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What is a Theoretical Framework? | A Step-by-Step Guide

Published on 14 February 2020 by Shona McCombes . Revised on 10 October 2022.

A theoretical framework is a foundational review of existing theories that serves as a roadmap for developing the arguments you will use in your own work.

Theories are developed by researchers to explain phenomena, draw connections, and make predictions. In a theoretical framework, you explain the existing theories that support your research, showing that your work is grounded in established ideas.

In other words, your theoretical framework justifies and contextualises your later research, and it’s a crucial first step for your research paper , thesis, or dissertation . A well-rounded theoretical framework sets you up for success later on in your research and writing process.

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Table of contents

Why do you need a theoretical framework, how to write a theoretical framework, structuring your theoretical framework, example of a theoretical framework, frequently asked questions about theoretical frameworks.

Before you start your own research, it’s crucial to familiarise yourself with the theories and models that other researchers have already developed. Your theoretical framework is your opportunity to present and explain what you’ve learned, situated within your future research topic.

There’s a good chance that many different theories about your topic already exist, especially if the topic is broad. In your theoretical framework, you will evaluate, compare, and select the most relevant ones.

By “framing” your research within a clearly defined field, you make the reader aware of the assumptions that inform your approach, showing the rationale behind your choices for later sections, like methodology and discussion . This part of your dissertation lays the foundations that will support your analysis, helping you interpret your results and make broader generalisations .

• In literature , a scholar using postmodernist literary theory would analyse The Great Gatsby differently than a scholar using Marxist literary theory.
• In psychology , a behaviourist approach to depression would involve different research methods and assumptions than a psychoanalytic approach.
• In economics , wealth inequality would be explained and interpreted differently based on a classical economics approach than based on a Keynesian economics one.

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To create your own theoretical framework, you can follow these three steps:

• Identifying your key concepts
• Evaluating and explaining relevant theories
• Showing how your research fits into existing research

1. Identify your key concepts

The first step is to pick out the key terms from your problem statement and research questions . Concepts often have multiple definitions, so your theoretical framework should also clearly define what you mean by each term.

To investigate this problem, you have identified and plan to focus on the following problem statement, objective, and research questions:

Problem : Many online customers do not return to make subsequent purchases.

Objective : To increase the quantity of return customers.

Research question : How can the satisfaction of company X’s online customers be improved in order to increase the quantity of return customers?

2. Evaluate and explain relevant theories

By conducting a thorough literature review , you can determine how other researchers have defined these key concepts and drawn connections between them. As you write your theoretical framework, your aim is to compare and critically evaluate the approaches that different authors have taken.

After discussing different models and theories, you can establish the definitions that best fit your research and justify why. You can even combine theories from different fields to build your own unique framework if this better suits your topic.

Make sure to at least briefly mention each of the most important theories related to your key concepts. If there is a well-established theory that you don’t want to apply to your own research, explain why it isn’t suitable for your purposes.

3. Show how your research fits into existing research

Apart from summarising and discussing existing theories, your theoretical framework should show how your project will make use of these ideas and take them a step further.

You might aim to do one or more of the following:

• Test whether a theory holds in a specific, previously unexamined context
• Use an existing theory as a basis for interpreting your results
• Critique or challenge a theory
• Combine different theories in a new or unique way

A theoretical framework can sometimes be integrated into a literature review chapter , but it can also be included as its own chapter or section in your dissertation. As a rule of thumb, if your research involves dealing with a lot of complex theories, it’s a good idea to include a separate theoretical framework chapter.

There are no fixed rules for structuring your theoretical framework, but it’s best to double-check with your department or institution to make sure they don’t have any formatting guidelines. The most important thing is to create a clear, logical structure. There are a few ways to do this:

• Draw on your research questions, structuring each section around a question or key concept
• Organise by theory cluster
• Organise by date

As in all other parts of your research paper , thesis, or dissertation , make sure to properly cite your sources to avoid plagiarism .

To get a sense of what this part of your thesis or dissertation might look like, take a look at our full example .

While a theoretical framework describes the theoretical underpinnings of your work based on existing research, a conceptual framework allows you to draw your own conclusions, mapping out the variables you may use in your study and the interplay between them.

A literature review and a theoretical framework are not the same thing and cannot be used interchangeably. While a theoretical framework describes the theoretical underpinnings of your work, a literature review critically evaluates existing research relating to your topic. You’ll likely need both in your dissertation .

A theoretical framework can sometimes be integrated into a  literature review chapter , but it can also be included as its own chapter or section in your dissertation . As a rule of thumb, if your research involves dealing with a lot of complex theories, it’s a good idea to include a separate theoretical framework chapter.

A literature review is a survey of scholarly sources (such as books, journal articles, and theses) related to a specific topic or research question .

It is often written as part of a dissertation , thesis, research paper , or proposal .

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Theoretical Framework – Types, Examples and Writing Guide

Table of Contents

Theoretical Framework

Definition:

Theoretical framework refers to a set of concepts, theories, ideas , and assumptions that serve as a foundation for understanding a particular phenomenon or problem. It provides a conceptual framework that helps researchers to design and conduct their research, as well as to analyze and interpret their findings.

In research, a theoretical framework explains the relationship between various variables, identifies gaps in existing knowledge, and guides the development of research questions, hypotheses, and methodologies. It also helps to contextualize the research within a broader theoretical perspective, and can be used to guide the interpretation of results and the formulation of recommendations.

Types of Theoretical Framework

Types of Types of Theoretical Framework are as follows:

Conceptual Framework

This type of framework defines the key concepts and relationships between them. It helps to provide a theoretical foundation for a study or research project .

Deductive Framework

This type of framework starts with a general theory or hypothesis and then uses data to test and refine it. It is often used in quantitative research .

Inductive Framework

This type of framework starts with data and then develops a theory or hypothesis based on the patterns and themes that emerge from the data. It is often used in qualitative research .

Empirical Framework

This type of framework focuses on the collection and analysis of empirical data, such as surveys or experiments. It is often used in scientific research .

Normative Framework

This type of framework defines a set of norms or values that guide behavior or decision-making. It is often used in ethics and social sciences.

Explanatory Framework

This type of framework seeks to explain the underlying mechanisms or causes of a particular phenomenon or behavior. It is often used in psychology and social sciences.

Components of Theoretical Framework

The components of a theoretical framework include:

• Concepts : The basic building blocks of a theoretical framework. Concepts are abstract ideas or generalizations that represent objects, events, or phenomena.
• Variables : These are measurable and observable aspects of a concept. In a research context, variables can be manipulated or measured to test hypotheses.
• Assumptions : These are beliefs or statements that are taken for granted and are not tested in a study. They provide a starting point for developing hypotheses.
• Propositions : These are statements that explain the relationships between concepts and variables in a theoretical framework.
• Hypotheses : These are testable predictions that are derived from the theoretical framework. Hypotheses are used to guide data collection and analysis.
• Constructs : These are abstract concepts that cannot be directly measured but are inferred from observable variables. Constructs provide a way to understand complex phenomena.
• Models : These are simplified representations of reality that are used to explain, predict, or control a phenomenon.

How to Write Theoretical Framework

A theoretical framework is an essential part of any research study or paper, as it helps to provide a theoretical basis for the research and guide the analysis and interpretation of the data. Here are some steps to help you write a theoretical framework:

• Identify the key concepts and variables : Start by identifying the main concepts and variables that your research is exploring. These could include things like motivation, behavior, attitudes, or any other relevant concepts.
• Review relevant literature: Conduct a thorough review of the existing literature in your field to identify key theories and ideas that relate to your research. This will help you to understand the existing knowledge and theories that are relevant to your research and provide a basis for your theoretical framework.
• Develop a conceptual framework : Based on your literature review, develop a conceptual framework that outlines the key concepts and their relationships. This framework should provide a clear and concise overview of the theoretical perspective that underpins your research.
• Identify hypotheses and research questions: Based on your conceptual framework, identify the hypotheses and research questions that you want to test or explore in your research.
• Test your theoretical framework: Once you have developed your theoretical framework, test it by applying it to your research data. This will help you to identify any gaps or weaknesses in your framework and refine it as necessary.
• Write up your theoretical framework: Finally, write up your theoretical framework in a clear and concise manner, using appropriate terminology and referencing the relevant literature to support your arguments.

Theoretical Framework Examples

Here are some examples of theoretical frameworks:

• Social Learning Theory : This framework, developed by Albert Bandura, suggests that people learn from their environment, including the behaviors of others, and that behavior is influenced by both external and internal factors.
• Maslow’s Hierarchy of Needs : Abraham Maslow proposed that human needs are arranged in a hierarchy, with basic physiological needs at the bottom, followed by safety, love and belonging, esteem, and self-actualization at the top. This framework has been used in various fields, including psychology and education.
• Ecological Systems Theory : This framework, developed by Urie Bronfenbrenner, suggests that a person’s development is influenced by the interaction between the individual and the various environments in which they live, such as family, school, and community.
• Feminist Theory: This framework examines how gender and power intersect to influence social, cultural, and political issues. It emphasizes the importance of understanding and challenging systems of oppression.
• Cognitive Behavioral Theory: This framework suggests that our thoughts, beliefs, and attitudes influence our behavior, and that changing our thought patterns can lead to changes in behavior and emotional responses.
• Attachment Theory: This framework examines the ways in which early relationships with caregivers shape our later relationships and attachment styles.
• Critical Race Theory : This framework examines how race intersects with other forms of social stratification and oppression to perpetuate inequality and discrimination.

When to Have A Theoretical Framework

Following are some situations When to Have A Theoretical Framework:

• A theoretical framework should be developed when conducting research in any discipline, as it provides a foundation for understanding the research problem and guiding the research process.
• A theoretical framework is essential when conducting research on complex phenomena, as it helps to organize and structure the research questions, hypotheses, and findings.
• A theoretical framework should be developed when the research problem requires a deeper understanding of the underlying concepts and principles that govern the phenomenon being studied.
• A theoretical framework is particularly important when conducting research in social sciences, as it helps to explain the relationships between variables and provides a framework for testing hypotheses.
• A theoretical framework should be developed when conducting research in applied fields, such as engineering or medicine, as it helps to provide a theoretical basis for the development of new technologies or treatments.
• A theoretical framework should be developed when conducting research that seeks to address a specific gap in knowledge, as it helps to define the problem and identify potential solutions.
• A theoretical framework is also important when conducting research that involves the analysis of existing theories or concepts, as it helps to provide a framework for comparing and contrasting different theories and concepts.
• A theoretical framework should be developed when conducting research that seeks to make predictions or develop generalizations about a particular phenomenon, as it helps to provide a basis for evaluating the accuracy of these predictions or generalizations.
• Finally, a theoretical framework should be developed when conducting research that seeks to make a contribution to the field, as it helps to situate the research within the broader context of the discipline and identify its significance.

Purpose of Theoretical Framework

The purposes of a theoretical framework include:

• Providing a conceptual framework for the study: A theoretical framework helps researchers to define and clarify the concepts and variables of interest in their research. It enables researchers to develop a clear and concise definition of the problem, which in turn helps to guide the research process.
• Guiding the research design: A theoretical framework can guide the selection of research methods, data collection techniques, and data analysis procedures. By outlining the key concepts and assumptions underlying the research questions, the theoretical framework can help researchers to identify the most appropriate research design for their study.
• Supporting the interpretation of research findings: A theoretical framework provides a framework for interpreting the research findings by helping researchers to make connections between their findings and existing theory. It enables researchers to identify the implications of their findings for theory development and to assess the generalizability of their findings.
• Enhancing the credibility of the research: A well-developed theoretical framework can enhance the credibility of the research by providing a strong theoretical foundation for the study. It demonstrates that the research is based on a solid understanding of the relevant theory and that the research questions are grounded in a clear conceptual framework.
• Facilitating communication and collaboration: A theoretical framework provides a common language and conceptual framework for researchers, enabling them to communicate and collaborate more effectively. It helps to ensure that everyone involved in the research is working towards the same goals and is using the same concepts and definitions.

Characteristics of Theoretical Framework

Some of the characteristics of a theoretical framework include:

• Conceptual clarity: The concepts used in the theoretical framework should be clearly defined and understood by all stakeholders.
• Logical coherence : The framework should be internally consistent, with each concept and assumption logically connected to the others.
• Empirical relevance: The framework should be based on empirical evidence and research findings.
• Parsimony : The framework should be as simple as possible, without sacrificing its ability to explain the phenomenon in question.
• Flexibility : The framework should be adaptable to new findings and insights.
• Testability : The framework should be testable through research, with clear hypotheses that can be falsified or supported by data.
• Applicability : The framework should be useful for practical applications, such as designing interventions or policies.

Advantages of Theoretical Framework

Here are some of the advantages of having a theoretical framework:

• Provides a clear direction : A theoretical framework helps researchers to identify the key concepts and variables they need to study and the relationships between them. This provides a clear direction for the research and helps researchers to focus their efforts and resources.
• Increases the validity of the research: A theoretical framework helps to ensure that the research is based on sound theoretical principles and concepts. This increases the validity of the research by ensuring that it is grounded in established knowledge and is not based on arbitrary assumptions.
• Enables comparisons between studies : A theoretical framework provides a common language and set of concepts that researchers can use to compare and contrast their findings. This helps to build a cumulative body of knowledge and allows researchers to identify patterns and trends across different studies.
• Helps to generate hypotheses: A theoretical framework provides a basis for generating hypotheses about the relationships between different concepts and variables. This can help to guide the research process and identify areas that require further investigation.
• Facilitates communication: A theoretical framework provides a common language and set of concepts that researchers can use to communicate their findings to other researchers and to the wider community. This makes it easier for others to understand the research and its implications.

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Theories are formulated to explain, predict, and understand phenomena and, in many cases, to challenge and extend existing knowledge within the limits of critical bounded assumptions or predictions of behavior. The theoretical framework is the structure that can hold or support a theory of a research study. The theoretical framework encompasses not just the theory, but the narrative explanation about how the researcher engages in using the theory and its underlying assumptions to investigate the research problem. It is the structure of your paper that summarizes concepts, ideas, and theories derived from prior research studies and which was synthesized in order to form a conceptual basis for your analysis and interpretation of meaning found within your research.

Abend, Gabriel. "The Meaning of Theory." Sociological Theory 26 (June 2008): 173–199; Kivunja, Charles. "Distinguishing between Theory, Theoretical Framework, and Conceptual Framework: A Systematic Review of Lessons from the Field." International Journal of Higher Education 7 (December 2018): 44-53; Swanson, Richard A. Theory Building in Applied Disciplines . San Francisco, CA: Berrett-Koehler Publishers 2013; Varpio, Lara, Elise Paradis, Sebastian Uijtdehaage, and Meredith Young. "The Distinctions between Theory, Theoretical Framework, and Conceptual Framework." Academic Medicine 95 (July 2020): 989-994.

Importance of Theory and a Theoretical Framework

Theories can be unfamiliar to the beginning researcher because they are rarely applied in high school social studies curriculum and, as a result, can come across as unfamiliar and imprecise when first introduced as part of a writing assignment. However, in their most simplified form, a theory is simply a set of assumptions or predictions about something you think will happen based on existing evidence and that can be tested to see if those outcomes turn out to be true. Of course, it is slightly more deliberate than that, therefore, summarized from Kivunja (2018, p. 46), here are the essential characteristics of a theory.

• It is logical and coherent
• It has clear definitions of terms or variables, and has boundary conditions [i.e., it is not an open-ended statement]
• It has a domain where it applies
• It has clearly described relationships among variables
• It describes, explains, and makes specific predictions
• It comprises of concepts, themes, principles, and constructs
• It must have been based on empirical data [i.e., it is not a guess]
• It must have made claims that are subject to testing, been tested and verified
• It must be clear and concise
• Its assertions or predictions must be different and better than those in existing theories
• Its predictions must be general enough to be applicable to and understood within multiple contexts
• Its assertions or predictions are relevant, and if applied as predicted, will result in the predicted outcome
• The assertions and predictions are not immutable, but subject to revision and improvement as researchers use the theory to make sense of phenomena
• Its concepts and principles explain what is going on and why
• Its concepts and principles are substantive enough to enable us to predict a future

Given these characteristics, a theory can best be understood as the foundation from which you investigate assumptions or predictions derived from previous studies about the research problem, but in a way that leads to new knowledge and understanding as well as, in some cases, discovering how to improve the relevance of the theory itself or to argue that the theory is outdated and a new theory needs to be formulated based on new evidence.

A theoretical framework consists of concepts and, together with their definitions and reference to relevant scholarly literature, existing theory that is used for your particular study. The theoretical framework must demonstrate an understanding of theories and concepts that are relevant to the topic of your research paper and that relate to the broader areas of knowledge being considered.

The theoretical framework is most often not something readily found within the literature . You must review course readings and pertinent research studies for theories and analytic models that are relevant to the research problem you are investigating. The selection of a theory should depend on its appropriateness, ease of application, and explanatory power.

The theoretical framework strengthens the study in the following ways :

• An explicit statement of  theoretical assumptions permits the reader to evaluate them critically.
• The theoretical framework connects the researcher to existing knowledge. Guided by a relevant theory, you are given a basis for your hypotheses and choice of research methods.
• Articulating the theoretical assumptions of a research study forces you to address questions of why and how. It permits you to intellectually transition from simply describing a phenomenon you have observed to generalizing about various aspects of that phenomenon.
• Having a theory helps you identify the limits to those generalizations. A theoretical framework specifies which key variables influence a phenomenon of interest and highlights the need to examine how those key variables might differ and under what circumstances.
• The theoretical framework adds context around the theory itself based on how scholars had previously tested the theory in relation their overall research design [i.e., purpose of the study, methods of collecting data or information, methods of analysis, the time frame in which information is collected, study setting, and the methodological strategy used to conduct the research].

By virtue of its applicative nature, good theory in the social sciences is of value precisely because it fulfills one primary purpose: to explain the meaning, nature, and challenges associated with a phenomenon, often experienced but unexplained in the world in which we live, so that we may use that knowledge and understanding to act in more informed and effective ways.

