recommendations and limitations in research

How to present limitations in research

Last updated

30 January 2024

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Limitations don’t invalidate or diminish your results, but it’s best to acknowledge them. This will enable you to address any questions your study failed to answer because of them.

In this guide, learn how to recognize, present, and overcome limitations in research.

• What is a research limitation?

Research limitations are weaknesses in your research design or execution that may have impacted outcomes and conclusions. Uncovering limitations doesn’t necessarily indicate poor research design—it just means you encountered challenges you couldn’t have anticipated that limited your research efforts.

Does basic research have limitations?

Basic research aims to provide more information about your research topic. It requires the same standard research methodology and data collection efforts as any other research type, and it can also have limitations.

• Common research limitations

Researchers encounter common limitations when embarking on a study. Limitations can occur in relation to the methods you apply or the research process you design. They could also be connected to you as the researcher.

Methodology limitations

Not having access to data or reliable information can impact the methods used to facilitate your research. A lack of data or reliability may limit the parameters of your study area and the extent of your exploration.

Your sample size may also be affected because you won’t have any direction on how big or small it should be and who or what you should include. Having too few participants won’t adequately represent the population or groups of people needed to draw meaningful conclusions.

Research process limitations

The study’s design can impose constraints on the process. For example, as you’re conducting the research, issues may arise that don’t conform to the data collection methodology you developed. You may not realize until well into the process that you should have incorporated more specific questions or comprehensive experiments to generate the data you need to have confidence in your results.

Constraints on resources can also have an impact. Being limited on participants or participation incentives may limit your sample sizes. Insufficient tools, equipment, and materials to conduct a thorough study may also be a factor.

Common researcher limitations

Here are some of the common researcher limitations you may encounter:

Time: some research areas require multi-year longitudinal approaches, but you might not be able to dedicate that much time. Imagine you want to measure how much memory a person loses as they age. This may involve conducting multiple tests on a sample of participants over 20–30 years, which may be impossible.

Bias: researchers can consciously or unconsciously apply bias to their research. Biases can contribute to relying on research sources and methodologies that will only support your beliefs about the research you’re embarking on. You might also omit relevant issues or participants from the scope of your study because of your biases.

Limited access to data : you may need to pay to access specific databases or journals that would be helpful to your research process. You might also need to gain information from certain people or organizations but have limited access to them. These cases require readjusting your process and explaining why your findings are still reliable.

• Why is it important to identify limitations?

Identifying limitations adds credibility to research and provides a deeper understanding of how you arrived at your conclusions.

Constraints may have prevented you from collecting specific data or information you hoped would prove or disprove your hypothesis or provide a more comprehensive understanding of your research topic.

However, identifying the limitations contributing to your conclusions can inspire further research efforts that help gather more substantial information and data.

• Where to put limitations in a research paper

A research paper is broken up into different sections that appear in the following order:

Introduction

Methodology

The discussion portion of your paper explores your findings and puts them in the context of the overall research. Either place research limitations at the beginning of the discussion section before the analysis of your findings or at the end of the section to indicate that further research needs to be pursued.

What not to include in the limitations section

Evidence that doesn’t support your hypothesis is not a limitation, so you shouldn’t include it in the limitation section. Don’t just list limitations and their degree of severity without further explanation.

• How to present limitations

You’ll want to present the limitations of your study in a way that doesn’t diminish the validity of your research and leave the reader wondering if your results and conclusions have been compromised.

Include only the limitations that directly relate to and impact how you addressed your research questions. Following a specific format enables the reader to develop an understanding of the weaknesses within the context of your findings without doubting the quality and integrity of your research.

Identify the limitations specific to your study

You don’t have to identify every possible limitation that might have occurred during your research process. Only identify those that may have influenced the quality of your findings and your ability to answer your research question.

Explain study limitations in detail

This explanation should be the most significant portion of your limitation section.

Link each limitation with an interpretation and appraisal of their impact on the study. You’ll have to evaluate and explain whether the error, method, or validity issues influenced the study’s outcome and how.

Propose a direction for future studies and present alternatives

In this section, suggest how researchers can avoid the pitfalls you experienced during your research process.

If an issue with methodology was a limitation, propose alternate methods that may help with a smoother and more conclusive research project. Discuss the pros and cons of your alternate recommendation.

Describe steps taken to minimize each limitation

You probably took steps to try to address or mitigate limitations when you noticed them throughout the course of your research project. Describe these steps in the limitation section.

• Limitation example

“Approaches like stem cell transplantation and vaccination in AD [Alzheimer’s disease] work on a cellular or molecular level in the laboratory. However, translation into clinical settings will remain a challenge for the next decade.”

The authors are saying that even though these methods showed promise in helping people with memory loss when conducted in the lab (in other words, using animal studies), more studies are needed. These may be controlled clinical trials, for example. 

However, the short life span of stem cells outside the lab and the vaccination’s severe inflammatory side effects are limitations. Researchers won’t be able to conduct clinical trials until these issues are overcome.

• How to overcome limitations in research

You’ve already started on the road to overcoming limitations in research by acknowledging that they exist. However, you need to ensure readers don’t mistake weaknesses for errors within your research design.

To do this, you’ll need to justify and explain your rationale for the methods, research design, and analysis tools you chose and how you noticed they may have presented limitations.

Your readers need to know that even when limitations presented themselves, you followed best practices and the ethical standards of your field. You didn’t violate any rules and regulations during your research process.

You’ll also want to reinforce the validity of your conclusions and results with multiple sources, methods, and perspectives. This prevents readers from assuming your findings were derived from a single or biased source.

• Learning and improving starts with limitations in research

Dealing with limitations with transparency and integrity helps identify areas for future improvements and developments. It’s a learning process, providing valuable insights into how you can improve methodologies, expand sample sizes, or explore alternate approaches to further support the validity of your findings.

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• USC Libraries
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Organizing Your Social Sciences Research Paper

• Limitations of the Study
• Purpose of Guide
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• Independent and Dependent Variables
• Glossary of Research Terms
• Reading Research Effectively
• Narrowing a Topic Idea
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The limitations of the study are those characteristics of design or methodology that impacted or influenced the interpretation of the findings from your research. Study limitations are the constraints placed on the ability to generalize from the results, to further describe applications to practice, and/or related to the utility of findings that are the result of the ways in which you initially chose to design the study or the method used to establish internal and external validity or the result of unanticipated challenges that emerged during the study.

Price, James H. and Judy Murnan. “Research Limitations and the Necessity of Reporting Them.” American Journal of Health Education 35 (2004): 66-67; Theofanidis, Dimitrios and Antigoni Fountouki. "Limitations and Delimitations in the Research Process." Perioperative Nursing 7 (September-December 2018): 155-163. .

Importance of...

Always acknowledge a study's limitations. It is far better that you identify and acknowledge your study’s limitations than to have them pointed out by your professor and have your grade lowered because you appeared to have ignored them or didn't realize they existed.

Keep in mind that acknowledgment of a study's limitations is an opportunity to make suggestions for further research. If you do connect your study's limitations to suggestions for further research, be sure to explain the ways in which these unanswered questions may become more focused because of your study.

Acknowledgment of a study's limitations also provides you with opportunities to demonstrate that you have thought critically about the research problem, understood the relevant literature published about it, and correctly assessed the methods chosen for studying the problem. A key objective of the research process is not only discovering new knowledge but also to confront assumptions and explore what we don't know.

Claiming limitations is a subjective process because you must evaluate the impact of those limitations . Don't just list key weaknesses and the magnitude of a study's limitations. To do so diminishes the validity of your research because it leaves the reader wondering whether, or in what ways, limitation(s) in your study may have impacted the results and conclusions. Limitations require a critical, overall appraisal and interpretation of their impact. You should answer the question: do these problems with errors, methods, validity, etc. eventually matter and, if so, to what extent?

Price, James H. and Judy Murnan. “Research Limitations and the Necessity of Reporting Them.” American Journal of Health Education 35 (2004): 66-67; Structure: How to Structure the Research Limitations Section of Your Dissertation. Dissertations and Theses: An Online Textbook. Laerd.com.

Descriptions of Possible Limitations

All studies have limitations . However, it is important that you restrict your discussion to limitations related to the research problem under investigation. For example, if a meta-analysis of existing literature is not a stated purpose of your research, it should not be discussed as a limitation. Do not apologize for not addressing issues that you did not promise to investigate in the introduction of your paper.

Here are examples of limitations related to methodology and the research process you may need to describe and discuss how they possibly impacted your results. Note that descriptions of limitations should be stated in the past tense because they were discovered after you completed your research.

Possible Methodological Limitations

• Sample size -- the number of the units of analysis you use in your study is dictated by the type of research problem you are investigating. Note that, if your sample size is too small, it will be difficult to find significant relationships from the data, as statistical tests normally require a larger sample size to ensure a representative distribution of the population and to be considered representative of groups of people to whom results will be generalized or transferred. Note that sample size is generally less relevant in qualitative research if explained in the context of the research problem.
• Lack of available and/or reliable data -- a lack of data or of reliable data will likely require you to limit the scope of your analysis, the size of your sample, or it can be a significant obstacle in finding a trend and a meaningful relationship. You need to not only describe these limitations but provide cogent reasons why you believe data is missing or is unreliable. However, don’t just throw up your hands in frustration; use this as an opportunity to describe a need for future research based on designing a different method for gathering data.
• Lack of prior research studies on the topic -- citing prior research studies forms the basis of your literature review and helps lay a foundation for understanding the research problem you are investigating. Depending on the currency or scope of your research topic, there may be little, if any, prior research on your topic. Before assuming this to be true, though, consult with a librarian! In cases when a librarian has confirmed that there is little or no prior research, you may be required to develop an entirely new research typology [for example, using an exploratory rather than an explanatory research design ]. Note again that discovering a limitation can serve as an important opportunity to identify new gaps in the literature and to describe the need for further research.
• Measure used to collect the data -- sometimes it is the case that, after completing your interpretation of the findings, you discover that the way in which you gathered data inhibited your ability to conduct a thorough analysis of the results. For example, you regret not including a specific question in a survey that, in retrospect, could have helped address a particular issue that emerged later in the study. Acknowledge the deficiency by stating a need for future researchers to revise the specific method for gathering data.
• Self-reported data -- whether you are relying on pre-existing data or you are conducting a qualitative research study and gathering the data yourself, self-reported data is limited by the fact that it rarely can be independently verified. In other words, you have to the accuracy of what people say, whether in interviews, focus groups, or on questionnaires, at face value. However, self-reported data can contain several potential sources of bias that you should be alert to and note as limitations. These biases become apparent if they are incongruent with data from other sources. These are: (1) selective memory [remembering or not remembering experiences or events that occurred at some point in the past]; (2) telescoping [recalling events that occurred at one time as if they occurred at another time]; (3) attribution [the act of attributing positive events and outcomes to one's own agency, but attributing negative events and outcomes to external forces]; and, (4) exaggeration [the act of representing outcomes or embellishing events as more significant than is actually suggested from other data].

Possible Limitations of the Researcher

• Access -- if your study depends on having access to people, organizations, data, or documents and, for whatever reason, access is denied or limited in some way, the reasons for this needs to be described. Also, include an explanation why being denied or limited access did not prevent you from following through on your study.
• Longitudinal effects -- unlike your professor, who can literally devote years [even a lifetime] to studying a single topic, the time available to investigate a research problem and to measure change or stability over time is constrained by the due date of your assignment. Be sure to choose a research problem that does not require an excessive amount of time to complete the literature review, apply the methodology, and gather and interpret the results. If you're unsure whether you can complete your research within the confines of the assignment's due date, talk to your professor.
• Cultural and other type of bias -- we all have biases, whether we are conscience of them or not. Bias is when a person, place, event, or thing is viewed or shown in a consistently inaccurate way. Bias is usually negative, though one can have a positive bias as well, especially if that bias reflects your reliance on research that only support your hypothesis. When proof-reading your paper, be especially critical in reviewing how you have stated a problem, selected the data to be studied, what may have been omitted, the manner in which you have ordered events, people, or places, how you have chosen to represent a person, place, or thing, to name a phenomenon, or to use possible words with a positive or negative connotation. NOTE :   If you detect bias in prior research, it must be acknowledged and you should explain what measures were taken to avoid perpetuating that bias. For example, if a previous study only used boys to examine how music education supports effective math skills, describe how your research expands the study to include girls.
• Fluency in a language -- if your research focuses , for example, on measuring the perceived value of after-school tutoring among Mexican-American ESL [English as a Second Language] students and you are not fluent in Spanish, you are limited in being able to read and interpret Spanish language research studies on the topic or to speak with these students in their primary language. This deficiency should be acknowledged.

Aguinis, Hermam and Jeffrey R. Edwards. “Methodological Wishes for the Next Decade and How to Make Wishes Come True.” Journal of Management Studies 51 (January 2014): 143-174; Brutus, Stéphane et al. "Self-Reported Limitations and Future Directions in Scholarly Reports: Analysis and Recommendations." Journal of Management 39 (January 2013): 48-75; Senunyeme, Emmanuel K. Business Research Methods. Powerpoint Presentation. Regent University of Science and Technology; ter Riet, Gerben et al. “All That Glitters Isn't Gold: A Survey on Acknowledgment of Limitations in Biomedical Studies.” PLOS One 8 (November 2013): 1-6.

Structure and Writing Style

Information about the limitations of your study are generally placed either at the beginning of the discussion section of your paper so the reader knows and understands the limitations before reading the rest of your analysis of the findings, or, the limitations are outlined at the conclusion of the discussion section as an acknowledgement of the need for further study. Statements about a study's limitations should not be buried in the body [middle] of the discussion section unless a limitation is specific to something covered in that part of the paper. If this is the case, though, the limitation should be reiterated at the conclusion of the section.

If you determine that your study is seriously flawed due to important limitations , such as, an inability to acquire critical data, consider reframing it as an exploratory study intended to lay the groundwork for a more complete research study in the future. Be sure, though, to specifically explain the ways that these flaws can be successfully overcome in a new study.

