research ethics committee review

Research organisations and research ethics committees - ESRC

Criteria for research ethics committee review.

These principles should be considered in relation to the nature of the research outlined, the context in which it is undertaken and the accepted norms and standards set by professional societies, disciplinary bodies and research organisations (ROs).

Researchers, ROs and research ethics committees (RECs) must ensure all proposals that have been recommended for funding by ESRC are appropriately reviewed before the actual research commences.

Role of a REC

A REC should review the research proposal and make a proportionate judgement concerning whether there is an appropriate balance of risks and benefits of the research.

RECs should give due regard to the consequences of the research for those directly involved in and affected by it, and to the interests of those who do not take part in the research but who might benefit or suffer from its outcomes in the future.

RECs also need to balance the safety of researchers, especially where they are working in covert situations or conducting lone fieldwork, and the benefits of the research.

RECs should review research proposals in terms of their ethics probity which will include consideration of the design, outputs and proposed conduct of the research. These should be considered in terms of the ethics issues raised (for example, whether the method of recruitment proposed puts undue pressure on individuals to participate) and the way in which they are addressed.

The scholarly or scientific standards or merits of the research are not the primary responsibility of the REC – these should be evaluated by appropriate peer review. Where the REC needs greater understanding of the scientific or scholarly merit of a proposal in order to make a judgement about ethics issues, it should seek the advice of an independent researcher with experience and expertise in the research methods and paradigm described in the proposal.

The knowledge and expectations that members of RECs bring to the ethics review of research proposals are fundamental to the way they are reviewing. This is particularly clear in some forms of qualitative research where it may be impossible or undesirable to obtain signed consent from each respondent at the outset of the research.

Where more than one perspective or ethics principle applies to a specific case, clear ethics reasoning will be required and debate should be encouraged.

Good ethics review requires sensitivity to the context in which a research study will be conducted, and good ethics reasoning requires careful thought and consideration.

Working collaboratively with researchers will best engage them in achieving the highest ethics standards in their work. Ethics review should be seen as a valuable part of research design, execution and dissemination rather than a troublesome hurdle to jump.

REC decision

RECs may give a favourable opinion on the proposal as submitted, give a provisional approval subject to the researcher meeting specified conditions (which may require further review), or reject the proposal on ethics grounds.

RECs should record and make clear how they come to their decisions, including whether ‘lead reviewers’ are designated for a proposal and whether decisions can be made on the basis of a majority view.

The decision made for a proposal, and the grounds on which it was made, should be recorded and provided to the researchers, and a copy kept on file with the proposal for a specified minimum period consistent with the RO’s policy on information retention. This period should extend beyond the lifetime of the project.

Accountability of REC decisions should be ensured within RO governance structures, and opinions given by RECs should be open to scrutiny. Certain aspects of research may need to remain confidential; for example, intellectual property needs to be protected, as do research findings pre-publication.

There should be clarity in REC operating procedures to ensure that this balance between openness and protection is consistently maintained.

Where a proposal does not meet the expected ethics standards or changes are required, it is important for the REC to give clear feedback on what needs to be amended.

Where an ethics proposal of ESRC-funded research is rejected, the ESRC lead officer should be notified by the RO representative (which may be the principal investigator or the RO’s research support office).

Ongoing review

As part of RO governance, RECs should serve to maintain ethics standards throughout the research lifecycle of a project and effectively and rapidly support researchers in resolving ethics issues as they arise. Ongoing monitoring and support should be proportionate to the nature and degree of risk and harm encountered in the research.

Where a study design is emergent, the REC should agree, with the researchers, procedures for ongoing ethics review (for example through submission of staged ethics applications relating to different aspects of the work, or through a Project Advisory Group).

Procedures for reporting to the REC (or a designated sub-committee) any unforeseen events that might challenge the ethical conduct of the research or which might provide grounds for discontinuing the study should be formally agreed with the researchers.

Where a REC or a designated sub-committee considers that a monitoring report or ad hoc audit by the RO has raised significant concerns about the ethics in the conduct of the study, it should request a full and detailed account of the research to be submitted for full ethics review conducted by the responsible REC. The REC should review the implications of the issues with assistance from non-conflicting advisory bodies, independent experts and mentors if required.

Where a principal REC or designated sub-committee considers that a study is being conducted in a way which is not in accord with the conditions of its review or in a way which does not appropriately protect the rights, dignity and welfare of research participants, it should initially arrange a meeting of all those concerned with a view to resolving the difficulties. In an extreme situation, the REC may withdraw its favourable opinion, and recommend to the appropriate body in the RO that the research be suspended or discontinued. ESRC should be informed of this decision and reserves the right to recoup its grant funding in extreme cases of ethics and research misconduct, pending further investigation.

Last updated: 16 March 2023

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• Open access
• Published: 18 August 2017

Improving the process of research ethics review

• Stacey A. Page   ORCID: orcid.org/0000-0001-6494-3671 1 , 2 &
• Jeffrey Nyeboer 3  

Research Integrity and Peer Review volume  2 , Article number:  14 ( 2017 ) Cite this article

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Research Ethics Boards, or Institutional Review Boards, protect the safety and welfare of human research participants. These bodies are responsible for providing an independent evaluation of proposed research studies, ultimately ensuring that the research does not proceed unless standards and regulations are met.

Concurrent with the growing volume of human participant research, the workload and responsibilities of Research Ethics Boards (REBs) have continued to increase. Dissatisfaction with the review process, particularly the time interval from submission to decision, is common within the research community, but there has been little systematic effort to examine REB processes that may contribute to inefficiencies. We offer a model illustrating REB workflow, stakeholders, and accountabilities.

Better understanding of the components of the research ethics review will allow performance targets to be set, problems identified, and solutions developed, ultimately improving the process.

Peer Review reports

Instances of research misconduct and abuse of research participants have established the need for research ethics oversight to protect the rights and welfare of study participants and the integrity of the research enterprise [ 1 , 2 ]. In response to such egregious events, national and international regulations have emerged that are intended to protect research participants (e.g. [ 3 , 4 , 5 ]).

Research Ethics Boards (REBs) also known as Institutional Review Boards (IRBs) and Research Ethics Committees (RECs) are charged with ensuring that research is planned and conducted in accordance with such laws and regulatory standards. In protecting the rights and welfare of participants, REBs must weigh possible harms to individuals against the plausible societal benefits of the research. They must ensure fair participant selection and, where applicable, confirm that appropriate provisions are in place for obtaining participant consent.

REBs often operate under the auspices of post-secondary institutions. Larger universities may support multiple REBs that serve different research areas, such as medical and health research and social science, psychology, and humanities research. Boards are constituted of people from a variety of backgrounds, each of whom contributes specific expertise to review and discussions. Members are appointed to the Board through established institutional practice. Nevertheless, most Board members bring a sincere interest and commitment to their roles. For university Faculty, Board membership may fulfil a service requirement that is part of their academic responsibilities.

The Canadian Tri-Council Policy Statement (TCPS2) advances a voluntary, self-governing model for REBs and institutions. The TCPS2 is a joint policy of Canada’s three federal research agencies (Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council), and institutional and researcher adherence to the policy standards is a condition of funding. Recognizing the independence of REBs in their decision-making, institutions are required to support their functioning. Central to the agreement is that institutions conducting research must establish an REB and ensure that it has the “necessary and sufficient ongoing financial and administrative resources” to fulfil its duties (TCPS2 [ 3 ] p. 68). A similar requirement for support of IRB functioning is included in the US Common Rule (45 CFR 46.103 [ 5 ]). The operationalization of “necessary and sufficient” is subjective and likely to vary widely. To the extent that the desired outcomes (i.e. timely reviews and approvals) depend on the allocation of these resources, they too will vary.

Time and research ethics review

From the academic hallways to the literature, characterizations of REBs and the research ethics review process are seldom complimentary. While numerous criticisms have been levelled, it is the time to decision that is most consistently maligned [ 6 , 7 , 8 , 9 , 10 , 11 ].

Factors associated with lengthy review time include incomplete or poorly completed applications [ 7 , 12 , 13 ], lack of administrative support [ 14 ], inadequately trained REB members [ 15 ], REB member competing commitments, expanding oversight requirements, and the sheer volume of applications [ 16 , 17 , 18 ]. Nevertheless, objective data on the inner workings of REBs are lacking [ 6 , 19 , 20 ].

Consequences of slow review times include centres’ withdrawing from multisite trials or limiting their participation in available trials [ 21 , 22 ], loss of needed research resources [ 23 ], and recruitment challenges in studies dependent on seasonal factors [ 24 ]. Lengthy time to study approval may ultimately delay patient access to potentially effective therapies [ 8 ].

Some jurisdictions have moved to regionalize or consolidate ethics review, using a centralized ethics review of protocols conducted on several sites. This enhances review efficiency for multisite research by removing the need for repeating reviews across centres [ 9 , 25 , 26 , 27 , 28 ]. Recommendations for systemic improvement include better standardization of review practices, enhanced training for REB members, and requiring accreditation of review boards [ 9 ].

The research ethics review processes are not well understood, and no gold standard exists against which to evaluate board practices [ 19 , 20 ]. Consequently, there is little information on how REBs may systematically improve their methods and outcomes. This paper presents a model based on stakeholder responsibilities in the process of research ethics review and illustrates how each makes contributions to the time an application spends in this process. This model focusses on REBs operating under the auspices of academic institutions, typical in Canada and the USA.

Modelling the research ethics review process

The research ethics review process may appear to some like the proverbial black box. An application is submitted and considered and a decision is made:

SUBMIT > REVIEW > DECISION

In reality, the first step to understanding and improving the process is recognizing that research ethics review involves more than just the REB. Contributing to the overall efficiency—or inefficiency—of the review are other stakeholders and their roles in the development and submission of the application and the subsequent movement of the application back and forth between PIs, administrative staff, reviewers, the Board, and the Chair, until ideally the application is deemed ready for approval.

Identifying how a research ethics review progresses permits better understanding of the workflow, including the administrative and technological supports, roles, and responsibilities. The goal is to determine where challenges in the system exist so they can be remediated and efficiencies gained.

One way of understanding details of the process is to model it. We have used a modelling approach based in part on a method advanced by Ishikawa and further developed by the second author (JN) [ 29 , 30 ]. Traditionally, the Ishikawa “fishbone” or cause and effect diagram has been used to represent the components of a manufacturing enterprise and its application facilitates understanding how the elements of an operation may cause inefficiencies. This modelling provides a means of analysing process dispersion (e.g. who is accountable for what specific outcomes) and is frequently used when trying to understand time delays in undertakings.

In our model (Fig.  1 ), “Categories” represent key role actions that trigger a subsequent series of work activities. The “Artefacts” are the products resulting from a set of completed activities and reflect staged movement in the process. Implicit in the model is a temporal sequence and the passage of time, represented by the arrows.

Basic business activity model

Applying this strategy to facilitate understanding of time delays in ethics review requires that the problem (i.e. time) be considered in the context of all stakeholders. This includes those involved in the development and submission of the application, those involved in the administrative movement of the application through the system, those involved in the substantive consideration and deliberation of the application, and those involved in the final decision-making.

