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The purpose of the Research Committee is to ensure an ongoing, robust research portfolio within the College that represents the breadth and depth of public health; reflects faculty strengths, student interests and community needs; promotes faculty and student success; engages communities in translating research into action; enhances the reputation of the College; and advances the field in meaningful and impactful ways.

• The COPH Research Committee will be comprised of 9 voting members (5 faculty members from each department or discipline, and 4 at-large members). Each department will elect one ranked senior faculty member (Associate or Full Professor) who is actively engaged in research.
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The Faculty Affairs Committee advises the Dean on matters related to the faculty in the College. Specific duties include, but are not limited to:

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• Establish a system to encourage interdisciplinary research across departments/disciplines as well as student-faculty research opportunities. Review research policies and procedures from across USF that impact COPH researchers.
• Coordinate with USF Research Council regarding research policies, procedures and protocols that impact COPH researchers.

(From  Governance Manual  page 9)

Funding Opportunities and Support

USF College of Public Health Capacity Building FY 2024-2025 Funding Application. Due Date: April 15, 2024 (11:59pm)

This funding mechanism has been created to enhance research capacity, establish new interdisciplinary research collaborations (domestic and international) and/or support community engaged research. The purpose of this grant is to lay the foundation and build collaborative partnerships that will facilitate capacity for community-engaged public health research. These funds could also be used to support projects that build communities capacity for research and engagement and seek to better equip stakeholders/communities to engage as meaningful partners in public health research. Click  here  for the application. 

Application for COPH faculty to keep residual funds. Academic Year 2023/2024   

This is a request for an exemption to the current COPH policy of the Research Committee retaining 50% of the fixed price residuals at the time of closeout. Consideration will be given to how the PI plans to use the residual funds and timeline for doing so. Click  here  for the application. 

Application for COPH faculty support for external review of proposals prior to submission. Academic Year 2023/2024

Consideration will be given to faculty rank, funds available, funding source and research team (e.g., inclusion of USF faculty/interdisciplinary faculty). As long as funds are available, the Research Committee will support a portion of the cost for external review if the application is approved. Click  here  for the application.

Faculty  Application for COPH support for publication/dissemination fees. Academic Year 2023/2024

Consideration will be given to faculty rank, funds available, journal quality and relevance to your field, and authorship (e.g., inclusion of other COPH students and/or faculty). As long as funds are available, the Research Committee will support a portion of the publication/dissemination fees if the application is approved. Click  here  for the application.

Student Application for COPH support for publication/dissemination fees. Academic Year 2023/2024

Consideration will be given to funds available, journal quality and relevance to your field, trajectory, and authorship (e.g., inclusion of other COPH students and/or faculty). As long as funds are available, the Research Committee will support a portion of the publication/dissemination fees if the application is approved. Click  here  for the application.

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• Committee Purpose The Research Committee shall set overall policy, provide guidance, plan development, and encourage excellence of research by the faculty of the School of Medicine. The committee may appoint such subcommittees as are required or deemed appropriate; e.g. subcommittees on human research, on safety, on isotopes, on resource utilization and planning, etc.  
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Oversight and guidance for the Institute’s research activities are provided by the organization’s Research Committee, which meets monthly to set research priorities. Research, clinical and administrative leaders participate on the Committee.

The role of the Research Committee is to evaluate whether a proposed project is consistent with the Institute’s mission, whether the appropriate resources are in place to conduct the research, and whether the study outcomes are likely to be useful. The Research Committee also helps potential researchers collaborate with organizational mentors and identify partnerships and support.

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Potential researchers must also complete the Research Committee questionnaire, which can be found on Mentor , the Institute’s Research Committee & IRB portal.

Note that there are two versions of the Research Committee questionnaire depending on whether the study will be reviewed by an external IRB or Institute’s IRB. Please submit the completed form via Mentor two weeks prior to the meeting date in order to ensure consideration of your proposal for review at the next meeting. If you do not have access to Mentor , please contact Elena Finver at [email protected].

The Research Committee meets on the first Monday of every month. After receiving approval from the Research Committee, an IRB application may be submitted.

Committees: Research Ethics Committees

• Reference work entry
• First Online: 01 January 2022
• Cite this reference work entry

• 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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Research: Human Subjects

Committees, Research Ethics Committees (See Research Ethics; Research Ethics Committees)

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

Google Scholar  

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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Correspondence to Ana Borovecki .

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Center for Healthcare Ethics, Duquesne University, Pittsburgh, PA, USA

Henk ten Have

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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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How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

• Carl H Coleman 1 &
• Marie-Charlotte Bouësseau 2  

BMC Medical Ethics volume  9 , Article number:  6 ( 2008 ) Cite this article

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Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.

Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.

The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.

Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed?

Peer Review reports

Many countries are investing significant resources in creating or strengthening "research ethics committees" (RECs) to review proposed research involving human participants, either within research institutions, as part of governmental agencies, or in the private sector. Implicit in these efforts is the assumption that REC review will result in research that better complies with applicable ethical principles. Yet, surprisingly little attention has been devoted to testing the empirical validity of this assumption. As a result, it is possible that countries are wasting scarce financial and human resources on processes that do not result in any real protections for research participants or their communities. In addition, without a system for evaluating RECs' actual impact, opportunities for remedying correctable problems with RECs are likely to be missed.

The importance of evaluating the effectiveness of RECs should be obvious. Yet, despite the emphasis on quality assessment in other areas of health care, "there has been near silence on the possibility of applying quality assessment techniques to ethics practices [ 1 ]." While the need for quality assessment in research ethics is beginning to receive greater attention [ 2 ], the focus has largely been on evaluating the quality of the deliberations that take place in RECs' meetings, as opposed to the impact of those deliberations on the research process itself.

Existing mechanisms for evaluating RECs are primarily limited to governmental or private auditing and accreditation programs. While both auditing and accreditation can make important contributions to the quality of research review systems, they are incapable of answering many critical questions about RECs' impact on research practices. Moreover, comprehensive auditing and accreditation programs require an investment of human and financial resources that is unfeasible for many low- and middle-income countries. In this article, we look beyond auditing and accreditation to consider other mechanisms for assessing and improving the quality of RECs' work.

While the focus of this article is RECs in low- and middle-income countries, the issues it addresses are relevant everywhere. In the United States, for example, an increasing chorus of critics has charged that the process of research ethics review imposes substantial costs for the research enterprise that exceed any benefits to research participants [ 3 , 4 ]. Determining whether the costs of ethics review are in fact justified requires a better understanding of the impact of ethics review on how research is actually performed.