But, do not use this as an excuse for not developing a thorough research paper! Review the tab in this guide for developing a research topic . If serious limitations exist, it generally indicates a likelihood that your research problem is too narrowly defined or that the issue or event under study is too recent and, thus, very little research has been written about it. If serious limitations do emerge, consult with your professor about possible ways to overcome them or how to revise your study.

When discussing the limitations of your research, be sure to:

• Describe each limitation in detailed but concise terms;
• Explain why each limitation exists;
• Provide the reasons why each limitation could not be overcome using the method(s) chosen to acquire or gather the data [cite to other studies that had similar problems when possible];
• Assess the impact of each limitation in relation to the overall findings and conclusions of your study; and,
• If appropriate, describe how these limitations could point to the need for further research.

Remember that the method you chose may be the source of a significant limitation that has emerged during your interpretation of the results [for example, you didn't interview a group of people that you later wish you had]. If this is the case, don't panic. Acknowledge it, and explain how applying a different or more robust methodology might address the research problem more effectively in a future study. A underlying goal of scholarly research is not only to show what works, but to demonstrate what doesn't work or what needs further clarification.

Aguinis, Hermam and Jeffrey R. Edwards. “Methodological Wishes for the Next Decade and How to Make Wishes Come True.” Journal of Management Studies 51 (January 2014): 143-174; Brutus, Stéphane et al. "Self-Reported Limitations and Future Directions in Scholarly Reports: Analysis and Recommendations." Journal of Management 39 (January 2013): 48-75; Ioannidis, John P.A. "Limitations are not Properly Acknowledged in the Scientific Literature." Journal of Clinical Epidemiology 60 (2007): 324-329; Pasek, Josh. Writing the Empirical Social Science Research Paper: A Guide for the Perplexed. January 24, 2012. Academia.edu; Structure: How to Structure the Research Limitations Section of Your Dissertation. Dissertations and Theses: An Online Textbook. Laerd.com; What Is an Academic Paper? Institute for Writing Rhetoric. Dartmouth College; Writing the Experimental Report: Methods, Results, and Discussion. The Writing Lab and The OWL. Purdue University.

Writing Tip

Don't Inflate the Importance of Your Findings!

After all the hard work and long hours devoted to writing your research paper, it is easy to get carried away with attributing unwarranted importance to what you’ve done. We all want our academic work to be viewed as excellent and worthy of a good grade, but it is important that you understand and openly acknowledge the limitations of your study. Inflating the importance of your study's findings could be perceived by your readers as an attempt hide its flaws or encourage a biased interpretation of the results. A small measure of humility goes a long way!

Another Writing Tip

Negative Results are Not a Limitation!

Negative evidence refers to findings that unexpectedly challenge rather than support your hypothesis. If you didn't get the results you anticipated, it may mean your hypothesis was incorrect and needs to be reformulated. Or, perhaps you have stumbled onto something unexpected that warrants further study. Moreover, the absence of an effect may be very telling in many situations, particularly in experimental research designs. In any case, your results may very well be of importance to others even though they did not support your hypothesis. Do not fall into the trap of thinking that results contrary to what you expected is a limitation to your study. If you carried out the research well, they are simply your results and only require additional interpretation.

Lewis, George H. and Jonathan F. Lewis. “The Dog in the Night-Time: Negative Evidence in Social Research.” The British Journal of Sociology 31 (December 1980): 544-558.

Yet Another Writing Tip

Sample Size Limitations in Qualitative Research

Sample sizes are typically smaller in qualitative research because, as the study goes on, acquiring more data does not necessarily lead to more information. This is because one occurrence of a piece of data, or a code, is all that is necessary to ensure that it becomes part of the analysis framework. However, it remains true that sample sizes that are too small cannot adequately support claims of having achieved valid conclusions and sample sizes that are too large do not permit the deep, naturalistic, and inductive analysis that defines qualitative inquiry. Determining adequate sample size in qualitative research is ultimately a matter of judgment and experience in evaluating the quality of the information collected against the uses to which it will be applied and the particular research method and purposeful sampling strategy employed. If the sample size is found to be a limitation, it may reflect your judgment about the methodological technique chosen [e.g., single life history study versus focus group interviews] rather than the number of respondents used.

Boddy, Clive Roland. "Sample Size for Qualitative Research." Qualitative Market Research: An International Journal 19 (2016): 426-432; Huberman, A. Michael and Matthew B. Miles. "Data Management and Analysis Methods." In Handbook of Qualitative Research . Norman K. Denzin and Yvonna S. Lincoln, eds. (Thousand Oaks, CA: Sage, 1994), pp. 428-444; Blaikie, Norman. "Confounding Issues Related to Determining Sample Size in Qualitative Research." International Journal of Social Research Methodology 21 (2018): 635-641; Oppong, Steward Harrison. "The Problem of Sampling in qualitative Research." Asian Journal of Management Sciences and Education 2 (2013): 202-210.

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• How to Write Recommendations in Research | Examples & Tips

How to Write Recommendations in Research | Examples & Tips

Published on 15 September 2022 by Tegan George .

Recommendations in research are a crucial component of your discussion section and the conclusion of your thesis , dissertation , or research paper .

As you conduct your research and analyse the data you collected , perhaps there are ideas or results that don’t quite fit the scope of your research topic . Or, maybe your results suggest that there are further implications of your results or the causal relationships between previously-studied variables than covered in extant research.

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Table of contents

What should recommendations look like, building your research recommendation, how should your recommendations be written, recommendation in research example, frequently asked questions about recommendations.

Recommendations for future research should be:

• Concrete and specific
• Supported with a clear rationale
• Directly connected to your research

Overall, strive to highlight ways other researchers can reproduce or replicate your results to draw further conclusions, and suggest different directions that future research can take, if applicable.

Relatedly, when making these recommendations, avoid:

• Undermining your own work, but rather offer suggestions on how future studies can build upon it
• Suggesting recommendations actually needed to complete your argument, but rather ensure that your research stands alone on its own merits
• Using recommendations as a place for self-criticism, but rather as a natural extension point for your work

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There are many different ways to frame recommendations, but the easiest is perhaps to follow the formula of research question   conclusion  recommendation. Here’s an example.

Conclusion An important condition for controlling many social skills is mastering language. If children have a better command of language, they can express themselves better and are better able to understand their peers. Opportunities to practice social skills are thus dependent on the development of language skills.

As a rule of thumb, try to limit yourself to only the most relevant future recommendations: ones that stem directly from your work. While you can have multiple recommendations for each research conclusion, it is also acceptable to have one recommendation that is connected to more than one conclusion.

These recommendations should be targeted at your audience, specifically toward peers or colleagues in your field that work on similar topics to yours. They can flow directly from any limitations you found while conducting your work, offering concrete and actionable possibilities for how future research can build on anything that your own work was unable to address at the time of your writing.

See below for a full research recommendation example that you can use as a template to write your own.

The current study can be interpreted as a first step in the research on COPD speech characteristics. However, the results of this study should be treated with caution due to the small sample size and the lack of details regarding the participants’ characteristics.

Future research could further examine the differences in speech characteristics between exacerbated COPD patients, stable COPD patients, and healthy controls. It could also contribute to a deeper understanding of the acoustic measurements suitable for e-health measurements.

While it may be tempting to present new arguments or evidence in your thesis or disseration conclusion , especially if you have a particularly striking argument you’d like to finish your analysis with, you shouldn’t. Theses and dissertations follow a more formal structure than this.

All your findings and arguments should be presented in the body of the text (more specifically in the discussion section and results section .) The conclusion is meant to summarize and reflect on the evidence and arguments you have already presented, not introduce new ones.

The conclusion of your thesis or dissertation should include the following:

• A restatement of your research question
• A summary of your key arguments and/or results
• A short discussion of the implications of your research

For a stronger dissertation conclusion , avoid including:

• Generic concluding phrases (e.g. “In conclusion…”)
• Weak statements that undermine your argument (e.g. “There are good points on both sides of this issue.”)

Your conclusion should leave the reader with a strong, decisive impression of your work.

In a thesis or dissertation, the discussion is an in-depth exploration of the results, going into detail about the meaning of your findings and citing relevant sources to put them in context.

The conclusion is more shorter and more general: it concisely answers your main research question and makes recommendations based on your overall findings.

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What are the limitations in research and how to write them?

Learn about the potential limitations in research and how to appropriately address them in order to deliver honest and ethical research.

It is fairly uncommon for researchers to stumble into the term research limitations when working on their research paper. Limitations in research can arise owing to constraints on design, methods, materials, and so on, and these aspects, unfortunately, may have an influence on your subject’s findings.

In this Mind The Graph’s article, we’ll discuss some recommendations for writing limitations in research , provide examples of various common types of limitations, and suggest how to properly present this information.

What are the limitations in research?

The limitations in research are the constraints in design, methods or even researchers’ limitations that affect and influence the interpretation of your research’s ultimate findings. These are limitations on the generalization and usability of findings that emerge from the design of the research and/or the method employed to ensure validity both internally and externally. 

Researchers are usually cautious to acknowledge the limitations of their research in their publications for fear of undermining the research’s scientific validity. No research is faultless or covers every possible angle. As a result, addressing the constraints of your research exhibits honesty and integrity .

Why should include limitations of research in my paper?

Though limitations tackle potential flaws in research, commenting on them at the conclusion of your paper, by demonstrating that you are aware of these limitations and explaining how they impact the conclusions that may be taken from the research, improves your research by disclosing any issues before other researchers or reviewers do . 

Additionally, emphasizing research constraints implies that you have thoroughly investigated the ramifications of research shortcomings and have a thorough understanding of your research problem. 

Limits exist in any research; being honest about them and explaining them would impress researchers and reviewers more than disregarding them. 

Remember that acknowledging a research’s shortcomings offers a chance to provide ideas for future research, but be careful to describe how your study may help to concentrate on these outstanding problems.

Possible limitations examples

Here are some limitations connected to methodology and the research procedure that you may need to explain and discuss in connection to your findings.

Methodological limitations

Sample size.

The number of units of analysis used in your study is determined by the sort of research issue being investigated. It is important to note that if your sample is too small, finding significant connections in the data will be challenging, as statistical tests typically require a larger sample size to ensure a fair representation and this can be limiting. 

Lack of available or reliable data

A lack of data or trustworthy data will almost certainly necessitate limiting the scope of your research or the size of your sample, or it can be a substantial impediment to identifying a pattern and a relevant connection.

Lack of prior research on the subject

Citing previous research papers forms the basis of your literature review and aids in comprehending the research subject you are researching. Yet there may be little if any, past research on your issue.

The measure used to collect data

After finishing your analysis of the findings, you realize that the method you used to collect data limited your capacity to undertake a comprehensive evaluation of the findings. Recognize the flaw by mentioning that future researchers should change the specific approach for data collection.

Issues with research samples and selection

Sampling inaccuracies arise when a probability sampling method is employed to choose a sample, but that sample does not accurately represent the overall population or the relevant group. As a result, your study suffers from “sampling bias” or “selection bias.”

Limitations of the research

When your research requires polling certain persons or a specific group, you may have encountered the issue of limited access to these interviewees. Because of the limited access, you may need to reorganize or rearrange your research. In this scenario, explain why access is restricted and ensure that your findings are still trustworthy and valid despite the constraint.

Time constraints

Practical difficulties may limit the amount of time available to explore a research issue and monitor changes as they occur. If time restrictions have any detrimental influence on your research, recognize this impact by expressing the necessity for a future investigation.

Due to their cultural origins or opinions on observed events, researchers may carry biased opinions, which can influence the credibility of a research. Furthermore, researchers may exhibit biases toward data and conclusions that only support their hypotheses or arguments.

The structure of the limitations section 

The limitations of your research are usually stated at the beginning of the discussion section of your paper so that the reader is aware of and comprehends the limitations prior to actually reading the rest of your findings, or they are stated at the end of the discussion section as an acknowledgment of the need for further research.

The ideal way is to divide your limitations section into three steps: 

1. Identify the research constraints; 

2. Describe in great detail how they affect your research; 

3. Mention the opportunity for future investigations and give possibilities. 

By following this method while addressing the constraints of your research, you will be able to effectively highlight your research’s shortcomings without jeopardizing the quality and integrity of your research.

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About Jessica Abbadia

Jessica Abbadia is a lawyer that has been working in Digital Marketing since 2020, improving organic performance for apps and websites in various regions through ASO and SEO. Currently developing scientific and intellectual knowledge for the community's benefit. Jessica is an animal rights activist who enjoys reading and drinking strong coffee.

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How to Present the Limitations of the Study Examples

What are the limitations of a study?

The limitations of a study are the elements of methodology or study design that impact the interpretation of your research results. The limitations essentially detail any flaws or shortcomings in your study. Study limitations can exist due to constraints on research design, methodology, materials, etc., and these factors may impact the findings of your study. However, researchers are often reluctant to discuss the limitations of their study in their papers, feeling that bringing up limitations may undermine its research value in the eyes of readers and reviewers.

In spite of the impact it might have (and perhaps because of it) you should clearly acknowledge any limitations in your research paper in order to show readers—whether journal editors, other researchers, or the general public—that you are aware of these limitations and to explain how they affect the conclusions that can be drawn from the research.

In this article, we provide some guidelines for writing about research limitations, show examples of some frequently seen study limitations, and recommend techniques for presenting this information. And after you have finished drafting and have received manuscript editing for your work, you still might want to follow this up with academic editing before submitting your work to your target journal.

Why do I need to include limitations of research in my paper?

Although limitations address the potential weaknesses of a study, writing about them toward the end of your paper actually strengthens your study by identifying any problems before other researchers or reviewers find them.

Furthermore, pointing out study limitations shows that you’ve considered the impact of research weakness thoroughly and have an in-depth understanding of your research topic. Since all studies face limitations, being honest and detailing these limitations will impress researchers and reviewers more than ignoring them.