The Conceptual Framework. College of Education. Alabama State University; Corvellec, Hervé, ed. What is Theory?: Answers from the Social and Cultural Sciences . Stockholm: Copenhagen Business School Press, 2013; Asher, Herbert B. Theory-Building and Data Analysis in the Social Sciences . Knoxville, TN: University of Tennessee Press, 1984; Drafting an Argument. Writing@CSU. Colorado State University; Kivunja, Charles. "Distinguishing between Theory, Theoretical Framework, and Conceptual Framework: A Systematic Review of Lessons from the Field." International Journal of Higher Education 7 (2018): 44-53; Omodan, Bunmi Isaiah. "A Model for Selecting Theoretical Framework through Epistemology of Research Paradigms." African Journal of Inter/Multidisciplinary Studies 4 (2022): 275-285; Ravitch, Sharon M. and Matthew Riggan. Reason and Rigor: How Conceptual Frameworks Guide Research . Second edition. Los Angeles, CA: SAGE, 2017; Trochim, William M.K. Philosophy of Research. Research Methods Knowledge Base. 2006; Jarvis, Peter. The Practitioner-Researcher. Developing Theory from Practice . San Francisco, CA: Jossey-Bass, 1999.

Strategies for Developing the Theoretical Framework

I.  Developing the Framework

Here are some strategies to develop of an effective theoretical framework:

• Examine your thesis title and research problem . The research problem anchors your entire study and forms the basis from which you construct your theoretical framework.
• Brainstorm about what you consider to be the key variables in your research . Answer the question, "What factors contribute to the presumed effect?"
• Review related literature to find how scholars have addressed your research problem. Identify the assumptions from which the author(s) addressed the problem.
• List  the constructs and variables that might be relevant to your study. Group these variables into independent and dependent categories.
• Review key social science theories that are introduced to you in your course readings and choose the theory that can best explain the relationships between the key variables in your study [note the Writing Tip on this page].
• Discuss the assumptions or propositions of this theory and point out their relevance to your research.

A theoretical framework is used to limit the scope of the relevant data by focusing on specific variables and defining the specific viewpoint [framework] that the researcher will take in analyzing and interpreting the data to be gathered. It also facilitates the understanding of concepts and variables according to given definitions and builds new knowledge by validating or challenging theoretical assumptions.

II.  Purpose

Think of theories as the conceptual basis for understanding, analyzing, and designing ways to investigate relationships within social systems. To that end, the following roles served by a theory can help guide the development of your framework.

• Means by which new research data can be interpreted and coded for future use,
• Response to new problems that have no previously identified solutions strategy,
• Means for identifying and defining research problems,
• Means for prescribing or evaluating solutions to research problems,
• Ways of discerning certain facts among the accumulated knowledge that are important and which facts are not,
• Means of giving old data new interpretations and new meaning,
• Means by which to identify important new issues and prescribe the most critical research questions that need to be answered to maximize understanding of the issue,
• Means of providing members of a professional discipline with a common language and a frame of reference for defining the boundaries of their profession, and
• Means to guide and inform research so that it can, in turn, guide research efforts and improve professional practice.

Adapted from: Torraco, R. J. “Theory-Building Research Methods.” In Swanson R. A. and E. F. Holton III , editors. Human Resource Development Handbook: Linking Research and Practice . (San Francisco, CA: Berrett-Koehler, 1997): pp. 114-137; Jacard, James and Jacob Jacoby. Theory Construction and Model-Building Skills: A Practical Guide for Social Scientists . New York: Guilford, 2010; Ravitch, Sharon M. and Matthew Riggan. Reason and Rigor: How Conceptual Frameworks Guide Research . Second edition. Los Angeles, CA: SAGE, 2017; Sutton, Robert I. and Barry M. Staw. “What Theory is Not.” Administrative Science Quarterly 40 (September 1995): 371-384.

Structure and Writing Style

The theoretical framework may be rooted in a specific theory , in which case, your work is expected to test the validity of that existing theory in relation to specific events, issues, or phenomena. Many social science research papers fit into this rubric. For example, Peripheral Realism Theory, which categorizes perceived differences among nation-states as those that give orders, those that obey, and those that rebel, could be used as a means for understanding conflicted relationships among countries in Africa. A test of this theory could be the following: Does Peripheral Realism Theory help explain intra-state actions, such as, the disputed split between southern and northern Sudan that led to the creation of two nations?

However, you may not always be asked by your professor to test a specific theory in your paper, but to develop your own framework from which your analysis of the research problem is derived . Based upon the above example, it is perhaps easiest to understand the nature and function of a theoretical framework if it is viewed as an answer to two basic questions:

• What is the research problem/question? [e.g., "How should the individual and the state relate during periods of conflict?"]
• Why is your approach a feasible solution? [i.e., justify the application of your choice of a particular theory and explain why alternative constructs were rejected. I could choose instead to test Instrumentalist or Circumstantialists models developed among ethnic conflict theorists that rely upon socio-economic-political factors to explain individual-state relations and to apply this theoretical model to periods of war between nations].

The answers to these questions come from a thorough review of the literature and your course readings [summarized and analyzed in the next section of your paper] and the gaps in the research that emerge from the review process. With this in mind, a complete theoretical framework will likely not emerge until after you have completed a thorough review of the literature .

Just as a research problem in your paper requires contextualization and background information, a theory requires a framework for understanding its application to the topic being investigated. When writing and revising this part of your research paper, keep in mind the following:

• Clearly describe the framework, concepts, models, or specific theories that underpin your study . This includes noting who the key theorists are in the field who have conducted research on the problem you are investigating and, when necessary, the historical context that supports the formulation of that theory. This latter element is particularly important if the theory is relatively unknown or it is borrowed from another discipline.
• Position your theoretical framework within a broader context of related frameworks, concepts, models, or theories . As noted in the example above, there will likely be several concepts, theories, or models that can be used to help develop a framework for understanding the research problem. Therefore, note why the theory you've chosen is the appropriate one.
• The present tense is used when writing about theory. Although the past tense can be used to describe the history of a theory or the role of key theorists, the construction of your theoretical framework is happening now.
• You should make your theoretical assumptions as explicit as possible . Later, your discussion of methodology should be linked back to this theoretical framework.
• Don’t just take what the theory says as a given! Reality is never accurately represented in such a simplistic way; if you imply that it can be, you fundamentally distort a reader's ability to understand the findings that emerge. Given this, always note the limitations of the theoretical framework you've chosen [i.e., what parts of the research problem require further investigation because the theory inadequately explains a certain phenomena].

The Conceptual Framework. College of Education. Alabama State University; Conceptual Framework: What Do You Think is Going On? College of Engineering. University of Michigan; Drafting an Argument. Writing@CSU. Colorado State University; Lynham, Susan A. “The General Method of Theory-Building Research in Applied Disciplines.” Advances in Developing Human Resources 4 (August 2002): 221-241; Tavallaei, Mehdi and Mansor Abu Talib. "A General Perspective on the Role of Theory in Qualitative Research." Journal of International Social Research 3 (Spring 2010); Ravitch, Sharon M. and Matthew Riggan. Reason and Rigor: How Conceptual Frameworks Guide Research . Second edition. Los Angeles, CA: SAGE, 2017; Reyes, Victoria. Demystifying the Journal Article. Inside Higher Education; Trochim, William M.K. Philosophy of Research. Research Methods Knowledge Base. 2006; Weick, Karl E. “The Work of Theorizing.” In Theorizing in Social Science: The Context of Discovery . Richard Swedberg, editor. (Stanford, CA: Stanford University Press, 2014), pp. 177-194.

Writing Tip

Borrowing Theoretical Constructs from Other Disciplines

An increasingly important trend in the social and behavioral sciences is to think about and attempt to understand research problems from an interdisciplinary perspective. One way to do this is to not rely exclusively on the theories developed within your particular discipline, but to think about how an issue might be informed by theories developed in other disciplines. For example, if you are a political science student studying the rhetorical strategies used by female incumbents in state legislature campaigns, theories about the use of language could be derived, not only from political science, but linguistics, communication studies, philosophy, psychology, and, in this particular case, feminist studies. Building theoretical frameworks based on the postulates and hypotheses developed in other disciplinary contexts can be both enlightening and an effective way to be more engaged in the research topic.

CohenMiller, A. S. and P. Elizabeth Pate. "A Model for Developing Interdisciplinary Research Theoretical Frameworks." The Qualitative Researcher 24 (2019): 1211-1226; Frodeman, Robert. The Oxford Handbook of Interdisciplinarity . New York: Oxford University Press, 2010.

Another Writing Tip

Don't Undertheorize!

Do not leave the theory hanging out there in the introduction never to be mentioned again. Undertheorizing weakens your paper. The theoretical framework you describe should guide your study throughout the paper. Be sure to always connect theory to the review of pertinent literature and to explain in the discussion part of your paper how the theoretical framework you chose supports analysis of the research problem or, if appropriate, how the theoretical framework was found to be inadequate in explaining the phenomenon you were investigating. In that case, don't be afraid to propose your own theory based on your findings.

Yet Another Writing Tip

What's a Theory? What's a Hypothesis?

The terms theory and hypothesis are often used interchangeably in newspapers and popular magazines and in non-academic settings. However, the difference between theory and hypothesis in scholarly research is important, particularly when using an experimental design. A theory is a well-established principle that has been developed to explain some aspect of the natural world. Theories arise from repeated observation and testing and incorporates facts, laws, predictions, and tested assumptions that are widely accepted [e.g., rational choice theory; grounded theory; critical race theory].

A hypothesis is a specific, testable prediction about what you expect to happen in your study. For example, an experiment designed to look at the relationship between study habits and test anxiety might have a hypothesis that states, "We predict that students with better study habits will suffer less test anxiety." Unless your study is exploratory in nature, your hypothesis should always explain what you expect to happen during the course of your research.

The key distinctions are:

• A theory predicts events in a broad, general context;  a hypothesis makes a specific prediction about a specified set of circumstances.
• A theory has been extensively tested and is generally accepted among a set of scholars; a hypothesis is a speculative guess that has yet to be tested.

Cherry, Kendra. Introduction to Research Methods: Theory and Hypothesis. About.com Psychology; Gezae, Michael et al. Welcome Presentation on Hypothesis. Slideshare presentation.

Still Yet Another Writing Tip

Be Prepared to Challenge the Validity of an Existing Theory

Theories are meant to be tested and their underlying assumptions challenged; they are not rigid or intransigent, but are meant to set forth general principles for explaining phenomena or predicting outcomes. Given this, testing theoretical assumptions is an important way that knowledge in any discipline develops and grows. If you're asked to apply an existing theory to a research problem, the analysis will likely include the expectation by your professor that you should offer modifications to the theory based on your research findings.

Indications that theoretical assumptions may need to be modified can include the following:

• Your findings suggest that the theory does not explain or account for current conditions or circumstances or the passage of time,
• The study reveals a finding that is incompatible with what the theory attempts to explain or predict, or
• Your analysis reveals that the theory overly generalizes behaviors or actions without taking into consideration specific factors revealed from your analysis [e.g., factors related to culture, nationality, history, gender, ethnicity, age, geographic location, legal norms or customs , religion, social class, socioeconomic status, etc.].

Philipsen, Kristian. "Theory Building: Using Abductive Search Strategies." In Collaborative Research Design: Working with Business for Meaningful Findings . Per Vagn Freytag and Louise Young, editors. (Singapore: Springer Nature, 2018), pp. 45-71; Shepherd, Dean A. and Roy Suddaby. "Theory Building: A Review and Integration." Journal of Management 43 (2017): 59-86.

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• Open access
• Published: 15 May 2024

Learning together for better health using an evidence-based Learning Health System framework: a case study in stroke

• Helena Teede 1 , 2   na1 ,
• Dominique A. Cadilhac 3 , 4   na1 ,
• Tara Purvis 3 ,
• Monique F. Kilkenny 3 , 4 ,
• Bruce C.V. Campbell 4 , 5 , 6 ,
• Coralie English 7 ,
• Alison Johnson 2 ,
• Emily Callander 1 ,
• Rohan S. Grimley 8 , 9 ,
• Christopher Levi 10 ,
• Sandy Middleton 11 , 12 ,
• Kelvin Hill 13 &
• Joanne Enticott   ORCID: orcid.org/0000-0002-4480-5690 1  

BMC Medicine volume  22 , Article number:  198 ( 2024 ) Cite this article

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In the context of expanding digital health tools, the health system is ready for Learning Health System (LHS) models. These models, with proper governance and stakeholder engagement, enable the integration of digital infrastructure to provide feedback to all relevant parties including clinicians and consumers on performance against best practice standards, as well as fostering innovation and aligning healthcare with patient needs. The LHS literature primarily includes opinion or consensus-based frameworks and lacks validation or evidence of benefit. Our aim was to outline a rigorously codesigned, evidence-based LHS framework and present a national case study of an LHS-aligned national stroke program that has delivered clinical benefit.

Current core components of a LHS involve capturing evidence from communities and stakeholders (quadrant 1), integrating evidence from research findings (quadrant 2), leveraging evidence from data and practice (quadrant 3), and generating evidence from implementation (quadrant 4) for iterative system-level improvement. The Australian Stroke program was selected as the case study as it provides an exemplar of how an iterative LHS works in practice at a national level encompassing and integrating evidence from all four LHS quadrants. Using this case study, we demonstrate how to apply evidence-based processes to healthcare improvement and embed real-world research for optimising healthcare improvement. We emphasize the transition from research as an endpoint, to research as an enabler and a solution for impact in healthcare improvement.

Conclusions

The Australian Stroke program has nationally improved stroke care since 2007, showcasing the value of integrated LHS-aligned approaches for tangible impact on outcomes. This LHS case study is a practical example for other health conditions and settings to follow suit.

Peer Review reports

Internationally, health systems are facing a crisis, driven by an ageing population, increasing complexity, multi-morbidity, rapidly advancing health technology and rising costs that threaten sustainability and mandate transformation and improvement [ 1 , 2 ]. Although research has generated solutions to healthcare challenges, and the advent of big data and digital health holds great promise, entrenched siloes and poor integration of knowledge generation, knowledge implementation and healthcare delivery between stakeholders, curtails momentum towards, and consistent attainment of, evidence-and value-based care [ 3 ]. This is compounded by the short supply of research and innovation leadership within the healthcare sector, and poorly integrated and often inaccessible health data systems, which have crippled the potential to deliver on digital-driven innovation [ 4 ]. Current approaches to healthcare improvement are also often isolated with limited sustainability, scale-up and impact [ 5 ].

Evidence suggests that integration and partnership across academic and healthcare delivery stakeholders are key to progress, including those with lived experience and their families (referred to here as consumers and community), diverse disciplines (both research and clinical), policy makers and funders. Utilization of evidence from research and evidence from practice including data from routine care, supported by implementation research, are key to sustainably embedding improvement and optimising health care and outcomes. A strategy to achieve this integration is through the Learning Health System (LHS) (Fig.  1 ) [ 2 , 6 , 7 , 8 ]. Although there are numerous publications on LHS approaches [ 9 , 10 , 11 , 12 ], many focus on research perspectives and data, most do not demonstrate tangible healthcare improvement or better health outcomes. [ 6 ]

Monash Learning Health System: The Learn Together for Better Health Framework developed by Monash Partners and Monash University (from Enticott et al. 2021 [ 7 ]). Four evidence quadrants: Q1 (orange) is evidence from stakeholders; Q2 (green) is evidence from research; Q3 (light blue) is evidence from data; and, Q4 (dark blue) is evidence from implementation and healthcare improvement

In developed nations, it has been estimated that 60% of care provided aligns with the evidence base, 30% is low value and 10% is potentially harmful [ 13 ]. In some areas, clinical advances have been rapid and research and evidence have paved the way for dramatic improvement in outcomes, mandating rapid implementation of evidence into healthcare (e.g. polio and COVID-19 vaccines). However, healthcare improvement is challenging and slow [ 5 ]. Health systems are highly complex in their design, networks and interacting components, and change is difficult to enact, sustain and scale up. [ 3 ] New effective strategies are needed to meet community needs and deliver evidence-based and value-based care, which reorients care from serving the provider, services and system, towards serving community needs, based on evidence and quality. It goes beyond cost to encompass patient and provider experience, quality care and outcomes, efficiency and sustainability [ 2 , 6 ].

The costs of stroke care are expected to rise rapidly in the next decades, unless improvements in stroke care to reduce the disabling effects of strokes can be successfully developed and implemented [ 14 ]. Here, we briefly describe the Monash LHS framework (Fig.  1 ) [ 2 , 6 , 7 ] and outline an exemplar case in order to demonstrate how to apply evidence-based processes to healthcare improvement and embed real-world research for optimising healthcare. The Australian LHS exemplar in stroke care has driven nationwide improvement in stroke care since 2007.

An evidence-based Learning Health System framework

In Australia, members of this author group (HT, AJ, JE) have rigorously co-developed an evidence-based LHS framework, known simply as the Monash LHS [ 7 ]. The Monash LHS was designed to support sustainable, iterative and continuous robust benefit of improved clinical outcomes. It was created with national engagement in order to be applicable to Australian settings. Through this rigorous approach, core LHS principles and components have been established (Fig.  1 ). Evidence shows that people/workforce, culture, standards, governance and resources were all key to an effective LHS [ 2 , 6 ]. Culture is vital including trust, transparency, partnership and co-design. Key processes include legally compliant data sharing, linkage and governance, resources, and infrastructure [ 4 ]. The Monash LHS integrates disparate and often siloed stakeholders, infrastructure and expertise to ‘Learn Together for Better Health’ [ 7 ] (Fig.  1 ). This integrates (i) evidence from community and stakeholders including priority areas and outcomes; (ii) evidence from research and guidelines; (iii) evidence from practice (from data) with advanced analytics and benchmarking; and (iv) evidence from implementation science and health economics. Importantly, it starts with the problem and priorities of key stakeholders including the community, health professionals and services and creates an iterative learning system to address these. The following case study was chosen as it is an exemplar of how a Monash LHS-aligned national stroke program has delivered clinical benefit.

