research governance framework 2022

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Research Governance Guidelines

Published: 10 June 2022

Version: 3 - January 2023

Please contact your nominees before you give us their names, to ascertain their availability and willingness to be appointed.

Trial Steering Committees and Study Steering Committees

All projects with an element of primary research are required to establish a Steering Committee. The following lists provide guidance on its role, constitution, composition, meeting requirements and primary reporting line. This information can be used as a template terms of reference.

The role of the Steering Committee

The role of the Steering Committee is to provide overall supervision for a project on behalf of the study's Sponsor and Funder and to ensure that it is conducted to the rigorous standards set out in the  UK Policy Framework for Health and Social Care and the Guidelines for  Good Clinical Practice. The day-to-day management of the study is the responsibility of the Chief Investigator, and as such the Chief Investigator may wish to set up a separate Study Management Group to assist with this function. The main features of the Steering Committee are as follows:

• To provide advice, through its Chair, to the study's funder, sponsor, Chief Investigator, host institution, and contractor
• To concentrate on the study's progress, adherence to the protocol, and patient safety (where appropriate), and to consider new information of relevance to the research question
• To uphold the rights, safety and well-being of the participants: these are the most important considerations and should prevail over the interests of the research
• To ensure appropriate ethical and other approvals are obtained in line with the project plan
• To agree proposals for substantial protocol amendments and provide advice to the sponsor and funder regarding approvals of such amendments
• To provide advice to the investigators on all aspects of the study

Constitution of a Steering Committee

• The relevant NIHR Programme Director will review the nominees and appoint the Chair and members
• Independent members must make up a minimum of 75% of the Committee membership (see definition of independence below)
• The minimum quoracy for any Steering Committee meeting to conduct business is 67% (two thirds) of the appointed membership
• Only appointed members will be entitled to vote (irrespective of their level of independence) and the Chair will have a casting vote
• The Chair and members must sign and maintain a log of potential conflicts and/or interests
• Attendance at Steering Committee meetings by non-members is at the discretion of the Chair
• The primary Steering Committee reporting line is via the Chair to the relevant NIHR Programme Director; however, communication is likely to be between the Chair and the NIHR Research Manager who has day to day responsibility for the study.

Please note: We advise you to keep the number of members on your Steering Committee to an easily manageable number, but preferably to no more than eight members in total.

Composition of the Steering Committee

• An Independent Chair (holding a substantive UK based appointment), the Steering Committee Chair does not need to be a study-specific content expert but needs to ensure that sufficient content expertise is available for the group to perform its oversight function effectively.
• An independent statistician or other person with expertise in the main methods used in the study
• At least one public member, preferably independent
• Others with clinical or other expertise relevant to the project, such as in health economics, social care, public health etc.
• Ideally, the Steering Committee should invite observers, including representatives of the sponsor and research network to meetings
• Justification for proposing members based overseas should be provided when you submit nominations

Steering Committee meetings

• Although there may be periods when more frequent meetings are necessary, the Steering Committee should meet at least annually
• Where a Data Monitoring and Ethics Committee (DMEC) is required, Steering Committee meetings should be scheduled to follow shortly after their meetings so that reports from the DMEC can be considered if appropriate
• Minutes of meetings should be sent to all members, the sponsor, and the funder, and be retained in the study master file

The responsibility for calling and organising Steering Committee meetings lies with the Chief Investigator, in association with the Chair.

The NIHR reserves the right to attend any meeting, therefore should be included in relevant invitations. In exceptional circumstances there may be occasions when the study Sponsor or NIHR will organise and administer these meetings.

The Role of the Chair of the Steering Committee

The Chair of the Steering Committee is directly answerable to the relevant NIHR programme, as funder. The Chair’s responsibilities include:

• Liaising with the Chief Investigator to arrange a meeting to finalise the protocol and to set up a schedule of meetings to align with the project plan
• Establishing clear reporting lines to the Funder, Sponsor, etc.
• Being familiar with relevant guidance documents and with the role of the DMEC if appropriate.
• Providing an independent, experienced opinion if conflicts arise between the needs of the research team, the funder, the sponsor, the participating organisations and/or any other agencies
• Leading the Steering Committee to provide regular, impartial oversight of the study, especially to identify and pre-empt problems
• Ensuring that changes to the protocol are debated and endorsed by the Steering Committee; letters of endorsement should be made available to the study team when requesting approval from the funder and sponsor for matters such as changes to the protocol
• Being available to provide independent advice as required, not just when Steering Committee meetings are scheduled
• Commenting on any extension requests and, where appropriate, providing a letter to the funder commenting on whether the extension request is supported or otherwise by the independent members of the Committee.
• Commenting in detail (when appropriate) regarding the continuation, extension or termination of the study.

Data Monitoring and Ethics Committee (DMEC)

The formation of a Data Monitoring and Ethics Committee (DMEC) is needed when there are particular risk factors involved in a study.

Most studies with an element of primary research are required to establish a DMEC. The following provides guidance on the role, constitution, composition and meeting requirements for a DMEC. This information can be used as a template terms of reference.

The role of the DMEC

The Data Monitoring and Ethics Committee's main role is as follows:

• In the case of a study with blinded/masked data, the DMEC is the only body involved that may have access to the unblinded comparative data. For other study types it has oversight of any primary data collected from participants, including qualitative data
• The role of DMEC members is to monitor these data and make recommendations to the Steering Committee on whether there are any ethical or safety reasons why the study should not continue
• The DMEC should uphold the safety, rights and well-being of the study participants: these are paramount considerations
• The DMEC should consider the need for any interim analysis advising the Steering Committee regarding the release of data and/or information
• The DMEC may be asked by the Steering Committee, Study Sponsor or Study Funder to consider data emerging from other related studies
• There are also rare occasions when the DMEC chair might be asked by the Study Funder, through the chair of the Steering Committee, to provide advice based on a confidential interim or futility analysis if serious concerns are raised about the viability of the study or if the research team are requesting significant extensions
• Criteria should be agreed (where appropriate) relating to the point at which continuation of the study is considered futile, and in the case of a randomised trial, the DMEC would only indicate if these had been passed or not as this would limit the potential for un-blinding.

Constitution of a DMEC

• Only appointed members will be entitled to vote and the Chair will have a casting vote
• The minimum quoracy for a meeting to conduct business is 67% (two thirds) of appointed members
• Attendance at DMEC meetings by non-members is at the discretion of the Chair
• The primary DMEC reporting line is via the Chair to the Steering Committee.

Composition of a DMEC

• All DMEC members are to be independent (with at least one member being UK based and/or holding a substantive UK based appointment)
• Membership of the DMEC should be small (3- 4 members) and comprise experts in the field, e.g. a clinician with experience in the relevant area and expert statistician. Membership might, on occasion, include members of the public.

DMEC meetings

• Responsibility for calling and organising DMEC meetings lies with the Chief Investigator, in association with the Chair of the DMEC. The study team should provide the DMEC with a comprehensive report, the content of which should be agreed in advance by the Chair of the DMEC
• The DMEC should meet at least annually, or more often as appropriate, and meetings should be timed so that reports can be fed into the Steering Committee
• Minutes of meetings should be sent to all members, the sponsor, the funder, and the Steering Committee, and a copy should be placed in the study master file. It should be noted that the minutes may have ‘in camera’ items redacted from some copies.

Independence

Independence (for both the Steering Committee and the Data Monitoring and Ethics Committee) is defined as follows:

• Not part of the same institution as any of the applicants or members of the study team
• Not part of the same institution that is acting as a recruitment or investigative centre, including Patient Identification Centres (PIC), identifying and referring patients to a recruitment or investigative centre (In both cases above ‘not part of the same institution’ means holding neither a substantive nor honorary contract or title with said institution)
• Not related to any of the applicants or study team members
• No other actual or perceived conflicts of interest
• For the Chair only; where competing bids for the same NIHR call were head to head the chair cannot have been an applicant on one of the competing applications

It is recognised that independence status of individual members of the above committees may change during the duration of the project, for example, a member may move from one institution to another, meaning that they would no longer be independent. It is the responsibility of the Chief Investigator to ensure that the funder is notified of such changes, and that the committees maintain the necessary level of experise and independence.

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What is research governance?

This section provides guidance on the responsibilities of the College in relation to research governance and principles of good practice for health and social care research

Research governance can be defined as a broad range of regulations, principles and standards of good practice that exist to achieve and continuously improve research quality across all aspects of healthcare in the UK and worldwide. It can also be defined as regulations, principles and standards for projects outside of healthcare research, including good study conduct.

Who does it apply to?

Research Governance applies to everyone connected to research including Chief Investigators, Researchers, their employer(s) or support staff. For those in healthcare research it can also apply to those in a healthcare role, such as care professionals.

By healthcare research, we mean  any health-related research which involves humans, their tissue and/or data.

Examples of such research would include: 

• Analysis of data from a patient's medical notes
• Observations 
• Conducting surveys
• Using non-invasive imaging
• Using blood or other tissue samples
• Inclusion in trials of drugs, devices, surgical procedures or other treatments

For non-healthcare research, this could include:

• Interviews with study participants
• Use of personal data
• Observations of participants

If you are involved in research of this kind, it is important that you are aware of your obligations to the healthcare or non-healthcare research process and the development of research governance. You must also be aware of the College's research misconduct  procedures.

Why is it needed?

Research Governance is needed to:

• Safeguard participants in research
• Protect researchers/investigators (by providing a clear framework to work within)
• Enhance ethical and scientific quality
• Minimise risk
• Monitor practice and performance
• Promote good practice and ensure lessons are learned

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UK Policy Framework for Health and Social Care Research

Introduction and background

1.  Context

2.  Purpose

4.  Implementation

5.  UK-wide responsibilities

6.  Development, status and maintenance

7.  Audience

8.  Principles that apply to all health and social care research

• Principles that apply to interventional health and social care research

Responsibilities

9.  Responsibilities of individuals and organisations

• Chief investigators

Research teams

• Contract research organisations
• Research sites

Regulators of professions

• Other regulators
• Health and social care providers

Glossary and Appendices

Appendix 1: remits, appendix 2: laws, appendix 3: relationship between principles and responsibilities, 1. context .

1.1. The Health Research Authority (HRA) and the UK Health Departments (The four UK Health Departments are the Department of Health (England), the Department of Health (Northern Ireland), the Scottish Government Health and Social Care Directorates and the Department for Health and Social Services (Wales)) are committed to an environment where:

• patients, service users [1] and the public (including carers, relatives of patients and service users and healthy volunteers) are given, and take, the opportunity to participate in health and social care research and to get involved in its design, management, conduct and dissemination, and are confident about doing so;
• safer, more efficient or more effective treatments, care and other services are developed and tested through ethical and scientifically sound research for the benefit of patients, service users and the public;
• applying to do research is simple and getting a decision is quick, with predictable timelines;
• researchers find it straightforward to do high-quality, ethical research;
• commissioners and providers of health and social care appreciate how health and social care research benefits patients, service users, staff and the public, and make their resources available for research;
• industry sees the UK as a great place to do health and social care research, and increases its investment for the benefit of patients and service users;
• money from charities and other research funders goes into carrying out research, not into navigating needless bureaucracy or duplicating previous work; and
• research projects get registered, the data and tissue they collect can be made available for future analysis, with adequate consent and privacy safeguards, and research findings (i.e. the findings that the research was designed to produce; for guidance on incidental and other health-related findings, (see  Wellcome policy position ) get published and summarised for those who took part in them.

1.2 Research is a core function of health and social care. It is essential for our health and well-being and for the care we receive. Research should improve the evidence base, reduce uncertainties and lead to improvements in care. Evidence; ( BMJ Content ), (BMJ Content), (Journals Content) suggests the quality of current care may be higher in organisations that take part in research, adopt a learning culture and implement research findings. Improved care can give people a better quality of life and the country benefits from more money and jobs if the UK environment for research attracts international research funders to invest and carry out their research here. Research develops the skills of staff in our universities, businesses and health and social care. It also involves patients, service users and the public in the pursuit of knowledge that may benefit them and others, not only by their participation in research but also by their involvement in setting research priorities, in the design, management, conduct and dissemination of research, in public engagement about research, as members of research approval bodies such as research ethics committees or in funding research through taxes and charitable donations.

2.1   The UK policy framework for health and social care research sets out principles of good practice in the management and conduct of health and social care research that take account of legal requirements and other standards. These principles protect and promote the interests of patients, service users and the public in health and social care research, by describing ethical conduct and proportionate (This means having an approach to mitigating risks that gives at least the same consideration to the risks that arise if the research does not take place as to those that arise if it does, and the same consideration to their likelihood as to their impact. The risk appetite should favour the research taking place. The prevailing focus should be on the risks to the potential participants and the target population, not on the reputational risks), assurance-based management of health and social care research, so as to support and facilitate high-quality research in the UK that has the confidence of patients, service users and the public.

2.2   This policy framework sets out principles and responsibilities at a high level that take account of relevant legislation in the UK. It will be supported by operational arrangements and guidance provided by the HRA and the Devolved Administrations, working in collaboration to ensure a consistent approach to co-ordinating and standardising regulatory practice. This will achieve compatibility across the UK for the management and conduct of health and social care research (Although this document is relevant to all health and social care research, its legal remit does not generally encompass children’s social care research in England or Scotland, except where the project also involves health research, adult social care research or children’s social care research in Northern Ireland or Wales.)

3.1 For the purpose of this policy framework, research is defined as the attempt to derive generalisable or transferable (NB This definition involves an attempt at generalisability or transferability, i.e. the project deliberately uses methods intended to achieve quantitative or qualitative findings that can be applied to settings or contexts other than those in which they were tested. The actual generalisability or transferability of some research findings may only become apparent once the project has been completed) new (Including new knowledge about existing treatments or care) knowledge to answer or refine relevant questions with scientifically sound methods (Projects that are not designed well enough to meet this definition are not exempt from this policy framework – paragraph 9.10.a.) This excludes audits of practice and service evaluations. It includes activities that are carried out in preparation for or as a consequence of the interventional part (This means the part of the research where a change in treatment, care or other services is made for the purpose of the research. It does not refer to other methodological ‘interventions’, e.g. issuing a postal survey) of the research, such as screening potential participants for eligibility, obtaining participants’ consent and publishing results. It also includes non-interventional health and social care research (i.e. projects that do not involve any change in standard treatment, care or other services), projects that aim to generate hypotheses, methodological research and descriptive research. Projects whose primary purpose is educational to the researcher, either in obtaining an educational qualification or in otherwise acquiring research skills, but which also fall into the definition of research, are in scope of this policy framework. Activities that are not research according to this definition should not be presented as research and need not be conducted or managed in accordance with this framework. A decision tool that provides a definitive answer about whether a project counts as research under this policy framework is available at the HRA decisions tool . 