Where should I put the limitations of the study in my paper?

Some limitations might be evident to researchers before the start of the study, while others might become clear while you are conducting the research. Whether these limitations are anticipated or not, and whether they are due to research design or to methodology, they should be clearly identified and discussed in the discussion section —the final section of your paper. Most journals now require you to include a discussion of potential limitations of your work, and many journals now ask you to place this “limitations section” at the very end of your article. 

Some journals ask you to also discuss the strengths of your work in this section, and some allow you to freely choose where to include that information in your discussion section—make sure to always check the author instructions of your target journal before you finalize a manuscript and submit it for peer review .

Limitations of the Study Examples

There are several reasons why limitations of research might exist. The two main categories of limitations are those that result from the methodology and those that result from issues with the researcher(s).

Common Methodological Limitations of Studies

Limitations of research due to methodological problems can be addressed by clearly and directly identifying the potential problem and suggesting ways in which this could have been addressed—and SHOULD be addressed in future studies. The following are some major potential methodological issues that can impact the conclusions researchers can draw from the research.

Issues with research samples and selection

Sampling errors occur when a probability sampling method is used to select a sample, but that sample does not reflect the general population or appropriate population concerned. This results in limitations of your study known as “sample bias” or “selection bias.”

For example, if you conducted a survey to obtain your research results, your samples (participants) were asked to respond to the survey questions. However, you might have had limited ability to gain access to the appropriate type or geographic scope of participants. In this case, the people who responded to your survey questions may not truly be a random sample.

Insufficient sample size for statistical measurements

When conducting a study, it is important to have a sufficient sample size in order to draw valid conclusions. The larger the sample, the more precise your results will be. If your sample size is too small, it will be difficult to identify significant relationships in the data.

Normally, statistical tests require a larger sample size to ensure that the sample is considered representative of a population and that the statistical result can be generalized to a larger population. It is a good idea to understand how to choose an appropriate sample size before you conduct your research by using scientific calculation tools—in fact, many journals now require such estimation to be included in every manuscript that is sent out for review.

Lack of previous research studies on the topic

Citing and referencing prior research studies constitutes the basis of the literature review for your thesis or study, and these prior studies provide the theoretical foundations for the research question you are investigating. However, depending on the scope of your research topic, prior research studies that are relevant to your thesis might be limited.

When there is very little or no prior research on a specific topic, you may need to develop an entirely new research typology. In this case, discovering a limitation can be considered an important opportunity to identify literature gaps and to present the need for further development in the area of study.

Methods/instruments/techniques used to collect the data

After you complete your analysis of the research findings (in the discussion section), you might realize that the manner in which you have collected the data or the ways in which you have measured variables has limited your ability to conduct a thorough analysis of the results.

For example, you might realize that you should have addressed your survey questions from another viable perspective, or that you were not able to include an important question in the survey. In these cases, you should acknowledge the deficiency or deficiencies by stating a need for future researchers to revise their specific methods for collecting data that includes these missing elements.

Common Limitations of the Researcher(s)

Study limitations that arise from situations relating to the researcher or researchers (whether the direct fault of the individuals or not) should also be addressed and dealt with, and remedies to decrease these limitations—both hypothetically in your study, and practically in future studies—should be proposed.

Limited access to data

If your research involved surveying certain people or organizations, you might have faced the problem of having limited access to these respondents. Due to this limited access, you might need to redesign or restructure your research in a different way. In this case, explain the reasons for limited access and be sure that your finding is still reliable and valid despite this limitation.

Time constraints

Just as students have deadlines to turn in their class papers, academic researchers might also have to meet deadlines for submitting a manuscript to a journal or face other time constraints related to their research (e.g., participants are only available during a certain period; funding runs out; collaborators move to a new institution). The time available to study a research problem and to measure change over time might be constrained by such practical issues. If time constraints negatively impacted your study in any way, acknowledge this impact by mentioning a need for a future study (e.g., a longitudinal study) to answer this research problem.

Conflicts arising from cultural bias and other personal issues

Researchers might hold biased views due to their cultural backgrounds or perspectives of certain phenomena, and this can affect a study’s legitimacy. Also, it is possible that researchers will have biases toward data and results that only support their hypotheses or arguments. In order to avoid these problems, the author(s) of a study should examine whether the way the research problem was stated and the data-gathering process was carried out appropriately.

Steps for Organizing Your Study Limitations Section

When you discuss the limitations of your study, don’t simply list and describe your limitations—explain how these limitations have influenced your research findings. There might be multiple limitations in your study, but you only need to point out and explain those that directly relate to and impact how you address your research questions.

We suggest that you divide your limitations section into three steps: (1) identify the study limitations; (2) explain how they impact your study in detail; and (3) propose a direction for future studies and present alternatives. By following this sequence when discussing your study’s limitations, you will be able to clearly demonstrate your study’s weakness without undermining the quality and integrity of your research.

Step 1. Identify the limitation(s) of the study

• This part should comprise around 10%-20% of your discussion of study limitations.

The first step is to identify the particular limitation(s) that affected your study. There are many possible limitations of research that can affect your study, but you don’t need to write a long review of all possible study limitations. A 200-500 word critique is an appropriate length for a research limitations section. In the beginning of this section, identify what limitations your study has faced and how important these limitations are.

You only need to identify limitations that had the greatest potential impact on: (1) the quality of your findings, and (2) your ability to answer your research question.

Step 2. Explain these study limitations in detail

• This part should comprise around 60-70% of your discussion of limitations.

After identifying your research limitations, it’s time to explain the nature of the limitations and how they potentially impacted your study. For example, when you conduct quantitative research, a lack of probability sampling is an important issue that you should mention. On the other hand, when you conduct qualitative research, the inability to generalize the research findings could be an issue that deserves mention.

Explain the role these limitations played on the results and implications of the research and justify the choice you made in using this “limiting” methodology or other action in your research. Also, make sure that these limitations didn’t undermine the quality of your dissertation .

Step 3. Propose a direction for future studies and present alternatives (optional)

• This part should comprise around 10-20% of your discussion of limitations.

After acknowledging the limitations of the research, you need to discuss some possible ways to overcome these limitations in future studies. One way to do this is to present alternative methodologies and ways to avoid issues with, or “fill in the gaps of” the limitations of this study you have presented.  Discuss both the pros and cons of these alternatives and clearly explain why researchers should choose these approaches.

Make sure you are current on approaches used by prior studies and the impacts they have had on their findings. Cite review articles or scientific bodies that have recommended these approaches and why. This might be evidence in support of the approach you chose, or it might be the reason you consider your choices to be included as limitations. This process can act as a justification for your approach and a defense of your decision to take it while acknowledging the feasibility of other approaches.

P hrases and Tips for Introducing Your Study Limitations in the Discussion Section

The following phrases are frequently used to introduce the limitations of the study:

• “There may be some possible limitations in this study.”
• “The findings of this study have to be seen in light of some limitations.”
•  “The first is the…The second limitation concerns the…”
•  “The empirical results reported herein should be considered in the light of some limitations.”
• “This research, however, is subject to several limitations.”
• “The primary limitation to the generalization of these results is…”
• “Nonetheless, these results must be interpreted with caution and a number of limitations should be borne in mind.”
• “As with the majority of studies, the design of the current study is subject to limitations.”
• “There are two major limitations in this study that could be addressed in future research. First, the study focused on …. Second ….”

For more articles on research writing and the journal submissions and publication process, visit Wordvice’s Academic Resources page.

And be sure to receive professional English editing and proofreading services , including paper editing services , for your journal manuscript before submitting it to journal editors.

Wordvice Resources

Proofreading & Editing Guide

Writing the Results Section for a Research Paper

How to Write a Literature Review

Research Writing Tips: How to Draft a Powerful Discussion Section

How to Captivate Journal Readers with a Strong Introduction

Tips That Will Make Your Abstract a Success!

APA In-Text Citation Guide for Research Writing

Additional Resources

• Diving Deeper into Limitations and Delimitations (PhD student)
• Organizing Your Social Sciences Research Paper: Limitations of the Study (USC Library)
• Research Limitations (Research Methodology)
• How to Present Limitations and Alternatives (UMASS)

Article References

Pearson-Stuttard, J., Kypridemos, C., Collins, B., Mozaffarian, D., Huang, Y., Bandosz, P.,…Micha, R. (2018). Estimating the health and economic effects of the proposed US Food and Drug Administration voluntary sodium reformulation: Microsimulation cost-effectiveness analysis. PLOS. https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002551

Xu, W.L, Pedersen, N.L., Keller, L., Kalpouzos, G., Wang, H.X., Graff, C,. Fratiglioni, L. (2015). HHEX_23 AA Genotype Exacerbates Effect of Diabetes on Dementia and Alzheimer Disease: A Population-Based Longitudinal Study. PLOS. Retrieved from https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001853

Writing Limitations of Research Study — 4 Reasons Why It Is Important!

It is not unusual for researchers to come across the term limitations of research during their academic paper writing. More often this is interpreted as something terrible. However, when it comes to research study, limitations can help structure the research study better. Therefore, do not underestimate significance of limitations of research study.

Allow us to take you through the context of how to evaluate the limits of your research and conclude an impactful relevance to your results.

Table of Contents

What Are the Limitations of a Research Study?

Every research has its limit and these limitations arise due to restrictions in methodology or research design.  This could impact your entire research or the research paper you wish to publish. Unfortunately, most researchers choose not to discuss their limitations of research fearing it will affect the value of their article in the eyes of readers.

However, it is very important to discuss your study limitations and show it to your target audience (other researchers, journal editors, peer reviewers etc.). It is very important that you provide an explanation of how your research limitations may affect the conclusions and opinions drawn from your research. Moreover, when as an author you state the limitations of research, it shows that you have investigated all the weaknesses of your study and have a deep understanding of the subject. Being honest could impress your readers and mark your study as a sincere effort in research.

Why and Where Should You Include the Research Limitations?

The main goal of your research is to address your research objectives. Conduct experiments, get results and explain those results, and finally justify your research question . It is best to mention the limitations of research in the discussion paragraph of your research article.

At the very beginning of this paragraph, immediately after highlighting the strengths of the research methodology, you should write down your limitations. You can discuss specific points from your research limitations as suggestions for further research in the conclusion of your thesis.

1. Common Limitations of the Researchers

Limitations that are related to the researcher must be mentioned. This will help you gain transparency with your readers. Furthermore, you could provide suggestions on decreasing these limitations in you and your future studies.

2. Limited Access to Information

Your work may involve some institutions and individuals in research, and sometimes you may have problems accessing these institutions. Therefore, you need to redesign and rewrite your work. You must explain your readers the reason for limited access.

3. Limited Time

All researchers are bound by their deadlines when it comes to completing their studies. Sometimes, time constraints can affect your research negatively. However, the best practice is to acknowledge it and mention a requirement for future study to solve the research problem in a better way.

4. Conflict over Biased Views and Personal Issues

Biased views can affect the research. In fact, researchers end up choosing only those results and data that support their main argument, keeping aside the other loose ends of the research.

Types of Limitations of Research

Before beginning your research study, know that there are certain limitations to what you are testing or possible research results. There are different types that researchers may encounter, and they all have unique characteristics, such as:

1. Research Design Limitations

Certain restrictions on your research or available procedures may affect your final results or research outputs. You may have formulated research goals and objectives too broadly. However, this can help you understand how you can narrow down the formulation of research goals and objectives, thereby increasing the focus of your study.

2. Impact Limitations

Even if your research has excellent statistics and a strong design, it can suffer from the influence of the following factors:

• Presence of increasing findings as researched
• Being population specific
• A strong regional focus.

3. Data or statistical limitations

In some cases, it is impossible to collect sufficient data for research or very difficult to get access to the data. This could lead to incomplete conclusion to your study. Moreover, this insufficiency in data could be the outcome of your study design. The unclear, shabby research outline could produce more problems in interpreting your findings.

How to Correctly Structure Your Research Limitations?

There are strict guidelines for narrowing down research questions, wherein you could justify and explain potential weaknesses of your academic paper. You could go through these basic steps to get a well-structured clarity of research limitations:

• Declare that you wish to identify your limitations of research and explain their importance,
• Provide the necessary depth, explain their nature, and justify your study choices.
• Write how you are suggesting that it is possible to overcome them in the future.

In this section, your readers will see that you are aware of the potential weaknesses in your business, understand them and offer effective solutions, and it will positively strengthen your article as you clarify all limitations of research to your target audience.

Know that you cannot be perfect and there is no individual without flaws. You could use the limitations of research as a great opportunity to take on a new challenge and improve the future of research. In a typical academic paper, research limitations may relate to:

1. Formulating your goals and objectives

If you formulate goals and objectives too broadly, your work will have some shortcomings. In this case, specify effective methods or ways to narrow down the formula of goals and aim to increase your level of study focus.

2. Application of your data collection methods in research

If you do not have experience in primary data collection, there is a risk that there will be flaws in the implementation of your methods. It is necessary to accept this, and learn and educate yourself to understand data collection methods.

3. Sample sizes

This depends on the nature of problem you choose. Sample size is of a greater importance in quantitative studies as opposed to qualitative ones. If your sample size is too small, statistical tests cannot identify significant relationships or connections within a given data set.

You could point out that other researchers should base the same study on a larger sample size to get more accurate results.

4. The absence of previous studies in the field you have chosen

Writing a literature review is an important step in any scientific study because it helps researchers determine the scope of current work in the chosen field. It is a major foundation for any researcher who must use them to achieve a set of specific goals or objectives.

However, if you are focused on the most current and evolving research problem or a very narrow research problem, there may be very little prior research on your topic. For example, if you chose to explore the role of Bitcoin as the currency of the future, you may not find tons of scientific papers addressing the research problem as Bitcoins are only a new phenomenon.