Australian Stroke Learning Health System

Internationally, the application of LHS approaches in stroke has resulted in improved stroke care and outcomes [ 12 ]. For example, in Canada a sustained decrease in 30-day in-hospital mortality has been found commensurate with an increase in resources to establish the multifactorial stroke system intervention for stroke treatment and prevention [ 15 ]. Arguably, with rapid advances in evidence and in the context of an ageing population with high cost and care burden and substantive impacts on quality of life, stroke is an area with a need for rapid research translation into evidence-based and value-based healthcare improvement. However, a recent systematic review found that the existing literature had few comprehensive examples of LHS adoption [ 12 ]. Although healthcare improvement systems and approaches were described, less is known about patient-clinician and stakeholder engagement, governance and culture, or embedding of data informatics into everyday practice to inform and drive improvement [ 12 ]. For example, in a recent review of quality improvement collaborations, it was found that although clinical processes in stroke care are improved, their short-term nature means there is uncertainty about sustainability and impacts on patient outcomes [ 16 ]. Table  1 provides the main features of the Australian Stroke LHS based on the four core domains and eight elements of the Learning Together for Better Health Framework described in Fig.  1 . The features are further expanded on in the following sections.

Evidence from stakeholders (LHS quadrant 1, Fig.  1 )

Engagement, partners and priorities.

Within the stroke field, there have been various support mechanisms to facilitate an LHS approach including partnership and broad stakeholder engagement that includes clinical networks and policy makers from different jurisdictions. Since 2008, the Australian Stroke Coalition has been co-led by the Stroke Foundation, a charitable consumer advocacy organisation, and Stroke Society of Australasia a professional society with membership covering academics and multidisciplinary clinician networks, that are collectively working to improve stroke care ( https://australianstrokecoalition.org.au/ ). Surveys, focus groups and workshops have been used for identifying priorities from stakeholders. Recent agreed priorities have been to improve stroke care and strengthen the voice for stroke care at a national ( https://strokefoundation.org.au/ ) and international level ( https://www.world-stroke.org/news-and-blog/news/world-stroke-organization-tackle-gaps-in-access-to-quality-stroke-care ), as well as reduce duplication amongst stakeholders. This activity is built on a foundation and culture of research and innovation embedded within the stroke ‘community of practice’. Consumers, as people with lived experience of stroke are important members of the Australian Stroke Coalition, as well as representatives from different clinical colleges. Consumers also provide critical input to a range of LHS activities via the Stroke Foundation Consumer Council, Stroke Living Guidelines committees, and the Australian Stroke Clinical Registry (AuSCR) Steering Committee (described below).

Evidence from research (LHS quadrant 2, Fig.  1 )

Advancement of the evidence for stroke interventions and synthesis into clinical guidelines.

To implement best practice, it is crucial to distil the large volume of scientific and trial literature into actionable recommendations for clinicians to use in practice [ 24 ]. The first Australian clinical guidelines for acute stroke were produced in 2003 following the increasing evidence emerging for prevention interventions (e.g. carotid endarterectomy, blood pressure lowering), acute medical treatments (intravenous thrombolysis, aspirin within 48 h of ischemic stroke), and optimised hospital management (care in dedicated stroke units by a specialised and coordinated multidisciplinary team) [ 25 ]. Importantly, a number of the innovations were developed, researched and proven effective by key opinion leaders embedded in the Australian stroke care community. In 2005, the clinical guidelines for Stroke Rehabilitation and Recovery [ 26 ] were produced, with subsequent merged guidelines periodically updated. However, the traditional process of periodic guideline updates is challenging for end users when new research can render recommendations redundant and this lack of currency erodes stakeholder trust [ 27 ]. In response to this challenge the Stroke Foundation and Cochrane Australia entered a pioneering project to produce the first electronic ‘living’ guidelines globally [ 20 ]. Major shifts in the evidence for reperfusion therapies (e.g. extended time-window intravenous thrombolysis and endovascular clot retrieval), among other advances, were able to be converted into new recommendations, approved by the Australian National Health and Medical Research Council within a few months of publication. Feedback on this process confirmed the increased use and trust in the guidelines by clinicians. The process informed other living guidelines programs, including the successful COVID-19 clinical guidelines [ 28 ].

However, best practice clinical guideline recommendations are necessary but insufficient for healthcare improvement and nesting these within an LHS with stakeholder partnership, enables implementation via a range of proven methods, including audit and feedback strategies [ 29 ].

Evidence from data and practice (LHS quadrant 3, Fig.  1 )

Data systems and benchmarking : revealing the disparities in care between health services. A national system for standardized stroke data collection was established as the National Stroke Audit program in 2007 by the Stroke Foundation [ 30 ] following various state-level programs (e.g. New South Wales Audit) [ 31 ] to identify evidence-practice gaps and prioritise improvement efforts to increase access to stroke units and other acute treatments [ 32 ]. The Audit program alternates each year between acute (commencing in 2007) and rehabilitation in-patient services (commencing in 2008). The Audit program provides a ‘deep dive’ on the majority of recommendations in the clinical guidelines whereby participating hospitals provide audits of up to 40 consecutive patient medical records and respond to a survey about organizational resources to manage stroke. In 2009, the AuSCR was established to provide information on patients managed in acute hospitals based on a small subset of quality processes of care linked to benchmarked reports of performance (Fig.  2 ) [ 33 ]. In this way, the continuous collection of high-priority processes of stroke care could be regularly collected and reviewed to guide improvement to care [ 34 ]. Plus clinical quality registry programs within Australia have shown a meaningful return on investment attributed to enhanced survival, improvements in quality of life and avoided costs of treatment or hospital stay [ 35 ].

Example performance report from the Australian Stroke Clinical Registry: average door-to-needle time in providing intravenous thrombolysis by different hospitals in 2021 [ 36 ]. Each bar in the figure represents a single hospital

The Australian Stroke Coalition endorsed the creation of an integrated technological solution for collecting data through a single portal for multiple programs in 2013. In 2015, the Stroke Foundation, AuSCR consortium, and other relevant groups cooperated to design an integrated data management platform (the Australian Stroke Data Tool) to reduce duplication of effort for hospital staff in the collection of overlapping variables in the same patients [ 19 ]. Importantly, a national data dictionary then provided the common data definitions to facilitate standardized data capture. Another important feature of AuSCR is the collection of patient-reported outcome surveys between 90 and 180 days after stroke, and annual linkage with national death records to ascertain survival status [ 33 ]. To support a LHS approach, hospitals that participate in AuSCR have access to a range of real-time performance reports. In efforts to minimize the burden of data collection in the AuSCR, interoperability approaches to import data directly from hospital or state-level managed stroke databases have been established (Fig.  3 ); however, the application has been variable and 41% of hospitals still manually enter all their data.

Current status of automated data importing solutions in the Australian Stroke Clinical Registry, 2022, with ‘ n ’ representing the number of hospitals. AuSCR, Australian Stroke Clinical Registry; AuSDaT, Australian Stroke Data Tool; API, Application Programming Interface; ICD, International Classification of Diseases; RedCAP, Research Electronic Data Capture; eMR, electronic medical records

For acute stroke care, the Australian Commission on Quality and Safety in Health Care facilitated the co-design (clinicians, academics, consumers) and publication of the national Acute Stroke Clinical Care Standard in 2015 [ 17 ], and subsequent review [ 18 ]. The indicator set for the Acute Stroke Standard then informed the expansion of the minimum dataset for AuSCR so that hospitals could routinely track their performance. The national Audit program enabled hospitals not involved in the AuSCR to assess their performance every two years against the Acute Stroke Standard. Complementing these efforts, the Stroke Foundation, working with the sector, developed the Acute and Rehabilitation Stroke Services Frameworks to outline the principles, essential elements, models of care and staffing recommendations for stroke services ( https://informme.org.au/guidelines/national-stroke-services-frameworks ). The Frameworks are intended to guide where stroke services should be developed, and monitor their uptake with the organizational survey component of the Audit program.

Evidence from implementation and healthcare improvement (LHS quadrant 4, Fig.  1 )

Research to better utilize and augment data from registries through linkage [ 37 , 38 , 39 , 40 ] and to ensure presentation of hospital or service level data are understood by clinicians has ensured advancement in the field for the Australian Stroke LHS [ 41 ]. Importantly, greater insights into whole patient journeys, before and after a stroke, can now enable exploration of value-based care. The LHS and stroke data platform have enabled focused and time-limited projects to create a better understanding of the quality of care in acute or rehabilitation settings [ 22 , 42 , 43 ]. Within stroke, all the elements of an LHS culminate into the ready availability of benchmarked performance data and support for implementation of strategies to address gaps in care.

Implementation research to grow the evidence base for effective improvement interventions has also been a key pillar in the Australian context. These include multi-component implementation interventions to achieve behaviour change for particular aspects of stroke care, [ 22 , 23 , 44 , 45 ] and real-world approaches to augmenting access to hyperacute interventions in stroke through the use of technology and telehealth [ 46 , 47 , 48 , 49 ]. The evidence from these studies feeds into the living guidelines program and the data collection systems, such as the Audit program or AuSCR, which are then amended to ensure data aligns to recommended care. For example, the use of ‘hyperacute aspirin within the first 48 h of ischemic stroke’ was modified to be ‘hyperacute antiplatelet…’ to incorporate new evidence that other medications or combinations are appropriate to use. Additionally, new datasets have been developed to align with evidence such as the Fever, Sugar, and Swallow variables [ 42 ]. Evidence on improvements in access to best practice care from the acute Audit program [ 50 ] and AuSCR is emerging [ 36 ]. For example, between 2007 and 2017, the odds of receiving intravenous thrombolysis after ischemic stroke increased by 16% 9OR 1.06 95% CI 1.13–1.18) and being managed in a stroke unit by 18% (OR 1.18 95% CI 1.17–1.20). Over this period, the median length of hospital stay for all patients decreased from 6.3 days in 2007 to 5.0 days in 2017 [ 51 ]. When considering the number of additional patients who would receive treatment in 2017 in comparison to 2007 it was estimated that without this additional treatment, over 17,000 healthy years of life would be lost in 2017 (17,786 disability-adjusted life years) [ 51 ]. There is evidence on the cost-effectiveness of different system-focussed strategies to augment treatment access for acute ischemic stroke (e.g. Victorian Stroke Telemedicine program [ 52 ] and Melbourne Mobile Stroke Unit ambulance [ 53 ]). Reciprocally, evidence from the national Rehabilitation Audit, where the LHS approach has been less complete or embedded, has shown fewer areas of healthcare improvement over time [ 51 , 54 ].

Within the field of stroke in Australia, there is indirect evidence that the collective efforts that align to establishing the components of a LHS have had an impact. Overall, the age-standardised rate of stroke events has reduced by 27% between 2001 and 2020, from 169 to 124 events per 100,000 population. Substantial declines in mortality rates have been reported since 1980. Commensurate with national clinical guidelines being updated in 2007 and the first National Stroke Audit being undertaken in 2007, the mortality rates for men (37.4 deaths per 100,000) and women (36.1 deaths per 100,0000 has declined to 23.8 and 23.9 per 100,000, respectively in 2021 [ 55 ].

Underpinning the LHS with the integration of the four quadrants of evidence from stakeholders, research and guidelines, practice and implementation, and core LHS principles have been addressed. Leadership and governance have been important, and programs have been established to augment workforce training and capacity building in best practice professional development. Medical practitioners are able to undertake courses and mentoring through the Australasian Stroke Academy ( http://www.strokeacademy.com.au/ ) while nurses (and other health professionals) can access teaching modules in stroke care from the Acute Stroke Nurses Education Network ( https://asnen.org/ ). The Association of Neurovascular Clinicians offers distance-accessible education and certification to develop stroke expertise for interdisciplinary professionals, including advanced stroke co-ordinator certification ( www.anvc.org ). Consumer initiative interventions are also used in the design of the AuSCR Public Summary Annual reports (available at https://auscr.com.au/about/annual-reports/ ) and consumer-related resources related to the Living Guidelines ( https://enableme.org.au/resources ).

The important success factors and lessons from stroke as a national exemplar LHS in Australia include leadership, culture, workforce and resources integrated with (1) established and broad partnerships across the academic-clinical sector divide and stakeholder engagement; (2) the living guidelines program; (3) national data infrastructure, including a national data dictionary that provides the common data framework to support standardized data capture; (4) various implementation strategies including benchmarking and feedback as well as engagement strategies targeting different levels of the health system; and (5) implementation and improvement research to advance stroke systems of care and reduce unwarranted variation in practice (Fig.  1 ). Priority opportunities now include the advancement of interoperability with electronic medical records as an area all clinical quality registry’s programs needs to be addressed, as well as providing more dynamic and interactive data dashboards tailored to the need of clinicians and health service executives.

There is a clear mandate to optimise healthcare improvement with big data offering major opportunities for change. However, we have lacked the approaches to capture evidence from the community and stakeholders, to integrate evidence from research, to capture and leverage data or evidence from practice and to generate and build on evidence from implementation using iterative system-level improvement. The LHS provides this opportunity and is shown to deliver impact. Here, we have outlined the process applied to generate an evidence-based LHS and provide a leading exemplar in stroke care. This highlights the value of moving from single-focus isolated approaches/initiatives to healthcare improvement and the benefit of integration to deliver demonstrable outcomes for our funders and key stakeholders — our community. This work provides insight into strategies that can both apply evidence-based processes to healthcare improvement as well as implementing evidence-based practices into care, moving beyond research as an endpoint, to research as an enabler, underpinning delivery of better healthcare.

Availability of data and materials

Not applicable

Abbreviations

Australian Stroke Clinical Registry

Confidence interval

• Learning Health System

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Acknowledgements

The following authors hold National Health and Medical Research Council Research Fellowships: HT (#2009326), DAC (#1154273), SM (#1196352), MFK Future Leader Research Fellowship (National Heart Foundation #105737). The Funders of this work did not have any direct role in the design of the study, its execution, analyses, interpretation of the data, or decision to submit results for publication.

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Helena Teede and Dominique A. Cadilhac contributed equally.

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Monash Centre for Health Research and Implementation, 43-51 Kanooka Grove, Clayton, VIC, Australia

Helena Teede, Emily Callander & Joanne Enticott

Monash Partners Academic Health Science Centre, 43-51 Kanooka Grove, Clayton, VIC, Australia

Helena Teede & Alison Johnson

Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Level 2 Monash University Research, Victorian Heart Hospital, 631 Blackburn Rd, Clayton, VIC, Australia

Dominique A. Cadilhac, Tara Purvis & Monique F. Kilkenny

Stroke Theme, The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, VIC, Australia

Dominique A. Cadilhac, Monique F. Kilkenny & Bruce C.V. Campbell

Department of Neurology, Melbourne Brain Centre, Royal Melbourne Hospital, Parkville, VIC, Australia

Bruce C.V. Campbell

Department of Medicine, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia

School of Health Sciences, Heart and Stroke Program, University of Newcastle, Hunter Medical Research Institute, University Drive, Callaghan, NSW, Australia

Coralie English

School of Medicine and Dentistry, Griffith University, Birtinya, QLD, Australia

Rohan S. Grimley

Clinical Excellence Division, Queensland Health, Brisbane, Australia

John Hunter Hospital, Hunter New England Local Health District and University of Newcastle, Sydney, NSW, Australia

Christopher Levi

School of Nursing, Midwifery and Paramedicine, Australian Catholic University, Sydney, NSW, Australia

Sandy Middleton

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HT: conception, design and initial draft, developed the theoretical formalism for learning health system framework, approved the submitted version. DAC: conception, design and initial draft, provided essential literature and case study examples, approved the submitted version. TP: revised the manuscript critically for important intellectual content, approved the submitted version. MFK: revised the manuscript critically for important intellectual content, provided essential literature and case study examples, approved the submitted version. BC: revised the manuscript critically for important intellectual content, provided essential literature and case study examples, approved the submitted version. CE: revised the manuscript critically for important intellectual content, provided essential literature and case study examples, approved the submitted version. AJ: conception, design and initial draft, developed the theoretical formalism for learning health system framework, approved the submitted version. EC: revised the manuscript critically for important intellectual content, approved the submitted version. RSG: revised the manuscript critically for important intellectual content, provided essential literature and case study examples, approved the submitted version. CL: revised the manuscript critically for important intellectual content, provided essential literature and case study examples, approved the submitted version. SM: revised the manuscript critically for important intellectual content, provided essential literature and case study examples, approved the submitted version. KH: revised the manuscript critically for important intellectual content, provided essential literature and case study examples, approved the submitted version. JE: conception, design and initial draft, developed the theoretical formalism for learning health system framework, approved the submitted version. All authors read and approved the final manuscript.

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Teede, H., Cadilhac, D.A., Purvis, T. et al. Learning together for better health using an evidence-based Learning Health System framework: a case study in stroke. BMC Med 22 , 198 (2024). https://doi.org/10.1186/s12916-024-03416-w

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• Published: 08 May 2024

Exploring the dynamics of consumer engagement in social media influencer marketing: from the self-determination theory perspective

• Chenyu Gu   ORCID: orcid.org/0000-0001-6059-0573 1 &
• Qiuting Duan 2  

Humanities and Social Sciences Communications volume  11 , Article number:  587 ( 2024 ) Cite this article

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Influencer advertising has emerged as an integral part of social media marketing. Within this realm, consumer engagement is a critical indicator for gauging the impact of influencer advertisements, as it encompasses the proactive involvement of consumers in spreading advertisements and creating value. Therefore, investigating the mechanisms behind consumer engagement holds significant relevance for formulating effective influencer advertising strategies. The current study, grounded in self-determination theory and employing a stimulus-organism-response framework, constructs a general model to assess the impact of influencer factors, advertisement information, and social factors on consumer engagement. Analyzing data from 522 samples using structural equation modeling, the findings reveal: (1) Social media influencers are effective at generating initial online traffic but have limited influence on deeper levels of consumer engagement, cautioning advertisers against overestimating their impact; (2) The essence of higher-level engagement lies in the ad information factor, affirming that in the new media era, content remains ‘king’; (3) Interpersonal factors should also be given importance, as influencing the surrounding social groups of consumers is one of the effective ways to enhance the impact of advertising. Theoretically, current research broadens the scope of both social media and advertising effectiveness studies, forming a bridge between influencer marketing and consumer engagement. Practically, the findings offer macro-level strategic insights for influencer marketing.