The model developed (Fig.  2 ) was based primarily on a review of the lead author’s (SP) institution’s REB application process. The model is generally consistent with the process and practices of several other REBs with which she has had experience over the past 20 years.

Research ethics activity model

What this model illustrates is that the research ethics review process is complex. There are numerous stakeholders involved, each of whom bears a portion of the responsibility for an application’s time in the system. The model illustrates a temporal sequence of events where, ideally, the movement of an application is unidirectional, left to right. Time is lost when applications stall or backflow in the process.

Stakeholders, accountabilities, and the research ethics review model

There are four main stakeholder groups in the research ethics review process: researchers/research teams, research ethics unit administrative staff, REB members, and the institution. Each plays a role in the transit of an application through the process and how well they undertake their role responsibilities affects the time that the application takes to move through. Table  1 presents a summary of recommendations for best practices.

Researchers

The researcher initiates the process of research ethics review by developing a proposal involving human participants and submitting an application. Across standards, the principal investigator is accountable for the conduct of the study, including adherence to research ethics requirements. Such standards are readily available both from the source (e.g. Panel on Research Ethics [Canada], National Institutes of Health [USA], Food and Drug Administration [USA]) and, typically, through institutional websites. Researchers have an obligation to be familiar with the rules for human participant research. Developing a sound proposal where ethics requirements are met at the outset places the application in a good position at the time of submission. Researchers are accountable for delays in review when ethical standards are not met and the application must be returned for revision. Tracking the reasons for return permits solutions, such as targeted educational activities, to be developed.

Core issues that investigators can address in the development of their applications include an ethical recruitment strategy, a sound consent process, and application of relevant privacy standards and legislation. Most research ethics units associated with institutions maintain websites where key information and resources may be found, such as consent templates, privacy standards, “frequently asked questions,” and application submission checklists [ 31 , 32 , 33 ]. Moreover, consulting with the REB in advance of submission may help researchers to prevent potentially challenging issues [ 15 ]. Investigators who are diligent in knowing about and applying required standards will experience fewer requests for revision and fewer stalls or backtracking once their applications are submitted. Some have suggested that researchers should be required, rather than merely expected, to have an understanding of legal and ethics standards before they are even permitted to submit an application [ 19 ].

The scholarly integrity of proposed research is an essential element of ethically acceptable human participant research. Researchers must be knowledgeable about the relevant scientific literature and present proposals that are justified based on what is known and where knowledge gaps exist. Research methods must be appropriate to the question and studies adequately powered. Novice or inexperienced researchers whose protocols have not undergone formal peer review (e.g. via supervisory committees, internal peer review committees, or competitive grant reviews) should seek consultation and informal peer review prior to ethics review to ensure the scientific validity of their proposals. While it is within the purview of REBs to question methods and design, it is not their primary mandate. Using REB resources for science review is an opportunity cost that can compromise efficient ethics review.

Finally, researchers are advised to review and proof their applications prior to submission to ensure that all required components have been addressed and the information in the application and supporting documents (e.g. consent forms, protocol) is consistent. Missing or discrepant information is causal to application return and therefore to time lost [ 7 ].

Administrators

Prior to submission, administrators may be the first point of contact for researchers seeking assistance with application requirements. Subsequently, they are often responsible for undertaking a preliminary, screening review of applications to make sure they are complete, with all required supporting documents and approvals in place. Once an application is complete, the administrative staff assign it to a reviewer. The reviewer may be a Board member or a subject-matter expert accountable to the Board.

Initial consultation and screening activities work best when staff have good knowledge of both institutional application requirements and ethics standards. Administrative checklists are useful tools to help ensure consistent application of standards in this preliminary application review. Poorly screened applications that reach reviewers may be delayed if the application must be returned to the administrator or the researcher for repair.

Reviewers typically send their completed reviews back to the administrators. In turn, the administrators either forward the applications to the Chair to consider (i.e. for delegated approval) or to a Board meeting agenda. In addition to ensuring that applications are complete, administrators may be accountable for monitoring how long a file is out for review. When reviews are delayed or incomplete for any reason, administrators may need to reassign the file to a different reviewer.

Administrators are therefore key players in the ethics review process, as they may be both initial resources for researchers and subsequently facilitate communication between researchers and Board members. Moreover, given past experience with both research teams and reviewers, they may be aware of areas where applicants struggle and when applications or reviews are likely to be deficient or delinquent. Actively tracking such patterns in the review process may reveal problems to which solutions can be developed. For example, applications consistently deficient in a specific area may signal the need for educational outreach and reviews that are consistently submitted late may provide impetus to recruit new Board members or reviewers.

REB members

The primary responsibility for evaluating the substantive ethics issues in applications and how they are managed rests with the REB members and the Chair. The Board may approve applications, approve pending modifications, or reject them based on their compliance with standards and regulations.

Like administrators, an REB member’s efficiency and review quality are enhanced by the use of standard tools, in this case standardized review templates, intended to guide reviewers and Board members to address a consistent set of criteria. Where possible, matching members’ expertise to the application to be reviewed also contributes to timely, good quality reviews.

REB functioning is enhanced with ongoing member training and education, yielding consistent, efficient application of ethics principles and regulatory standards [ 15 ]. This may be undertaken in a variety of ways, including Board member retreats, regular circulation of current articles, and attending presentations and conferences. REB Chairs are accountable to ensure consistency in the decisions made by the Board (TCPS 2014, Article 6.8). This demands that Chairs thoroughly understand ethical principles and regulatory standards and that they maintain awareness of previous decisions. Much time can be spent at Board meetings covering old ground. The use of REB decision banks has been recommended as a means of systematizing a record of precedents, thus contributing to overall quality improvement [ 34 ].

Institution

Where research ethics review takes place under the auspices of an academic institution, the institutions must typically take responsibility to adequately support the functioning of their Boards and promote a positive culture of research ethics [ 3 , 5 ]. Supporting the financial and human resource costs of participating in ongoing education (e.g. retreats, speakers, workshops, conferences) is therefore the responsibility of the institution.

Operating an REB is costly [ 35 ]. It is reasonable to assume that there is a relationship between the adequacy of resources allocated to the workload and flow and the time to an REB decision. Studies have demonstrated wide variability in times to determination [ 8 , 9 , 10 , 22 ]. However, comparisons are difficult to make because of confounding factors such as application volume, number of staff, number of REB members, application quality, application type (e.g. paper vs. electronic), and protocol complexity. Despite these variables, it appears that setting a modal target turnaround time of 6 weeks (±2 weeks) is reasonable and in line with the targets set in the European Union and the UK’s National Health Service [ 36 , 37 ]. Tracking the time spent at each step in the model may reveal where applications are typically delayed for long periods and may be indicative of areas where more resources need to be allocated or workflows redesigned.

As institutions grow their volumes of research, workloads correspondingly increase for institutional REBs. To maintain service levels, institutions need to ensure that resources allocated to REBs match the volume and intensity of work. Benchmarking costs (primarily human resources) relative to the number of applications and time to a decision will help to inform the allocation of resources needed to maintain desired service levels.

Finally, most REB members typically volunteer their Board services to the institution. Despite their good-faith intent to serve, Board members occasionally find that researchers view them as obstacles to or adversaries in the research enterprise. Board members may believe that researchers do not value the time and effort they contribute to review, while researchers may believe the REB and its members are unreasonable, obstructive, and a “thorn in their side” [ 15 ]. Clearly, relationships can be improved. Nevertheless, improving the timeliness and efficiency of research ethics review should help to soothe fevered brows on both sides of the issue.

Upshur [ 12 ] has previously noted that the contributions to research ethics such as Board membership and application review need to be accorded the same academic prestige as serving on peer review grant panels and editorial boards and undertaking manuscript reviews. In doing so, institutions will help to facilitate a culture of respect for, and shared commitment to, research ethics review, which may only benefit the process.

The activities, roles, and responsibilities identified in the ethics review model illustrate that it is a complex activity and that “the REB” is not a single entity. Multiple stakeholders each bear a portion of the accountability for how smoothly a research ethics application moves through the process. Time is used most efficiently when forward momentum is maintained and the application advances. Delays occur when the artefact (i.e. either the application or the application review) is not advanced as the accountable stakeholders fail to discharge their responsibilities or when the artefact fails to meet a standard and it is sent back. Ensuring that all stakeholders understand and are able to operationalize their responsibilities is essential. Success depends in part on the institutional context, where standards and expectations should be well communicated, and resources like education and administrative support provided, so that capacity to execute responsibilities is assured.

Applying this model will assist in identifying activities, accountabilities, and baseline performance levels. This information will contribute to improving local practice when deficiencies are identified and solutions implemented, such as training opportunities or reduction in duplicate activities. It will also facilitate monitoring as operational improvements over baseline performance could be measured. Where activities and benchmarks are well defined and consistent, comparisons both within and across REBs can be made.

Finally, this paper focused primarily on administrative efficiency in the context of research ethics review time. However, the identified problems and their suggested solutions would contribute not only to enhanced timeliness of review but also to enhanced quality of review and therefore human participant protection.

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Acknowledgements

The authors would like to thank Dr. Michael C. King for his review of the manuscript draft.

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Authors’ contributions

The listed authors (SP, JN) have each undertaken the following: made substantial contributions to conception and design of the model; been involved in drafting the manuscript; have read and given final approval of the version to be published and participated sufficiently in the work to take public responsibility for appropriate portions of the content; and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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SP is the Chair of the Conjoint Health Research Ethics Board at the University of Calgary. She is also a member of the Human Research Ethics Board at Mount Royal University and a member of the Research Ethics Board at the Alberta College of Art and Design. She serves on the Board of Directors for the Canadian Association of Research Ethics Boards.

JN is an Executive Technology Consultant specializing in Enterprise and Business Architecture. He has worked on process improvement initiatives across multiple industries as well as on the delivery of technology-based solutions. He was the project manager for the delivery of the IRISS online system for the Province of Alberta’s Health Research Ethics Harmonization initiative.

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Research Ethics Committee review

Research Ethics Committees (RECs) review research applications and give an opinion about whether the research is ethical. They look at areas such as the proposed participant involvement and are entirely independent of research sponsors (that is, the organisations which are responsible for the management and conduct of the research), funders and investigators. This enables them to put participants at the centre of their review. 

For most applicants to the Health Research Authority (HRA), the REC review forms part of the overall HRA Approval process. For some projects that do not require HRA Approval, such as research tissue banks and research databases , or  research taking place outside the NHS such as Phase 1 trials in healthy volunteers , REC review may still be required. 

This section describes the REC review process , whether this is part of HRA Approval or stand-alone. 

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Committees: Research Ethics Committees

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• Ana Borovecki 2  

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Research ethics committees have become a permanent fixture when it comes to ethics of research. They are essential part of quality control of research protocol, and their existence and work are thoroughly described in all important international documents dealing with research ethics issues. In this contribution history, development and different types of research ethics committees are discussed. The functions, structure, and locale of research ethics committees are also addressed. The global dimension of the work of research ethics committees is also discussed.