It is important that you learn to identify research limitations examples at each step. Whatever field you choose, feel free to add the shortcoming of your work. This is mainly because you do not have many years of experience writing scientific papers or completing complex work. Therefore, the depth and scope of your discussions may be compromised at different levels compared to academics with a lot of expertise. Include specific points from limitations of research. Use them as suggestions for the future.

Have you ever faced a challenge of writing the limitations of research study in your paper? How did you overcome it? What ways did you follow? Were they beneficial? Let us know in the comments below!

Frequently Asked Questions

Setting limitations in our study helps to clarify the outcomes drawn from our research and enhance understanding of the subject. Moreover, it shows that the author has investigated all the weaknesses in the study.

Scope is the range and limitations of a research project which are set to define the boundaries of a project. Limitations are the impacts on the overall study due to the constraints on the research design.

Limitation in research is an impact of a constraint on the research design in the overall study. They are the flaws or weaknesses in the study, which may influence the outcome of the research.

1. Limitations in research can be written as follows: Formulate your goals and objectives 2. Analyze the chosen data collection method and the sample sizes 3. Identify your limitations of research and explain their importance 4. Provide the necessary depth, explain their nature, and justify your study choices 5. Write how you are suggesting that it is possible to overcome them in the future

Excellent article ,,,it has helped me big

This is very helpful information. It has given me an insight on how to go about my study limitations.

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Home » Delimitations in Research – Types, Examples and Writing Guide

Delimitations in Research – Types, Examples and Writing Guide

Table of Contents

Delimitations

Definition:

Delimitations refer to the specific boundaries or limitations that are set in a research study in order to narrow its scope and focus. Delimitations may be related to a variety of factors, including the population being studied, the geographical location, the time period, the research design , and the methods or tools being used to collect data .

The Importance of Delimitations in Research Studies

Here are some reasons why delimitations are important in research studies:

• Provide focus : Delimitations help researchers focus on a specific area of interest and avoid getting sidetracked by tangential topics. By setting clear boundaries, researchers can concentrate their efforts on the most relevant and significant aspects of the research question.
• Increase validity : Delimitations ensure that the research is more valid by defining the boundaries of the study. When researchers establish clear criteria for inclusion and exclusion, they can better control for extraneous variables that might otherwise confound the results.
• Improve generalizability : Delimitations help researchers determine the extent to which their findings can be generalized to other populations or contexts. By specifying the sample size, geographic region, time frame, or other relevant factors, researchers can provide more accurate estimates of the generalizability of their results.
• Enhance feasibility : Delimitations help researchers identify the resources and time required to complete the study. By setting realistic parameters, researchers can ensure that the study is feasible and can be completed within the available time and resources.
• Clarify scope: Delimitations help readers understand the scope of the research project. By explicitly stating what is included and excluded, researchers can avoid confusion and ensure that readers understand the boundaries of the study.

Types of Delimitations in Research

Here are some types of delimitations in research and their significance:

Time Delimitations

This type of delimitation refers to the time frame in which the research will be conducted. Time delimitations are important because they help to narrow down the scope of the study and ensure that the research is feasible within the given time constraints.

Geographical Delimitations

Geographical delimitations refer to the geographic boundaries within which the research will be conducted. These delimitations are significant because they help to ensure that the research is relevant to the intended population or location.

Population Delimitations

Population delimitations refer to the specific group of people that the research will focus on. These delimitations are important because they help to ensure that the research is targeted to a specific group, which can improve the accuracy of the results.

Data Delimitations

Data delimitations refer to the specific types of data that will be used in the research. These delimitations are important because they help to ensure that the data is relevant to the research question and that the research is conducted using reliable and valid data sources.

Scope Delimitations

Scope delimitations refer to the specific aspects or dimensions of the research that will be examined. These delimitations are important because they help to ensure that the research is focused and that the findings are relevant to the research question.

How to Write Delimitations

In order to write delimitations in research, you can follow these steps:

• Identify the scope of your study : Determine the extent of your research by defining its boundaries. This will help you to identify the areas that are within the scope of your research and those that are outside of it.
• Determine the time frame : Decide on the time period that your research will cover. This could be a specific period, such as a year, or it could be a general time frame, such as the last decade.
• I dentify the population : Determine the group of people or objects that your study will focus on. This could be a specific age group, gender, profession, or geographic location.
• Establish the sample size : Determine the number of participants that your study will involve. This will help you to establish the number of people you need to recruit for your study.
• Determine the variables: Identify the variables that will be measured in your study. This could include demographic information, attitudes, behaviors, or other factors.
• Explain the limitations : Clearly state the limitations of your study. This could include limitations related to time, resources, sample size, or other factors that may impact the validity of your research.
• Justify the limitations : Explain why these limitations are necessary for your research. This will help readers understand why certain factors were excluded from the study.

When to Write Delimitations in Research

Here are some situations when you may need to write delimitations in research:

• When defining the scope of the study: Delimitations help to define the boundaries of your research by specifying what is and what is not included in your study. For instance, you may delimit your study by focusing on a specific population, geographic region, time period, or research methodology.
• When addressing limitations: Delimitations can also be used to address the limitations of your research. For example, if your data is limited to a certain timeframe or geographic area, you can include this information in your delimitations to help readers understand the limitations of your findings.
• When justifying the relevance of the study : Delimitations can also help you to justify the relevance of your research. For instance, if you are conducting a study on a specific population or region, you can explain why this group or area is important and how your research will contribute to the understanding of this topic.
• When clarifying the research question or hypothesis : Delimitations can also be used to clarify your research question or hypothesis. By specifying the boundaries of your study, you can ensure that your research question or hypothesis is focused and specific.
• When establishing the context of the study : Finally, delimitations can help you to establish the context of your research. By providing information about the scope and limitations of your study, you can help readers to understand the context in which your research was conducted and the implications of your findings.

Examples of Delimitations in Research

Examples of Delimitations in Research are as follows:

Research Title : “Impact of Artificial Intelligence on Cybersecurity Threat Detection”

Delimitations :

• The study will focus solely on the use of artificial intelligence in detecting and mitigating cybersecurity threats.
• The study will only consider the impact of AI on threat detection and not on other aspects of cybersecurity such as prevention, response, or recovery.
• The research will be limited to a specific type of cybersecurity threats, such as malware or phishing attacks, rather than all types of cyber threats.
• The study will only consider the use of AI in a specific industry, such as finance or healthcare, rather than examining its impact across all industries.
• The research will only consider AI-based threat detection tools that are currently available and widely used, rather than including experimental or theoretical AI models.

Research Title: “The Effects of Social Media on Academic Performance: A Case Study of College Students”

Delimitations:

• The study will focus only on college students enrolled in a particular university.
• The study will only consider social media platforms such as Facebook, Twitter, and Instagram.
• The study will only analyze the academic performance of students based on their GPA and course grades.
• The study will not consider the impact of other factors such as student demographics, socioeconomic status, or other factors that may affect academic performance.
• The study will only use self-reported data from students, rather than objective measures of their social media usage or academic performance.

Purpose of Delimitations

Some Purposes of Delimitations are as follows:

• Focusing the research : By defining the scope of the study, delimitations help researchers to narrow down their research questions and focus on specific aspects of the topic. This allows for a more targeted and meaningful study.
• Clarifying the research scope : Delimitations help to clarify the boundaries of the research, which helps readers to understand what is and is not included in the study.
• Avoiding scope creep : Delimitations help researchers to stay focused on their research objectives and avoid being sidetracked by tangential issues or data.
• Enhancing the validity of the study : By setting clear boundaries, delimitations help to ensure that the study is valid and reliable.
• Improving the feasibility of the study : Delimitations help researchers to ensure that their study is feasible and can be conducted within the time and resources available.

Applications of Delimitations

Here are some common applications of delimitations:

• Geographic delimitations : Researchers may limit their study to a specific geographic area, such as a particular city, state, or country. This helps to narrow the focus of the study and makes it more manageable.
• Time delimitations : Researchers may limit their study to a specific time period, such as a decade, a year, or a specific date range. This can be useful for studying trends over time or for comparing data from different time periods.
• Population delimitations : Researchers may limit their study to a specific population, such as a particular age group, gender, or ethnic group. This can help to ensure that the study is relevant to the population being studied.
• Data delimitations : Researchers may limit their study to specific types of data, such as survey responses, interviews, or archival records. This can help to ensure that the study is based on reliable and relevant data.
• Conceptual delimitations : Researchers may limit their study to specific concepts or variables, such as only studying the effects of a particular treatment on a specific outcome. This can help to ensure that the study is focused and clear.

Advantages of Delimitations

Some Advantages of Delimitations are as follows:

• Helps to focus the study: Delimitations help to narrow down the scope of the research and identify specific areas that need to be investigated. This helps to focus the study and ensures that the research is not too broad or too narrow.
• Defines the study population: Delimitations can help to define the population that will be studied. This can include age range, gender, geographical location, or any other factors that are relevant to the research. This helps to ensure that the study is more specific and targeted.
• Provides clarity: Delimitations help to provide clarity about the research study. By identifying the boundaries and limitations of the research, it helps to avoid confusion and ensures that the research is more understandable.
• Improves validity: Delimitations can help to improve the validity of the research by ensuring that the study is more focused and specific. This can help to ensure that the research is more accurate and reliable.
• Reduces bias: Delimitations can help to reduce bias by limiting the scope of the research. This can help to ensure that the research is more objective and unbiased.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Implications or Recommendations in Research: What's the Difference?

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High-quality research articles that get many citations contain both implications and recommendations. Implications are the impact your research makes, whereas recommendations are specific actions that can then be taken based on your findings, such as for more research or for policymaking.

Updated on August 23, 2022

That seems clear enough, but the two are commonly confused.

This confusion is especially true if you come from a so-called high-context culture in which information is often implied based on the situation, as in many Asian cultures. High-context cultures are different from low-context cultures where information is more direct and explicit (as in North America and many European cultures).

Let's set these two straight in a low-context way; i.e., we'll be specific and direct! This is the best way to be in English academic writing because you're writing for the world.

Implications and recommendations in a research article

The standard format of STEM research articles is what's called IMRaD:

• Introduction
• Discussion/conclusions

Some journals call for a separate conclusions section, while others have the conclusions as the last part of the discussion. You'll write these four (or five) sections in the same sequence, though, no matter the journal.

The discussion section is typically where you restate your results and how well they confirmed your hypotheses. Give readers the answer to the questions for which they're looking to you for an answer.

At this point, many researchers assume their paper is finished. After all, aren't the results the most important part? As you might have guessed, no, you're not quite done yet.

The discussion/conclusions section is where to say what happened and what should now happen

The discussion/conclusions section of every good scientific article should contain the implications and recommendations.

The implications, first of all, are the impact your results have on your specific field. A high-impact, highly cited article will also broaden the scope here and provide implications to other fields. This is what makes research cross-disciplinary.

Recommendations, however, are suggestions to improve your field based on your results.

These two aspects help the reader understand your broader content: How and why your work is important to the world. They also tell the reader what can be changed in the future based on your results.

These aspects are what editors are looking for when selecting papers for peer review.

Implications and recommendations are, thus, written at the end of the discussion section, and before the concluding paragraph. They help to “wrap up” your paper. Once your reader understands what you found, the next logical step is what those results mean and what should come next.

Then they can take the baton, in the form of your work, and run with it. That gets you cited and extends your impact!

The order of implications and recommendations also matters. Both are written after you've summarized your main findings in the discussion section. Then, those results are interpreted based on ongoing work in the field. After this, the implications are stated, followed by the recommendations.

Writing an academic research paper is a bit like running a race. Finish strong, with your most important conclusion (recommendation) at the end. Leave readers with an understanding of your work's importance. Avoid generic, obvious phrases like "more research is needed to fully address this issue." Be specific.

The main differences between implications and recommendations (table)

Now let's dig a bit deeper into actually how to write these parts.

What are implications?

Research implications tell us how and why your results are important for the field at large. They help answer the question of “what does it mean?” Implications tell us how your work contributes to your field and what it adds to it. They're used when you want to tell your peers why your research is important for ongoing theory, practice, policymaking, and for future research.

Crucially, your implications must be evidence-based. This means they must be derived from the results in the paper.

Implications are written after you've summarized your main findings in the discussion section. They come before the recommendations and before the concluding paragraph. There is no specific section dedicated to implications. They must be integrated into your discussion so that the reader understands why the results are meaningful and what they add to the field.

A good strategy is to separate your implications into types. Implications can be social, political, technological, related to policies, or others, depending on your topic. The most frequently used types are theoretical and practical. Theoretical implications relate to how your findings connect to other theories or ideas in your field, while practical implications are related to what we can do with the results.

Key features of implications

• State the impact your research makes
• Helps us understand why your results are important
• Must be evidence-based
• Written in the discussion, before recommendations
• Can be theoretical, practical, or other (social, political, etc.)

Examples of implications

Let's take a look at some examples of research results below with their implications.

The result : one study found that learning items over time improves memory more than cramming material in a bunch of information at once .

The implications : This result suggests memory is better when studying is spread out over time, which could be due to memory consolidation processes.

The result : an intervention study found that mindfulness helps improve mental health if you have anxiety.

The implications : This result has implications for the role of executive functions on anxiety.

The result : a study found that musical learning helps language learning in children .

The implications : these findings suggest that language and music may work together to aid development.

What are recommendations?

As noted above, explaining how your results contribute to the real world is an important part of a successful article.

Likewise, stating how your findings can be used to improve something in future research is equally important. This brings us to the recommendations.

Research recommendations are suggestions and solutions you give for certain situations based on your results. Once the reader understands what your results mean with the implications, the next question they need to know is "what's next?"

Recommendations are calls to action on ways certain things in the field can be improved in the future based on your results. Recommendations are used when you want to convey that something different should be done based on what your analyses revealed.

Similar to implications, recommendations are also evidence-based. This means that your recommendations to the field must be drawn directly from your results.

