lives.

• 10 Jul 2023
• In Practice

The Harvard Business School Faculty Summer Reader 2023

Need a book recommendation for your summer vacation? HBS faculty members share their reading lists, which include titles that explore spirituality, design, suspense, and more.

• 01 Jun 2023

A Nike Executive Hid His Criminal Past to Turn His Life Around. What If He Didn't Have To?

Larry Miller committed murder as a teenager, but earned a college degree while serving time and set out to start a new life. Still, he had to conceal his record to get a job that would ultimately take him to the heights of sports marketing. A case study by Francesca Gino, Hise Gibson, and Frances Frei shows the barriers that formerly incarcerated Black men are up against and the potential talent they could bring to business.

• 04 Apr 2023

Two Centuries of Business Leaders Who Took a Stand on Social Issues

Executives going back to George Cadbury and J. N. Tata have been trying to improve life for their workers and communities, according to the book Deeply Responsible Business: A Global History of Values-Driven Leadership by Geoffrey Jones. He highlights three practices that deeply responsible companies share.

• 14 Mar 2023

Can AI and Machine Learning Help Park Rangers Prevent Poaching?

Globally there are too few park rangers to prevent the illegal trade of wildlife across borders, or poaching. In response, Spatial Monitoring and Reporting Tool (SMART) was created by a coalition of conservation organizations to take historical data and create geospatial mapping tools that enable more efficient deployment of rangers. SMART had demonstrated significant improvements in patrol coverage, with some observed reductions in poaching. Then a new predictive analytic tool, the Protection Assistant for Wildlife Security (PAWS), was created to use artificial intelligence (AI) and machine learning (ML) to try to predict where poachers would be likely to strike. Jonathan Palmer, Executive Director of Conservation Technology for the Wildlife Conservation Society, already had a good data analytics tool to help park rangers manage their patrols. Would adding an AI- and ML-based tool improve outcomes or introduce new problems? Harvard Business School senior lecturer Brian Trelstad discusses the importance of focusing on the use case when determining the value of adding a complex technology solution in his case, “SMART: AI and Machine Learning for Wildlife Conservation.”

• 14 Feb 2023

Does It Pay to Be a Whistleblower?

In 2013, soon after the US Securities and Exchange Commission (SEC) had started a massive whistleblowing program with the potential for large monetary rewards, two employees of a US bank’s asset management business debated whether to blow the whistle on their employer after completing an internal review that revealed undisclosed conflicts of interest. The bank’s asset management business disproportionately invested clients’ money in its own mutual funds over funds managed by other banks, letting it collect additional fees—and the bank had not disclosed this conflict of interest to clients. Both employees agreed that failing to disclose the conflict was a problem, but beyond that, they saw the situation very differently. One employee, Neel, perceived the internal review as a good-faith effort by senior management to identify and address the problem. The other, Akash, thought that the entire business model was problematic, even with a disclosure, and believed that the bank may have even broken the law. Should they escalate the issue internally or report their findings to the US Securities and Exchange Commission? Harvard Business School associate professor Jonas Heese discusses the potential risks and rewards of whistleblowing in his case, “Conflicts of Interest at Uptown Bank.”

• 17 Jan 2023

Good Companies Commit Crimes, But Great Leaders Can Prevent Them

It's time for leaders to go beyond "check the box" compliance programs. Through corporate cases involving Walmart, Wells Fargo, and others, Eugene Soltes explores the thorny legal issues executives today must navigate in his book Corporate Criminal Investigations and Prosecutions.

Princeton Dialogues on AI and Ethics

Princeton University

Case Studies

Princeton Dialogues on AI and Ethics Case Studies

The development of artificial intelligence (AI) systems and their deployment in society gives rise to ethical dilemmas and hard questions. By situating ethical considerations in terms of real-world scenarios, case studies facilitate in-depth and multi-faceted explorations of complex philosophical questions about what is right, good and feasible. Case studies provide a useful jumping-off point for considering the various moral and practical trade-offs inherent in the study of practical ethics.

Case Study PDFs : The Princeton Dialogues on AI and Ethics has released six long-format case studies exploring issues at the intersection of AI, ethics and society. Three additional case studies are scheduled for release in spring 2019.

Methodology : The Princeton Dialogues on AI and Ethics case studies are unique in their adherence to five guiding principles: 1) empirical foundations, 2) broad accessibility, 3) interactiveness, 4) multiple viewpoints and 5) depth over brevity.

How should political actors behave? What is good representation? When is it appropriate to make a compromise? Is releasing confidential information ever justified? How do you change deeply entrenched social norms? Should you? These are just some of the questions raised by the teaching cases in this section, which ask students to consider the implications and ramifications of real-world ethical scenarios, with sources of conflict ranging from personal to structural dilemmas.

Fallen Idol? Aung San Suu Kyi & the Rohingya Humanitarian Crisis Epilogue

Publication Date: January 25, 2024

This epilogue accompanies, "Fallen Idol? Aung San Suu Kyi & the Rohingya Humanitarian Crisis," HKS Case Number 2139.0. Soon after Myanmar’s longtime democracy crusader and opposition leader, Aung San Suu Kyi, was...

Climate Resilience in New York City: The Battle over East River Park

Publication Date: November 28, 2023

What makes climate change different as a policy challenge? Why is it so hard to solve? And how can we balance the need for the right technical solutions with the importance of having the process be as democratic and participatory as possible?The...

Reckoning with History: Confederate Monuments in American Cities Practitioner Guide

Publication Date: November 15, 2023

This practitioner guide accompanies case 2235.0. When the Reverend Clementa Pinckney and eight worshipers were massacred during bible study at the Emanuel African Methodist Episcopal church in Charleston, South Carolina in 2015, a widely...

Reckoning with History: Confederate Monuments in American Cities (Abridged)

This is an abridged version of case 2235.0. Abstract: When the Reverend Clementa Pinckney and eight worshipers were massacred during bible study at the Emanuel African Methodist Episcopal church in Charleston, South Carolina in 2015, a widely...

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Publication Date: March 3, 2023

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Publication Date: June 8, 2022

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The Making of a Public Health Catastrophe: A Step-by-Step Guide to the Flint Water Crisis

Publication Date: January 12, 2022

The Flint water crisis, which began in 2014, is widely regarded as a textbook example of structural racism and injustice. This teaching case provides a close examination of the building blocks of the catastrophe, some all-too-familiar in...

Making a Statement: Mayor Libby Schaaf and the Sanctuary City of Oakland, CA Practitioner Guide

Publication Date: October 8, 2020

This practitioner guide accompanies HKS Case 2191.0. In February 2018, Oakland Mayor Libby Schaaf learned through unofficial sources that Immigration and Customs Enforcement (ICE) was planning to arrest a large number of undocumented...

Making a Statement: Mayor Libby Schaaf and the Sanctuary City of Oakland, CA Epilogue

This epilogue accompanies HKS Case 2191.0. In February 2018, Oakland Mayor Libby Schaaf learned through unofficial sources that Immigration and Customs Enforcement (ICE) was planning to arrest a large number of undocumented immigrants in her...

Making a Statement: Mayor Libby Schaaf and the Sanctuary City of Oakland, CA

In February 2018, Oakland Mayor Libby Schaaf learned through unofficial sources that Immigration and Customs Enforcement (ICE) was planning to arrest a large number of undocumented immigrants in her city. Oakland had been a “sanctuary...

Antanas Mockus: The Prohibition of Fireworks in Bogotá Sequel

Publication Date: October 10, 2019

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Research and Practice of AI Ethics: A Case Study Approach Juxtaposing Academic Discourse with Organisational Reality

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• Published: 08 March 2021
• Volume 27 , article number  16 , ( 2021 )

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• Mark Ryan   ORCID: orcid.org/0000-0003-4850-0111 1 ,
• Josephina Antoniou 2 ,
• Laurence Brooks 3 ,
• Tilimbe Jiya 4 ,
• Kevin Macnish 5 &
• Bernd Stahl 3  

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This study investigates the ethical use of Big Data and Artificial Intelligence (AI) technologies (BD + AI)—using an empirical approach. The paper categorises the current literature and presents a multi-case study of 'on-the-ground' ethical issues that uses qualitative tools to analyse findings from ten targeted case-studies from a range of domains. The analysis coalesces identified singular ethical issues, (from the literature), into clusters to offer a comparison with the proposed classification in the literature. The results show that despite the variety of different social domains, fields, and applications of AI, there is overlap and correlation between the organisations’ ethical concerns. This more detailed understanding of ethics in AI + BD is required to ensure that the multitude of suggested ways of addressing them can be targeted and succeed in mitigating the pertinent ethical issues that are often discussed in the literature.

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Introduction

Big Data and Artificial Intelligence (BD + AI) are emerging technologies that offer great potential for business, healthcare, the public sector, and development agencies alike. The increasing impact of these two technologies and their combined potential in these sectors can be highlighted for diverse organisational aspects such as for customisation of organisational processes and for automated decision making. The combination of Big Data and AI, often in the form of machine learning applications, can better exploit the granularity of data and analyse it to offer better insights into behaviours, incidents, and risk, eventually aiming at positive organisational transformation.

Big Data offers fresh and interesting insights into structural patterns, anomalies, and decision-making in a broad range of different applications (Cuquet & Fensel, 2018 ), while AI provides predictive foresight, intelligent recommendations, and sophisticated modelling. The integration and combination of AI + BD offer phenomenal potential for correlating, predicting and prescribing recommendations in insurance, human resources (HR), agriculture, and energy, as well as many other sectors. While BD + AI provides a wide range of benefits, they also pose risks to users, including but not limited to privacy infringements, threats of unemployment, discrimination, security concerns, and increasing inequalities (O’Neil, 2016 ). Footnote 1 Adequate and timely policy needs to be implemented to prevent many of these risks occurring.

One of the main limitations preventing key decision-making for ethical BD + AI use is that there are few rigorous empirical studies carried out on the ethical implications of these technologies across multiple application domains. This renders it difficult for policymakers and developers to identify when ethical issues resulting from BD + AI use are only relevant for isolated domains and applications, or whether there are repeated/universal concerns which can be seen across different sectors. While the field lacks literature evaluating ethical issues Footnote 2 ‘on the ground’, there are even fewer multi-case evaluations.

This paper provides a cohesive multi-case study analysis across ten different application domains, including domains such as government, agriculture, insurance, and the media. It reviews ethical concerns found within these case studies to establish cross-cutting thematic issues arising from the implementation and use of BD + AI. The paper collects relevant literature and proposes a simple classification of ethical issues (short term, medium term, long term), which is then juxtaposed with the ethical concerns highlighted from the multiple-case study analysis. This multiple-case study analysis of BD + AI offers an understanding of current organisational practices.

The work described in this paper makes an important contribution to the literature, based on its empirical findings. By presenting the ethical issues across an array of application areas, the paper provides much-needed rigorous empirical insight into the social and organisational reality of ethics of AI + BD. Our empirical research brings together a collection of domains that gives a broad oversight about issues that underpin the implementation of AI. Through its empirical insights the paper provides a basis for a broader discussion of how these issues can and should be addressed.

This paper is structured in six main sections: this introduction is followed by a literature review, which allows for an integrated review of ethical issues, contrasting them with those found in the cases. This provides the basis for a categorisation or classification of ethical issues in BD + AI. The third section contains a description of the interpretivist qualitative case study methodology used in this paper. The subsequent section provides an overview of the organisations participating in the cases to contrast similarities and divisions, while also comparing the diversity of their use of BD + AI. Footnote 3 The fifth section provides a detailed analysis of the ethical issues derived from using BD + AI, as identified in the cases. The concluding section analyses the differences between theoretical and empirical work and spells out implications and further work.

Literature Review

An initial challenge that any researcher faces when investigating ethical issues of AI + BD is that, due to the popularity of the topic, there is a vast and rapidly growing literature to be considered. Ethical issues of AI + BD are covered by a number of academic venues, including some specific ones such as the AAAI/ACM Conference on AI, Ethics, and Society ( https://dl.acm.org/doi/proceedings/10.1145/3306618 ), policy initiative and many publicly and privately financed research reports (Whittlestone, Nyrup, Alexandrova, Dihal, & Cave, 2019 ). Initial attempts to provide overviews of the area have been published (Jobin, 2019 ; Mittelstadt, Allo, Taddeo, Wachter, & Floridi, 2016 ), but there is no settled view on what counts as an ethical issue and why. In this paper we aim to provide a broad overview of issues found through the case studies. This paper puts forward what are commonly perceived to be ethical issues within the literature or concerns that have ethical impacts and repercussions. We explicitly do not apply a particular philosophical framework of ethics but accept as ethical issues those issues that we encounter in the literature. This review is based on an understanding of the current state of the literature by the paper's authors. It is not a structured review and does not claim comprehensive coverage but does share some interesting insights.

To be able to undertake the analysis of ethical issues in our case studies, we sought to categorise the ethical issues found in the literature. There are potentially numerous ways of doing so and our suggestion does not claim to be authoritative. Our suggestion is to order ethical issues in terms of their temporal horizon, i.e., the amount of time it is likely to take to be able to address them. Time is a continuous variable, but we suggest that it is possible to sort the issues into three clusters: short term, medium term, and long term (see Fig.  1 ).

Temporal horizon for addressing ethical issues

As suggested by Baum ( 2017 ), it is best to acknowledge that there will be ethical issues and related mitigating activities that cannot exclusively fit in as short, medium or long term.

ather than seeing it as an authoritative classification, we see this as a heuristic that reflects aspects of the current discussion. One reason why this categorisation is useful is that the temporal horizon of ethical issues is a potentially useful variable, with companies often being accused of favouring short-term gains over long-term benefits. Similarly, short-term issues must be able to be addressed on the local level for short-term fixes to work.

Short-term issues

These are issues for which there is a reasonable assumption that they are capable of being addressed in the short term. We do not wish to quantify what exactly counts as short term, as any definition put forward will be contentious when analysing the boundaries and transition periods. A better definition of short term might therefore be that such issues can be expected to be successfully addressed in technical systems that are currently in operation or development. Many of the issues we discuss under the heading of short-term issues are directly linked to some of the key technologies driving the current AI debate, notably machine learning and some of its enabling techniques and approaches such as neural networks and reinforcement learning.

Many of the advantages promised by BD + AI involve the use of personal data, data which can be used to identify individuals. This includes health data; customer data; ANPR data (Automated Number Plate Recognition); bank data; and even includes data about farmers’ land, livestock, and harvests. Issues surrounding privacy and control of data are widely discussed and recognized as major ethical concerns that need to be addressed (Boyd & Crawford, 2012 ; Tene & Polonetsky, 2012 , 2013 ; Mittelstadt, Allo, Taddeo, Wachter, & Floridi, 2016 ; Jain, Gyanchandani, & Khare, 2016 ; Mai, 2016 ; Macnish, 2018 ). The concern surrounding privacy can be put down to a combination of a general level of awareness of privacy issues and the recently-introduced General Data Protection Regulation (GDPR). Closely aligned with privacy issues are those relating to transparency of processes dealing with data, which can often be classified as internal, external, and deliberate opaqueness (Burrell, 2016 ; Lepri, Staiano, Sangokoya, Letouzé, & Oliver, 2017 ; Mittelstadt, Allo, Taddeo, Wachter, & Floridi, 2016 ).

The Guidelines for Trustworthy AI Footnote 4 were released in 2018 by the High-Level Expert Group on Artificial Intelligence (AI HLEG Footnote 5 ), and address the need for technical robustness and safety, including accuracy, reproducibility, and reliability. Reliability is further linked to the requirements of diversity, fairness, and social impact because it addresses freedom from bias from a technical point of view. The concept of reliability, when it comes to BD + AI, refers to the capability to verify the stability or consistency of a set of results (Bush, 2012 ; Ferraggine, Doorn, & Rivera, 2009 ; Meeker and Hong, 2014 ).

If a technology is unreliable, error-prone, and unfit-for-purpose, adverse ethical issues may result from decisions made by the technology. The accuracy of recommendations made by BD + AI is a direct consequence of the degree of reliability of the technology (Barolli, Takizawa, Xhafa, & Enokido, 2019 ). Bias and discrimination in algorithms may be introduced consciously or unconsciously by those employing the BD + AI or because of algorithms reflecting pre-existing biases (Baroccas and Selbst, 2016 ). Examples of bias have been documented often reflecting “an imbalance in socio-economic or other ‘class’ categories—ie, a certain group or groups are not sampled as much as others or at all” (Panch et al., 2019 ). have the potential to affect levels of inequality and discrimination, and if biases are not corrected these systems can reproduce existing patterns of discrimination and inherit the prejudices of prior decision makers (Barocas & Selbst, 2016 , p. 674). An example of inherited prejudices is documented in the United States, where African-American citizens, more often than not, have been given longer prison sentences than Caucasians for the same crime.

Medium-term issues

Medium-term issues are not clearly linked to a particular technology but typically arise from the integration of AI techniques including machine learning into larger socio-technical systems and contexts. They are thus related to the way life in modern societies is affected by new technologies. These can be based on the specific issues listed above but have their main impact on the societal level. The use of BD + AI may allow individuals’ behaviour to be put under scrutiny and surveillance , leading to infringements on privacy, freedom, autonomy, and self-determination (Wolf, 2015 ). There is also the possibility that the increased use of algorithmic methods for societal decision-making may create a type of technocratic governance (Couldry & Powell, 2014 ; Janssen & Kuk, 2016 ), which could infringe on people’s decision-making processes (Kuriakose & Iyer, 2018 ). For example, because of the high levels of public data retrieval, BD + AI may harm people’s freedom of expression, association, and movement, through fear of surveillance and chilling effects (Latonero, 2018 ).

Corporations have a responsibility to the end-user to ensure compliance, accountability, and transparency of their BD + AI (Mittelstadt, Allo, Taddeo, Wachter, & Floridi, 2016 ). However, when the source of a problem is difficult to trace, owing to issues of opacity, it becomes challenging to identify who is responsible for the decisions made by the BD + AI. It is worth noting that a large-scale survey in Australia in 2020 indicated that 57.9% of end-users are not at all confident that most companies take adequate steps to protect user data. The significance of understanding and employing responsibility is an issue targeted in many studies (Chatfield et al., 2017 ; Fothergill et al., 2019 ; Jirotka et al., 2017 ; Pellé & Reber, 2015 ). Trust and control over BD + AI as an issue is reiterated by a recent ICO report demonstrating that most UK citizens do not trust organisations with their data (ICO, 2017 ).

Justice is a central concern in BD + AI (Johnson, 2014 , 2018 ). As a starting point, justice consists in giving each person his or her due or treating people equitably (De George, p. 101). A key concern is that benefits will be reaped by powerful individuals and organisations, while the burden falls predominantly on poorer members of society (Taylor, 2017 ). BD + AI can also reflect human intentionality, deploying patterns of power and authority (Portmess & Tower, 2015 , p. 1). The knowledge offered by BD + AI is often in the hands of a few powerful corporations (Wheeler, 2016 ). Power imbalances are heightened because companies and governments can deploy BD + AI for surveillance, privacy invasions and manipulation, through personalised marketing efforts and social control strategies (Lepri, Staiano, Sangokoya, Letouzé, & Oliver, 2017 , p. 11). They play a role in the ascent of datafication, especially when specific groups (such as corporate, academic, and state institutions) have greater unrestrained access to big datasets (van Dijck, 2014 , p. 203).

Discrimination , in BD + AI use, can occur when individuals are profiled based on their online choices and behaviour, but also their gender, ethnicity and belonging to specific groups (Calders, Kamiran, & Pechenizkiy, 2009 ; Cohen et al., 2014 ; and Danna & Gandy, 2002 ). Data-driven algorithmic decision-making may lead to discrimination that is then adopted by decision-makers and those in power (Lepri, Staiano, Sangokoya, Letouzé, & Oliver, 2017 , p. 4). Biases and discrimination can contribute to inequality . Some groups that are already disadvantaged may face worse inequalities, especially if those belonging to historically marginalised groups have less access and representation (Barocas & Selbst, 2016 , p. 685; Schradie, 2017 ). Inequality-enhancing biases can be reproduced in BD + AI, such as the use of predictive policing to target neighbourhoods of largely ethnic minorities or historically marginalised groups (O’Neil, 2016 ).

BD + AI offers great potential for increasing profit, reducing physical burdens on staff, and employing innovative sustainability practices (Badri, Boudreau-Trudel, & Souissi, 2018 ). They offer the potential to bring about improvements in innovation, science, and knowledge; allowing organisations to progress, expand, and economically benefit from their development and application (Crawford et al., 2014 ). BD + AI are being heralded as monumental for the economic growth and development of a wide diversity of industries around the world (Einav & Levin, 2014 ). The economic benefits accrued from BD + AI may be the strongest driver for their use, but BD + AI also holds the potential to cause economic harm to citizens and businesses or create other adverse ethical issues (Newman, 2013 ).

However, some in the literature view the co-development of employment and automation as somewhat naïve outlook (Zuboff, 2015 ). BD + AI companies may benefit from a ‘post-labour’ automation economy, which may have a negative impact on the labour market (Bossman, 2016 ), replacing up to 47% of all US jobs within the next 20 years (Frey & Osborne, 2017 ). The professions most at risk of affecting employment correlated with three of our case studies: farming, administration support and the insurance sector (Frey & Osborne, 2017 ).

Long-term issues

Long-term issues are those pertaining to fundamental aspects of nature of reality, society, or humanity. For example, that AI will develop capabilities far exceeding human beings (Kurzweil, 2006 ). At this point, sometimes called the ‘ singularity ’ machines achieve human intelligence, are expected to be able to improve on themselves and thereby surpass human intelligence and become superintelligent (Bostrom, 2016 ). If this were to happen, then it might have dystopian consequences for humanity as often depicted in science fiction. Also, it stands to reason that the superintelligent, or even just the normally intelligent machines may acquire a moral status.

It should be clear that these expectations are not universally shared. They refer to what is often called ‘ artificial general intelligence’ (AGI), a set of technologies that emulate human reasoning capacities more broadly. Footnote 6

Furthermore, if we may acquire new capabilities, e.g. by using technical implants to enhance human nature. The resulting being might be called a transhuman , the next step of human evolution or development. Again, it is important to underline that this is a contested idea (Livingstone, 2015 ) but one that has increasing traction in public discourse and popular science accounts (Harari, 2017 ).

We chose this distinction of three groups of issues for understanding how mitigation strategies within organisations can be contextualised. We concede that this is one reading of the literature and that many others are possible. In this account of the literature we tried to make sense of the current discourse to allow us to understand our empirical findings which are introduced in the following sections.

Case Study Methodology

Despite the impressive amount of research undertaken on ethical issues of AI + BD (e.g. Mittelstadt, Allo, Taddeo, Wachter, & Floridi, 2016 ; Zwitter, 2014 ), there are few case studies exploring such issues. This paper builds upon this research and employs an interpretivist methodology to do so, focusing on how, what, and why questions relevant to the ethical use of BD + AI (Walsham, 1995a , b ). The primary research questions for the case studies were: How do organisations perceive ethical concerns related to BD + AI and in what ways do they deal with them?

We sought to elicit insights from interviews, rather than attempting to reach an objective truth about the ethical impacts of BD + AI. The interpretivist case study approach (Stake 2003) allowed the researchers ‘to understand ‘reality’ as the blending of the various (and sometimes conflicting) perspectives which coexist in social contexts, the common threads that connect the different perspectives and the value systems that give rise to the seeming contradictions and disagreements around the topics discussed. Whether one sees this reality as static (social constructivism) or dynamic (social constructionism) was also a point of consideration, as they both belong in the same “family” approach where methodological flexibility is as important a value as rigour’ (XXX).

Through extensive brainstorming within the research team, and evaluations of relevant literature, 16 social application domains were established as topics for case study analysis. Footnote 7 The project focused on ten out of these application domains in accordance with the partners’ competencies. The case studies have covered ten domains, and each had their own unique focus, specifications, and niches, which added to the richness of the evaluations (Table 1 ).