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Borovecki, A., ten Have, H., & Oreskovic, S. (2009). Ethics committees in Croatia: Studies in bioethics . Saarbrücken: VDM Verlag Dr. Müller.

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Bouëssau, M. S., et al. (2009). Research ethics committees: Basic concepts for capacity building . Geneva: WHO.

Glasa, J. (Ed.). (2000). Ethics committees in central and Eastern Europe . Bratislava: Institute of Medical Ethics and Bioethics.

Huriet, C. (2009). Article 19: ethics committees. In H. A. M. J. ten Have & S. J. Michele (Eds.), The UNESCO universal declaration on bioethics and human rights background principles and application (pp. 265–270). Paris: UNESCO.

Jonsen, A. R., Veatch, R. M., & le Roy, W. (1998). Source book in bioethics. A documentary history . Washington, DC: Georgetown University Press.

Levine, R. J. (2004). Research ethics committees. In W. T. Reich (Ed.), Encyclopaedia of bioethics (Vol. IV, pp. 2311–2316). New York, NY: Macmillan Simon and Schuster.

ten Have, H. (2005). Establishing bioethics committees guide No. 1 (pp. 40–52). Paris: UNESCO.

Further Readings

Amdur, R., & Bankert, E. A. (2011). Institutional review board: Member handbook (3rd ed.). Sudbury, MA: Jones and Bartlett Publishers.

Emanuel, E. J., et al. (Eds.). (2008). The Oxford textbook of clinical research ethics (pp. 541–588). Oxford/New York: Oxford University Press.

Schrag, Z. M. (2010). Ethical imperialism. Institutional Review Boards and the Social Sciences, 1965–2009 . Baltimore: The Johns Hopkins University Press.

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Andrija Stampar School of Public Health, School of Medicine, University of Zagreb, Zagreb, Croatia

Ana Borovecki

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Borovecki, A. (2016). Committees: Research Ethics Committees. In: ten Have, H. (eds) Encyclopedia of Global Bioethics. Springer, Cham. https://doi.org/10.1007/978-3-319-09483-0_104

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Research Article

Research ethics review during the COVID-19 pandemic: An international study

Roles Conceptualization, Formal analysis, Investigation, Methodology, Visualization, Writing – original draft

Current address: Dalla Lana School of Public Health, University of Toronto, Toronto, Canada

Affiliation Lunenfeld-Tanenbaum Research Institute, Bridgepoint Collaboratory for Research and Innovation, Sinai Health, Toronto, Canada

Roles Conceptualization, Writing – review & editing

Affiliation Institute for the History and Philosophy of Science and Technology, University of Toronto, Toronto, Canada

Roles Conceptualization, Funding acquisition, Methodology, Validation, Writing – review & editing

Affiliation School of Public Health, The University of Sydney, Sydney, Australia

Roles Conceptualization, Formal analysis, Funding acquisition, Investigation, Methodology, Supervision, Writing – review & editing

Affiliations Lunenfeld-Tanenbaum Research Institute, Bridgepoint Collaboratory for Research and Innovation, Sinai Health, Toronto, Canada, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada

Roles Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Validation, Writing – review & editing

* E-mail: [email protected]

Affiliation Faculty of Health Sciences, Western University, London, Canada

• Fabio Salamanca-Buentello, 
• Rachel Katz, 
• Diego S. Silva, 
• Ross E. G. Upshur, 
• Maxwell J. Smith

• Published: April 16, 2024
• https://doi.org/10.1371/journal.pone.0292512
• Reader Comments

Research ethics review committees (ERCs) worldwide faced daunting challenges during the COVID-19 pandemic. There was a need to balance rapid turnaround with rigorous evaluation of high-risk research protocols in the context of considerable uncertainty. This study explored the experiences and performance of ERCs during the pandemic. We conducted an anonymous, cross-sectional, global online survey of chairs (or their delegates) of ERCs who were involved in the review of COVID-19-related research protocols after March 2020. The survey ran from October 2022 to February 2023 and consisted of 50 items, with opportunities for descriptive responses to open-ended questions. Two hundred and three participants [130 from high-income countries (HICs) and 73 from low- and middle-income countries (LMICs)] completed our survey. Respondents came from diverse entities and organizations from 48 countries (19 HICs and 29 LMICs) in all World Health Organization regions. Responses show little of the increased global funding for COVID-19 research was allotted to the operation of ERCs. Few ERCs had pre-existing internal policies to address operation during public health emergencies, but almost half used existing guidelines. Most ERCs modified existing procedures or designed and implemented new ones but had not evaluated the success of these changes. Participants overwhelmingly endorsed permanently implementing several of them. Few ERCs added new members but non-member experts were consulted; quorum was generally achieved. Collaboration among ERCs was infrequent, but reviews conducted by external ERCs were recognized and validated. Review volume increased during the pandemic, with COVID-19-related studies being prioritized. Most protocol reviews were reported as taking less than three weeks. One-third of respondents reported external pressure on their ERCs from different stakeholders to approve or reject specific COVID-19-related protocols. ERC members faced significant challenges to keep their committees functioning during the pandemic. Our findings can inform ERC approaches towards future public health emergencies. To our knowledge, this is the first international, COVID-19-related study of its kind.

Citation: Salamanca-Buentello F, Katz R, Silva DS, Upshur REG, Smith MJ (2024) Research ethics review during the COVID-19 pandemic: An international study. PLoS ONE 19(4): e0292512. https://doi.org/10.1371/journal.pone.0292512

Editor: Collins Atta Poku, Kwame Nkrumah University of Science and Technology, GHANA

Received: September 5, 2023; Accepted: March 23, 2024; Published: April 16, 2024

Copyright: © 2024 Salamanca-Buentello et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All relevant data for this study are within the paper and its Supporting Information files. Additionally, the raw survey data are available from the figshare database ( https://doi.org/10.6084/m9.figshare.24076704 ).

Funding: This study was funded by Canadian Institutes of Health Research grant #C150-2019-11 ( https://cihr-irsc.gc.ca/e/193.html ) awarded to MJS. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Introduction

The ethical review of research protocols during public health emergencies (PHEs) such as the COVID-19 pandemic is a daunting endeavour. Committees tasked with assessing the ethical acceptability of research projects, which we refer to as ethics review committees (ERCs) but are also variably called research ethics boards, research ethics committees, ethics review boards, and institutional review boards, face challenges to reviewing research protocols swiftly while maintaining a high degree of rigour, all under suboptimal conditions and uncertainty. ERCs must balance the urge for rapid turnaround and flexibility with the requirement for intense scrutiny given that new projects often propose innovative but high-risk diagnostic, therapeutic, or preventive approaches to address the PHE. This is especially challenging in the case of countries with fragile health systems, poor infrastructure, and little experience conducting medical research, and also of countries experiencing protracted emergencies [ 1 – 5 ].

Failure to ensure rigour and depth during rapid ethics reviews in public health emergencies may place research participants at risk [ 6 ]. In such challenging circumstances, ERCs must consider how interventions, study design, eligibility criteria, community engagement, and approaches to vulnerable populations impact scientific validity, participant autonomy, respect for persons, welfare, justice, and social value [ 2 , 7 – 9 ]. Additional demands on ERCs may include the ability to incorporate and respond swiftly to newly available knowledge, to provide monitoring and oversight of research, and to grapple with the impact of the PHE on those involved in the research process, such as research participants, investigators, and ERC members and staff [ 7 ].

Public health emergencies force ERCs to make reasonable adjustments and design innovative strategies to address the various components of research ethics review while still adhering to ethical principles [ 3 , 6 , 7 , 10 ]. Moreover, after a PHE, changes implemented to secure continued operations of ERCs must be evaluated to determine their success and whether they should be permanently put in place to improve the everyday functioning of the committees.

Given the challenges that ERCs worldwide faced during the COVID-19 pandemic, we aimed in this exploratory study to identify their experiences in the attempt to adapt to this PHE. We were particularly interested in the availability of pandemic-specific support, the promptness of protocol review, the volume of protocols received, the modifications to and innovations in operational procedures and policies and the evaluation of their outcomes, the anticipated permanence of such changes beyond the pandemic, the presence of pressure from different stakeholders on ERCs, the efforts to ensure quorum, the changes to the composition of ERCs, and the approaches to strengthen inter-ERC collaboration. To our knowledge, this is the first international, COVID-19-related study of its kind.

This international, cross-sectional, exploratory online survey was conducted by researchers from Western University, the University of Toronto, and the Lunenfeld–Tanenbaum Research Institute in Canada, and the University of Sydney in Australia, in collaboration with the World Health Organization’s COVID-19 Ethics and Governance Working Group.

Inclusion criteria

We used targeted purposive and criterion sampling to invite Chairs and members of ERCs who were actively involved in the ethics review of COVID-19 research protocols to participate in this study. To ensure eligibility of participants, the first question of the survey asked respondents to confirm whether they had reviewed COVID-19-related research protocols during the pandemic. Responding to our survey was entirely voluntary. For the purposes of this study, we considered March 2020 as the beginning of this PHE. We specifically targeted individuals from all WHO regions. Participants were assigned to either of two categories: high-income countries (HICs) or low- and middle-income countries (LMICs), according to their reported country of residence. To do this, we used the World Bank classification of countries ( https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups ), which is based on gross national income per capita. We adopted this widely used categorization notwithstanding its limitations in terms of hiding power imbalances and reducing important differences among countries to questions of economics [ 11 ].

Survey questionnaire

The complete questionnaire is available as S1 Appendix . The overall structure and flow of the survey questionnaire, which consisted of a main “trunk” of 37 items organized into 11 thematic categories, is shown in Fig 1 . As can be seen in this figure, eight of these items branched into different survey flow elements based on respondents’ answers; seven of these eight items branched into elements with questions (six of them contained two questions). Thus, in total, the questionnaire, written in English, included 50 questions. We privileged close-ended over open-ended questions, but we allowed respondents the opportunity to provide additional comments for some items. We pilot-tested the online questionnaire with a small group of experts who fulfilled the inclusion criteria. This helped polish the wording of the questions and also assess and improve the logistics of the administration of the survey.

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https://doi.org/10.1371/journal.pone.0292512.g001

Data collection

The invitation to participate in the survey explained the nature and purpose of our study, the inclusion criteria used to select participants, a summary of the procedures involved, and the URL link to the survey. These invitations were initially distributed by email by the WHO’s COVID-19 Ethics and Governance Working Group through the email listserv of the 13th Global Summit of National Ethics Committees (an event that took place in September 2022). The Working Group identified additional potential participants among its extensive contact networks. We also circulated the invitation to experts identified by the research team. Invitations could also be forwarded to individuals designated by ERCs.

Our survey was active from October 11, 2022, to February 28, 2023. We used the Qualtrics Experience Management (XM) online platform to administer the questionnaire, which was open only to individuals who received the invitation with the link to the survey.

Data analysis

The analysis of the findings of this exploratory study employed descriptive statistics and stratified the comparison between responses of participants from HICs with those of participants from LMICs. To facilitate the examination of the results, tables were prepared showing the number and percentage of respondents from HICs and LMICs who answered each question in the survey. Qualitative data (descriptive responses to open-ended questions) were evaluated using thematic analysis and the constant comparative method.