The goal of the recommendations is to make clear, specific, and realistic suggestions to future researchers before they conduct a similar experiment. No matter what area your research is in, there will always be further research to do. Try to think about what would be helpful for other researchers to know before starting their work.

Recommendations are also written in the discussion section. They come after the implications and before the concluding paragraphs. Similar to the implications, there is usually no specific section dedicated to the recommendations. However, depending on how many solutions you want to suggest to the field, they may be written as a subsection.

Key features of recommendations

• Statements about what can be done differently in the field based on your findings
• Must be realistic and specific
• Written in the discussion, after implications and before conclusions
• Related to both your field and, preferably, a wider context to the research

Examples of recommendations

Here are some research results and their recommendations.

A meta-analysis found that actively recalling material from your memory is better than simply re-reading it .

• The recommendation: Based on these findings, teachers and other educators should encourage students to practice active recall strategies.

A medical intervention found that daily exercise helps prevent cardiovascular disease .

• The recommendation: Based on these results, physicians are recommended to encourage patients to exercise and walk regularly. Also recommended is to encourage more walking through public health offices in communities.

A study found that many research articles do not contain the sample sizes needed to statistically confirm their findings .

The recommendation: To improve the current state of the field, researchers should consider doing power analysis based on their experiment's design.

What else is important about implications and recommendations?

When writing recommendations and implications, be careful not to overstate the impact of your results. It can be tempting for researchers to inflate the importance of their findings and make grandiose statements about what their work means.

Remember that implications and recommendations must be coming directly from your results. Therefore, they must be straightforward, realistic, and plausible.

Another good thing to remember is to make sure the implications and recommendations are stated clearly and separately. Do not attach them to the endings of other paragraphs just to add them in. Use similar example phrases as those listed in the table when starting your sentences to clearly indicate when it's an implication and when it's a recommendation.

When your peers, or brand-new readers, read your paper, they shouldn't have to hunt through your discussion to find the implications and recommendations. They should be clear, visible, and understandable on their own.

That'll get you cited more, and you'll make a greater contribution to your area of science while extending the life and impact of your work.

The AJE Team

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Research Limitations & Delimitations

What they are and how they’re different (with examples)

By: Derek Jansen (MBA) | Expert Reviewed By: David Phair (PhD) | September 2022

If you’re new to the world of research, you’ve probably heard the terms “ research limitations ” and “ research delimitations ” being thrown around, often quite loosely. In this post, we’ll unpack what both of these mean, how they’re similar and how they’re different – so that you can write up these sections the right way.

Overview: Limitations vs Delimitations

• Are they the same?
• What are research limitations
• What are research delimitations
• Limitations vs delimitations

First things first…

Let’s start with the most important takeaway point of this post – research limitations and research delimitations are not the same – but they are related to each other (we’ll unpack that a little later). So, if you hear someone using these two words interchangeably, be sure to share this post with them!

Research Limitations

Research limitations are, at the simplest level, the weaknesses of the study, based on factors that are often outside of your control as the researcher. These factors could include things like time , access to funding, equipment , data or participants . For example, if you weren’t able to access a random sample of participants for your study and had to adopt a convenience sampling strategy instead, that would impact the generalizability of your findings and therefore reflect a limitation of your study.

Research limitations can also emerge from the research design itself . For example, if you were undertaking a correlational study, you wouldn’t be able to infer causality (since correlation doesn’t mean certain causation). Similarly, if you utilised online surveys to collect data from your participants, you naturally wouldn’t be able to get the same degree of rich data that you would from in-person interviews .

Simply put, research limitations reflect the shortcomings of a study , based on practical (or theoretical) constraints that the researcher faced. These shortcomings limit what you can conclude from a study, but at the same time, present a foundation for future research . Importantly, all research has limitations , so there’s no need to hide anything here – as long as you discuss how the limitations might affect your findings, it’s all good.

Research Delimitations

Alright, now that we’ve unpacked the limitations, let’s move on to the delimitations .

Research delimitations are similar to limitations in that they also “ limit ” the study, but their focus is entirely different. Specifically, the delimitations of a study refer to the scope of the research aims and research questions . In other words, delimitations reflect the choices you, as the researcher, intentionally make in terms of what you will and won’t try to achieve with your study. In other words, what your research aims and research questions will and won’t include.

As we’ve spoken about many times before, it’s important to have a tight, narrow focus for your research, so that you can dive deeply into your topic, apply your energy to one specific area and develop meaningful insights. If you have an overly broad scope or unfocused topic, your research will often pull in multiple, even opposing directions, and you’ll just land up with a muddy mess of findings .

So, the delimitations section is where you’ll clearly state what your research aims and research questions will focus on – and just as importantly, what they will exclude . For example, you might investigate a widespread phenomenon, but choose to focus your study on a specific age group, ethnicity or gender. Similarly, your study may focus exclusively on one country, city or even organization. As long as the scope is well justified (in other words, it represents a novel, valuable research topic), this is perfectly acceptable – in fact, it’s essential. Remember, focus is your friend.

Need a helping hand?

Conclusion: Limitations vs Delimitations

Ok, so let’s recap.

Research limitations and research delimitations are related in that they both refer to “limits” within a study. But, they are distinctly different. Limitations reflect the shortcomings of your study, based on practical or theoretical constraints that you faced.

Contrasted to that, delimitations reflect the choices that you made in terms of the focus and scope of your research aims and research questions. If you want to learn more about research aims and questions, you can check out this video post , where we unpack those concepts in detail.

Psst... there’s more!

This post was based on one of our popular Research Bootcamps . If you're working on a research project, you'll definitely want to check this out ...

You Might Also Like:

18 Comments

Good clarification of ideas on how a researcher ought to do during Process of choice

Thank you so much for this very simple but explicit explanation on limitation and delimitation. It has so helped me to develop my masters proposal. hope to recieve more from your site as time progresses

Thank you for this explanation – very clear.

Thanks for the explanation, really got it well.

This website is really helpful for my masters proposal

Thank you very much for helping to explain these two terms

I spent almost the whole day trying to figure out the differences

when I came across your notes everything became very clear

thanks for the clearly outlined explanation on the two terms, limitation and delimitation.

Very helpful Many thanks 🙏

Excellent it resolved my conflict .

I would like you to assist me please. If in my Research, I interviewed some participants and I submitted Questionnaires to other participants to answered to the questions, in the same organization, Is this a Qualitative methodology , a Quantitative Methodology or is it a Mixture Methodology I have used in my research? Please help me

How do I cite this article in APA format

Really so great ,finally have understood it’s difference now

Getting more clear regarding Limitations and Delimitation and concepts

I really appreciate your apt and precise explanation of the two concepts namely ; Limitations and Delimitations.

This is a good sources of research information for learners.

thank you for this, very helpful to researchers

Very good explained

Great and clear explanation, after a long confusion period on the two words, i can now explain to someone with ease.

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• Open access
• Published: 18 April 2024

Research ethics and artificial intelligence for global health: perspectives from the global forum on bioethics in research

• James Shaw 1 , 13 ,
• Joseph Ali 2 , 3 ,
• Caesar A. Atuire 4 , 5 ,
• Phaik Yeong Cheah 6 ,
• Armando Guio Español 7 ,
• Judy Wawira Gichoya 8 ,
• Adrienne Hunt 9 ,
• Daudi Jjingo 10 ,
• Katherine Littler 9 ,
• Daniela Paolotti 11 &
• Effy Vayena 12  

BMC Medical Ethics volume  25 , Article number:  46 ( 2024 ) Cite this article

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The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022.

The GFBR is an annual meeting organized by the World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was “Ethics of AI in Global Health Research”. The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022.

We describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships.

Conclusions

The 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research.

Peer Review reports

Introduction

The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice [ 1 , 2 , 3 ]. Beyond the growing number of AI applications being implemented in health care, capabilities of AI models such as Large Language Models (LLMs) expand the potential reach and significance of AI technologies across health-related fields [ 4 , 5 ]. Discussion about effective, ethical governance of AI technologies has spanned a range of governance approaches, including government regulation, organizational decision-making, professional self-regulation, and research ethics review [ 6 , 7 , 8 ]. In this paper, we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health research, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022. Although applications of AI for research, health care, and public health are diverse and advancing rapidly, the insights generated at the forum remain highly relevant from a global health perspective. After summarizing important context for work in this domain, we highlight categories of ethical issues emphasized at the forum for attention from a research ethics perspective internationally. We then outline strategies proposed for research, innovation, and governance to support more ethical AI for global health.

In this paper, we adopt the definition of AI systems provided by the Organization for Economic Cooperation and Development (OECD) as our starting point. Their definition states that an AI system is “a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments. AI systems are designed to operate with varying levels of autonomy” [ 9 ]. The conceptualization of an algorithm as helping to constitute an AI system, along with hardware, other elements of software, and a particular context of use, illustrates the wide variety of ways in which AI can be applied. We have found it useful to differentiate applications of AI in research as those classified as “AI systems for discovery” and “AI systems for intervention”. An AI system for discovery is one that is intended to generate new knowledge, for example in drug discovery or public health research in which researchers are seeking potential targets for intervention, innovation, or further research. An AI system for intervention is one that directly contributes to enacting an intervention in a particular context, for example informing decision-making at the point of care or assisting with accuracy in a surgical procedure.

The mandate of the GFBR is to take a broad view of what constitutes research and its regulation in global health, with special attention to bioethics in Low- and Middle- Income Countries. AI as a group of technologies demands such a broad view. AI development for health occurs in a variety of environments, including universities and academic health sciences centers where research ethics review remains an important element of the governance of science and innovation internationally [ 10 , 11 ]. In these settings, research ethics committees (RECs; also known by different names such as Institutional Review Boards or IRBs) make decisions about the ethical appropriateness of projects proposed by researchers and other institutional members, ultimately determining whether a given project is allowed to proceed on ethical grounds [ 12 ].

However, research involving AI for health also takes place in large corporations and smaller scale start-ups, which in some jurisdictions fall outside the scope of research ethics regulation. In the domain of AI, the question of what constitutes research also becomes blurred. For example, is the development of an algorithm itself considered a part of the research process? Or only when that algorithm is tested under the formal constraints of a systematic research methodology? In this paper we take an inclusive view, in which AI development is included in the definition of research activity and within scope for our inquiry, regardless of the setting in which it takes place. This broad perspective characterizes the approach to “research ethics” we take in this paper, extending beyond the work of RECs to include the ethical analysis of the wide range of activities that constitute research as the generation of new knowledge and intervention in the world.

Ethical governance of AI in global health

The ethical governance of AI for global health has been widely discussed in recent years. The World Health Organization (WHO) released its guidelines on ethics and governance of AI for health in 2021, endorsing a set of six ethical principles and exploring the relevance of those principles through a variety of use cases. The WHO guidelines also provided an overview of AI governance, defining governance as covering “a range of steering and rule-making functions of governments and other decision-makers, including international health agencies, for the achievement of national health policy objectives conducive to universal health coverage.” (p. 81) The report usefully provided a series of recommendations related to governance of seven domains pertaining to AI for health: data, benefit sharing, the private sector, the public sector, regulation, policy observatories/model legislation, and global governance. The report acknowledges that much work is yet to be done to advance international cooperation on AI governance, especially related to prioritizing voices from Low- and Middle-Income Countries (LMICs) in global dialogue.

One important point emphasized in the WHO report that reinforces the broader literature on global governance of AI is the distribution of responsibility across a wide range of actors in the AI ecosystem. This is especially important to highlight when focused on research for global health, which is specifically about work that transcends national borders. Alami et al. (2020) discussed the unique risks raised by AI research in global health, ranging from the unavailability of data in many LMICs required to train locally relevant AI models to the capacity of health systems to absorb new AI technologies that demand the use of resources from elsewhere in the system. These observations illustrate the need to identify the unique issues posed by AI research for global health specifically, and the strategies that can be employed by all those implicated in AI governance to promote ethically responsible use of AI in global health research.

RECs and the regulation of research involving AI

RECs represent an important element of the governance of AI for global health research, and thus warrant further commentary as background to our paper. Despite the importance of RECs, foundational questions have been raised about their capabilities to accurately understand and address ethical issues raised by studies involving AI. Rahimzadeh et al. (2023) outlined how RECs in the United States are under-prepared to align with recent federal policy requiring that RECs review data sharing and management plans with attention to the unique ethical issues raised in AI research for health [ 13 ]. Similar research in South Africa identified variability in understanding of existing regulations and ethical issues associated with health-related big data sharing and management among research ethics committee members [ 14 , 15 ]. The effort to address harms accruing to groups or communities as opposed to individuals whose data are included in AI research has also been identified as a unique challenge for RECs [ 16 , 17 ]. Doerr and Meeder (2022) suggested that current regulatory frameworks for research ethics might actually prevent RECs from adequately addressing such issues, as they are deemed out of scope of REC review [ 16 ]. Furthermore, research in the United Kingdom and Canada has suggested that researchers using AI methods for health tend to distinguish between ethical issues and social impact of their research, adopting an overly narrow view of what constitutes ethical issues in their work [ 18 ].

The challenges for RECs in adequately addressing ethical issues in AI research for health care and public health exceed a straightforward survey of ethical considerations. As Ferretti et al. (2021) contend, some capabilities of RECs adequately cover certain issues in AI-based health research, such as the common occurrence of conflicts of interest where researchers who accept funds from commercial technology providers are implicitly incentivized to produce results that align with commercial interests [ 12 ]. However, some features of REC review require reform to adequately meet ethical needs. Ferretti et al. outlined weaknesses of RECs that are longstanding and those that are novel to AI-related projects, proposing a series of directions for development that are regulatory, procedural, and complementary to REC functionality. The work required on a global scale to update the REC function in response to the demands of research involving AI is substantial.