The Increasing Role of REC Review

REC review is a cornerstone of international guidelines on research with human participants. For example, the Council for International Organizations of Medical Sciences (CIOMS) states that "all proposals to conduct research involving human subjects must be submitted for review and approval to one or more independent ethical and scientific review committees [ 5 ]." Similar obligations appear in guidelines issued by the International Conference on Harmonization (ICH) [ 6 ], the Council of Europe [ 7 ], and UNESCO [ 8 ]. These guidelines require RECs to ensure that the risks of proposed studies are reasonable in relation to the anticipated benefits, that the investigators have adequate plans for obtaining participants' informed consent, and that other ethical issues, such as confidentiality and equitable participant selection, have been adequately addressed.

However, these international guidelines are not legally binding in countries that have not chosen to adopt them. Thus, whether REC review is required for any particular study depends on the requirements of national laws and policies. In the United States and many other wealthy countries, review by an REC is mandatory for most research involving human participants [ 9 ]. By contrast, in many low-income countries, there are no laws requiring REC oversight, or laws that exist are incomplete or under-enforced [ 10 , 11 ]. When research is conducted in collaboration with foreign research sponsors, some type of ethics review may be required by the laws of the sponsor's country, but such laws do not always require review by local RECs. For example, while the United States Food and Drug Administration (FDA) has extensive regulations governing REC review for clinical trials conducted pursuant to an Investigational New Drug Application (IND), those regulations do not apply to foreign trials not conducted pursuant to an IND. Instead, the FDA will accept data from non-IND foreign trials as long as the trial "conforms to the ethical principles contained in the Declaration of Helsinki [ 12 ]," which contains only very general provisions on ethical review.

In recent years, however, many low and middle-income countries have begun to pay greater attention to developing or strengthening RECs. For example, at the 2004 Ministerial Summit on Health Research in Mexico City, health officials from 58 countries called for national governments to adopt regulations providing for the "ethical oversight" of research [ 13 ]. In many African countries, governments have enacted, or are in the process of enacting, legislation requiring REC review of research involving human participants [ 14 , 15 ]. Even without a governmental mandate, many research institutions in resource-poor countries have created RECs on their own initiative, sometimes in collaboration with other countries [ 11 ] or with non-governmental organizations [ 16 ].

One reason for this increasing interest in RECs is that research sponsors are conducting more of their studies in low and middle-income countries, both because it is less expensive [ 17 ] and because it has become increasingly difficult to find a sufficient number of qualified participants in the sponsors' home countries [ 18 ]. In addition, a few highly-publicized controversies have led to greater attention to the potential for exploitation in the context of international collaborative research. For example, a lawsuit currently pending against the foreign sponsors of a Nigerian study of an anti-meningitis drug alleges that children in the control group were not given adequate medications, that parents were not told that effective treatment for meningitis was readily available outside of the study, and that documents claiming that the study had been approved by a Nigerian ethics review process were forged [ 19 ]. Publicity about cases like this has given sponsors a greater incentive to support the development of local RECs.

Challenges for REC Review

For a country that lacks any research oversight system, creating a review process – any review process – is likely to have a positive impact. For example, requiring researchers to submit their protocols to RECs creates an incentive for researchers to actually have written protocols. Requiring them to document the informed consent process reduces the likelihood that individuals will be enrolled in studies without even being asked for consent. In other words, simply requiring prior approval to do research should help weed out the truly egregious cases of researcher misconduct.

Designing a system to evaluate the ethical acceptability of studies that pass this minimal screening function raises more challenging conceptual and practical difficulties. On the most basic level, the very concept of "ethics review" is inherently ambiguous, particularly in the critical area of risk-benefit assessment. Identifying the risks and potential benefits of research, and determining whether the balance between them is "reasonable," depend not only on scientific arguments but also on value judgments that usually have no clearly right or wrong resolution. In the absence of objective standards, RECs must rely on individuals' discretionary judgments, an approach that risks overemphasizing the personal values and biases of the individuals who happen to be serving on the committee [ 20 ]. In addition, the discretionary nature of risk-benefit assessment increases the potential for inconsistent decision-making, not only between different RECs but also within a single REC as it confronts similar issues from meeting to meeting. Of course, in a pluralistic society, absolute uniformity in ethical decision-making is neither realistic nor desirable. However, widespread inconsistency, particularly within a single REC, creates the impression that ethical standards are being applied in an arbitrary manner.

Some RECs deal with the amorphous nature of risk-benefit assessment by spending most of their time on detail-oriented questions that appear more susceptible to objective resolution, such as parsing the wording of informed consent forms [ 21 ]. Unfortunately, while rewriting consent forms is undoubtedly important in some situations, when it becomes the primary focus of ethics review larger ethical questions can easily become lost. Indeed, some critics charge that an obsessive focus on rewriting consent forms can actually undermine the protection of research participants, as it may simply result in longer and more confusing forms that participants will be less likely to understand [ 22 ].

On a more practical level, the effectiveness of REC review is often hampered by insufficient financial and human resources [ 15 ]. These limitations make it difficult to create committees with sufficient expertise and diversity, to provide funding for staff support, and to provide training for committee members. Ensuring the independence of RECs can also be a significant challenge. For example, in institutional-based RECs, committee members may be asked to vote on proposals submitted by colleagues who are personal friends, or by senior members of their department who control decisions about promotion and tenure.

The problem of independence is particularly acute for RECs in low and middle-income countries. Because such countries may depend on the financial or other benefits associated with foreign-sponsored research, RECs may be under explicit or implicit pressure not to reject research protocols or to insist on changes that might lead sponsors to take their studies elsewhere [ 23 ]. Adding to these problems is the fact that, in many resource-poor countries, RECs must carry out their work in the absence of a well-developed regulatory structure or a culture of compliance with administrative and procedural requirements.

Existing Oversight Mechanisms for RECs

In many countries, REC oversight is the responsibility of national governmental agencies. In the United States, for example, the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) are responsible for overseeing most RECs in the country (where they are known as institutional review boards, or IRBs). These agencies conduct site visits of selected programs, either without cause or in response to a specific problem, and they also have less formal procedures for responding to individual complaints. OHRP's site visits include a review of 20–35 randomly-selected protocols and meeting minutes dating back one to four years [ 24 ].

Some countries require RECs to go through a formal process of governmental accreditation. For example, in New Zealand, the Health Research Council accredits research ethics committees. If a study proceeds without the approval of an accredited ethics committee, participants who suffer injuries may not be eligible for compensation from the country's no-fault compensation system [ 25 ]. Approval by an accredited committee is also necessary for researchers to obtain access to data held by the New Zealand Health Information Service database [ 26 ]. Accreditation usually involves a combination of self-assessment and external reviews, focusing on issues like committee membership, operating procedures, and the documentation of meetings [ 27 ].