Research ethics approval

Our study received approval from Western University’s Non-Medical Research Ethics Board (Protocol ID 120455). Additionally, it was evaluated by the World Health Organization Research Ethics Review Committee (Protocol ID CERC.0181) and was exempted from further review. The use of the Qualtrics platform facilitated data collection and management while respecting the privacy and confidentiality of participants. Respondents indicated their consent to participate in our survey by selecting a button labelled “I consent” at the end of the letter of information and consent, which appeared on the first page of the questionnaire. Responses were anonymous to protect participants’ privacy and confidentiality and encourage the open sharing of experiences.

Reporting survey results

While no universally agreed-upon reporting standards for surveys exist like there are for clinical trials and meta-analyses, the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network has recently (2021) proposed a checklist for reporting of survey studies [ 12 ]. EQUATOR has been responsible for the development of several of these standards, including the Consolidated Standards of Reporting Trials (CONSORT) for randomized control trials; Strengthening the Reporting of Observational studies in Epidemiology (STROBE) for observational studies; and Preferred Reporting Items for Systemic Reviews and Meta-analyses (PRISMA) for systematic reviews and meta-analyses. Even though this is not a globally recognized official standard, it is quite useful, and we have ensured that our manuscript fulfills all the reporting requirements included in this checklist.

Characterization of survey respondents

Two hundred and eighty-one individuals opened our survey. Of these, 250 answered the first question, which confirmed whether respondents fulfilled our inclusion criteria, and with which we could confirm their eligibility. Forty-three individuals explicitly indicated that they did not meet our criteria. Thus, the initial number of suitable respondents was 207. As expected in surveys such as ours in which participants are allowed to skip questions, the number of respondents per question varied slightly, from a maximum of 207 to a minimum of 147.

Of the 204 participants who indicated their sex / gender, 120 (58.8%) were female, 82 (40.2%) were male, one (0.5%) preferred to self-describe, and one (0.5%) preferred not to disclose this information ( Box 1 , Table a ). The proportion of females was higher in HICs (64.9%) than in LMICs (47.9%); thus, the distribution of respondents by sex / gender was more balanced in LMICs than in HICs. As shown in Box 1 , Table b , more than three quarters of respondents (77.9%) were 45 years old or older. This was true for both HICs and LMICs. Most respondents provided ethics review for national bodies such as national ethics committees or national public health organizations; more than a quarter participated in ERCs linked to academic or research institutions ( Box 1 , Table c ). However, while almost half of respondents from HICs were members of ERCs affiliated with national bodies, only one quarter of participants from LMICs provided ethics review for such organizations. In contrast, in LMICs, 40% of respondents were members of ERCs associated with academic or research institutions. Furthermore, only 20% of participants from LMICs and 13.9% of participants from HICs provided ethics review for health care facilities.

Box 1. Characterization of survey participants

https://doi.org/10.1371/journal.pone.0292512.t001

In terms of the WHO region for which ethics review was provided, all regions were represented in our survey ( S1 Table in S2 Appendix ). More than one third of respondents reviewed research protocols from Europe, almost one fifth from the Americas, one tenth from Africa, and less than one tenth each from the other WHO regions.

Table 1 shows the number of respondents by country of residence. Participants from 48 countries (19 HICs and 29 LMICs) responded to our survey. Of the 203 individuals who indicated their country of residence, 130 (64%) were from HICs and 73 (36%) from LMICs. There was a large contingent of respondents from the UK (93).

https://doi.org/10.1371/journal.pone.0292512.t002

Two thirds of respondents had six or more years of experience as ERC members. This is true for participants from both HICs and LMICs ( S2 Table in S2 Appendix ).

As shown in S3 Table in S2 Appendix , about one half of respondents (52%) were involved in only one ERC. This pattern was common for participants from HICs and LMICs. However, more than one third of respondents from HICs participated in three or more ERCs during the COVID-19 pandemic. Of those who indicated involvement with multiple ERCs, close to one half specified that such participation was simultaneous ( S4 Table in S2 Appendix ).

Support for the operation of ERCs during the pandemic

As shown in S5 Table in S2 Appendix , an overwhelming majority (78.4%) of respondents indicated that their ERCs received no additional support for the operation of their committees during the pandemic. This lack of support was more pronounced in the case of ERCs in LMICs. For the minority of ERCs that did receive support, this consisted mainly of administrative and human resources, with one quarter of respondents from LMICs stating that their ERCs also received financial support, in contrast to only 12.5% of those from HICs ( S6 Table in S2 Appendix ). In terms of specific areas supported, participants from both HICs and LMICs mentioned teleconferencing and virtual meeting capabilities, information technology, support staff, assistance for ERC reviewers, and training of ERC members ( Table 2 ). Interestingly, while 20% of respondents from HICs chose ERC support staff as one of the areas that received assistance, only 7.5% of those from LMICs did.

https://doi.org/10.1371/journal.pone.0292512.t003

In their descriptive responses, participants alluded to support for covering the costs of using online platforms for meetings and protocol review, and for acquiring or upgrading hardware such as laptops and webcams. In one ERC, members were able to claim costs of setting up teleconferencing and of telephone calls if dialling into a meeting. In other ERCs, information technology training was offered, along with technical support for the use of online platforms. It is important to note that almost half of respondents from HICs, but close to the totality (91.4%) of those from LMICs, indicated that their ERCs lacked any pre-pandemic financial planning that included provisions for the support of the committees during a public health emergency ( S7 Table in S2 Appendix ).

Modification of existing procedures or policies

Respondents from both HICs and LMICs overwhelmingly (more than 75% of participants in both cases) reported that their ERCs modified existing procedures or policies to operate during the pandemic ( S8 Table in S2 Appendix ). The most frequently modified domain was meeting logistics, followed by meeting frequency and procedures for protocol review and approval ( S9 Table in S2 Appendix ).

In terms of modifications to review procedures, several participants pointed out in their descriptive responses that their ERCs fast-tracked the review of pandemic-related studies, shortening the timeline to review and approve protocols. ERC members were expected to complete the review of these protocols within a few days and, in some cases, 24 hours. To facilitate such a quick turnaround, some ERCs created special sub-committees that would conduct very fast protocol reviews. Moreover, participants emphasized the importance of simplifying and increasing the flexibility of administrative processes. For example, several respondents indicated that their ERCs switched entirely to the use of online platforms for protocol review, eliminating the need for paper documents.

Numerous participants stated that all ERC meetings were conducted virtually (as opposed to face-to-face) during the pandemic, which, in their view, enabled ERC members and researchers to participate regardless of geographical location, prevented contagion, and allowed rapid turnaround of reviews. Even in the case of virtual sessions, all other full meeting requirements such as quorum had to be met. Some ERCs modified their meetings to open a permanent slot in their agendas for COVID-19-related research or added urgent full meetings to discuss top-priority pandemic-related trial protocols. In other cases, members were permanently available to review COVID-19-related protocols, with those pertaining to other topics addressed less frequently.

While most respondents acknowledged the advantages of using online platforms during the pandemic to organize ERC meetings and to review research protocols, several participants highlighted the challenges that the use of such technologies entailed, particularly for new and more senior members of the ERCs who felt uncomfortable using these platforms. Some individuals deplored the loss of quality in the dynamics among ERC members (stilted conversations, fewer informal interactions) compared against the benefits of face-to-face meetings. Resistance to working online for some was compounded by difficulties accessing the internet and the lack of adequate electronic devices to do so.

Regarding the modification of protocol requirements, respondents mentioned adding safety procedures for study participants and members of the research teams, facilitating remote documentation of consent, and changing the policies regarding the use of non-anonymized data from health service and public health records for the duration of the pandemic to allow more unrestrained use of data. Some ERCs transitioned from requiring the physical signature of conflict-of-interest declaration forms to an email declaration.

As shown in Table 3 , only a minority of respondents indicated that their ERCs conducted a formal evaluation of the success or failure of modifying existing procedures or policies (28% of participants from HICs and 17% of those from LMICs). More than one quarter of respondents did not know whether such modifications had been assessed.

https://doi.org/10.1371/journal.pone.0292512.t004

Design and implementation of new procedures and policies

Almost two-thirds of respondents from both HICs and LMICs reported that their ERCs had designed and implemented new procedures and policies to address the challenges brought about by the pandemic ( S10 Table in S2 Appendix ). As in the case of modifications to ERC processes, innovations occurred mainly in the areas of meeting logistics and frequency, and of procedures for protocol review and approval ( S11 Table in S2 Appendix ). This was the case for ERCs in both HICs and LMICs.

In their descriptive responses, participants mentioned the development and implementation of new standard operating procedures (SOPs) and the integration of ad hoc committees, some including specialists, for urgent, accelerated protocol review. Such fast-track ERCs could review studies in one or two days, considerably shortening the time to complete reviews. One respondent considered the most successful innovation to be the formation of a “pool” of committee members ready to be convened at very short notice to quickly review COVID-19-related protocols. Such an ad hoc committee enabled applications to be reviewed and turned around very quickly. Of note, survey participants did not explicitly specify in their descriptive responses whether these ad hoc committees were integrated exclusively by existing ERC members, or if external experts and specialists were invited to take part in them. Similarly, respondents did not comment on whether existing SOPs contemplated the creation of ad hoc committees, on the way these entities were governed, or on the modifications made to SOPs to allow the integration of such committees.

The proportion of ERCs that formally evaluated the success or failure of new procedures and policies was analogous to that described for modifications to SOPs. Table 4 shows that just 37% of respondents from HICs and 21% of those from LMICs reported that their ERCs conducted such an evaluation.

https://doi.org/10.1371/journal.pone.0292512.t005

Permanently putting into effect modifications and innovations

A substantial majority of respondents (almost three quarters of those from HICs and more than four-fifths of those from LMICs) stated that many of the modifications and innovations to operating procedures implemented during the pandemic should be permanently put into effect ( S12 Table in S2 Appendix ), particularly in the areas of meeting logistics and frequency, procedures for protocol review and approval, and training of ethics review committee members in new or modified procedures ( S13 Table in S2 Appendix ). Several participants argued in their descriptive responses that virtual online meetings should be a permanent feature of ERC operations, as they increase efficiency and preclude many of the disadvantages of face-to-face meetings. Another recommendation was to enable the integration of ad hoc committees during times of increased demand. Similarly, respondents emphasized the relevance of facilitating the incorporation of new expert members to the ERCs as required. However, 20% of participants from HICs and 50% of those from LMICs indicated that their ERCs had no support to permanently implement modifications or innovations established during the COVID-19 pandemic ( S14 Table in S2 Appendix ).

Policies, procedures, and guidelines for public health emergencies

It is noteworthy that almost half of respondents from HICs and three-quarters of participants from LMICs indicated that their ERCs did not have internal policies, procedures, or guidelines before the pandemic that could orient members regarding the functioning of the committees during PHEs ( S15 Table in S2 Appendix ). Regarding the use of internal guidelines, some ERCs adapted existing documents, while others developed entirely new procedures. In the absence of specific internal guidelines, some SOPs explicitly privileged expedited review during health crises.