The qualitative analysis approach adopted in this study focused on these ten standalone operational case studies that were directly related to the application domains presented in Table 1 . These individual case studies provide valuable insights (Yin, 2014 , 2015 ); however, a multiple-case study approach offers a more comprehensive analysis of ethical issues related to BD + AI use (Herriott & Firestone, 1983 ). Thus, this paper adopts a multiple-case study methodology to identify what insights can be obtained from the ten cases, identifies whether any generalisable understandings can be retrieved, and evaluates how different organisations deal with issues pertaining to BD + AI development and use. The paper does not attempt to derive universal findings from this analysis, in line with the principles of interpretive research, but further attempts to gain an in-depth understanding of the implications of selected BD + AI applications.

The data collection was guided by specific research questions identified through each case, including five desk research questions (see appendix 1); 24 interview questions (see appendix 2); and a checklist of 17 potential ethical issues, developed by the project leader Footnote 8 (see appendix 3). A thematic analysis framework was used to ‘highlight, expose, explore, and record patterns within the collected data. The themes were patterns across data sets that were important to describe several ethical issues which arise through the use of BD  +  AI across different types of organisations and application domains’ (XXX).

A workshop was then held after the interviews were carried out. The workshop brought together the experts in the case study team to discuss their findings. This culminated in 26 ethical issues Footnote 9 that were inductively derived from the data collected throughout the interviews (see Fig.  2 and Table 3). Footnote 10 In order to ensure consistency and rigour in the multiple-case study approach, researchers followed a standardised case study protocol (Yin, 2014 ). Footnote 11

The Prevalence of Ethical Issues in the Case Studies

Thirteen different organisations were interviewed for 10 case studies, consisting of 22 interviews in total. Footnote 12 These ranged from 30 min to 1 ½ hours in-person or Skype interviews. The participants that were selected for interviews represented a very broad range of application domains and organisations that use BD + AI. The case study organisations were selected according to their relevance to the overall case study domains and considering their fit with the domains and likelihood of providing interesting insights. The interviewees were then selected according to their ability to explain their BD + AI and its role in their organisation. In addition to interviews, a document review provided supporting information about the organisation. Thus, websites and published material were used to provide background to the research.

Findings: Ten Case Studies

This section gives a brief overview of the cases, before analysing their similarities and differences. It also highlights the different types of BD + AI being used, and the types of data used by the BD + AI in the case study organisations, before conducting an ethical analysis of the cases. Table 2 presents an overview of the 10 cases to show the roles of the interviewees, the focus of the technologies being used, and the data retrieved by each organisation’s BD + AI. All interviews were conducted in English.

The types of organisations that were used in the case studies varied extensively. They included start-ups (CS10), niche software companies (CS1), national health insurers (Organisation X in CS6), national energy providers (CS7), chemical/agricultural multinational (CS3), and national (CS9) and international (CS8) telecommunications providers. The case studies also included public (CS2, Organisation 1 and 4 in CS4) and semi-public (Organisation 2 in CS4) organisations, as well as a large scientific research project (CS5).

The types of individuals interviewed also varied extensively. For example, CS6 and CS7 did not have anyone with a specific technical background, which limited the possibility of analysing issues related to the technology itself. Some case studies only had technology experts (such as CS1, CS8, and CS9), who mostly concentrated on technical issues, with much less of a focus on ethical concerns. Other case studies had a combination of both technical and policy-focused experts (i.e. CS3, CS4, and CS5). Footnote 13

Therefore, it must be made fundamentally clear that we are not proposing that all of the interviewees were authorities in the field, or that even collectively they represent a unified authority on the matter, but instead, that we are hoping to show what are the insights and perceived ethical issues of those currently working with AI on the ground view as ethical concerns. While the paper is presenting the ethical concerns found within an array of domains, we do not claim that any individual case study is representative of their entire industry, but instead, our intent was to capture a wide diversity of viewpoints, domains, and applications of AI, to encompass a broad amalgamation of concerns. We should also state that this is not a shortcoming of the study but that it is the normal approach that social science often takes.

The diversity of organisations and their application focus areas also varied. Some organisations focused more so on the Big Data component of their AI, while others more strictly on the AI programming and analytics. Even when organisations concentrated on a specific type of BD + AI, such as Big Data, its use varied immensely, including retrieval (CS1), analysis (CS2), predictive analytics (CS10), and transactional value (Organisation 2 in CS4). Some domains adopted BD + AI earlier and more emphatically than others (such as communications, healthcare, and insurance). Also, the size, investment, and type of organisation played a part in the level of BD + AI innovation (for example, the two large multinationals in CS3 and CS8 had well-developed BD + AI).

The maturity level of BD + AI was also determined by how it was integrated, and its importance, within an organisation. For instance, in organisations where BD + AI were fundamental for the success of the business (e.g. CS1 and CS10), they played a much more important role than in companies where there was less of a reliance (e.g. CS7). In some organisations, even when BD + AI was not central to success, the level of development was still quite advanced because of economic investment capabilities (e.g. CS3 and CS8).

These differences provided important questions to ask throughout this multi-case study analysis, such as: Do certain organisations respond to ethical issues relating to BD + AI in a certain way? Does the type of interviewee affect the ethical issues discussed—e.g. case studies without technical experts, those that only had technical experts, and those that had both? Does the type of BD + AI used impact the types of ethical issues discussed? What significance does the type of data retrieved have on ethical issues identified by the organisations? These inductive ethical questions provided a template for the qualitative analysis in the following section.

Ethical Issues in the Case Studies

Based on the interview data, the ethical issues identified in the case studies were grouped into six specific thematic sections to provide a more conducive, concise, and pragmatic methodology. Those six sections are: control of data, reliability of data, justice, economic issues, role of organisations, and individual freedoms. From the 26 ethical issues, privacy was the only ethical issue addressed in all 10 case studies, which was not surprising because it has received a great deal of attention recently because of the GDPR. Also, security, transparency, and algorithmic bias are regularly discussed in the literature, so we expected them to be significant issues across many of the cases. However, there were many issues that received less attention in the literature—such as access to BD + AI, trust, and power asymmetries—which were discussed frequently in the interviews. In contrast to this, there were ethical issues that were heavily discussed in the literature which received far less attention in the interviews, such as employment, autonomy, and criminal or malicious use of BD + AI (Fig.  2 ).

The ethical analysis was conducted using a combination of literature reviews and interviews carried out with stakeholders. The purpose of the interviews was to ensure that there were no obvious ethical issues faced by stakeholders in their day-to-day activities which had been missed in the academic literature. As such, the starting point was not an overarching normative theory, which might have meant that we looked for issues which fit well with the theory but ignored anything that fell outside of that theory. Instead the combined approach led to the identification of the 26 ethical issues, each labelled based on particular words or phrases used in the literature or by the interviewees. For example, the term "privacy" was used frequently and so became the label for references to and instances of privacy-relevant concerns. In this section we have clustered issues together based on similar problems faced (e.g. accuracy of data and accuracy of algorithms within the category of ‘reliability of data’).

In an attempt to highlight similar ethical issues and improve the overall analysis to better capture similar perspectives, the research team decided to use the method of clustering, a technique often used in data mining to efficiently group similar elements together. Through discussion in the research team, and bearing in mind that the purpose of the clustering process was to form clusters that would enhance understanding of the impact of these ethical issues, we arrived at the following six clusters: the control of data (covering privacy, security, and informed consent); the reliability of data (accuracy of data and accuracy of algorithms); justice (power asymmetries, justice, discrimination, and bias); economic issues (economic concerns, sustainability, and employment); the role of organisations (trust and responsibility); and human freedoms (autonomy, freedom, and human rights). Both the titles and the precise composition of each cluster of issues are the outcome of a reasoned agreement of the research team. However, it should be clear that we could have used different titles and different clustering. The point is not that each cluster forms a distinct group of ethical issues, independent from any other. Rather the ethical issues faced overlap and play into one another, but to present them in a manageable format we have opted to use this bottom-up clustering approach.

Human Freedoms

An interviewee from CS10 stated that they were concerned about human rights because they were an integral part of the company’s ethics framework. This was beneficial to their business because they were required to incorporate human rights to receive public funding by the Austrian government. The company ensured that they would not grant ‘full exclusivity on generated social unrest event data to any single party, unless the data is used to minimise the risk of suppression of unrest events, or to protect the violation of human rights’ (XXX). The company demonstrates that while BD + AI has been criticised for infringing upon human rights in the literature, they also offer the opportunity to identify and prevent human rights abuses. The company’s moral framework definitively stemmed from regulatory and funding requirements, which lends itself to the benefit of effective ethical top-down approaches, which is a divisive topic in the literature, with diverging views about whether top-down or bottom-up approaches are better options for improved AI ethics.

Trust & Responsibility

Responsibility was a concern in 5 of the case studies, confirming the importance it is given in the literature (see Sect.  3 ). Trust appeared in seven of the case studies. The cases focused on concerns found in the literature, such as BD + AI use in policy development, public distrust about automated decision-making and the integrity of corporations utilising datafication methods (van Dijck 2014 ).

Trust and control over BD + AI were an issue throughout the case studies. The organisation from the predictive intelligence case study (CS10) identified that their use of social media data raised trust issues. They converged with perspectives found in the literature that when people feel disempowered to use or be part of the BD + AI development process, they tend to lose trust in the BD + AI (Accenture, 2016 , 2017 ). In CS6, stakeholders (health insurers) trusted the decisions made by BD + AI when they were engaged and empowered to give feedback on how their data was used. Trust is enhanced when users can refuse the use of their data (CS7), which correlates with the literature. Companies discussed the benefits of establishing trustworthy relationships. For example, in CS9, they have “ been trying really hard to avoid the existence of fake [mobile phone] base stations, because [these raise] an issue with the trust that people put in their networks” (XXX).

Corporations need to determine the objective of the data analysis (CS3), what data is required for the BD + AI to work (CS2), and accountability for when it does not work as intended or causes undesirable outcomes (CS4). The issue here is whether the organisation takes direct responsibility for these outcomes, or, if informed consent has been given, can responsibility be shared with the granter of consent (CS3). The cases also raised the question of ‘responsible to whom’, the person whose data is being used or the proxy organisation who has provided data (CS6). For example, in the insurance case study, the company stated that they only had a responsibility towards the proxy organisation and not the sources of the data. All these issues are covered extensively in the literature in most application domains.

Control of Data

Concerns surrounding the control of data for privacy reasons can be put down to a general awareness of privacy issues in the press, reinforced by the recently-introduced GDPR. This was supported in the cases, where interviewees expressed the opinion that the GDPR had raised general awareness of privacy issues (CS1, CS9) or that it had lent weight to arguments concerning the importance of privacy (CS8).

The discussion of privacy ranged from stressing that it was not an issue for some interviewees, because there was no personal information in the data they used (CS4), to its being an issue for others, but one which was being dealt with (CS2 and CS8). One interviewee (CS5) expressed apprehension that privacy concerns conflicted with scientific innovation, introducing hitherto unforeseen costs. This view is not uncommon in scientific and medical innovation, where harms arising from the use of anonymised medical data are often seen as minimal and the potential benefits significant (Manson & O’Neill, 2007 ). In other cases (CS1), there was a confusion between anonymisation (data which cannot be traced back to the originating source) and pseudonymisation (where data can be traced back, albeit with difficulty) of users’ data. A common response from the cases was that providing informed consent for the use of personal data waived some of the rights to privacy of the user.

Consent may come in the form of a company contract Footnote 14 or an individual agreement. Footnote 15 In the former, the company often has the advantage of legal support prior to entering a contract and so should be fully aware of the information provided. In individual agreements, though, the individual is less likely to be legally supported, and so may be at risk of exploitation through not reading the information sufficiently (CS3), or of responding without adequate understanding (CS9). In one case (CS5), referring to anonymised data, consent was implied rather than given: the interviewee suggested that those involved in the project may have contributed data without giving clear informed consent. The interviewee also noted that some data may have been shared without the permission, or indeed knowledge, of those contributing individuals. This was acknowledged by the interviewee as a potential issue.

In one case (CS6), data was used without informed consent for fraud detection purposes. The interviewees noted that their organisation was working within the parameters of national and EU legislation, which allows for non-consensual use of data for these ends. One interviewee in this case stated that informed consent was sought for every novel use of the data they held. However, this was sought from the perceived owner of the data (an insurance company) rather than from the originating individuals. This case demonstrates how people may expect their data to be used without having a full understanding of the legal framework under which the data are collected. For example, data relating to individuals may legally be accessed for fraud detection without notifying the individual and without relying on the individual’s consent.

This use of personal data for fraud detection in CS6 also led to concerns regarding opacity. In both CS6 and CS10 there was transparency within the organisations (a shared understanding among staff as to the various uses of the data) but that did not extend to the public outside those organisations. In some cases (CS5) the internal transparency/external opacity meant that those responsible for developing BD + AI were often hard to meet. Of those who were interviewed in CS5, many did not know the providence of the data or the algorithms they were using. Equally, some organisations saw external opacity as integral to the business environment in which they were operating (CS9, CS10) for reasons of commercial advantage. The interviewee in CS9 cautioned that this approach, coupled with a lack of public education and the speed of transformation within the industry, would challenge any meaningful level of public accountability. This would render processes effectively opaque to the public, despite their being transparent to experts.

Reliability of Data

There can be multiple sources of unreliability in BD + AI. Unreliability originating from faults in the technology can lead to algorithmic bias, which can cause ethical issues such as unfairness, discrimination, and general negative social impact (CS3 and CS6). Considering algorithmic bias as a key input to data reliability, there exist two types of issues that may need to be addressed. Primarily, bias may stem from the input data, referred to as training data, if such data excludes adequate representation of the world, e.g. gender-biased datasets (CS6). Secondly, an inadequate representation of the world may be the result of lack of data, e.g. a correctly designed algorithm to learn from and predict a rare disease, may not have sufficient representative data to achieve correct predictions (CS5). In either case the input data are biased and may result in inaccurate decision-making and recommendations.

The issues of reliability of data stemming from data accuracy and/or algorithmic bias, may escalate depending on their use, as for example in predictive or risk-assessment algorithms (CS10). Consider the risks of unreliable data in employee monitoring situations (CS1), detecting pests and diseases in agriculture (CS3), in human brain research (CS5) or cybersecurity applications (CS8). Such issues are not singular in nature but closely linked to other ethical issues such as information asymmetries, trust, and discrimination. Consequently, the umbrella issue of reliability of data must be approached from different perspectives to ensure the validity of the decision-making processes of the BD + AI.

Data may over-represent some people or social groups who are likely to be already privileged or under-represent disadvantaged and vulnerable groups (CS3). Furthermore, people who are better positioned to gain access to data and have the expertise to interpret them may have an unfair advantage over people devoid of such competencies. In addition, BD + AI can work as a tool of disciplinary power, used to evaluate people’s conformity to norms representing the standards of disciplinary systems (CS5). We focus on the following aspects of justice in our case study analysis: power asymmetries, discrimination, inequality, and access.

The fact that issues of power can arise in public as well as private organisations was discussed in our case studies. The smart city case (CS4) showed that the public organisations were aware of potential problems arising from companies using public data and were trying to put legal safeguards in place to avoid such misuse. As a result of misuse, there is the potential that cities, or the companies with which they contract, may use data in harmful or discriminatory ways. Our case study on the use of BD + AI in scientific research showed that the interviewees were acutely aware of the potential of discrimination (CS10). They stated that biases in the data may not be easy to identify, and may lead to misclassification or misinterpretation of findings, which may in turn skew results. Discrimination refers to the recognition of difference, but it may also refer to unjust treatment of different categories of people based on their gender, sex, religion, race, class, or disability. BD + AI are often employed to distinguish between different cases, e.g. between normal and abnormal behaviour in cybersecurity. Determining whether such classification entails discrimination in the latter sense can be difficult, due to the nature of the data and algorithms involved.

Examples of potential inequality based on BD + AI could be seen in several case studies. The agricultural case (CS3) highlighted the power differential between farmers and companies with potential implications for inequality, but also the global inequality between farmers, linked to farming practices in different countries (CS3). Subsistence farmers in developing countries, for example, might find it more difficult to benefit from these technologies than large agro-businesses. The diverging levels of access to BD + AI entail different levels of ability to benefit from them and counteract possible disadvantages (CS3). Some companies restrict access to their data entirely, and others sell access at a fee, while others offer small datasets to university-based researchers (Boyd & Crawford, 2012 , p. 674).

Economic Issues

One economic impact of BD + AI outlined in the agriculture case study (CS3) focused on whether this technology, and their ethical implementation, were economically affordable. If BD + AI could not improve economic efficiency, they would be rejected by the end-user, whether they were more productive, sustainable, and ethical options. This is striking, as it raises a serious challenge for the AI ethics literature and industry. It establishes that no matter how well intentioned and principled AI ethics guidelines and charters are, unless their implementation can be done in an economically viable way, their implementation will be challenged and resisted by those footing the bill.

The telecommunications case study (CS9) focused on how GDPR legislation may economically impact businesses using BD + AI by creating disparities in competitiveness between EU and non-EU companies developing BD + AI. Owing to the larger data pools of the latter, their BD + AI may prove to be more effective than European-manufactured alternatives, which cannot bypass the ethical boundaries of European law in the same way (CS8). This is something that is also being addressed in the literature and is a very serious concern for the future profitability and development of AI in Europe (Wallace & Castro, 2018 ). The literature notes additional issues in this area that were not covered in the cases. There is the potential that the GDPR will increase costs of European AI companies by having to manually review algorithmic decision-making; the right to explanation could reduce AI accuracy; and the right to erasure could damage AI systems (Wallace & Castro, 2018 , p. 2).

One interviewee stated that public–private BD + AI projects should be conducted in a collaborative manner, rather than a sale-of-service (CS4). However, this harmonious partnership is often not possible. Another interviewee discussed the tension between public and private interests on their project—while the municipality tried to focus on citizen value, the ICT company focused on the project’s economic success. The interviewee stated that the project would have terminated earlier if it were the company’s decision, because it was unprofitable (CS4). This is a huge concern in the literature, whereby private interests will cloud, influence, and damage public decision-making within the city because of their sometimes-incompatible goals (citizen value vs. economic growth) (Sadowski & Pasquale, 2015 ). One interviewee said that the municipality officials were aware of the problems of corporate influence and thus are attempting to implement the approach of ‘data sovereignty’ (CS2).

During our interviews, some viewed BD + AI as complementary to human employment (CS3), collaborative with such employment (CS4), or as a replacement to employment (CS6). The interviewees from the agriculture case study (CS3) stated that their BD + AI were not sufficiently advanced to replace humans and were meant to complement the agronomist, rather than replace them. However, they did not indicate what would happen when the technology is advanced enough, and it becomes profitable to replace the agronomist. The insurance company interviewee (CS6) stated that they use BD + AI to reduce flaws in personal judgment. The literature also supports this viewpoint, where BD + AI is seen to offer the potential to evaluate cases impartially, which is beneficial to the insurance industry (Belliveau, Gray, & Wilson, 2019 ). Footnote 16 The interviewee reiterated this and also stated that BD + AI would reduce the number of people required to work on fraud cases. The interviewee stated that BD + AI are designed to replace these individuals, but did not indicate whether their jobs were secure or whether they would be retrained for different positions, highlighting a concern found in the literature about the replacement and unemployment of workers by AI (Bossman, 2016 ). In contrast to this, a municipality interviewee from CS4 stated that their chat-bots are used in a collaborative way to assist customer service agents, allowing them to concentrate on higher-level tasks, and that there are clear policies set in place to protect their jobs.

Sustainability was only explicitly discussed in two interviews (CS3 and CS4). The agriculture interviewees stated that they wanted to be the ‘first’ to incorporate sustainability metrics into agricultural BD + AI, indicating a competitive and innovative rationale for their company (CS3). Whereas the interviewee from the sustainable development case study (CS4) stated that their goal of using BD + AI was to reduce Co2 emissions and improve energy and air quality. He stated that there are often tensions between ecological and economic goals and that this tension tends to slow down the efforts of BD + AI public–private projects—an observation also supported by the literature (Keeso, 2014 ). This tension between public and private interests in BD + AI projects was a recurring issue throughout the cases, which will be the focus of the next section on the role of organisations.

Discussion and Conclusion

The motivation behind this paper is to come to a better understanding of ethical issues related to BD + AI based on a rich empirical basis across different application domains. The exploratory and interpretive approach chosen for this study means that we cannot generalise from our research to all possible examples of BD + AI, but it does allow us to generalise to theory and rich insights (Walsham, 1995a , b , 2006 ). These theoretical insights can then provide the basis for further empirical research, possibly using other methods to allow an even wider set of inputs to move beyond some of the limitations of the current study.

Organisational Practice and the Literature

The first point worth stating is that there is a high level of consistency both among the case studies and between cases and literature. Many of the ethical issues identified cut across the cases and are interpreted in similar ways by different stakeholders. The frequency distribution of ethical issues indicates that very few, if any, issues are relevant to all cases but many, such as privacy, have a high level of prevalence. Despite appearing in all case studies, privacy was not seen as overly problematic and could be dealt with in the context of current regulatory principles (GDPR). Most of the issues that we found in the literature (see Sect.  2 ) were also present in the case studies. In addition to privacy and data protection, this included accuracy, reliability, economic and power imbalances, justice, employment, discrimination and bias, autonomy and human rights and freedoms.

Beyond the general confirmation of the relevance of topics discussed in the literature, though, the case studies provide some further interesting insights. From the perspective of an individual case some societal factors are taken for granted and outside of the control of individual actors. For example, intellectual property regimes have significant and well-recognised consequences for justice, as demonstrated in the literature. However, there is often little that individuals or organisations can do about them. Even in cases where individuals may be able to make a difference and the problem is clear, it is not always obvious how to do this. Some well-publicised discrimination cases may be easy to recognise, for example where an HR system discriminates against women or where a facial recognition system discriminates against black people. But in many cases, it may be exceedingly difficult to recognise discrimination where it is not clear how a person is discriminated against. If, for example, an image-based medical diagnostic system leads to disadvantages for people with genetic profiles, this may not be easy to identify.

With regards to the classification of the literature suggested in Sect.  2 along the temporal dimension, we can see that the attention of the case study respondents seems to be correlated to the temporal horizon of the issues. The issues we see as short-term figures most prominently, whereas the medium-term issues, while still relevant and recognisable, appear to be less pronounced. The long-term questions are least visible in the cases. This is not very surprising, as the short-term issues are those that are at least potentially capable of being addressed relatively quickly and thus must be accessible on the local level. Organisations deploying or using AI therefore are likely to have a responsibility to address these issues and our case studies have shown that they are aware of this and putting measures in place. This is clearly true for data protection or security issues. The medium-term issues that are less likely to find local resolutions still figure prominently, even though an individual organisation has less influence on how they can be addressed. Examples of this would be questions of unemployment, justice, or fairness. There was little reference to what we call long-term issues, which can partly be explained by the fact that the type of AI user organisations we investigated have very limited influence on how they are perceived and how they may be addressed.

Interpretative Differences on Ethical Issues

Despite general agreement on the terminology used to describe ethical issues, there are often important differences in interpretation and understanding. In the first ethics theme, control of data, the perceptions of privacy ranged from ‘not an issue’ to an issue that was being dealt with. Some of this arose from the question of informed consent and the GDPR. However, a reliance on legislation, such as GDPR, without full knowledge of the intricacies of its details (i.e. that informed consent is only one of several legal bases of lawful data processing), may give rise to a false sense of security over people’s perceived privacy. This was also linked to the issue of transparency (of processes dealing with data), which may be external to the organisation (do people outside understand how an organisation holds and processes their data), or internal (how well does the organisation understand the algorithms developed internally) and sometimes involve deliberate opacity (used in specific contexts where it is perceived as necessary, such as in monitoring political unrest and its possible consequences). Therefore, a clearer and more nuanced understanding of privacy and other ethical terms raised here might well be useful, albeit tricky to derive in a public setting (for an example of complications in defining privacy, see Macnish, 2018 ).