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Introduction.

Recent studies have highlighted an escalating aversion among audiences towards traditional online ads, leading to a diminishing effectiveness of traditional online advertising methods (Lou et al., 2019 ). In an effort to overcome these challenges, an increasing number of brands are turning to influencers as their spokespersons for advertising. Utilizing influencers not only capitalizes on their significant influence over their fan base but also allows for the dissemination of advertising messages in a more native and organic manner. Consequently, influencer-endorsed advertising has become a pivotal component and a growing trend in social media advertising (Gräve & Bartsch, 2022 ). Although the topic of influencer-endorsed advertising has garnered increasing attention from scholars, the field is still in its infancy, offering ample opportunities for in-depth research and exploration (Barta et al., 2023 ).

Presently, social media influencers—individuals with substantial follower bases—have emerged as the new vanguard in advertising (Hudders & Lou, 2023 ). Their tweets and videos possess the remarkable potential to sway the purchasing decisions of thousands if not millions. This influence largely hinges on consumer engagement behaviors, implying that the impact of advertising can proliferate throughout a consumer’s entire social network (Abbasi et al., 2023 ). Consequently, exploring ways to enhance consumer engagement is of paramount theoretical and practical significance for advertising effectiveness research (Xiao et al., 2023 ). This necessitates researchers to delve deeper into the exploration of the stimulating factors and psychological mechanisms influencing consumer engagement behaviors (Vander Schee et al., 2020 ), which is the gap this study seeks to address.

The Stimulus-Organism-Response (S-O-R) framework has been extensively applied in the study of consumer engagement behaviors (Tak & Gupta, 2021 ) and has been shown to integrate effectively with self-determination theory (Yang et al., 2019 ). Therefore, employing the S-O-R framework to investigate consumer engagement behaviors in the context of influencer advertising is considered a rational approach. The current study embarks on an in-depth analysis of the transformation process from three distinct dimensions. In the Stimulus (S) phase, we focus on how influencer factors, advertising message factors, and social influence factors act as external stimuli. This phase scrutinizes the external environment’s role in triggering consumer reactions. During the Organism (O) phase, the research explores the intrinsic psychological motivations affecting individual behavior as posited in self-determination theory. This includes the willingness for self-disclosure, the desire for innovation, and trust in advertising messages. The investigation in this phase aims to understand how these internal motivations shape consumer attitudes and perceptions in the context of influencer marketing. Finally, in the Response (R) phase, the study examines how these psychological factors influence consumer engagement behavior. This part of the research seeks to understand the transition from internal psychological states to actual consumer behavior, particularly how these states drive the consumers’ deep integration and interaction with the influencer content.

Despite the inherent limitations of cross-sectional analysis in capturing the full temporal dynamics of consumer engagement, this study seeks to unveil the dynamic interplay between consumers’ psychological needs—autonomy, competence, and relatedness—and their varying engagement levels in social media influencer marketing, grounded in self-determination theory. Through this lens, by analyzing factors related to influencers, content, and social context, we aim to infer potential dynamic shifts in engagement behaviors as psychological needs evolve. This approach allows us to offer a snapshot of the complex, multi-dimensional nature of consumer engagement dynamics, providing valuable insights for both theoretical exploration and practical application in the constantly evolving domain of social media marketing. Moreover, the current study underscores the significance of adapting to the dynamic digital environment and highlights the evolving nature of consumer engagement in the realm of digital marketing.

Literature review

Stimulus-organism-response (s-o-r) model.

The Stimulus-Response (S-R) model, originating from behaviorist psychology and introduced by psychologist Watson ( 1917 ), posits that individual behaviors are directly induced by external environmental stimuli. However, this model overlooks internal personal factors, complicating the explanation of psychological states. Mehrabian and Russell ( 1974 ) expanded this by incorporating the individual’s cognitive component (organism) into the model, creating the Stimulus-Organism-Response (S-O-R) framework. This model has become a crucial theoretical framework in consumer psychology as it interprets internal psychological cognitions as mediators between stimuli and responses. Integrating with psychological theories, the S-O-R model effectively analyzes and explains the significant impact of internal psychological factors on behavior (Koay et al., 2020 ; Zhang et al., 2021 ), and is extensively applied in investigating user behavior on social media platforms (Hewei & Youngsook, 2022 ). This study combines the S-O-R framework with self-determination theory to examine consumer engagement behaviors in the context of social media influencer advertising, a logic also supported by some studies (Yang et al., 2021 ).

Self-determination theory

Self-determination theory, proposed by Richard and Edward (2000), is a theoretical framework exploring human behavioral motivation and personality. The theory emphasizes motivational processes, positing that individual behaviors are developed based on factors satisfying their psychological needs. It suggests that individual behavioral tendencies are influenced by the needs for competence, relatedness, and autonomy. Furthermore, self-determination theory, along with organic integration theory, indicates that individual behavioral tendencies are also affected by internal psychological motivations and external situational factors.

Self-determination theory has been validated by scholars in the study of online user behaviors. For example, Sweet applied the theory to the investigation of community building in online networks, analyzing knowledge-sharing behaviors among online community members (Sweet et al., 2020 ). Further literature review reveals the applicability of self-determination theory to consumer engagement behaviors, particularly in the context of influencer marketing advertisements. Firstly, self-determination theory is widely applied in studying the psychological motivations behind online behaviors, suggesting that the internal and external motivations outlined within the theory might also apply to exploring consumer behaviors in influencer marketing scenarios (Itani et al., 2022 ). Secondly, although research on consumer engagement in the social media influencer advertising context is still in its early stages, some studies have utilized SDT to explore behaviors such as information sharing and electronic word-of-mouth dissemination (Astuti & Hariyawan, 2021 ). These behaviors, which are part of the content contribution and creation dimensions of consumer engagement, may share similarities in the underlying psychological motivational mechanisms. Thus, this study will build upon these foundations to construct the Organism (O) component of the S-O-R model, integrating insights from SDT to further understand consumer engagement in influencer marketing.

Consumer engagement

Although scholars generally agree at a macro level to define consumer engagement as the creation of additional value by consumers or customers beyond purchasing products, the specific categorization of consumer engagement varies in different studies. For instance, Simon and Tossan interpret consumer engagement as a psychological willingness to interact with influencers (Simon & Tossan, 2018 ). However, such a broad definition lacks precision in describing various levels of engagement. Other scholars directly use tangible metrics on social media platforms, such as likes, saves, comments, and shares, to represent consumer engagement (Lee et al., 2018 ). While this quantitative approach is not flawed and can be highly effective in practical applications, it overlooks the content aspect of engagement, contradicting the “content is king” principle of advertising and marketing. We advocate for combining consumer engagement with the content aspect, as content engagement not only generates more traces of consumer online behavior (Oestreicher-Singer & Zalmanson, 2013 ) but, more importantly, content contribution and creation are central to social media advertising and marketing, going beyond mere content consumption (Qiu & Kumar, 2017 ). Meanwhile, we also need to emphasize that engagement is not a fixed state but a fluctuating process influenced by ongoing interactions between consumers and influencers, mediated by the evolving nature of social media platforms and the shifting sands of consumer preferences (Pradhan et al., 2023 ). Consumer engagement in digital environments undergoes continuous change, reflecting a journey rather than a destination (Viswanathan et al., 2017 ).

The current study adopts a widely accepted definition of consumer engagement from existing research, offering operational feasibility and aligning well with the research objectives of this paper. Consumer engagement behaviors in the context of this study encompass three dimensions: content consumption, content contribution, and content creation (Muntinga et al., 2011 ). These dimensions reflect a spectrum of digital engagement behaviors ranging from low to high levels (Schivinski et al., 2016 ). Specifically, content consumption on social media platforms represents a lower level of engagement, where consumers merely click and read the information but do not actively contribute or create user-generated content. Some studies consider this level of engagement as less significant for in-depth exploration because content consumption, compared to other forms, generates fewer visible traces of consumer behavior (Brodie et al., 2013 ). Even in a study by Qiu and Kumar, it was noted that the conversion rate of content consumption is low, contributing minimally to the success of social media marketing (Qiu & Kumar, 2017 ).

On the other hand, content contribution, especially content creation, is central to social media marketing. When consumers comment on influencer content or share information with their network nodes, it is termed content contribution, representing a medium level of online consumer engagement (Piehler et al., 2019 ). Furthermore, when consumers actively upload and post brand-related content on social media, this higher level of behavior is referred to as content creation. Content creation represents the highest level of consumer engagement (Cheung et al., 2021 ). Although medium and high levels of consumer engagement are more valuable for social media advertising and marketing, this exploratory study still retains the content consumption dimension of consumer engagement behaviors.

Theoretical framework

Internal organism factors: self-disclosure willingness, innovativeness, and information trust.

In existing research based on self-determination theory that focuses on online behavior, competence, relatedness, and autonomy are commonly considered as internal factors influencing users’ online behaviors. However, this approach sometimes strays from the context of online consumption. Therefore, in studies related to online consumption, scholars often use self-disclosure willingness as an overt representation of autonomy, innovativeness as a representation of competence, and trust as a representation of relatedness (Mahmood et al., 2019 ).

The use of these overt variables can be logically explained as follows: According to self-determination theory, individuals with a higher level of self-determination are more likely to adopt compensatory mechanisms to facilitate behavior compared to those with lower self-determination (Wehmeyer, 1999 ). Self-disclosure, a voluntary act of sharing personal information with others, is considered a key behavior in the development of interpersonal relationships. In social environments, self-disclosure can effectively alleviate stress and build social connections, while also seeking societal validation of personal ideas (Altman & Taylor, 1973 ). Social networks, as para-social entities, possess the interactive attributes of real societies and are likely to exhibit similar mechanisms. In consumer contexts, personal disclosures can include voluntary sharing of product interests, consumption experiences, and future purchase intentions (Robertshaw & Marr, 2006 ). While material incentives can prompt personal information disclosure, many consumers disclose personal information online voluntarily, which can be traced back to an intrinsic need for autonomy (Stutzman et al., 2011 ). Thus, in this study, we consider the self-disclosure willingness as a representation of high autonomy.

Innovativeness refers to an individual’s internal level of seeking novelty and represents their personality and tendency for novelty (Okazaki, 2009 ). Often used in consumer research, innovative consumers are inclined to try new technologies and possess an intrinsic motivation to use new products. Previous studies have shown that consumers with high innovativeness are more likely to search for information on new products and share their experiences and expertise with others, reflecting a recognition of their own competence (Kaushik & Rahman, 2014 ). Therefore, in consumer contexts, innovativeness is often regarded as the competence dimension within the intrinsic factors of self-determination (Wang et al., 2016 ), with external motivations like information novelty enhancing this intrinsic motivation (Lee et al., 2015 ).

Trust refers to an individual’s willingness to rely on the opinions of others they believe in. From a social psychological perspective, trust indicates the willingness to assume the risk of being harmed by another party (McAllister, 1995 ). Widely applied in social media contexts for relational marketing, information trust has been proven to positively influence the exchange and dissemination of consumer information, representing a close and advanced relationship between consumers and businesses, brands, or advertising endorsers (Steinhoff et al., 2019 ). Consumers who trust brands or social media influencers are more willing to share information without fear of exploitation (Pop et al., 2022 ), making trust a commonly used representation of the relatedness dimension in self-determination within consumer contexts.

Construction of the path from organism to response: self-determination internal factors and consumer engagement behavior

Following the logic outlined above, the current study represents the internal factors of self-determination theory through three variables: self-disclosure willingness, innovativeness, and information trust. Next, the study explores the association between these self-determination internal factors and consumer engagement behavior, thereby constructing the link between Organism (O) and Response (R).

Self-disclosure willingness and consumer engagement behavior

In the realm of social sciences, the concept of self-disclosure willingness has been thoroughly examined from diverse disciplinary perspectives, encompassing communication studies, sociology, and psychology. Viewing from the lens of social interaction dynamics, self-disclosure is acknowledged as a fundamental precondition for the initiation and development of online social relationships and interactive engagements (Luo & Hancock, 2020 ). It constitutes an indispensable component within the spectrum of interactive behaviors and the evolution of interpersonal connections. Voluntary self-disclosure is characterized by individuals divulging information about themselves, which typically remains unknown to others and is inaccessible through alternative sources. This concept aligns with the tenets of uncertainty reduction theory, which argues that during interpersonal engagements, individuals seek information about their counterparts as a means to mitigate uncertainties inherent in social interactions (Lee et al., 2008 ). Self-disclosure allows others to gain more personal information, thereby helping to reduce the uncertainty in interpersonal relationships. Such disclosure is voluntary rather than coerced, and this sharing of information can facilitate the development of relationships between individuals (Towner et al., 2022 ). Furthermore, individuals who actively engage in social media interactions (such as liking, sharing, and commenting on others’ content) often exhibit higher levels of self-disclosure (Chu et al., 2023 ); additional research indicates a positive correlation between self-disclosure and online engagement behaviors (Lee et al., 2023 ). Taking the context of the current study, the autonomous self-disclosure willingness can incline social media users to read advertising content more attentively and share information with others, and even create evaluative content. Therefore, this paper proposes the following research hypothesis:

H1a: The self-disclosure willingness is positively correlated with content consumption in consumer engagement behavior.

H1b: The self-disclosure willingness is positively correlated with content contribution in consumer engagement behavior.

H1c: The self-disclosure willingness is positively correlated with content creation in consumer engagement behavior.

Innovativeness and consumer engagement behavior

Innovativeness represents an individual’s propensity to favor new technologies and the motivation to use new products, associated with the cognitive perception of one’s self-competence. Individuals with a need for self-competence recognition often exhibit higher innovativeness (Kelley & Alden, 2016 ). Existing research indicates that users with higher levels of innovativeness are more inclined to accept new product information and share their experiences and discoveries with others in their social networks (Yusuf & Busalim, 2018 ). Similarly, in the context of this study, individuals, as followers of influencers, signify an endorsement of the influencer. Driven by innovativeness, they may be more eager to actively receive information from influencers. If they find the information valuable, they are likely to share it and even engage in active content re-creation to meet their expectations of self-image. Therefore, this paper proposes the following research hypotheses:

H2a: The innovativeness of social media users is positively correlated with content consumption in consumer engagement behavior.

H2b: The innovativeness of social media users is positively correlated with content contribution in consumer engagement behavior.

H2c: The innovativeness of social media users is positively correlated with content creation in consumer engagement behavior.

Information trust and consumer engagement

Trust refers to an individual’s willingness to rely on the statements and opinions of a target object (Moorman et al., 1993 ). Extensive research indicates that trust positively impacts information dissemination and content sharing in interpersonal communication environments (Majerczak & Strzelecki, 2022 ); when trust is established, individuals are more willing to share their resources and less suspicious of being exploited. Trust has also been shown to influence consumers’ participation in community building and content sharing on social media, demonstrating cross-cultural universality (Anaya-Sánchez et al., 2020 ).

Trust in influencer advertising information is also a key predictor of consumers’ information exchange online. With many social media users now operating under real-name policies, there is an increased inclination to trust information shared on social media over that posted by corporate accounts or anonymously. Additionally, as users’ social networks partially overlap with their real-life interpersonal networks, extensive research shows that more consumers increasingly rely on information posted and shared on social networks when making purchase decisions (Wang et al., 2016 ). This aligns with the effectiveness goals of influencer marketing advertisements and the characteristics of consumer engagement. Trust in the content posted by influencers is considered a manifestation of a strong relationship between fans and influencers, central to relationship marketing (Kim & Kim, 2021 ). Based on trust in the influencer, which then extends to trust in their content, people are more inclined to browse information posted by influencers, share this information with others, and even create their own content without fear of exploitation or negative consequences. Therefore, this paper proposes the following research hypotheses:

H3a: Information trust is positively correlated with content consumption in consumer engagement behavior.

H3b: Information trust is positively correlated with content contribution in consumer engagement behavior.

H3c: Information trust is positively correlated with content creation in consumer engagement behavior.

Construction of the path from stimulus to organism: influencer factors, advertising information factors, social factors, and self-determination internal factors

Having established the logical connection from Organism (O) to Response (R), we further construct the influence path from Stimulus (S) to Organism (O). Revisiting the definition of influencer advertising in social media, companies, and brands leverage influencers on social media platforms to disseminate advertising content, utilizing the influencers’ relationships and influence over consumers for marketing purposes. In addition to consumer’s internal factors, elements such as companies, brands, influencers, and the advertisements themselves also impact consumer behavior. Although factors like the brand image perception of companies may influence consumer behavior, considering that in influencer marketing, companies and brands do not directly interact with consumers, this study prioritizes the dimensions of influencers and advertisements. Furthermore, the impact of social factors on individual cognition and behavior is significant, thus, the current study integrates influencers, advertisements, and social dimensions as the Stimulus (S) component.

Influencer factors: parasocial identification

Self-determination theory posits that relationships are one of the key motivators influencing individual behavior. In the context of social media research, users anticipate establishing a parasocial relationship with influencers, resembling real-life relationships. Hence, we consider the parasocial identification arising from users’ parasocial interactions with influencers as the relational motivator. Parasocial interaction refers to the one-sided personal relationship that individuals develop with media characters (Donald & Richard, 1956 ). During this process, individuals believe that the media character is directly communicating with them, creating a sense of positive intimacy (Giles, 2002 ). Over time, through repeated unilateral interactions with media characters, individuals develop a parasocial relationship, leading to parasocial identification. However, parasocial identification should not be directly equated with the concept of social identification in social identity theory. Social identification occurs when individuals psychologically de-individualize themselves, perceiving the characteristics of their social group as their own, upon identifying themselves as part of that group. In contrast, parasocial identification refers to the one-sided interactional identification with media characters (such as celebrities or influencers) over time (Chen et al., 2021 ). Particularly when individuals’ needs for interpersonal interaction are not met in their daily lives, they turn to parasocial interactions to fulfill these needs (Shan et al., 2020 ). Especially on social media, which is characterized by its high visibility and interactivity, users can easily develop a strong parasocial identification with the influencers they follow (Wei et al., 2022 ).