There are also voluntary accreditation programs for RECs. The largest of these is run by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) [ 28 ]. Obtaining AAHRPP accreditation is an intensive process that usually takes 12–18 months, including both document reviews and a 2–4 day site visit during which dozens of persons involved in all aspects of the research program are individually interviewed. In order to be accredited, programs must demonstrate not only that they are in compliance with all applicable regulatory requirements, but also that they have developed guidelines for addressing certain issues not expressly covered by the regulations (e.g., standards governing the participation of decisionally incapacitated persons in research). While most of the programs that have received AAHRPP accreditation are located in the United States, AAHRPP has also accredited programs in Canada, Singapore, and South Korea.

In addition to AAHRPP, the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), a network of local and regional ethics organizations working with several United Nations organizations, has established a voluntary "recognition" program for RECs. The program offers recognition to RECs that demonstrate that they "(1) have a structure and composition appropriate to the amount and nature of research being conducted; (2) have appropriate management and operational procedures; (3) review protocols in a timely fashion according to established procedure; (4) adequately and effectively communicate decisions to investigators; and (5) have appropriate practices regarding documentation and archiving [ 29 ]." The SIDCER program includes educational components designed to support RECs' progress toward recognition. Committees from China, Philippines, South Korea, Thailand and Taiwan have already been recognized through this process.

Finally, some mechanisms also exist for evaluating the qualifications of individual REC members. For example, a non-profit organization in the United States called Public Responsibility in Medicine and Research (PRIMR) offers a certification program for IRB members and staff, which "evaluates and validates individuals' knowledge of ethical principles, historical events, regulatory requirements, and operational and functional issues relating to IRBs and other human subjects protection programs [ 30 ]." Persons who pass the certification test are authorized to include the acronym CIP ("certified IRB professional") in their professional titles.

All of these mechanisms can make important contributions to the quality of the ethics review process. Auditing and accreditation programs encourage RECs to develop standardized policies and procedures, which helps promote the consistent application of ethical principles. They also provide a means for checking whether RECs are actually adhering to the policies and procedures they claim to be following. Private accreditation programs have the added advantage of encouraging RECs to develop policies and procedures for issues that are insufficiently addressed at the regulatory level. Certification programs for REC members can complement the accreditation process by promoting a common base of knowledge about applicable ethical and regulatory principles. Moreover, both accreditation and certification are likely to enhance the status of RECs within their own institutions, which may make it easier for RECs to gain necessary institutional resources.

However, these mechanisms also have inherent limitations. Most significantly, they focus primarily on questions about RECs' structure and process, such as how committees are constituted, whether their standard operating procedures are complete, and whether the process of protocol review is adequately documented [ 31 ]. One danger with this focus is that it may exacerbate RECs' tendency to emphasize form over substance. A recent study of OHRP enforcement activities highlights this problem; it found that "the agency continues to nitpick consent forms, depends upon (and demands) extensive documentation of compliance activities, and finds the remedy for most problems to be 'more' – review of studies, internal monitoring procedures, education, forms." The result of this focus, the authors conclude, is "a culture of red tape rather than a culture of ethics [ 24 ]."

A larger concern with an exclusive focus on structure and process is that it is incapable of answering the bottom-line question: whether REC review actually protects the rights and interests of research participants and their communities. For example, the fact that an REC has documented that it has considered a protocol's risks and potential benefits does not mean that it has done a good job identifying or weighing these factors. Nor does it show that studies that are approved by the committee have more favorable risk-benefit profiles than those that are turned down. Similarly, the fact that an REC has concluded that a consent form contains all relevant information does not mean that prospective participants who read the form will actually understand or absorb the information, or that it will have any appreciable impact on their decision-making process. In short, all that auditing and accreditation programs tell us is whether RECs are carrying out the specific tasks that have been assigned to them. While this is certainly an important question, even an affirmative answer does not prove that an REC system "works."

Integrating Quality Assurance Principles into REC Assessment

Principles developed through decades of experience with quality assurance and improvement in other areas of health care can guide the development of effective oversight programs for RECs. The most basic of these principles is that, before the quality of any program or service can be evaluated, the relevant elements of quality must be identified with precision. Quality is a multifaceted concept, including factors like the technical competence with which an activity is performed, the impact of the activity on morbidity and mortality, and the activity's cost effectiveness. Choosing which of these goals to emphasize "requires a commitment to finding out what patients and the community need, want, and expect from the health service [ 32 ]."

Thus, the first step in developing a comprehensive quality assurance program for RECs should be to identify what prospective research participants and their communities hope to get out of the ethics review process. For example, is the concern that people are being misled into enrolling in studies in which they would have refused to participate had they known what they were getting into? If so, it would be useful to know whether REC review has an impact on the number of people who go through the informed consent process and then decide not to participate. Alternatively, the goal might be to increase the extent to which participants feel respected in the research process, regardless of whether they end up making different decisions about participating [ 33 ]. In that case, we should try to find out whether REC review actually affects participants' subjective experiences in studies or their attitudes about research. Both of these questions, of course, depend on first determining whether prospective participants understand the information that has been presented to them in the consent process. While some research related to this question has already been conducted [ 34 ], assessing participants' understanding has not yet been systematically integrated into the process of REC oversight.

Similar questions can be raised about the process of risk-benefit assessment. For example, is REC review considered important because of a concern that research is generally "too risky"? If so, we should look at whether adopting an REC process actually affects the riskiness of research – perhaps by investigating whether REC review has an impact on the incidence of adverse events. Or is the concern that, without RECs, research might not address the health needs of the local community? In that case, we might want to see whether studies approved by an REC are in fact consistent with the local community's needs.

These broad outcome-oriented questions will not always be easy to answer. Outcomes assessment is one of the trickiest areas of quality assurance; numerous confounding variables can undermine the validity of simple before-and-after comparisons. For example, in many health care programs, outcome measurements such as mortality rates can be useful indicators of the quality of services, but they may also reflect "differences in the resources available, the risk factors of the patient group, data accuracy, and chance alone [ 35 ]." Likewise, an increase in adverse events following the creation of an REC does not necessarily mean that the REC is a failure; it may instead reflect a shift towards studies related to more serious conditions, where the greater potential benefits justify a higher degree of risk. Developing methodologically sound measures of assessing REC outcomes is an area ripe for further research.

Another important dimension of quality assurance that existing oversight efforts do not incorporate is the basic question of whether RECs' guidance to researchers is actually being followed. For example, do researchers really utilize the informed consent processes described in their protocols, or do they simply hand prospective participants a consent form and ask them to sign it? RECs could adopt a variety of relatively simple methods to generate information relevant to this question, such as soliciting feedback from prospective participants through questionnaires or suggestion boxes. Or, borrowing a practice used in other health care settings, they could use actors to play the role of prospective research participants, in order to evaluate how people are treated when they go through the informed consent process [ 32 ]. While these measures would require some additional resources, they are far less expensive than many other methods of quality assurance – for example, going through an 18-month process of obtaining accreditation.