3.2 This policy framework applies to health and social care research that is within the responsibility of the HRA or Devolved Administrations' Health Departments (appendix 1 ). This includes: 

• research concerned with protection and promotion of public health;
• research undertaken in or by (including health or social care research funded by any of the UK Health Departments) a UK health Department, its non-Departmental public bodies or the NHS (References to the NHS include Health and Social Care (HSC) in Northern Ireland) and social care providers (Reference to NHS and social care providers include contractors providing services under contract with care providers or commissioners (including services purchased by service users from their own resources or their ‘personal budget’), e.g. general practitioners (GPs), privately run treatment centres, care homes, magnetic resonance imaging (MRI) services); and
• clinical and non-clinical research, research undertaken by NHS or social care staff using the resources of health and social care providers and any research undertaken within the health and social care systems (including research involving prison health services) that might have an impact on the quality of those services.

3.3 The activity of involving patients, service users or the public in the design, management, conduct or dissemination of research should not be managed as though it is research in its own right. Information on arrangements and controls relating to public involvement is available from INVOLVE .

3.4 This document draws on relevant sources (These sources include legislation (appendix 2) and other publications about good research practice, such as the ADASS/SSRG resource pack for social care , ESRC Framework for Research Ethics , the principles of ICH GCP , the previous Research Governance Frameworks, RESPECT Code of Practice , UUK Concordat to support research integrity  and WMA Declaration of Helsinki ) but cannot exhaustively compile all the principles, requirements and standards that may be issued separately by individual bodies with an interest in research. In particular, it does not repeat requirements and expectations that apply generally and are not specific to health and social care research, such as professional standards or legislation regarding age of legal capacity, equality, health and safety, Welsh language, whistle blowing etc. It remains the responsibility of those to whom relevant legal requirements and professional standards apply to ensure that they also meet those requirements and standards, in line with the guiding principles set out in this policy framework.

3.5 The principles and responsibilities set out in this policy framework are deliberately at a high level and apply to health research and social care research equally. However, health research and social care research can be different in nature, scale, setting, volume and funding, as well as in the mix of stakeholders, organisational context and range of academic disciplines. Individuals and organisations with responsibilities under this policy framework are therefore expected to take appropriate account of these differences when reflecting the principles and responsibilities set out in this document in their own policies, procedures and practice.

4. Implementation

4.1 This policy framework largely sets out what is (or should be) already happening. It is therefore not expected to add to the workload of researchers or others with responsibilities under this framework. The intention is to remove unnecessary bureaucracy for researchers, both in what the framework expects of them directly and what it expects of others that then affects them. Implementation of this high-level policy framework is supported by national operational policies and guidance, standard operating procedures (SOPs) and operational platforms. Individuals and organisations with responsibilities under this policy framework are expected to adopt these operational provisions wherever relevant, not design their own, and should reflect in their existing policies, procedures and practice the principles and responsibilities set out in this policy framework and in the relevant operational provisions. The operational provisions which support implementation of this policy framework include (The HRA provides these by agreement with the Devolved Administrations for UK-wide use)

• resources for researchers and sponsors - HRA planning and improving research page;
• expectations and requirements for research ethics committee review, and standards and guidance for research ethics committees;
• information for patients, service users and the public; and 
• systems for applying for and managing research approvals - the Integrated Research Application System (IRAS) at My Research Project and the HRA Assessment and Review Portal (HARP).

4.2 These operational provisions support people with responsibilities for the management and conduct of research to comply with this policy framework. They also encourage the pursuit of high-quality research that:

• involves patients, service users and the public appropriately in its design, management, conduct and dissemination;
• meets the needs of patients, service users and the public;
• accesses participants and information quickly and efficiently;
• minimises the risk of harm to participants and protects their confidentiality in accordance with their consent, where required, and the law; and 
• produces findings that will improve the evidence base and may lead to better health and well-being.

5. UK-wide responsibilities

5.1 The policy framework reflects the relevant legislation in the UK and takes account, where relevant, of the application of this legislation in each UK country while supporting UK-wide compatibility and consistency. The policy framework is consistent with recognised ethical standards and with models of good practice as they apply to particular types of research involving human participants (References to participants include people whose data or tissues are involved in a research project.) In reflecting these, the policy framework has taken care to recognise the value of their proportionate application to different types of research.

5.2 In accordance with the Care Act 2014 and with the agreement of the Devolved Administrations (The Devolved Administrations include the Department of Health (Northern Ireland), the Scottish Ministers and the Welsh Ministers), this policy framework replaces the Research Governance Frameworks previously issued in each of the four UK countries.

5.3 Although responsibilities for health and social care services have been devolved to the administrations in Northern Ireland, Scotland and Wales, the four UK Health Departments are committed to maintaining compatible standards for research ethics (Covered separately in Governance arrangements for research ethics committees, SOPs and guidance – see HRA about us page , management and conduct across the UK. Otherwise, cross-border research could be undermined by incompatible expectations between England, Northern Ireland, Scotland and Wales. With the agreement of the Devolved Administrations and/or, where applicable, the UK Ethics Committee Authority (UKECA) (UKECA is the body that establishes, recognises, monitors and approves the standard operating procedures of research ethics committees that review clinical trials of investigational medicinal products. UKECA’s members are the HRA, the Department of Health (Northern Ireland), the Scottish Ministers and the Welsh Ministers), the HRA may publish policy, guidance and procedures that are UK-wide. Except where otherwise stated, these UK-wide publications, including this document, apply to all health and social care research (Apart from research that is wholly in children’s social care in England or Scotland, which is outside the remit of the HRA and the Scottish Government Health and Social Care Directorates). While ensuring UK-wide compatibility, these documents take into account where legal and operational differences do exist (appendix 2 for details) and proactively address them to minimise their potential impact on cross-border research

6. Development, status and maintenance

6.1. This policy framework has been developed in partnership between the four UK Health Departments and the HRA. It applies in England, Northern Ireland, Scotland and Wales.

6.2. In accordance with Section 111(6) and (7) of the Care Act 2014, the status of this document is statutory guidance to which local authorities, NHS trusts and NHS foundation trusts in England must have regard (This means deviating only when there is a justified reason for doing so). Compliance with this guidance by them and other health and social care providers (such as independent contractors in primary care and private and voluntary organisations providing services under contract) also helps bodies that commission care to fulfil their legal duty under the Health and Social Care Act 2012 to promote the conduct of research.

6.3. Maintenance of the policy framework is undertaken by the HRA in conjunction with the Devolved Administrations. It will be updated on a regular basis to link to relevant references and will be revised in light of significant developments (e.g. changes in clinical trials regulation) or otherwise at intervals agreed between the HRA and Devolved Administrations.

7. Audience

7.1. This document is aimed primarily at individuals and organisations with responsibilities for the management and conduct of research. Summaries for different audiences, such as patients, service users and the public, are available on the HRA website.

8. Principles that apply to all health and social care research 

8.1 The following statement of principles serves as a benchmark for  good practice that the management and conduct of all health and social care research in the UK are expected to meet.

Principle 1: Safety 

The safety and well-being of the individual prevail over the interests of science and society.

Principle 2: Competence 

All the people involved in managing and conducting a research project are qualified by education, training and experience, or otherwise competent under the supervision of a suitably qualified person, to perform their tasks.

Principle 3: Scientific and Ethical Conduct 

Research projects are scientifically sound and guided by ethical principles in all their aspects.

Principle 4: Patient, Service User and Public Involvement 

Patients, service users and the public are involved in the design, management, conduct and dissemination of research, unless otherwise justified.

Principle 5: Integrity, Quality and Transparency 

Research is designed, reviewed, managed and undertaken in a way that ensures integrity, quality and transparency.

Principle 6: Protocol 

The design and procedure of the research are clearly described and justified in a research proposal or protocol, where applicable conforming to a standard template and/or specified contents - see   HRA Planning and Improving Research page .

Principle 7: Legality

The researchers and sponsor familiarise themselves with relevant legislation and guidance in respect of managing and conducting the research.

Principle 8: Benefits and Risks 

Before the research project is started, any anticipated benefit for the individual participant and other present and future recipients of the health or social care in question is weighed against the foreseeable risks and inconveniences once they have been mitigated (A formal, structured risk assessment is only expected where identified as essential. The risk: benefit ratio will normally be sufficiently described and considered as part of review processes such as research ethics committee review.)

Principle 9: Approval 

A research project is started only if a research ethics committee and any other relevant approval body (i.e. the HRA, the Administration of Radioactive Substances Advisory Committee (ARSAC), the Human Fertilisation and Embryology Authority (HFEA) or the Medicines and Healthcare products Regulatory Agency (MHRA)) have favourably reviewed the research proposal or protocol and related information, where their review is expected or required.

Principle 10: Information about the Research

In order to avoid waste, information about research projects (other than those for educational purposes) is made publicly available before they start (unless a deferral is agreed by or on behalf of the research ethics committee).

Principle 11: Accessible Findings 

Other than research for educational purposes and early phase trials, the findings, whether positive or negative, are made accessible, with adequate consent and privacy safeguards, in a timely manner after they have finished, in compliance with any applicable regulatory standards, i.e. legal requirements or expectations of regulators. In addition, where appropriate , information about the findings of the research is available, in a suitable format and timely manner, to those who took part in it, unless otherwise justified.

Principle 12: Choice 

Research participants (Either directly, or indirectly through the involvement of data or tissue that could identify them) are afforded respect and autonomy, taking account of their capacity to understand. Where there is a difference between the research and the standard practice that they might otherwise experience, research participants are given information to understand the distinction and make a choice, unless a research ethics committee agrees otherwise. Where participants’ explicit consent is sought, it is voluntary and informed. Where consent is refused or withdrawn, this is done without reprisal.

Principle 13: Insurance and Indemnity 

Adequate (Special provision is not expected unless existing arrangements (e.g. professional insurance, membership of NHS Litigation Authority schemes) provide inadequate cover) provision is made for insurance or indemnity to cover liabilities which may arise in relation to the design, management and conduct of the research project.

Principle 14: Respect for Privacy 

All information collected for or as part of the research project is recorded, handled and stored appropriately and in such a way and for such time that it can be accurately reported, interpreted and verified, while the confidentiality of individual research participants remains appropriately protected. Data and tissue collections are managed in a transparent way that demonstrates commitment to their appropriate use for research and appropriate protection of privacy.

Principle 15: Compliance 

Sanctions for non-compliance with these principles may include appropriate and proportionate administrative, contractual or legal measures by funders, employers, relevant professional and statutory regulators, and other bodies.

Principles that apply to interventional health and social care research 

8.2 In addition to the principles above, the following principles apply to interventional research only, i.e. where a change in treatment, care or other services is made for the purpose of research:

Principle 16: Justified Intervention 

The intended deviation from normal treatment, care or other services is adequately supported by the available information (including evidence from previous research).

Principle 17: Ongoing Provision of Treatment 

The research proposal or protocol and the participant information sheet explain the special arrangements, if any, after the research intervention period has ended (e.g. continuing or changing the treatment, care or other services that were introduced for the purposes of the research).

Principle 18: Integrity of the Care Record 

All information about treatment, care or other services provided as part of the research project and their outcomes is recorded, handled and stored appropriately and in such a way and for such time that it can be understood, where relevant, by others involved in the participant’s care and accurately reported, interpreted and verified, while the confidentiality of records of the participants remains protected.

Principle 19: Duty of Care 

The duty of care owed by health and social care providers continues to apply when their patients and service users take part in research. A relevant health or social care professional (Who may or (particularly where the research team is not local to the research site) may not be a member of the research team) retains responsibility for the treatment, care or other services given to patients and service users as research participants and for decisions about their treatment, care or other services. If an unmanageable conflict arises between research and patient interests, the duty to the participant as a patient prevails.

9. Responsibilities of individuals and organisations 

9.1 There should be clear designation of responsibility and accountability with clear lines of communication between all those involved in research. Communication pathways should be clear in terms of what, how, who, when and why, with documented (Any documentation should be proportionate. Roles and responsibilities should be agreed and understood by all the relevant parties but are not expected to be re-documented separately if their description for the purpose of review processes such as research ethics committee review is sufficient) roles and responsibilities. Dialogue and collaboration have a central role within a research project. Clear, upfront discussion of issues and agreement of principles and procedures for each project are essential to its effective conduct and success, as well as mitigating some risks. All individuals and organisations with responsibilities under this policy framework should understand the value of research to health and social care and recognise the importance of co-operation and shared endeavour as critical to its success. Those with experience of good practice in the management and conduct of research are encouraged to share their knowledge with novices.

Chief investigators 

9.2. The chief investigator is the overall lead researcher for a research project (Outside the UK the term Coordinating Investigator or Investigator may be used). In addition to their responsibilities if they are members of a research team, chief investigators are responsible for the overall conduct of a research project, including:

• a) satisfying themselves that the research proposal or protocol takes into account any relevant systematic reviews, other research evidence and research in progress (Research studies may replicate previous research, but should acknowledge the reason for doing so), that it makes effective use of patient, service user and public involvement where appropriate and that it is scientifically sound, safe (i.e. that the risk of harm has been minimised as much as possible and is not expected to outweigh the benefits), ethical, legal and feasible and remains so for the duration of the research, taking account of developments while the research is ongoing;
• b) satisfying themselves that the research proposal or protocol has been submitted for appropriate independent expert (‘peer’) review (For educational research, the chief investigator will be a supervisor who may provide an appropriate level of review) and revised in light of that review;
• c) satisfying themselves that, if expected or required, the proposal has been submitted for review by and obtained approval from a research ethics committee and any other relevant approval bodies;
• satisfying themselves (For multi-site projects, this may be delegated to the principal investigator at each research site) that everyone involved in the conduct of the research is qualified by education, training (Training should be appropriate and proportionate to the type of research undertaken, and should cover the responsibilities of researchers set out in relevant legislation and standards – HRA planning and improving research page )
• d) and experience, or otherwise competent, to discharge their roles in the project;
• e) satisfying themselves that the information given to potential participants is in a suitable format and is clear and relevant to their participation in the research and, where consent is required, to their decision-making about taking part in the research – HRA decision tool . 
• f) adhering to the agreed arrangements (paragraph 8.10) for making information about the research publicly available before it starts (unless a deferral is agreed by or on behalf of the research ethics committee);
• g) adhering to the agreed arrangements (paragraph 8.11) for making data and tissue accessible, with adequate consent and privacy safeguards, in a timely manner after the research has finished (Funders or others may set expectations about making data and tissue available);
• h) starting the research only once the sponsor has confirmed that everything is ready for it to begin;
• i) adhering to the agreed procedures and arrangements for reporting (e.g. progress reports, safety reports) and for monitoring the research, including its conduct, the participants’ safety and well-being and the ongoing suitability of the approved proposal or protocol in light of adverse events or other developments; and
• j) adhering to the agreed arrangements for making information about the findings of the research available, including, where appropriate to participants.