Parasocial identification and self-disclosure willingness

Theories like uncertainty reduction, personal construct, and social exchange are often applied to explain the emergence of parasocial identification. Social media, with its convenient and interactive modes of information dissemination, enables consumers to easily follow influencers on media platforms. They can perceive the personality of influencers through their online content, viewing them as familiar individuals or even friends. Once parasocial identification develops, this pleasurable experience can significantly influence consumers’ cognitions and thus their behavioral responses. Research has explored the impact of parasocial identification on consumer behavior. For instance, Bond et al. found that on Twitter, the intensity of users’ parasocial identification with influencers positively correlates with their continuous monitoring of these influencers’ activities (Bond, 2016 ). Analogous to real life, where we tend to pay more attention to our friends in our social networks, a similar phenomenon occurs in the relationship between consumers and brands. This type of parasocial identification not only makes consumers willing to follow brand pages but also more inclined to voluntarily provide personal information (Chen et al., 2021 ). Based on this logic, we speculate that a similar relationship may exist between social media influencers and their fans. Fans develop parasocial identification with influencers through social media interactions, making them more willing to disclose their information, opinions, and views in the comment sections of the influencers they follow, engaging in more frequent social interactions (Chung & Cho, 2017 ), even if the content at times may be brand or company-embedded marketing advertisements. In other words, in the presence of influencers with whom they have established parasocial relationships, they are more inclined to disclose personal information, thereby promoting consumer engagement behavior. Therefore, we propose the following research hypotheses:

H4: Parasocial identification is positively correlated with consumer self-disclosure willingness.

H4a: Self-disclosure willingness mediates the impact of parasocial identification on content consumption in consumer engagement behavior.

H4b: Self-disclosure willingness mediates the impact of parasocial identification on content contribution in consumer engagement behavior.

H4c: Self-disclosure willingness mediates the impact of parasocial identification on content creation in consumer engagement behavior.

Parasocial identification and information trust

Information Trust refers to consumers’ willingness to trust the information contained in advertisements and to place themselves at risk. These risks include purchasing products inconsistent with the advertised information and the negative social consequences of erroneously spreading this information to others, leading to unpleasant consumption experiences (Minton, 2015 ). In advertising marketing, gaining consumers’ trust in advertising information is crucial. In the context of influencer marketing on social media, companies, and brands leverage the social connection between influencers and their fans. According to cognitive empathy theory, consumers project their trust in influencers onto the products endorsed, explaining the phenomenon of ‘loving the house for the crow on its roof.’ Research indicates that parasocial identification with influencers is a necessary condition for trust development. Consumers engage in parasocial interactions with influencers on social media, leading to parasocial identification (Jin et al., 2021 ). Consumers tend to reduce their cognitive load and simplify their decision-making processes, thus naturally adopting a positive attitude and trust towards advertising information disseminated by influencers with whom they have established parasocial identification. This forms the core logic behind the success of influencer marketing advertisements (Breves et al., 2021 ); furthermore, as mentioned earlier, because consumers trust these advertisements, they are also willing to share this information with friends and family and even engage in content re-creation. Therefore, we propose the following research hypotheses:

H5: Parasocial identification is positively correlated with information trust.

H5a: Information trust mediates the impact of parasocial identification on content consumption in consumer engagement behavior.

H5b: Information trust mediates the impact of parasocial identification on content contribution in consumer engagement behavior.

H5c: Information trust mediates the impact of parasocial identification on content creation in consumer engagement behavior.

Influencer factors: source credibility

Source credibility refers to the degree of trust consumers place in the influencer as a source, based on the influencer’s reliability and expertise. Numerous studies have validated the effectiveness of the endorsement effect in advertising (Schouten et al., 2021 ). The Source Credibility Model, proposed by the renowned American communication scholar Hovland and the “Yale School,” posits that in the process of information dissemination, the credibility of the source can influence the audience’s decision to accept the information. The credibility of the information is determined by two aspects of the source: reliability and expertise. Reliability refers to the audience’s trust in the “communicator’s objective and honest approach to providing information,” while expertise refers to the audience’s trust in the “communicator being perceived as an effective source of information” (Hovland et al., 1953 ). Hovland’s definitions reveal that the interpretation of source credibility is not about the inherent traits of the source itself but rather the audience’s perception of the source (Jang et al., 2021 ). This differs from trust and serves as a precursor to the development of trust. Specifically, reliability and expertise are based on the audience’s perception; thus, this aligns closely with the audience’s perception of influencers (Kim & Kim, 2021 ). This credibility is a cognitive statement about the source of information.

Source credibility and self-disclosure willingness

Some studies have confirmed the positive impact of an influencer’s self-disclosure on their credibility as a source (Leite & Baptista, 2022 ). However, few have explored the impact of an influencer’s credibility, as a source, on consumers’ self-disclosure willingness. Undoubtedly, an impact exists; self-disclosure is considered a method to attempt to increase intimacy with others (Leite et al., 2022 ). According to social exchange theory, people promote relationships through the exchange of information in interpersonal communication to gain benefits (Cropanzano & Mitchell, 2005 ). Credibility, deriving from an influencer’s expertise and reliability, means that a highly credible influencer may provide more valuable information to consumers. Therefore, based on the social exchange theory’s logic of reciprocal benefits, consumers might be more willing to disclose their information to trustworthy influencers, potentially even expanding social interactions through further consumer engagement behaviors. Thus, we propose the following research hypotheses:

H6: Source credibility is positively correlated with self-disclosure willingness.

H6a: Self-disclosure willingness mediates the impact of Source credibility on content consumption in consumer engagement behavior.

H6b: Self-disclosure willingness mediates the impact of Source credibility on content contribution in consumer engagement behavior.

H6c: Self-disclosure willingness mediates the impact of Source credibility on content creation in consumer engagement behavior.

Source credibility and information trust

Based on the Source Credibility Model, the credibility of an endorser as an information source can significantly influence consumers’ acceptance of the information (Shan et al., 2020 ). Existing research has demonstrated the positive impact of source credibility on consumers. Djafarova, in a study based on Instagram, noted through in-depth interviews with 18 users that an influencer’s credibility significantly affects respondents’ trust in the information they post. This credibility is composed of expertise and relevance to consumers, and influencers on social media are considered more trustworthy than traditional celebrities (Djafarova & Rushworth, 2017 ). Subsequently, Bao and colleagues validated in the Chinese consumer context, based on the ELM model and commitment-trust theory, that the credibility of brand pages on Weibo effectively fosters consumer trust in the brand, encouraging participation in marketing activities (Bao & Wang, 2021 ). Moreover, Hsieh et al. found that in e-commerce contexts, the credibility of the source is a significant factor influencing consumers’ trust in advertising information (Hsieh & Li, 2020 ). In summary, existing research has proven that the credibility of the source can promote consumer trust. Influencer credibility is a significant antecedent affecting consumers’ trust in the advertised content they publish. In brand communities, trust can foster consumer engagement behaviors (Habibi et al., 2014 ). Specifically, consumers are more likely to trust the advertising content published by influencers with higher credibility (more expertise and reliability), and as previously mentioned, consumer engagement behavior is more likely to occur. Based on this, the study proposes the following research hypotheses:

H7: Source credibility is positively correlated with information trust.

H7a: Information trust mediates the impact of source credibility on content consumption in consumer engagement behavior.

H7b: Information trust mediates the impact of source credibility on content contribution in consumer engagement behavior.

H7c: Information trust mediates the impact of source credibility on content creation in consumer engagement behavior.

Advertising information factors: informative value

Advertising value refers to “the relative utility value of advertising information to consumers and is a subjective evaluation by consumers.” In his research, Ducoffe pointed out that in the context of online advertising, the informative value of advertising is a significant component of advertising value (Ducoffe, 1995 ). Subsequent studies have proven that consumers’ perception of advertising value can effectively promote their behavioral response to advertisements (Van-Tien Dao et al., 2014 ). Informative value of advertising refers to “the information about products needed by consumers provided by the advertisement and its ability to enhance consumer purchase satisfaction.” From the perspective of information dissemination, valuable advertising information should help consumers make better purchasing decisions and reduce the effort spent searching for product information. The informational aspect of advertising has been proven to effectively influence consumers’ cognition and, in turn, their behavior (Haida & Rahim, 2015 ).

Informative value and innovativeness

As previously discussed, consumers’ innovativeness refers to their psychological trait of favoring new things. Studies have shown that consumers with high innovativeness prefer novel and valuable product information, as it satisfies their need for newness and information about new products, making it an important factor in social media advertising engagement (Shi, 2018 ). This paper also hypothesizes that advertisements with high informative value can activate consumers’ innovativeness, as the novelty of information is one of the measures of informative value (León et al., 2009 ). Acquiring valuable information can make individuals feel good about themselves and fulfill their perception of a “novel image.” According to social exchange theory, consumers can gain social capital in interpersonal interactions (such as social recognition) by sharing information about these new products they perceive as valuable. Therefore, the current study proposes the following research hypothesis:

H8: Informative value is positively correlated with innovativeness.

H8a: Innovativeness mediates the impact of informative value on content consumption in consumer engagement behavior.

H8b: Innovativeness mediates the impact of informative value on content contribution in consumer engagement behavior.

H8c: Innovativeness mediates the impact of informative value on content creation in consumer engagement behavior.

Informative value and information trust

Trust is a multi-layered concept explored across various disciplines, including communication, marketing, sociology, and psychology. For the purposes of this paper, a deep analysis of different levels of trust is not undertaken. Here, trust specifically refers to the trust in influencer advertising information within the context of social media marketing, denoting consumers’ belief in and reliance on the advertising information endorsed by influencers. Racherla et al. investigated the factors influencing consumers’ trust in online reviews, suggesting that information quality and value contribute to increasing trust (Racherla et al., 2012 ). Similarly, Luo and Yuan, in a study based on social media marketing, also confirmed that the value of advertising information posted on brand pages can foster consumer trust in the content (Lou & Yuan, 2019 ). Therefore, by analogy, this paper posits that the informative value of influencer-endorsed advertising can also promote consumer trust in that advertising information. The relationship between trust in advertising information and consumer engagement behavior has been discussed earlier. Thus, the current study proposes the following research hypotheses:

H9: Informative value is positively correlated with information trust.

H9a: Information trust mediates the impact of informative value on content consumption in consumer engagement behavior.

H9b: Information trust mediates the impact of informative value on content contribution in consumer engagement behavior.

H9c: Information trust mediates the impact of informative value on content creation in consumer engagement behavior.

Advertising information factors: ad targeting accuracy

Ad targeting accuracy refers to the degree of match between the substantive information contained in advertising content and consumer needs. Advertisements containing precise information often yield good advertising outcomes. In marketing practice, advertisers frequently use information technology to analyze the characteristics of different consumer groups in the target market and then target their advertisements accordingly to achieve precise dissemination and, consequently, effective advertising results. The utility of ad targeting accuracy has been confirmed by many studies. For instance, in the research by Qiu and Chen, using a modified UTAUT model, it was demonstrated that the accuracy of advertising effectively promotes consumer acceptance of advertisements in WeChat Moments (Qiu & Chen, 2018 ). Although some studies on targeted advertising also indicate that overly precise ads may raise concerns about personal privacy (Zhang et al., 2019 ), overall, the accuracy of advertising information is effective in enhancing advertising outcomes and is a key element in the success of targeted advertising.

Ad targeting accuracy and information trust

In influencer marketing advertisements, due to the special relationship recognition between consumers and influencers, the privacy concerns associated with ad targeting accuracy are alleviated (Vrontis et al., 2021 ). Meanwhile, the informative value brought by targeting accuracy is highlighted. More precise advertising content implies higher informative value and also signifies that the advertising content is more worthy of consumer trust (Della Vigna, Gentzkow, 2010 ). As previously discussed, people are more inclined to read and engage with advertising content they trust and recognize. Therefore, the current study proposes the following research hypotheses:

H10: Ad targeting accuracy is positively correlated with information trust.

H10a: Information trust mediates the impact of ad targeting accuracy on content consumption in consumer engagement behavior.

H10b: Information trust mediates the impact of ad targeting accuracy on content contribution in consumer engagement behavior.

H10c: Information trust mediates the impact of ad targeting accuracy on content creation in consumer engagement behavior.

Social factors: subjective norm

The Theory of Planned Behavior, proposed by Ajzen ( 1991 ), suggests that individuals’ actions are preceded by conscious choices and are underlain by plans. TPB has been widely used by scholars in studying personal online behaviors, these studies collectively validate the applicability of TPB in the context of social media for researching online behaviors (Huang, 2023 ). Additionally, the self-determination theory, which underpins this chapter’s research, also supports the notion that individuals’ behavioral decisions are based on internal cognitions, aligning with TPB’s assertions. Therefore, this paper intends to select subjective norms from TPB as a factor of social influence. Subjective norm refers to an individual’s perception of the expectations of significant others in their social relationships regarding their behavior. Empirical research in the consumption field has demonstrated the significant impact of subjective norms on individual psychological cognition (Yang & Jolly, 2009 ). A meta-analysis by Hagger, Chatzisarantis ( 2009 ) even highlighted the statistically significant association between subjective norms and self-determination factors. Consequently, this study further explores its application in the context of influencer marketing advertisements on social media.

Subjective norm and self-disclosure willingness

In numerous studies on social media privacy, subjective norms significantly influence an individual’s self-disclosure willingness. Wirth et al. ( 2019 ) based on the privacy calculus theory, surveyed 1,466 participants and found that personal self-disclosure on social media is influenced by the behavioral expectations of other significant reference groups around them. Their research confirmed that subjective norms positively influence self-disclosure of information and highlighted that individuals’ cognitions and behaviors cannot ignore social and environmental factors. Heirman et al. ( 2013 ) in an experiment with Instagram users, also noted that subjective norms could promote positive consumer behavioral responses. Specifically, when important family members and friends highly regard social media influencers as trustworthy, we may also be more inclined to disclose our information to influencers and share this information with our surrounding family and friends without fear of disapproval. In our subjective norms, this is considered a positive and valuable interactive behavior, leading us to exhibit engagement behaviors. Based on this logic, we propose the following research hypotheses:

H11: Subjective norms are positively correlated with self-disclosure willingness.

H11a: Self-disclosure willingness mediates the impact of subjective norms on content consumption in consumer engagement behavior.

H11b: Self-disclosure willingness mediates the impact of subjective norms on content contribution in consumer engagement behavior.

H11c: Self-disclosure willingness mediates the impact of subjective norms on content creation in consumer engagement behavior.

Subjective norm and information trust

Numerous studies have indicated that subjective norms significantly influence trust (Roh et al., 2022 ). This can be explained by reference group theory, suggesting people tend to minimize the effort expended in decision-making processes, often looking to the behaviors or attitudes of others as a point of reference; for instance, subjective norms can foster acceptance of technology by enhancing trust (Gupta et al., 2021 ). Analogously, if a consumer’s social network generally holds positive attitudes toward influencer advertising, they are also more likely to trust the endorsed advertisement information, as it conserves the extensive effort required in gathering product information (Chetioui et al., 2020 ). Therefore, this paper proposes the following research hypotheses:

H12: Subjective norms are positively correlated with information trust.

H12a: Information trust mediates the impact of subjective norms on content consumption in consumer engagement behavior.

H12b: Information trust mediates the impact of subjective norms on content contribution in consumer engagement behavior.

H12c: Information trust mediates the impact of subjective norms on content creation in consumer engagement behavior.

Conceptual model

In summary, based on the Stimulus (S)-Organism (O)-Response (R) framework, this study constructs the external stimulus factors (S) from three dimensions: influencer factors (parasocial identification, source credibility), advertising information factors (informative value, Ad targeting accuracy), and social influence factors (subjective norms). This is grounded in social capital theory and the theory of planned behavior. drawing on self-determination theory, the current study constructs the individual psychological factors (O) using self-disclosure willingness, innovativeness, and information trust. Finally, the behavioral response (R) is constructed using consumer engagement, which includes content consumption, content contribution, and content creation, as illustrated in Fig. 1 .

Consumer engagement behavior impact model based on SOR framework.

Materials and methods

Participants and procedures.

The current study conducted a survey through the Wenjuanxing platform to collect data. Participants were recruited through social media platforms such as WeChat, Douyin, Weibo et al., as samples drawn from social media users better align with the research purpose of our research and ensure the validity of the sample. Before the survey commenced, all participants were explicitly informed about the purpose of this study, and it was made clear that volunteers could withdraw from the survey at any time. Initially, 600 questionnaires were collected, with 78 invalid responses excluded. The criteria for valid questionnaires were as follows: (1) Respondents must have answered “Yes” to the question, “Do you follow any influencers (internet celebrities) on social media platforms?” as samples not using social media or not following influencers do not meet the study’s objective, making this question a prerequisite for continuing the survey; (2) Respondents had to correctly answer two hidden screening questions within the questionnaire to ensure that they did not randomly select scores; (3) The total time taken to complete the questionnaire had to exceed one minute, ensuring that respondents had sufficient time to understand and thoughtfully answer each question; (4) Respondents were not allowed to choose the same score for eight consecutive questions. Ultimately, 522 valid questionnaires were obtained, with an effective rate of 87.00%, meeting the basic sample size requirements for research models (Gefen et al., 2011 ). Detailed demographic information of the study participants is presented in Table 1 .

Measurements

To ensure the validity and reliability of the data analysis results in this study, the measurement tools and scales used in this chapter were designed with reference to existing established research. The main variables in the survey questionnaire include parasocial identification, source credibility, informative value, ad targeting accuracy, subjective norms, self-disclosure willingness, innovativeness, information trust, content consumption, content contribution, and content creation. The measurement scale for parasocial identification was adapted from the research of Schramm and Hartmann, comprising 6 items (Schramm & Hartmann, 2008 ). The source credibility scale was combined from the studies of Cheung et al. and Luo & Yuan’s research in the context of social media influencer marketing, including 4 items (Cheung et al., 2009 ; Lou & Yuan, 2019 ). The scale for informative value was modified based on Voss et al.‘s research, consisting of 4 items (Voss et al., 2003 ). The ad targeting accuracy scale was derived from the research by Qiu Aimei et al., 2018 ) including 3 items. The subjective norm scale was adapted from Ajzen’s original scale, comprising 3 items (Ajzen, 2002 ). The self-disclosure willingness scale was developed based on Chu and Kim’s research, including 3 items (Chu & Kim, 2011 ). The innovativeness scale was formulated following the study by Sun et al., comprising 4 items (Sun et al., 2006 ). The information trust scale was created in reference to Chu and Choi’s research, including 3 items (Chu & Choi, 2011 ). The scales for the three components of social media consumer engagement—content consumption, content contribution, and content creation—were sourced from the research by Buzeta et al., encompassing 8 items in total (Buzeta et al., 2020 ).