Some issues from the literature were not mentioned in the cases, such as warfare. This can easily be explained by our choice of case studies, none of which drew on work done in this area. It indicates that even a set of 10 case studies falls short of covering all issues.

A further empirical insight is in the category we called ‘role of organisations’, which covers trust and responsibility. Trust is a key term in the discussion of the ethics of AI, prominently highlighted by the focus on trustworthy AI by the EU’s High-Level Expert Group, among others. We put this into the ‘role of organisations’ category because our interaction with the case study respondents suggested that they felt it was part of the role of their organisations to foster trust and establish responsibilities. But we are open to the suggestion that these are concepts on a slightly different level that may provide the link between specific issues in applications and broader societal debate.

Next Steps: Addressing the Ethics of AI and Big Data

This paper is predominantly descriptive, and it aims to provide a theoretically sound and empirically rich account of ethical concerns in AI + BD. While we hope that it proves to be insightful it is only a first step in the broader journey towards addressing and resolving these issues. The categorisation suggested here gives an initial indication of which type of actor may be called upon to address which type of issue. The distinction between micro-, meso- and macro perspectives suggested by Haenlein and Kaplan ( 2019 ) resonates to some degree with our categorisation of issues.

This points to the question what can be done to address these ethical issues and by whom should it be done? We have not touched on this question in the theoretical or empirical part of the paper, but the question of mitigation is the motivating force behind much of the AI + BD ethics research. The purpose of understanding these ethical questions is to find ways of addressing them.

This calls for a more detailed investigation of the ethical nature of the issues described here. As indicated earlier, we did not begin with a specific ethical theoretical framework imposed onto the case studies, but did have some derived ethics concepts which we explored within the context of the cases and allowed others to emerge over the course of the interviews. One issue is the philosophical question whether the different ethical issues discussed here are of a similar or comparable nature and what characterises them as ethical issues. This is not only a philosophical question but also a practical one for policymakers and decision makers. We have alluded to the idea that privacy and data protection are ethical issues, but they also have strong legal implications and can also be human rights issues. It would therefore be beneficial to undertake a further analysis to investigate which of these ethical issues are already regulated and to what degree current regulation covers BD + AI, and how this varies across the various EU nations and beyond.

Another step could be to expand an investigation like the one presented here to cover the ethics of AI + BD debate with a focus on suggested resolutions and policies. This could be achieved by adopting the categorisation and structure presented here and extending it to the currently discussed option for addressing the ethical issues. These include individual and collective activities ranging from technical measures to measure bias in data or individual professional guidance to standardisation, legislation, the creation of a specific regulator and many more. It will be important to understand how these measures are conceptualised as well as which ones are already used to which effect. Any such future work, however, will need to be based on a sound understanding of the issues themselves, which this paper contributes to. The key contribution of the paper, namely the presentation of empirical findings from 10 case studies show in more detail how ethical issues play out in practice. While this work can and should be expanded by including an even broader variety of cases and could be supplemented by other empirical research methods, it marks an important step in the development of our understanding of these ethical issues. This should form a part of the broader societal debate about what these new technologies can and should be used for and how we can ensure that their consequences are beneficial for individuals and society.

Throughout the paper, XXX will be used to anonymise relevant text that may identify the authors, either through the project and/or publications resulting from the individual case studies. All case studies have been published individually. Several the XXX references in the findings refer to these individual publications which provide more detail on the cases than can be provided in this cross-case analysis.

The ethical issues that we discussed throughout the case studies refers to issues broadly construed as ethical issues, or issues that have ethical significance. While some issues may not be directly obvious how they are ethical issues, they may give rise to significant harm relevant to ethics. For example, accuracy of data may not explicitly be an ethical issue, if inaccurate data is used in algorithms, it may lead to discrimination, unfair bias, or harms to individuals.

Such as chat-bots, natural language processing AI, IoT data retrieval, predictive risk analysis, cybersecurity machine-learning, and large dataset exchanges.

https://ec.europa.eu/futurium/en/ai-alliance-consultation/guidelines/1 .

https://ec.europa.eu/digital-single-market/en/high-level-expert-group-artificial-intelligence .

The type of AI currently in vogue, as outlined earlier, is based on machine learning, typically employing artificial neural networks for big data analysis. This is typically seen as ‘narrow AI’ and it is not clear whether there is a way from narrow to general AI, even if one were to accept that achieving general AI is fundamentally possible.

The 16 social domains were: Banking and securities; Healthcare; Insurance; Retail and wholesale trade; Science; Education; Energy and utilities; Manufacturing and natural resources; Agriculture; Communications, media and entertainment; Transportation; Employee monitoring and administration; Government; Law enforcement and justice; Sustainable development; and Defence and national security.

This increased to 26 ethical issues following a group brainstorming session at the case study workshop.

The nine additional ethical issues from the initial 17 drafted by the project leader were: human rights, transparency, responsibility, ownership of data, algorithmic bias, integrity, human rights, human contact, and accuracy of data.

The additional ethical issues were access to BD + AI, accuracy of data, accuracy of recommendations, algorithmic bias, economic, human contact, human rights, integrity, ownership of data, responsibility, and transparency. Two of the initial ethical concerns were removed (inclusion of stakeholders and environmental impact). The issues raised concerning inclusion of stakeholders were deemed to be sufficiently included in access to BD + AI, and those relating to environmental impact were felt to be sufficiently covered by sustainability.

The three appendices attached in this paper comprise much of this case study protocol.

CS4 evaluated four organisations, but one of these organisations was also part of CS2 – Organisation 1. CS6 analysed two insurance organisations.

Starting out, we aimed to have both policy/ethics-focused experts within the organisation and individuals that could also speak with us about the technical aspects of the organisation’s BD + AI. However, this was often not possible, due to availability, organisations’ inability to free up resources (e.g. employee’s time) for interviews, or lack of designated experts in those areas.

For example, in CS1, CS6, and CS8.

For example, in CS2, CS3, CS4, CS5, CS6, and CS9.

As is discussed elsewhere in this paper, algorithms also hold the possibility of reinforcing our prejudices and biases or creating new ones entirely.

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Acknowledgements

This SHERPA Project has received funding from the European Union’s Horizon 2020 Framework Programme for Research and Innovation under the Specific Grant Agreement No. 786641. The author(s) acknowledge the contribution of the consortium to the development and design of the case study approach.

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Appendix 1: Desk Research Questions

Number Research Question.

In which sector is the organisation located (e.g. industry, government, NGO, etc.)?

What is the name of the organisation?

What is the geographic scope of the organisation?

What is the name of the interviewee?

What is the interviewee’s role within the organisation?

Appendix 2: Interview Research Questions

No Research Question.

What involvement has the interviewee had with BD + AI within the organisation?

What type of BD + AI is the organisation using? (e.g. IBM Watson, Google Deepmind)

What is the field of application of the BD + AI (e.g. administration, healthcare, retail)

Does the BD + AI work as intended or are there problems with its operation?

What are the innovative elements introduced by the BD + AI (e.g. what has the technology enabled within the organisation?)

What is the level of maturity of the BD + AI ? (i.e. has the technology been used for long at the organisation? Is it a recent development or an established approach?)

How does the BD + AI interact with other technologies within the organisation?

What are the parameters/inputs used to inform the BD + AI ? (e.g. which sorts of data are input, how is the data understood within the algorithm?). Does the BD + AI collect and/or use data which identifies or can be used to identify a living person (personal data)?. Does the BD + AI collect personal data without the consent of the person to whom those data relate?

What are the principles informing the algorithm used in the BD + AI (e.g. does the algorithm assume that people walk in similar ways, does it assume that loitering involves not moving outside a particular radius in a particular time frame?). Does the BD + AI classify people into groups? If so, how are these groups determined? Does the BD + AI identify abnormal behaviour? If so, what is abnormal behaviour to the BD + AI ?

Are there policies in place governing the use of the BD + AI ?

How transparent is the technology to administrators within the organisation, to users within the organisation?

Who are the stakeholders in the organisation?

What has been the impact of the BD + AI on stakeholders?

How transparent is the technology to people outside the organisation?

Are those stakeholders engaged with the BD + AI ? (e.g. are those affected aware of the BD + AI, do they have any say in its operation?). If so, what is the nature of this engagement? (focus groups, feedback, etc.)

In what way are stakeholders impacted by the BD + AI ? (e.g. what is the societal impact: are there issues of inequality, fairness, safety, filter bubbles, etc.?)

What are the costs of using the BD + AI to stakeholders? (e.g. potential loss of privacy, loss of potential to sell information, potential loss of reputation)

What is the expected longevity of this impact? (e.g. is this expected to be temporary or long-term?)

Are those stakeholders engaged with the BD + AI ? (e.g. are those affected aware of the BD + AI, do they have any say in its operation?)

If so, what is the nature of this engagement? (focus groups, feedback, etc.)

Appendix 3: Checklist of Ethical Issues

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Ryan, M., Antoniou, J., Brooks, L. et al. Research and Practice of AI Ethics: A Case Study Approach Juxtaposing Academic Discourse with Organisational Reality. Sci Eng Ethics 27 , 16 (2021). https://doi.org/10.1007/s11948-021-00293-x

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• Crime Prevention & Criminal Justice Reform
• Crime Prevention, Criminal Justice & SDGs
• UN Congress on Crime Prevention & Criminal Justice
• Commission on Crime Prevention & Criminal Justice
• Conference of the Parties to UNTOC
• Conference of the States Parties to UNCAC
• Rules for Simulating Crime Prevention & Criminal Justice Bodies
• Crime Prevention & Criminal Justice
• Engage with Us
• Contact Us about MUN
• Conferences Supporting E4J
• Cyberstrike
• Play for Integrity
• Running out of Time
• Zorbs Reloaded
• Developing a Rationale for Using the Video
• Previewing the Anti-Corruption Video
• Viewing the Video with a Purpose
• Post-viewing Activities
• Previewing the Firearms Video
• Rationale for Using the Video
• Previewing the Human Trafficking Video
• Previewing the Organized Crime Video
• Previewing the Video
• Criminal Justice & Crime Prevention
• Corruption & Integrity
• Human Trafficking & Migrant Smuggling
• Firearms Trafficking
• Terrorism & Violent Extremism
• Introduction & Learning Outcomes
• Corruption - Baseline Definition
• Effects of Corruption
• Deeper Meanings of Corruption
• Measuring Corruption
• Possible Class Structure
• Core Reading
• Advanced Reading
• Student Assessment
• Additional Teaching Tools
• Guidelines for Stand-Alone Course
• Appendix: How Corruption Affects the SDGs
• What is Governance?
• What is Good Governance?
• Corruption and Bad Governance
• Governance Reforms and Anti-Corruption
• Guidelines for Stand-alone Course
• Corruption and Democracy
• Corruption and Authoritarian Systems
• Hybrid Systems and Syndromes of Corruption
• The Deep Democratization Approach
• Political Parties and Political Finance
• Political Institution-building as a Means to Counter Corruption
• Manifestations and Consequences of Public Sector Corruption
• Causes of Public Sector Corruption
• Theories that Explain Corruption
• Corruption in Public Procurement
• Corruption in State-Owned Enterprises
• Responses to Public Sector Corruption
• Preventing Public Sector Corruption
• Forms & Manifestations of Private Sector Corruption
• Consequences of Private Sector Corruption
• Causes of Private Sector Corruption
• Responses to Private Sector Corruption
• Preventing Private Sector Corruption
• Collective Action & Public-Private Partnerships against Corruption
• Transparency as a Precondition
• Detection Mechanisms - Auditing and Reporting
• Whistle-blowing Systems and Protections
• Investigation of Corruption
• Introduction and Learning Outcomes
• Brief background on the human rights system
• Overview of the corruption-human rights nexus
• Impact of corruption on specific human rights
• Approaches to assessing the corruption-human rights nexus
• Human-rights based approach
• Defining sex, gender and gender mainstreaming
• Gender differences in corruption
• Theories explaining the gender–corruption nexus
• Gendered impacts of corruption
• Anti-corruption and gender mainstreaming
• Manifestations of corruption in education
• Costs of corruption in education
• Causes of corruption in education
• Fighting corruption in education
• Core terms and concepts
• The role of citizens in fighting corruption
• The role, risks and challenges of CSOs fighting corruption
• The role of the media in fighting corruption
• Access to information: a condition for citizen participation
• ICT as a tool for citizen participation in anti-corruption efforts
• Government obligations to ensure citizen participation in anti-corruption efforts
• Teaching Guide
• Brief History of Terrorism
• 19th Century Terrorism
• League of Nations & Terrorism
• United Nations & Terrorism
• Terrorist Victimization
• Exercises & Case Studies
• Radicalization & Violent Extremism
• Preventing & Countering Violent Extremism
• Drivers of Violent Extremism
• International Approaches to PVE &CVE
• Regional & Multilateral Approaches
• Defining Rule of Law
• UN Global Counter-Terrorism Strategy
• International Cooperation & UN CT Strategy
• Legal Sources & UN CT Strategy
• Regional & National Approaches
• International Legal Frameworks
• International Human Rights Law
• International Humanitarian Law
• International Refugee Law
• Current Challenges to International Legal Framework
• Defining Terrorism
• Criminal Justice Responses
• Treaty-based Crimes of Terrorism
• Core International Crimes
• International Courts and Tribunals
• African Region
• Inter-American Region
• Asian Region
• European Region
• Middle East & Gulf Regions
• Core Principles of IHL
• Categorization of Armed Conflict
• Classification of Persons
• IHL, Terrorism & Counter-Terrorism
• Relationship between IHL & intern. human rights law
• Limitations Permitted by Human Rights Law
• Derogation during Public Emergency
• Examples of States of Emergency & Derogations
• International Human Rights Instruments
• Regional Human Rights Instruments
• Extra-territorial Application of Right to Life
• Arbitrary Deprivation of Life
• Death Penalty
• Enforced Disappearances
• Armed Conflict Context
• International Covenant on Civil and Political Rights
• Convention against Torture et al.
• International Legal Framework
• Key Contemporary Issues
• Investigative Phase
• Trial & Sentencing Phase
• Armed Conflict
• Case Studies
• Special Investigative Techniques
• Surveillance & Interception of Communications
• Privacy & Intelligence Gathering in Armed Conflict
• Accountability & Oversight of Intelligence Gathering
• Principle of Non-Discrimination
• Freedom of Religion
• Freedom of Expression
• Freedom of Assembly
• Freedom of Association
• Fundamental Freedoms
• Definition of 'Victim'
• Effects of Terrorism
• Access to Justice
• Recognition of the Victim
• Human Rights Instruments
• Criminal Justice Mechanisms
• Instruments for Victims of Terrorism
• National Approaches
• Key Challenges in Securing Reparation
• Topic 1. Contemporary issues relating to conditions conducive both to the spread of terrorism and the rule of law
• Topic 2. Contemporary issues relating to the right to life
• Topic 3. Contemporary issues relating to foreign terrorist fighters
• Topic 4. Contemporary issues relating to non-discrimination and fundamental freedoms
• Module 16: Linkages between Organized Crime and Terrorism
• Thematic Areas
• Content Breakdown
• Module Adaptation & Design Guidelines
• Teaching Methods
• Acknowledgements
• 1. Introducing United Nations Standards & Norms on CPCJ vis-à-vis International Law
• 2. Scope of United Nations Standards & Norms on CPCJ
• 3. United Nations Standards & Norms on CPCJ in Operation
• 1. Definition of Crime Prevention
• 2. Key Crime Prevention Typologies
• 2. (cont.) Tonry & Farrington’s Typology
• 3. Crime Problem-Solving Approaches
• 4. What Works
• United Nations Entities
• Regional Crime Prevention Councils/Institutions
• Key Clearinghouses
• Systematic Reviews
• 1. Introduction to International Standards & Norms
• 2. Identifying the Need for Legal Aid
• 3. Key Components of the Right of Access to Legal Aid
• 4. Access to Legal Aid for Those with Specific Needs
• 5. Models for Governing, Administering and Funding Legal Aid
• 6. Models for Delivering Legal Aid Services
• 7. Roles and Responsibilities of Legal Aid Providers
• 8. Quality Assurance and Legal Aid Services
• 1. Context for Use of Force by Law Enforcement Officials
• 2. Legal Framework
• 3. General Principles of Use of Force in Law Enforcement
• 4. Use of Firearms
• 5. Use of “Less-Lethal” Weapons
• 6. Protection of Especially Vulnerable Groups
• 7. Use of Force during Assemblies
• 1. Policing in democracies & need for accountability, integrity, oversight
• 2. Key mechanisms & actors in police accountability, oversight
• 3. Crosscutting & contemporary issues in police accountability
• 1. Introducing Aims of Punishment, Imprisonment & Prison Reform
• 2. Current Trends, Challenges & Human Rights
• 3. Towards Humane Prisons & Alternative Sanctions
• 1. Aims and Significance of Alternatives to Imprisonment
• 2. Justifying Punishment in the Community
• 3. Pretrial Alternatives
• 4. Post Trial Alternatives
• 5. Evaluating Alternatives
• 1. Concept, Values and Origin of Restorative Justice
• 2. Overview of Restorative Justice Processes
• 3. How Cost Effective is Restorative Justice?
• 4. Issues in Implementing Restorative Justice
• 1. Gender-Based Discrimination & Women in Conflict with the Law
• 2. Vulnerabilities of Girls in Conflict with the Law
• 3. Discrimination and Violence against LGBTI Individuals
• 4. Gender Diversity in Criminal Justice Workforce
• 1. Ending Violence against Women
• 2. Human Rights Approaches to Violence against Women
• 3. Who Has Rights in this Situation?
• 4. What about the Men?
• 5. Local, Regional & Global Solutions to Violence against Women & Girls
• 1. Understanding the Concept of Victims of Crime
• 2. Impact of Crime, including Trauma
• 3. Right of Victims to Adequate Response to their Needs
• 4. Collecting Victim Data
• 5. Victims and their Participation in Criminal Justice Process
• 6. Victim Services: Institutional and Non-Governmental Organizations
• 7. Outlook on Current Developments Regarding Victims
• 8. Victims of Crime and International Law
• 1. The Many Forms of Violence against Children
• 2. The Impact of Violence on Children
• 3. States' Obligations to Prevent VAC and Protect Child Victims
• 4. Improving the Prevention of Violence against Children
• 5. Improving the Criminal Justice Response to VAC
• 6. Addressing Violence against Children within the Justice System
• 1. The Role of the Justice System
• 2. Convention on the Rights of the Child & International Legal Framework on Children's Rights
• 3. Justice for Children
• 4. Justice for Children in Conflict with the Law
• 5. Realizing Justice for Children
• 1a. Judicial Independence as Fundamental Value of Rule of Law & of Constitutionalism
• 1b. Main Factors Aimed at Securing Judicial Independence
• 2a. Public Prosecutors as ‘Gate Keepers’ of Criminal Justice
• 2b. Institutional and Functional Role of Prosecutors
• 2c. Other Factors Affecting the Role of Prosecutors
• Basics of Computing
• Global Connectivity and Technology Usage Trends
• Cybercrime in Brief
• Cybercrime Trends
• Cybercrime Prevention
• Offences against computer data and systems
• Computer-related offences
• Content-related offences
• The Role of Cybercrime Law
• Harmonization of Laws
• International and Regional Instruments
• International Human Rights and Cybercrime Law
• Digital Evidence
• Digital Forensics
• Standards and Best Practices for Digital Forensics
• Reporting Cybercrime
• Who Conducts Cybercrime Investigations?
• Obstacles to Cybercrime Investigations
• Knowledge Management
• Legal and Ethical Obligations
• Handling of Digital Evidence
• Digital Evidence Admissibility
• Sovereignty and Jurisdiction
• Formal International Cooperation Mechanisms
• Informal International Cooperation Mechanisms
• Data Retention, Preservation and Access
• Challenges Relating to Extraterritorial Evidence
• National Capacity and International Cooperation
• Internet Governance
• Cybersecurity Strategies: Basic Features
• National Cybersecurity Strategies
• International Cooperation on Cybersecurity Matters
• Cybersecurity Posture
• Assets, Vulnerabilities and Threats
• Vulnerability Disclosure
• Cybersecurity Measures and Usability
• Situational Crime Prevention
• Incident Detection, Response, Recovery & Preparedness
• Privacy: What it is and Why it is Important
• Privacy and Security
• Cybercrime that Compromises Privacy
• Data Protection Legislation
• Data Breach Notification Laws
• Enforcement of Privacy and Data Protection Laws
• Intellectual Property: What it is
• Types of Intellectual Property
• Causes for Cyber-Enabled Copyright & Trademark Offences
• Protection & Prevention Efforts
• Online Child Sexual Exploitation and Abuse
• Cyberstalking and Cyberharassment
• Cyberbullying
• Gender-Based Interpersonal Cybercrime
• Interpersonal Cybercrime Prevention
• Cyber Organized Crime: What is it?
• Conceptualizing Organized Crime & Defining Actors Involved
• Criminal Groups Engaging in Cyber Organized Crime
• Cyber Organized Crime Activities
• Preventing & Countering Cyber Organized Crime
• Cyberespionage
• Cyberterrorism
• Cyberwarfare
• Information Warfare, Disinformation & Electoral Fraud
• Responses to Cyberinterventions
• Framing the Issue of Firearms
• Direct Impact of Firearms
• Indirect Impacts of Firearms on States or Communities
• International and National Responses
• Typology and Classification of Firearms
• Common Firearms Types
• 'Other' Types of Firearms
• Parts and Components
• History of the Legitimate Arms Market
• Need for a Legitimate Market
• Key Actors in the Legitimate Market
• Authorized & Unauthorized Arms Transfers
• Illegal Firearms in Social, Cultural & Political Context
• Supply, Demand & Criminal Motivations
• Larger Scale Firearms Trafficking Activities
• Smaller Scale Trafficking Activities
• Sources of Illicit Firearms
• Consequences of Illicit Markets
• International Public Law & Transnational Law
• International Instruments with Global Outreach
• Commonalities, Differences & Complementarity between Global Instruments
• Tools to Support Implementation of Global Instruments
• Other United Nations Processes
• The Sustainable Development Goals
• Multilateral & Regional Instruments
• Scope of National Firearms Regulations
• National Firearms Strategies & Action Plans
• Harmonization of National Legislation with International Firearms Instruments
• Assistance for Development of National Firearms Legislation
• Firearms Trafficking as a Cross-Cutting Element
• Organized Crime and Organized Criminal Groups
• Criminal Gangs
• Terrorist Groups
• Interconnections between Organized Criminal Groups & Terrorist Groups
• Gangs - Organized Crime & Terrorism: An Evolving Continuum
• International Response
• International and National Legal Framework
• Firearms Related Offences
• Role of Law Enforcement
• Firearms as Evidence
• Use of Special Investigative Techniques
• International Cooperation and Information Exchange
• Prosecution and Adjudication of Firearms Trafficking
• Teaching Methods & Principles
• Ethical Learning Environments
• Overview of Modules
• Module Adaption & Design Guidelines
• Table of Exercises
• Basic Terms
• Forms of Gender Discrimination
• Ethics of Care
• Case Studies for Professional Ethics
• Case Studies for Role Morality
• Additional Exercises
• Defining Organized Crime
• Definition in Convention
• Similarities & Differences
• Activities, Organization, Composition
• Thinking Critically Through Fiction
• Excerpts of Legislation
• Research & Independent Study Questions
• Legal Definitions of Organized Crimes
• Criminal Association
• Definitions in the Organized Crime Convention
• Criminal Organizations and Enterprise Laws
• Enabling Offence: Obstruction of Justice
• Drug Trafficking
• Wildlife & Forest Crime
• Counterfeit Products Trafficking
• Falsified Medical Products
• Trafficking in Cultural Property
• Trafficking in Persons
• Case Studies & Exercises
• Extortion Racketeering
• Loansharking
• Links to Corruption
• Bribery versus Extortion
• Money-Laundering
• Liability of Legal Persons
• How much Organized Crime is there?
• Alternative Ways for Measuring
• Measuring Product Markets
• Risk Assessment
• Key Concepts of Risk Assessment
• Risk Assessment of Organized Crime Groups
• Risk Assessment of Product Markets
• Risk Assessment in Practice
• Positivism: Environmental Influences
• Classical: Pain-Pleasure Decisions
• Structural Factors
• Ethical Perspective
• Crime Causes & Facilitating Factors
• Models and Structure
• Hierarchical Model
• Local, Cultural Model
• Enterprise or Business Model
• Groups vs Activities
• Networked Structure
• Jurisdiction
• Investigators of Organized Crime
• Controlled Deliveries
• Physical & Electronic Surveillance
• Undercover Operations
• Financial Analysis
• Use of Informants
• Rights of Victims & Witnesses
• Role of Prosecutors
• Adversarial vs Inquisitorial Legal Systems
• Mitigating Punishment
• Granting Immunity from Prosecution
• Witness Protection
• Aggravating & Mitigating Factors
• Sentencing Options
• Alternatives to Imprisonment
• Death Penalty & Organized Crime
• Backgrounds of Convicted Offenders
• Confiscation
• Confiscation in Practice
• Mutual Legal Assistance (MLA)
• Extradition
• Transfer of Criminal Proceedings
• Transfer of Sentenced Persons
• Module 12: Prevention of Organized Crime
• Adoption of Organized Crime Convention
• Historical Context
• Features of the Convention
• Related international instruments
• Conference of the Parties
• Roles of Participants
• Structure and Flow
• Recommended Topics
• Background Materials
• What is Sex / Gender / Intersectionality?
• Knowledge about Gender in Organized Crime
• Gender and Organized Crime
• Gender and Different Types of Organized Crime
• Definitions and Terminology
• Organized crime and Terrorism - International Legal Framework
• International Terrorism-related Conventions
• UNSC Resolutions on Terrorism
• Organized Crime Convention and its Protocols
• Theoretical Frameworks on Linkages between Organized Crime and Terrorism
• Typologies of Criminal Behaviour Associated with Terrorism
• Terrorism and Drug Trafficking
• Terrorism and Trafficking in Weapons
• Terrorism, Crime and Trafficking in Cultural Property
• Trafficking in Persons and Terrorism
• Intellectual Property Crime and Terrorism
• Kidnapping for Ransom and Terrorism
• Exploitation of Natural Resources and Terrorism
• Review and Assessment Questions
• Research and Independent Study Questions
• Criminalization of Smuggling of Migrants
• UNTOC & the Protocol against Smuggling of Migrants
• Offences under the Protocol
• Financial & Other Material Benefits
• Aggravating Circumstances
• Criminal Liability
• Non-Criminalization of Smuggled Migrants
• Scope of the Protocol
• Humanitarian Exemption
• Migrant Smuggling v. Irregular Migration
• Migrant Smuggling vis-a-vis Other Crime Types
• Other Resources
• Assistance and Protection in the Protocol
• International Human Rights and Refugee Law
• Vulnerable groups
• Positive and Negative Obligations of the State
• Identification of Smuggled Migrants
• Participation in Legal Proceedings
• Role of Non-Governmental Organizations
• Smuggled Migrants & Other Categories of Migrants
• Short-, Mid- and Long-Term Measures
• Criminal Justice Reponse: Scope
• Investigative & Prosecutorial Approaches
• Different Relevant Actors & Their Roles
• Testimonial Evidence
• Financial Investigations
• Non-Governmental Organizations
• ‘Outside the Box’ Methodologies
• Intra- and Inter-Agency Coordination
• Admissibility of Evidence
• International Cooperation
• Exchange of Information
• Non-Criminal Law Relevant to Smuggling of Migrants
• Administrative Approach
• Complementary Activities & Role of Non-criminal Justice Actors
• Macro-Perspective in Addressing Smuggling of Migrants
• Human Security
• International Aid and Cooperation
• Migration & Migrant Smuggling
• Mixed Migration Flows
• Social Politics of Migrant Smuggling
• Vulnerability
• Profile of Smugglers
• Role of Organized Criminal Groups
• Humanitarianism, Security and Migrant Smuggling
• Crime of Trafficking in Persons
• The Issue of Consent
• The Purpose of Exploitation
• The abuse of a position of vulnerability
• Indicators of Trafficking in Persons
• Distinction between Trafficking in Persons and Other Crimes
• Misconceptions Regarding Trafficking in Persons
• Root Causes
• Supply Side Prevention Strategies
• Demand Side Prevention Strategies
• Role of the Media
• Safe Migration Channels
• Crime Prevention Strategies
• Monitoring, Evaluating & Reporting on Effectiveness of Prevention
• Trafficked Persons as Victims
• Protection under the Protocol against Trafficking in Persons
• Broader International Framework
• State Responsibility for Trafficking in Persons
• Identification of Victims
• Principle of Non-Criminalization of Victims
• Criminal Justice Duties Imposed on States
• Role of the Criminal Justice System
• Current Low Levels of Prosecutions and Convictions
• Challenges to an Effective Criminal Justice Response
• Rights of Victims to Justice and Protection
• Potential Strategies to “Turn the Tide”
• State Cooperation with Civil Society
• Civil Society Actors
• The Private Sector
• Comparing SOM and TIP
• Differences and Commonalities
• Vulnerability and Continuum between SOM & TIP
• Labour Exploitation
• Forced Marriage
• Other Examples
• Children on the Move
• Protecting Smuggled and Trafficked Children
• Protection in Practice
• Children Alleged as Having Committed Smuggling or Trafficking Offences
• Basic Terms - Gender and Gender Stereotypes
• International Legal Frameworks and Definitions of TIP and SOM
• Global Overview on TIP and SOM
• Gender and Migration
• Key Debates in the Scholarship on TIP and SOM
• Gender and TIP and SOM Offenders
• Responses to TIP and SOM
• Use of Technology to Facilitate TIP and SOM
• Technology Facilitating Trafficking in Persons
• Technology in Smuggling of Migrants
• Using Technology to Prevent and Combat TIP and SOM
• Privacy and Data Concerns
• Emerging Trends
• Demand and Consumption
• Supply and Demand
• Implications of Wildlife Trafficking
• Legal and Illegal Markets
• Perpetrators and their Networks
• Locations and Activities relating to Wildlife Trafficking
• Environmental Protection & Conservation
• CITES & the International Trade in Endangered Species
• Organized Crime & Corruption
• Animal Welfare
• Criminal Justice Actors and Agencies
• Criminalization of Wildlife Trafficking
• Challenges for Law Enforcement
• Investigation Measures and Detection Methods
• Prosecution and Judiciary
• Wild Flora as the Target of Illegal Trafficking
• Purposes for which Wild Flora is Illegally Targeted
• How is it Done and Who is Involved?
• Consequences of Harms to Wild Flora
• Terminology
• Background: Communities and conservation: A history of disenfranchisement
• Incentives for communities to get involved in illegal wildlife trafficking: the cost of conservation
• Incentives to participate in illegal wildlife, logging and fishing economies
• International and regional responses that fight wildlife trafficking while supporting IPLCs
• Mechanisms for incentivizing community conservation and reducing wildlife trafficking
• Critiques of community engagement
• Other challenges posed by wildlife trafficking that affect local populations
• Global Podcast Series
• Apr. 2021: Call for Expressions of Interest: Online training for academics from francophone Africa
• Feb. 2021: Series of Seminars for Universities of Central Asia
• Dec. 2020: UNODC and TISS Conference on Access to Justice to End Violence
• Nov. 2020: Expert Workshop for University Lecturers and Trainers from the Commonwealth of Independent States
• Oct. 2020: E4J Webinar Series: Youth Empowerment through Education for Justice
• Interview: How to use E4J's tool in teaching on TIP and SOM
• E4J-Open University Online Training-of-Trainers Course
• Teaching Integrity and Ethics Modules: Survey Results
• Grants Programmes
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University Module Series: Integrity & Ethics