9.3. Students should not normally (Exception is made for an experienced care practitioner or manager undertaking an educational qualification for continuing professional development or a doctoral-level study while employed by a health or social care provider or a university, or for a researcher undertaking a doctoral-level study in receipt of a fellowship) take the role of chief investigator at any level of study, as this function should be undertaken by supervisors or course leaders.

• a) Relevant supervisors (or course leaders, where different) should be encouraged to develop and lead research projects that individual students at master’s level and below can contribute to at different stages. Undergraduate students should only conduct research projects in isolation that involve direct contact with patients, service users or the public in a health or social care setting if on-site supervision arrangements mitigate any risks.
• b) A research culture should be fostered amongst relevant undergraduate students by encouraging an awareness of health and social care research, research ethics and public involvement, and enabling them to develop skills in research methods. Students from courses that are not primarily related to health and social care, such as business studies or IT, who wish to undertake research involving patients or service users, their data or tissue, or the public in a health or social care setting should have a co-supervisor with relevant experience that will help them understand the care context and the associated research process.
• c) The contribution of students to the development, conduct and reporting of the research should be appropriately acknowledged like that of other contributors, e.g. in accordance with journal editors’ authorship criteria.

9.4. Research should (Or must, if there is a legal requirement, e.g. in the case of clinical trials of investigational medicinal products) be conducted in accordance with a research proposal or protocol – a document that describes clearly what will be done in the research. This is important so that the researchers can all understand consistently what they are supposed to do and so that the research can be properly analysed and, if necessary, reproduced. Public involvement (i.e. working in collaboration with patients, service users or the public in the design, management, conduct or dissemination of research) plays an important role in research design and planning. Well-planned and well-written research proposals, protocols and procedures are key to carrying out research successfully. They help avoid subsequent amendments (Where research deliberately entails modifying parameters or procedures during its course (e.g. adaptive clinical trials, iterative approaches in qualitative research), amendments should be avoided by the proposal or protocol specifying the adaptation schedule and processes up front), which are time-consuming and costly for the funder, the researchers and the approval bodies. However, high-quality research proposals, protocols and procedures are only effective if they are followed. Not adhering to the research proposal or protocol has the potential for adverse impact and reputational risk to all parties involved. For research participants, this compromises any informed consent given; for the researcher, it creates a scientific risk that the research data (or their credibility) may be compromised; and for sponsors, there is often a financial and resource implication, particularly where a suspension to recruitment or extensive investigation are involved.

9.5. Research proposals, protocols and procedures should be clear, comprehensive and easily accessible to the research team. Good document management and version control are essential so that, for instance, the same single version of the research proposal or protocol is being followed in the same way by everyone involved. Otherwise, the data collected could not be reliably compared, undermining the findings of the research. There is often an expectation or requirement for documents to be revised and updated during the lifespan of studies and these expectations and requirements may come from various organisations. It is important to ensure that changes to the research proposal or protocol are submitted for review, if expected or required, by a research ethics committee and any other relevant approval bodies and, if approved (Or if they give effect to urgent safety measures), that they are introduced uniformly across all relevant research sites.

9.6. The research team is the group of people involved in the conduct of a research project. It may include care professionals, academics, patients and service users, members of the public, research professionals, students and/or scientists. Research team members’ accountability should be clearly agreed between them and their employer(s) (Or directly with the sponsor, where this accountability does not arise in the context of their employment, e.g. in the case of research team members who are patients, service users or the public) and documented, especially where multiple disciplines, collaborating organisations or patients, service users and the public are involved in a single research team. For multi-site research, a single research team led by the chief investigator may undertake the activity at all the sites, or there may be different research teams at different sites, led either by the chief investigator or by a principal investigator who takes responsibility for the conduct of the research at the site. Research teams are responsible for:

• a) demonstrating to chief investigators and sponsors their suitability to conduct the research;
• b) acquiring any particular knowledge and skills in order to conduct the research;
• c) conducting the research according to the approved research proposal or protocol and any complementary information (such as the research ethics committee application form), in compliance with any applicable regulatory standards and guidance;
• d) providing information in a suitable format for potential participants that is clear and relevant to their participation in the research and, where consent is required, to their decision-making about taking part in the research; and
• e) ensuring participants’ safety and well-being in relation to their participation in the research (e.g. by asking questions about the patient’s experience with the research intervention) and reporting adverse events where expected or required.

9.7. Where consent is sought:

• a) potential research participants should be provided, normally by the research team, with the information (Guidance on preparation of participant information, including proportionate arrangements, is available at  www.hra-decisiontools.org.uk/consent ) they need to help them decide whether they wish to take part in research or not, and should be given reasonable time to reach their decision. The information should be provided in a suitable format. Unless otherwise justified (e.g. by feedback from public involvement), the information should include a concise explanation of relevant research evidence and research in progress that shows why the proposed research is justified;
• b) a permanent and accessible copy of any information sheet should normally be made available to all participants; and
• c) consent should be documented and available for inspection by relevant regulators.

9.8. Proportionality should be applied to the provision of information to potential research participants (Guidance on applying a proportionate approach to the process of seeking consent is available at HRA Planning and Improving research page ). The more research deviates from established practice or otherwise detrimentally affects the balance between the anticipated risks and benefits, the greater the amount of information that needs to be provided to potential participants. By the same token, the closer the research is to standard practice, the less need there is to provide patients and service users with detailed and lengthy information. For instance, pragmatic trials looking at the effectiveness of routinely used standard treatments should be facilitated so that patients can be recruited in a way that complies with the law but does not unduly burden either patients or the care professionals seeking their consent.

9.9. The funder is the organisation or group of organisations providing funding for the research project. The funder is normally the sponsor in the case of commercial research. The funder is responsible for:

• a) assessing (or arranging for assessment of) the scientific quality, the relevance of the research to the target population and, if appropriate, the value for money of the research as proposed, involving patients, service users and the public where appropriate in funding decisions;
• b) reviewing information about the attribution of costs to confirm that costs to all parties (including excess treatment costs) have been identified and described in accordance with national guidance – Government Publications Guidance where applicable, and that the costs are not disproportionate compared to the value of the output;
• c) considering (with advice if necessary) whether the research is really achievable within the settings as a whole in which it is intended to be carried out, particularly in view of the priorities and constraints in health and social care if the research will have an impact on care provision;
• d) making ongoing funding conditional on a sponsor and relevant approvals (paragraph 8.9, including footnote 26) being in place before the research begins (but not before initial funding is released, as some funding may be needed in order to put these in place); and
• e) using contracts (e.g. model agreements, where applicable – see  UKCRC Governance and conditions of funding to promote compliance with this policy framework, in particular to encourage arrangements (paragraphs 8.10 and 8.11) for making information about research publicly available before it starts (unless a deferral is agreed by or on behalf of the research ethics committee) and for retaining and making accurate findings, data and tissue accessible, with adequate consent and privacy safeguards, in a timely manner after it has finished.

9.10. The sponsor is the individual, organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project. All health and social care research has a sponsor. The sponsor is normally expected to be the employer of the chief investigator in the case of non-commercial research or the funder in the case of commercial research (The employer or funder is not automatically the sponsor; they explicitly accept the responsibilities of being the sponsor). The sponsor has overall responsibility for the research, including:

• a) identifying and addressing poorly designed or planned research and poor-quality research proposals, protocols or applications and ensuring that research proposals and protocols: - take into account systematic reviews of relevant existing research evidence and other relevant research in progress, - make appropriate use of patient, service user and public involvement and - are scientifically sound (e.g. through independent expert review) (For educational research, the scientific validity and quality may be established by the chief investigator (i.e. the supervisor) at a level appropriate to the nature of the course), safe, ethical, legal and feasible and remain so for the duration of the research, taking account of developments while the research is ongoing;
• b) satisfying itself that the investigators, research team and research sites are suitable;
• c) ensuring that roles and responsibilities of the parties involved in the research and any delegation by the sponsor of its tasks are agreed and documented;
• d) ensuring adequate (provision is made for insurance or indemnity to cover liabilities which may arise in relation to the design, management and conduct of the research project; and
• e) ensuring appropriate arrangements are made for making information about the research publicly available before it starts (unless a deferral is agreed by or on behalf of the research ethics committee); agreeing appropriate arrangements for making data and tissue accessible, with adequate consent and privacy safeguards, in a timely manner after it has finished; and ensuring arrangements for information about the findings of the research to be made available, including, where appropriate, to participants (For educational research, registration, accessibility of data and tissues, and dissemination may be limited to institutional arrangements);
• f) ensuring that, where expected or required, the research has approval from a research ethics committee (Whether outright or following a provisional opinion, resubmission or appeal) and any other relevant approval bodies before it begins;
• g) verifying that regulatory and practical arrangements are in place, before permitting the research to begin in a safe and timely manner;
• h) putting and keeping in place arrangements for adequate finance and management of the research project, including its competent risk management and data management;
• i) ensuring that effective procedures and arrangements are kept in place and adhered to for reporting (e.g. progress reports, safety reports) and for monitoring the research, including its conduct and the ongoing suitability of the approved proposal or protocol in light of adverse events or other developments.

9.11. Sponsors of clinical trials of investigational medicinal products have particular legal duties – see the HRA Planning and Improving Research  page for details.

9.12. Universities and colleges should accept the role of sponsor for all educational research conducted by their own students, unless the student is employed by a health or social care provider that prefers to take on this role. Sponsors of educational research should ensure that supervisors can and do carry out the activities involved in fulfilling this role. Where the academic supervisor cannot adequately satisfy the sponsor’s oversight responsibilities due to location or expertise, the sponsor should agree co-supervision arrangements with a local care practitioner.

Contract research organisations 

9.13. A contract research organisation (CRO) is a person or an organisation (commercial, academic or other) contracted by the sponsor to perform one or more of the sponsor’s activities. A sponsor may delegate any or all of these activities to a CRO, but the ultimate responsibility, e.g. for the quality and integrity of the research data, always resides with the sponsor (This does not prevent appropriate CROs from acting as the sponsor’s legal representative – see the HRA Planning and Improving Research page. The CRO is responsible for implementing quality assurance and quality control in respect of the activities delegated to it. Any activity that is delegated to and assumed by a CRO should be specified in writing. Any activity not specifically delegated to and assumed by a CRO is retained by the sponsor.

Research sites 

9.14.Research sites are the organisations with day-to-day responsibility for the locations where a research project is carried out. In health and social care research, they are often providers of health or social care and/or the employer of members of the research team. Research sites are responsible (Where the location of the research is wholly independent of any of the individuals and organisations with responsibilities under this policy framework, e.g. a public or private space that is not under contract for the research, such as a public library or a café), these responsibilities fall instead to the principal investigator’s employer, except 9.14.b, which is waived) for:

• a) demonstrating to relevant approval bodies and sponsors that the location is suitable for the research;
• b) being aware of all research activity being undertaken in or through the site;
• c) ensuring that the roles and responsibilities of individuals at the site and any collaborating parties are agreed and documented for individual research projects; and
• d) satisfying themselves (e.g. by taking assurances from others in a position to give them) that, if expected or required, the research has approval from a research ethics committee and any other relevant approval bodies before research participants take part (including indirectly, through the involvement of data or tissue that is likely to identify them).

9.15.  Research sites (Where the location is independent as above, ‘principal investigator’s employer’ should be read for ‘site’ in paragraphs 9.15 and 9.16, except 9.16.f, where ‘research team’ should be substituted) should have confidence in accepting assurances from other bodies about the compliance with relevant legislation and national standards of proposed research activities, without duplicating review of those proposals. Accepting assurances carried out to national standards reduces the organisation’s risk of misunderstanding or misinterpreting its obligations. The HRA indemnifies NHS research sites that accept assurances from the HRA against any claim covered by the NHS Litigation Authority arising as a result of incorrect assurances. If an NHS organisation undertakes its own checks that duplicate the assessments made by the HRA, the organisation will be liable for its own decisions made on the results of those checks and any consequences of those decisions. Organisations remain responsible, including through monitoring and training, for ensuring that the research activities are conducted in accordance with their applicable legal obligations.

9.16. Research funding should not be wasted, and the production of evidence to inform future care should not be hampered or delayed by poor information or processes at research sites:

• a) Research sites are expected to make information available about their capacity and capability to support different types of research so that sponsors can tell quickly and easily where they should place their studies to best effect e.g.  NIHR Policy and Standards page .
• b) Research sites are expected to keep themselves in a position to be able promptly, efficiently and proportionately to assess their ability to take part in an individual research project. Research sites should have good, up-to-date working knowledge of their research capacity and capability. When undertaking any additional enquiries in deciding whether to take part in a specific research project, those enquiries are expected to be proportionate and timely.
• c) If a site needs to put in place additional arrangements to support a specific research project at the intended location, that process should take into account the views of the sponsor and research team about the timetable for starting the research at that location, particularly for multi-centre projects.
• d) Research sites are expected to accept reliable assurances from others in a position to give them. This includes assurances about the ethics and safety of the research project, its compliance with the law and other standards (e.g. confidentiality), the suitability of contracts and costings and the competence, character and indemnification of members of the research team who are not substantively employed at the site, including patients, service users and the public. Decisions about research team members’ suitability should not be based on inappropriate HR processes, such as disproportionate training expectations (e.g. GCP or health and safety training for individuals, roles or projects that do not need it), irrelevant occupational health checks (e.g. vaccination history where there is no contact with patients or service users) or duplicative checks of character.
• e) Research sites should take steps to avoid disproportionate ‘one size fits all’ processes and duplication of effort, especially in requesting and assessing information, e.g. when research sites are involved in multi-centre projects or when they do repeat business with chief investigators, sponsors etc already known from previous projects.
• f) Research involving participants who get transferred to another research site is expected to be facilitated by the transferring site (A transferring site will have been a research site for the project. Where an organisation is simply identifying participants for research taking place elsewhere, it does not count as a transferring site) providing all relevant information to the receiving site to support the receiving site’s continuation of the research. The transfer of participants from a transferring site should be correspondingly well managed by the receiving site.
• g) Where there is an urgent need or small window of opportunity for relevant ethical research, such as public health emergencies, quick co-operation among relevant parties to facilitate the research is expected.
• h) Research sites may designate staff to facilitate these activities that fulfil their responsibilities under this policy framework. Such staff may act as a shared resource across more than one site.

9.17. Regulators of professions such as the General Dental Council, General Medical Council, General Pharmaceutical Council, Health and Care Professions Council and Nursing and Midwifery Council are responsible for professional standards and for ensuring compliance with these standards, e.g. by assessing fitness to practise. These standards normally apply to, and should therefore treat, the professionals’ research activity in the same way as their provision of care, teaching etc. In cases where research misconduct also constitutes professional misconduct, the regulator of the relevant profession retains its responsibility for taking action, alongside any action taken by other bodies such as other relevant regulators, the researcher’s employer and the police.