Finally, and most importantly, a "monitoring system is not an end in itself [ 36 ];" the information generated through an assessment process must be used to stimulate improvements in practice. Doing this requires a commitment to a process of continuous quality improvement, in which information from the assessment process is disseminated to key decision-makers and incorporated into practice. Thus, an REC might ask researchers involved in approved studies to report back about the most common questions asked by prospective participants during the informed consent process, and then use this information to change the way they evaluate informed consent forms in the future. Global or regional meetings of RECs, as well as online discussion forums, can provide valuable opportunities for sharing information and identifying and promoting best practices. In addition to disseminating information among REC members, it is important to share findings about REC practices with external audiences like administrative authorities and community leaders.

Low and middle-incomes countries are increasingly demonstrating their capacity to put into practice concrete mechanisms for enforcing ethical requirements. International cooperation has been a key factor in this progress. However, it is not clear whether these systems have led to substantial improvements in the way that research is actually conducted. It is time to look beyond the basic question of whether RECs are complying with existing standards to the larger question of whether compliance with these standards is having the desired results.

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Coleman, C.H., Bouësseau, MC. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Med Ethics 9 , 6 (2008). https://doi.org/10.1186/1472-6939-9-6

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I. Research Committees Statutory Rights and Obligations

• Research Committees (RC) are expected to carry out the relevant policies of the ISA and to follow the ISA Statutes. Each member of each RC should have a copy of the Statutes of the ISA. The points below follow the spirit of the ISA Statutes. Where the Statutes do not cover relevant details, they have been supplemented to give guidance on practical interpretation.
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The reports are reviewed by the Research Coordinating Committee at its meetings every two years.

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Approved by ISA Research Council, Montreal, August 1997.  The ISA Research Council approved four sets of recommendations:

• Basic minimum requirements
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A. Basic minimum requirements

• A1. Submit to ISA Secretariat current list of RC members whose dues are collected directly by the RC.
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• B2.1 Keep accounting system and report accounts to members regularly.
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• B2.4 Encourage participation of sociologists from low GNI countries.
• B3.1 Hold regular elections for Board officers providing for turnover of officers.
• B3.2 Make provision for continuity of business across elections.
• B3.3 Set up clear division of labour among Board members.
• B3.4 Set up system to ensure participation in decision-making of all Board members.
• B4.1 Encourage individual ISA membership among all RC members.
• B4.2 Organise full programme of high quality sessions at ISA World Congresses.
• B4.3 Meet deadlines set up for the organisation of the World Congress.
• B4.4 Respond promptly to ISA Secretariat's request for routine information and send copies of newsletter to Secretariat and VP(Research).
• B4.5 Ensure that your representative to ISA Research Council will be able to attend the meetings.
• B5.1 Have regular newsletter with at least two issues per year.
• B5.2 Have at least one interim conference (or other academic activity) and business meeting between World Congresses.
• B5.3 Have a system of paper selection to ensure quality & geographical representation.
• B5.4 Encourage membership from different countries.
• B5.5 Encourage scholarly publications from RC activities.

C. Suggestions for ISA Executive and Secretariat on support and incentives

• C1. Produce booklet on ISA philosophy, aims and requirements for Research Committees.
• C2. Provide training for Research Committee officers at World Congresses.
• C3. Use RC's framework to consult RC officers and involve them organisationally.
• C4. Offer a computer template via e-mail for response to Secretariat's requests.
• C5.1 best reporting of activities;
• C5.2 greatest increase in ISA membership;
• C5.3 most useful newsletter;
• C5.4 greatest improvement in running of RC over specified period;
• C5.5 best-run small and large RCs.

D. Suggestions for ISA Executive and Secretariat on dealing with RCs' shortcomings

• D1. Send a communique of the action(s) likely to follow with one year time limit.
• D2. RCs receiving communique will be put on probationary status.
• D3. Provide advice or support to RCs in dealing with shortcomings through either experienced individuals, or a group nominated by the ISA Research Council, or the Research Coordinating Committee.
• D4. When there is refusal to meet ISA criteria, appropriate action involves the number of World Congress sessions allocated.
• D5. Demotion or closure of a RC is appropriate only when warning had been given and sufficient improvement had not been shown by the specified deadline.

E. Transition policy for low-membership RC/WG/TG

      Approved by the Research Coordinating Committee in April 2017

• E1. If the membership of an RC (WG) falls below the newly required 50 (25) ISA members in good-standing, the ISA Executive Secretariat will alert President and Secretary of that unit and encourage measures to increase its membership.
• E2. If an RC (WG) has been unable to reach a threshold of at least 50% of the newly required threshold of 50 (25) ISA members in good standing for more than two consecutive years, the Vice-President for Research, or a representative appointed by her or him, will contact the Board of the RC (WG) to discuss the situation and measures for increasing the membership numbers.
• E3. If an RC (WG) has been unable to reach a threshold of at least 50% of the newly required 50 (25) ISA members in good standing for more than a term of four consecutive years, the Research Coordinating Committee will consider proposing to the EC sanctions, which could include demotion or closure, while duly weighing the unit’s level of activities, plans, and other circumstances.
• E4. The percentage thresholds in (2.) and (3.) shall be increased to 65% at year-end 2018 and to 80% at year-end 2022, with the full requirements being phased in at year-end 2026.

V. Policy for ISA awards

1. general principles.

• Any ISA awards should be for significant contributions to sociology, to international issues directly related to the ISA’s mission, or to the ISA as such.
• All proposals for new awards should need the approval of the ISA Executive Committee. Any proposal for a new award should specify its purpose and form, indicate who would be eligible for it, estimate its costs and show how those could be covered, and provide information on whether there were any existing awards or prizes of similar character.
• There should not be more than one award of a similar nature (e.g. specifically for junior sociologists, or general whole-career achievement), and overlap with awards or prizes given by other bodies (in particular, the Rokkan Prize of the International Social Science Council for comparative research by a younger person) should be avoided.
• Unless awards are aimed at a particular category of person, special care should be taken in the procedures and personnel involved to ensure that gender, language, nationality etc do not stand in the way of equal opportunity to win the award.
• Issues of general policy for ISA awards should be decided by the Executive Committee, though it would probably be appropriate to have a subcommittee responsible for formulating proposals. However, such issues will not arise often, so it would be unnecessary that this should be a standing subcommittee.
• If Research Committees have awards or prizes, they should be consistent with the ISA’s general policy, and should be described as an award of Research Committee X of the ISA (not of the RC without mention of the ISA, or of the ISA alone); proposals for the establishment of such awards or prizes should be submitted to the ISA Executive Committee for approval.
• The award of any awards from the whole ISA, the Research Council or the CNA should be announced at a World Congress (where this might form part of a special ceremony), so they should be given every four years. The timetable leading up to this would need to be planned so that recipients could be sure to be able to attend the World Congress. If there were awards associated with a particular Research Committee or region, they could be given at interim meetings of the appropriate body.