Module 12: integrity, ethics and law.

  This module is a resource for lecturers  

Case studies.

Choose one or more of the following case studies and lead a discussion which allows students to address and debate issues of integrity, ethics and law. If time allows, let the students vote on which case studies they want to discuss.

For lecturers teaching large classes, case studies with multiple parts and different methods of solution lend themselves well to the group size and energy in such an environment. Lecturers can begin by having students vote on which case study they prefer. Lecturers could break down analysis of the chosen case study into steps which appear to students in sequential order, thereby ensuring that larger groups stay on track. Lecturers may instruct students to discuss questions in a small group without moving from their seat, and nominate one person to speak for the group if called upon. There is no need to provide excessive amounts of time for group discussion, as ideas can be developed further with the class as a whole. Lecturers can vary the group they call upon to encourage responsive participation.

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O'Mathúna D, Iphofen R, editors. Ethics, Integrity and Policymaking: The Value of the Case Study [Internet]. Cham (CH): Springer; 2022. doi: 10.1007/978-3-031-15746-2_1

Ethics, Integrity and Policymaking: The Value of the Case Study [Internet].

Chapter 1 making a case for the case: an introduction.

Dónal O’Mathúna and Ron Iphofen .

Affiliations

Published online: November 3, 2022.

This chapter agues for the importance of case studies in generating evidence to guide and/or support policymaking across a variety of fields. Case studies can offer the kind of depth and detail vital to the nuances of context, which may be important in securing effective policies that take account of influences not easily identified in more generalised studies. Case studies can be written in a variety of ways which are overviewed in this chapter, and can also be written with different purposes in mind. At the same time, case studies have limitations, particularly when evidence of causation is sought. Understanding these can help to ensure that case studies are appropriately used to assist in policymaking. This chapter also provides an overview of the types of case studies found in the rest of this volume, and briefly summarises the themes and topics addressed in each of the other chapters.

1.1. Judging the Ethics of Research

When asked to judge the ethical issues involved in research or any evidence-gathering activity, any research ethicist worth their salt will (or should) reply, at least initially: ‘It depends’. This is neither sophistry nor evasive legalism. Instead, it is a specific form of casuistry used in ethics in which general ethical principles are applied to the specifics of actual cases and inferences made through analogy. It is valued as a structured yet flexible approach to real-world ethical challenges. Case study methods recognise the complexities of depth and detail involved in assessing research activities. Another way of putting this is to say: ‘Don’t ask me to make a judgement about a piece of research until I have the details of the project and the context in which it will or did take place.’ Understanding and fully explicating a context is vital as far as ethical research (and evidence-gathering) is concerned, along with taking account of the complex interrelationship between context and method (Miller and Dingwall 1997 ).

This rationale lies behind this collection of case studies which is one outcome from the EU-funded PRO-RES Project. 1 One aim of this project was to establish the virtues, values, principles and standards most commonly held as supportive of ethical practice by researchers, scientists and evidence-generators and users. The project team conducted desk research, workshops and consulted throughout the project with a wide range of stakeholders (PRO-RES 2021a ). The resulting Scientific, Trustworthy, and Ethical evidence for Policy (STEP) ACCORD was devised, which all stakeholders could sign up to and endorse in the interests of ensuring any policies which are the outcome of research findings are based upon ethical evidence (PRO-RES 2021b ).

By ‘ethical evidence’ we mean results and findings that have been generated by research and other activities during which the standards of research ethics and integrity have been upheld (Iphofen and O’Mathúna 2022 ). The first statement of the STEP ACCORD is that policy should be evidence-based, meaning that it is underpinned by high-quality research, analysis and evidence (PRO-RES 2021b ). While our topic could be said to be research ethics, we have chosen to refer more broadly to evidence-generating activities. Much debate has occurred over the precise definition of research under the apparent assumption that ‘non-research projects’ fall outside the purview of requirements to obtain ethics approval from an ethics review body. This debate is more about the regulation of research than the ethics of research and has contributed to an unbalanced approach to the ethics of research (O’Mathúna 2018 ). Research and evidence-generating activities raise many ethical concerns, some similar and some distinct. When the focus is primarily on which projects need to obtain what sort of ethics approval from which type of committee, the ethical issues raised by those activities themselves can receive insufficient attention. This can leave everyone involved with these activities either struggling to figure out how to manage complex and challenging ethical dilemmas or pushing ahead with those activities confident that their approval letter means they have fulfilled all their ethical responsibilities. Unfortunately, this can lead to a view that research ethics is an impediment and burden that must be overcome so that the important work in the research itself can get going.

The alternative perspective advocated by PRO-RES, and the authors of the chapters in this volume, is that ethics underpins all phases of research, from when the idea for a project is conceived, all the way through its design and implementation, and on to how its findings are disseminated and put into practice in individual decisions or in policy. Given the range of activities involved in all these phases, multiple types of ethical issues can arise. Each occurs in its own context of time and place, and this must be taken into account. While ethical principles and theories have important contributions to make at each of these points, case studies are also very important. These allow for the normative effects of various assumptions and declarations to be judged in context. We therefore asked the authors of this volume’s chapters to identify various case studies which would demonstrate the ethical challenges entailed in various types of research and evidence-generating activities. These illustrative case studies explore various innovative topics and fields that raise challenges requiring ethical reflection and careful policymaking responses. The cases highlight diverse ethical issues and provide lessons for the various options available for policymaking (see Sect.  1.6 . below). Cases are drawn from many fields, including artificial intelligence, space science, energy, data protection, professional research practice and pandemic planning. The issues are examined in different locations, including Europe, India, Africa and in global contexts. Each case is examined in detail and also helps to anticipate lessons that could be learned and applied in other situations where ethical evidence is needed to inform evidence-based policymaking.

1.2. The Case for Cases

Case studies have increasingly been used, particularly in social science (Exworthy and Powell 2012 ). Many reasons underlie this trend, one being the movement towards evidence-based practice. Case studies provide a methodology by which a detailed study can be conducted of a social unit, whether that unit is a person, an organization, a policy or a larger group or system (Exworthy and Powell 2012 ). The case study is amenable to various methodologies, mostly qualitative, which allow investigations via documentary analyses, interviews, focus groups, observations, and more.

At the same time, consensus is lacking over the precise nature of a case study. Various definitions have been offered, but Yin ( 2017 ) provides a widely cited definition with two parts. One is that a case study is an in-depth inquiry into a real-life phenomenon where the context is highly pertinent. The second part of Yin’s definition addresses the many variables involved in the case, the multiple sources of evidence explored, and the inclusion of theoretical propositions to guide the analysis. While Yin’s emphasis is on the case study as a research method, he identifies important elements of broader relevance that point to the particular value of the case study for examining ethical issues.

Other definitions of case studies emphasize their story or narrative aspects (Gwee 2018 ). These stories frequently highlight a dilemma in contextually rich ways, with an emphasis on how decisions can be or need to be made. Case studies are particularly helpful with ethical issues to provide crucial context and explore (and evaluate) how ethical decisions have been made or need to be made. Classic cases include the Tuskegee public health syphilis study, the Henrietta Lacks human cell line case, the Milgram and Zimbardo psychology cases, the Tea Room Trade case, and the Belfast Project in oral history research (examined here in Chap. 10 ). Cases exemplify core ethical principles, and how they were applied or misapplied; in addition, they examine how policies have worked well or not (Chaps. 2 , 3 and 5 ). Cases can examine ethics in long-standing issues (like research misconduct (Chap. 7 ), energy production (Chap. 8 ), or Chap. 11 ’s consideration of researchers breaking the law), or with innovations in need of further ethical reflection because of their novelty (like extended space flight (Chap. 9 ) and AI (Chaps. 13 and 14 ), with the latter looking at automation in legal systems). These case studies help to situate the innovations within the context of widely regarded ethical principles and theories, and allow comparisons to be made with other technologies or practices where ethical positions have been developed. In doing so, these case studies offer pointers and suggestions for policymakers given that they are the ones who will develop applicable policies.

1.3. Research Design and Causal Inference

Not everyone is convinced of the value of the case study. It must be admitted that they have limitations, which we will reflect on shortly. Yet we believe that others go too far in their criticisms, revealing instead some prejudices against the value of the case (Yin 2017 ). In what has become a classic text for research design, Campbell and Stanley ( 1963 ) have few good words for what they call the ‘One Shot Case Study.’ They rank it below two other ‘pre-experimental’ designs—the One-Group Pretest–Posttest and the Static-Group Comparison—and conclude that case studies “have such a total absence of control to be of almost no scientific value” (Campbell and Stanley 1963 , 6). The other designs have, in turn, a baseline and outcome measure and some degree of comparative analysis which provides them some validity. Such a criticism is legitimate if one prioritises the experimental method as the most superior in terms of effectiveness evidence and, as for Campbell and Stanley, one is striving to assess the effectiveness of educational interventions.

What is missing from that assessment is that different methodologies are more appropriate for different kinds of questions. Questions of causation and whether a particular treatment, policy or educational strategy is more effective than another are best answered by experimental methods. While experimental designs are better suited to explore causal relationships, case studies are more suited to explore “how” and “why” questions (Yin 2017 ). It can be more productive to view different methodologies as complementing one another, rather than examining them in hierarchical terms.

The case study approach draws on a long tradition in ethnography and anthropology: “It stresses the importance of holistic perspectives and so has more of a ‘humanistic’ emphasis. It recognises that there are multiple influences on any single individual or group and that most other methods neglect the thorough understanding of this range of influences. They usually focus on a chosen variable or variables which are tested in terms of their influence. A case study tends to make no initial assumptions about which are the key variables—preferring to allow the case to ‘speak for itself’” (Iphofen et al. 2009 , 275). This tradition has sometimes discouraged people from conducting or using case studies on the assumption that they take massive amounts of time and lead to huge reports. This is the case with ethnography, but the case study method can be applied in more limited settings and can lead to high-quality, concise reports.

Another criticism of case studies is that they cannot be used to make generalizations. Certainly, there are limits to their generalisability, but the same is true of experimental studies. One randomized controlled trial cannot be generalised to the whole population without ensuring that its details are evaluated in the context of how it was conducted.

Similarly, it should not be assumed that generalisability can adequately guide practice or policy when it comes to the specifics of an individual case. A case study should not be used to support statistical generalizations (that the same percentage found in the case will be found in the general public). But a case study can be used to expand and generalize theories and thus have much usefulness. It affords a method of examining the specific (complex) interactions occurring in a case which can only be known from the details. Such an analysis can be carried out for individuals, policies or interventions.

The current COVID-19 pandemic demonstrates the dangers of generalising in the wrong context. Some people have very mild cases of COVID-19 or are asymptomatic. Others get seriously ill and even die. Sometimes people generalise from cases they know and assume they will have mild symptoms. Then they refuse to take the COVID-19 vaccine, basically generalising from similar cases. Mass vaccination is recommended for the sake of the health of the public (generalised health) and to limit the spread of a deadly virus. Cases are reported of people having adverse reactions to COVID-19 vaccines, and some people generalise from these that they will not take whatever risks might be involved in receiving the vaccine themselves. It might be theoretically possible to discover which individuals WILL react adversely to immunisation on a population level. But it is highly complex and expensive to do so, and takes an extensive period of time. Given the urgency of benefitting the health of ‘the public’, policymakers have decided that the risks to a sub-group are warranted. Only after the emergence of epidemiological data disclosing negative effects of some vaccines on some individuals will it become more clear which characteristics typify those cases which are likely to experience the adverse effects, and more accurately quantify the risks of experiencing those effects.

Much literature now points to the advantages and disadvantages of case studies (Gomm et al. 2000 ), and how to use them and conduct them with adequate rigour to ensure the validity of the evidence generated (Schell 1992 ; Yin 2011 , 2017 ). At the same time, legitimate critiques have been made of some case studies because they have been conducted without adequate rigor, in unsystematic ways, or in ways that allowed bias to have more influence than evidence (Hammersley 2001 ). Part of the problem here is similar to interviewing, where some will assume that since interviews are a form of conversation, anyone can do it. Case studies have some similarities to stories, but that doesn’t mean they are quick and easy ways to report on events. That view can lead to the situation where “most people feel that they can prepare a case study, and nearly all of us believe we can understand one. Since neither view is well founded, the case study receives a lot of approbation it does not deserve” (Hoaglin et al., cited in Yin 2017 , 16).

Case studies can be conducted and used in a wide range of ways (Gwee 2018 ). Case studies can be used as a research method, as a teaching tool, as a way of recording events so that learning can be applied to practice, and to facilitate practical problem-solving skills (Luck et al. 2006 ). Significant differences exist between a case study that was developed and used in research compared to one used for teaching (Yin 2017 ). A valid rationale for studying a ‘case’ should be provided so that it is clear that the proposed method is suitable to the topic and subject being studied. The unit of study for a case could be an individual person, social group, community, or society. Sometimes that specific case alone will constitute the actual research project. Thus, the study could be of one individual’s experience, with insights and understanding gained of the individual’s situation which could be of use to understand others’ experiences. Often there will be attempts made at a comparison between cases—one organisation being compared to another, with both being studied in some detail, and in terms of the same or similar criteria. Given this variety, it is important to use cases in ways appropriate to how they were generated.

The case study continues to be an important piece of evidence in clinical decision-making in medicine and healthcare. Here, case studies do not demonstrate causation or effectiveness, but are used as an important step in understanding the experiences of patients, particularly with a new or confusing set of symptoms. This was clearly seen as clinicians published case studies describing a new respiratory infection which the world now knows to be COVID-19. Only as case studies were generated, and the patterns brought together in larger collections of cases, did the characteristics of the illness come to inform those seeking to diagnose at the bedside (Borges do Nascimento et al. 2020 ). Indeed case studies are frequently favoured in nursing, healthcare and social work research where professional missions require a focus on the care of the individual and where cases facilitate making use of the range of research paradigms (Galatzer-Levy et al. 2000 ; Mattaini 1996 ; Gray 1998 ; Luck et al. 2006 ).

1.4. Devil’s in the Detail

Our main concern in this collection is not with case study aetiology but rather to draw on the advantages of the method to highlight key ethical issues related to the use of evidence in influencing policy. Thus, we make no claim to causal ‘generalisation’ on the basis of these reports—but instead we seek to help elucidate ethics issues, if even theoretical, and anticipate responses and obstacles in similar situations and contexts that might help decision-making in novel circumstances. A key strength of case studies is their capacity to connect abstract theoretical concepts to the complex realities of practice and the real world (Luck et al. 2006 ). Ethics cases clearly fit this description and allow the contextual details of issues and dilemmas to be included in discussions of how ethical principles apply as policy is being developed.

Since cases are highly focussed on the specifics of the situation, more time can be given over to data gathering which may be of both qualitative and quantitative natures. Given the many variables involved in the ‘real life’ setting, increased methodological flexibility is required (Yin 2017 ). This means seeking to maximise the data sources—such as archives (personal and public), records (such as personal diaries), observations (participant and covert) and interviews (face-to-face and online)—and revisiting all sources when necessary and as case participants and time allows.

1.5. Cases and Policymaking

Case studies allow researchers and practitioners to learn from the specifics of a situation and apply that learning in similar situations. Ethics case studies allow such reflection to facilitate the development of ethical decision-making skills. This volume has major interests in ethics and evidence-generation (research), but also in a third area: policymaking. Cases can influence policymaking, such as how one case can receive widespread attention and become the impetus to create policy that aims to prevent similar cases. For example, the US federal Brady Law was enacted in 1993 to require background checks on people before they purchase a gun (ATF 2021 ). The law was named for White House Press Secretary James Brady, and his case became widely known in the US. He was shot and paralyzed during John Hinckley, Jr.’s 1981 assassination attempt on President Ronald Reagan. Another example, this time in a research context, was how the Tuskegee Syphilis Study led, after its public exposure in 1971, to the US Department of Health, Education and Welfare appointing an expert panel to examine the ethics of that case. This resulted in federal policymakers enacting the National Research Act in 1974, which included setting up a national commission that published the Belmont Report in 1976. This report continues to strongly influence research ethics practice around the world. These examples highlight the power of a case study to influence policymaking.