Other regulators 

9.18. Regulators are statutory bodies that oversee particular activities according to their functions, which are set out in legislation. There are a number of regulators in the UK with a remit for activities related to health and social care research (the HRA) or to health research only (the Human Fertilisation and Embryology Authority, the Human Tissue Authority and the Medicines and Healthcare products Regulatory Agency).

• a) The HRA, HFEA, MHRA and the Administration of Radioactive Substances Advisory Committee all have a role in co-operating with each other to approve research, and with the HTA (which licenses storage of tissue for research, not the research itself). This co-operation is underpinned by agreements between these bodies which set out how they work together to improve and simplify the regulatory environment, or arrange for one body to perform functions on behalf of others.
• b) The HRA and the Devolved Administrations work together to co-ordinate and standardise the regulation of health and social care research.

9.19. The HRA has a specific role to ensure the following:

• a) The regulation of health and social care research is proportionate, so that research that is clearly lower-risk gets processed accordingly.
• b) Guidance for researchers is provided by the HRA on behalf of the Devolved Administrations for UK-wide use.
• c) Applications to all the key research approval bodies are made through a single UK-wide Integrated Research Application System provided by the HRA.
• d) Guidance is provided in one, easily accessible location.
• e) Responses to applicants are standardised and timelines are predictable.
• f) That HRA takes responsibility and liability for approvals where checks have been carried out only by the HRA and not by other organisations.

9.20. Employers are the organisations employing the chief investigator and members of the research team (Excluding employers of people whose role in the research is not part of their employment, e.g. research team members who are patients, service users or the public.) The chief investigator’s employer is normally the sponsor in the case of non-commercial research. Employers may also be funders, research sites and/or care providers. Employers are expected to:

• a) encourage a high-quality research culture, including - ensuring employees are supported in and held to account for conducting research in a professional manner, including research integrity, and - ensuring effective management of employees and their work, including employees’ safety, well-being, work environment and facilities, - ensuring financial management and calculation of costs in support of financial probity and - ensuring agreement with their partners (This is particularly important for jointly funded posts and other dual employment, e.g. care professionals who also have a university role) (e.g. funders, sponsors, collaborators, commercial partners, network members, integrated board etc) and employees about accountability and division of responsibilities, including arrangements for any intellectual property arising from research;
• b) ensure researchers understand and discharge their responsibilities;
• c) follow good HR practice, including in the provision of assurances about researchers’ suitability (paragraph 9.16.d; also 9.2.d, 9.6.a and 9.10.b); provide written procedures, supervision and training that support accountability and effective collaboration; encourage care with financial resources; raise awareness of the wider environment within which health and social care research is conducted; and bridge any gap between employees’ current competence and the competence needed for their work; and
• d) take proportionate, effective action in the event of errors and breaches or if misconduct or fraud are suspected.

9.21. Employers of research staff should ensure appropriate individual learning and competence. This includes acknowledging existing experience, qualifications and skills, rather than just giving training. Relevant training given should have measurable learning outcomes that are competence-based and directly linked to the competencies demanded by the employee’s role and the procedures (such as SOPs) relevant to that role. It is important to confirm that individual members of the research team have an adequate level of awareness of the correct procedures, what those entail and the importance of following them. It is also important to understand the wider context of any error or breach that does occur. Systems should be in place not only to enable the identification of failures or breaches but also to place responsibility with the relevant party. For instance, if an error or breach occurs owing to insufficient time to complete a number of tasks, providing training will not in itself solve the problem or reduce the risk of a repeat. Lessons learnt from experience should be identified and implemented, including through incorporation into training and personal development.

9.22. It is important to encourage open and honest reporting. It is widely recognised in health and social care that a culture of openness and honesty encourages safety. Incident reporting is important in all research and is strongly encouraged so that lessons can be learnt and improvements made. Errors can only be rectified and improvements made to reduce adverse impacts and increase the quality of research outcomes if they are reported in a timely way. For this to be truly effective, a culture of openness and honesty is essential, with a focus on improvement rather than blame.

Health and social care providers 

9.23. Providers are organisations that provide health or social care. This includes organisations providing services under contract with NHS or local authority providers or commissioners (Including purchasing of services undertaken directly by those receiving care or support, from their own resources or from their ‘personal budgets’, i.e. local authority funding managed by or on behalf of the service user), e.g. general practitioners (GPs), privately run treatment centres, care homes or magnetic resonance imaging (MRI) services. Providers’ involvement in research is generally as research sites, when they may also be the employer of members of the research team and responsible for research participants’ care. A provider is normally the sponsor for non-commercial research if it is the chief investigator’s employer. Health and social care providers may also provide services to research sites, such as identifying potential participants or making information available for research elsewhere. Where research participants are recruited independently of providers (e.g. patients identified through a disease charity or staff identified through a professional society), those providers have no decision to make about taking part in the research unless they are also research sites. In addition to any responsibilities they may have in their capacities as sites, employers and/or sponsors, providers should recognise the importance of research in improving treatments, care and other services and their outcomes by:

• a) promoting opportunities to take part in health and social care research - see  NIHR News and NIHR Support  pages for examples;
• b) retaining responsibility for the care of their patients and service users as research participants, including agreeing any associated excess NHS tariff treatment costs - see  NHS England page for guidance; and
• c) having regard to this policy framework according to their legal duty under Section 111(7) of the Care Act 2014 (Applies in England to local authorities, NHS trusts and NHS foundation trusts) and contributing to the fulfilment of their commissioners’ legal duties to promote research under the Health and Social Care Act 2012.

Glossary and Apendices

This policy framework applies to particular areas of health and social care in each UK country, according to the remit of the relevant body: 

Similarities and differences in application across the UK of the legal requirements reflected in this policy framework are as follows:

The relationship between the principles of good practice in the management and conduct of social care research and the responsibilities of individuals in the organisations are set out below:

[1] This document uses the term ‘patients and service users’ to mean recipients of health care, social care or other services and support provided by or on behalf of health or social care organisations) and the public (including carers, relatives of patients and service users and healthy volunteer

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Research governance and the dynamics of science: A framework for the study of governance effects on research fields

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Maria Nedeva, Mayra M Tirado, Duncan A Thomas, Research governance and the dynamics of science: A framework for the study of governance effects on research fields, Research Evaluation , Volume 32, Issue 1, January 2023, Pages 116–127, https://doi.org/10.1093/reseval/rvac028

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This article offers a framework for the study of research governance effects on scientific fields framed by notions of research quality and the epistemic, organizational, and career choices they entail. The framework interprets the contested idea of ‘quality’ as an interplay involving notion origins, quality attributes, and contextual sites. We mobilize the origin and site components, to frame organizational-level events where quality notions inform selections, or selection events . Through the dynamic interplay between notions selected at specific sites , we contend, local actors enact research quality cumulatively , by making choices that privilege certain notions over others. In this article, we contribute in four ways. First, we propose an approach to study research governance effects on scientific fields. Second, we introduce first- and second-level effects of research governance paving the way to identify mechanisms through which these different levels of effects occur. Third, we assert that interactions between research spaces and fields leading to effects occur in the context of research organizations, and at nine key selection events. Fourth, and lastly, we discuss an empirical test on an illustration case to demonstrate how this approach can be applied.

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UKRI policy on the governance of good research practice (GRP)

UKRI’s revised policy on the governance of GRP to support best practice in managing research and research misconduct allegations for UKRI funded activities.

Revised UKRI policy on the governance of good research practice (PDF)

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Good research practice guidance on research misconduct investigations: guidance for research organisations (PDF)

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This is the revised UK Research and Innovation (UKRI) governance of GRP policy replacing the Research Councils UK (RCUK) policy on the governance of good research conduct.

The policy aims to set out UKRI expectations to organisations. To have in place policies and activities that support a positive environment within which all individuals involved in the research process can discuss, adopt and develop good research practice.

This guidance should be read alongside the UKRI policy on the governance of good research practice. This will support organisations to have fair, transparent and robust policies and procedures in place to enable them to respond to and address incidents of research misconduct.

• 2 April 2024 Policy document updated.
• 1 June 2023 Guidance for research organisations document updated.

This is the website for UKRI: our seven research councils, Research England and Innovate UK. Let us know if you have feedback or would like to help improve our online products and services .

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Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic: a qualitative study

• Julio Arturo Canario Guzmán   ORCID: orcid.org/0000-0003-2947-4165 1 , 2 ,
• Jessie Orlich 3 ,
• Renata Mendizábal-Cabrera 4 ,
• Argentina Ying 5 ,
• Claude Vergès 5 ,
• Eleonora Espinoza 6 , 7 ,
• Mario Soriano 8 ,
• Elsy Cárcamo 7 ,
• Briana Beltrán 9 ,
• Eddys Rafael Mendoza Marrero 1 ,
• Reyna Sepulveda 1 ,
• Claudia Nieto Anderson 7 ,
• Nicole Feune de Colombi 10 ,
• Roxana Lescano 11 ,
• Eddy Pérez-Then 12 ,
• Trudie Lang 10 &
• Jackeline Alger 6 , 7  

Health Research Policy and Systems volume  20 , Article number:  138 ( 2022 ) Cite this article

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Good governance and regulatory supervision are required to conduct research in an international public health emergency context and to ensure compliance with ethical standards. The “Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic” study is a regional effort in which research ethics stakeholders participated in addressing research ethics governance and preparedness response challenges to the COVID-19 pandemic in Central America and the Dominican Republic.

A qualitative action research study was conducted following a participatory approach. Research ethics stakeholders in Central America and the Dominican Republic were mapped; a regional webinar and three virtual workshops were conducted discussing research ethics governance, ethics review and collaborative research practice during the pandemic. A roundtable session presented results and obtained feedback on a draft of a policy to strengthen regional research ethics governance.

Countries across Central America and the Dominican Republic are at different stages in their development of research ethics systems. Countries with more established systems before COVID-19 were better organized and prepared to respond. This finding argues against improvisation and supports further work on strengthening governance of research ethics systems. Community engagement in research ethics public policy-making is practically absent in the region. Research and research ethics collaboration schemes are lacking amongst the countries; however, there are incipient initiatives in the region, such as the Central America and Caribbean Network of Research Ethics Committees. A policy brief with recommendations on how to advance towards strengthening the governance of research ethics systems was prepared and submitted to the Central American Integration System for analysis and possible approval.

National research ethics systems in Central America and the Dominican Republic were unprepared to respond to the COVID-19 pandemic with respect to research oversight and effective collaboration. In most cases, national research ethics systems were found to be weak, and regional research collaboration was practically absent. To promote collaboration, a joint strategy needs to be developed with a regional vision towards sharing knowledge and best practices.

Peer Review reports

Strengthening governance of health research systems

A coordinated worldwide research response is needed to fight the COVID-19 pandemic. To accomplish this, ethical and regulatory challenges must be overcome [ 1 , 2 ]. Governance is a core function of health research systems. According to WHO, research governance must be strengthened in ways that allow for effective, efficient and ethical collaboration among multiple stakeholders [ 1 ].

Defining research ethics systems and their governance

Hyder et al. [ 3 ] describe research ethics systems as “a component of the stewardship function of health research systems”. Since governance has been identified as a core function of health systems [ 4 ] and national health research systems (NHRS) [ 5 ], research ethics itself, as a system, requires a governance function to secure achievement of its objectives.

Several authors have addressed the topic of governance and frameworks for research ethics in times of global health emergencies [ 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 ]. The Pan American Health Organization (PAHO) developed a systemic approach with two strategic lines of action, objectives and indicators for strengthening the national research ethics systems (NRES) and emergency preparedness [ 12 ]. The governance function of such a NRES has not been fully described and needs to be further operationalized as general orientation for those aiming to implement effective research ethics systems.

In this paper, we refer to research ethics systems as the actors, institutions and activities whose primary purpose in research is to ensure ethical standards and procedures in the conduct of human research. The governance function of a research ethics system implies the ability to formulate strategic policy direction, ensure good regulation, set and monitor ethical standards, and ensure accountability and transparency . Hence, such research ethics governance includes mechanisms to ensure the functioning of the system to achieve compliance. The Virtual Health Library (VHL) defines health sector stewardship/governance as the “participation of stakeholders who are concerned with the definition and implementation of policies, programmes and practices that promote equitable and sustainable health systems” [ 13 ]. In this definition of governance, we underscore the participatory and democratic nature that concerns experts and the public alike. In this effort, we embraced this “participatory” view of governance rather than the mere exercise of authority, control, administration and government power to design, formulate and implement policies [ 14 ].

Health research and research ethics: regional context

Despite advances in NHRS in the region, fragmentation and lack of coordination have been noted previously [ 15 , 16 ]. In Latin America, research priorities for the COVID-19 pandemic were identified with participants from various countries [ 17 ]; however, the status of adoption of these recommendations by national authorities remains unknown. Thus, by early 2021, issues surrounding research ethics governance and oversight during the COVID-19 pandemic, specifically on Guideline 20 related to ethics review procedures in emergency situations as identified in the International Ethical Guidelines for Health-related Research Involving Humans [ 18 ], had not yet been assessed, and was an evident topic to be addressed in this region and globally. Additionally, we considered that research stakeholders’ insight regarding policies and practices of the research ethics system as a response to the pandemic, community engagement in health research and scientific collaboration were relevant topics to better understand the dynamics of research ethics systems in these countries.

To answer these questions, an international collaborative research study titled “Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic” (the GoEtiCA study) was proposed. The goal was to determine the status of research ethics systems in the Central American and Dominican Republic region (CA-DR), specifically in the context of the COVID-19 pandemic, and to identify scientific and community collaborations that emerged in response to this emergency. These goals were considered a first step to promote the development, formalization and adoption of a set of recommendations for improving the research ethics governance with an emphasis on public health emergencies (PHEs) in Central America and the Dominican Republic.

This is an action research study, based on a qualitative participatory approach [ 19 ]. An interdisciplinary and international research team was formed, including at least one research ethics expert representing each of the countries involved in the study. An international advisory group of experienced and recognized professionals in the fields of research ethics and global health was also established. Members of the advisory committee for the project came from Peru, Argentina, the Dominican Republic and the United Kingdom.

An exploratory approach was followed, triangulating data collected with multiple tools collated at different points in time (Fig.  1 ). The CA-DR region comprises eight countries; ethical approval for the study was obtained from six of them (Dominican Republic, Honduras, Costa Rica, Panama, Guatemala and El Salvador). We were unable to contact research ethics experts from Belize and Nicaragua; therefore, local ethical approval was not sought, and these two countries were not included in the study.