These issues take greater urgency in the context of global health [ 19 ]. Teixeira da Silva (2022) described the global practice of “ethics dumping”, where researchers from high income countries bring ethically contentious practices to RECs in low-income countries as a strategy to gain approval and move projects forward [ 20 ]. Although not yet systematically documented in AI research for health, risk of ethics dumping in AI research is high. Evidence is already emerging of practices of “health data colonialism”, in which AI researchers and developers from large organizations in high-income countries acquire data to build algorithms in LMICs to avoid stricter regulations [ 21 ]. This specific practice is part of a larger collection of practices that characterize health data colonialism, involving the broader exploitation of data and the populations they represent primarily for commercial gain [ 21 , 22 ]. As an additional complication, AI algorithms trained on data from high-income contexts are unlikely to apply in straightforward ways to LMIC settings [ 21 , 23 ]. In the context of global health, there is widespread acknowledgement about the need to not only enhance the knowledge base of REC members about AI-based methods internationally, but to acknowledge the broader shifts required to encourage their capabilities to more fully address these and other ethical issues associated with AI research for health [ 8 ].

Although RECs are an important part of the story of the ethical governance of AI for global health research, they are not the only part. The responsibilities of supra-national entities such as the World Health Organization, national governments, organizational leaders, commercial AI technology providers, health care professionals, and other groups continue to be worked out internationally. In this context of ongoing work, examining issues that demand attention and strategies to address them remains an urgent and valuable task.

The GFBR is an annual meeting organized by the World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, REC members and other actors to engage with challenges and opportunities specifically related to research ethics. Each year the GFBR meeting includes a series of case studies and keynotes presented in plenary format to an audience of approximately 100 people who have applied and been competitively selected to attend, along with small-group breakout discussions to advance thinking on related issues. The specific topic of the forum changes each year, with past topics including ethical issues in research with people living with mental health conditions (2021), genome editing (2019), and biobanking/data sharing (2018). The forum is intended to remain grounded in the practical challenges of engaging in research ethics, with special interest in low resource settings from a global health perspective. A post-meeting fellowship scheme is open to all LMIC participants, providing a unique opportunity to apply for funding to further explore and address the ethical challenges that are identified during the meeting.

In 2022, the focus of the GFBR was “Ethics of AI in Global Health Research”. The forum consisted of 6 case study presentations (both short and long form) reporting on specific initiatives related to research ethics and AI for health, and 16 governance presentations (both short and long form) reporting on actual approaches to governing AI in different country settings. A keynote presentation from Professor Effy Vayena addressed the topic of the broader context for AI ethics in a rapidly evolving field. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. The 2-day forum addressed a wide range of themes. The conference report provides a detailed overview of each of the specific topics addressed while a policy paper outlines the cross-cutting themes (both documents are available at the GFBR website: https://www.gfbr.global/past-meetings/16th-forum-cape-town-south-africa-29-30-november-2022/ ). As opposed to providing a detailed summary in this paper, we aim to briefly highlight central issues raised, solutions proposed, and the challenges facing the research ethics community in the years to come.

In this way, our primary aim in this paper is to present a synthesis of the challenges and opportunities raised at the GFBR meeting and in the planning process, followed by our reflections as a group of authors on their significance for governance leaders in the coming years. We acknowledge that the views represented at the meeting and in our results are a partial representation of the universe of views on this topic; however, the GFBR leadership invested a great deal of resources in convening a deeply diverse and thoughtful group of researchers and practitioners working on themes of bioethics related to AI for global health including those based in LMICs. We contend that it remains rare to convene such a strong group for an extended time and believe that many of the challenges and opportunities raised demand attention for more ethical futures of AI for health. Nonetheless, our results are primarily descriptive and are thus not explicitly grounded in a normative argument. We make effort in the Discussion section to contextualize our results by describing their significance and connecting them to broader efforts to reform global health research and practice.

Uniquely important ethical issues for AI in global health research

Presentations and group dialogue over the course of the forum raised several issues for consideration, and here we describe four overarching themes for the ethical governance of AI in global health research. Brief descriptions of each issue can be found in Table  1 . Reports referred to throughout the paper are available at the GFBR website provided above.

The first overarching thematic issue relates to the appropriateness of building AI technologies in response to health-related challenges in the first place. Case study presentations referred to initiatives where AI technologies were highly appropriate, such as in ear shape biometric identification to more accurately link electronic health care records to individual patients in Zambia (Alinani Simukanga). Although important ethical issues were raised with respect to privacy, trust, and community engagement in this initiative, the AI-based solution was appropriately matched to the challenge of accurately linking electronic records to specific patient identities. In contrast, forum participants raised questions about the appropriateness of an initiative using AI to improve the quality of handwashing practices in an acute care hospital in India (Niyoshi Shah), which led to gaming the algorithm. Overall, participants acknowledged the dangers of techno-solutionism, in which AI researchers and developers treat AI technologies as the most obvious solutions to problems that in actuality demand much more complex strategies to address [ 24 ]. However, forum participants agreed that RECs in different contexts have differing degrees of power to raise issues of the appropriateness of an AI-based intervention.

The second overarching thematic issue related to whether and how AI-based systems transfer from one national health context to another. One central issue raised by a number of case study presentations related to the challenges of validating an algorithm with data collected in a local environment. For example, one case study presentation described a project that would involve the collection of personally identifiable data for sensitive group identities, such as tribe, clan, or religion, in the jurisdictions involved (South Africa, Nigeria, Tanzania, Uganda and the US; Gakii Masunga). Doing so would enable the team to ensure that those groups were adequately represented in the dataset to ensure the resulting algorithm was not biased against specific community groups when deployed in that context. However, some members of these communities might desire to be represented in the dataset, whereas others might not, illustrating the need to balance autonomy and inclusivity. It was also widely recognized that collecting these data is an immense challenge, particularly when historically oppressive practices have led to a low-trust environment for international organizations and the technologies they produce. It is important to note that in some countries such as South Africa and Rwanda, it is illegal to collect information such as race and tribal identities, re-emphasizing the importance for cultural awareness and avoiding “one size fits all” solutions.

The third overarching thematic issue is related to understanding accountabilities for both the impacts of AI technologies and governance decision-making regarding their use. Where global health research involving AI leads to longer-term harms that might fall outside the usual scope of issues considered by a REC, who is to be held accountable, and how? This question was raised as one that requires much further attention, with law being mixed internationally regarding the mechanisms available to hold researchers, innovators, and their institutions accountable over the longer term. However, it was recognized in breakout group discussion that many jurisdictions are developing strong data protection regimes related specifically to international collaboration for research involving health data. For example, Kenya’s Data Protection Act requires that any internationally funded projects have a local principal investigator who will hold accountability for how data are shared and used [ 25 ]. The issue of research partnerships with commercial entities was raised by many participants in the context of accountability, pointing toward the urgent need for clear principles related to strategies for engagement with commercial technology companies in global health research.

The fourth and final overarching thematic issue raised here is that of consent. The issue of consent was framed by the widely shared recognition that models of individual, explicit consent might not produce a supportive environment for AI innovation that relies on the secondary uses of health-related datasets to build AI algorithms. Given this recognition, approaches such as community oversight of health data uses were suggested as a potential solution. However, the details of implementing such community oversight mechanisms require much further attention, particularly given the unique perspectives on health data in different country settings in global health research. Furthermore, some uses of health data do continue to require consent. One case study of South Africa, Nigeria, Kenya, Ethiopia and Uganda suggested that when health data are shared across borders, individual consent remains necessary when data is transferred from certain countries (Nezerith Cengiz). Broader clarity is necessary to support the ethical governance of health data uses for AI in global health research.

Recommendations for ethical governance of AI in global health research

Dialogue at the forum led to a range of suggestions for promoting ethical conduct of AI research for global health, related to the various roles of actors involved in the governance of AI research broadly defined. The strategies are written for actors we refer to as “governance leaders”, those people distributed throughout the AI for global health research ecosystem who are responsible for ensuring the ethical and socially responsible conduct of global health research involving AI (including researchers themselves). These include RECs, government regulators, health care leaders, health professionals, corporate social accountability officers, and others. Enacting these strategies would bolster the ethical governance of AI for global health more generally, enabling multiple actors to fulfill their roles related to governing research and development activities carried out across multiple organizations, including universities, academic health sciences centers, start-ups, and technology corporations. Specific suggestions are summarized in Table  2 .

First, forum participants suggested that governance leaders including RECs, should remain up to date on recent advances in the regulation of AI for health. Regulation of AI for health advances rapidly and takes on different forms in jurisdictions around the world. RECs play an important role in governance, but only a partial role; it was deemed important for RECs to acknowledge how they fit within a broader governance ecosystem in order to more effectively address the issues within their scope. Not only RECs but organizational leaders responsible for procurement, researchers, and commercial actors should all commit to efforts to remain up to date about the relevant approaches to regulating AI for health care and public health in jurisdictions internationally. In this way, governance can more adequately remain up to date with advances in regulation.

Second, forum participants suggested that governance leaders should focus on ethical governance of health data as a basis for ethical global health AI research. Health data are considered the foundation of AI development, being used to train AI algorithms for various uses [ 26 ]. By focusing on ethical governance of health data generation, sharing, and use, multiple actors will help to build an ethical foundation for AI development among global health researchers.

Third, forum participants believed that governance processes should incorporate AI impact assessments where appropriate. An AI impact assessment is the process of evaluating the potential effects, both positive and negative, of implementing an AI algorithm on individuals, society, and various stakeholders, generally over time frames specified in advance of implementation [ 27 ]. Although not all types of AI research in global health would warrant an AI impact assessment, this is especially relevant for those studies aiming to implement an AI system for intervention into health care or public health. Organizations such as RECs can use AI impact assessments to boost understanding of potential harms at the outset of a research project, encouraging researchers to more deeply consider potential harms in the development of their study.

Fourth, forum participants suggested that governance decisions should incorporate the use of environmental impact assessments, or at least the incorporation of environment values when assessing the potential impact of an AI system. An environmental impact assessment involves evaluating and anticipating the potential environmental effects of a proposed project to inform ethical decision-making that supports sustainability [ 28 ]. Although a relatively new consideration in research ethics conversations [ 29 ], the environmental impact of building technologies is a crucial consideration for the public health commitment to environmental sustainability. Governance leaders can use environmental impact assessments to boost understanding of potential environmental harms linked to AI research projects in global health over both the shorter and longer terms.

Fifth, forum participants suggested that governance leaders should require stronger transparency in the development of AI algorithms in global health research. Transparency was considered essential in the design and development of AI algorithms for global health to ensure ethical and accountable decision-making throughout the process. Furthermore, whether and how researchers have considered the unique contexts into which such algorithms may be deployed can be surfaced through stronger transparency, for example in describing what primary considerations were made at the outset of the project and which stakeholders were consulted along the way. Sharing information about data provenance and methods used in AI development will also enhance the trustworthiness of the AI-based research process.

Sixth, forum participants suggested that governance leaders can encourage or require community engagement at various points throughout an AI project. It was considered that engaging patients and communities is crucial in AI algorithm development to ensure that the technology aligns with community needs and values. However, participants acknowledged that this is not a straightforward process. Effective community engagement requires lengthy commitments to meeting with and hearing from diverse communities in a given setting, and demands a particular set of skills in communication and dialogue that are not possessed by all researchers. Encouraging AI researchers to begin this process early and build long-term partnerships with community members is a promising strategy to deepen community engagement in AI research for global health. One notable recommendation was that research funders have an opportunity to incentivize and enable community engagement with funds dedicated to these activities in AI research in global health.

Seventh, forum participants suggested that governance leaders can encourage researchers to build strong, fair partnerships between institutions and individuals across country settings. In a context of longstanding imbalances in geopolitical and economic power, fair partnerships in global health demand a priori commitments to share benefits related to advances in medical technologies, knowledge, and financial gains. Although enforcement of this point might be beyond the remit of RECs, commentary will encourage researchers to consider stronger, fairer partnerships in global health in the longer term.

Eighth, it became evident that it is necessary to explore new forms of regulatory experimentation given the complexity of regulating a technology of this nature. In addition, the health sector has a series of particularities that make it especially complicated to generate rules that have not been previously tested. Several participants highlighted the desire to promote spaces for experimentation such as regulatory sandboxes or innovation hubs in health. These spaces can have several benefits for addressing issues surrounding the regulation of AI in the health sector, such as: (i) increasing the capacities and knowledge of health authorities about this technology; (ii) identifying the major problems surrounding AI regulation in the health sector; (iii) establishing possibilities for exchange and learning with other authorities; (iv) promoting innovation and entrepreneurship in AI in health; and (vi) identifying the need to regulate AI in this sector and update other existing regulations.

Ninth and finally, forum participants believed that the capabilities of governance leaders need to evolve to better incorporate expertise related to AI in ways that make sense within a given jurisdiction. With respect to RECs, for example, it might not make sense for every REC to recruit a member with expertise in AI methods. Rather, it will make more sense in some jurisdictions to consult with members of the scientific community with expertise in AI when research protocols are submitted that demand such expertise. Furthermore, RECs and other approaches to research governance in jurisdictions around the world will need to evolve in order to adopt the suggestions outlined above, developing processes that apply specifically to the ethical governance of research using AI methods in global health.

Research involving the development and implementation of AI technologies continues to grow in global health, posing important challenges for ethical governance of AI in global health research around the world. In this paper we have summarized insights from the 2022 GFBR, focused specifically on issues in research ethics related to AI for global health research. We summarized four thematic challenges for governance related to AI in global health research and nine suggestions arising from presentations and dialogue at the forum. In this brief discussion section, we present an overarching observation about power imbalances that frames efforts to evolve the role of governance in global health research, and then outline two important opportunity areas as the field develops to meet the challenges of AI in global health research.