One of the challenges for policymakers, though, is that compelling cases can often be provided for opposite sides of an issue. Also, while the Belmont Report has been praised for articulating a small number of key ethical principles, how those principles should be applied in specific instances of research remains an ongoing challenge and a point of much discussion. This is particularly relevant for innovative techniques and technologies. Hence the importance of cases interacting with general principles and leading to ongoing reflection and debate over the applicable cases. At the same time, new areas of research and evidence generation activities will lead to questions about how existing ethical principles and values apply. New case studies can help to facilitate that reflection, which can then allow policymakers to consider whether existing policy should be adapted or whether whole new areas of policy are needed.

Case studies also can play an important role in learning from and evaluating policy. Policymakers tend to focus on practical, day-to-day concerns and with the introduction of new programmes (Exworthy and Peckam 2012 ). Time and resources may be scant when it comes to evaluating how well existing policies are performing or reflecting on how policies can be adapted to overcome shortcomings (Hunter 2003 ). Effective policies may exist elsewhere (historically or geographically) and be more easily adapted to a new context instead of starting policymaking from scratch. Case studies can permit learning from past policies (or situations where policies did not exist), and they can illuminate various factors that should be explored in more detail in the context of the current issue or situation. Chaps. 2 , 3 and 5 in this volume are examples of this type of case study.

1.6. The Moral Gain

This volume reflects the ambiguity of ethical dilemmas in contemporary policymaking. Analyses will reflect current debates where consensus has not been achieved yet. These cases illustrate key points made throughout the PRO-RES project: that ethical decision-making is a fluid enterprise, where values, principles and standards must constantly be applied to new situations, new events and new research developments. The cases illustrate how no ‘one point’ exists in the research process where judgements about ethics can be regarded as ‘final.’ Case studies provide excellent ways for readers to develop important decision-making skills.

Research produces novel products and processes which can have broad implications for society, the environment and relationships. Research methods themselves are modified or applied in new ways and places, requiring further ethical reflection. New topics and whole fields of research develop and require careful evaluation and thoughtful responses. New case studies are needed because research constantly generates new issues and new ethics questions for policymaking.

The cases found in this volume address a wide range of topics and involve several disciplines. The cases were selected by the parameters of the PRO-RES project and the Horizon 2020 funding call to which it responded. First, the call was concerned with both research ethics and scientific integrity and each of the cases addresses one or both of these areas. The call sought projects that addressed non-medical research, and the cases here address disciplines such as social sciences, engineering, artificial intelligence and One Health. The call also sought particular attention be given to (a) covert research, (b) working in dangerous areas/conflict zones and (c) behavioral research collecting data from social media/internet sources. Hence, we included cases that addressed each of these areas. Finally, while an EU-funded project can be expected to have a European focus, the issues addressed have global implications. Therefore, we wanted to include cases studies from outside Europe and did so by involving authors from India and Africa to reflect on the volume’s areas of interest.

The first case study offered in this volume (Chap. 2 ) examines a significant policy approach taken by the European Union to address ethics and integrity in research and innovation: Responsible Research and Innovation (RRI). This chapter examines the lessons that can be learned from RRI in a European context. Chapter 3 elaborates on this topic with another policy learning case study, but this time examining RRI in India. One of the critiques made of RRI is that it can be Euro-centric. This case study examines this claim, and also describes how a distinctively Indian concept, Scientific Temper, can add to and contextualise RRI. Chapter 4 takes a different approach in being a case study of the development of research ethics guidance in the United Kingdom (UK). It explores the history underlying the research ethics framework commissioned by the UK Research Integrity Office (UKRIO) and the Association of Research Managers and Administrators (ARMA), and points to lessons that can be learned about the policy-development process itself.

While staying focused on policy related to research ethics, the chapters that follow include case studies that address more targeted concerns. Chapter 5 examines the impact of the European Union’s (EU) General Data Protection Regulation (GDPR) in the Republic of Croatia. Research data collected in Croatia is used to explore the handling of personal data before and after the introduction of GDPR. This case study aims to provide lessons learned that could contribute to research ethics policies and procedures in other European Member States.

Chapter 6 moves from policy itself to the role of policy advisors in policymaking. This case study explores the distinct responsibilities of those elevated to the role of “policy advisor,” especially given the current lack of policy to regulate this field or how its advice is used by policymakers. Next, Chap. 7 straddles the previous chapters’ focus on policy and its evaluation while introducing the focus of the next section on historical case studies. This chapter uses the so-called “race for the superconductor” as a case study by which the PRO-RES ethics framework is used to explore specific ethical dilemmas (PRO-RES 2021b ). This case study is especially useful for policymakers because of how it reveals the multiple difficulties in balancing economic, political, institutional and professional requirements and values.

The next case study continues the use of historical cases, but here to explore the challenges facing innovative research into unorthodox energy technology that has the potential to displace traditional energy suppliers. The wave power case in Chap. 8 highlights how conducting research with integrity can have serious consequences and come with considerable cost. The case also points to the importance of transparency in how evidence is used in policymaking so that trust in science and scientists is promoted at the same time as science is used in the public interest. Another area of cutting-edge scientific innovation is explored in Chap. 9 , but this time looking to the future. This case study examines space exploration, and specifically the ethical issues around establishing safe exposure standards for astronauts embarking on extended duration spaceflights. This case highlights the ethical challenges in policymaking focused on an elite group of people (astronauts) who embark on extremely risky activities in the name of science and humanity.

Chapter 10 moves from the physical sciences to the social sciences. The Belfast Project provides a case study to explore the ethical challenges of conducting research after violent conflict. In this case, researchers promised anonymity and confidentiality to research participants, yet that was overturned through legal proceedings which highlighted the limits of confidentiality in research. This case points to the difficulty of balancing the value of research archives in understanding conflict against the value of providing juridical evidence to promote justice. Another social science case is examined in Chap. 11 , this time in ethnography. This so-called ‘urban explorer’ case study explores the justifications that might exist for undertaking covert research where researchers break the law (in this case by trespassing) in order to investigate a topic that would remain otherwise poorly understood. This case raises a number of important questions for policymakers around: the freedoms that researchers should be given to act in the public interest; when researchers are justified in breaking the law; and what responsibilities and consequences researchers should accept if they believe they are justified in doing so.

Further complexity in research and evidence generation is introduced in Chap. 12 . A case study in One Health is used to explore ethical issues at the intersection of animal, human and environmental ethics. The pertinence of such studies has been highlighted by COVID-19, yet policies lag behind in recognising the urgency and complexity of initiating investigations into novel outbreaks, such as the one discussed here that occurred among animals in Ethiopia. Chapter 13 retains the COVID-19 setting, but returns the attention to technological innovation. Artificial intelligence (AI) is the focus of these two chapters in the volume, here examining the ethical challenges arising from the emergency authorisation of using AI to respond to the public health needs created by the COVID-19 pandemic. Chapter 14 addresses a longer term use of AI in addressing problems and challenges in the legal system. Using the so-called Robodebt case, the chapter explores the reasons why legal systems are turning to AI and other automated procedures. The Robodebt case highlights problems when AI algorithms are built on inaccurate assumptions and implemented with little human oversight. This case shows the massive problems for hundreds of thousands of Australians who became victims of poorly conceived AI and makes recommendations to assist policymakers to avoid similar debacles. The last chapter (Chap. 15 ) draws some general conclusions from all the cases that are relevant when using case studies.

1.7. Into the Future

This volume focuses on ethics in research and professional integrity and how we can be clear about the lessons that can be drawn to assist policymakers. The cases provided cover a wide range of situations, settings, and disciplines. They cover international, national, organisational, group and individual levels of concern. Each case raises distinct issues, yet also points to some general features of research, evidence-generation, ethics and policymaking. All the studies illustrate the difficulties of drawing clear ‘boundaries’ between the research and the context. All these case studies show how in real situations dynamic judgements have to be made about many different issues. Guidelines and policies do help and are needed. But at the same time, researchers, policymakers and everyone else involved in evidence generation and evidence implementation need to embody the virtues that are central to good research. Judgments will need to be made in many areas, for example, about how much transparency can be allowed, or is ethically justified; how much risk can be taken, both with participants’ safety and also with the researchers’ safety; how much information can be disclosed to or withheld from participants in their own interests and for the benefit of the ‘science’; and many others. All of these point to just how difficult it can be to apply common standards across disciplines, professions, cultures and countries. That difficulty must be acknowledged and lead to open discussions with the aim of improving practice. The cases presented here point to efforts that have been made towards this. None of them is perfect. Lessons must be learned from all of them, towards which Chap. 15 aims to be a starting point. Only by openly discussing and reflecting on past practice can lessons be learned that can inform policymaking that aims to improve future practice. In this way, ethical progress can become an essential aspect of innovation in research and evidence-generation.

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PRO-RES is a European Commission-funded project aiming to PROmote ethics and integrity in non-medical RESearch by building a supported guidance framework for all non-medical sciences and humanities disciplines adopting social science methodologies. This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 788352. Open access fees for this volume were paid for through the PRO-RES funding.

Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/ ), which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made.

The images or other third party material in this chapter are included in the chapter's Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.

• Cite this Page O’Mathúna D, Iphofen R. Making a Case for the Case: An Introduction. 2022 Nov 3. In: O'Mathúna D, Iphofen R, editors. Ethics, Integrity and Policymaking: The Value of the Case Study [Internet]. Cham (CH): Springer; 2022. Chapter 1. doi: 10.1007/978-3-031-15746-2_1
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In this Page

• Judging the Ethics of Research
• The Case for Cases
• Research Design and Causal Inference
• Devil’s in the Detail
• Cases and Policymaking
• The Moral Gain
• Into the Future

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These studies provide a foundation for discussing ethical issues so we can better integrate data ethics in real life.

To help us think seriously about data ethics, we need case studies that we can discuss, argue about, and come to terms with as we engage with the real world. Good case studies give us the opportunity to think through problems before facing them in real life. And case studies show us that ethical problems aren't simple. They are multi-faceted, and frequently there's no single right answer. And they help us to recognize there are few situations that don't raise ethical questions.

Princeton's  Center for Information Technology Policy  and  Center for Human Values  have created four anonymized  case studies  to promote the discussion of ethics. The first of these studies,  Automated Healthcare App , discusses a smartphone app designed to help adult onset diabetes patients. It raises issues like paternalism, consent, and even language choices. Is it OK to “nudge” patients toward more healthy behaviors? What about automatically moderating the users’ discussion groups to emphasize scientifically accurate information? And how do you deal with minorities who don’t respond to treatment as well? Could the problem be the language itself that is used to discuss treatment?

The next case study,  Dynamic Sound Identification , covers an application that can identify voices, raising issues about privacy, language, and even gender. How far should developers go in identifying potential harm that can be caused by an application? What are acceptable error rates for an application that can potentially do harm? How can a voice application handle people with different accents or dialects? And what responsibility do developers have when a small experimental tool is bought by a large corporation that wants to commercialize it?

The  Optimizing Schools  case study deals with the problem of finding at-risk children in school systems. Privacy and language are again an issue; it also raises the issue of how decisions to use data are made. Who makes those decisions, and who needs to be informed about them? What are the consequences when people find out how their data has been used? And how do you interpret the results of an experiment? Under what conditions can you say that a data experiment has really yielded improved educational results?

The final case study,  Law Enforcement Chatbots , raises issues about the tradeoff between liberty and security, entrapment, openness and accountability, and compliance with international law.

None of these issues are simple, and there are few (if any) "right answers." For example, it’s easy to react against perceived paternalism in a medical application, but the purpose of such an application is to encourage patients to comply with their treatment program. It’s easy to object to monitoring students in a public school, but students are minors, and schools by nature handle a lot of private personal data. Where is the boundary between what is, and isn’t, acceptable? What's important isn’t getting to the correct answer on any issue, but to make sure the issue is discussed and understood, and that we know what tradeoffs we are making. What is important is that we get practice in discussing ethical issues and put that practice to work in our jobs. That’s what these case studies give us.

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Chapter 4: Case Studies

An introduction to the case studies in Ethics in the Science Classroom.

The teaching of ethics is particularly suited to the use of illustrative case studies. Such narratives can be used to present examples of a range of significant ethical issues related to some human enterprise and many of the complexities associated with each of the issues. The cases can be either fictional or they can be based on actual events.

In our Summer Institute instructional program we used a series of real-life case studies to illustrate several of the key ethical issues related to science. The teachers found these cases helpful in enhancing their in-depth understanding of the issue and in suggesting practical topics for the development of classroom ethics lessons.

In this chapter we present six such case studies, including five that were used, to good effect, during our Summer Institute instructional program. Each is based on a real case. The cases and major associated ethics issues are: Overly Ambitious Researchers -- Fabricating Data (scientific misconduct); The Millkan Case (issues related to the collection, treatment and presentation of scientific data); The Tuskegee Syphilis Study (issues concerning research on human subjects and the influence of racial prejudice on science); The Search For the Structure of DNA (competition vs. cooperation, and sexism in science); The XYY Controversy (genetics and biotechnology research issues); and Love Canal (environmental protection issues).

Each case includes:

1- Introduction . A discussion of the nature and significance of the types of moral issues raised in the case.

2- Background. Background discussion designed to place the case in an appropriate context.

3- Case Study. A narrative presentation of the particulars of the case.

4- Readings and Resources. A brief list of suggested readings (as well as videos and other educational material) that can be consulted to get a more thorough understanding of the case in question, related cases, and the associated ethics/values issue.

5- The Issues. Sets of questions designed to elicit thought and exploration concerning both the specific ethics/values issues raised by the case, as well as related issues.

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This material is based upon work supported by the National Science Foundation under Award No. 2055332. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Science Foundation.

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Cultural Relativity and Acceptance of Embryonic Stem Cell Research

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There is a debate about the ethical implications of using human embryos in stem cell research, which can be influenced by cultural, moral, and social values. This paper argues for an adaptable framework to accommodate diverse cultural and religious perspectives. By using an adaptive ethics model, research protections can reflect various populations and foster growth in stem cell research possibilities.

INTRODUCTION

Stem cell research combines biology, medicine, and technology, promising to alter health care and the understanding of human development. Yet, ethical contention exists because of individuals’ perceptions of using human embryos based on their various cultural, moral, and social values. While these disagreements concerning policy, use, and general acceptance have prompted the development of an international ethics policy, such a uniform approach can overlook the nuanced ethical landscapes between cultures. With diverse viewpoints in public health, a single global policy, especially one reflecting Western ethics or the ethics prevalent in high-income countries, is impractical. This paper argues for a culturally sensitive, adaptable framework for the use of embryonic stem cells. Stem cell policy should accommodate varying ethical viewpoints and promote an effective global dialogue. With an extension of an ethics model that can adapt to various cultures, we recommend localized guidelines that reflect the moral views of the people those guidelines serve.

Stem cells, characterized by their unique ability to differentiate into various cell types, enable the repair or replacement of damaged tissues. Two primary types of stem cells are somatic stem cells (adult stem cells) and embryonic stem cells. Adult stem cells exist in developed tissues and maintain the body’s repair processes. [1] Embryonic stem cells (ESC) are remarkably pluripotent or versatile, making them valuable in research. [2] However, the use of ESCs has sparked ethics debates. Considering the potential of embryonic stem cells, research guidelines are essential. The International Society for Stem Cell Research (ISSCR) provides international stem cell research guidelines. They call for “public conversations touching on the scientific significance as well as the societal and ethical issues raised by ESC research.” [3] The ISSCR also publishes updates about culturing human embryos 14 days post fertilization, suggesting local policies and regulations should continue to evolve as ESC research develops. [4]  Like the ISSCR, which calls for local law and policy to adapt to developing stem cell research given cultural acceptance, this paper highlights the importance of local social factors such as religion and culture.

I.     Global Cultural Perspective of Embryonic Stem Cells

Views on ESCs vary throughout the world. Some countries readily embrace stem cell research and therapies, while others have stricter regulations due to ethical concerns surrounding embryonic stem cells and when an embryo becomes entitled to moral consideration. The philosophical issue of when the “someone” begins to be a human after fertilization, in the morally relevant sense, [5] impacts when an embryo becomes not just worthy of protection but morally entitled to it. The process of creating embryonic stem cell lines involves the destruction of the embryos for research. [6] Consequently, global engagement in ESC research depends on social-cultural acceptability.

a.     US and Rights-Based Cultures

In the United States, attitudes toward stem cell therapies are diverse. The ethics and social approaches, which value individualism, [7] trigger debates regarding the destruction of human embryos, creating a complex regulatory environment. For example, the 1996 Dickey-Wicker Amendment prohibited federal funding for the creation of embryos for research and the destruction of embryos for “more than allowed for research on fetuses in utero.” [8] Following suit, in 2001, the Bush Administration heavily restricted stem cell lines for research. However, the Stem Cell Research Enhancement Act of 2005 was proposed to help develop ESC research but was ultimately vetoed. [9] Under the Obama administration, in 2009, an executive order lifted restrictions allowing for more development in this field. [10] The flux of research capacity and funding parallels the different cultural perceptions of human dignity of the embryo and how it is socially presented within the country’s research culture. [11]

b.     Ubuntu and Collective Cultures

African bioethics differs from Western individualism because of the different traditions and values. African traditions, as described by individuals from South Africa and supported by some studies in other African countries, including Ghana and Kenya, follow the African moral philosophies of Ubuntu or Botho and Ukama , which “advocates for a form of wholeness that comes through one’s relationship and connectedness with other people in the society,” [12] making autonomy a socially collective concept. In this context, for the community to act autonomously, individuals would come together to decide what is best for the collective. Thus, stem cell research would require examining the value of the research to society as a whole and the use of the embryos as a collective societal resource. If society views the source as part of the collective whole, and opposes using stem cells, compromising the cultural values to pursue research may cause social detachment and stunt research growth. [13] Based on local culture and moral philosophy, the permissibility of stem cell research depends on how embryo, stem cell, and cell line therapies relate to the community as a whole. Ubuntu is the expression of humanness, with the person’s identity drawn from the “’I am because we are’” value. [14] The decision in a collectivistic culture becomes one born of cultural context, and individual decisions give deference to others in the society.

Consent differs in cultures where thought and moral philosophy are based on a collective paradigm. So, applying Western bioethical concepts is unrealistic. For one, Africa is a diverse continent with many countries with different belief systems, access to health care, and reliance on traditional or Western medicines. Where traditional medicine is the primary treatment, the “’restrictive focus on biomedically-related bioethics’” [is] problematic in African contexts because it neglects bioethical issues raised by traditional systems.” [15] No single approach applies in all areas or contexts. Rather than evaluating the permissibility of ESC research according to Western concepts such as the four principles approach, different ethics approaches should prevail.

Another consideration is the socio-economic standing of countries. In parts of South Africa, researchers have not focused heavily on contributing to the stem cell discourse, either because it is not considered health care or a health science priority or because resources are unavailable. [16] Each country’s priorities differ given different social, political, and economic factors. In South Africa, for instance, areas such as maternal mortality, non-communicable diseases, telemedicine, and the strength of health systems need improvement and require more focus. [17] Stem cell research could benefit the population, but it also could divert resources from basic medical care. Researchers in South Africa adhere to the National Health Act and Medicines Control Act in South Africa and international guidelines; however, the Act is not strictly enforced, and there is no clear legislation for research conduct or ethical guidelines. [18]

Some parts of Africa condemn stem cell research. For example, 98.2 percent of the Tunisian population is Muslim. [19] Tunisia does not permit stem cell research because of moral conflict with a Fatwa. Religion heavily saturates the regulation and direction of research. [20] Stem cell use became permissible for reproductive purposes only recently, with tight restrictions preventing cells from being used in any research other than procedures concerning ART/IVF.  Their use is conditioned on consent, and available only to married couples. [21] The community's receptiveness to stem cell research depends on including communitarian African ethics.

c.     Asia

Some Asian countries also have a collective model of ethics and decision making. [22] In China, the ethics model promotes a sincere respect for life or human dignity, [23] based on protective medicine. This model, influenced by Traditional Chinese Medicine (TCM), [24] recognizes Qi as the vital energy delivered via the meridians of the body; it connects illness to body systems, the body’s entire constitution, and the universe for a holistic bond of nature, health, and quality of life. [25] Following a protective ethics model, and traditional customs of wholeness, investment in stem cell research is heavily desired for its applications in regenerative therapies, disease modeling, and protective medicines. In a survey of medical students and healthcare practitioners, 30.8 percent considered stem cell research morally unacceptable while 63.5 percent accepted medical research using human embryonic stem cells. Of these individuals, 89.9 percent supported increased funding for stem cell research. [26] The scientific community might not reflect the overall population. From 1997 to 2019, China spent a total of $576 million (USD) on stem cell research at 8,050 stem cell programs, increased published presence from 0.6 percent to 14.01 percent of total global stem cell publications as of 2014, and made significant strides in cell-based therapies for various medical conditions. [27] However, while China has made substantial investments in stem cell research and achieved notable progress in clinical applications, concerns linger regarding ethical oversight and transparency. [28] For example, the China Biosecurity Law, promoted by the National Health Commission and China Hospital Association, attempted to mitigate risks by introducing an institutional review board (IRB) in the regulatory bodies. 5800 IRBs registered with the Chinese Clinical Trial Registry since 2021. [29] However, issues still need to be addressed in implementing effective IRB review and approval procedures.

The substantial government funding and focus on scientific advancement have sometimes overshadowed considerations of regional cultures, ethnic minorities, and individual perspectives, particularly evident during the one-child policy era. As government policy adapts to promote public stability, such as the change from the one-child to the two-child policy, [30] research ethics should also adapt to ensure respect for the values of its represented peoples.

Japan is also relatively supportive of stem cell research and therapies. Japan has a more transparent regulatory framework, allowing for faster approval of regenerative medicine products, which has led to several advanced clinical trials and therapies. [31] South Korea is also actively engaged in stem cell research and has a history of breakthroughs in cloning and embryonic stem cells. [32] However, the field is controversial, and there are issues of scientific integrity. For example, the Korean FDA fast-tracked products for approval, [33] and in another instance, the oocyte source was unclear and possibly violated ethical standards. [34] Trust is important in research, as it builds collaborative foundations between colleagues, trial participant comfort, open-mindedness for complicated and sensitive discussions, and supports regulatory procedures for stakeholders. There is a need to respect the culture’s interest, engagement, and for research and clinical trials to be transparent and have ethical oversight to promote global research discourse and trust.

d.     Middle East

Countries in the Middle East have varying degrees of acceptance of or restrictions to policies related to using embryonic stem cells due to cultural and religious influences. Saudi Arabia has made significant contributions to stem cell research, and conducts research based on international guidelines for ethical conduct and under strict adherence to guidelines in accordance with Islamic principles. Specifically, the Saudi government and people require ESC research to adhere to Sharia law. In addition to umbilical and placental stem cells, [35] Saudi Arabia permits the use of embryonic stem cells as long as they come from miscarriages, therapeutic abortions permissible by Sharia law, or are left over from in vitro fertilization and donated to research. [36] Laws and ethical guidelines for stem cell research allow the development of research institutions such as the King Abdullah International Medical Research Center, which has a cord blood bank and a stem cell registry with nearly 10,000 donors. [37] Such volume and acceptance are due to the ethical ‘permissibility’ of the donor sources, which do not conflict with religious pillars. However, some researchers err on the side of caution, choosing not to use embryos or fetal tissue as they feel it is unethical to do so. [38]

Jordan has a positive research ethics culture. [39] However, there is a significant issue of lack of trust in researchers, with 45.23 percent (38.66 percent agreeing and 6.57 percent strongly agreeing) of Jordanians holding a low level of trust in researchers, compared to 81.34 percent of Jordanians agreeing that they feel safe to participate in a research trial. [40] Safety testifies to the feeling of confidence that adequate measures are in place to protect participants from harm, whereas trust in researchers could represent the confidence in researchers to act in the participants’ best interests, adhere to ethical guidelines, provide accurate information, and respect participants’ rights and dignity. One method to improve trust would be to address communication issues relevant to ESC. Legislation surrounding stem cell research has adopted specific language, especially concerning clarification “between ‘stem cells’ and ‘embryonic stem cells’” in translation. [41] Furthermore, legislation “mandates the creation of a national committee… laying out specific regulations for stem-cell banking in accordance with international standards.” [42] This broad regulation opens the door for future global engagement and maintains transparency. However, these regulations may also constrain the influence of research direction, pace, and accessibility of research outcomes.

e.     Europe

In the European Union (EU), ethics is also principle-based, but the principles of autonomy, dignity, integrity, and vulnerability are interconnected. [43] As such, the opportunity for cohesion and concessions between individuals’ thoughts and ideals allows for a more adaptable ethics model due to the flexible principles that relate to the human experience The EU has put forth a framework in its Convention for the Protection of Human Rights and Dignity of the Human Being allowing member states to take different approaches. Each European state applies these principles to its specific conventions, leading to or reflecting different acceptance levels of stem cell research. [44]

For example, in Germany, Lebenzusammenhang , or the coherence of life, references integrity in the unity of human culture. Namely, the personal sphere “should not be subject to external intervention.” [45]  Stem cell interventions could affect this concept of bodily completeness, leading to heavy restrictions. Under the Grundgesetz, human dignity and the right to life with physical integrity are paramount. [46] The Embryo Protection Act of 1991 made producing cell lines illegal. Cell lines can be imported if approved by the Central Ethics Commission for Stem Cell Research only if they were derived before May 2007. [47] Stem cell research respects the integrity of life for the embryo with heavy specifications and intense oversight. This is vastly different in Finland, where the regulatory bodies find research more permissible in IVF excess, but only up to 14 days after fertilization. [48] Spain’s approach differs still, with a comprehensive regulatory framework. [49] Thus, research regulation can be culture-specific due to variations in applied principles. Diverse cultures call for various approaches to ethical permissibility. [50] Only an adaptive-deliberative model can address the cultural constructions of self and achieve positive, culturally sensitive stem cell research practices. [51]

II.     Religious Perspectives on ESC

Embryonic stem cell sources are the main consideration within religious contexts. While individuals may not regard their own religious texts as authoritative or factual, religion can shape their foundations or perspectives.