All scales were appropriately revised for the context of social media influencer marketing. To avoid issues with scoring neutral attitudes, a uniform Likert seven-point scale was used for each measurement item (ranging from 1 to 7, representing a spectrum from ‘strongly disagree’ to ‘strongly agree’). After the overall design of the questionnaire was completed, a pre-test was conducted with 30 social media users to ensure that potential respondents could clearly understand the meaning of each question and that there were no obstacles to answering. This pre-test aimed to prevent any difficulties or misunderstandings in the questionnaire items. The final version of the questionnaire is presented in Table 2 .

Data analysis

Since the model framework of the current study is derived from theoretical deductions of existing research and, while logically constructed, does not originate from an existing research model, this study still falls under the category of exploratory research. According to the analysis suggestions of Hair and other scholars, in cases of exploratory research model frameworks, it is more appropriate to choose Smart PLS for Partial Least Squares Path Analysis (PLS) to conduct data analysis and testing of the research model (Hair et al., 2012 ).

Measurement of model

In this study, careful data collection and management resulted in no missing values in the dataset. This ensured the integrity and reliability of the subsequent data analysis. As shown in Table 3 , after deleting measurement items with factor loadings below 0.5, the final factor loadings of the measurement items in this study range from 0.730 to 0.964. This indicates that all measurement items meet the retention criteria. Additionally, the Cronbach’s α values of the latent variables range from 0.805 to 0.924, and all latent variables have Composite Reliability (CR) values greater than the acceptable value of 0.7, demonstrating that the scales of this study have passed the reliability test requirements (Hair et al., 2019 ). All latent variables in this study have Average Variance Extracted (AVE) values greater than the standard acceptance value of 0.5, indicating that the convergent validity of the variables also meets the standard (Fornell & Larcker, 1981 ). Furthermore, the results show that the Variance Inflation Factor (VIF) values for each factor are below 10, indicating that there are no multicollinearity issues with the scales in this study (Hair, 2009 ).

The current study then further verified the discriminant validity of the variables, with specific results shown in Table 4 . The square roots of the average variance extracted (AVE) values for all variables (bolded on the diagonal) are greater than the Pearson correlation coefficients between the variables, indicating that the discriminant validity of the scales in this study meets the required standards (Fornell & Larcker, 1981 ). Additionally, a single-factor test method was employed to examine common method bias in the data. The first unrotated factor accounted for 29.71% of the variance, which is less than the critical threshold of 40%. Therefore, the study passed the test and did not exhibit serious common method bias (Podsakoff et al., 2003 ).

To ensure the robustness and appropriateness of our structural equation model, we also conducted a thorough evaluation of the model fit. Initially, through PLS Algorithm calculations, the R 2 values of each variable were greater than the standard acceptance value of 0.1, indicating good predictive accuracy of the model. Subsequently, Blindfolding calculations were performed, and the results showed that the Stone-Geisser Q 2 values of each variable were greater than 0, demonstrating that the model of this study effectively predicts the relationships between variables (Dijkstra & Henseler, 2015 ). In addition, through CFA, we also obtained some indicator values, specifically, χ 2 /df = 2.528 < 0.3, RMSEA = 0.059 < 0.06, SRMR = 0.055 < 0.08. Given its sensitivity to sample size, we primarily focused on the CFI, TLI, and NFI values, CFI = 0.953 > 0.9, TLI = 0.942 > 0.9, and NFI = 0.923 > 0.9 indicating a good fit. Additionally, RMSEA values below 0.06 and SRMR values below 0.08 were considered indicative of a good model fit. These indices collectively suggested that our model demonstrates a satisfactory fit with the data, thereby reinforcing the validity of our findings.

Research hypothesis testing

The current study employed a Bootstrapping test with a sample size of 5000 on the collected raw data to explore the coefficients and significance of the paths in the research model. The final test data results of this study’s model are presented in Table 5 .

The current study employs S-O-R model as the framework, grounded in theories such as self-determination theory and theory of planned behavior, to construct an influence model of consumer engagement behavior in the context of social media influencer marketing. It examines how influencer factors, advertisement information factors, and social influence factors affect consumer engagement behavior by impacting consumers’ psychological cognitions. Using structural equation modeling to analyze collected data ( N  = 522), it was found that self-disclosure willingness, innovativeness, and information trust positively influence consumer engagement behavior, with innovativeness having the largest impact on higher levels of engagement. Influencer factors, advertisement information factors, and social factors serve as effective external stimuli, influencing psychological motivators and, consequently, consumer engagement behavior. The specific research results are illustrated in Fig. 2 .

Tested structural model of consumer engagement behavior.

The impact of psychological motivators on different levels of consumer engagement: self-disclosure willingness, innovativeness, and information trust

The research analysis indicates that self-disclosure willingness and information trust are key drivers for content consumption (H1a, H2a validated). This aligns with previous findings that individuals with a higher willingness to disclose themselves show greater levels of engagement behavior (Chu et al., 2023 ); likewise, individuals who trust advertisement information are more inclined to engage with advertisement content (Kim, Kim, 2021 ). Moreover, our study finds that information trust has a stronger impact on content consumption, underscoring the importance of trust in the dissemination of advertisement information. However, no significant association was found between individual innovativeness and content consumption (H3a not validated).

Regarding the dimension of content contribution in consumer engagement, self-disclosure willingness, information trust, and innovativeness all positively impact it (H1b, H2b, and H3b all validated). This is consistent with earlier research findings that individuals with higher self-disclosure willingness are more likely to like, comment on, or share content posted by influencers on social media platforms (Towner et al., 2022 ); the conclusions of this paper also support that innovativeness is an important psychological driver for active participation in social media interactions (Kamboj & Sharma, 2023 ). However, at the level of consumer engagement in content contribution, while information trust also exerts a positive effect, its impact is the weakest, although information trust has the strongest impact on content consumption.

In social media advertising, the ideal outcome is the highest level of consumer engagement, i.e., content creation, meaning consumers actively join in brand content creation, seeing themselves as co-creators with the brand (Nadeem et al., 2021 ). Our findings reveal that self-disclosure willingness, innovativeness, and information trust all positively influence content creation (H1c, H2c, and H3c all validated). The analysis found that similar to the impact on content contribution, innovativeness has the most significant effect on encouraging individual content creation, followed by self-disclosure willingness, with information trust having the least impact.

In summary, while some previous studies have shown that self-disclosure willingness, innovativeness, and information trust are important factors in promoting consumer engagement (Chu et al., 2023 ; Nadeem et al., 2021 ; Geng et al., 2021 ), this study goes further by integrating and comparing all three within the same research framework. It was found that to trigger higher levels of consumer engagement behavior, trust is not the most crucial psychological motivator; rather, the most effective method is to stimulate consumers’ innovativeness, thus complementing previous research. Subsequently, this study further explores the impact of different stimulus factors on various psychological motivators.

The influence of external stimulus factors on psychological motivators: influencer factors, advertisement information factors, and social factors

The current findings indicate that influencer factors, such as parasocial identification and source credibility, effectively enhance consumer engagement by influencing self-disclosure willingness and information trust. This aligns with prior research highlighting the significance of parasocial identification (Shan et al., 2020 ). Studies suggest parasocial identification positively impacts consumer engagement by boosting self-disclosure willingness and information trust (validated H4a, H4b, H4c, and H5a), but not content contribution or creation through information trust (H5b, H5c not validated). Source credibility’s influence on self-disclosure willingness was not significant (H6 not validated), thus negating the mediating effect of self-disclosure willingness (H6a, H6b, H6c not validated). Influencer credibility mainly affects engagement through information trust (H7a, H7b, H7c validated), supporting previous findings (Shan et al., 2020 ).

Advertisement factors (informative value and ad targeting accuracy) promote engagement through innovativeness and information trust. Informative value significantly impacts higher-level content contribution and creation through innovativeness (H8b, H8c validated), while ad targeting accuracy influences consumer engagement at all levels mainly through information trust (H10a, H10b, H10c validated).

Social factors (subjective norms) enhance self-disclosure willingness and information trust, consistent with previous research (Wirth et al., 2019 ; Gupta et al., 2021 ), and further promote consumer engagement across all levels (H11a, H11b, H11c, H12a, H12b, and H12c all validated).

In summary, influencer, advertisement, and social factors impact consumer engagement behavior by influencing psychological motivators, with influencer factors having the greatest effect on content consumption, advertisement content factors significantly raising higher-level consumer engagement through innovativeness, and social factors also influencing engagement through self-disclosure willingness and information trust.

Implication

From a theoretical perspective, current research presents a comprehensive model of consumer engagement within the context of influencer advertising on social media. This model not only expands the research horizon in the fields of social media influencer advertising and consumer engagement but also serves as a bridge between two crucial themes in new media advertising studies. Influencer advertising has become an integral part of social media advertising, and the construction of a macro model aids researchers in understanding consumer psychological processes and behavioral patterns. It also assists advertisers in formulating more effective strategies. Consumer engagement, focusing on the active role of consumers in disseminating information and the long-term impact on advertising effectiveness, aligns more closely with the advertising effectiveness measures in the new media context than traditional advertising metrics. However, the intersection of these two vital themes lacks comprehensive research and a universal model. This study constructs a model that elucidates the effects of various stimuli on consumer psychology and engagement behaviors, exploring the connections and mechanisms through different mediating pathways. By differentiating levels of engagement, the study offers more nuanced conclusions for diverse advertising objectives. Furthermore, this research validates the applicability of self-determination theory in the context of influencer advertising effectiveness. While this psychological theory has been utilized in communication behavior research, its effectiveness in the field of advertising requires further exploration. The current study introduces self-determination theory into the realm of influencer advertising and consumer engagement, thereby expanding its application in the field of advertising communication. It also responds to the call from the advertising and marketing academic community to incorporate more psychological theories to explain the ‘black box’ of consumer psychology. The inclusion of this theory re-emphasizes the people-centric approach of this research and highlights the primary role of individuals in advertising communication studies.

From a practical perspective, this study provides significant insights for adapting marketing strategies to the evolving media landscape and the empowered role of audiences. Firstly, in the face of changes in the communication environment and the empowerment of audience communication capabilities, traditional marketing approaches are becoming inadequate for new media advertising needs. Traditional advertising focuses on direct, point-to-point effects, whereas social media advertising aims for broader, point-to-mass communication, leveraging audience proactivity to facilitate the viral spread of content across online social networks. Secondly, for brands, the general influence model proposed in this study offers guidance for influencer advertising strategy. If the goal is to maximize reach and brand recognition with a substantial advertising budget, partnering with top influencers who have a large following can be an effective strategy. However, if the objective is to maximize cost-effectiveness with a limited budget by leveraging consumer initiative for secondary spread, the focus should be on designing advertising content that stimulates consumer creativity and willingness to innovate. Thirdly, influencers are advised to remain true to their followers. In influencer marketing, influencers attract advertisers through their influence over followers, converting this influence into commercial gain. This influence stems from the trust followers place in the influencer, thus influencers should maintain professional integrity and prioritize the quality of information they share, even when presented with advertising opportunities. Lastly, influencers should assert more control over their relationships with advertisers. In traditional advertising, companies and brands often exert significant control over the content. However, in the social media era, influencers should negotiate more creative freedom in their advertising partnerships, asserting a more equal relationship with advertisers. This approach ensures that content quality remains high, maintaining the trust influencers have built with their followers.

Limitations and future directions

while this study offers valuable insights into the dynamics of influencer marketing and consumer engagement on social media, several limitations should be acknowledged: Firstly, constrained by the research objectives and scope, this study’s proposed general impact model covers three dimensions: influencers, advertisement information, and social factors. However, these dimensions are not limited to the five variables discussed in this paper. Therefore, we call for future research to supplement and explore more crucial factors. Secondly, in the actual communication environment, there may be differences in the impact of communication effectiveness across various social media platforms. Thus, future research could also involve comparative studies and explorations between different social media platforms. Thirdly, the current study primarily examines the direct effects of various factors on consumer engagement. However, the potential interaction effects between these variables (e.g., how influencers’ credibility might interact with advertisement information quality) are not extensively explored. Future research could investigate these complex interrelationships for a more holistic understanding. Lastly, our study, being cross-sectional, offers preliminary insights into the complex and dynamic nature of engagement between social media influencers and consumers, yet it does not incorporate the temporal dimension. The diverse impacts of psychological needs on engagement behaviors hint at an underlying dynamism that merits further investigation. Future research should consider employing longitudinal designs to directly observe how these dynamics evolve over time.

The findings of the current study not only theoretically validate the applicability of self-determination theory in the field of social media influencer marketing advertising research but also broaden the scope of advertising effectiveness research from the perspective of consumer engagement. Moreover, the research framework offers strategic guidance and reference for influencer marketing strategies. The main conclusions of this study can be summarized as follows.

Innovativeness is the key factor in high-level consumer engagement behavior. Content contribution represents a higher level of consumer engagement compared to content consumption, as it not only requires consumers to dedicate attention to viewing advertising content but also to share this information across adjacent nodes within their social networks. This dissemination of information is a pivotal factor in the success of influencer marketing advertisements. Hence, companies and brands prioritize consumers’ content contribution over mere viewing of advertising content (Qiu & Kumar, 2017 ). Compared to content consumption and contribution, content creation is considered the highest level of consumer engagement, where consumers actively create and upload brand-related content, and it represents the most advanced outcome sought by enterprises and brands in advertising campaigns (Cheung et al., 2021 ). The current study posits that to pursue better outcomes in social media influencer advertising marketing, enhancing consumers’ willingness for self-disclosure, innovativeness, and trust in advertising information are effective strategies. However, the crux lies in leveraging the consumer’s subjective initiative, particularly in boosting their innovativeness. If the goal is simply to achieve content consumption rather than higher levels of consumer engagement, the focus should be on fostering trust in advertising information. There is no hierarchy in the efficacy of different strategies; they should align with varying marketing contexts and advertising objectives.

The greatest role of social media influencers lies in attracting online traffic. information trust is the core element driving content consumption, and influencer factors mainly affect consumer engagement behaviors through information trust. Therefore, this study suggests that the primary role of influencers in social media advertising is to attract online traffic, i.e., increase consumer behavior regarding ad content consumption (reducing avoidance of ad content), and help brands achieve the initial goal of making consumers “see and complete ads.” However, their impact on further high-level consumer engagement behaviors is limited. This mechanism serves as a reminder to advertisers not to overestimate the effects of influencers in marketing. Currently, top influencers command a significant portion of the ad budget, which could squeeze the budget for other aspects of advertising, potentially affecting the overall effectiveness of the campaign. Businesses and brands should consider deeper strategic implications when planning their advertising campaigns.

Valuing Advertising Information Factors, Content Remains King. Our study posits that in the social media influencer marketing context, the key to enhancing consumer contribution and creation of advertising content lies primarily in the advertising information factors. In other words, while content consumption is important, advertisers should objectively assess the role influencers play in advertising. In the era of social media, content remains ‘king’ in advertising. This view indirectly echoes the points made in the previous paragraph: influencers effectively perform initial ‘online traffic generation’ tasks in social media, but this role should not be overly romanticized or exaggerated. Whether it’s companies, brands, or influencers, providing consumers with advertisements rich in informational value is crucial to achieving better advertising outcomes and potentially converting consumers into stakeholders.

Subjective norm is an unignorable social influence factor. Social media is characterized by its network structure of information dissemination, where a node’s information is visible to adjacent nodes. For instance, if user A likes a piece of content C from influencer I, A’s follower B, who may not follow influencer I, can still see content C via user A’s page. The aim of marketing in the social media era is to influence a node and then spread the information to adjacent nodes, either secondarily or multiple times (Kumar & Panda, 2020 ). According to the Theory of Planned Behavior, an individual’s actions are influenced by significant others in their lives, such as family and friends. Previous studies have proven the effectiveness of the Theory of Planned Behavior in influencing attitudes toward social media advertising (Ranjbarian et al., 2012 ). Current research further confirms that subjective norms also influence consumer engagement behaviors in influencer marketing on social media. Therefore, in advertising practice, brands should not only focus on individual consumers but also invest efforts in groups that can influence consumer decisions. Changing consumer behavior in the era of social media marketing doesn’t solely rely on the company’s efforts.

As communication technology advances, media platforms will further empower individual communicative capabilities, moving beyond the era of the “magic bullet” theory. The distinction between being a recipient and a transmitter of information is increasingly blurred. In an era where everyone is both an audience and an influencer, research confined to the role of the ‘recipient’ falls short of addressing the dynamics of ‘transmission’. Future research in marketing and advertising should thus focus more on the power of individual transmission. Furthermore, as Marshall McLuhan famously said, “the medium is the extension of man.” The evolution of media technology remains human-centric. Accordingly, future marketing research, while paying heed to media transformations, should emphasize the centrality of the ‘human’ element.

Data availability

The datasets generated and/or analyzed during the current study are not publicly available due to privacy issues. Making the full data set publicly available could potentially breach the privacy that was promised to participants when they agreed to take part, and may breach the ethics approval for the study. The data are available from the corresponding author on reasonable request.

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Acknowledgements

The authors thank all the participants of this study. The participants were all informed about the purpose and content of the study and voluntarily agreed to participate. The participants were able to stop participating at any time without penalty. Funding for this study was provided by Minjiang University Research Start-up Funds (No. 324-32404314).

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Conceptualization: CG; methodology: CG and QD; software: CG and QD; validation: CG; formal analysis: CG and QD; investigation: CG and QD; resources: CG; data curation: CG and QD; writing—original draft preparation: CG; writing—review and editing: CG; visualization: CG; project administration: CG. All authors have read and agreed to the published version of the manuscript.

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Correspondence to Chenyu Gu .