In contrast to the widespread absence of internal guidelines, the ERCs of one quarter of respondents from HICs and of almost half of those from LMICs used external guidelines not developed by their committees to govern their operation during the pandemic ( S16 Table in S2 Appendix ). Members of several committees referred to publicly available national and international guidelines. A selection of the most consulted documents appears in Box 2 .

Box 2. National and international external guidelines* that survey respondents reported were used by their ERCs to manage operations during the COVID-19 pandemic

International health organizations.

• Council for International Organizations of Medical Sciences, & World Health Organization (2016). International Ethical Guidelines for Health-related Research Involving Humans (Fourth Ed.). Council for International Organizations of Medical Sciences. https://doi.org/10.56759/rgxl7405

• Pan-American Health Organization (2020). Guidance for ethics oversight of COVID-19 research in response to emerging evidence. https://iris.paho.org/handle/10665.2/53021

• Pan-American Health Organization (2020). Guidance and strategies to streamline ethics review and oversight of COVID-19-related research. https://iris.paho.org/handle/10665.2/52089

• Pan-American Health Organization (2020). Template and operational guidance for the ethics review and oversight of COVID-19-related research. https://iris.paho.org/handle/10665.2/52086

• Pan-American Health Organization (2022). Catalyzing ethical research in emergencies. Ethics guidance, lessons learned from the COVID-19 pandemic, and pending agenda. https://iris.paho.org/handle/10665.2/56139

• Red de América Latina y el Caribe de Comités Nacionales de Bioética—United Nations Educational, Scientific and Cultural Organization (UNESCO) (2020). Ante las investigaciones biomédicas por la pandemia de enfermedad infecciosa por coronavirus Covid-19. https://redbioetica.com.ar/wp-content/uploads/2020/03/Declaracion-RED-ALAC-CNBS-Investigaciones-Covid-19.pdf

• World Health Organization (2016). Guidance for managing ethical issues in infectious disease outbreaks. World Health Organization. https://apps.who.int/iris/handle/10665/250580

• World Health Organization (2020). Key criteria for the ethical acceptability of COVID-19 human challenge studies. https://apps.who.int/iris/handle/10665/331976

• World Health Organization (2020). Guidance for research ethics committees for rapid review of research during public health emergencies. https://apps.who.int/iris/handle/10665/332206

• World Health Organization (‎2020)‎. Ethical standards for research during public health emergencies: distilling existing guidance to support COVID-19 R&D. https://apps.who.int/iris/handle/10665/331507

Bioethics centres

• Nuffield Council of Bioethics (2020). Ethical considerations in responding to the COVID-19 pandemic. https://www.nuffieldbioethics.org/assets/pdfs/Ethical-considerations-in-responding-to-the-COVID-19-pandemic.pdf

The Hastings Center: Berlinger N et al . (2020). Ethical Framework for Health Care Institutions Responding to Novel Coronavirus SARS-CoV-2 (COVID-19). Guidelines for Institutional Ethics Services Responding to COVID-19. https://www.thehastingscenter.org/ethicalframeworkcovid19/

Scientific publications mentioned by respondents

• Saxena et al. (2019). Ethics preparedness: facilitating ethics review during outbreaks—recommendations from an expert panel. https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-019-0366-x

National guidelines

Resolución 908/2020. Ministerio de Salud de Argentina: https://www.argentina.gob.ar/normativa/nacional/resoluci%C3%B3n-908-2020-337359/texto

• Normativas da Comissão Nacional de Ética em Pesquisa: http://conselho.saude.gov.br/normativas-conep?view=default

• Consejo Nacional de Investigación en Salud de Costa Rica (CONIS) (2020). COMUNICADO 2: Recomendaciones para realizar investigación biomédica durante el periodo de la emergencia sanitaria por COVID-19 en Costa Rica. https://www.ministeriodesalud.go.cr/gestores_en_salud/conis/circulares/comunicado_cec_oac_oic_20082020.pdf

El Salvador

• Comité Nacional de Ética de la Investigación en Salud de El Salvador (2015). Manual de procedimientos operativos estándar para comités de ética de la investigación en salud. https://www.cneis.org.sv/wp-content/uploads/2018/07/MANUAL-CNEIS.pdf

• Indian Council of Medical Research (2017). National ethical guidelines for biomedical and health research involving human participants. https://ethics.ncdirindia.org/asset/pdf/ICMR_National_Ethical_Guidelines.pdf

• Indian Council of Medical Research (2020).National guidelines for ethics committees reviewing biomedical & health research during COVID-19 pandemic. https://main.icmr.nic.in/sites/default/files/guidelines/EC_Guidance_COVID19_06_05_2020.pdf

• Kenya Medical Research Institute Scientific and Ethics Review Unit (2019). KEMRI SERU guidelines for the conduct of research during the covid-19 pandemic in Kenya. https://www.kemri.go.ke/wp-content/uploads/2019/11/KEMRI-SERU_GUIDELINES-FOR-THE-CONDUCT-OF-RESEARCH-DURING-THE-COVID_8-June-2020_Final.pdf

Garis Panduan Pengurusan COVID-19 di Malaysia No.5 [COVID-19 Management Guidelines in Malaysia No.5] (2020). Ministry of Health of Malaysia. https://covid-19.moh.gov.my/garis-panduan/garis-panduan-kkm

• Government of Pakistan National COVID Command and Operation Center (NCOC) Guidelines (2020). [No longer available, as NCOC ceased operations on April 1, 2022)]

South Africa

• Department of Health, Republic of South Africa (2015). Ethics in Health Research: Principles, Processes and Structures (2d Ed). https://www.sun.ac.za/english/research-innovation/Research-Development/Documents/Integrity%20and%20Ethics/DoH%202015%20Ethics%20in%20Health%20Research%20-%20Principles,%20Processes%20and%20Structures%202nd%20Ed.pdf

South Korea

• Government of the Republic of Korea (2014). Bioethics and Safety Act (Act No. 12844). https://elaw.klri.re.kr/eng_mobile/viewer.do?hseq=33442&type=part&key=36

United Kingdom

• United Kingdom Health Departments / Research Ethics Service (2022). Standard Operating Procedures for Research Ethics Committees (Version 7.6). https://www.hra.nhs.uk/documents/3090/RES_Standard_Operating_Procedures_Version_7.6_September_2022_Final.pdf . [In particular, several respondents from the UK mentioned Section 9 of this document, which addresses expedited review in situations such as public health emergencies.]

• Health Research Authority (2020). https://www.hra.nhs.uk/approvals-amendments/

• Health Research Authority (2020). https://www.hra.nhs.uk/covid-19-research/covid-19-guidance-sponsors-sites-and-researchers/

• Department of Health and Social Care (2020). Coronavirus (COVID-19): notification to organisations to share information. https://www.gov.uk/government/publications/coronavirus-covid-19-notification-of-data-controllers-to-share-information

* We defined “external guidelines” as those not developed internally by participants’ ERCs

Changes in workload

Respondents stated that the workload of ERC members increased considerably during the pandemic because of the increase in the number of protocols reviewed and also due to the urgency that the approval of COVID-19-related studies demanded. More than half of participants indicated that the volume of protocols received for review increased, both for studies assigned to delegated / expedited review, and for protocols that underwent full review ( S17 Table in S2 Appendix ). The increase in the volume of protocols had unexpected consequences. For example, in one HIC, the number of applicants who were summoned to discuss their protocols with ERCs in online meetings increased proportionally to the escalation in the volume of protocols submitted. In another case, ERC members were burdened with additional tasks such as working closely with the investigators of rejected COVID-19 protocols to improve their applications until these could be approved.

In terms of the time it took ERCs to process and approve protocols during the pandemic, participants confirmed in their descriptive responses that the turnaround time for ERC review was markedly shortened, from weeks or even months to just a few days. In general, more than half of survey participants indicated that, before the pandemic, the duration of the review process, from the time of initial submission to full approval, was between three and eight weeks ( S18 Table in S2 Appendix ). In contrast, during the pandemic, this process was substantially reduced to less than two weeks for both delegated / expedited review and full review. However, this decrease was more pronounced in HICs than in LMICs ( S19 Table in S2 Appendix ). Unsurprisingly, the approval of COVID-19-related research protocols was faster than that of non-COVID-19 studies. More than two-thirds of respondents indicated that delegated / expedited review of COVID-19-related protocols took less than five weeks; this was the case for more than half of full reviews. The process was longer in LMICs, though ( S20 Table in S2 Appendix ). Conversely, protocol review was slightly longer for non-COVID-19 studies, except in the case of full reviews in LMICs, which participants reported took between three and more than 12 weeks ( S21 Table in S2 Appendix ).

Presence of external pressure on ERCs

While only 14% of respondents from HICs reported that their ERCs were subjected to different types of external pressure to both approve and reject research protocols, one third of participants from LMICs (34%) faced such a challenge ( S22 Table in S2 Appendix ). The perceived demand mentioned most frequently involved pressures to rush studies through the review process at the expense of proper examination and ethical oversight. This was especially evident in the case of COVID-19 vaccine clinical trials. Some participants highlighted their defense of the autonomy of their ERCs in the face of external influences by using, for example, research policies developed and implemented specifically for the pandemic as a tool for transparent decision-making and as a safeguard against external pressures. One ERC successfully resisted government pressure to approve a research protocol related to a domestic PCR test, human trials of locally developed ventilators, and a placebo-controlled vaccine trial proposed despite the existence of six emergency-authorized vaccines and ongoing mass vaccination.

While some respondents acknowledged that entities such as national governments were understandably impatient for preventive, diagnostic, and therapeutic measures to combat the pandemic, they still emphasized the need for proper and thorough review of research protocols. One respondent stated that institutional authorities that favoured or sponsored certain studies sought their immediate approval and considered ERCs as inconvenient hindrances to achieve this goal. Several participants described instances in which ERCs, particularly in LMICs, received pressure to approve alternative medicine clinical trials.

Types of COVID-19 protocols reviewed by ERCs

Given the range of challenges brought about by the COVID-19 pandemic, it was interesting to determine the proportion of protocols received by ERCs according to the research area in which they could be classified, namely, diagnostics, therapeutics, vaccines, pharmacovigilance, or other topics such as behavioural research. Our results suggest that between one-half and two-thirds of ERCs received from one to 10 studies in each area ( Table 5 ). In other words, all areas of COVID-19 research were covered in these protocols submitted to ERCs of both HICs and LMICs. However, it must be noted that between one-third and one-half of respondents could not classify the protocols received by their ERCs (perhaps due to not tracking such information).

https://doi.org/10.1371/journal.pone.0292512.t006

Prioritization of protocols for ethics review

Overwhelmingly, and as expected, participants reported that their ERCs considered COVID-19-related protocols urgent and thus prioritized their review and approval over that of others, particularly in terms of expediting the review of these studies and privileging their discussion during committee meetings. More than three quarters of respondents from HICs and almost two-thirds of those from LMICs indicated that their ERCs gave priority to COVID-19-related studies ( S23 Table in S2 Appendix ). In fact, in one case, an ERC stopped reviewing non-COVID-19-related protocols altogether. Some ERCs gave precedence to the review of COVID-19-related studies according to the priorities determined by their national governments. Others were assigned studies by an ad hoc national entity that triaged the research protocols. Interestingly, however, as shown in S23 Table in S2 Appendix , 15% of respondents from HICs and 27% of those from LMICs stated that their ERCs did not give priority to pandemic-related studies.