The study’s model and exploratory approach, GoEtiCA study, 2021

Document search: national laws, regulations and policies

A search was conducted for all available regulatory documentation within participating countries, including laws, regulations and policies specific to research ethics. Summary charts were organized for each country; charts were reviewed for accuracy, and information on each country’s ethical governance and regulations was updated as necessary.

Research ethics and stakeholder mapping

A purposeful heterogeneous sampling strategy was employed [ 20 ]. A key stakeholder mapping exercise was conducted to identify researchers, representatives of community-based organizations (CBOs), research ethics committee (REC) members and government officials residing or working in institutions in CA-DR. Contact information for the study’s target population was identified via public and freely accessible public and private organization websites, including ministries of health (MoHs) and other ministries and institutions associated with higher education, scientific and technological endeavours, national commissions on bioethics (NCBs), health research centres and institutes, RECs and CBOs within the health sector. REC members were identified through the Central America and Caribbean Network of Research Ethics Committees [ 21 ]. The mapping exercise resulted in a database containing 356 key stakeholder contacts from the eight countries of the Central American Integration System (SICA, by its acronym in Spanish).

Qualitative data: workshops

Participants from six countries (Costa Rica, El Salvador, Guatemala, Honduras, Panama and the Dominican Republic) were invited by email to an online informative session. An open call was also published on social media Footnote 1 inviting researchers across the region to the online session. Participants completed registration voluntarily, with documented informed consent. During the session, objectives and methods of the study were presented and attendees were invited to participate in study activities. Figure  2 details the number of participants by activity. Data collection was completed by 23 April 2021.

Number of participants by activity, GoEtiCA study, 2021

Three workshops were organized, each focusing on a thematic cluster, as detailed in Fig.  3 .

Thematic clusters as shown on promotional banners used for announcing the workshops, GoEtiCA Study, 2021

Participants from the stakeholder mapping exercise and webinar attendees were invited to the workshops. Key research stakeholders from Latin America (Mexico, Colombia, Venezuela and Argentina) who attended the online informative session as subject experts were asked to participate in the workshops as listeners-observers. Each workshop was conducted and recorded using the Zoom platform meeting function and lasted 2.5 hours. Participants were informed that their involvement in the study was voluntary, and consent was obtained at the time of individual voluntary registration for workshops.

Figure  4 shows participant attendance at each of the four participative events (workshops 1–3, roundtable) by country.

Participants in each of the study’s four events, by country and gender, GoEtiCA study, 2021. Legend 1 = workshop 1; 2 = workshop 2; 3 = workshop 3; 4 = roundtable

Figure  5 shows workshop and roundtable participant distribution by research stakeholder group. Findings were summarized by thematic cluster.

Workshop and roundtable participants by research stakeholder group, GoEtiCA study, 2021. CBO community-based organization, REC research ethics committee

During each workshop, presentations were offered on the thematic cluster, triggering questions posed by research team members (Table 1 ). Workshop attendees were encouraged to participate freely. The audience was divided into groups using the Zoom breakout rooms function, and subthemes were discussed. Breakout rooms were moderated by a research team member; a research assistant took notes during the discussion. The moderator used a discussion guide prepared beforehand as a guideline to channel the dialogue towards the specific objectives set forth for this study. Participants were warned against confidentiality breaches; they were asked not to disclose any information revealed in the breakout rooms.

Breakout room discussions were followed by a plenary session, where each group presented their conclusions.

A pragmatic thematic analysis followed. The summarized rapporteur text from breakout room activities, notes from research assistants and moderators, and records of participants as well as chat interactions during the workshops were sources of qualitative data. To ensure confidentiality, all data were stored securely on encrypted drives, password-protected through secure login; use was restricted to the study team and authorized personnel.

Roundtable session: validation of policy brief

A fourth workshop (roundtable) was organized to present preliminary research results. Six panellists representing each of the countries involved in the study offered a succinct commentary, focused on strengthening research ethics governance in the region. Specifically, emphasis was placed on building consensus around a proposal for regional ethical governance policy and regulation of health research in the CA-DR region in response to the COVID-19 pandemic and in preparation for future PHEs.

Theme 1: governance and regulations for research ethics

The status of research ethics systems and adoption of international ethical standards for human research.

In our document search, we found that health research regulation across the CA-DR region is very uneven, ranging from no regulation at all to the application of highly restrictive measures to research. Only Costa Rica and Panama have laws regulating health research. The MoHs in Honduras, Guatemala, El Salvador and the Dominican Republic have mandates that regulate health research; however, regulation is not fully established and may sometimes be lax, unwritten and/or informal, with incipient research ethics systems.

Only three countries (50%) have established a formal written policy for health research and formal research priorities. However, all six countries included in this study have official agencies in charge of regulating health research activities. Except for Honduras, each country has a national REC (NREC) in charge of ethics review or, as in Costa Rica, in charge of supervising local committees that carry out ethics review. Only in Costa Rica and Panama are the NRECs mandated by law. The NRECs in El Salvador, the Dominican Republic and Guatemala operate under the mandate of the MoH.

For example, when asked about research ethics policies and regulations, one study participant described the Honduran system as fragmented or incomplete:

I think that we lack that regulatory framework. [The system] is perceived as unfinished, sometimes fragmented, stagnated. There is still no vision of that regulatory framework…We are in the very early stages. (Professor/researcher, Honduras, Workshop 1)

Only Panama and Costa Rica have established a system for registration and accreditation of RECs. National training programmes in research ethics are notably absent, even for members of the NREC (Table 2 ).

Theme 2: ethics review preparedness and response to PHEs: COVID-19 times

Ethics review preparedness and response at the national and regional levels.

Formal national research priorities specific to COVID-19 were not identified in any of these countries (Table 3 ). In spite of lack of formalization of priorities and the identification of funding, study participants reported an increased number of protocols and the inability to respond to the demand.

There has been lack of coordination, which was exacerbated during the pandemic with the increase in demand for COVID-19-related reviews. (REC member, Dominican Republic, Workshop 2)

During the COVID-19 pandemic, five out of six countries adopted changes to the ethics review process implemented due to the need to meet virtually and adopt electronic submission of protocols (Table 3 ). Only Panama officially established an accelerated procedures for ethics review.

Ethics committee members have acknowledged that they do not have expertise in the use of technology and digital tools for ethics review. They have been reluctant to incorporate virtual work, due to factors such as age, accessibility, interest, time, duplication of effort and work overload.

Virtuality and the use of technology for reviews have their limitations. Some members did not adapt to it, some withdrew since they could not handle it, and others continued to collaborate, but by email. (REC member, El Salvador, Workshop 2)

Double review processes with ethics review by more than one REC caused duplications that increased the burden for both ethics committee members and researchers (e.g. protocols submitted to several committees at the same time in some countries).

Articulation of ethics review collaborative efforts during the pandemic

There is a gap between the number of COVID-19 studies registered in ClinicalTrials.gov by August 2021 and the number of studies on COVID-19 approved and reported by national research ethics authorities (Table 3 ). Five out of six countries have a registry of approved protocols, but none of them requires prospective registration of clinical trials. We could not find evidence of collaborative efforts on ethics review during the pandemic, for example, to avoid double review processes or reduce the number of reviews by various ethics committees.

Table 3 presents a summary of the ethics review preparedness and responses to PHE during the time of COVID-19.

Theme 3: collaboration and international cooperation during the COVID-19 pandemic

Regulatory framework for health research and promotion of collaboration (intersectoral, interdisciplinary, inter-institutional).

Formal international cooperation between health research institutions was found to be almost nonexistent within the region. Participants in the workshops were unable to contribute substantially to this question. We could not identify studies undertaken by at least two collaborators from the LAC (Latin America and the Caribbean) region.

Community engagement in research ethics governance processes

The need for community participation to establish public policies on research ethics was identified by study participants. An example of best practice of good governance was found in Panama (Table 4 ), where a regulatory framework was developed with the strong participation of civil society.

Three years ago, we were working on the regulatory framework of our country; enforcement began in force in 2019 and it is now Law 84. It was an important exercise for all stakeholders involved in health. It was a win-win for all actors: research subjects, researchers, and the country. (Government official, Panama, Workshop 1)

None of the other countries indicated having involved the community in the development of research ethics regulations.

Prevailing practices in countries to promote open dialogue and protection for participants in scientific research among researchers, regulators and the public

Other important issues are the promotion of scientific collaboration among stakeholders and the promotion of responsible conduct of research. There is little awareness of the importance of responsible conduct in research. Another participant stated:

Responsible behaviour implies that researchers must become aware of the importance of adhering to responsible practices in the development of research. This awareness can be strengthened through our work context and from training of human resources, beginning at the undergraduate level. At the postgraduate level, there must be more training. (Professor, Honduras, Workshop 3)

Table 4 presents a summary of the international cooperation and collaboration among research stakeholders described by study participants from each country.

Challenges to move forward in the context of COVID-19 and strengthen governance and regulation of health research

The main challenge identified was increasing the capacity to respond effectively to ethical review requests during PHEs. Most opinions were directed towards the formalization of the role of ethics committee members and the need for training opportunities for all involved in the research process: researchers, REC members, and undergraduate and graduate students.

Formalization of the work of RECs Many ethics committees in the region lack resources to carry out their functions. Financial and technological resources are missing primarily for equipment and support staff, as well as REC member compensation for review and oversight of research protocols. Despite efforts to adapt the review process, the ad honorem status of most ethics committee members in the region was identified as one of the reasons for delays in the review and approval of research studies. Therefore, REC needs should be considered in institutional budgets to cover the costs of training and time for protocol review. Time and effort of members within institutions should be recognized as part of their job responsibility, and compensation for external members should be provided.

Capacity-building in research ethics and collaborative practices Recommendations were oriented towards the development of training programmes in research ethics, such as workshops with active learning methods, as well as international exchange programmes and training programmes for undergraduate and graduate students, including master’s degrees in research ethics. It was highlighted that scholarships to ensure access to training are needed. All this could be accomplished through international and regional collaboration.

The CA-DR region has significant potential for developing strong and solid mechanisms for sharing experiences to improve research ethics governance. This potential is evident in examples of progress across the different countries in the region in terms of regulatory frameworks, prioritization of initiatives, funding, ethics committee networks, ethics committee training and community representation in research [ 16 , 22 , 23 , 24 ]. The GoEtiCA participatory action research project allowed a broad audience to meet virtually and provide insight, experiences and recommendations. We acknowledge differences in the level of knowledge in the composition of our participant sample and stakeholders; however, democracy is all about accepting different opinions. Our findings align with the conclusion of Rodriguez and Lolas [ 25 ]: “Research integrity only will become alive with public debate and reflection about scientific advances, while preserving human dignity and autonomy. Research ethics should be discussed with the general public and integrate their views in the process of policy development. This was the main gain of the collaborative effort.”

Challenges to the governance and regulation of research ethics

Many countries were shown to be insufficiently prepared to respond to the pandemic, as their own research ethics systems were not opportunely and fully developed. While pragmatic solutions are needed in times of crisis, such as the COVID-19 pandemic, time and resources must be invested beforehand by host countries, in particular to develop NRES as part of NHRS. As Mathur [ 26 ] stated, “An ethically conscious, well informed and updated governance framework which identifies the relevant stakeholders, defines their roles and responsibilities, lays down an implementation plan and a monitoring strategy, can safeguard the ethical values of the society, promote good science and deliver better outcomes.” Strict regulations are not always best; an appropriate balance is needed between regulating and promoting research both during and before/after a pandemic. Collaboration within and across regions is key to overcoming obstacles and working towards robust research ethics governance at national and regional levels [ 27 ].

Aguilera et al. [ 27 ] found that “Most countries have adopted legal instruments to govern research with human participants and have implemented national bodies tasked with the oversight of RECs. However, performance regarding ethics training policies and clinical trial registration was less advanced, and efforts to adopt policies on responsible conduct of research and accelerated ethics review of emergency research did not meet the PAHO objectives in most countries.” Countries must do more to develop policies, procedures and standard operating procedures for fast-tracked and rigorous ethics review during emergencies [ 27 ].

Challenges to ethics review during COVID-19 and future PHEs

Despite the existence of the Council for International Organizations of Medical Sciences (CIOMS) Ethical Guideline 20 on Research in Disaster and Disease Outbreak Situations [ 18 ], implementation of operating procedures based on this guideline has been limited. Palmero et al. [ 22 ] concluded that “[c]ontinuing efforts should be directed to strengthen [Latin American] countries’ research capacity to respond timely and ethically to future health emergencies”. In this study we confirm that there is a clear need to improve ethics review practices in light of the difficulties identified by study participants.

Challenges for international collaboration and cooperation during the COVID-19 pandemic

Articulation and coordination of the research response to the pandemic in CA-DR was weak. The number of COVID-19 studies registered in ClinicalTrials.gov by August 2021 showed the low intensity of the research environment in the region and could indicate that studies are not registered prospectively in clinical trial registration platforms, although most of the research ethics national bodies internally do register the approved protocols.

In the CA-DR region, accredited training opportunities are scarce. As training programmes are not always available, the most common sources of training are international programmes that are limited to conceptual aspects of training. Most often, these programmes do not provide specific details on national regulations and practices. International courses cannot substitute national training programmes that are comprehensive, accredited and adapted to local settings. One option to optimize resources may be training programmes with a regional perspective. Ángeles-Llerenas et al. [ 28 ] concluded that “[i]nvestments in REC member training and infrastructure are needed to ensure compliance of REC evaluations with the standards for ethical conduct of research”.

The uniqueness of this work lies in its collaborative and participatory methodology, where diverse stakeholders in health research systems in different countries were engaged and involved in the study. It was essential to start by motivating stakeholder participation, promoting dialogue and improving communication and coordination. This preparation allowed moving towards consensus-building around identified goals, which were the allocation of resources for priority research areas and the strengthening of ethical governance and regulations in health research.

A policy brief proposal was prepared from this deliberative and open dialogue (Additional file 1 ), representing the perspective of a broad range of research stakeholders in the region. GoEtiCA researchers presented the policy proposal to the Council of Ministers of Health within SICA (COMISCA).

Limitations

Ethics approvals of the GoEtiCA protocol in participating countries took longer than planned, primarily because the process began at the end of 2020, when several ethics committees in the region were experiencing an end-of-the-year recess. The GoEtiCA protocol also underwent substantial changes during the ethics review process and was updated to include requirements from the different ethics committees. These updates created additional delays that were not considered in the study’s initial planning phase. These GoEtiCA protocol issues are clear indicators of the challenges investigators face when conducting multisite and multi-institutional research studies. In an ideal scenario, all the RECs could have come together for a single, concurrent REC review that would work for all involved.