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• Published: 13 May 2024

Sexual and reproductive health implementation research in humanitarian contexts: a scoping review

• Alexandra Norton 1 &
• Hannah Tappis 2  

Reproductive Health volume  21 , Article number:  64 ( 2024 ) Cite this article

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Meeting the health needs of crisis-affected populations is a growing challenge, with 339 million people globally in need of humanitarian assistance in 2023. Given one in four people living in humanitarian contexts are women and girls of reproductive age, sexual and reproductive health care is considered as essential health service and minimum standard for humanitarian response. Despite growing calls for increased investment in implementation research in humanitarian settings, guidance on appropriate methods and analytical frameworks is limited.

A scoping review was conducted to examine the extent to which implementation research frameworks have been used to evaluate sexual and reproductive health interventions in humanitarian settings. Peer-reviewed papers published from 2013 to 2022 were identified through relevant systematic reviews and a literature search of Pubmed, Embase, PsycInfo, CINAHL and Global Health databases. Papers that presented primary quantitative or qualitative data pertaining to a sexual and reproductive health intervention in a humanitarian setting were included.

Seven thousand thirty-six unique records were screened for inclusion, and 69 papers met inclusion criteria. Of these, six papers explicitly described the use of an implementation research framework, three citing use of the Consolidated Framework for Implementation Research. Three additional papers referenced other types of frameworks used in their evaluation. Factors cited across all included studies as helping the intervention in their presence or hindering in their absence were synthesized into the following Consolidated Framework for Implementation Research domains: Characteristics of Systems, Outer Setting, Inner Setting, Characteristics of Individuals, Intervention Characteristics, and Process.

This review found a wide range of methodologies and only six of 69 studies using an implementation research framework, highlighting an opportunity for standardization to better inform the evidence for and delivery of sexual and reproductive health interventions in humanitarian settings. Increased use of implementation research frameworks such as a modified Consolidated Framework for Implementation Research could work toward both expanding the evidence base and increasing standardization.

Plain English summary

Three hundred thirty-nine million people globally were in need of humanitarian assistance in 2023, and meeting the health needs of crisis-affected populations is a growing challenge. One in four people living in humanitarian contexts are women and girls of reproductive age, and provision of sexual and reproductive health care is considered to be essential within a humanitarian response. Implementation research can help to better understand how real-world contexts affect health improvement efforts. Despite growing calls for increased investment in implementation research in humanitarian settings, guidance on how best to do so is limited. This scoping review was conducted to examine the extent to which implementation research frameworks have been used to evaluate sexual and reproductive health interventions in humanitarian settings. Of 69 papers that met inclusion criteria for the review, six of them explicitly described the use of an implementation research framework. Three used the Consolidated Framework for Implementation Research, a theory-based framework that can guide implementation research. Three additional papers referenced other types of frameworks used in their evaluation. This review summarizes how factors relevant to different aspects of implementation within the included papers could have been organized using the Consolidated Framework for Implementation Research. The findings from this review highlight an opportunity for standardization to better inform the evidence for and delivery of sexual and reproductive health interventions in humanitarian settings. Increased use of implementation research frameworks such as a modified Consolidated Framework for Implementation Research could work toward both expanding the evidence base and increasing standardization.

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Over the past few decades, the field of public health implementation research (IR) has grown as a means by which the real-world conditions affecting health improvement efforts can be better understood. Peters et al. put forward the following broad definition of IR for health: “IR is the scientific inquiry into questions concerning implementation – the act of carrying an intention into effect, which in health research can be policies, programmes, or individual practices (collectively called interventions)” [ 1 ].

As IR emphasizes real-world circumstances, the context within which a health intervention is delivered is a core consideration. However, much IR implemented to date has focused on higher-resource settings, with many proposed frameworks developed with particular utility for a higher-income setting [ 2 ]. In recognition of IR’s potential to increase evidence across a range of settings, there have been numerous reviews of the use of IR in lower-resource settings as well as calls for broader use [ 3 , 4 ]. There have also been more focused efforts to modify various approaches and frameworks to strengthen the relevance of IR to low- and middle-income country settings (LMICs), such as the work by Means et al. to adapt a specific IR framework for increased utility in LMICs [ 2 ].

Within LMIC settings, the centrality of context to a health intervention’s impact is of particular relevance in humanitarian settings, which present a set of distinct implementation challenges [ 5 ]. Humanitarian responses to crisis situations operate with limited resources, under potential security concerns, and often under pressure to relieve acute suffering and need [ 6 ]. Given these factors, successful implementation of a particular health intervention may require different qualities than those that optimize intervention impact under more stable circumstances [ 7 ]. Despite increasing recognition of the need for expanded evidence of health interventions in humanitarian settings, the evidence base remains limited [ 8 ]. Furthermore, despite its potential utility, there is not standardized guidance on IR in humanitarian settings, nor are there widely endorsed recommendations for the frameworks best suited to analyze implementation in these settings.

Sexual and reproductive health (SRH) is a core aspect of the health sector response in humanitarian settings [ 9 ]. Yet, progress in addressing SRH needs has lagged far behind other services because of challenges related to culture and ideology, financing constraints, lack of data and competing priorities [ 10 ]. The Minimum Initial Service Package (MISP) for SRH in Crisis Situations is the international standard for the minimum set of SRH services that should be implemented in all crisis situations [ 11 ]. However, as in other areas of health, there is need for expanded evidence for planning and implementation of SRH interventions in humanitarian settings. Recent systematic reviews of SRH in humanitarian settings have focused on the effectiveness of interventions and service delivery strategies, as well as factors affecting utilization, but have not detailed whether IR frameworks were used [ 12 , 13 , 14 , 15 ]. There have also been recent reviews examining IR frameworks used in various settings and research areas, but none have explicitly focused on humanitarian settings [ 2 , 16 ].

Given the need for an expanded evidence base for SRH interventions in humanitarian settings and the potential for IR to be used to expand the available evidence, a scoping review was undertaken. This scoping review sought to identify IR approaches that have been used in the last ten years to evaluate SRH interventions in humanitarian settings.

This review also sought to shed light on whether there is a need for a common framework to guide research design, analysis, and reporting for SRH interventions in humanitarian settings and if so, if there are any established frameworks already in use that would be fit-for-purpose or could be tailored to meet this need.

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews was utilized to guide the elements of this review [ 17 ]. The review protocol was retrospectively registered with the Open Science Framework ( https://osf.io/b5qtz ).

Search strategy

A two-fold search strategy was undertaken for this review, which covered the last 10 years (2013–2022). First, recent systematic reviews pertaining to research or evaluation of SRH interventions in humanitarian settings were identified through keyword searches on PubMed and Google Scholar. Four relevant systematic reviews were identified [ 12 , 13 , 14 , 15 ] Table 1 .

Second, a literature search mirroring these reviews was conducted to identify relevant papers published since the completion of searches for the most recent review (April 2017). Additional file 1 includes the search terms that were used in the literature search [see Additional file 1 ].

The literature search was conducted for papers published from April 2017 to December 2022 in the databases that were searched in one or more of the systematic reviews: PubMed, Embase, PsycInfo, CINAHL and Global Health. Searches were completed in January 2023 Table 2 .

Two reviewers screened each identified study for alignment with inclusion criteria. Studies in the four systematic reviews identified were considered potentially eligible if published during the last 10 years. These papers then underwent full-text review to confirm satisfaction of all inclusion criteria, as inclusion criteria were similar but not fully aligned across the four reviews.

Literature search results were exported into a citation manager (Covidence), duplicates were removed, and a step-wise screening process for inclusion was applied. First, all papers underwent title and abstract screening. The remaining papers after abstract screening then underwent full-text review to confirm satisfaction of all inclusion criteria. Title and abstract screening as well as full-text review was conducted independently by both authors; disagreements after full-text review were resolved by consensus.

Data extraction and synthesis

The following content areas were summarized in Microsoft Excel for each paper that met inclusion criteria: publication details including author, year, country, setting [rural, urban, camp, settlement], population [refugees, internally displaced persons, general crisis-affected], crisis type [armed conflict, natural disaster], crisis stage [acute, chronic], study design, research methods, SRH intervention, and intervention target population [specific beneficiaries of the intervention within the broader population]; the use of an IR framework; details regarding the IR framework, how it was used, and any rationale given for the framework used; factors cited as impacting SRH interventions, either positively or negatively; and other key findings deemed relevant to this review.

As the focus of this review was on the approach taken for SRH intervention research and evaluation, the quality of the studies themselves was not assessed.

Twenty papers underwent full-text review due to their inclusion in one or more of the four systematic reviews and meeting publication date inclusion criteria. The literature search identified 7,016 unique papers. After full-text screening, 69 met all inclusion criteria and were included in the review. Figure  1 illustrates the search strategy and screening process.

Flow chart of paper identification

Papers published in each of the 10 years of the review timeframe (2013–2022) were included. 29% of the papers originated from the first five years of the time frame considered for this review, with the remaining 71% papers coming from the second half. Characteristics of included publications, including geographic location, type of humanitarian crisis, and type of SRH intervention, are presented in Table  3 .

A wide range of study designs and methods were used across the papers, with both qualitative and quantitative studies well represented. Twenty-six papers were quantitative evaluations [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 ], 17 were qualitative [ 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 ], and 26 used mixed methods [ 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 ]. Within the quantitative evaluations, 15 were observational, while five were quasi-experimental, five were randomized controlled trials, and one was an economic evaluation. Study designs as classified by the authors of this review are summarized in Table  4 .

Six papers (9%) explicitly cited use of an IR framework. Three of these papers utilized the Consolidated Framework for Implementation Research (CFIR) [ 51 , 65 , 70 ]. The CFIR is a commonly used determinant framework that—in its originally proposed form in 2009—is comprised of five domains, each of which has constructs to further categorize factors that impact implementation. The CFIR domains were identified as core content areas influencing the effectiveness of implementation, and the constructs within each domain are intended to provide a range of options for researchers to select from to “guide diagnostic assessments of implementation context, evaluate implementation progress, and help explain findings.” [ 87 ] To allow for consistent terminology throughout this review, the original 2009 CFIR domains and constructs are used.

Guan et al. conducted a mixed methods study to assess the feasibility and effectiveness of a neonatal hepatitis B immunization program in a conflict-affected rural region of Myanmar. Guan et al. report mapping data onto the CFIR as a secondary analysis step. They describe that “CFIR was used as a comprehensive meta-theoretical framework to examine the implementation of the Hepatitis B Virus vaccination program,” and implementation themes from multiple study data sources (interviews, observations, examination of monitoring materials) were mapped onto CFIR constructs. They report their results in two phases – Pre-implementation training and community education, and Implementation – with both anchored in themes that they had mapped onto CFIR domains and constructs. All but six constructs were included in their analysis, with a majority summarized in a table and key themes explored further in the narrative text. They specify that most concerns were identified within the Outer Setting and Process domains, while elements identified within the Inner Setting domain provided strength to the intervention and helped mitigate against barriers [ 70 ].

Sarker et al. conducted a qualitative study to assess provision of maternal, newborn and child health services to Rohingya refugees residing in camps in Cox’s Bazar, Bangladesh. They cite using CFIR as a guide for thematic analysis, applying it after a process of inductive and deductive coding to index these codes into the CFIR domains. They utilized three of the five CFIR domains (Outer Setting, Inner Setting, and Process), stating that the remaining two domains (Intervention Characteristics and Characteristics of Individuals) were not relevant to their analysis. They then proposed two additional CFIR domains, Context and Security, for use in humanitarian contexts. In contrast to Guan et al., CFIR constructs are not used nor mentioned by Sarker et al., with content under each domain instead synthesized as challenges and potential solutions. Regarding the CFIR, Sarker et al. write, “The CFIR guided us for interpretative coding and creating the challenges and possible solutions into groups for further clarification of the issues related to program delivery in a humanitarian crisis setting.” [ 51 ]

Sami et al. conducted a mixed methods case study to assess the implementation of a package of neonatal interventions at health facilities within refugee and internally displaced persons camps in South Sudan. They reference use of the CFIR earlier in the study than Sarker et al., basing their guides for semi-structured focus group discussions on the CFIR framework. They similarly reference a general use of the CFIR framework as they conducted thematic analysis. Constructs are referenced once, but they do not specify whether their application of the CFIR framework included use of domains, constructs, or both. This may be in part because they then applied an additional framework, the World Health Organization (WHO) Health System Framework, to present their findings. They describe a nested approach to their use of these frameworks: “Exploring these [CFIR] constructs within the WHO Health Systems Framework can identify specific entry points to improve the implementation of newborn interventions at critical health system building blocks.” [ 65 ]

Three papers cite use of different IR frameworks. Bolan et al. utilized the Theoretical Domains Framework in their mixed methods feasibility study and pilot cluster randomized trial evaluating pilot use of the Safe Delivery App by maternal and newborn health workers providing basic emergency obstetric and newborn care in facilities in the conflict-affected Maniema province of the Democratic Republic of the Congo (DRC). They used the Theroetical Domains Framework in designing interview questions, and further used it as the coding framework for their analysis. Similar to the CFIR, the Theoretical Domains Framework is a determinant framework that consists of domains, each of which then includes constructs. Bolan et al. utilized the Theoretical Domains Framework at the construct level in interview question development and at the domain level in their analysis, mapping interview responses to eight of the 14 domains [ 83 ]. Berg et al. report using an “exploratory design guided by the principles of an evaluation framework” developed by the Medical Research Council to analyze the implementation process, mechanisms of impact, and outcomes of a three-pillar training intervention to improve maternal and neonatal healthcare in the conflict-affected South Kivu province of the DRC [ 67 , 88 ]. Select components of this evaluation framework were used to guide deductive analysis of focus group discussions and in-depth interviews [ 67 ]. In their study of health workers’ knowledge and attitudes toward newborn health interventions in South Sudan, before and after training and supply provision, Sami et al. report use of the Conceptual Framework of the Role of Attitudes in Evidence-Based Practice Implementation in their analysis process. The framework was used to group codes following initial inductive coding analysis of in-depth interviews [ 72 ].

Three other papers cite use of specific frameworks in their intervention evaluation [ 19 , 44 , 76 ]. As a characteristic of IR is the use of an explicit framework to guide the research, the use of the frameworks in these three papers meets the intention of IR and serves the purpose that an IR framework would have in strengthening the analytical rigor. Castle et al. cite use of their program’s theory of change as a framework for a mixed methods evaluation of the provision of family planning services and more specifically uptake of long-acting reversible contraception use in the DRC. They describe use of the theory of change to “enhance effectiveness of [long-acting reversible contraception] access and uptake.” [ 76 ] Thommesen et al. cite use of the AAAQ (Availability, Accessibility, Acceptability and Quality) framework in their qualitative study assessing midwifery services provided to pregnant women in Afghanistan. This framework is focused on the “underlying elements needed for attainment of optimum standard of health care,” but the authors used it in this paper to evaluate facilitators and barriers to women accessing midwifery services [ 44 ]. Jarrett et al. cite use of the Centers for Disease Control and Prevention’s (CDC) Guidelines for Evaluating Public Health Surveillance Systems to explore the characteristics of a population mobility, mortality and birth surveillance system in South Kivu, DRC. Use of these CDC guidelines is cited as one of four study objectives, and commentary is included in the Results section pertaining to each criteria within these guidelines, although more detail regarding use of these guidelines or the authors’ experience with their use in the study is not provided [ 19 ].

Overall, 22 of the 69 papers either explicitly or implicitly identified IR as relevant to their work. Nineteen papers include a focus on feasibility (seven of which did not otherwise identify the importance of exploring questions concerning implementation), touching on a common outcome of interest in implementation research [ 89 ].

While a majority of papers did not explicitly or implicitly use an IR framework to evaluate their SRH intervention of focus, most identified factors that facilitated implementation when they were present or served as a barrier when absent. Sixty cite factors that served as facilitators and 49 cite factors that served as barriers, with just three not citing either. Fifty-nine distinct factors were identified across the papers.

Three of the six studies that explicitly used an IR framework used the CFIR, and the CFIR is the only IR framework that was used by multiple studies. As previously mentioned, Means et al. put forth an adaptation of the CFIR to increase its relevance in LMIC settings, proposing a sixth domain (Characteristics of Systems) and 11 additional constructs [ 2 ]. Using the expanded domains and constructs as proposed by Means et al., the 59 factors cited by papers in this review were thematically grouped into the six domains: Characteristics of Systems, Outer Setting, Inner Setting, Characteristics of Individuals, Intervention Characteristics, and Process. Within each domain, alignment with CFIR constructs was assessed for, and alignment was found with 29 constructs: eight of Means et al.’s 11 constructs, and 21 of the 39 standard CFIR constructs. Three factors did not align with any construct (all fitting within the Outer Setting domain), and 14 aligned with a construct label but not the associated definition. Table 5 synthesizes the mapping of factors affecting SRH intervention implementation to CFIR domains and constructs, with the construct appearing in italics if it is considered to align with that factor by label but not by definition.

Table 6 lists the CFIR constructs that were not found to have alignment with any factor cited by the papers in this review.

This scoping review sought to assess how IR frameworks have been used to bolster the evidence base for SRH interventions in humanitarian settings, and it revealed that IR frameworks, or an explicit IR approach, are rarely used. All four of the systematic reviews identified with a focus on SRH in humanitarian settings articulate the need for more research examining the effectiveness of SRH interventions in humanitarian settings, with two specifically citing a need for implementation research/science [ 12 , 13 ]. The distribution of papers across the timeframe included in this review does suggest that more research on SRH interventions for crisis-affected populations is taking place, as a majority of relevant papers were published in the second half of the review period. The papers included a wide range of methodologies, which reflect the differing research questions and contexts being evaluated. However, it also invites the question of whether there should be more standardization of outcomes measured or frameworks used to guide analysis and to facilitate increased comparison, synthesis and application across settings.