Furthermore, our results show that almost one-third of respondents from HICs and almost half of those from LMICs indicated that, for their ERCs, the review of some types of COVID-19-related studies took precedence over that of others ( S24 Table in S2 Appendix ). In their descriptive responses, participants explicitly mentioned prioritizing clinical trials, particularly those focused on COVID-19 vaccine development and safety monitoring; studies related to therapeutic agents for the treatment of COVID-19; protocols about diagnostics and prognostic factors; epidemiological studies, including those related to the natural history of COVID-19 and serosurveillance; and research affecting public health policy. In the case of one ERC in a HIC with very low infection rates resulting from successful public health measures, priority was given to vaccine trials and observational research on vaccine monitoring and community incidence.

Membership of ERCs during the pandemic

One of the main challenges that ERCs worldwide faced during the pandemic was making certain that the number and expertise of their members enabled the efficient operation of the committees under such demanding circumstances. Most survey respondents indicated that their ERCs were able to ensure quorum (80% of participants from HICs, but only 60% of those from LMICs); however, one-third of respondents from LMICs stated that quorum in their ERCs was infrequently met ( S25 Table in S2 Appendix ). Two-thirds of participants from HICs and three quarters of those from LMICs reported that their committees had taken measures to ensure continuity of adequate review of research protocols in case existing members became unavailable due to the pandemic ( S26 Table in S2 Appendix ).

ERCs in both HICs and LMICs did invite new members or appointed alternate ones to ensure quorum and inclusion of individuals with appropriate expertise. Yet, consulting expert non-members seems to have been preferred to incorporating individuals to the committee. Only 13% of respondents from HICs and 24% of those from LMICs indicated that their ERCs had added new members to accelerate protocol review during the pandemic ( S27 Table in S2 Appendix ). Similarly, 11% of participants from HICs and 37% of those from LMICs added new members with specific expertise ( S28 Table in S2 Appendix ). In contrast, almost one-third of individuals from HICs, but close to two-thirds of those from LMICs, stated that their committees had consulted expert non-members to address novel areas of research or to provide enhanced scrutiny of research protocols ( S29 Table in S2 Appendix ). In their descriptive responses, participants expressed that, in some cases, ERCs incorporated new members who were available at quick notice and comfortable with the use of online platforms for meetings and protocol review. A similar approach consisted of integrating virtual ad hoc committees solely to review COVID-19-related-protocols. For some ERCs, national legislation complicated getting additional support or adding new members. Another factor complicating the integration of ERCs was that clinical responsibilities of individuals directly in the care of COVID-19 patients soared, hindering their participation in committee meetings. One participant reported that some ERC members could not fulfill their duties in their respective ERCs because they had become highly sought-after “media celebrity” experts.

Survey respondents suggested that it would be worthwhile to assess the psychological and emotional challenges that ERC members faced when having to evaluate protocols using new, unfamiliar procedures under extreme pressure. Also, it is worth reiterating that, according to several participants, many ERC members, particularly older ones, deplored the loss of features common to face-to-face meetings, such as a warmer, more informal and welcoming environment that favoured interpersonal interactions. Other respondents expressed their desire for constructive and supportive feedback and for more appreciative and generous gestures of gratitude for the extraordinary efforts of ERCs. However, a few participants considered that being able to respond in a useful way to a public health crisis as ERC members was in itself very gratifying and validating.

National and international collaboration

While 38.5% of respondents from HICs and 40% of those from LMICs reported the presence of national and international collaboration among ERCs to standardize emergency operations and procedures during the pandemic, almost one-third of participants from HICs were unsure about the existence of such collaboration ( S30 Table in S2 Appendix ). Almost half of respondents from HICs, but more than two-thirds of those from LMICs, indicated that their ERCs did not have strategies to harmonize multiple review processes ( S31 Table in S2 Appendix ). Most participants (55% of those from HICs and 63% of those from LMICs) reported that their ERCs relied on established procedures to recognize and validate research protocol reviews conducted by other committees ( S32 Table in S2 Appendix ). About one half of respondents from HICs, but almost two-thirds of those from LMICs, affirmed that their ERCs collaborated with scientific committees that pre-reviewed or prioritized pandemic-related research protocols ( S33 Table in S2 Appendix ).

Almost 50% of participants from HICs, but little more than a third of those from LMICs, reported the presence of centralized ethics review of research protocols for multicentre studies related to COVID-19 ( S34 Table in S2 Appendix ). Conversely, one-third of respondents from HICs, but more than two-thirds of those from LMICs, stated that their ERCs did not consider the formation of Joint Scientific Advisory Committees, Data Safety Review Committees, Data Access Committees, or a Joint Ethics Review Committee integrated with representatives of ethics committees of all institutions and countries involved in COVID-19-related research ( S35 Table in S2 Appendix ).

In their descriptive responses, participants noted the need for better inter-ERC collaboration and communication at the national and international levels to share successful strategies and avoid effort duplication. A case of very successful national inter-ERC collaboration is worth mentioning. Respondents from one particular LMIC stated that, given the critical and unforeseen absence of the national entity responsible for health research ethics during the pandemic, ERCs throughout the country joined forces to create an ad hoc spontaneous informal national network of all ERC chairs and co-chairs (it also included members of the national drug regulator) to strengthen mutual support, enhance communication among ERCs, identify best practices, and share academic and ethics resources.

ERCs faced considerable challenges during the COVID-19 pandemic. Demands were placed on them to urgently review an increased volume of protocols while maintaining rigour, all under suboptimal conditions and uncertainty. Yet, our findings suggest ERCs reviewed a greater volume of protocols and did so faster than before the pandemic. Against this backdrop, our results also reveal that, despite billions of dollars having been invested into the research and development (R&D) ecosystem to support the COVID-19 research response, little to no additional resources were directed to ERCs to support or expedite their functions. This should be particularly sobering for those who raise complaints about ERCs being an “obstacle” to research [ 13 – 16 ]. It may also help to explain other challenges experienced by ERCs during the pandemic, such as the absence of internal policies or guidelines for adapting to a PHE, the collateral damage sustained from deprioritizing non-COVID-19 protocols, and the pressures felt to rush protocols through review.

Our finding that ERCs wish to sustain many of the modifications made to their operations during the COVID-19 pandemic should be interpreted in light of the fact that ERCs also report having received little or no support during the COVID-19 pandemic as well as exiguous support for the maintenance of any modifications they would like to make permanent into the future. While it is expected that the research ethics ecosystem learn from this experience and enhance operations for future threats, it is difficult to see how this will be possible without significant investment. While no one seems to disagree that the research ethics ecosystem should strive for greater efficiency and collaboration, especially during PHEs, investments are required to achieve these aims. Simply put, the experience of ERCs during the COVID-19 pandemic, while herculean in many respects, was a function of necessity and is unlikely to be sustainable.

Extant literature reporting the challenges faced by ERCs during the COVID-19 pandemic is scant and tends to be limited to the early phases of this PHE. Most studies published on this topic are confined to single countries or geographical regions, with only one study including 14 countries in Africa, Asia, Australia, and Europe[ 17 ]. Several of these contributions focus exclusively on one ERC, usually associated with an academic or health care institution. The literature includes descriptions of ERC operations during the pandemic in Central America and the Dominican Republic [ 18 ], China [ 19 ], Ecuador [ 20 ], Egypt [ 21 ], Germany [ 22 ], India [ 23 – 25 ], Iran [ 10 ], Ireland [ 26 ], Kenya [ 27 ], Kyrgyzstan [ 28 ], Latin America [ 29 ], the Netherlands [ 30 ], Pakistan [ 31 ], South Africa [ 32 , 33 ], Turkey [ 34 ], and the United States [ 35 – 37 ]. Most of these studies reported results from surveys, interviews, focus groups, and documentary analysis, including review of research protocols, ERC meeting minutes, and existing SOPs. Participants usually consisted of ERC chairpersons and members, clinical and biomedical researchers, institutional representatives, and laypeople. Most studies based on surveys and interviews included fewer than 30 respondents, with only some having more than 100 participants.

Our findings agree with this literature. Given that our study is truly global in scope, it considerably broadens what is known about the operation of ERCs during the COVID-19 pandemic and clears a path towards greater consensus on strategies to prepare for and respond during future PHEs.

In this literature, several studies emphasize the lack of support and resources to operate during the pandemic. The vast majority of ERCs made numerous modifications to their SOPs. In particular, the use of online platforms for ERC meetings and for protocol review was ubiquitous. However, ERC members across studies pointed out several disadvantages of such platforms, including lack of familiarity and technical know-how, particularly in the case of more senior members of the committees. Only a few institutions provided training, equipment, and technical support for the use of these online platforms. Consistent with our findings, almost no ERCs in these studies reported having internal policies, procedures, or guidelines to operate during a PHE. National regulations on this topic, where available, were often unclear, contradictory, rapidly changing, vague, or difficult to interpret. Conversely, several ERCs availed themselves of international guidelines ( Box 2 ), in particular those prepared by WHO [ 38 – 41 ] and PAHO [ 42 – 45 ].

In terms of changes in workload, all ERCs in the studies mentioned earlier experienced a dramatic increase in the number of COVID-19-related protocols received, which had to be reviewed very quickly in the face of pressure for expedited approvals from researchers, institutions, governments, and the media. The surge in the volume of protocols, along with shortened timelines for turnaround, severely strained ERC members’ ability to conduct rigorous, thorough, high-quality assessments. Despite feeling overwhelmed, ERC members participating in these studies managed to fulfill their responsibilities, sometimes at great personal cost.

Given the urgency to examine and approve an ever-increasing number of COVID-19 research protocols, previous studies report several strategies implemented by ERCs worldwide to prioritize their review. This frequently meant that the assessment of non-COVID-19-related studies was postponed or even abandoned. Similarly, non-interventional COVID-19 protocols were given secondary importance. Prioritization of COVID-19 protocols by type of study was rare.

Despite numerous staffing challenges, most ERCs in the studies examined were able to ensure quorum. In some cases, their institutions provided training sessions to update committee members on the rapidly changing landscape of basic and clinical knowledge about COVID-19. A less frequently used approach was to incorporate new members with relevant expertise into the ERCs. One common strategy across different countries was the integration of ad hoc committees focused exclusively on the review of COVID-19 -related protocols.

The topic of centralized review of pandemic-related research is rather contentious in this literature. While some studies report ERC members favouring such an approach, others consider that a single national ERC in charge of PHE-specific ethics review is bound to be unsuccessful due to the importance of local context in responding to PHEs. In Ecuador, forcing researchers to submit their protocols to a seven-member centralized ad hoc ERC caused considerable delays in the approval process and instead severely impeded the execution of COVID-19-related studies [ 20 ].