The other major limitation of the study was the inability to recruit participants from all Central American countries. To obtain ethical approval, the research team made all possible efforts to identify in-country collaborators, efforts that included dissemination and local promotion of the study to key players and searches for comprehensive information on local regulatory documents and practices in all Central American countries. Initially, the study aimed to include all the countries within the SICA region, but that was not possible since a local research collaborator could not be identified or effectively contacted in Belize and Nicaragua. Notwithstanding the difficulties in conducting this study, it is important to highlight the transparency, strong collaboration and participatory approach that led to notable results.

Frameworks and strategies to improve research ethics governance within the CA-DR region are needed. Although there are recent initiatives that may have a positive impact in terms of research collaboration and capacity-building in the region, this study found that none of these initiatives is focused on research ethics and its governance [ 29 , 30 ]. There is a history of previous research advocacy in the region [ 31 ] as part of international collaboration strategies, but these strategies and the advocacy are still at the beginning stages. The COVID-19 pandemic has provided an opportunity to plant the seed of collaboration among RECs [ 32 ]. However, formalization of collaboration remains necessary; informal, unplanned activities are marginal responses to the COVID-19 pandemic. Challenges experienced in the CA-DR region are not unique to this region. The learning process from other epidemics regarding the role of preparedness seems to be slow [ 33 ], as some countries were unable to respond adequately and make the changes demanded by the current pandemic context. Ethnographic studies may be needed to understand cultural practices and regulatory differences in research ethics governance. It is possible to create and establish mutual trust and equitable scientific collaboration that favours rapid accessibility and timely information-sharing; the feasibility of adaptation to the local requirements of each nation can likewise be assessed and determined [ 34 ].

Availability of data and materials

Datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

The open call was released through social media of partner institutions in the region and the Etikos ( https://etikos.do/ ) and The Global Health Network ( https://tghn.org/ ) webpages.

Abbreviations

Central America and the Dominican Republic

Community-based organization

Council for International Organizations of Medical Sciences

Ministry of Health

National commission on bioethics

National health research system

National research ethics committee

National research ethics system

Public health emergency

Research ethics committee

Sistema de la Integración Centroamericana (Integration System of Central America and the Dominican Republic)

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Acknowledgements

We thank SICA—the Central American Integration System—for their valuable support for this study. Central America Network of Research Ethics Committees. The authors Julio Arturo Canario Guzmán, Jackeline Alger, Jessie Orlich, Renata Mendizábal-Cabrera, Argentina Ying, Claude Vergès, Eleonora Espinoza, Mario Soriano, Elsy Cárcamo, Eddys Rafael Mendoza are members.

This study is part of an Epidemic Ethics/WHO initiative which has been supported by FCDO/Wellcome Grant 214711/Z/18/Z.

Author information

Authors and affiliations.

Fundación Etikos, Inc., Santo Domingo, Dominican Republic

Julio Arturo Canario Guzmán, Eddys Rafael Mendoza Marrero & Reyna Sepulveda

Centro Nacional de Investigaciones en Salud Materno Infantil Dr. Hugo Mendoza (CENISMI), Santo Domingo, Dominican Republic

Julio Arturo Canario Guzmán

Instituto Costarricense de Investigaciones Clínicas, San Jose, Costa Rica

Jessie Orlich

Centro de Estudios en Salud, Universidad del Valle de Guatemala, Guatemala, Guatemala

Renata Mendizábal-Cabrera

Universidad de Panamá, Panama, Panama

Argentina Ying & Claude Vergès

Facultad de Ciencias Médicas, Universidad Nacional Autónoma de Honduras (UNAH), Tegucigalpa, Honduras

Eleonora Espinoza & Jackeline Alger

Instituto de Enfermedades Infecciosas y Parasitología Antonio Vidal, Tegucigalpa, Honduras

Eleonora Espinoza, Elsy Cárcamo, Claudia Nieto Anderson & Jackeline Alger

Comisión Nacional Ética de Investigación en Salud, San Salvador, El Salvador

Mario Soriano

Centro Nacional de Educación Médica Continua (CENEMEC), Colegio Médico de Honduras, Tegucigalpa, Honduras

Briana Beltrán

Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom

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Proposal for the governance and ethical regulation of health research in Central America and the Dominican Republic in the context of the COVID-19 pandemic.

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A common framework for health data governance standards

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Navigating data governance associated with real-world data for public benefit: an overview in the uk and future considerations, monica catherine jones.

1 Faculty of Medicine and Health, University of Leeds, Leeds, UK

2 School of Health and Related Research, The University of Sheffield Faculty of Medicine Dentistry and Health, Sheffield, UK

Suzanne M Mason

3 School of Health and Related Research, The University of Sheffield, Sheffield, UK

4 Health Informatics, NHS Sheffield CCG, Sheffield, UK

Matthew Franklin

Associated data.

Real-world data encompass data primarily captured for the provision or operation of services, for example, electronic health records for direct care purposes, but which may have secondary uses for informing research or commissioning. Public benefit is potentially forfeited by the underutilisation of real-world data for secondary uses, in part due to risk aversion when faced with the prospect of navigating necessary and important data governance processes. Such processes can be perceived as complex, daunting, time-consuming and exposing organisations to risk. By providing an overview description and discussion around the role of six key legal and information governance frameworks and their role regarding responsible data access, linkage and sharing, our intention is to make data governance a less daunting prospect and reduce the perception that it is a barrier to secondary uses, thus enabling public benefit.

Introduction

The use of the terms ‘real-world data’ (RWD) and ‘real-world evidence’ (RWE) in the context of health decision-making has grown substantially in the last 20 years, although unified and consistent definitions of these terms remain elusive. 1 2 Often referred to as ‘administrative’, ‘observational’, ‘routine’, ‘large’ or even ‘big’ data sources; over the last decade, they have become of increasing interest to those conducting health technology assessments, to provide policy-makers with evidence to inform decision-making and develop guidance on the reimbursement and administration of new health technologies within a care system. 2–4 For example, the National Institute for Health and Care Excellence (NICE) for England and Wales, within their RWE framework, suggests RWD is: ‘Data relating to patient health or experience or care delivery collected outside the context of a highly controlled clinical trial’ 5 ; relatedly, NICE’s definition of RWE is simply: ‘evidence generated from the analysis of RWD’. 5 As such, RWD includes administrative (eg, Hospital Episode Statistics), registry (eg, National Cancer Registration and Analysis Service) or survey data on populations (eg, Health Survey for England) among other routine data sources, which can comprise stand-alone or linked datasets. 6–8

RWD have a range of potential uses that could lead to public health and non-health benefits (eg, well-being, independence and empowerment). 9–12 For example, as a complement or substitute to primary data collection within RCTs, for example, to reduce or avoid responder burden or loss to follow-up. Alternatively, RWD can be analysed in its own right to assess associations between factors involving medical and/or public health (eg, frailty and mortality), or for the purpose of causal inference (eg, estimating average treatment effects). 13–15 Such data could be used to inform the development of new health technologies, for example, artificial intelligence (AI) and other digital health technologies that use routine data within risk prediction and/or machine learning processes. 16 17 Secondary uses of data can also inform more than just academic research, for example, when it is employed by local and national commissioning agencies and governing bodies to inform performance monitoring, policy decision-making, guide public spending decisions (eg, commissioning new care services across health and social care sectors), and Population Health Management. However and related to all these example contexts which could lead to public benefit 10 11 : the use and sharing of RWD presents particular challenges, especially around data protection and associated data governance. Public benefit is potentially forfeited by the underutilisation of RWD for secondary uses, in part due to risk aversion when faced with the prospect of navigating necessary and important data governance processes, although there are other barriers to sharing and using RWD which can include organisational features and process factors. 9–11 18

The aim of this article is to explore how we can make data governance a less daunting prospect and reduce the perception that it is a barrier to secondary uses, relative to processes and gateways for responsible use of data with public benefit as a focal point. As such, within this article, we focus on the legal and information governance (IG) structures associated with secondary uses of data relating to individuals primarily captured for the provision or operation of health and care services; in this article, we particularly focus on the UK’s Data Protection Act 2018, General Data Protection Regulation (GDPR) 2018, common law duty of confidentiality, National Health Service (NHS) Act 2006 section 251, Control of Patient Information (COPI) Regulations 2002 and the Health and Care Act 2022. 19–23 23 We also make comparisons between the UK’s and other countries’ (ie, US) frameworks for data protection and security, and associated initiatives such as the Five Safes framework and the increasing interest and use of Trusted Research Environments (TREs). A TRE is a highly secure computing environment that provides remote access to health data for approved researchers to use in research. 24 They are usually owned and managed by public funded bodies such as the NHS in the UK.

What is IG?

IG refers to a framework and set of practices that are designed to ensure the effective and secure management of information within an organisation. It encompasses the policies, procedures, systems and controls that govern the collection, storage, use, sharing and disposal of information. 20 In the context of healthcare, IG is of utmost importance due to the sensitive and confidential nature of patient data. It aims to protect patient information, ensure its accuracy and accessibility, and promote the responsible and lawful use of data. Effective IG involves the development and implementation of policies, staff training, appropriate technology infrastructure, risk assessment and management, regular audits, and compliance monitoring. By adhering to these principles and practices, organisations can ensure the confidentiality, integrity and availability of patient information while promoting trust and confidence in health and social care systems.

Introducing the bedrock: GDPR, Data Protection Act 2018 and the common law duty of confidentiality

Since 2018, the UK has had new rules around how to handle personal data: the GDPR, as enacted in the UK by the Data Protection Act 2018. 19 20 A guide exists for understanding UK GDPR which explains the general data protection regime that applies to most UK businesses and organisations processing data relating to identifiable, living persons. 20 In summary, this guide defines data protection principles, rights and obligations, summarises key points, answers frequently asked questions, and contains practical checklists to help people comply with GDPR. Additionally, the NHS Health Research Authority (HRA) provides GDPR operational guidance for research, 25 and the Information Commissioner’s Office (ICO) issues data protection guidance. 26 An important aspect for consideration is that the UK GDPR defines data ‘controllers’ and ‘processors’:

• A controller determines the purposes and means of processing personal data.
• A processor is responsible for processing personal data under the direction of a controller.

As such, key aspects of the GDPR are to help define and operationalise responsibilities of data controllers, while also improving the rights and notification of the data subjects. GDPR covers the whole of Europe, but confidence, privacy legislation and tort law are country specific. Overall, this helps people to know what to do and how to do it when dealing with data relating to living persons.

The common law duty of confidentiality (also referred to as the ‘common law duty of confidence’), unlike GDPR and the Data Protection Act, is not defined by a written document but is instead based on previous court decisions and principles established by the Courts and Tribunals Judiciary. Broadly, there is a legal precedent that information given in confidence, or under an expectation of confidence, must not be disclosed without the information provider’s agreement unless there is another valid lawful basis. 27 In contrast to GDPR, the duty of confidence applies to information provided by individuals even after their death. Health and care information relating to a person is generally considered to be owed a duty of confidence. This type of information is often termed ‘confidential patient information’.

Common law duty of confidentiality and the NHS Act 2006 section 251 (England and Wales)

Obtaining agreement from each patient to access their health and social care information for large-scale or population-level analyses is rarely practical and important historical records of patients who have since died would be unavailable. Where it can be shown that there are no alternative practical means and that there is demonstrable potential public benefit, the common law duty of confidentiality can be set aside. This enables confidential patient information to be shared for specific purposes without the explicit agreement of the individual patients, without the controller being in breach of their duty of confidence when circumstances are justified. The NHS HRA decides whether to approve an application but their decision is strongly guided by advice from the independent Confidentiality Advisory Group (CAG) with due regard to guidance by the National Data Guardian. 28 The CAG expects applicants to provide a mechanism for patients to opt-out from their data being used for secondary purposes on a project-by-project basis. The final decision of whether to share data or not rests with the data controller, but all parties must comply with UK Data Protection Legislation and NHS (or other appropriate) data security standards at all times.

A moment of realisation: COVID-19 pandemic and the COPI notices

When the COVID-19 pandemic started, there was a realisation of the requirement for greater and more timely access to a wider variety of data to manage the public health response to the pandemic. The Secretary of State for Health and Social Care issued Notices under Regulation 3 (4) of the Health Service COPI Regulations 2002 29 : these notices directed health and care providers and, particularly, NHS Digital (then national collator of information about health and social care in England) to share confidential patient information with authorised organisations for the purposes of managing the COVID-19 pandemic. This has been very useful for implementing public health interventions, but also for monitoring the pandemic, informing key decisions affecting population health and enabling research focused on delivering public benefit. It is important to note that the COPI Notices did not remove the requirements for organisations to comply with UK Data Protection Legislation and NHS (or other appropriate) data security standards.

The COPI Notice(s) issued over the course of the COVID-19 pandemic were limited in scope to permit the processing (including sharing) of data solely for the purpose of supporting the government’s response to COVID-19. The majority of these COPI notices expired on 30 June 2022. 30–33 Most COVID-19-related projects requiring ongoing processing of confidential patient information (in England and Wales) have now transitioned to use another legal basis for the processing of this data, mainly section 251 of the NHS Act 2006. The public benefit achieved due to the timely sharing of patient data enabled by the COPI notices has highlighted that further public benefits could be achieved through the appropriate sharing and use of such RWD for purpose beyond purely the response to the COVID-19 pandemic. 9–12

Instigating further change: the Health and Care Act 2022

The Health and Care Act 2022 dismantles many of the structures established by the Health and Social Care Act 2012 34 and is intended to reinforce the ambitions of the NHS Long Term Plan. 23 34 35 The Act puts Integrated Care Systems (ICSs) on a statutory footing and provides for the Care Quality Commission to assess how local authorities deliver their adult social care functions. It has established an Integrated Care Board and an Integrated Care Partnership in every part of England. The Act enables NHS England (among others) to publish data specifications detailing information which providers would be obliged to submit to NHS Digital, and makes it a criminal offence to share that data inappropriately. The Act has pushed forward the publication of mandatory information standards for the processing of information (including collection and storage), which requires health and social care providers to comply with such standards rather than, as previously, have regard to them; this requirement also extends to private providers. 35 The Act requires NHS Digital to promote the effective and efficient planning, development and provision of health services and of adult social care in England. 35 The Act also makes it clear that NHS Digital may share information for purposes connected with the provision of healthcare or adult social care or the promotion of health including for research purposes. 35 Alongside other considerations within the Act’s ‘Health and Adult Social Care: Information’ section, the Act outlines requirements for providers to share ‘anonymous’ information—the nature and sharing of anonymous data aligns with the Data Protection Act and GDPR 2018, 19 but also common law duty of confidentiality; as such, the Act aligns with current data governance legislation rather than extending it.