2. Nominations and Selection Process

• Some awards might be intended specifically for ISA members, and others not; that should be decided when an award is first established.
• Nominations should be invited from all ISA members, at a date which would allow reasonable opportunities for discussion and liaison before the deadline for their submission was reached. A nomination should normally require more than one supporting member, the number to be specified; the form that it should take would always be that of providing evidence for the merits of the candidate nominated for the award, but what that should consist of would need to be laid down in relation to the nature of the specific award in question. (For instance, the nomination of a single publication would be quite different from the nomination of the record of a whole career.)
• A sub-committee or jury should be set up with members appropriate to the particular task; at least one of those members, who will act as chairperson, should be drawn from the Executive Committee. If the award is made by the Research Council, proposals for membership of the jury should be made by the Research Coordinating Committee to the Research Council; if it is made by the Council of National Associations, the National Associations Liaison Committee should make proposals to the CNA.
• The jury should report its proposed award to the Executive Committee, which should be required to approve the award; the grounds on which the EC considers approval should be only those of procedural correctness and conformity with general ISA policy on awards.

VI. Policy on Research Committee* journals

*All the points made here would apply equally to Working Groups and Thematic Groups.

ISA warmly encourages RCs to run their own journals if the market and the resources of personnel and intellectual work are there.  However, there are some guidelines, listed below, which should be borne in mind.

• RCs do not require permission to set up their own journals; however, they should inform the ISA Secretariat if they propose to do so, notify the Secretariat when one is actually established, and include information about the journal’s progress in their annual reports.
• RC journals may be run entirely by one RC, or cooperatively with another RC or some other body outside ISA. (If an outside body is potentially involved, the Vice-President for Publications should be informed before any decisions are reached in case issues are raised about the suitability of the partnership.) Whichever is the case, the journal and associated material such as web sites should acknowledge the ISA connection, for instance by including a statement that the RC is an RC of the ISA.  However, it must not be stated that the journal is sponsored by ISA (as distinct from the particular RC), or the ISA logo used on it, unless the proposal to do so has been approved by the ISA Publications Committee.
• It is expected that any RC journal will set up arrangements for journal governance and continuity, and follow customary academic practice.  It should establish an editorial board if one is wanted, an appropriate division of labour for editorial tasks, a system of refereeing, and provision for the observation of relevant ethical standards. It is also expected that these arrangements, and the practical working of the journal, will observe ISA’s commitments to internationalism and to the goal of equality in opportunities for participation.  The provision of some material in languages other than English is encouraged.
• Sage is currently the ISA publisher.  Our contract with them does not require all journals associated with ISA to be published by Sage, though to create one which could reasonably be seen as in direct competition with the Sage ISA ones would not be acceptable. Sage would be interested to consider proposals to publish any new RC journals.
• The only funding that ISA might provide for an RC journal is the regular activity grant from the RCC, of which each RC may apply for one during a four-year period, which the RC could use for that purpose. No office support is available, but the Publications Committee would, however, be happy to offer advice on the practical issues involved in running a journal, and to help publicise RC-sponsored journals.  A link to the journal from the ISA web site can be provided.

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The Structure and Function of Research Ethics Committees in Africa: A Case Study

* To whom correspondence should be addressed. E-mail: [email protected]

• Adnan Ali Hyder,
• Ademola Ajuwon,
• John Appiah-Poku,
• Nicola Barsdorf,
• Dya Eldin Elsayed,
• Mantoa Mokhachane,
• Bavon Mupenda,
• Paul Ndebele,
• Godwin Ndossi,
• Bornwell Sikateyo,
• Godfrey Tangwa,
• Paulina Tindana
• Nancy E Kass, 
• Adnan Ali Hyder, 
• Ademola Ajuwon, 
• John Appiah-Poku, 
• Nicola Barsdorf, 
• Dya Eldin Elsayed, 
• Mantoa Mokhachane, 
• Bavon Mupenda, 
• Paul Ndebele, 

Published: January 23, 2007

• https://doi.org/10.1371/journal.pmed.0040003
• Reader Comments

Citation: Kass NE, Hyder AA, Ajuwon A, Appiah-Poku J, Barsdorf N, Elsayed DE, et al. (2007) The Structure and Function of Research Ethics Committees in Africa: A Case Study. PLoS Med 4(1): e3. https://doi.org/10.1371/journal.pmed.0040003

Copyright: © 2007 Kass 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.

Funding: This project was funded, in part, by a grant from the Fogarty International Center, National Institutes of Health R25 TW01604.

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

Abbreviations: FWA, Federal Wide Assurance; IRB, institutional review board; JHU, Johns Hopkins University; REC, research ethics committee; WHO, World Health Organization

According to international guidelines [ 1 , 2 ] and several nations' laws [ 3–5 ], research with humans requires independent ethics committee review. In the United States, committees are called institutional review boards (IRBs) [ 6 ]; elsewhere they generally are called research ethics committees (RECs). Committees are designed to: provide third party review, thereby minimizing conflicts of interest; protect the welfare of research participants through attention to risks, benefits, and informed consent; and avoid exploitation of vulnerable individuals and populations.

Most literature examining RECs comes from wealthier countries. One US study found “serious concerns” with the quality of 14% of IRB reviews [ 7 ]. Another found that IRBs focused predominantly on consent documentation, spending less time examining voluntariness, selection of participants, and risk [ 8 ]. Many US [ 9–15 ] and international [ 16–18 ] studies have found that different research ethics committees reach different conclusions when reviewing the same study.

Several scholars and advisory bodies have made recommendations to address challenges facing US IRBs [ 19–22 ]. However, there has been little research examining procedures, strengths, and challenges of RECs in developing countries. Two case reports describe disagreements between host and sponsoring country RECs [ 23 , 24 ], and an international survey reports differences in sponsoring and host country reviews [ 25 ]. Three articles describe RECs within one country (Turkey [ 26 ], Granada [ 27 ], and Sudan [ 28 ]), and five within a larger region.

Rivera described 20 RECs in Latin America, finding that only 45% had standard operating procedures and that members had limited training [ 29 ]. Coker examined RECs in Central and Eastern Europe [ 30 ]. Ten countries had national committees, most committees included non-medical members, and three provided training. The World Health Organization's (WHO) Southeast Asian Regional Office, finding that only some of the 16 respondents had national RECs, called for capacity development in the area of research ethics [ 31 ].

Most literature examining research ethics committees comes from wealthier countries.

The WHO African Regional Office found that 36% of member countries had no REC. In the countries that did have RECs, most RECs met monthly, five met quarterly, and one never met [ 32 ]. Finally, Milford examined African RECs' resource needs in the context of HIV vaccine trial preparedness, finding that 97% believed African RECs had inadequate training in ethics and HIV vaccine trials and 80% believed African RECs had inadequate training in health research ethics.