Dialogue about power is not unfamiliar in global health, especially given recent contributions exploring what it would mean to de-colonize global health research, funding, and practice [ 30 , 31 ]. Discussions of research ethics applied to AI research in global health contexts are deeply infused with power imbalances. The existing context of global health is one in which high-income countries primarily located in the “Global North” charitably invest in projects taking place primarily in the “Global South” while recouping knowledge, financial, and reputational benefits [ 32 ]. With respect to AI development in particular, recent examples of digital colonialism frame dialogue about global partnerships, raising attention to the role of large commercial entities and global financial capitalism in global health research [ 21 , 22 ]. Furthermore, the power of governance organizations such as RECs to intervene in the process of AI research in global health varies widely around the world, depending on the authorities assigned to them by domestic research governance policies. These observations frame the challenges outlined in our paper, highlighting the difficulties associated with making meaningful change in this field.

Despite these overarching challenges of the global health research context, there are clear strategies for progress in this domain. Firstly, AI innovation is rapidly evolving, which means approaches to the governance of AI for health are rapidly evolving too. Such rapid evolution presents an important opportunity for governance leaders to clarify their vision and influence over AI innovation in global health research, boosting the expertise, structure, and functionality required to meet the demands of research involving AI. Secondly, the research ethics community has strong international ties, linked to a global scholarly community that is committed to sharing insights and best practices around the world. This global community can be leveraged to coordinate efforts to produce advances in the capabilities and authorities of governance leaders to meaningfully govern AI research for global health given the challenges summarized in our paper.

Limitations

Our paper includes two specific limitations that we address explicitly here. First, it is still early in the lifetime of the development of applications of AI for use in global health, and as such, the global community has had limited opportunity to learn from experience. For example, there were many fewer case studies, which detail experiences with the actual implementation of an AI technology, submitted to GFBR 2022 for consideration than was expected. In contrast, there were many more governance reports submitted, which detail the processes and outputs of governance processes that anticipate the development and dissemination of AI technologies. This observation represents both a success and a challenge. It is a success that so many groups are engaging in anticipatory governance of AI technologies, exploring evidence of their likely impacts and governing technologies in novel and well-designed ways. It is a challenge that there is little experience to build upon of the successful implementation of AI technologies in ways that have limited harms while promoting innovation. Further experience with AI technologies in global health will contribute to revising and enhancing the challenges and recommendations we have outlined in our paper.

Second, global trends in the politics and economics of AI technologies are evolving rapidly. Although some nations are advancing detailed policy approaches to regulating AI more generally, including for uses in health care and public health, the impacts of corporate investments in AI and political responses related to governance remain to be seen. The excitement around large language models (LLMs) and large multimodal models (LMMs) has drawn deeper attention to the challenges of regulating AI in any general sense, opening dialogue about health sector-specific regulations. The direction of this global dialogue, strongly linked to high-profile corporate actors and multi-national governance institutions, will strongly influence the development of boundaries around what is possible for the ethical governance of AI for global health. We have written this paper at a point when these developments are proceeding rapidly, and as such, we acknowledge that our recommendations will need updating as the broader field evolves.

Ultimately, coordination and collaboration between many stakeholders in the research ethics ecosystem will be necessary to strengthen the ethical governance of AI in global health research. The 2022 GFBR illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research.

Data availability

All data and materials analyzed to produce this paper are available on the GFBR website: https://www.gfbr.global/past-meetings/16th-forum-cape-town-south-africa-29-30-november-2022/ .

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Acknowledgements

We would like to acknowledge the outstanding contributions of the attendees of GFBR 2022 in Cape Town, South Africa. This paper is authored by members of the GFBR 2022 Planning Committee. We would like to acknowledge additional members Tamra Lysaght, National University of Singapore, and Niresh Bhagwandin, South African Medical Research Council, for their input during the planning stages and as reviewers of the applications to attend the Forum.

This work was supported by Wellcome [222525/Z/21/Z], the US National Institutes of Health, the UK Medical Research Council (part of UK Research and Innovation), and the South African Medical Research Council through funding to the Global Forum on Bioethics in Research.

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JS led the writing, contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. JA contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. CA contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. PYC contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. AE contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. JWG contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. AH contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. DJ contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. KL contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. DP contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper. EV contributed to conceptualization and analysis, critically reviewed and provided feedback on drafts of this paper, and provided final approval of the paper.

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Shaw, J., Ali, J., Atuire, C.A. et al. Research ethics and artificial intelligence for global health: perspectives from the global forum on bioethics in research. BMC Med Ethics 25 , 46 (2024). https://doi.org/10.1186/s12910-024-01044-w

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Rollins Research Review: WASH-Related Recommendations, Equity in PrEP Uptake, and the Effects of COVID-19 on Health Care Workers’ and Black Men’s Wellbeing

By Shelby Crosier

Last month, Rollins researchers authored papers on a wealth of public health topics. Find summaries of a few highlights below.

Title:  Priority gender-specific indicators for WASH monitoring under SDG targets 6.1 and 6.2: Recommendations for National and Global Monitoring

Organization: The WHO/UNICEF Joint Monitoring Programme for Water Supply, Sanitation and Hygiene (JMP)

Rollins Authors: Bethany Caruso, PhD; Sheela Sinharoy, PhD; Madeleine Patrick; Nicole Stephan

Important Takeaways:

• The WHO/UNICEF JMP partnered with Emory to review opportunities for monitoring gender and prioritizing gender-specific indicators under their water, sanitation, and hygiene (WASH) targets. The authors produced a 60-page report after a multi-year, multi-phase initiative.
• Proportion (%) of individuals who have experienced water insecurity in the last four weeks, by sex and age.
• Sex and age distribution of primary household water collector.
• Proportion (%) of individuals who felt unsafe collecting water in the last four weeks due to fear of being harmed or assaulted by someone, by sex and age.
• The gender-specific indicators identified in this report will enable national and global monitoring bodies to identify gender and age inequalities related to WASH, track changes over time, and provide national governments with the data needed for taking action to address inequalities.

Title:  Equity of PrEP Uptake by Race, Ethnicity, Sex and Region in the United States in the First Decade of PrEP: A Population-Based Analysis

Journal: The Lancet Regional Health

Rollins Authors: Patrick Sullivan, DVM; Stephanie DuBose; Jodie Guest, PhD; Aaron Siegler, PhD

• Although pre-exposure prophylaxis (PrEP) has been approved for HIV prevention in the U.S. for over a decade, uptake of PrEP has been slow, even for populations at higher risk of HIV infection.
• Rollins researchers used pharmacy data to look at the number of PrEP users across different regions, races, ethnicities, and sexes between 2012 and 2021.
• Over the study period, PrEP use went up among all racial and ethnic groups, sexes, and regions. However, the PrEP-to-need ratio (a measure of PrEP usage relative to a population’s HIV risk) showed that PrEP uptake is not equitable across any of those three measures. For instance, PrEP use is lowest in Black and Hispanic populations, who experience the largest share of HIV infections.
• To increase equitable uptake of PrEP and decrease new HIV infections, it is important that interventions focus on getting PrEP to the populations that need it the most.

Title:  Systemic Effects of the COVID Pandemic on Rural Black American Men’s Interpersonal Relationships: A Phenomenological Examination

Journal: PLOS One

Rollins Author: Michael Curtis, PhD

• Studies have shown that the psychological and economic effects of the COVID-19 pandemic disproportionately affected Black men living in the rural South, but not much research has been done about the effects on their social networks.
• In this study, researchers interviewed 17 Black men in rural Georgia to learn about how the pandemic affected their interpersonal relationships.
• All men reported that the pandemic majorly impacted their relationships—often allowing them to improve relationships with family members but causing distress in romantic relationships. Many participants also felt disconnected from their communities during the pandemic.
• These findings highlight the importance of considering men’s relational health in pandemic recovery efforts.

Title:  Providing Trauma-Informed Care During a Pandemic: How Health Care Workers at Ryan White-Funded Clinics in the Southeastern United States Responded to COVID-19 and Its Effects on Their Well-Being

Journal: Journal of the International Association of Providers of AIDS Care

Rollins Author: Caroline Kokubun; Katherine Anderson; Olivia Manders; Ameeta Kalokhe, MD; Jessica Sales, PhD

• The COVID-19 pandemic is a traumatic event which has increased levels of burnout among health care workers, especially those who work in under-resourced settings like Ryan White Clinics—which provide care for under- and uninsured people living with HIV.
• Researchers analyzed qualitative interviews with health care workers at Ryan White Clinics to explore their wellbeing and experiences with trauma-informed care during the pandemic.
• Health care workers reported higher levels of stress, burnout, fear, and challenges with clinic operations, which negatively impacted their wellbeing. While awareness of trauma-informed care practices to increase wellbeing rose during the pandemic, it was not practiced consistently across clinics.
• Implementing trauma-informed care practices in Ryan White Clinics and similar health care settings could help safeguard the mental health and wellbeing of health care workers.

Associated Topics:

• Behavioral, Social, and Health Education Sciences
• Environmental Health
• Epidemiology
• Global Health
• Diversity, Equity, and Inclusion
• Health Disparities
• Safe Water and Sanitation
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Duke University Research Needs Phase 2 Report and Service Recommendations

Executive summary.

In 2022, Duke conducted a comprehensive study of Research IT Needs, across all its non-clinical scholarly domains. Following the release of the December 2022 summary report, Duke’s Vice President for Information Technology, Vice President for Research and Innovation and Vice Provost for Library Affairs teamed up with others to sponsor Phase 2 of the effort—developing service proposals to meet the Phase 1 needs expressed by faculty, which encompass much more than IT.

From January-May 2023, six cross-functional staff teams—each with faculty representation—drew up 39 proposed services to address Phase 1 expressed needs. After further service refinement and faculty and sponsor feedback, twelve services are recommended for implementation and they comprise three overarching service clusters , illustrated below, with the relative service priority of each enumerated:

Together these three overarching service clusters and their twelve services reflect a coordinated and integrated research support program across the Office for Research and Innovation (ORI), Office of Information Technology (OIT), Duke University Libraries (DUL) and others, in conjunction with Schools. Five of the twelve proposed service are already being actively pursued by service partners.

These services advance to Phase 3 which will focus on the funding approaches to implement the services (July-September 2023). Phase 3 will be led by financial experts and is likely to involve a multimillion-dollar funding increment on top of the indirect cost recoveries already in place today that support Duke’s research endeavor (in excess of $300M). The funding approaches identified in the Phase 3 process are expected to vary for different services, from university (allocation) funded, to direct-to-grant funded, to overhead (indirect cost recovery) funded. Philanthropy may also be relevant and in some cases a service might be funded in part or in full by internal budget reallocation at the service provider level (but this is assumed to be the exception rather than the norm).

Beyond these twelve services, other proposed services were compelling and may represent targets for future funding or local (School-specific) pilots. As one survey respondent put it, “the solutions are so refined that they ALL sound nearly equally compelling.” Of note, two pilots are already being pursued with Engineering for services that were not advanced to Phase 3 because their need was more localized.

Background and Context for Phase 2

From February-November 2022, Duke’s Information Technology Advisory Council (ITAC) undertook an assessment of Research IT Needs at Duke. The assessment invited participation from 37 faculty and 2 research/teaching staff 1 who were identified by deans and drawn from non-clinical scholarly domains. Their input was synthesized into six major findings and ten recommendations reflecting areas of common, perceived need. It is important to note that various findings and recommendations extended beyond the IT domain to encompass research support more generally.

The result of the assessment was presented to Academic Council on December 1, and a summary report 2 was simultaneously released to document the process and outcomes. Soon after, the Vice President for Information Technology, Vice President for Research and Innovation and Vice Provost for Library Affairs joined together as the three primary sponsors in establishing Phase 2 of the Research IT Needs assessment. The Phase 2 work was designed to be carried out by six cross- functional teams, whose purpose was to identify, develop and prioritize service proposals or projects that would be responsive to the recommendations identified by researchers in the Phase 1 effort.

Phase 2 Working Group Formation and Service Proposal Development and Consolidation

In January 2023, the primary sponsors identified charges and membership for six working groups (teams), one for each of the Phase 1 finding in areas of People, Process/Structure and Technology. The primary sponsors solicited eight other leaders (deans and other administrative executives), each of whom joined in sponsoring one of the Phase 2 working groups. The teams were identified as Groups A-F, corresponding to the finding from Phase 1 on which they were tasked to work.

Each team was largely comprised of staff drawn from ORI, DUL, OIT, and DHTS (Duke Health Technology Solutions), with others. The concentration of membership from these units was acknowledgement that those groups were likely providers of future services and solutions arising from Phase 2. Each group also included at least two faculty champions and other faculty consultees who were selected to monitor the working group’s emerging service and project proposals to ensure the process remained researcher-centric and solutions were responsive to the faculty needs. A total of 55 individuals—26 staff and 29 faculty—were invited to participate in the six Phase 2 working groups, serving in distinct roles as Leads, Members, Faculty Champions, Faculty Consultees, Consulting Experts, and Staff Facilitators. Six of the faculty invited to engage in Phase 2 were active participants from Phase 1 and their inclusion provided a feedback loop between the phases. Other Phase 2 faculty were drawn from ITAC (9) to retain linkage to the body that initiated and oversaw Phase 1, and the balance (14) were drawn from faculty at large in response to Phase 1 feedback from deans, the provost, Academic Council, and others. (See Appendix A for membership and charges.)

1 For simplicity, this report will refer to both the 39 faculty and 2 research/teaching staff participants in Phase 1 as faculty.

2 The full report from Phase 1 is available at https://duke.is/72sjn.

Working groups met with sponsors in February to receive their charge, then each group met weekly over the next ten weeks to review Phase 1 findings, evaluate existing resources and associated gaps, and identify solutions they believed would be responsive to the needs expressed in Phase 1. Meeting frequency for Phase 2 participants was based on role, with each team’s 3-4 leads called on more extensively (weekly) than members (bi-weekly) or faculty champions (3 times in the 10 weeks).

Faculty had the option to engage as extensively as they wished, some choosing to participate deeply and others electing limited participation. Consultees /experts were called upon only as needed.