The Qur'an states:

“And indeed We created man from a quintessence of clay. Then We placed within him a small quantity of nutfa (sperm to fertilize) in a safe place. Then We have fashioned the nutfa into an ‘alaqa (clinging clot or cell cluster), then We developed the ‘alaqa into mudgha (a lump of flesh), and We made mudgha into bones, and clothed the bones with flesh, then We brought it into being as a new creation. So Blessed is Allah, the Best of Creators.” [52]

Many scholars of Islam estimate the time of soul installment, marked by the angel breathing in the soul to bring the individual into creation, as 120 days from conception. [53] Personhood begins at this point, and the value of life would prohibit research or experimentation that could harm the individual. If the fetus is more than 120 days old, the time ensoulment is interpreted to occur according to Islamic law, abortion is no longer permissible. [54] There are a few opposing opinions about early embryos in Islamic traditions. According to some Islamic theologians, there is no ensoulment of the early embryo, which is the source of stem cells for ESC research. [55]

In Buddhism, the stance on stem cell research is not settled. The main tenets, the prohibition against harming or destroying others (ahimsa) and the pursuit of knowledge (prajña) and compassion (karuna), leave Buddhist scholars and communities divided. [56] Some scholars argue stem cell research is in accordance with the Buddhist tenet of seeking knowledge and ending human suffering. Others feel it violates the principle of not harming others. Finding the balance between these two points relies on the karmic burden of Buddhist morality. In trying to prevent ahimsa towards the embryo, Buddhist scholars suggest that to comply with Buddhist tenets, research cannot be done as the embryo has personhood at the moment of conception and would reincarnate immediately, harming the individual's ability to build their karmic burden. [57] On the other hand, the Bodhisattvas, those considered to be on the path to enlightenment or Nirvana, have given organs and flesh to others to help alleviate grieving and to benefit all. [58] Acceptance varies on applied beliefs and interpretations.

Catholicism does not support embryonic stem cell research, as it entails creation or destruction of human embryos. This destruction conflicts with the belief in the sanctity of life. For example, in the Old Testament, Genesis describes humanity as being created in God’s image and multiplying on the Earth, referencing the sacred rights to human conception and the purpose of development and life. In the Ten Commandments, the tenet that one should not kill has numerous interpretations where killing could mean murder or shedding of the sanctity of life, demonstrating the high value of human personhood. In other books, the theological conception of when life begins is interpreted as in utero, [59] highlighting the inviolability of life and its formation in vivo to make a religious point for accepting such research as relatively limited, if at all. [60] The Vatican has released ethical directives to help apply a theological basis to modern-day conflicts. The Magisterium of the Church states that “unless there is a moral certainty of not causing harm,” experimentation on fetuses, fertilized cells, stem cells, or embryos constitutes a crime. [61] Such procedures would not respect the human person who exists at these stages, according to Catholicism. Damages to the embryo are considered gravely immoral and illicit. [62] Although the Catholic Church officially opposes abortion, surveys demonstrate that many Catholic people hold pro-choice views, whether due to the context of conception, stage of pregnancy, threat to the mother’s life, or for other reasons, demonstrating that practicing members can also accept some but not all tenets. [63]

Some major Jewish denominations, such as the Reform, Conservative, and Reconstructionist movements, are open to supporting ESC use or research as long as it is for saving a life. [64] Within Judaism, the Talmud, or study, gives personhood to the child at birth and emphasizes that life does not begin at conception: [65]

“If she is found pregnant, until the fortieth day it is mere fluid,” [66]

Whereas most religions prioritize the status of human embryos, the Halakah (Jewish religious law) states that to save one life, most other religious laws can be ignored because it is in pursuit of preservation. [67] Stem cell research is accepted due to application of these religious laws.

We recognize that all religions contain subsets and sects. The variety of environmental and cultural differences within religious groups requires further analysis to respect the flexibility of religious thoughts and practices. We make no presumptions that all cultures require notions of autonomy or morality as under the common morality theory , which asserts a set of universal moral norms that all individuals share provides moral reasoning and guides ethical decisions. [68] We only wish to show that the interaction with morality varies between cultures and countries.

III.     A Flexible Ethical Approach

The plurality of different moral approaches described above demonstrates that there can be no universally acceptable uniform law for ESC on a global scale. Instead of developing one standard, flexible ethical applications must be continued. We recommend local guidelines that incorporate important cultural and ethical priorities.

While the Declaration of Helsinki is more relevant to people in clinical trials receiving ESC products, in keeping with the tradition of protections for research subjects, consent of the donor is an ethical requirement for ESC donation in many jurisdictions including the US, Canada, and Europe. [69] The Declaration of Helsinki provides a reference point for regulatory standards and could potentially be used as a universal baseline for obtaining consent prior to gamete or embryo donation.

For instance, in Columbia University’s egg donor program for stem cell research, donors followed standard screening protocols and “underwent counseling sessions that included information as to the purpose of oocyte donation for research, what the oocytes would be used for, the risks and benefits of donation, and process of oocyte stimulation” to ensure transparency for consent. [70] The program helped advance stem cell research and provided clear and safe research methods with paid participants. Though paid participation or covering costs of incidental expenses may not be socially acceptable in every culture or context, [71] and creating embryos for ESC research is illegal in many jurisdictions, Columbia’s program was effective because of the clear and honest communications with donors, IRBs, and related stakeholders.  This example demonstrates that cultural acceptance of scientific research and of the idea that an egg or embryo does not have personhood is likely behind societal acceptance of donating eggs for ESC research. As noted, many countries do not permit the creation of embryos for research.

Proper communication and education regarding the process and purpose of stem cell research may bolster comprehension and garner more acceptance. “Given the sensitive subject material, a complete consent process can support voluntary participation through trust, understanding, and ethical norms from the cultures and morals participants value. This can be hard for researchers entering countries of different socioeconomic stability, with different languages and different societal values. [72]

An adequate moral foundation in medical ethics is derived from the cultural and religious basis that informs knowledge and actions. [73] Understanding local cultural and religious values and their impact on research could help researchers develop humility and promote inclusion.

IV.     Concerns

Some may argue that if researchers all adhere to one ethics standard, protection will be satisfied across all borders, and the global public will trust researchers. However, defining what needs to be protected and how to define such research standards is very specific to the people to which standards are applied. We suggest that applying one uniform guide cannot accurately protect each individual because we all possess our own perceptions and interpretations of social values. [74] Therefore, the issue of not adjusting to the moral pluralism between peoples in applying one standard of ethics can be resolved by building out ethics models that can be adapted to different cultures and religions.

Other concerns include medical tourism, which may promote health inequities. [75] Some countries may develop and approve products derived from ESC research before others, compromising research ethics or drug approval processes. There are also concerns about the sale of unauthorized stem cell treatments, for example, those without FDA approval in the United States. Countries with robust research infrastructures may be tempted to attract medical tourists, and some customers will have false hopes based on aggressive publicity of unproven treatments. [76]

For example, in China, stem cell clinics can market to foreign clients who are not protected under the regulatory regimes. Companies employ a marketing strategy of “ethically friendly” therapies. Specifically, in the case of Beike, China’s leading stem cell tourism company and sprouting network, ethical oversight of administrators or health bureaus at one site has “the unintended consequence of shifting questionable activities to another node in Beike's diffuse network.” [77] In contrast, Jordan is aware of stem cell research’s potential abuse and its own status as a “health-care hub.” Jordan’s expanded regulations include preserving the interests of individuals in clinical trials and banning private companies from ESC research to preserve transparency and the integrity of research practices. [78]

The social priorities of the community are also a concern. The ISSCR explicitly states that guidelines “should be periodically revised to accommodate scientific advances, new challenges, and evolving social priorities.” [79] The adaptable ethics model extends this consideration further by addressing whether research is warranted given the varying degrees of socioeconomic conditions, political stability, and healthcare accessibilities and limitations. An ethical approach would require discussion about resource allocation and appropriate distribution of funds. [80]

While some religions emphasize the sanctity of life from conception, which may lead to public opposition to ESC research, others encourage ESC research due to its potential for healing and alleviating human pain. Many countries have special regulations that balance local views on embryonic personhood, the benefits of research as individual or societal goods, and the protection of human research subjects. To foster understanding and constructive dialogue, global policy frameworks should prioritize the protection of universal human rights, transparency, and informed consent. In addition to these foundational global policies, we recommend tailoring local guidelines to reflect the diverse cultural and religious perspectives of the populations they govern. Ethics models should be adapted to local populations to effectively establish research protections, growth, and possibilities of stem cell research.

For example, in countries with strong beliefs in the moral sanctity of embryos or heavy religious restrictions, an adaptive model can allow for discussion instead of immediate rejection. In countries with limited individual rights and voice in science policy, an adaptive model ensures cultural, moral, and religious views are taken into consideration, thereby building social inclusion. While this ethical consideration by the government may not give a complete voice to every individual, it will help balance policies and maintain the diverse perspectives of those it affects. Embracing an adaptive ethics model of ESC research promotes open-minded dialogue and respect for the importance of human belief and tradition. By actively engaging with cultural and religious values, researchers can better handle disagreements and promote ethical research practices that benefit each society.

This brief exploration of the religious and cultural differences that impact ESC research reveals the nuances of relative ethics and highlights a need for local policymakers to apply a more intense adaptive model.

[1] Poliwoda, S., Noor, N., Downs, E., Schaaf, A., Cantwell, A., Ganti, L., Kaye, A. D., Mosel, L. I., Carroll, C. B., Viswanath, O., & Urits, I. (2022). Stem cells: a comprehensive review of origins and emerging clinical roles in medical practice.  Orthopedic reviews ,  14 (3), 37498. https://doi.org/10.52965/001c.37498

[2] Poliwoda, S., Noor, N., Downs, E., Schaaf, A., Cantwell, A., Ganti, L., Kaye, A. D., Mosel, L. I., Carroll, C. B., Viswanath, O., & Urits, I. (2022). Stem cells: a comprehensive review of origins and emerging clinical roles in medical practice.  Orthopedic reviews ,  14 (3), 37498. https://doi.org/10.52965/001c.37498

[3] International Society for Stem Cell Research. (2023). Laboratory-based human embryonic stem cell research, embryo research, and related research activities . International Society for Stem Cell Research. https://www.isscr.org/guidelines/blog-post-title-one-ed2td-6fcdk ; Kimmelman, J., Hyun, I., Benvenisty, N.  et al.  Policy: Global standards for stem-cell research.  Nature   533 , 311–313 (2016). https://doi.org/10.1038/533311a

[4] International Society for Stem Cell Research. (2023). Laboratory-based human embryonic stem cell research, embryo research, and related research activities . International Society for Stem Cell Research. https://www.isscr.org/guidelines/blog-post-title-one-ed2td-6fcdk

[5] Concerning the moral philosophies of stem cell research, our paper does not posit a personal moral stance nor delve into the “when” of human life begins. To read further about the philosophical debate, consider the following sources:

Sandel M. J. (2004). Embryo ethics--the moral logic of stem-cell research.  The New England journal of medicine ,  351 (3), 207–209. https://doi.org/10.1056/NEJMp048145 ; George, R. P., & Lee, P. (2020, September 26). Acorns and Embryos . The New Atlantis. https://www.thenewatlantis.com/publications/acorns-and-embryos ; Sagan, A., & Singer, P. (2007). The moral status of stem cells. Metaphilosophy , 38 (2/3), 264–284. http://www.jstor.org/stable/24439776 ; McHugh P. R. (2004). Zygote and "clonote"--the ethical use of embryonic stem cells.  The New England journal of medicine ,  351 (3), 209–211. https://doi.org/10.1056/NEJMp048147 ; Kurjak, A., & Tripalo, A. (2004). The facts and doubts about beginning of the human life and personality.  Bosnian journal of basic medical sciences ,  4 (1), 5–14. https://doi.org/10.17305/bjbms.2004.3453

[6] Vazin, T., & Freed, W. J. (2010). Human embryonic stem cells: derivation, culture, and differentiation: a review.  Restorative neurology and neuroscience ,  28 (4), 589–603. https://doi.org/10.3233/RNN-2010-0543

[7] Socially, at its core, the Western approach to ethics is widely principle-based, autonomy being one of the key factors to ensure a fundamental respect for persons within research. For information regarding autonomy in research, see: Department of Health, Education, and Welfare, & National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.; For a more in-depth review of autonomy within the US, see: Beauchamp, T. L., & Childress, J. F. (1994). Principles of Biomedical Ethics . Oxford University Press.

[8] Sherley v. Sebelius , 644 F.3d 388 (D.C. Cir. 2011), citing 45 C.F.R. 46.204(b) and [42 U.S.C. § 289g(b)]. https://www.cadc.uscourts.gov/internet/opinions.nsf/6c690438a9b43dd685257a64004ebf99/$file/11-5241-1391178.pdf

[9] Stem Cell Research Enhancement Act of 2005, H. R. 810, 109 th Cong. (2001). https://www.govtrack.us/congress/bills/109/hr810/text ; Bush, G. W. (2006, July 19). Message to the House of Representatives . National Archives and Records Administration. https://georgewbush-whitehouse.archives.gov/news/releases/2006/07/20060719-5.html

[10] National Archives and Records Administration. (2009, March 9). Executive order 13505 -- removing barriers to responsible scientific research involving human stem cells . National Archives and Records Administration. https://obamawhitehouse.archives.gov/the-press-office/removing-barriers-responsible-scientific-research-involving-human-stem-cells

[11] Hurlbut, W. B. (2006). Science, Religion, and the Politics of Stem Cells.  Social Research ,  73 (3), 819–834. http://www.jstor.org/stable/40971854

[12] Akpa-Inyang, Francis & Chima, Sylvester. (2021). South African traditional values and beliefs regarding informed consent and limitations of the principle of respect for autonomy in African communities: a cross-cultural qualitative study. BMC Medical Ethics . 22. 10.1186/s12910-021-00678-4.

[13] Source for further reading: Tangwa G. B. (2007). Moral status of embryonic stem cells: perspective of an African villager. Bioethics , 21(8), 449–457. https://doi.org/10.1111/j.1467-8519.2007.00582.x , see also Mnisi, F. M. (2020). An African analysis based on ethics of Ubuntu - are human embryonic stem cell patents morally justifiable? African Insight , 49 (4).

[14] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics , 22 (2), 112–122. https://doi.org/10.1111/dewb.12324

[15] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics, 22(2), 112–122. https://doi.org/10.1111/dewb.12324

[16] Jackson, C.S., Pepper, M.S. Opportunities and barriers to establishing a cell therapy programme in South Africa.  Stem Cell Res Ther   4 , 54 (2013). https://doi.org/10.1186/scrt204 ; Pew Research Center. (2014, May 1). Public health a major priority in African nations . Pew Research Center’s Global Attitudes Project. https://www.pewresearch.org/global/2014/05/01/public-health-a-major-priority-in-african-nations/

[17] Department of Health Republic of South Africa. (2021). Health Research Priorities (revised) for South Africa 2021-2024 . National Health Research Strategy. https://www.health.gov.za/wp-content/uploads/2022/05/National-Health-Research-Priorities-2021-2024.pdf

[18] Oosthuizen, H. (2013). Legal and Ethical Issues in Stem Cell Research in South Africa. In: Beran, R. (eds) Legal and Forensic Medicine. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32338-6_80 , see also: Gaobotse G (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[19] United States Bureau of Citizenship and Immigration Services. (1998). Tunisia: Information on the status of Christian conversions in Tunisia . UNHCR Web Archive. https://webarchive.archive.unhcr.org/20230522142618/https://www.refworld.org/docid/3df0be9a2.html

[20] Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[21] Kooli, C. Review of assisted reproduction techniques, laws, and regulations in Muslim countries.  Middle East Fertil Soc J   24 , 8 (2020). https://doi.org/10.1186/s43043-019-0011-0 ; Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142

[22] Pang M. C. (1999). Protective truthfulness: the Chinese way of safeguarding patients in informed treatment decisions. Journal of medical ethics , 25(3), 247–253. https://doi.org/10.1136/jme.25.3.247

[23] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[24] Wang, Y., Xue, Y., & Guo, H. D. (2022). Intervention effects of traditional Chinese medicine on stem cell therapy of myocardial infarction.  Frontiers in pharmacology ,  13 , 1013740. https://doi.org/10.3389/fphar.2022.1013740

[25] Li, X.-T., & Zhao, J. (2012). Chapter 4: An Approach to the Nature of Qi in TCM- Qi and Bioenergy. In Recent Advances in Theories and Practice of Chinese Medicine (p. 79). InTech.

[26] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students.  Stem cells international ,  2021 , 6667743. https://doi.org/10.1155/2021/6667743

[27] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students.  Stem cells international ,  2021 , 6667743. https://doi.org/10.1155/2021/6667743

[28] Zhang, J. Y. (2017). Lost in translation? accountability and governance of Clinical Stem Cell Research in China. Regenerative Medicine , 12 (6), 647–656. https://doi.org/10.2217/rme-2017-0035

[29] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences , 8(1).  https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199

[30] Chen, H., Wei, T., Wang, H.  et al.  Association of China’s two-child policy with changes in number of births and birth defects rate, 2008–2017.  BMC Public Health   22 , 434 (2022). https://doi.org/10.1186/s12889-022-12839-0

[31] Azuma, K. Regulatory Landscape of Regenerative Medicine in Japan.  Curr Stem Cell Rep   1 , 118–128 (2015). https://doi.org/10.1007/s40778-015-0012-6

[32] Harris, R. (2005, May 19). Researchers Report Advance in Stem Cell Production . NPR. https://www.npr.org/2005/05/19/4658967/researchers-report-advance-in-stem-cell-production

[33] Park, S. (2012). South Korea steps up stem-cell work.  Nature . https://doi.org/10.1038/nature.2012.10565

[34] Resnik, D. B., Shamoo, A. E., & Krimsky, S. (2006). Fraudulent human embryonic stem cell research in South Korea: lessons learned.  Accountability in research ,  13 (1), 101–109. https://doi.org/10.1080/08989620600634193 .

[35] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

[36] Association for the Advancement of Blood and Biotherapies.  https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulatory-for-cellular-therapies/international-competent-authorities/saudi-arabia

[37] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia.  BMC medical ethics ,  21 (1), 35. https://doi.org/10.1186/s12910-020-00482-6

[38] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics , 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6

Culturally, autonomy practices follow a relational autonomy approach based on a paternalistic deontological health care model. The adherence to strict international research policies and religious pillars within the regulatory environment is a great foundation for research ethics. However, there is a need to develop locally targeted ethics approaches for research (as called for in Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6), this decision-making approach may help advise a research decision model. For more on the clinical cultural autonomy approaches, see: Alabdullah, Y. Y., Alzaid, E., Alsaad, S., Alamri, T., Alolayan, S. W., Bah, S., & Aljoudi, A. S. (2022). Autonomy and paternalism in Shared decision‐making in a Saudi Arabian tertiary hospital: A cross‐sectional study. Developing World Bioethics , 23 (3), 260–268. https://doi.org/10.1111/dewb.12355 ; Bukhari, A. A. (2017). Universal Principles of Bioethics and Patient Rights in Saudi Arabia (Doctoral dissertation, Duquesne University). https://dsc.duq.edu/etd/124; Ladha, S., Nakshawani, S. A., Alzaidy, A., & Tarab, B. (2023, October 26). Islam and Bioethics: What We All Need to Know . Columbia University School of Professional Studies. https://sps.columbia.edu/events/islam-and-bioethics-what-we-all-need-know

[39] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[40] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics.  Research Ethics ,  17 (2), 228-241.  https://doi.org/10.1177/1747016120966779

[41] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[42] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[43] The EU’s definition of autonomy relates to the capacity for creating ideas, moral insight, decisions, and actions without constraint, personal responsibility, and informed consent. However, the EU views autonomy as not completely able to protect individuals and depends on other principles, such as dignity, which “expresses the intrinsic worth and fundamental equality of all human beings.” Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[44] Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164) https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164 (forbidding the creation of embryos for research purposes only, and suggests embryos in vitro have protections.); Also see Drabiak-Syed B. K. (2013). New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France.  Biotechnology Law Report ,  32 (6), 349–356. https://doi.org/10.1089/blr.2013.9865

[45] Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3

[46] Tomuschat, C., Currie, D. P., Kommers, D. P., & Kerr, R. (Trans.). (1949, May 23). Basic law for the Federal Republic of Germany. https://www.btg-bestellservice.de/pdf/80201000.pdf

[47] Regulation of Stem Cell Research in Germany . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-germany

[48] Regulation of Stem Cell Research in Finland . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-finland

[49] Regulation of Stem Cell Research in Spain . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-spain

[50] Some sources to consider regarding ethics models or regulatory oversights of other cultures not covered:

Kara MA. Applicability of the principle of respect for autonomy: the perspective of Turkey. J Med Ethics. 2007 Nov;33(11):627-30. doi: 10.1136/jme.2006.017400. PMID: 17971462; PMCID: PMC2598110.

Ugarte, O. N., & Acioly, M. A. (2014). The principle of autonomy in Brazil: one needs to discuss it ...  Revista do Colegio Brasileiro de Cirurgioes ,  41 (5), 374–377. https://doi.org/10.1590/0100-69912014005013

Bharadwaj, A., & Glasner, P. E. (2012). Local cells, global science: The rise of embryonic stem cell research in India . Routledge.