Additional information on how African RECs function, including their staffing, operating procedures, strengths, and challenges would be useful for African and international researchers working within Africa, and for growing efforts to enhance ethics capacity on this vast continent. We therefore used a case study approach to shed light on the structure and functioning of RECs in Africa.

The Johns Hopkins Bloomberg School of Public Health received a training grant from the Fogarty International Center in 2000 to train three African professionals in bioethics each year [ 33 ]. Several of these professionals explicitly seek to increase the scholarly and administrative capacity of their African RECs. In 2004, program faculty and trainees created a structured questionnaire to document the history, composition, functioning, financing, strengths, and challenges of RECs with which the trainees were affiliated. Questionnaires were completed by e-mail. Follow up e-mails clarified responses. Data were entered into Microsoft Excel and tabulated. Trainees and faculty met for two days in 2005 to refine concepts and work on the manuscript.

Results of Our Case Study

Eleven of the 12 trainees who attended the program in 2001–2004 collaborated. Nine had personal experience on one or more African REC. Another trainee secured information from her institution's REC; one contributed no data. One trainee worked with two committees in his country; another worked with two committees from two countries. Twice, two trainees from the same country were affiliated with different RECs. Thus, twelve RECs were included in this case study from nine African countries: Democratic Republic of the Congo, Ghana (2), Kenya, Nigeria, South Africa (2), Sudan (2), Tanzania, Zambia, and Zimbabwe.

History of research ethics committees.

The oldest committee was from South Africa, established in 1967. The REC of the Medical Research Council of Zimbabwe was formed in 1974 but had intermittent functioning until 1992, when it became more formally established. Two RECs began in the 1980s; eight were started within the last five years, including two (Kenya and Democratic Republic of the Congo) created by the trainee the year before data collection.

Six of the 12 RECs had Federal Wide Assurances (FWAs) from the US government, an indication that the institution had received US research funds or collaborated with US institutions [ 34 ]. Two RECs were established as a requirement of international collaboration. The remaining RECs were established because of a recognized need for independent ethics review. Trainees' efforts were responsible for existing or pending FWAs of three African institutions.

Composition.

RECs ranged from nine to 31 members. One included only physicians and scientists, while most had clinicians, social scientists, economists, nutritionists, pharmacists, statisticians, pastors, and lawyers. Ten had lay or non-scientist members; two did not (see Table 1 ). One required that a third of the members should be lay persons, including a traditional chief and representatives from local organizations. Another asked the local community to nominate a community member. None required gender balance, but all consciously included both men and women.

• PPT PowerPoint slide
• PNG larger image
• TIFF original image

Composition of RECs in Case Study

https://doi.org/10.1371/journal.pmed.0040003.t001

REC meetings.

One REC recently stopped meeting in person; reviews were conducted by the chair or individual members. All other committees met in person: two met irregularly, based on need; another met twice per year or as needed; one met every two months; and seven met monthly.

All committees (except the one that did not meet) had requirements for quorum (half, or half plus one). One required two-thirds attendance. Meeting quorum, in general, was not difficult. One trainee said members were committed to duties; two said meetings were scheduled in advance or on weekends. Two said quorum was a problem. One described significant member turnover; another said busy members had problems with punctuality and attendance.

Training of REC members.

Two committees had members with no training. Six RECs had received training only since the Johns Hopkins University (JHU)–Fogarty trainee returned and provided it. Four RECs had individual members who attended external workshops; one committee conducted Good Clinical Practice courses semi-annually.

Conflicts of interest.

All RECs required that members be excused if their protocol was under review. Other potential conflicts were raised, however, which may be harder to manage. Two discussed conflicts posed when a departmental colleague had a protocol under review. One said such reviews were sent to another department, even to a department with less expertise, to avoid conflicts. Another described unease voicing objections when fellow members' protocols were reviewed, fearing being labeled unfriendly. Another believed community members were loathe to reject protocols because studies bring employment. Another said protocols bring income to the institution and sometimes questions were not raised so projects could clear quickly.

Procedural and administrative issues.

Most RECs had basic administrative capabilities, although the REC that no longer met in person lacked any administrative infrastructure. Two RECs lacked standard operating procedures. Nine had such procedures in place, five of which had been written by the trainee upon returning to Africa. All eleven RECs that met kept minutes.

All RECs had a mechanism for reviewing research project amendments to approved studies, although most did not require a review for study changes or amendments. In four RECs, the JHU–Fogarty trainee created the amendment mechanism. Of the 12 RECs, two routinely conducted annual reviews (both instituted this practice after the trainee returned to Africa); two conducted annual reviews when required by an external funder or driven by the principal investigator; and eight did not conduct annual reviews.

All trainees said REC funding was a challenge. Three had no operating funds whatsoever. For the other nine, funding came solely or in combination from government (2), foreign agencies (1), and/or fees for reviews (6). Fees for review varied greatly. One REC used a “sliding scale,” charging US$5 for proposals submitted by students, US$10 for studies submitted by post-graduate trainees, and US$20 for all other research proposals. Another did not charge for institutional applications, but required US$365 for external applications and US$585 for industry studies. Some used a “fixed fee” structure, such as US$100 for all applications or 1% of the study's budget, once funded. All RECs benefited from “in-kind” donations of institutional resources, such as space, photocopying, mail distribution, and services of staff with other responsibilities.

Eight RECs did not pay members (though some reimbursed travel); four paid a “sitting allowance.” Five RECs had paid staff; seven did not. RECs that paid staff all had budgetary allotments or charged fees.

REC review.

The number of protocols reviewed per year varied tremendously. Three RECs reviewed eight to 12 protocols per year, three reviewed 30–50, five reviewed 100–250, and one reviewed 600 per year. Two RECs with small portfolios only reviewed internally funded protocols. Most reviewed a mixture of internal and external projects.

Seven RECs required all protocols to be reviewed, although two started this policy only after the JHU–Fogarty trainee returned to the institution. The five other RECs only reviewed research when required by the funder. Review time generally corresponded to the frequency with which the REC met. Most completed reviews in one to two months, ranging from two weeks to more than three months. Four RECs looked equally at science, ethics, and budget, while another four reviewed science and ethics, but not budget. Two spent little time on ethics, while another focused almost exclusively on ethics as another committee reviewed the science.

Trainees mentioned several strengths of their RECs. First, the creation of so many new committees is a strength in itself. Also, many committees have at least a few members who received some training in ethics, through the REC, the JHU–Fogarty trainee, or external workshops. Several trainees mentioned that their REC has a reputation with sponsors for integrity and/or that the REC provides useful feedback to researchers.

Challenges.