The main challenge of the Health and Care Act 2022 23 in the UK is to implement significant changes to the organisation and operation of the NHS. The Act’s creation of ICSs brings together NHS providers, local authorities and other health and care organisations to plan and deliver care for their populations. The challenge lies in ensuring that these ICSs operate effectively, with clear lines of accountability and governance, and that they provide high-quality, patient-centred care, while also addressing health inequalities and managing costs effectively, which could be achieved through appropriate sharing and use of RWD. 12

What else is needed: a change in the data landscape

Bringing data together on a project-by-project basis (eg, through one time data extracts) is inefficient. NHS HRA support is required for each project wishing to link together patient-level health or care data held by more than one organisation and can only be used for that project. The Digital Economy Act (DEA) 2017 created a framework for enabling public authorities to share information with accredited researchers for approved projects seeking to deliver public benefit. 36 Before data are made available to researchers, it is linked and depersonalised by independent, accredited data processors to ensure the data is no longer reasonably likely to reidentify persons or businesses. Researchers and their projects must be accredited before gaining access and the data can only be accessed within an accredited safe environment. Finally, all research outputs are independently checked to ensure they meet statistical disclosure control guidelines; this is known as the Five Safes framework, which we have described in table 1 when comparing alignment of the framework to the UK’s healthcare IG regulations. 37

Comparing alignment of the UK healthcare IG regulations against the Five Safes dimensions

IG, information governance.

Unfortunately, health and care data are explicitly excluded from the DEA 2017, despite the public benefits that could be achieved by including health and care data within the Act. This exclusion means that it is currently necessary to seek dual approvals for projects seeking to combine and link health and care data with data from other domains (eg, economic and crime data) made accessible under the DEA 2017. This dual approval process is not documented and requires coordination between approval bodies.

Discussion of the differences between IG regulations

Navigating healthcare IG regulations can be complex, especially when it comes to understanding the differences between regulations in different countries. In the UK, healthcare IG is primarily governed by several key regulations and guidelines. As such, in table 2 , we discuss some of the key differences between the healthcare IG regulations in the UK to aid researchers in navigating this field.

Summarising some key differences between IG regulations, and associated organisations and principles

IG, information governance; NHS, National Health Service.

Researchers navigating the field of healthcare IG in the UK should familiarise themselves with these regulations, guidelines and organisations. Seeking advice from research ethics committees, NHS Digital, the HRA and the NIHR can provide valuable support and ensure compliance with the relevant regulations. 25 Staying up to date with evolving regulations is also essential as healthcare IG is an evolving field that responds to technological advancements and changing societal expectations. The UK’s IG jurisdiction and other countries, such as the USA with Health Insurance Portability and Accountability Act, also have several key differences in their approach to data protection and privacy, with some examples provided in table 3 using the UK and USA as case studies. 38

Some differences in approaches to data protection and privacy between countries—a UK versus US case study

Practical examples of approaches to data governance

Health Data Research UK (HDR UK) is a national institute in the UK that aims to harness the power of health data to improve patient care, enable ground-breaking research and drive innovation in healthcare. 24 It brings together expertise from universities, research organisations, NHS trusts and industry partners to facilitate the secure and responsible use of health data. Another regional initiative is the Yorkshire Health and Care Record (YHCR), which is a collaboration between the NHS and local authorities in the Yorkshire and Humber region. 39 The YHCR aims to create a comprehensive digital health and care record for the region’s population, integrating data from multiple sources to provide a holistic view of an individual’s health and care information.

These initiatives demonstrate an innovative approach to data governance and sharing. Both HDR UK and YHCR have implemented robust data governance practices, with examples including:

• Consent and patient engagement: HDR UK and YHCR prioritise patient engagement and consent. They involve patients and the public in decision-making processes related to data sharing, ensuring transparency and accountability. Patients are provided with clear information about how their data will be used and given the choice to opt out if they wish.
• Secure data infrastructure: Both initiatives invest in secure data infrastructure to protect patient information. This includes employing encryption techniques, access controls and anonymisation methods to minimise the risk of reidentification.
• Data access frameworks: HDR UK and YHCR have established data access frameworks that govern how researchers and organisations can access and use health data. These frameworks outline the criteria for accessing data, including obtaining appropriate approvals, demonstrating research merit, and adhering to strict data security and privacy standards.
• Ethical approvals and governance bodies: HDR UK and YHCR have established ethical approvals processes and governance bodies to ensure that research projects using health data adhere to ethical guidelines. These bodies review research proposals and monitor ongoing projects to ensure compliance with data protection regulations and ethical principles.

HDR UK and YHCR are provided as examples for descriptive purposes only, noting regionally and nationally, within and across countries, such institutions and initiatives are developing and evolving.

How the NHS connects datasets as an investment for public benefit

There are initiatives focused on integrating various datasets within the NHS to create a comprehensive and interoperable health information system, with the goal being to improve patient care, enhance research capabilities and drive efficiencies within the healthcare system. By connecting datasets from different sources, such as electronic health records, hospital data, primary care data and social care data, the NHS aims to gain a holistic view of patient health, enabling healthcare providers to make more informed decisions and improve health outcomes. This initiative represents a significant investment in data infrastructure and technology to enable seamless data sharing and analysis for public benefit. 9–11

While the specific details and progress of this initiative may vary over time, it underscores the importance of data governance and privacy considerations. The NHS is committed to ensuring that patient data is handled securely and in compliance with legal and ethical standards. Robust data governance frameworks, including consent mechanisms, anonymisation techniques and strict access controls, are put in place to safeguard patient privacy and maintain public trust. Investing in data connectivity and interoperability within the NHS holds the potential to unlock valuable insights, enable research collaborations, and enhance the delivery of healthcare services. However, it is crucial to ensure that these efforts are accompanied by strong governance mechanisms to protect patient privacy and maintain data security.

Our recommendations and future considerations

Understanding this regulatory landscape can be challenging for health and care providers, commissioners, research institutions and the general public—here we have provided an overview of six key legal and IG frameworks of which people should be aware to make the responsible use, linkage and sharing of data a less daunting prospect. We have provided references to further information and useful guidance, such as ICO’s guide to UK GDPR 20 ; although such guidance is not infallible, it is useful to guide secondary uses of data.

Through reflecting on good practice exemplars both nationally, for example, HDR UK, and regionally, for example, the YHCR, it is possible to work within these necessary legal and IG frameworks to enable analysis to answer a range of health and social care questions. 24 39 40 As another example, NHS Digital’s national TRE in England uses the COPI Notice for its legal gateway for access to healthcare data. 41 The direction of travel in the UK is strongly towards TRE/Secure Data Environments and is government led, although there is still some merit in pairwise collaboration while this is put in place. 42 Pairwise collaboration in the context of TREs can have several benefits— table 4 gives an overview of some of these benefits. It is important to note that while pairwise collaboration has its merits, it should be conducted within the framework of the TREs’ guidelines and governance mechanisms to ensure data security, privacy and ethical considerations.

An overview of merits related to pairwise collaboration in the context of Trusted Research Environments (TREs)

Enabling access to data for secondary uses through TREs complying with the Five Safes Framework reassures data suppliers and the public, compared with provisioning data extracts for individual projects—see also tables 1 and 4 . The Five Safes model also improves efficiency by making it possible to make the same data available for many different, suitably approved, projects without the need for the data provider to disseminate multiple data extracts to different organisations. This efficiency was demonstrated by the use of NHS England’s NHS COVID-19 Data Store TRE and the ONS Secure Research Service (TRE) hosted Public Health Research Database to generate evidence to inform the response to the COVID-19 pandemic. As of March 2022, NHS Digital’s TRE is supported by a government announcement that up to £200 million is being invested to enable more secure and efficient access to NHS data through TREs and digital clinical trial services, with an initial focus on NHS Digital data to help researchers understand the impact of COVID-19 on cardiovascular disease and cancer. 43 This national TRE has been extremely useful as an indicator as to the power of unlocking data, hopefully paving the way for extended uses, with clear responsibilities and checks/balances, for public benefit as recommended in the Goldacre Review. 12 Another example is Clinical Practice Research Datalink. This is one of the most extensive linked databases of primary, secondary and other care data. It has given many research opportunities in the past. There has been an effort to combine this data at the national level, but still, there are legal challenges, as described in this paper.

When enabling and using data for secondary uses, it is also important to have shared learning to avoid making mistakes in the future. A key partner in the responsible use of data is the public who both have a vested interest in the use and protection of data for which they are the subject, but also the beneficiaries and even funders (eg, via charities and public funded agencies) of care programmes informed by the associated generated evidence base. The public should be fully informed in a transparent and useful manner as to the secondary uses, users and public benefits of utilising RWD, including how data governance can support the whole process. 9 44

Our article is a necessarily shortened overview of key legal and IG aspects to consider when accessing, storing or using RWD. It is geared towards those who want to use data for secondary uses, for public benefit, but feel they do not have sufficient understanding of data governance to get started, or members of the general public who want to grasp a better understanding of data governance. We hope this article informs and encourages responsible access to health and care data for the realisation of public benefit.

Supplementary Material

Acknowledgments.

We would like to thank our other coapplicants as part of the 'Unlocking Data to Inform Public Health Policy and Practice' project, which included: Susan Baxter, Annette Haywood, Sebastian Hinde, Daniel Howdon, Anthea Sutton, Mark Clowes, James Lomas, Louise Brewins, Philip Truby, Michelle Horspool, Kamil Sterniczuk, Jennifer Saunders, and Christopher Gibbons. We would like to thank our Study Steering Committee (SSC) for providing valuable insight and guiding our study throughout: Steven Senior (Chair), Gerry Richardson (Deputy Chair), Katherine Brown, William Whittaker, Emily Tweed, Shane Mullen, Vanessa Powell-Hoyland, Barbara Coyle, Abbygail Jaccard. We thank our Patient and Public Involvement (PPI) group for making sure the public has a voice when guiding our study; our PPI group included Sarah Markham, Della Ogunleye, Terry Lock, among other members who preferred to remain anonymous. We thank Lauren Hartley, Emma Bennett and Amanda Lane for providing valuable administrative support to the project. We also thank all staff across the Sheffield City Council in particular Steve Eccleston, City of York Council, and Sheffield Clinical Commissioning Group who took part in our workshops and provided us with their insight, knowledge, and experience that made the project possible.

Special acknowledgement: Louise Brewins sadly passed away during the conduct of this research study. We especially thank Louise for her input and insight during the study, as well as for her professionalism but also friendly and upbeat attitude throughout. On behalf of the research team and colleagues across the city councils, CCG and universities: Louise will be sadly missed.

Contributors: Concept and design: MF, MCJ, TS and SMM. Drafting of the manuscript: MCJ, TS, MF, SMM and AE. Critical revision of the paper for important intellectual content: MCJ, TS, MF, SMM and AE. Obtaining funding: MF, TS, MCJ and SMM.

Funding: This study/project is funded by the National Institute for Health and Care Research (NIHR) Public Health Research (PHR) programme (NIHR award identifier: 133634) with in-kind support provided by the NIHR Applied Research Collaboration Yorkshire and Humber (ARC-YH; NIHR award identifier: 200166). The funding agreement ensured the authors’ independence in developing the purview of the manuscript, writing and publishing the manuscript.

Disclaimer: The NIHR had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

Competing interests: MCJ, TS, SMM, AM and MF report no other funding other from the NIHR, during the conduct of the study. No other disclosures were reported.

Provenance and peer review: Not commissioned; externally peer reviewed.

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A New Era of Policy in Solar Geoengineering

At a glance, key challenge, policy insight, an assessment of the 2023 white house research plan and recommendations for future research governance, introduction.

The state of climate impacts on human systems is growing in severity. The Intergovernmental Panel on Climate Change (IPCC) Sixth Assessment Report indicates that climate change has adversely impacted water and food security, public health, and infrastructure across economic sectors (IPCC 2022). These impacts are significantly worsening across regions, amplified in the most vulnerable regions.

Mounting concerns that reducing emissions and scaling up carbon dioxide removal (CDR) will be insufficient to limit these severe and worsening climate impacts are starting to drive a broader conversation around solar geoengineering.

Solar geoengineering (SG), also known as solar radiation management/modification (SRM), refers to a set of proposed, large-scale, deliberate methods to increase the amount of sunlight reflected into space, which would reduce global mean temperatures. It is a small but growing field with recent momentum across the public, private, and academic sectors.

Historically, the topic of SG has been deeply controversial in the climate change community, with extreme hesitancy and taboo surrounding both scientific and governance engagement in the field. While there is still reticence, major institutions and organizations with strong influence are showing signs of a major shift in perception, activity, and interest over the last two to three years. Research efforts are starting to expand, there has been a significant increase in focus on SG governance—both domestically and globally, and press coverage is mounting.

The question of how SG research and governance should proceed is still fraught with nuance and considerable debate. Yet the diversity of actors participating in the field has also remained extremely narrow across geographies and sectors with minimal discussion around how justice principles intersect with SG.

From a justice perspective, SG is double-edged. SG may have the potential to limit harm and suffering from climate change, but it also has the potential to exacerbate or create new forms of harm and injustice. We don’t yet know what role SG could play due to the uncertainty of the science, but also because we don’t yet know what climate-vulnerable communities may want (Taiwo and Talati, 2021).

This policy brief will provide a summary of relevant terms and the state of the field, share an analysis of recent U.S. activity, explore the implications for domestic and international climate policy, and provide cross-sectoral recommendations for how SG governance and policy can move forward in both a just and scientifically robust manner.

The Status of Solar Geoengineering  

While climate impacts are becoming more severe and frequent, global efforts to limit warming to 1.5°C are proving to be insufficient. While SG cannot address the root cause of climate change, it is an approach that may be able to address some types of climate impacts while mitigation, adaptation, and carbon dioxide removal are pursued more robustly.

The understanding of what SG impacts might look like, especially in the context of climate change impacts, is extremely limited, and more research is needed to understand what they may look like across different regions. There is an array of approaches, illustrated in Figure 1, and associated potential impacts (which could be beneficial or harmful) across physical and social systems. The most prominent of these approaches are stratospheric aerosol injection (SAI) and marine cloud brightening (MCB).

The implications of such a global technology merit a better understanding of governance for both research and potential deployment. Governance is a complex term. It is not simply oversight or regulation but is defined as any system of formal or informal rules or voluntary guidelines intended to affect or influence research or potential deployment (The Alliance for Just Deliberation on Solar Geoengineering 2023).

This includes the structure of funding, frameworks for transparency and public engagement, and potential international negotiations or agreements. Actors in governance are not only governments, but span academia and research institutions, civil society, and philanthropy. Research governance specifically is essential to build trust, ensure responsible activity, and create better research outcomes. 