As shown in our results, in some countries ERCs strengthened collaboration networks during the pandemic. A notable case was the creation of a spontaneous, informal, ad hoc group in South Africa—the Research Ethics Support in COVID-19 Pandemic (RESCOP)—by ERC chairpersons and members as a response to the lack of national ethics guidance and the unexpected critical absence of the National Health Research Ethics Council at the most crucial moment in the pandemic [ 33 ]. This example highlights the clear need for national governance and oversight for research ethics to ensure accountability and responsiveness of ERCs [ 46 ].

A common topic of concern across ERCs in several countries was the set of unique challenges to obtaining informed consent during the pandemic, especially in the case of patients unable to give consent, such as those who were severely ill, isolated, or in the intensive care unit. Thus, it was necessary to find innovative alternative strategies to obtain consent.

Recommendations

The recommendations presented in Box 3 aim to strengthen the resiliency of ERCs during future public health emergencies. They are based upon our careful analysis of survey responses, and thus articulate, in a way, the concerns and expectations of the participants in our study. These recommendations closely align with the national and international guidelines listed in Box 2 , particularly with those published by WHO.

Box 3. Recommendations to strengthen the resiliency of ERCs during future public health emergencies

• Increase and assign an adequate proportion of the budgets of ethics review committees (ERCs) for:

○ their continued operation during public health emergencies (PHEs), especially in terms of online teleconferencing and review platforms

○ sustaining select modifications and innovations designed and implemented during PHEs

• Increase awareness of the value of ERCs in the research and development (R&D) ecosystem as a means of protecting research participants, ensuring social value, and promoting public trust in research outputs, rather than as a bureaucratic nuisance

• Evaluate the success or failure of modifications and innovations designed and implemented during PHEs

• Develop a “first aid kit” for each ERC that includes:

○ Existing external guidelines for committee operation during a PHE

○ Internal contingency plans designed by the ERC or its home institution that adapt existing external guidelines to local contexts

○ A directory of expert non-members available for consultation

○ Easy-to-follow checklists that incorporate the essential elements needed to function during a PHE

• Familiarize ERC members with the “first aid kit” through periodic capacity building activities

• Consider the psychological and emotional challenges that ERC members face during PHEs

• Devise strategies to defend and safeguard ERCs’ autonomy against external pressures

• Promote national and regional collaboration networks of ERCs that strengthen their resiliency during PHEs

• Facilitate collaboration between ERCs and scientific committees

Limitations and strengths

In terms of the limitations of our study, it would have been desirable to include participants from more countries, and a larger number of respondents from each country. It was probably difficult to reach a higher response rate due to “pandemic fatigue”. Non-native English speakers, especially in LMICs, may have excluded themselves from our survey. Absent or unreliable internet access could have limited the participation of some participants, particularly in LMICs. The number of ERC members that provided ethics review for health care facilities was relatively low. Despite the anonymity of their answers, respondents may have been reluctant to share specific instances of external pressures impinging upon their ERCs. The large number of participants from the UK (93 out of 281) likely skewed the results from HICs, and from experiences in the UK in particular.

We chose to present our results descriptively and did not perform any analytic tests for statistically significant differences in responses. This was because we were unable to determine a denominator, so we could not meet the requirements for many significance tests. Non-parametric tests could have been used, but we think reporting statistical significance in this context would not be informative. Non-response bias could also influence our results. This could be non-differential in its effects as our results cohere with the literature thus far reported.

To our knowledge, this is the first examination at a global level of the challenges faced by ERCs during the COVID-19 pandemic, and the strategies used to address them. Also, our study compares for the first time several dimensions of the operation of ERCs during the pandemic between committees in HICs and those in LMICs. All WHO regions were represented in our study, as participants from 48 countries (19 HICs and 29 LMICs) responded to our survey. There was an adequate balance in terms of the sex / gender of respondents. Furthermore, the ample experience of the study participants as ERC members (two thirds of respondents had six or more years of experience in this role) strengthens the generalizability of our findings. The recommendations suggested by the study participants are quite relevant to combating future public health emergencies. In general, all these strengths give credence to the validity, reliability, and accuracy of our results.

Supporting information

S1 appendix. qualtrics questionnaire..

https://doi.org/10.1371/journal.pone.0292512.s001

S2 Appendix. Supplementary tables.

https://doi.org/10.1371/journal.pone.0292512.s002

Acknowledgments

We are very grateful to all the members of ethics review committees from around the world who participated in our survey. We also want to express our gratitude to Andreas Reis and Katherine Littler of the Global Health Ethics and Governance Unit, World Health Organization, and to the following members of the World Health Organization COVID-19 Ethics and Governance Working Group, for their inputs on the survey instrument and manuscript: Aasim Ahmad, Thalia Arawi, Caesar Atuire, Oumou Bah-Sow, Anant Bhan, Ingrid Callies, Angus Dawson, Jean-François Delfraissy, Ezekiel Emanuel, Ruth Faden, Tina Garanis-Papadatos, Prakash Ghimire, Dirceu Greco, Calvin Ho, Patrik Hummel, Zubairu Iliyasu, Mohga Kamal-Yanni, Sharon Kaur, So Yoon Kim, Sonali Kochhar, Ruipeng Lei, Ahmed Mandil, Julian März, Ignacio Mastroleo, Roli Mathur, Signe Mežinska, Ryoko Miyazaki-Krause, Keymanthri Moodley, Suerie Moon, Michael Parker, Carla Saenz, G. Owen Schaefer, Ehsan Shamsi-Gooshki, Jerome Singh, Beatriz Thomé, Teck Chuan Voo, Jonathan Wolff, and Xiaomei Zhai.

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Research Ethics Review Committee (RERC)

What is the research ethics review committee (rerc).

The Research Ethics Review Committee (RERC) is an internal group within GLSEN that has been designated to review and monitor research that involves human subjects (i.e., people). Like other institutional review boards (IRBs), the RERC plays an important role in protecting the rights and welfare of people involved in GLSEN research. The RERC ensures that any research conducted by or associated with GLSEN follows established ethical principles that are aligned with GLSEN’s mission.

What does the RERC do?

The RERC has the authority to approve, require modifications in order to secure approval or disapprove research proposals that are submitted to the RERC for review. The RERC generally reviews research proposals submitted by the GLSEN Research Institute (e.g., GLSEN National School Climate Survey) as well as proposals submitted by GLSEN affiliates for research to be conducted as part of their GLSEN responsibilities. The RERC also reviews proposals by non-GLSEN researchers who wish to recruit participants for their research within the GLSEN organization that are related to GLSEN’s mission, which is to provide a safe and inclusive school environment for all LGBTQ+ students in K-12 grades, regardless of their sexual orientation, gender identity, and gender expression.

When should you contact the Research Ethics Review Committee?

You should contact the RERC at [email protected] if:

• You are affiliated with a GLSEN chapter or another GLSEN entity (e.g., GLSEN National Student Council) and are planning to conduct research involving human subjects as part of your GLSEN responsibilities (if you are not sure whether the proposed activity constitutes research with human subjects, also contact the RERC);
• You are affiliated with a GLSEN chapter or other GLSEN entity and want to promote your own non-GLSEN research study through GLSEN, including your own or other GLSEN chapters;
• You are a researcher outside of GLSEN who wants to promote your research study through GLSEN.

Note that GLSEN would only consider promoting outside research if it is related to GLSEN’s mission.

If you are not sure what constitutes human subjects research, the following is a list of what might constitute human subjects research:

• You want to administer an online or in-person survey to human subjects (e.g., LGBTQ+ high school students, elementary school teachers, parents with school-aged children, etc.).
• You want to conduct interviews that involve human subjects (e.g., LGBTQ+ high school students, elementary school teachers, parents with school-aged children, etc.).
• You want to conduct focus groups that involve human subjects (e.g., LGBTQ+ high school students, elementary school teachers, parents with school-aged children, etc.).
• You want to use already existing data that involve human subjects (e.g., LGBTQ+ high school students, elementary school teachers, parents with school-aged children, etc.);
• You plan on publishing findings from data you collected based on any of the above methods.

If you are still not sure if your proposed activity constitutes research, please contact the RERC at [email protected] as soon as possible so that an RERC member can help you determine whether your activity requires RERC review.

Note that if you are interested in using any existing data from GLSEN’s research, by and large we do not provide our datasets to researchers outside of GLSEN. Please contact the RERC at [email protected] if you have further questions.

What are some GLSEN activities that do not require RERC approval?

The following are examples of GLSEN chapters or other entities that engage in GLSEN activities that do not require RERC approval:

• Internal polls of the board or volunteers or donors, about chapter strategy;
• GLSEN-approved evaluation forms for professional development workshops;
• Collecting data for internal use only such as those listed above, and not publishing the findings.

Now that you have contacted the RERC, and your study or proposed study meets any of the above criteria, what is the next step?

If you are affiliated with a GLSEN chapter and are planning to conduct research involving human subjects as part of your GLSEN responsibilities, you will need to complete the RERC Proposed Research Application Form .

If you are affiliated with a GLSEN chapter and want to promote your own non-GLSEN research study through GLSEN, you will need to complete the RERC Research Promotion Application Form .

If you are a researcher external to GLSEN who wants to promote your own research study through GLSEN, and your study is related to GLSEN’s mission, you will need to complete the RERC Research Promotion Application Form .

Please submit your completed application to [email protected] .

You have completed the application form, and have sent it to the RERC. How long will it take to receive a decision from the RERC?

If you completed the RERC Proposed Research Application Form, the RERC chair will review your application and determine whether it will require a review by the full committee.

If it is determined that the application does not require full committee review, then the process should take no longer than 3-4 weeks for the RERC chair to send you a decision.

If the application is determined to require full RERC review, the committee meets once a quarter (January, April, July, and October) to review applications. Please provide your completed application one month prior to the full committee meeting date, so that the committee members have sufficient time to thoroughly review your application. You will receive a decision from the RERC chair within 1-2 weeks following the full committee meeting.

Once your study is approved, you will receive an official approval letter from the RERC chair. Note that the approval letter is valid for one full year from the date of approval. If you have not completed your study within one year following the date of approval, and want to continue conducting the study, your study will have to be renewed.

What if I want to renew my study because it has not yet been completed and it has been one full year since my study was approved by the RERC?

You will need to complete the RERC Continuing Review Form . Once you submit your completed Continuing Review Form, you should receive a decision from the RERC chair within one week.

Please submit your completed form to [email protected] .

I have completed my study. Is there anything else that I need to do?

Yes. You will need to complete the RERC Close Out Form . Once you submit your completed Close Out Form, you should receive a response from the RERC chair within one week that your study has been closed.

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Sr. Operations Manager Pronouns: She/Her

Senior Research Associate Pronouns: She/Her

Caitlin (or Caitie) has a PhD in Developmental Psychology with a portfolio in Women’s and Gender Studies from the University of Texas at Austin. She has experience teaching, evaluating, and conducting research in schools of all levels. Caitie’s research specialties include the experiences of transgender and nonbinary youth, LGBTQ+ youth in sports, and elementary education. Before GLSEN, Caitie worked as an Evaluation Analyst at the Austin Independent School District and she has taught at the undergrad and preschool level. Outside of work Caitie loves live music, attempting complicated and new recipes, and women’s soccer.