For further research on specific European countries regarding ethical and regulatory framework, we recommend this database: Regulation of Stem Cell Research in Europe . Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-europe   

[51] Klitzman, R. (2006). Complications of culture in obtaining informed consent. The American Journal of Bioethics, 6(1), 20–21. https://doi.org/10.1080/15265160500394671 see also: Ekmekci, P. E., & Arda, B. (2017). Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights.  Cultura (Iasi, Romania) ,  14 (2), 159–172.; For why trust is important in research, see also: Gray, B., Hilder, J., Macdonald, L., Tester, R., Dowell, A., & Stubbe, M. (2017). Are research ethics guidelines culturally competent?  Research Ethics ,  13 (1), 23-41.  https://doi.org/10.1177/1747016116650235

[52] The Qur'an  (M. Khattab, Trans.). (1965). Al-Mu’minun, 23: 12-14. https://quran.com/23

[53] Lenfest, Y. (2017, December 8). Islam and the beginning of human life . Bill of Health. https://blog.petrieflom.law.harvard.edu/2017/12/08/islam-and-the-beginning-of-human-life/

[54] Aksoy, S. (2005). Making regulations and drawing up legislation in Islamic countries under conditions of uncertainty, with special reference to embryonic stem cell research. Journal of Medical Ethics , 31: 399-403.; see also: Mahmoud, Azza. "Islamic Bioethics: National Regulations and Guidelines of Human Stem Cell Research in the Muslim World." Master's thesis, Chapman University, 2022. https://doi.org/10.36837/ chapman.000386

[55] Rashid, R. (2022). When does Ensoulment occur in the Human Foetus. Journal of the British Islamic Medical Association , 12 (4). ISSN 2634 8071. https://www.jbima.com/wp-content/uploads/2023/01/2-Ethics-3_-Ensoulment_Rafaqat.pdf.

[56] Sivaraman, M. & Noor, S. (2017). Ethics of embryonic stem cell research according to Buddhist, Hindu, Catholic, and Islamic religions: perspective from Malaysia. Asian Biomedicine,8(1) 43-52.  https://doi.org/10.5372/1905-7415.0801.260

[57] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[58] Lecso, P. A. (1991). The Bodhisattva Ideal and Organ Transplantation.  Journal of Religion and Health ,  30 (1), 35–41. http://www.jstor.org/stable/27510629 ; Bodhisattva, S. (n.d.). The Key of Becoming a Bodhisattva . A Guide to the Bodhisattva Way of Life. http://www.buddhism.org/Sutras/2/BodhisattvaWay.htm

[59] There is no explicit religious reference to when life begins or how to conduct research that interacts with the concept of life. However, these are relevant verses pertaining to how the fetus is viewed. (( King James Bible . (1999). Oxford University Press. (original work published 1769))

Jerimiah 1: 5 “Before I formed thee in the belly I knew thee; and before thou camest forth out of the womb I sanctified thee…”

In prophet Jerimiah’s insight, God set him apart as a person known before childbirth, a theme carried within the Psalm of David.

Psalm 139: 13-14 “…Thou hast covered me in my mother's womb. I will praise thee; for I am fearfully and wonderfully made…”

These verses demonstrate David’s respect for God as an entity that would know of all man’s thoughts and doings even before birth.

[60] It should be noted that abortion is not supported as well.

[61] The Vatican. (1987, February 22). Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation Replies to Certain Questions of the Day . Congregation For the Doctrine of the Faith. https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_19870222_respect-for-human-life_en.html

[62] The Vatican. (2000, August 25). Declaration On the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells . Pontifical Academy for Life. https://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20000824_cellule-staminali_en.html ; Ohara, N. (2003). Ethical Consideration of Experimentation Using Living Human Embryos: The Catholic Church’s Position on Human Embryonic Stem Cell Research and Human Cloning. Department of Obstetrics and Gynecology . Retrieved from https://article.imrpress.com/journal/CEOG/30/2-3/pii/2003018/77-81.pdf.

[63] Smith, G. A. (2022, May 23). Like Americans overall, Catholics vary in their abortion views, with regular mass attenders most opposed . Pew Research Center. https://www.pewresearch.org/short-reads/2022/05/23/like-americans-overall-catholics-vary-in-their-abortion-views-with-regular-mass-attenders-most-opposed/

[64] Rosner, F., & Reichman, E. (2002). Embryonic stem cell research in Jewish law. Journal of halacha and contemporary society , (43), 49–68.; Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[65] Schenker J. G. (2008). The beginning of human life: status of embryo. Perspectives in Halakha (Jewish Religious Law).  Journal of assisted reproduction and genetics ,  25 (6), 271–276. https://doi.org/10.1007/s10815-008-9221-6

[66] Ruttenberg, D. (2020, May 5). The Torah of Abortion Justice (annotated source sheet) . Sefaria. https://www.sefaria.org/sheets/234926.7?lang=bi&with=all&lang2=en

[67] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.),  Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues  (pp. 79-94). Berkeley: University of California Press.  https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005

[68] Gert, B. (2007). Common morality: Deciding what to do . Oxford Univ. Press.

[69] World Medical Association (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA , 310(20), 2191–2194. https://doi.org/10.1001/jama.2013.281053 Declaration of Helsinki – WMA – The World Medical Association .; see also: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979).  The Belmont report: Ethical principles and guidelines for the protection of human subjects of research . U.S. Department of Health and Human Services.  https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

[70] Zakarin Safier, L., Gumer, A., Kline, M., Egli, D., & Sauer, M. V. (2018). Compensating human subjects providing oocytes for stem cell research: 9-year experience and outcomes.  Journal of assisted reproduction and genetics ,  35 (7), 1219–1225. https://doi.org/10.1007/s10815-018-1171-z https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063839/ see also: Riordan, N. H., & Paz Rodríguez, J. (2021). Addressing concerns regarding associated costs, transparency, and integrity of research in recent stem cell trial. Stem Cells Translational Medicine , 10 (12), 1715–1716. https://doi.org/10.1002/sctm.21-0234

[71] Klitzman, R., & Sauer, M. V. (2009). Payment of egg donors in stem cell research in the USA.  Reproductive biomedicine online ,  18 (5), 603–608. https://doi.org/10.1016/s1472-6483(10)60002-8

[72] Krosin, M. T., Klitzman, R., Levin, B., Cheng, J., & Ranney, M. L. (2006). Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa.  Clinical trials (London, England) ,  3 (3), 306–313. https://doi.org/10.1191/1740774506cn150oa

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[74] Msoroka, M. S., & Amundsen, D. (2018). One size fits not quite all: Universal research ethics with diversity.  Research Ethics ,  14 (3), 1-17.  https://doi.org/10.1177/1747016117739939

[75] Pirzada, N. (2022). The Expansion of Turkey’s Medical Tourism Industry.  Voices in Bioethics ,  8 . https://doi.org/10.52214/vib.v8i.9894

[76] Stem Cell Tourism: False Hope for Real Money . Harvard Stem Cell Institute (HSCI). (2023). https://hsci.harvard.edu/stem-cell-tourism , See also: Bissassar, M. (2017). Transnational Stem Cell Tourism: An ethical analysis.  Voices in Bioethics ,  3 . https://doi.org/10.7916/vib.v3i.6027

[77] Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation,  New Genetics and Society , 30:2, 141-153, DOI:  10.1080/14636778.2011.574375

[78] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East.  Nature  510, 189. https://doi.org/10.1038/510189a

[79] International Society for Stem Cell Research. (2024). Standards in stem cell research . International Society for Stem Cell Research. https://www.isscr.org/guidelines/5-standards-in-stem-cell-research

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Mifrah Hayath

SM Candidate Harvard Medical School, MS Biotechnology Johns Hopkins University

Olivia Bowers

MS Bioethics Columbia University (Disclosure: affiliated with Voices in Bioethics)

Article Details

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• Open access
• Published: 10 May 2024

Translating global evidence into local implementation through technical assistance: a realist evaluation of the Bloomberg philanthropies initiative for global Road safety

• Rachel Neill   ORCID: orcid.org/0000-0002-1110-5479 1 ,
• Angélica López Hernández 1 ,
• Adam D. Koon 1 &
• Abdulgafoor M. Bachani 1  

Globalization and Health volume  20 , Article number:  42 ( 2024 ) Cite this article

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Traffic-related crashes are a leading cause of premature death and disability. The safe systems approach is an evidence-informed set of innovations to reduce traffic-related injuries and deaths. First developed in Sweden, global health actors are adapting the model to improve road safety in low- and middle-income countries via technical assistance (TA) programs; however, there is little evidence on road safety TA across contexts. This study investigated how, why, and under what conditions technical assistance influenced evidence-informed road safety in Accra (Ghana), Bogotá (Colombia), and Mumbai (India), using a case study of the Bloomberg Philanthropies Initiative for Global Road Safety (BIGRS).

We conducted a realist evaluation with a multiple case study design to construct a program theory. Key informant interviews were conducted with 68 government officials, program staff, and other stakeholders. Documents were utilized to trace the evolution of the program. We used a retroductive analysis approach, drawing on the diffusion of innovation theory and guided by the context-mechanism-outcome approach to realist evaluation.

TA can improve road safety capabilities and increase the uptake of evidence-informed interventions. Hands-on capacity building tailored to specific implementation needs improved implementers’ understanding of new approaches. BIGRS generated novel, city-specific analytics that shifted the focus toward vulnerable road users. BIGRS and city officials launched pilots that brought evidence-informed approaches. This built confidence by demonstrating successful implementation and allowing government officials to gauge public perception. But pilots had to scale within existing city and national contexts. City champions, governance structures, existing political prioritization, and socio-cultural norms influenced scale-up.

The program theory emphasizes the interaction of trust, credibility, champions and their authority, governance structures, political prioritization, and the implement-ability of international evidence in creating the conditions for road safety change. BIGRS continues to be a vehicle for improving road safety at scale and developing coalitions that assist governments in fulfilling their role as stewards of population well-being. Our findings improve understanding of the complex role of TA in translating evidence-informed interventions to country-level implementation and emphasize the importance of context-sensitive TA to increase impact.

Road traffic crashes are the leading cause of death for persons aged 5–29 years age [ 1 ], and the 12th leading cause of deaths overall [ 2 ]. Road traffic mortality is three times higher in low-income countries than high-income countries (HICs), despite low-income countries having less than 1% of global motor vehicles [ 2 ]. Over half of traffic-related deaths are vulnerable road users (e.g., pedestrians, cyclists, and motorcyclists) [ 2 ].

Attention to road safety has grown, supported by evidence on the severity of the problem and solutions [ 3 ]. Successive ‘Decades of Action for Road Safety’ have raised awareness, and new institutions have improved policy cohesion and civil society mobilization [ 3 ]. The global road safety community has also cohered around a consensus-based solution – the safe system approach – developed in Sweden and increasingly applied globally. The safe system approach is a human-centered, proactive approach that shifts the focus of road safety from preventing crashes and improving road user behavior to preventing deaths and injuries while accounting for human error [ 4 ]. Despite global momentum, there is limited implementation of the safe system approach in low- and middle-income countries (LMICs) [ 3 , 5 , 6 ]. Global road safety programs emphasize the adaptation of the safe systems model to LMICs [ 5 , 7 ], even though the implementation context in LMICs varies significantly [ 8 ].

The role of technical assistance

Technical assistance (TA) is one way to increase the uptake of the safe system approach and other evidence-informed interventions. TA is a capacity-building process to design and/or improve the quality, effectiveness, and efficiency of programs and policies, [ 9 ]. Multi-country TA programs seek to translate the safe system approach to LMICs to reduce traffic-related injuries and mortality. The Bloomberg Philanthropies Initiative for Global Road Safety (BIGRS) is one of the largest and longest-standing multi-country road safety TA programs. This analysis concerns BIGRS Phase II, which provided a common package of TA interventions to ten LMIC city governments from 2014 to 2019. By the end of Phase II, cities differed considerably on the scale and scope of implementation.

BIGRS’ differential experiences across LMIC cities present an empirical case study on the feasibility of adapting common technical approaches across divergent contexts and the TA’s role. How much influence does TA have? What is the role of context in shaping TA providers’ and recipients’ agency?

A diverse body of scholarship concerns these questions and can guide empirical inquiry. Diffusion of innovation theory describes the process of transferring an evidence-informed intervention from one setting to another [ 10 , 11 ] and has been used to explore TA effectiveness [ 9 ]. Diffusion of innovation theory focuses on intervention characteristics, intervention adaptation, and how adaptation influences adoption and fidelity [ 10 , 11 , 12 ]. Greenhalgh’s Determinants of Diffusion, Dissemination, and Implementation of Innovations in Health Service Delivery and Organization Conceptual Model builds on diffusion of innovation theory by mapping considerations that influence the uptake of innovations. These include credibility, personal relationships, effective communication,translation of the innovation to meet end-users needs, and support to adopters [ 12 ]. More broadly, social science theories consider the role of structural context (e.g., laws, social norms, and governance) and pragmatic implementation contexts (e.g., individuals, relationships, and organizational cultures) in determining adaptation, and implementation [ 13 ]. These literature bring different perspectives to explain change through the interaction of interventions, actors, and context.

However, there is limited application of this literature to understand TA, especially road safety TA. A growing body of case studies describes what works and does not work for improving road safety in LMICs [ 14 , 15 , 16 ]. Limited research emphasizes political will, intervention tailoring, human and financial resources for dissemination [ 17 ], the best practice exchange [ 18 ], technology transfer [ 19 ], and the power of multi-sectoral coalitions [ 20 ] to translate road safety evidence into practice. However, despite the existence of several multi-million-dollar road safety TA and funding programs [ 21 , 22 , 23 , 24 , 25 ], we did not identify any evidence on the role of TA in supporting or inhibiting road safety improvements – a key evidence gap.

Study objective

This study aims to improve understanding of if, how, why, and under what conditions TA programs strengthen evidence-informed road safety programs in LMICs. We do this via a realist evaluation with a multiple case study design of BIGRS’ implementation, comparing how common TA interventions interacted with contextual factors to produce differential observable outcomes in Accra, Bogotá, and Mumbai. These findings are distilled into a program theory that provides insight into how ‘global’ approaches are translated to country-level implementation and can be used to guide TA’s design and implementation.

Realist evaluation connects theories of ‘how the world works’ with ‘how a program works’ to explain how interventions trigger mechanisms in different contexts [ 26 ]. We used a realist evaluation methodology [ 27 ] to identify how, why, and under what conditions TA can strengthen evidence-informed road safety, with a multiple case study design to improve understanding of how BIGRS worked in diverse contexts [ 28 , 29 ] [ 26 ]. This methodology was selected to identify the underlying mechanisms driving the program’s differential outcomes in different contexts [ 27 ].

• Realist evaluation

Programs are theories about how something works. They are embedded into open systems and adaptively interact with the context. Intervention outcomes result from engagement between program actors and contexts [ 27 ]. An intervention-context-mechanism-outcome pattern (ICMO) represents this [ 27 ] (Table  1 ).

We adhered to the Realist and Meta-narrative Evidence Syntheses: Evolving Standards (RAMSES) II reporting guidelines for realist evaluation to guide design, data collection, and analysis [ 26 ], provided in Additional File 1 . The study protocol is in Additional File 2 .

Study setting

Bloomberg Philanthropies’ BIGRS Phase Two was implemented in Accra, Addis Ababa, Bandung, Bangkok, Bogotá, Fortaleza, Mumbai, Ho Chi Min, Sao Paulo, and Shanghai from 2014 to 2019 and is the focus of this study. BIGRS is currently in its third phase and has scaled up to 27 cities and two states across Latin America, sub-Saharan Africa, and Asia.

Cities applied for BIGRS-supported TA by submitting a proposal that demonstrated their commitment to and plans for road safety. This is important because it meant that cities demonstrated a common commitment and desired TA, at least in theory. Funding for interventions (e.g., re-designing an intersection or mass media campaigns) came from city governments.

BIGRS’ TA came with a technical agenda – aligned to the safe system approach – on how road safety should be improved. BIGRS’ scope was tailored to city needs within pre-existing parameters and excluding funding for capital construction. To provide TA, BIGRS seconded staff into leading road safety agencies to build institutional capacity for change. Embedded staff supported BIGRS interventions, provided direct TA to city counterparts, and often, provided cross-cutting support to city officials. In addition, seven international partner organizations managed technical activities. Partners and embedded staff were aligned to technical areas and often worked with different counterparts (e.g., an enforcement partner working with the police, an infrastructure partner working with an engineering unit).

Case design and sampling

A multiple case study design was utilized; see Additional file 3 for details. Only cities continuing into BIGRS Phase Three were eligible for selection to ensure access to informants. We purposefully selected three cities – Accra, Ghana; Bogotá, Colombia; and Mumbai, India – with different baseline characteristics described in Table  2 .

Data collection

Key informant interviews (KIIs) were our primary data source, and documents were secondary. Program documents were used to build an initial program theory, develop the interview guides, and follow ‘hunches’ about how an intervention worked in a context [ 35 , 36 ]. We also snowballed documents from interviews to confirm and triangulate interview findings.

Key informant interviews

We used a theoretical sampling approach to select informants based on their ICMO potential [ 27 ]. We iteratively sampled informants until saturation – when interviews provided no new insights [ 37 ]. Table  3 describes the KII sample. Road safety governance models influenced the balance of KII types. Road safety governance in Accra and Mumbai is more diffused than Bogotá, which had fewer government informants. KIIs also varied across cities due to differential access to informants. To overcome this disadvantage, we triangulated findings with the document review.

Interviews were conducted from January 2020 to November 2022 by two members of the research team with doctoral-level training in qualitative methods. Participants were contacted via email and invited to a one-hour interview on barriers and enablers to BIGRS and mechanisms associated with program outcomes. Interviews in Mumbai were conducted via Zoom. Interviews in Bogotá and Accra were conducted in-person and on Zoom.

A realist approach to interviewing was used to build an iterative understanding of how the program worked, test our interpretations, and seek alternative explanations (Additional file 3 ). Interviews were recorded and transcribed with permission. Fifty-one interviews were conducted in English, recorded, and transcribed. Seventeen interviews were conducted in Spanish by a native speaker, recorded, transcribed, and translated into English by a certified translator.

Data collection and analysis were done iteratively using a process of retroduction [ 35 , 36 , 38 ] (Fig.  1 ).

Iterative analysis process

As is common in this literature [ 39 ], BIGRS’ theory of change (TOC) was used as the initial program theory (IPT). Following guidance on realist evaluation analysis [ 38 ], we iteratively identified ICMOs and compared them to the IPT and broader literature to develop the program theory. This included an initial thematic coding of the data, a second round of theory refinement coding where themes were split into ICMOs, triangulation of findings from the documents and interviews, and comparison of the findings with existing theory to deepen our understanding of plausible mechanisms. Additional file 3 describes this process in more detail. We conducted this analysis in NVivo12.

Regular discussions were held across the research team to define and iterate on the codebook, discuss emergent themes, and review ICMO configurations. Memos were developed in Microsoft Word and documented ICMO iterations. Draft findings were shared with a subset of the participants for feedback and validation before program theory finalization.

In 2014, BIGRS initiated a common TA program in Accra, Bogotá, and Mumbai. TA interventions, individuals providing and receiving TA, the city context, and the national-level road safety context influenced implementation. Table  4 outlines interventions and outcomes. Interventions are grouped under two outcomes: (1) improved road safety capabilities (via capacity building and data) and (2) increased the uptake of evidence-informed road safety interventions (via infrastructure, enforcement, and policy support).

We present one example per case that demonstrates how different interventions worked together to achieve different outcomes in case study cities. Interventions (i), mechanisms (m), contexts (c), and outcomes (o) are denoted in the text. Reference to KII data is provided as M# for Mumbai, B# for Bogotá, A# for Accra, and G# for KIs working across multiple cities. 

Transforming junctions on Mumbai’s congested streets

When BIGRS began, Mumbai’s road safety officials used high-level figures on traffic fatalities supplemented with national or state-level statistics to guide road safety decision making (c) . The city-specific data required to target road safety interventions was buried in paper-based police records of variable quality (c) . A government official in Mumbai describes:

" That is [a] very big [problem] because we are not like other countries, we are not getting the data correctly.” – M17

In response, BIGRS’ TA first sought to improve surveillance data. An embedded surveillance coordinator partnered with the police to catalog and analyze city surveillance data and package it in new annual city road safety reports (i) [ 40 ]. Infrastructure assessments (i) further demonstrated how specific road junctions contributed to injuries and mortality (o). BIGRS staff described the change in data availability:

“[Before] there were no reports at all […]. Now I have […] a 40-page report that talks about who the road users are, […] a list of high-risk junctions and corridors […], a map that details the hotspots where crashes are occurring […] which vehicle is causing maximum crashes, […] the time of the day, the month of the year, the day of the week.” – M8

New data demonstrated that half of traffic-related crash victims were pedestrians, which was further reported by local city media [ 41 , 42 ]. Providing granular, city-specific data shifted the focus (m) of government towards pedestrian safety (M8, M12, M17). The same BIGRS staff member described:

“The government didn't know that so many pedestrians were dying in crashes. These reports help bring that to light. And when that came to light, they started taking a more serious approach.” – M8

The emphasis on pedestrians was echoed by city government officials, who agreed that the data was illuminating (M12, M17). But the city also required solutions for this perception shift to lead to concrete action. The same government official describes the challenges (c) :

“We lack the best instrument in the old system to make the road elevated, or a road underpass is very difficult because the traffic on that high main road. […] That is very critical because it we are really facing problems.” – M17

BIGRS provided the safe system approach as a solution– but how would it work in Mumbai? This question was a central concern in all cities, especially in densely populated Mumbai, where participants described the street as a ‘contested space’ (M9, M2, M21) (c) . Implementing the safe system approach in Mumbai required a complex adaptation process (G5, M2, M9, G6, M7) (i) . A BIGRS infrastructure partner described:

“We’re constantly trying to balance Global Best Practices versus what can be done in an Indian city while pushing boundaries to be able to think outside the box. […] it's helpful to show International Best Practices, but also at the same time, balancing it out with what’s actually possible in Indian cities.” – M9

Implement-ability was top of mind for city government officials taking risks by trying a new approach (c) . BIGRS staff had to recognize those risks and work collaboratively with city government counterparts to understand how international approaches could work within local realities (B15, M13) (c) . A BIGRS staff member described this:

“[When you introduce international examples], there are a lot of questions and pushback saying, ‘how could this be done [here]? That was also instructive to us. How do you deal with such situations?” – M13

Short-term demonstration projects – for example, temporarily changing traffic flow using cones and other local, low-cost materials (i) – allowed city government counterparts to see the safe system approach in action on their street in a low-risk context, demonstrating that a new approach was possible (B15, M11, G7, M9, B7, M17). A city official describes:

“People are generally not aware of the things [happening outside India], [but] the problems are same. […] That can be taken only if you can show them the models […] because firsthand information from those people is much more important.” – M17

Seeing the possibility of change was perceived to shift the focus of road safety towards vulnerable road users and especially pedestrians (M18B, B15, M11, G7, M9, M15, M18, M17, M2, G2, M9, M7, M14, M8) (m) . It also created a ‘how-to’ moment, enabling city government counterparts to internalize both the concept and implementation feasibility (m). A city official describes what he learned:

“[I learned] new technical things, that might be there's been a certain technical change in junction design or in the road design. […] we were not able to do that thing nicely already […] We were able to grab that opportunity properly.” – M18

Once city government counterparts understood the potential of the safe system approach (o) , BIGRS TA worked with city officials to use the data and select specific junctions for re-design (i) . Data was critical because it helped target infrastructure improvement to junctions with an outsized number of crashes. A BIGRS staff described:

“Now [Mumbai city government are] not just randomly doing the interventions. They're very focused on where crashes are occurring, who the victims are, who the perpetrators are, and how to ensure that these crashes don't occur at all.” – M8

Once the mechanism for change was triggered, transforming junctions started with a pilot (i). Pilots ensured that the safe systems approach was feasible and appropriately adapted to the context, that its impact on different road users was understood and planned for, and that the re-design successfully reduced crashes [ 43 , 44 , 45 ]. Pilots also allowed the city government to understand public sentiment about the changes (c) [ 43 ] . If the public was supportive, this reduced the risk to city officials trying a new approach (m) . The city government counterpart’s confidence in new approaches grew (m). This was further reinforced by data showing that infrastructure redesign positively impacted traffic flow [ 43 ]. A pilot’s success was described as leading to exponential growth in implementation (M21, M1) [ 44 , 46 , 47 ]. A BIGRS partner described:

“If you see our work, it has exponentially grown in impact. […] From that one [pilot] corridor, we […] build a relationship and trust […] and so we got a chance to do design in the intersection. Then you try it with temporary sort of barricades and then it became a big thing. And then one thing just kept leading to another to another.” – M21

As implementation took off, BIGRS engaged local media to spread awareness about the junction transformations (i) (M11). After seeing firsthand what could be accomplished, the city government also committed to improving high-risk intersections in the city. However, despite growing momentum and support from both city government and city engineers to transform individual junctions, the bottom-up pilot approach presented practical scale and sustainability challenges despite this government commitment (M9, M13, documents) (c). A BIGRs partner described:

“It's a challenge at times, when the city does not have the funds allocated in that year. If you do manage a successful pilot and the city takes on doing it, then it's great because they can be scaled up. But in many cases […] pilots are sort of left as just that.” – M9

BIGRS partners described city government approvals as challenges preventing scale. In contrast, city government participants urged respect for government processes and timelines, which they saw as paramount to success (c). In managing these processes, city officials also took on significant work to enable each infrastructure re-design (M12, M18) – a contribution that often went unacknowledged (c).