Influential processes and institutions are beginning to engage with the topic in important and different ways (see some examples in Table 1). There has also been increasing funding (though on a much smaller scale relative to other climate funding) from philanthropy as well as the U.S. government, which is currently approximately $11M/year (U.S. Congress 2023). It is still important to note, however, that there are still very few civil society organizations, policymakers, and academic institutions engaged in the topic, especially in climate-vulnerable regions.

A Major Shift in U.S. Activity

Of recent examples, the congressionally-mandated White House report is significant as the first U.S. federal policy engagement in SG outside of appropriations and the first major government report on the topic globally. Understanding the content of the report, how this report came into being, and the process by which the report was developed all bear significance for how policy around SG may evolve in the future.  

White House Report Origins and Process

The report was authored by the White House Office of Science and Technology Policy (OSTP). It was supported by a cross-agency working group that included members from the U.S. Global Change Research Program, the National Oceanic and Atmospheric Administration (NOAA), the Department of Energy (DOE), the National Science Foundation (NSF), the Department of Defense, the Environmental Protection Agency (EPA), NASA, and the Department of State, among others.

The U.S. Congress mandated the White House report in fiscal year 2022 (FY22) appropriations report language with the following relevant sections (U.S. Congress 2022):

NOAA is directed to support OSTP, in coordination with DOE and NSF to provide a five-year plan, not later than 180 days after enactment of this Act, with a scientific assessment of solar and other rapid climate interventions in the context of near-term climate risks and hazards. The report shall include: (1) the definition of goals in relevant areas of scientific research; (2) capabilities required to model, analyze, observe, and monitor atmospheric composition; (3) climate impacts and the Earth’s radiation budget; and (4) the coordination of Federal research and investments to deliver this assessment to manage near-term climate risk and research in climate intervention.

The congressional directive also subsequently requests that OSTP develop a “research governance framework to provide guidance on transparency, engagement, and risk management for publicly funded work in solar geoengineering research.”

Importantly, the authors were very clear that this report was only pursued due to the congressional mandate, with further major action in this space unlikely in the near term. The report states:

The issuance of this report does not signal any Executive Branch policy decision(s) regarding SRM. The report is only a response to the Congressional directive. Any future decisions around Federal SRM activities, including SRM research, must be considered in the broader context of scientific and societal factors, Administration priorities, and available resources.

While this signals that further action from the Biden administration will likely not be taken until there is a larger push, the congressional directive does exist, and the report enumerates U.S. government perspectives that did not yet exist prior to its release.

The external engagement process for the writing of this report is also important to consider as public participation and inclusion are emphasized as being critical in this field by major institutions and researchers—including by this report itself (UNEP 2023; NAS 2023; OSTP 2023).

There was a public comment period, but it was only open for 21 days (USGCRP, 2022). In addition, only the congressional language was provided to comment upon rather than a draft of the report. Overall, there was also minimal formal consultation with the expert community, especially the governance community, and with international institutions or experts.

White House Report Summary

Substantive highlights of the report include:

Strong support for expanded research, including outdoor experimentation. The report states that outdoor experiments would be valuable alongside modeling and lab-based research. Importantly, there is more support from recent reports and open letters for expanded research (UNEP 2023; Hiar 2023). But outdoor experimentation remains one of the most fraught areas of SG, with some coalitions and groups calling for bans on such activities (Bierman et al., 2021; CAN International 2019).

The report also supports expanded scenario-based research and the development of monitoring capabilities to detect potential deployment from other actors. Significantly, the report supported an international assessment of the state of the SG field—a proposal that was also suggested by recent assessments this year (UNEP 2023; Climate Overshoot Commission 2023), as well as in a 2019 UN environment assembly resolution that failed, partly due to the U.S. government (Chemnick 2019). 

Strong support for robust research governance, but little discussion on implementation. Significantly, the report stated that research should adhere to clear research governance standards, including transparency, oversight, safety, public consultation, international cooperation, and periodic review. It also suggested that any research program should be coordinated by USGCRP and helpfully notes the need for co-evolving standards as research progresses.

However, the dedicated “initial research governance framework” offered few details on how to accomplish any of these goals. The recommendations listed did not draw from existing frameworks nor had tangible next steps or activities.

Most notably, while there was support for public consultation, there was also no discussion on how it would be built or funded, who would run and oversee such activity, and the different needs for which engagement would be necessary.

Support for international research cooperation. The report discusses a high-level framework around why international cooperation is necessary, what cooperation should be on, whom cooperation might be with, and potential approaches (e.g., type and forum). There is a significant emphasis on building a culture of collaboration in an international context for both research and its governance.

The report recognizes that global partnerships can help build the foundation for a more inclusive field across sectors. However, there is limited discussion on how to empower the Global South and climate-vulnerable countries in research and governance processes and what fora might enable more equitable power distribution.

Support for risk-risk framework. The report supports the use of a risk-risk framework, an important lens that has become more prevalent in SG literature. This framework states that the potential risks and benefits associated with SG must be considered relative to those associated with climate change. The report states that this framing “would contribute to the necessary context in which policymakers can consider the potential suitability of SRM as a component of climate policy”.

Support for an understanding of justice implications, but not holistically. A discussion of environmental justice included a recognition of the potential of SG to both reduce or exacerbate inequities and highlighted the risks facing vulnerable and frontline communities. The report also helpfully raised issues of procedural justice (fairness in decision-making) as well as intergenerational concerns.

However, justice was only included as a “gap to inform research” rather than woven throughout the report as an overarching set of principles to guide a potential framework, including governance.

Missing pieces. Overall, there were several missing pieces in the report, including a discussion of the role of civil society, a robust discussion of the role of the Global South and climate-vulnerable countries, and how to build transparency beyond a research database. 

Broad Implications

There are considerable high-level implications for SG research and governance, both domestically and internationally, especially in the context of volatile political environments.

One of the most consequential aspects is the existence of the report itself as the first major indication of U.S. federal policy involvement. One major outcome of such involvement is motivating more participation in SG discussions and research in other countries and in international bodies. While it remains to be seen how international governments or institutions will respond, the report is starting to be included in new discussions.  

However, whether U.S. government interest is coming at the right time is a challenging question considering the political environment of the United States. SG research, especially outdoor experimentation, remains controversial. The context of what party is in power has a huge bearing on how potential federally-led, small-scale experimentation could be perceived.

For many in the SG field, and as stated in this brief, support for robust mitigation must be a priority and the foundation for potential consideration of SG. If that is not the case, the legitimacy of any research outcomes would be in question.

Broadly, the indication of public institutions involving themselves is also an important one. Public programs are a means of oversight and transparency. However, the type of public institution (e.g., a science agency versus a military institution) can drastically impact the level of public trust. Erosion in public perception of federal bodies could also create deeper levels of mistrust and misinformation. In this context, the role of civil society and academic bodies is critical to serve as institutions that can build accountability, legitimacy, and credibility.

Future Recommendations

As discussions and activity around SG grow, there must be more clarity around governance, the institutions involved, and requirements for research. Research will need to answer critical questions around the impacts, social dimensions, and potential viability for SG in the context of climate change, but the types and scale of research pursued and under what frameworks require more focused consideration.

The following are high-level recommendations for SG research governance for institutions conducting research, building research agendas, or participating in its governance. Responsible, equitable research is not possible without well-built, collaborative, and co-evolving governance mechanisms in place.

• Research governance must be anticipatory, built collaboratively across sectors, and ultimately widely accepted across institutions. Researchers, especially for potential small-scale outdoor experimentation, must be able to function within a well-understood environment to be able to plan successfully. Further, publics must be able to trust the processes that research is functioning within for research outcomes to have legitimacy.
• Any research agenda must include a robust plan and guidance for meaningful public participation and necessary capacity building. Public input cannot be a one-off but rather a much more substantive and robust process across a range of publics and stakeholders throughout a research process, especially for outdoor experimentation (i.e., from development to implementation to analysis and publication).
• Clear pathways for legitimate collaboration with climate-vulnerable communities and nations must be enumerated, prioritized, and pursued in the research enterprise itself—including in the development of research questions, relevant scenarios, and the necessary governance frameworks.
• Any research program must be created with full transparency surrounding guidance, funding, goals, outcomes, and involved actors.
• The building and implementation of a research program should not only involve academia but also be deeply engaged with civil society. Civil society is a key sector in connecting with communities, building inclusion, and providing accountability.
• Participation from institutions, organizations, or processes in SG discussions should not be painted as advocacy. There cannot be a taboo placed on organizations or individuals wanting to engage in SG discussion and deliberation.

Shuchi Talati

The Alliance for Just Deliberation on Solar Geoengineering. 2023. Building Solar Geoengineering Governance Capacity . Washington DC. https://sgdeliberation.org/wp-content/uploads/2023/04/DSG-White-Paper_Capacity-Building.pdf

The Alliance for Just Deliberation on Solar Geoengineering. 2023. Key Concepts and Definitions. Accessed September 25, 2023. https://sgdeliberation.org/resources/definitions/#solargeo

Biermann F., J. Oomen, A. Gupta, S.H. Ali, K. Conca, M.A. Hajer, P. Kashwan, LJ Kotzé, M. Leach, D. Messner. 2022. “Solar Geoengineering: The Case for an International Non-use Agreement.” Wiley Interdisciplinary Reviews: Climate Change 13(3): e754.

Chemnick, Jean. 2019. “U.S. Blocks U.N. Resolution on Geoengineering.” Scientific American . https://www.scientificamerican.com/article/u-s-blocks-u-n-resolution-on-geoengineering/

Climate Action Network. 2019. “Climate Action Network Position on Solar Radiation Modification (SRM).” Accessed October 15, 2023. http://www.climatenetwork.org/sites/default/files/can_position_solar_radiation_management_srm_september_2019.pdf  

Climate Overshoot Commission. 2023. Reducing the Risks of Climate Overshoot . Accessed October 15, 2023. https://www.overshootcommission.org/_files/ugd/0c3b70_bab3b3c1cd394745b387a594c9a68e2b.pdf

European Commission. 2023. “Joint Communication to the European Parliament and the Council.” Accessed September 25, 2023. https://www.eeas.europa.eu/sites/default/files/documents/2023/JOIN_2023_19_1_EN_ACT_part1_v7.pdf

European Commission. 2023. Scoping Paper: Solar Radiation Modification . Accessed September 25, 2023. https://research-and-innovation.ec.europa.eu/system/files/2023-08/Scoping_paper_SRM.pdf

IPCC. 2021. Working Group I Contribution to the Sixth Assessment Report of the Intergovernmental Panel on Climate Change , 10.1017/9781009157896.

IPCC. 2022a. Working Group II Contribution to the Sixth Assessment Report of the Intergovernmental Panel on Climate Change , 10.1017/9781009325844.

—. 2022b. Working Group III Contribution to the Sixth Assessment Report of the Intergovernmental Panel on Climate Change . https://www.ipcc.ch/report/ar6/wg3/downloads/report/IPCC_AR6_WGIII_FullReport.pdf

Hiar, Corbin. 2023. “Efforts to Block Sunlight Get Boost from Prominent Scientists.” E&E News . https://www.eenews.net/articles/efforts-to-block-sunlight-get-boost-from-prominent-scientists/

Keutsch Group. n.d. “SCoPEx: Stratospheric Controlled Perturbation Experiment.” Accessed October 15, 2023. https://www.keutschgroup.com/scopex

National Academies of Sciences, Engineering, and Medicine. 2021. Reflecting Sunlight: Recommendations for Solar Geoengineering Research and Research Governance. Washington, DC: The National Academies Press.

Táíwò, Olúfẹ́mi O. and Shuchi Talati. 2021. “Who Are the Engineers? Solar Geoengineering Research and Justice.”  Global Environmental Politics  2022; 22 (1): 12–18. https://doi.org/10.1162/glep_a_00620

UNESCO World Commission on the Ethics of Scientific Knowledge and Technology. 2023. Report of the World Commission on the Ethics of Scientific Knowledge and Technology (COMEST) on the Ethics of Climate Engineering . Accessed December 6, 2023. https://unesdoc.unesco.org/ark:/48223/pf0000386677

United Nations Environment Programme. 2023. “One Atmosphere: An Independent Expert Review on Solar Radiation Modification Research and Deployment. Kenya, Nairobi.

United Nations Human Rights Council. 2023. Impact of New Technologies Intended for Climate Protection [NTCPs] on the Enjoyment of Human Rights. Report of the Human Rights Council Advisory Committee . Accessed October 15, 2023. https://undocs.org/A/HRC/54/47

U.S. Global Change Research Program. 2022. “Request for Input to a Five-Year Plan for Research on Climate Intervention.” Last Modified August 19, 2022. https://www.globalchange.gov/content/request-input-five-year-climate-intervention-research-plan

U.S. House, 2022. Consolidated Appropriations Act, 2022. “Division B—Commerce, Justice, Science, and Related Agencies Appropriations Act.” 117th Congress, Washington, DC. https://docs.house.gov/billsthisweek/20220307/BILLS-117RCP35-JES-DIVISION-B.pdf

White House Office of Science and Technology Policy. 2023. “Congressionally Mandated Research Plan and an Initial Research Governance Framework Related to Solar Radiation Modification.” Washington DC: Office of Science and Technology Policy.

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Congressionally-Mandated Report on Solar Radiation Modification

The White House Office of Science and Technology Policy (OSTP) is releasing a report in response to a Congressional mandate in the Consolidated Appropriations Act 2022 related to solar radiation modification, also known as solar geoengineering. The report, which was developed in coordination with the National Oceanic and Atmospheric Administration and other key federal agencies, identifies critical knowledge gaps and scopes potential research areas that could improve understanding of risks and benefits posed by solar radiation modification.

Importantly, this report does not signify any change in policy or activity by the Biden-Harris Administration, which remains focused on reducing emissions, increasing resilience, advancing environmental justice, and achieving true energy security. Release of this report fulfills a Congressional mandate, and there are no plans underway to establish a comprehensive research program focused on solar radiation modification.

Report Takeaways:

The report cautions that any potential comprehensive research program must encompass the societal as well as the scientific dimensions of solar radiation modification and highlights several key priority areas for further solar radiation modification research, including:

• Determining climate and environmental impacts of solar radiation modification deployment
• Assessing potential societal outcomes and ecological consequences
• Examining how research might be done in cooperation among international partners

The report also acknowledges that research on solar radiation modification impacts to date has been ad hoc and fragmented, rather than being the product of a comprehensive strategy. As a result, substantial knowledge gaps and uncertainties exist in many critical areas.

The full report can be found here .

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Organised jointly by Global Epistemologies and the Forum on Decentering the Human , in this talk Sandra Wachter (Oxford) and Jack Stilgoe (UCL), will join Mario Slugan (QMUL) and John Adenitire (QMUL) to discuss recent developments in AI cognition and to assess how these should influence legal and ethical approaches to AI. Moderated by Elke Schwarz (QMUL).

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