Three of the six papers that used an IR framework utilized the CFIR. Guan et al. used the CFIR at both a domain and construct level, Sarker et al. used the CFIR at the domain level, and Sami et al. did not specify which CFIR elements were used in informing the focus group discussion guide [ 51 , 65 , 70 ]. It is challenging to draw strong conclusions about the applicability of CFIR in humanitarian settings based on the minimal use of CFIR and IR frameworks within the papers reviewed, although Guan et al. provides a helpful model for how analysis can be structured around CFIR domains and constructs. It is worth considering that the minimal use of IR frameworks, and more specifically CFIR constructs, could be in part because that level of prescriptive categorization does not allow for enough fluidity in humanitarian settings. It also raises questions about the appropriate degree of standardization to pursue for research done in these settings.

The mapping of factors affecting SRH intervention implementation provides an example of how a modified CFIR framework could be used for IR in humanitarian contexts. This mapping exercise found factors that mapped to all five of the original CFIR domains as well as the sixth domain proposed by Means et al. All factors fit well within the definition for the selected domain, indicating an appropriate degree of fit between these existing domains and the factors identified as impacting SRH interventions in humanitarian settings. On a construct level, however, the findings were more variable, with one-quarter of factors not fully aligning with any construct. Furthermore, over 40% of the CFIR constructs (including the additional constructs from Means et al.) were not found to align with any factors cited by the papers in this review, also demonstrating some disconnect between the parameters posed by the CFIR constructs and the factors cited as relevant in a humanitarian context.

It is worth noting that while the CFIR as proposed in 2009 was used in this assessment, as well as in the included papers which used the CFIR, an update was published in 2022. Following a review of CFIR use since its publication, the authors provide updates to construct names and definitions to “make the framework more applicable across a range of innovations and settings.” New constructs and subconstructs were also added, for a total of 48 constructs and 19 subconstructs across the five domains [ 90 ]. A CFIR Outcomes Addendum was also published in 2022, based on recommendations for the CFIR to add outcomes and intended to be used as a complement to the CFIR determinants framework [ 91 ]. These expansions to the CFIR framework may improve applicability of the CFIR in humanitarian settings. Several constructs added to the Outer Setting domain could be of particular utility – critical incidents, local attitudes, and local conditions, each of which could help account for unique challenges faced in contexts of crisis. Sub-constructs added within the Inner Setting domain that seek to clarify structural characteristics and available resources would also be of high utility based on mapping of the factors identified in this review to the original CFIR constructs. As outcomes were not formally included in the CFIR until the 2022 addendum, a separate assessment of implementation outcomes was not undertaken in this review. However, analysis of the factors cited by papers in this review as affecting implementation was derived from the full text of the papers and thus captures content relevant to implementation determinants that is contained within the outcomes.

Given the demonstrated need for additional flexibility within an IR framework for humanitarian contexts, while not a focus of this review, it is worth considering whether a different framework could provide a better fit than the CFIR. Other frameworks have differing points of emphasis that would create different opportunities for flexibility but that do not seem to resolve the challenges experienced in applying the CFIR to a humanitarian context. As one example, the EPIS (Exploration, Preparation, Implementation, Sustainment) Framework considers the impact of inner and outer context on each of four implementation phases; while the constructs within this framework are broader than the CFIR, an emphasis on the intervention characteristics is missing, a domain where stronger alignment within the CFIR is also needed [ 92 ]. Alternatively, the PRISM (Practical, Robust Implementation and Sustainability Model) framework is a determinant and evaluation framework that adds consideration of context factors to the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) outcomes framework. It has a stronger emphasis on intervention aspects, with sub-domains to account for both organization and patient perspectives within the intervention. While PRISM does include aspects of context, external environment considerations are less robust and intentionally less comprehensive in scope, which would not provide the degree of alignment possible between the Characteristics of Systems and Outer Setting CFIR domains for the considerations unique to humanitarian environments [ 93 ].

Reflecting on their experience with the CFIR, Sarker et al. indicate that it can be a “great asset” in both evaluating current work and developing future interventions. They also encourage future research of humanitarian health interventions to utilize the CFIR [ 51 ]. The other papers that used the CFIR do not specifically reflect on their experience utilizing it, referring more generally to having felt that it was a useful tool [ 65 , 70 ]. On their use of an evaluation framework, Berg et al. reflected that it lent useful structure and helped to identify aspects affecting implementation that otherwise would have gone un-noticed [ 67 ]. The remaining studies that utilized an IR framework did not specifically comment on their experience with its use [ 72 , 83 ]. While a formal IR framework was not engaged by other studies, a number cite a desire for IR to contribute further detail to their findings [ 21 , 37 ].

In their recommendations for strengthening the evidence base for humanitarian health interventions, Ager et al. speak to the need for “methodologic innovation” to develop methodologies with particular applicability in humanitarian settings [ 7 ]. As IR is not yet routinized for SRH interventions, this could be opportune timing for the use of a standardized IR framework to gauge its utility. Using an IR framework to assess factors influencing implementation of the MISP in initial stages of a humanitarian response, and interventions to support more comprehensive SRH service delivery in protracted crises, could lend further rigor and standardization to SRH evaluations, as well as inform strategies to improve MISP implementation over time. Based on categorizing factors identified by these papers as relevant for intervention evaluation, there does seem to be utility to a modified CFIR approach. Given the paucity of formal IR framework use within SRH literature, it would be worth conducting similar scoping exercises to assess for explicit use of IR frameworks within the evidence base for other health service delivery areas in humanitarian settings. In the interim, the recommended approach from this review for future IR on humanitarian health interventions would be a modified CFIR approach with domain-level standardization and flexibility for constructs that may standardize over time with more use. This would enable use of a common analytical framework and vocabulary at the domain level for stakeholders to describe interventions and the factors influencing the effectiveness of implementation, with constructs available to use and customize as most appropriate for specific contexts and interventions.

This review had a number of limitations. As this was a scoping review and a two-part search strategy was used, the papers summarized here may not be comprehensive of those written pertaining to SRH interventions over the past 10 years. Papers from 2013 to 2017 that would have met this scoping review’s inclusion criteria may have been omitted due to being excluded from the systematic reviews. The review was limited to papers available in English. Furthermore, this review did not assess the quality of the papers included or seek to assess the methodology used beyond examination of the use of an IR framework. It does, however, serve as a first step in assessing the extent to which calls for implementation research have been addressed, and identify entry points for strengthening the science and practice of SRH research in humanitarian settings.

With one in 23 people worldwide in need of humanitarian assistance, and financing required for response plans at an all-time high, the need for evidence to guide resource allocation and programming for SRH in humanitarian settings is as important as ever [ 94 ]. Recent research agenda setting initiatives and strategies to advance health in humanitarian settings call for increased investment in implementation research—with priorities ranging from research on effective strategies for expanding access to a full range of contraceptive options to integrating mental health and psychosocial support into SRH programming to capturing accurate and actionable data on maternal and perinatal mortality in a wide range of acute and protracted emergency contexts [ 95 , 96 ]. To truly advance guidance in these areas, implementation research will need to be conducted across diverse humanitarian settings, with clear and consistent documentation of both intervention characteristics and outcomes, as well as contextual and programmatic factors affecting implementation.

Conclusions

Implementation research has potential to increase impact of health interventions particularly in crisis-affected settings where flexibility, adaptability and context-responsive approaches are highlighted as cornerstones of effective programming. There remains significant opportunity for standardization of research in the humanitarian space, with one such opportunity occurring through increased utilization of IR frameworks such as a modified CFIR approach. Investing in more robust sexual and reproductive health research in humanitarian contexts can enrich insights available to guide programming and increase transferability of learning across settings.

Availability of data and materials

The datasets analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

Availability, Accessibility, Acceptability and Quality

Centers for Disease Control and Prevention

Consolidated Framework for Implementation Research

Democratic Republic of the Congo

Exploration, Preparation, Implementation, Sustainment

• Implementation research

Low and middle income country

Minimum Initial Service Package

Practical, Robust Implementation and Sustainability Model

Preferred Reporting Items for Systematic Reviews and Meta-Analyses

Reach, Effectiveness, Adoption, Implementation, Maintenance

• Sexual and reproductive health

World Health Organization

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Research Frameworks: Critical Components for Reporting Qualitative Health Care Research

Qualitative health care research can provide insights into health care practices that quantitative studies cannot. However, the potential of qualitative research to improve health care is undermined by reporting that does not explain or justify the research questions and design. The vital role of research frameworks for designing and conducting quality research is widely accepted, but despite many articles and books on the topic, confusion persists about what constitutes an adequate underpinning framework, what to call it, and how to use one. This editorial clarifies some of the terminology and reinforces why research frameworks are essential for good-quality reporting of all research, especially qualitative research.

Qualitative research provides valuable insights into health care interactions and decision-making processes – for example, why and how a clinician may ignore prevailing evidence and continue making clinical decisions the way they always have. 1 The perception of qualitative health care research has improved since a 2016 article by Greenhalgh et al. highlighted the higher contributions and citation rates of qualitative research than those of contemporaneous quantitative research. 2 The Greenhalgh et al. article was subsequently supported by an open letter from 76 senior academics spanning 11 countries to the editors of the British Medical Journal . 3 Despite greater recognition and acceptance, qualitative research continues to have an “uneasy relationship with theory,” 4 which contributes to poor reporting.

As an editor for the Journal of Patient-Centered Research and Reviews , as well as Human Resources for Health , I have seen several exemplary qualitative articles with clear and coherent reporting. On the other hand, I have often been concerned by a lack of rigorous reporting, which may reflect and reinforce the outdated perception of qualitative research as the “soft option.” 5 Qualitative research is more than conducting a few semi-structured interviews, transcribing the audio recordings verbatim, coding the transcripts, and developing and reporting themes, including a few quotes. Qualitative research that benefits health care is time-consuming and labor-intensive, requires robust design, and is rooted in theory, along with comprehensive reporting. 6

What Is “Theory”?

So fundamental is theory to qualitative research that I initially toyed with titling this editorial, “ Theory: the missing link in qualitative health care research articles ,” before deeming that focus too broad. As far back as 1967, Merton 6 warned that “the word theory threatens to become meaningless.” While it cannot be overstated that “atheoretical” studies lack the underlying logic that justifies researchers’ design choices, the word theory is so overused that it is difficult to understand what constitutes an adequate theoretical foundation and what to call it.

Theory, as used in the term theoretical foundation , refers to the existing body of knowledge. 7 , 8 The existing body of knowledge consists of more than formal theories , with their explanatory and predictive characteristics, so theory implies more than just theories . Box 1 9 – 12 defines the “building blocks of formal theories.” 9 Theorizing or theory-building starts with concepts at the most concrete, experiential level, becoming progressively more abstract until a higher-level theory is developed that explains the relationships between the building blocks. 9 Grand theories are broad, representing the most abstract level of theorizing. Middle-range and explanatory theories are progressively less abstract, more specific to particular phenomena or cases (middle-range) or variables (explanatory), and testable.

The Building Blocks of Formal Theories 9

The importance of research frameworks.

Researchers may draw on several elements to frame their research. Generally, a framework is regarded as “a set of ideas that you use when you are forming your decisions and judgements” 13 or “a system of rules, ideas, or beliefs that is used to plan or decide something.” 14 Research frameworks may consist of a single formal theory or part thereof, any combination of several theories or relevant constructs from different theories, models (as simplified representations of formal theories), concepts from the literature and researchers’ experiences.

Although Merriam 15 was of the view that every study has a framework, whether explicit or not, there are advantages to using an explicit framework. Research frameworks map “the territory being investigated,” 8 thus helping researchers to be explicit about what informed their research design, from developing research questions and choosing appropriate methods to data analysis and interpretation. Using a framework makes research findings more meaningful 12 and promotes generalizability by situating the study and interpreting data in more general terms than the study itself. 16

Theoretical and Conceptual Frameworks

The variation in how the terms theoretical and conceptual frameworks are used may be confusing. Some researchers refer to only theoretical frameworks 17 , 18 or conceptual frameworks, 19 – 21 while others use the terms interchangeably. 7 Other researchers distinguish between the two. For example, Miles, Huberman & Saldana 8 see theoretical frameworks as based on formal theories and conceptual frameworks derived inductively from locally relevant concepts and variables, although they may include theoretical aspects. Conversely, some researchers believe that theoretical frameworks include formal theories and concepts. 18 Others argue that any differences between the two types of frameworks are semantic and, instead, emphasize using a research framework to provide coherence across the research questions, methods and interpretation of the results, irrespective of what that framework is called.

Like Ravitch and Riggan, 22 I regard conceptual frameworks (CFs) as the broader term. Including researchers’ perspectives and experiences in CFs provides valuable sources of originality. Novel perspectives guard against research repeating what has already been stated. 23 The term theoretical framework (TF) may be appropriate where formal published and identifiable theories or parts of such theories are used. 24 However, existing formal theories alone may not provide the current state of relevant concepts essential to understanding the motivation for and logic underlying a study. Some researchers may argue that relevant concepts may be covered in the literature review, but what is the point of literature reviews and prior findings unless authors connect them to the research questions and design? Indeed, Sutton & Straw 25 exclude literature reviews and lists of prior findings as an adequate foundation for a study, along with individual lists of variables or constructs (even when the constructs are defined), predictions or hypotheses, and diagrams that do not propose relationships. One or more of these aspects could be used in a research framework (eg, in a TF), and the literature review could (and should) focus on the theories or parts of theories (constructs), offer some critique of the theory and point out how they intend to use the theory. This would be more meaningful than merely describing the theory as the “background” to the study, without explicitly stating why and how it is being used. Similarly, a CF may include a discussion of the theories being used (basically, a TF) and a literature review of the current understanding of any relevant concepts that are not regarded as formal theory.

It may be helpful for authors to specify whether they are using a theoretical or a conceptual framework, but more importantly, authors should make explicit how they constructed and used their research framework. Some studies start with research frameworks of one type and end up with another type, 8 , 22 underscoring the need for authors to clarify the type of framework used and how it informed their research. Accepting the sheer complexity surrounding research frameworks and lamenting the difficulty of reducing the confusion around these terms, Box 2 26 – 31 and Box 3 offer examples highlighting the fundamental elements of theoretical and conceptual frameworks while acknowledging that they share a common purpose.

Examples of How Theoretical Frameworks May Be Used

Examples of how conceptual frameworks may be used, misconceptions about qualitative research.

Qualitative research’s “uneasy relationship with theory” 4 may be due to several misconceptions. One possible misconception is that qualitative research aims to build theory and thus does not need theoretical grounding. The reality is that all qualitative research methods, not just Grounded Theory studies focused on theory building, may lead to theory construction. 16 Similarly, all types of qualitative research, including Grounded Theory studies, should be guided by research frameworks. 16

Not using a research framework may also be due to misconceptions that qualitative research aims to understand people’s perspectives and experiences without examining them from a particular theoretical perspective or that theoretical foundations may influence researchers’ interpretations of participants’ meanings. In fact, in the same way that participants’ meanings vary, qualitative researchers’ interpretations (as opposed to descriptions) of participants’ meaning-making will differ. 32 , 33 Research frameworks thus provide a frame of reference for “making sense of the data.” 34

Studies informed by well-defined research frameworks can make a world of difference in alleviating misconceptions. Good qualitative reporting requires research frameworks that make explicit the combination of relevant theories, theoretical constructs and concepts that will permeate every aspect of the research. Irrespective of the term used, research frameworks are critical components of reporting not only qualitative but also all types of research.

Acknowledgments

In memory of Martie Sanders: supervisor, mentor, and colleague. My deepest gratitude for your unfailing support and guidance. I feel your loss.

Conflicts of Interest: None.

Cultural Relativity and Acceptance of Embryonic Stem Cell Research

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

INTRODUCTION

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

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

I.     Global Cultural Perspective of Embryonic Stem Cells

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

a.     US and Rights-Based Cultures

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

b.     Ubuntu and Collective Cultures

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

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

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

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

c.     Asia

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

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

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

d.     Middle East

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

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

e.     Europe

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

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

II.     Religious Perspectives on ESC

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

The Qur'an states:

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

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

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

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

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

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

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

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

III.     A Flexible Ethical Approach

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

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

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

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

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

IV.     Concerns

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Mifrah Hayath

SM Candidate Harvard Medical School, MS Biotechnology Johns Hopkins University

Olivia Bowers

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

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William Lawrence Tower’s Beetles: Experimental Evolution and the Manipulation of Inheritance

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William Lawrence Tower’s work on the evolution of the Colorado Potato Beetle ( Leptinotarsa decemlineata ), documenting the environmental induction of mutation and speciation, made him a leading figure in experimental genetics during the first decade of the 20th century. His research program served as a model for other experimental evolution studies seeking to demonstrate the environmental modification of inheritance. Tower enjoyed the support of influential figures in the field, despite well-known problems that plagued Tower’s earlier academic career. The validity of his genetic work, and other findings reported by Tower, were later challenged. The Tower affair illustrates how questionable and possibly fraudulent scientific practices can be tolerated to explore certain experimental directions and theoretical frameworks, particularly at the frontier of expanding disciplines. When needed, those explorations can be forestalled or extinguished by exploiting conspicuous vulnerabilities of rogue practitioners. In Tower’s case, both unrefuted allegations of scientific misconduct and personal problems dissolved his institutional support, leading to a swift ouster from academic science. Tower’s downfall discredited soft inheritance and neo-Lamarckian conceptions in the field of experimental genetics, facilitating the discipline’s embrace of a hard inheritance model that featured a hereditary material resistant to environmental modification.

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I am grateful to Garland Allen, Janet Browne, Alex Csiszar, Brendan Kosztyo, Melissa Richards, Morgan Richards, Alexander Sopilniak Mints, and members of Harvard University’s Modern Science Working Group and Cornell University’s Science Studies Reading Group for their suggestions and comments on different versions of the manuscript. I wish to express my gratitude to Maggie Drain and John Strom for their help accessing materials within the Carnegie Institution of Washington archive. I also am grateful for the assistance of Diane M. Rielinger at the Marine Biological Laboratory archive, as well as that of Scott Sanders at the Antioch College archive. Special thanks to Nathaniel Comfort for sharing unpublished work, and to the two anonymous reviewers whose comments and suggestions greatly strengthened this paper.

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Richards, E.J. William Lawrence Tower’s Beetles: Experimental Evolution and the Manipulation of Inheritance. J Hist Biol (2024). https://doi.org/10.1007/s10739-024-09771-x

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