Inadequate training and funding consistently were mentioned as the biggest challenges. These scholars acknowledged significant time and effort for member training. Reviewers were often poorly equipped to review according to ethics criteria, which led to a disproportionate focus on the science. Trainees mentioned inadequate training of staff and administrators in REC procedures; one trainee raised the issue that RECs have weak monitoring systems due to funding constraints.

Budget constraints were mentioned by nearly everyone. Running an REC is expensive, and one trainee suggested that for this reason poor countries will simply avoid the creation of a REC unless required. Another said that governments must be made aware of the importance of research ethics to convince them to fund RECs. Several mentioned that REC members had multiple responsibilities and thus, they would be more committed if they could be paid, especially since serving on the REC might actually deny them income they would otherwise have received for that time. One REC had no stationery, space, computers, or communication facilities. In another, a foreign investigator donated $200 for stationery supplies when the REC started, but there were no other funds for staff or infrastructure. An REC started by the JHU–Fogarty trainee used the trainee's personal laptop for its official business. Trainees also used their reentry grants provided by the JHU program to help enhance REC infrastructure.

Another challenge was the tendency of a few RECs to “rubber stamp” approvals in order to secure international funding. Related to this challenge, a couple of trainees raised a concern about REC independence. One said outsiders, researchers, and politicians could interfere in the REC process, and another said the “culture of corruption” is prevalent in some parts of Africa, which could affect the integrity of the committee. In some regions, investigators could engage in “IRB shopping,” whereby they could submit their protocol to a new REC if it was rejected by a first. A few trainees were concerned about possible abuse of the expedited review option in their RECs, as expedited reviews do not incur the delay and expense of convening a full committee meeting. Two specifically mentioned a lack of national guidelines and local operating procedures as a challenge to good work. Another voiced a concern that institutions would often select “top management” individuals to be members who might not have appropriate skills or time.

Suggestions.

Given the challenges raised, it was not surprising to hear trainees suggest the need for more training, funding, independence, and political commitment to improve REC functioning. In addition, innovative suggestions also emerged: training workshops on how to interpret ethics principles in light of local norms; public outreach programs about research; creation of networks of African RECs to share materials, resources, and capacity building; creation of mechanisms to facilitate communication between host and sponsor country RECs; joint meetings between REC members and investigators to brainstorm solutions to shared challenges; human rights advocacy to help enhance participants' and researchers' awareness about rights in research; and more empirical research on ethics and African research.

This case study reports on the experience of ten African professionals with 12 African RECs. These 12 RECs represent a range of experiences, from a committee formed 30 years ago to two recent ones. All, to greater or lesser extents, are functional, although one never meets as a committee. All cite the need for additional training, more attention to ethics issues, and more funding for staffing, transportation, and supplies.

Many challenges described here are not unique to African RECs. Wealthier countries, too, have heard criticism about inadequate funding, staffing, and training of committees [ 35–40 ]. Poor countries, however, inevitably feel these needs more acutely. Further, additional challenges may arise from resources being limited. We heard of institutions or community members exerting pressure to approve research that would bring jobs, infrastructure development, money, and intellectual cache to the local setting. Kilama suggested that poverty itself is a threat to independence, since poverty can blind researchers, participants, and RECs alike to any problems in studies that bring jobs, medicines, or prestige to a community [ 41 ]. Challenges to people's integrity may be more typical where individuals can expedite or bypass usual procedures through informal transfer of funds, as occurs in some countries.

External mandates often were the impetus for a committee forming and, in some cases, contributed start-up resources. While some committees still only review externally sponsored projects, others used external requirements as a catalyst to create a conscientious committee, committed to ethics review, training, and integrity. Absent the external mandate, changes may have happened more slowly.

Encouraging lessons.

Positive lessons can be drawn from this case study. First, research ethics review is increasingly routine in Africa. More African institutions require and are equipped to provide review, all but one of the committees in this case study meet in person, and membership is relatively diverse. There are growing opportunities in Africa for training in Good Clinical Practice and research methodology. Increasingly, African investigators submit to international journals that require REC review as a condition of publication; African journals now, also, generally require REC review of published studies [ 42 , 43 ], and a special meeting of the Forum for African Medical Editors in 2005 developed further guidelines for journal submission and review, including guidelines related to ethics [ 42 ]. Nonetheless, several of these committees are new, and some were created by the trainee. In the future, other researchers may start an African collaboration, find no RECs exist locally, and will need to facilitate creation of one. More guidance exists to assist in this task, but it can appear somewhat daunting [ 44 ].

Second, these experiences suggest committees become more stable, equipped, and trained over time. Thus, some challenges described may reflect how new most African RECs are. Committees with the longest history are the most established with regard to procedures, funding, and staffing. One trainee described his REC focusing almost entirely on science when first created, with community members deferring to scientific ones. Over time, members gained training and experience, and reviews began to include more ethics.

Third, this case study suggests individuals can make a difference. RECs included here were not random: a professional associated with them had just completed intensive training in research ethics. Nonetheless, with limited funds and variable institutional support, a small number of individuals created two RECs, others created and implemented standard operating procedures, review forms, and regular review where none existed, and most now provide training for members, researchers, and/or the public.

Further progress likely will involve a confluence of funders' requirements for review, institutional commitments, and individual contributions. Indeed, successful change requires systemic commitment. One individual cannot effect long-term change without institutional support, which is more likely with national requirements for review [ 45 ]. National policies are more likely to be developed when international funders, aid agencies, and journals establish that RECs are required and review must be the norm. National and institutional commitment must be set as policy and implemented through influx of resources for RECs.

To make committees' work meaningful, however, there must be a commitment, as many have suggested, to training and better resources. We join others calling for a shared library of resources, model standard operating procedures [ 46 ], model consent forms, and copies of training presentations; fortunately, such resources increasingly are available through the Internet. African professionals must find means to access continuing ethics education [ 41 , 47 ]. Challenging ethics dilemmas will always arise in research; those tasked with resolving them will need ongoing support and training to navigate reasonable solutions.

Limitations of our case study.

This case study has several limitations. The data are self-reported, through the lens of individuals who received intensive training in research ethics. Thus, their views may reflect more sophisticated understanding of how RECs should function than other REC members might provide. Further, the capacity of RECs, as reported, was often recently enhanced due to the efforts of the JHU–Fogarty trainee. Most new African RECs presumably are not started with these resources and intellectual capacity development, so the speed with which new RECs develop procedures and skills for ethics review may happen more slowly.

This report describes 12 RECs in Africa. It does not claim to be representative of African RECs as a whole. Further, this case study examined REC functioning but does not attempt to draw a conclusion about how ethical research is in Africa. Even the most conscientious REC review does not guarantee a well-executed study. Without study monitoring, it is impossible to know the relationship between REC quality and the quality of approved research [ 48 , 49 ].