Director of Research Pronouns: He/Him

Dr. Joseph Kosciw is Director of the GLSEN Research Institute. GLSEN is recognized worldwide as an innovative leader in the education, youth development and civil rights sectors fighting to end bias-based bullying, violence and discrimination in K-12 schools and promote a culture of respect for all. For nearly two decades, the GLSEN Research Institute has supported the organization's mission by conducting original research on issues of sexual orientation and gender identity/expression in K-12 education and evaluating GLSEN programs and initiatives. The Institute also provides technical assistance to local GLSEN chapters and other safe school advocates in the U.S. who wish to conduct research on LGBTQ student experiences, and houses GLSEN's international initiatives which provide technical assistance to NGO and education leaders on LGBT issues in education across the globe.

Dr. Kosciw has a Ph.D. in Community Psychology from New York University, a B.A. in Psychology from the College of Arts and Sciences and an M.S.Ed. in Psychological Services in Education from the Graduate School of Education at the University of Pennsylvania.

Dr. Kosciw trained as a family therapist and has worked as a school counselor and psychoeducational consultant in elementary and secondary schools. He has been conducting community-based research for over 20 years, including program evaluations for non-profit service organizations and for local government. Under his leadership, GLSEN Research focuses on understanding the school experiences of all students, specifically as they are related to issues regarding sexual orientation and gender identity/expression, the school experiences of LGBT parents, perceptions of educators and school administrators regarding school climate, and the utility of school- and community-based efforts regarding bullying and harassment and efforts to create safe and affirming learning environments. GLSEN’s research is widely used for education policy advocacy as well as commonly cited in public media regarding LGBT student issues and school safety.

Kosciw’s work has been published in diverse scholarly and practitioner journals, including the Journal of Youth and Adolescence, the Journal of School Violence, and the Prevention Researcher. He also serves on the editorial board of the Journal of LGBT Youth: The Interdisciplinary Quarterly of Practice, Research, Policy, and Theory. He has also appeared on numerous national television and radio programs as an expert on LGBT student experiences.

In addition to his passions for community-based research, Dr. Kosciw is passionate about dogs, Eurovision, and Ukrainian pop music.

Accounting Manager Pronouns: He/Him/His

Senior Accounting Manager Pronouns: She/Her/Hers

Ashley joined GLSEN in 2005 as a Finance Associate to support the accounting processes of the GLSEN National Office and Chapter Network. Ashley's work in the non-profit sector began at the Huntington's Disease Society of America as the Chapter Operations Coordinator, working similarly with both the National Office and Chapter Network. Prior to that, Ashley has held positions at Credit Lyonnais and served as a legal clerk.

Youth Programs Associate Pronouns: They/Them

Onyx is a multi-talented artist, activist, writer, and model who dreams of using art to amplify their voice and produce positive social change. They were named GLSEN's Student Advocate of the Year in 2019 due to their work with GSAs and GSA coalitions. In their free time, they enjoy making clothes, reading, and playing classical guitar. They are now a student at Harvard University, a Point Foundation Scholar, and a GLAAD/Teen Vogue 20 Under 20 Honoree.

Rainbow Library Program Manager Pronouns: He/Him/His

Michael Rady (he/him) is a queer educator, organizer, and reader. Michael believes radical transformation is needed in American education to deliver equity for all learners, especially BIPOC students and LGBTQ+ students. Before joining GLSEN, Michael was a third-grade teacher, curriculum writer, and Senate education policy staffer. Michael’s involvement in LGBTQ+ inclusive education started when he was asked to lead the LGBTQ+ staff community group for a network of public schools in the Northeast. Interest in the group grew immensely: it increased to over 500 members, marched in pride parades, and transformed internal policies for LGBTQ+ staff and students. In 2018, Michael joined GLSEN’s Connecticut chapter to launch the Rainbow Library, a program that sends queer-affirming books to schools. Since then, the program has grown to thousands of locations in dozens of states. He sees the Rainbow Library not only as way to help youth access queer-affirming literature, but as a bridge to other LGBTQ+ supports and policy changes. Originally from New York, Michael currently splits his time between Nashville, Tennessee, where his partner and their dog, Reese, reside, and Cambridge, Massachusetts, where Michael is pursuing a Master of Education at the Harvard Graduate School of Education.

Indie is a trans nonbinary queer neurodivergent artist. Their experience being a homeless queer/trans youth shaped their devotion to youth work and social justice. Indie has over 10 years of experience working directly with youth in various way, from case management with homeless youth to community organizing development of queer and trans students. They have a passion for making mediocre art and cuddling with their adorable fur-babies.

Individual Giving Manager Pronouns: She/Her/Hers

Aubri Tuero is a development professional living in Salt Lake City, Utah. She holds a Master of International Service in Global Governance, Politics, and Security from American University in Washington, DC and a dual Bachelor of Art in History and Film & Media Arts from the University of Utah. Ms. Tuero is also a board member of Friends of Gilgal Sculpture Garden, working to preserve public art in Utah. In her personal life she enjoys taking her dog Vito to the park and discussing books with her Short Book Club.

Corporate and Foundation Relations Manager Pronouns: She/Her

Database Manager Pronouns: She/Her

Jacqueline Schweiger (she/her) is the Database Manager at GLSEN, where she processes and reports on donor and gift information. She has worked in nonprofit development for a number of years, including at GLAAD, the French Institute Alliance Française, and the Museum of Jewish Heritage - A Living Memorial to the Holocaust.

Jacqueline graduated from the University of Virginia and holds a master’s degree in Art Business from Sotheby's Institute of Art. In her free time, she enjoys reading, swimming laps, and spending time with her family.

Senior Major Gifts and Individual Giving Officer Pronouns: He/Him/His

Manager of Network Capacity Building Pronouns: She/Her and They/Them

Growing up in rural Ohio, Lyndsey knew a more just, loving, and liberated world was possible, even if she didn’t understand how; as an adult they understand that building that world requires community, action, anti-racist practice, and a lot of humility. Using practical, learner-centered approaches, Lyndsey partners with organizers, artists, academics, faith leaders, and educators to facilitate practices that invite all to get more comfortable with discomfort in order to build solidarity and courage. Lyndsey brings nearly 15 years of anti-oppression training, program design, and coaching focused on growing queer liberation and reproductive freedom through multi-racial organizing centered in iteration, experimentation, and healing. They were one of the founding directors and board members of Nashville Launch Pad, a LGBTQ+ affirming emergency shelter for youth 18-24, and serves on the Board of Directors for SisterSong Women of Color Reproductive Justice Collective. Lyndsey is southern by the way of y’all, perpetually curious, and camp kid at heart (with over 20 years working collaboratively to design camp and youth leadership experiences).

Community Mobilization Manager Pronouns: He/Him

Born and raised in Cincinnati, Ohio, Jamond has spent his career working to improve the cognitive, physical, and social-emotional outcomes for young people from cradle to career.

Most recently Jamond provided professional development and capacity building support to the Ohio Department of Education's 21st CCLC network. Additionally, he has served as Youth Development & Education Program Director for the YMCA of Greater Cincinnati, Senior Manager for Community Strategies at StrivePartnership and as Technical Advisor for the YMCA of the USA.

As a trainer and skilled facilitator, Jamond has worked all across the country helping organizations, school districts, and municipalities build capacity while developing strategies to ensure diversity, inclusion, and equity. In addition, Jamond is a multidisciplinary artist having worked professionally as a costume designer, actor, and writer. When he is not trying to save the world, he is busy working his most important job: Dad.

Deputy Executive Director for Programs and Power Building Pronouns: They/Them/Theirs

Deputy Executive Director of Communications and Marketing Pronouns: He/Him/His

David is an accomplished and progressive marketing, communications and public relations professional with extensive experience in the multi-faceted for- and not-for-profit national and international arenas. Before GLSEN, he was the Chief Marketing and Communications Officer at the Tenement Museum where he was responsible for all communications, marketing, advertising, brand management, media and public relations.

Prior to joining the Tenement Museum, he was the Marketing and Development Director for New York City’s Chinatown as part of the post-9/11 revitalization efforts. There he oversaw the Explore Chinatown tourism marketing campaign as well as the production of events such as Taste of Chinatown and Lunar Stages to draw visitors back to the neighborhood.

He has provided unique and unorthodox marketing approaches to a diverse roster of projects and institutions including New York City, where he helped create the landmark “I Love New York” campaign, The Metropolitan Opera and GMHC and amfAR during the early years of the HIV/AIDS epidemic.

He has spoken nationally and internationally on public relations, multiculturalism and diversity marketing and outreach in Birmingham (UK), Vancouver, Washington D.C., San Antonio and London; and is an Adjunct Professor at the New School teaching Arts & Cultural Marketing and Introduction to Nonprofit Management.

Chief of Staff and Deputy Executive Director for Public Policy and Research Pronouns: He, Him, His/They, Them, Theirs

Aaron Ridings (he/they) is the Chief of Staff and Deputy Executive Director for Public Policy and Research at GLSEN. In this role, he is responsible for working closely with the Executive Director to streamline operations and align cross-departmental programming to increase GLSEN’s impact. They directly oversee the Research Institute and the Public Policy Office.

They have a lifelong connection to K-12 learning communities through their parents who are a retired public school teacher and volunteer school board budget committee member. He joined the national staff team in 2019 after first being engaged with GLSEN as a member of the National Safe Schools Roundtable representing the Oregon Safe Schools and Communities Coalition in 2010. His experience at the intersections of LGBTQ+ justice, civil rights, and K–12 education includes being a member of the Steering Committee for Schools Uniting Neighborhoods, a community schools program based in the Portland, Oregon metro region, and leading a local education agency policy research project with the State of Oregon Program Design and Evaluation Services.

Throughout their 20 year career in public service, they have passed progressive policies and advanced LGBTQ+ inclusive data collection in partnership with federal, state, city, county, school district, and tribal governments. He previously served as a Senior Fellow at the Western States Center, Associate Director of the LGBTQ+ Research and Communications Project at the Center for American Progress, along with several roles at Basic Rights Oregon and other LGBTQ+-missioned organizations. Aaron was a long-time aide to Multnomah County, Oregon Chair Deborah Kafoury and most recently had stints working for Washington, D.C. Mayor Muriel Bowser and U.S. Representative Sharice Davids (KS-3). He has been an active volunteer for electoral and issue campaigns and is a former member of the Victory Fund Campaign Board and several national and state campaign committees.

His advocacy has been recognized with emerging leadership awards from the first annual Queer Heroes Northwest Awards, City of Portland, Oregon Human Rights Commission, Native American Youth and Family Center, and the Native American Rehabilitation Association of the Northwest. Aaron has a Master of Public Administration with an Award of Excellence for Community Engagement from Portland State University.

He enjoys living in Washington, D.C. and making time to visit his family’s farm in Oregon.

• 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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Received : 31 October 2023

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DOI : https://doi.org/10.1186/s12910-024-01044-w

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