By early April, the six working groups had identified 39 potential services they believed could help meet the researcher needs expressed in Phase 1. These services are describ ed in Appendix B. On April 6 a poster session was organized for all six groups, with sponsors and participants from both phases of the project invited. More than 50 individuals attended, about half representing Phase 2 staff leads, members, consulting experts and facilitators, and the other half consisting of faculty and sponsors. The poster session stimulated conversation across the various working groups and faculty provided feedback regarding the 39 proposed services (see Appendix C ). As a result, ten service proposals were consolidated into other, similar proposals, leaving 29 distinct services / proposals for further consideration. ( Appendix D details the consolidation process.)

During April and early May, a readout for each working group was held with its sponsors to discuss and refine proposed services. The status of the Phase 2 effort also was reviewed with several groups at the end of the academic year: with Deans Cabinet on April 24, with the Faculty Subcommittee of EROC (Executive Research Oversight Committee) on May 2 and with ITAC on May 11.

In May, poster session feedback, sponsor readouts, and guidance from a faculty expert in survey design were used to further pare the 29 distinct services/projects down the 21 service proposals that were most responsive to the overall needs of researchers as expressed in Phase 1. (See Appendix D. )

Prioritization Process and Resulting Categories of Recommended Outcomes

Proposed services were rated by faculty and sponsors, then graphed. As the following conceptual graph illustrates, they fell into five broad categories with three associated outcomes: twelve services are recommended to advance to Phase 3 for funding strategy development; two services require further evaluation; and at least five services may represent partnering opportunities with Schools.

Appendix E provides an actual graph showing how each distinct Phase 2 service aligns with the different categories (or falls outside them), based on faculty and sponsor ratings, as well as cost. Categories and related services are described next, with estimated costs noted in shorthand ($-$$$).

Faculty Top Quartile Priorities: Faculty from Phases 1&2 (n=58) were surveyed regarding proposed services. Response rate was an impressive 67% overall and based on mean faculty ratings 3 , five top quartile services emerged as highest priority (each with an average score >2.2 score on 3-point scale). The faculty survey responses and write-in commen ts appear in Appendix F.

• Add 15-20 FTEs spanning Libraries, ORI, OIT and Schools to enable and improve new categories of research support and provide more consistent offerings to units. ($$$)
• Devise tools to manage data over its life cycle , understand storage cost, and clarify where data reside. Provide storage capacity to meet 80% of active research project need. ($$)
• Enhance VM provisions (processing / memory) in the Duke Compute Cluster (DCC)

that are provided to researchers; extend access to graduate (PhD) students and postdocs. ($)

• Provide storage flexibility to meet differing research needs (secure + public access) that are

compliant w/ regulations for storage retention. ($$$)

• Develop training programs for faculty and students (grad and undergrad) and ensure IT personnel are well trained on research support services. ($$)

Sponsor Additional Priorities: Sponsors next rated strategic impact of the proposed services 4 and four more service priorities resulted. Each garnering an average sponsor rating >4.5 and was also highly rated by faculty (scoring above the median).

• Better support AI/ML and other research through GPU capacity in the DCC, similar to the

DCC’s on-demand CPUs access (shared and scavenged). ($)

• Use a risk-based approach to establish security and compliance expectations at a project level, based on regulations, risk, and data classification; include guidance for how exceptions can be requested. ($$)
• Build cross-department virtual teams , to better support personnel across Schools and in ORI, OIT, and Libraries, using 1-3 FTEs to manage, develop and support the personnel. ($$)
• Institute protected enclaves to encapsulate individual project data with requisite security protections; enable authorized access/data movement based on the project circumstances. ($$)

High Impact/Low-Cost Priorities: Finally, very rough cost estimate ranges were developed by working group staff, as low ($, <$150K), medium ($$, $150K-$750K), or high ($$$, >$750K). These estimates define the bubble size in the graph in Appendix E and are noted for each service above and below. Three additional services emerge as a result, each with high strategic impact and lower estimated cost:

• Develop a self-service tool to guide service selection based on data classification, access

attributes, etc. (like Cornell’s “Finder tool”). ($)

• Provide secure DCC services that are functionally equivalent to OIT's existing virtual machine (VM) and other offerings. ($)
• Support faculty startup packages /semi-autonomous sub-clusters, delivering priority / immediate access to ‘owners’ while expanding the DCC and leveraging spare cycles. ($)

3 NB: Eight lower-rated services were excluded from the Faculty Survey but were placed along the X-axis of the Appendix E bubble graph based on Poster Session ratings of those services, relative to other service ratings.

4 Sponsors rated all 29 consolidated services/projects, incorporating the eight lower/deferred priority items not presented in the faculty survey. This was in recognition that there could be certain services of high strategic value to the institution, but which would not necessarily be highly rated by individual faculty.

These twelve services recommended for Phase 3 form three broad service clusters , with the number beside each service corresponding to its overall priority as determined by the process detailed above.

On-the-Bubble Service Priorities: Two other services are worthy of further evaluation: both had reasonably high ratings by sponsors (4.0-4.25), but each received slightly lower faculty ratings and has an estimated annual cost that requires further financial validation:

• Create Data Continuity Services that ensure data integrity and availability , including providing the storage associated with maintaining data continuity. ($$-$$$)
• Create a single, central protected research network rather than the separate ones provided by OIT and DHTS. ($-$$)

Of note, a project to pilot moving a Basic Sciences unit to OIT’s network is being explored.

School Based Priorities: Variation in priorities across scholarly domains motivates further discussion. Appendix G gives more detail on services with high domain-specific ratings but not promoted in the global process. One service highly rated by Basic Sciences/Nursing (create a single, central protected research network) already appears in the On-the-Bubble category above, with its strategy identified.

In addition, five other services rated highly within one or two domains, but not overall. These reflect collaborative opportunities with specific service partners (designated to the right of each service):

Of course, other services not called out above as collaborative opportunities can certainly be pursued, especially where the service has low estimated implementation costs or where creative approaches to implementation might be pursued. Consider, for example, two other services that were of particular interest to faculty in Natural Sciences/Environment (Create/optimize a special- purpose VM environment for graphical intensive work ) and Engineering (Formalize/extend special purpose FastMPI cluster ). In both cases the sponsors perceive opportunities to develop proposals with domain faculty to fund these services via foundation or federal agency grants. In the case of the Engineering FastMPI cluster, the graph in Appendix E shows two points, differenting its two cost approaches: one if funded institutionally and the other reflecting funding through grants.

This type of creative partnering could lead to implementation of considerably more than the twelve services initially prioritized and advanced to Phase 3. Of significance, this Research IT Needs process has already spurred creative implementation approaches for two pilots with Engineering. The FastMPI cluster referenced above is being funded primarily by Engineering, then opportunistically, an education cluster (School priority (c) above) will be created through the “trickle down” of some legacy Engineering MPI equipment, already operated by OIT. Each cluster’s usage model will follow the DCC model, where a primary queue provides priority access to the designated Pratt function(s), and lower priority queue(s) provide other researchers throughout Duke with ‘scavenger’ access to unused computational nodes.

Conclusion and Next Steps

The twelve services enumerated on page 3 now advance to Phase 3, due to their high likelihood of enhancing Research IT (and related) support across Duke. These services will form a coordinated and integrated research support program across the Office of Information Technology (OIT), Office of Research and Innovation (ORI), Duke University Libraries (DUL) and others, in conjunction with Schools. They will be pursued via the three Service Clusters articulated on page 4. Service partners have already launched initial work for five of the twelve priority services with low- cost estimates ($), even ahead of the essential and anticipated funding commitments in Phase 3.

Although implementing these services requires an incremental multimillion-dollar investment, the process through Phases 1 & 2 reinforces that even despite Duke’s extensive existing investment in research, new technological, regulatory, and competitive challenges demand appreciable, further investment for Duke to remain preeminent among research universities.

Phase 3 will aim to develop funding strategies for these services, in aggregate and individually. This will likely involve a combination of allocated funding, F&A/Indirect rate changes, services billed direct to grants, philanthropy or other approaches. Financial experts, along with sponsors and other leaders, will guide the Phase 3 work and develop financial proposals over the first quarter of FY24.

In parallel, two services identified on page 4 that do not advance to Phase 3 will be more fully studied by service providers / sponsors as potential targets for pilots in FY25. Further evaluation will refine their service definitions, cost estimates, and / or identify alternative approaches.

Finally, five further services designated as (a)-(e) on page 4 (and possibly others), reflect potential partnering opportunities among sponsors and individual Schools, at a pace and scale determined by the parties and based on localized priorities and resources at the service provider and School level. These services are estimated to be modest in cost (estimated <$150K), but because their value—at least initially—is believed to be more localized, they become opportunities to be funded by Schools.

The sponsors acknowledge and thank the many faculty and staff who have contributed to the process to date and are optimistic that after Phase 3 and the twelve initial service implementations, that some non-prioritized services above may become candidates to pursue in a future stage of this project.

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• Science & Research
• Science and Research Special Topics
• Advancing Regulatory Science

Recall of patient-reported symptoms and function in episodic disease/conditions, specifically temporomandibular disorders

CERSI Collaborators: Triangle CERSI: Antonia Bennett, PhD; Theresa Coles, PhD; Pei Feng Lim, DDS; Lesley Skalla, PhD; Laura Mkumba, MSc; Deborah Usinger, BA.

FDA Collaborators: Caiyan Zhang; Jeffery Toy; Beth Stirling; Andrew Steen; Devon Allison; Fraser Bocell; Lexie Perreras; Eva Rorer; Srinivas Nandkumar

CERSI Subcontractors: Flying Buttress Associates- Jeph Herrin, PhD

CERSI In-Kind Collaborators: OptumLabs - William Crown, PhD; University of San Francisco - Sanket Dhruva, MD

Non-Federal Entity Collaborators: Johnson and Johnson- Karla Childers, MSJ, Paul Coplan, ScD, MBA, Stephen Johnston, MSc

Project Start Date: September 1, 2023

Regulatory Science Framework

Charges : Modernize Development & Evaluation of FDA-Regulated Products; Clinical Outcome Assessment Topic Area : Substance Use & Misuse-->

Regulatory Science Challenge

Patient-reported outcome (PRO) questionnaires ask patients about their symptoms and how their condition may interfere with activities of daily living (functional limitations). This information can be important inputs when evaluating medical products, for example, for medical device safety and effectiveness. Sometimes, the questions ask patients to remember and report the information within a certain time frame. For example, “How do you feel now?”, “How do you feel in the past 7 days”, “How do you feel in the last month?”. This time frame is the “recall period.” The recall period needs to be long enough for a patient’s recollection to be complete, but also short enough for patients to more easily remember information. For conditions like temporomandibular disorders (TMDs) where symptoms might vary over time, the appropriate recall period for TMD PRO questionnaires is unclear.

Project Description and Goals

Patients with conditions like TMD may have symptoms that vary over time in how intense or frequent they are and how much they interfere with activities of daily living. This project aims to find the best ways to measure these patient-reported symptoms and functional limitations. Investigators will first look at results of scientific studies to see what is already known about recall periods for TMD symptoms and TMD PRO questionnaires. Then, investigators will survey adult TMD patients and clinicians who treat TMD to learn more about the patterns and timing of symptoms and functional limitations that are common in TMDs. A diverse sample of patients will be surveyed, with a mix of age, gender, race, and disease length and severity. Clinicians will have a wide range of specialties and relevant experience with treating TMD. Results will be analyzed and serve as a basis for developing recall period recommendations for TMD symptoms and functional limitations.

Research Outcomes/Results

Two hundred and twenty-three patients with a mean age of 65 years completed the survey. These patients preferred a higher chance of good biopsy outcomes, and a lower chance of erectile dysfunction caused by the treatment and urinary incontinence after treatment. The patients stated in the survey that they are willing to accept:

• a 15.1%-point increase in erectile dysfunction caused by the treatment to achieve a 10%-point increase in a good biopsy outcome after HIFU ablation, and
• an 8.5%-point increase in urinary incontinence for a 10%-point increase in a good biopsy.

Also, further analysis revealed that patients who thought their cancer was more aggressive were more willing to tolerate urinary incontinence. Younger men were willing to tolerate less erectile dysfunction risk than older men. Respondents with a greater than college level of education were less willing to tolerate erectile dysfunction or urinary incontinence.

Research Impacts

Incorporating patient preference information into decisions that FDA makes about regulating devices is one of the major goals of FDA’s Center for Devices and Radiological Health (CDRH). Study findings show that patients prefer specific outcomes related to prostate ablation therapies like HIFU. The study results may help inform the design and regulation of current and future prostate tissue ablation devices by providing information about outcomes that patients most desire.

Publications

• PMID: 34677594; Citation: Wallach JD, Deng Y, McCoy RG, Dhruva SS, Herrin J, Berkowitz A, Polley EC, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Shah ND, Ross JS, Lyon TD. Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment.  JAMA Netw Open. 2021;4(10):e2130587. doi:10.1001/jamanetworkopen.2021.30587 .
• PMID: 36191949; Citation: Deng Y, Polley EC, Wallach JD, Dhruva SS, Herrin J, Quinto K, Gandotra C, Crown W, Noseworthy P, Yao X, Lyon TD, Shah ND, Ross JS, McCoy RG. Emulating the GRADE trial using real world data: retrospective comparative effectiveness study. BMJ . 2022 Oct 3;379:e070717. doi: 10.1136/bmj-2022-070717 .

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• Events and Workshops

Think Better with Mario Small

• May 03, 2024
• Think Better Series
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Video Transcript

On Wednesday, May 1, 2024, social scientist Mario Small (Columbia University) joined Chicago Booth's Nick Epley to explore who we turn to when navigating difficult times. One might assume we rely most on close relationships, but Small's research finds that we often confide in more casual acquaintances with whom we have less-complicated relationships. 

This event was part of the Think Better speaker series  hosted by the Roman Family Center for Decision Research. 

A full recap and transcript are forthcoming. 

Related Topics

• Roman Family Center for Decision Research
• Behavioral Science

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