Comparison of Mumbai’s infrastructure experience with other BIGRS cities

The Mumbai infrastructure example is illustrative of common dynamics. In Bogotá, capacity building was similarly perceived as successful when it used hands-on components specifically relevant to the participants (B15, G2, B9, B7, B14), and when facilitators used a coaching model that emphasized the participant’s experience (B15, B5, B9, G2).

Accra’s and Bogotá’s infrastructure TA were also targeted at bottom-up approaches (G6, A9, A5, A6, A8, M9) and guided by city-specific data (i ), but with limited scale. In Accra, BIGRS focused on low- or no-cost interventions (e.g, changing signal times for pedestrian crosswalks, widening pedestrian medians (i) ) (A5, A6, A8) because the city did not control the infrastructure budget and could not budget for new interventions. BIGRS also worked with the city to re-design the infamously dangerous Lapaz intersection to improve pedestrian safety, which was funded directly by BIGRS via a small grants program (i) [ 48 ]. In Bogotá, tactical urbanism demonstrated speed-calming measures, and feedback from road users was gathered (i) (B2). However, despite promising pilots, the lack of BIGRS’ ability to influence upstream changes to road procurement tenders and design guidelines limited the scale of infrastructure outcomes in each city.

Enforcing road safety legislation in Accra

In Accra, road safety legislation existed but needed to be enforced (c). In the words of a national road safety agency staff , “there’s no real commitment in solving some of these things.” (A17). BIGRS’ enforcement interventions started with relationship building (i). A BIGRS partner describes:

“How important it is to have this relationship with the high-level police officers. Because we cannot just go to a city or road police agency and say that this is what we want to do.” – A22

Trainings on the safe systems approach (i) and evidence-based enforcement operations were enabled by leadership support from the Superintendent of Police (A4) and the Mayor of Accra who championed road safety and several BIGRS initiatives (A4, A6, A3, A5, A8, A1, program documents) [ 48 , 49 ] (c) .

However, translating training into implementation quickly stalled because the police force required equipment and certification for implementing enforcement operations (c) (A1, A4, A6, program documents) . BIGRS’ partners then donated new drink-driving and speed enforcement equipment under the condition that the city utilized the equipment to conduct enforcement pilots (i) . These donations were accompanied by training and certification processes (A1, A4, A25, program documents) (c) .

While the lack of equipment could be directly addressed by BIGRS, the disconnect between city-level enforcement efforts and Ghana’s centralized policing structure could not be so easily overcome. City police did not have the authority to conduct enforcement operations (c) , so in exchange for the donated equipment, the police formed a dedicated tri-partite pilot task force with the authority to use the donated equipment in a series of roadside speed and drink-driving enforcement operations  (i) .

New training and improved accuracy of the equipment were perceived to reduce conflict between police and citizens during enforcement and improved transparency in the enforcement operations (A1, A4, A25, program documents), reducing the perception of risk of public blowback (m). A high-ranking police officer describes the perceived increase in acceptability from the public:

“they don’t complain, they go to the court […] because you’ve told us that the device arefor enforcement operations (A4, A25) limiting further […] the very latest speed device, speed detection devices [equipment] because we’ve told the whole world about it.” – A25

The collective intervention – piloting the enforcement approach, supported by training and in tandem with appropriate equipment – was also received positively by the police. A senior police officer described a shift in focus towards ensuring road safety (m):

“What I’ve realised is, what a positive impact on our capability to be able to ensure road safety. [..]. With the devices, we can go to the route when they see us, all cars, cars you know approaching the robot, reduce their speed and that has really resulted in a lot of improvement.” – A25

However, while the pilot taskforce did conduct enforcement operations, a series of upstream barriers prevented the taskforce from scaling up. Most practically, the police force still lacked dedicated vehicles for enforcement operations (A4, A25) limiting further implementation. More broadly, the social and political context (A1, A4) (c) remained unconducive to enforcement. A BIGRS staff describes:

“During [the enforcement pilot], we did a special round of data collection for speed, and the data showed that there was a reduction in speed. However, the moment could not be sustained. Some of the feedback they got from the police was that [the] police could not boldly or fearlessly enforce.” – A1

Another challenge was that the required authority to change enforcement practices was vested in national agencies instead of the city government, limiting the ability of city police to institutionalize new enforcement operations (A4, program documents) (c). Finally, the transfer of police was described as a challenge to sustaining enforcement interventions (A4, A2, program documents) (c). A BIGRS partner described:

“We can work with person, everything agreed, and then just before we roll out, he's been transferred or there's a rotation, and we have to change everything.” — A22

Comparison of Accra’s enforcement experience with other BIGRS cities

Across the enforcement TA provided in the three cities, building trust with senior police officers was repeatedly emphasized (A4, B4, M16, G7, G10). Using former senior police officers from other countries was seen as key to building that neccessary trust (B4, M16, G7, G10) (c).

Like Bogotá, Accra’s enforcement interventions took place within broader city road safety prioritization (c), and BIGRS donations ensured police had the right equipment (i) , leading to increased enforcement (B8, G12, A4, A1, A22, A25) (o) . However, Bogotá’s enforcement was described as widespread and sustained (B8, G12), while in Accra, enforcement operations remained limited (o). The authority of the police to conduct enforcement was the key difference (c).

In contrast, India was moving towards an automated speed enforcement model, which contrasted with the model proposed by BIGRS (c) . Although automated and roadside enforcement co-exist (and they did in Bogotá), BIGRS’ roadside enforcement model did not align to the broader policy agenda in Mumbai and was not implemented.

Reducing city-wide speed limits in Bogotá – an example of policy change

Before BIGRS, improved mobility had been the focus of several consecutive city administrations (c) . A BIGRS partner described the favorable baseline environment:

“Bogotá has been concerned about road safety for a long time. [Bogotá] already had a Road Safety Directorate; […] there was already a direction with a super great team. It was easy to work in Bogotá because institutionally, they were already armed.” – B13

During Phase II, a new Secretary of Mobility with a public health background further elevated road safety in city administration (c)  which was perceived as critical to the city's subsequent policy change (B1, B11, B12, B13, B14, B15, B16). A city official explained:

“ It is about setting priorities. So, we [the secretariat], from the first day, said the priority is road safety, and we will do everything possible to make it so.” – Bogotá 2

Alongside a change in government, BIGRS also hired new embedded staff, some who were former members of city government, all who were local to Bogotá, and all who were passionately committed to improving road safety (c) (B12). However, support for road safety did not immediately translate to speed. Instead, city officials were interested in reducing drunk driving and were explicitly resistant to tackling speed ( c) . This was due both to concerns that reducing speed would increase traffic and also a perceived lack of concern from the population over speed (G12, G5, B8, B12). A BIGRS staff recalled:

“Even when communicating to [the] Mayor, he had the issue of road safety in his heart the main thing he communicated and did not want to do. ‘Do not slow down on arterial roads’” – B12

However, BIGRS’ analyses of city data (i) identified that speed was a serious concern on arterial roads at night (B8, B12, G5, G8). A BIGRS partner in Bogotá described:

“The first thing I did was share with the Police the data that clearly showed that most of the deaths occurred at night or early in the morning when most roads were empty.” – B8

This was further demonstrated by a modeling study (i) showing both the relationship between speed and the crash rate and that the change in speed limits would not impact average travel times. This study was important evidence, which was only possible because the city’s existing speed detection infrastructure provided the modeling data (B12) (c).

The presentation of this novel information to city officials was perceived to shift the focus of city officials by demonstrating that speeding was prevalent at night when roads were empty, and that reducing speed wouldn’t worsen traffic (m) . City officials used this data to select five arterial road corridors with high speeds, crashes, and deaths to pilot a reduced speed limit of 50 km per hour (kmph) (o and i) .

The speed reduction pilot required close collaboration between the Secretariat of Mobility and the police to conduct nighttime enforcement (c). However, the police lacked necessary nighttime radar equipment (c) (B8, G12), a gap subsequently filled by BIGRS’ donations (i) . TA was provided for the police to use the equipment and to conduct safe nighttime operations (i), increasing enforcement campaigns in the pilot speed management corridors (o). A BIGRS staff described:

“ [It] was clear when you make enforcement operations visible, like speed enforcement down that avenue. In a matter of months, we already saw a reduction [in speed].” – G12

The new roadside enforcement was complemented by automated speed detection cameras ( c) ; however, the public was skeptical of the speed cameras' threatening the pilot’s success (c). Public messaging campaigns were therefore developed using city data to demonstrate the rationale behind the speed reduction and enforcement ( i ). A BIGRS staff described:

“Legitimacy has to do with road users' acceptance of this type of control. […] What decisions were made? Make visible the places where photodetection cameras are installed. They were published on the website of the Ministry of Mobility, and there was a strong media drive to make these cameras visible and associate the cameras with the issue of life-saving cameras.” –B8

BIGRS also provided monitoring and evaluation support (i) which quickly demonstrating the pilot’s effectiveness (o). A BIGRS staff described:

“In a matter of months, I already saw a reduction [in deaths]. That gave the Secretary of Mobility the confidence, trust like, ‘OK, like this is working, we are reducing deaths where we are not messing up traffic. Let's do it.’” – G12

A city official recalled the importance of the pilots:

“Yes, yes, yes, that was very well done. The expressive power of those corridors, of the first ones” – B14

Because of the positive pilot results, the city increased the number of corridors with lowered speed limits (o). The results of the pilot were also shared with the public, reinforcing the message that the speed reduction corridors were lifesaving interventions (G12, G5) (i) and further reducing the perception of risk in lowering the speed limit by building public support (m). As the pilot gained increased support, city counterparts used the data to develop a technical document justifying the lowered speed limits to Bogotá’s city council. A BIGRS staff described:

“To be able to argue before the City Council, it was necessary to argue with objective judgment elements […] Why did they decide to slow down? Not because it occurred to us. No, the speed was lowered because this technical document allows us to support making that decision.” – B8

Aided by the pilot’s success and with the support built through public messaging campaigns, the city council maintained the 50 km/h speed limit on the pilot corridors (o). However, the city council initially did not have the authority to change city-wide speed limits permanently (c), preventing scale-up until a window of opportunity opened in 2020. During the 2020 COVID-19 pandemic, a state of emergency was declared, giving temporary executive authority to the Mayor (c) . Although the Secretary of Mobility (the champion of the pilot) had changed, their successor became a new champion. They successfully argued that the speed limit reduction was preventing traffic crashes, thereby reducing non-COVID-19 health emergencies and freeing up healthcare capacity during the pandemic. This allowed the Mayor to extend the speed reductions city-wide in alignment with the WHO’s advised 50 km/h (o).

Reflecting on Bogotá’s experience with BIGRS, a city official described how BIGRS’ comprehensive TA approach was important in supporting the city’s road safety vision:

“We wanted to build how this systemic vision of approaching the problem. And then Bloomberg supported us with communications, technical, infrastructure, traffic calming, and enforcement issues.” – B2

City officials and BIGRS staff alike credited city leadership for continuously supporting road safety throughout several administrations and for giving political support to technical staff who brought changes to the city (c). One government official commented:

“ Everyone, I think, without exception, has supported this work. I believe that the first requirement to choose a city is that there is willingness. What has been in Bogotá, really, is the political will of the leaders to carry it out. Without it, you do nothing .” – B14

Comparison of Bogotá’s policy experience with other BIGRS cities

The scale of change in Bogotá’s road safety programming stands apart from the other case studies. Second to this was Accra; the city government formed a new road safety council and developed the city's first Pedestrian Action Plan (o). Like Bogotá, BIGRS in Accra leveraged city prioritization for road safety and provided city-specific evidence (i), which focused city stakeholders’ efforts on the importance of pedestrian safety (A8, A1, A5, A3, program documents). Also, like Bogotá, the Mayor was a champion who lent convening power to the development of Accra’s action plan (4, A6, A3, A5, A8, A1, program documents) (c) . The Accra Pedestrian Action Plan was further perceived to improve coordination of different road stakeholders towards a common goal (A8, A1, A5, A3, A6, program documents).

In Mumbai, in contrast, BIGRS staff and partners described a lack of an individual champion with the authority to advance road safety policy and planning at the city level as a key challenge (M10, M11, M12, M13, M14, M15, M21).

Revised program theory

The revised program theory for BIGRS should be considered an initial attempt to synthesize across both positive cases (where outcomes were observed) and negative cases (where outcomes were limited by specific factors) to distill a set of higher-level statements about how BIGRS works at the city level and the contexts that enable or constrain its success.

The first program theory is improved road safety capabilities, focused on capacity and data use interventions described by BIGRS staff and partners as precursors to implementation in each case study city.

Program theory for improved road safety capabilities:

Providing TA to increase capacity and data use (i), if delivered via trusted and credible TA providers who provide hands-on coaching support tailored to city needs and with counterparts interested in engaging with road safety, can strengthen road safety capabilities (o) because it shifts the focus of city officials towards evidence-informed approaches and creates a how-to moment to improve road safety through the safe system approach (m). This outcome is enabled by city prioritization of road safety (c) and can be disrupted if city government officials change (c) .

The second program theory is increasing the uptake of evidence-informed implementation of road safety interventions. In this theory, capacity building and data now comprise the necessary context that supports the interventions, and BIGRS and city officials are characterized as working together to implement.

Program theory for increasing the uptake of evidence-informed implementation of road safety interventions:

If trusted and credible TA providers, working with and through city champions (c), undertake a successful pilot (i), guided by city-specific data that targets interventions (c) , and with facilitation of city implementation via dedicated equipment, training and other supportive resources (i) , then this can increase the uptake of evidence-informed road safety interventions (o). This occurs because a pilot builds confidence that the safe systems approach is feasible in a specific road context (m) , and it reduces the perception of risk in adopting a new approach (m) by allowing city officials to gauge public sentiment. The scale and sustainability of the outcome(s) are determined by the city’s existing prioritization of road safety, the authority of the individuals and road safety agencies targeted in the intervention, and existing socio-cultural norms (c) . It can be disrupted if city government officials change (c) .

BIGRS’ interventions sought to accelerate cities’ adoption of the safe system approach. What united city officials were two questions – will it work here, and how? To answer those questions, TA needed to go beyond recommending that a safe system approach would work, to demonstrating how it could work, to prove that it worked (without provoking negative reactions from the public).

How did TA work?

TA provider credibility and ability to navigate the city context were important. This was demonstrated by embedded staff who continuously connected the evidence-base and resources of international partners with the tacit knowledge and goals of city agencies. By playing a dual ‘insider-outsider’ role, embedded staff worked to create a favorable context for interventions and made interventions a better fit for the context. This describes the role of boundary-spanners who bridge insider and outsider roles to facilitate the adoption of an intervention [ 12 ].

How TA was provided was also essential. TA providers needed to understand the context and work effectively within it, not against it. Capacity-building activities needed to follow a coaching model, amplifying the existing knowledge, needs, and priorities of decision-makers. Interventions needed to be immediately relevant to the context, or TA providers risked losing credibility. BIGRS embedded staff and partners based full-time in the city again had the advantage here. This finding aligns with calls for TA to be context-sensitive [ 50 , 51 ] and aligns with the characteristics of successful change agents [ 12 ].

Why did TA work (or not work)?

The mechanism ‘shifting the focus’ was about data. Aligning with diffusion of innovation theory, data framed a ‘felt need’ for change [ 52 ] in all cities to different degrees. Bogotá was an early adopter; new data was presented within the context of political commitment to road safety, and pre-existing automated enforcement infrastructure enabled BIGRS to develop data-driven machine learning models to predict the results of the speed enforcement pilot. In Mumbai, in comparision, most of BIGRS’ Phase II activities focused on building city data capabilities to catalyze this shift in focus. ‘Shifting the focus’ was further enhanced by city officials’ ability to establish fora for governing the use of data to support policy decisions, consistent with international norms [ 53 ].

But ‘shifting the focus’ was also directly facilitated by BIGRS, making it the most uncertain mechanism. An alternative conceptualization is that BIGRS ‘shifted the focus’ by dedicating resources to specific interventions, informed by its data, which the city endorsed.

The second mechanism, creating a ‘how-to moment’, comes from diffusion of innovation’s knowledge phase [ 52 ]. Adopters must understand how an innovation works, especially if the innovation is complex [ 52 ]. Pilots allowed officials to see change in action, built confidence, and reduced the risk of stakeholder discontent from changing the road environment [ 12 , 52 ]. BIGRS also had an advantage; infrastructure re-design and enforcement are trial-able approaches with quickly observable outcomes which supports innovation adoption [ 10 , 12 ].

Under what conditions did TA work (or not work)?

Moving from the first program theory outcome (‘strengthened road safety capabilities’) to the second (‘increasing evidence-informed interventions’) required more than triggering individual-level mechanisms. To change implementation, individual-level mechanisms had to translate into institutional actions by city officials– e.g., approving pilots, allocating resources, and implementing interventions. It was here that context was critical.

City champions were key to enabling change. Champions are important in diffusion of innovation theory [ 12 ] and were critical here. However, following structure-agent theory, city champions could only change areas within their control [ 54 ] and their agency varied. Comparing Bogotá and Accra is instructive. Bogotá had considerable latitude to change road safety practices, while Accra’s pilot task force failed to scale due to limited institutional and normative authority to enforce legislation. Officials in road safety agencies lamented this alongside BIGRS staff, suggesting that the interventions were compatible with the context [ 52 ] but that the city's agency was constrained.

Structural, or outer, contexts therefore determined the feasibility of converting individual and city level mechanisms into outcomes. Diffusion of innovation theory considers that innovation may not be ‘compatible’ with the context or that the system may not be ‘ready’ for change, which was important in these cases. But more important, however, was how the innovation was introduced, who introduced it, the city's priorities, and city’s authority to adopt the innovation. This points to a critical consideration – if the dissemination approach of how the innovation is introduced is incompatible with structural context, adoption will be slow or unsuccessful (even if the innovation itself fits the context).

Boundary spanning – crossing boundaries to negotiate interactions and translate knowledge from different settings [ 55 ] – is one way to bridge the gap between proposed solutions and local contexts. A 2017 multi-county nutrition project found that boundary spanning was feasible and useful to navigate context-specific challenges [ 56 ]. Our study suggests that boundary spanning – if those doing the boundary spanning are deeply embedded within the local context – could be a useful model for delivering TA. Engaging boundary spanners from the beginning to work with city government officials to design TA programs around local problems and priorities, rather than providing both with a model from elsewhere to adapt, is a practical way to design more context-sensitive TA and surface local innovations [ 13 ].

Strengths and limitations

The goal of this study was to learn from implementation experience and develop a program theory. We did not quantitatively measure outcomes, a limitation. To improve trustworthiness, we triangulated findings across cities and data sources. However, outcomes were mainly validated with informants due to a lack of access to documents across BIGRS partners, creating some uncertainty. Another limitation was the overrepresentation of BIGRS staff and partners in our sample as compared to government officials and other city stakeholders. The reasons for this were both practical – e.g., scheduling interviews over Zoom, governance differences across cities – and representative of broader findings – government official turnover limited available informants. Finally, several authors (but not the first author) were involved in BIGRS’ implementation, which required continual bracketing when analyzing the data.

Our multiple case study design was a strength, enabling ICMO comparison across cities, reducing uncertainty, and increasing confidence. Iterative data collection and validation of the program theory with participants further reduced uncertainty because we could discuss uncertainties with participants and dig deeper. We also verified our interpretations with documents.

We identified broadly applicable insights into the role of TA in strengthening evidence-informed road safety in LMICs and distilled these into a program theory, contributing to knowledge on multisectoral TA programs in global health. Our study is the first we know of to empirically analyze the role of TA in influencing road safety in LMICs. BIGRS’ program theory emphasizes the interaction of trust, credibility, champions and their authority, governance structures, political prioritization, and the implement-ability of evidence in creating the conditions for road safety change. Designing context-specific TA appropriate for structural contexts is critical. If decision makers prioritize road safety, TA can accompany local leaders in adapting international approaches to local realities. In this way, we see cross-country multisectoral projects as important opportunities to improve population health.

Availability of data and materials

Data generated and analyzed during this study are included in this article. Key informants were assured that the raw transcripts would not be shared.

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Acknowledgements

The authors wish to acknowledge Dr. Jeremy Shiffman, Dr. Svea Closser, and Dr. Nukhba Zia of the Johns Hopkins University Bloomberg School of Public Health who provided comments on an earlier version of this manuscript. The authors also thank Sylviane Ratte, Director, Road Safety Program and Sara Whitehead, Consultant, Public Health and Preventive Medicine, Road Safety Program, at Vital Strategies who provided valuable comments on this research and support in contacting key informants. The authors also wish to thank Alma H. Ramírez of Teasa Translate for providing translation and transcription services for the study. Finally, the authors wish to thank the study participants who generously provided their time and valuable insights.

This project was supported by Bloomberg Philanthropies through the Bloomberg Philanthropies Initiative for Global Road Safety (Grant No. 111882). The funders were not involved in this study or development of this manuscript.

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Neill, R., Hernández, A.L., Koon, A.D. et al. Translating global evidence into local implementation through technical assistance: a realist evaluation of the Bloomberg philanthropies initiative for global Road safety. Global Health 20 , 42 (2024). https://doi.org/10.1186/s12992-024-01041-z

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Background and purpose: To test the hypothesis that the incidence of Creutzfeldt-Jakob disease (CJD) has remained constant, we calculated the rate of hospitalizations for CJD in the United States using the National Inpatient Sample (NIS) from 2000 to 2019. Methods: We used ICD-9 and ICD-10 codes to identify people hospitalized with presumed CJD in the National Inpatient Sample (NIS) from 2000 to 2019. Survey weights were used to calculate nationally representative estimates. We used 2000 census data to calculate age-adjusted standardized rates of CJD hospitalizations by sex and race-ethnicity and then used Joinpoint regression to evaluate changes in those rates. Results: From 2000 to 2019, there were 11,064 admissions for CJD across the U.S. Across this period, the age-adjusted rate of CJD-related hospitalizations increased significantly from 1.25 (95% CI, 1.25-1.26) to 1.98 (95% CI, 1.98-1.99) per million U.S. adults per year, with a significant annual percentage change between 2004 and 2013 of 7.6% (95% CI, 4.4%-10.9%). Conclusions: The incidence of CJD increased in the United States from 2000 to 2019, with a significant increase specifically between 2004 and 2013, though the overall case rate remains low.

Competing Interest Statement

Dr. Seitz and Ms. Zhang report no conflicts. Dr. Navi has received personal compensation for medicolegal consulting on neurological disorders. Dr. Kamel serves as a PI for the NIH-funded ARCADIA trial (NINDS U01NS095869), which receives in-kind study drug from the BMS-Pfizer Alliance for Eliquis and ancillary study support from Roche Diagnostics; as Deputy Editor for JAMA Neurology; on clinical trial steering/ executive committees for Medtronic, Janssen, and Javelin Medical; and on endpoint adjudication committees for AstraZeneca, Novo Nordisk, and Boehringer Ingelheim. He has an ownership interest in TETMedical, Inc. Dr. Merkler has received personal compensation for medicolegal consulting on neurological disorders.

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