This case study examines the history, operations, strengths, and challenges of 12 African RECs. We hope this will help researchers working in Africa better understand the landscape of ethics review and help funders target resources for capacity development in a continent where health research is so critical to development, and local responsibility for research functions is critical for research.

Supporting Information

Alternative language abstract s1. french translation of the abstract by bm.

https://doi.org/10.1371/journal.pmed.0040003.sd001

(31 KB DOC).

Acknowledgments

We are grateful for the research assistance of Rachel Harrison.

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The University Research Committee is the faculty’s voice to the research administration.

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• Evaluate and advise on consulting policies and practices and promote their continuous improvement;
• Inform the faculty on the availability of support for research and professional development, and to assist as it can in securing such support; and
• Recommend to the Vice Chancellor the allocations to be made from the Research and Innovation Seed Funding (RISF) Program.

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• Coordinate with the faculty representative from your College to ensure a minimum of one of you is able to attend at least 80% of the URC meetings,
• Share resources and updates from ORI and research partners  to your College, 
• Evaluate and advise on research-related topics, 
• Provide regular updates from your College to the URC, and
• Vote in polls and participate in surveys both during the meeting and when asked via email after meetings.
• 1.5 hours per month for 10 months of the year to attend URC meetings (hybrid).
• Additional time spent within your College sharing research updates and gathering questions/concerns to be brought back to a future URC meeting. 
• Additional representation at events as requested.
• Appointments to the University Research Committee are managed at the college level. The Associate Dean for Research for each College has the authority to select two representatives to serve on this committee.

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• Attend a minimum of 80% of the URC meetings,
• Share resources and updates from your unit,
• Answer questions URC members have that concern your area of expertise, and 
• Bring questions or areas of concern raised during a URC meeting back to your group/unit.
• 1.5 hours per month for 10 months of the year to attend URC meetings.
• Additional time spent within your group/unit bringing concerns to the attention of the appropriate team.
• Ex-officio members are provided appointments by virtue of another position.
• Appointments are regularly reviewed by ORI staff with adjustments made to the number of appointees and the departments/units represented.
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Research ethics committees: A forum where scientists, editors, and policymakers can cooperate during pandemics

Francesco chirico.

1 Post-graduate School of Occupational Health, Università Cattolica del Sacro Cuore, Rome, Italy

2 Centro Sanitario Polifunzionale di Milano, Health Service Department, Italian State Police, Ministry of the Interior, Milan, Italy

Katrina A. Bramstedt

3 Department of Medicine, Khalifa University College of Medicine and Health Sciences, Abu Dhabi, UAE

During public health pandemics such as COVID-19, cooperative behaviors among scientists, journal editors, policy makers and research ethics committees, are essential to promote scientific integrity and societal trust in translational research and resultant public health decisions. This cooperation is possible by expanding the current way of working to include stakeholders beyond the research team via community events and special communication channels sponsored by research ethics committees. Research ethics committees with wider communication channels, increased transparency, and enhanced knowledge exchange have the potential to improve research design, performance, dissemination, and ultimately public benefit.

During the Coronavirus Disease 2019 (COVID-19) pandemic, a fast-track peer review of COVID-19 papers submitted to journals has replaced the traditional, more time-consuming peer review process, causing concern among stakeholders in scholarly publishing. 1 However, “quick publishing” 2 is a pandemic-related phenomenon that may produce low-quality literature and, subsequently, more retractions. 3 Sometimes, even retracted articles continue to be repeatedly cited by sloppy scholars. Additionally, predatory journals and researchers can leverage the pandemic as a tool to propel their own goals. 4 Predatory journals were a troublesome presence long-before the emergence of COVID-19; however, the fast pace and competitive pandemic research setting is a ripe arena making researchers an easy target by these unscrupulous journals that provide little or no peer review, rapid publishing, and open access. 5 COVID-19 is one of the biggest public health challenges the world has confronted, and rapid, high-quality research plays a key role in the fight against the virus. Identifying categories of people that should be prioritized for COVID-19 vaccination (including boosters), as well as lockdown and physical distancing policies, are examples of how decision-making relies on scientific findings. 6 , 7 When scientists and policymakers have different attitudes and goals, this can hamper collaboration; 8 however, by working together during pandemics such as COVID-19, scientific findings can be translated into beneficial policies and procedures for the health of society.

Worldwide, the role of research ethics committees (also known as institutional review boards) has been to review and approve human research proposals to ensure novel research questions, robust study design, and the protection of research participant safety and welfare. Committee structure is generally a mix of lay volunteers and professional scientists, sometimes with subspecialty committees (e.g. social science, medical). Ideally, research ethics committees should have a multidisciplinary membership that reaches beyond the science, and also includes ethicists and patients concerned with the contextual aspects of research that impact methodology, data privacy, and the application of the research across populations. 9 The Chair at the helm of these committees is expected to guide the review process to ensure timely and constructive feedback to researchers so that their research protocols are optimized before receiving approval for study launch.

To do their job effectively, research ethics committees need to understand the research they are reviewing. Part of achieving this is by way of assigning protocol reviews to topic specialists within the committee, as well as the use of external expert reviewers as needed. Additionally, the committees can receive input from the Principal Investigator directly, answering queries and providing clarifications. We propose that the input mechanism to research ethics committees be widened for additional purposes related to understanding research proposals, as well as stakeholder opinions, and community impact. If publishers interface with research ethics committees, they can potentially develop better understandings of jurisdictional approval/exemption requirements, thereby avoiding publication delays due to incorrect assumptions or lack of awareness. If policy makers interface with research ethics committees, they can potentially develop an understanding of research risks and benefits across communities—something that is especially important if their community is facing a public health threat and they are vulnerable (e.g. socioeconomically disadvantaged, special cultural values).

While there is a time for closed [private] sessions, research ethics committees should be open to dialog with all research stakeholders (not only scientists) to gain a fuller understanding of research applications and implications, risks and benefits, and strategies for risk mitigation, as well as optimized delivery of the research review process so as to ensure a timely study launch (reducing study delays). This view is consistent with that of the World Health Organization which states, “For a [committee] decision to be ethically legitimate, it must be made in an open and inclusive process that takes into account the views of all stakeholders. Thus, research ethics committees should be encouraged to include individuals from diverse professional and social backgrounds and, where appropriate, to solicit input proactively from the community.” 9

Johns Hopkins Medicine Institutional Review Board (a research ethics committee in USA) provides an annual Community Day during which the public is invited to dialog with them about research ethics, research protections, and the research review process. 10 Events like these are important because research ethics committees and research participants (patients/community members) can have differing views regarding priorities. 11 Also, community-based participatory research will benefit from direct interaction with research ethics committees because research has shown that often these committees are not prepared for this type of research with these key stakeholders who are in fact helping shape the research question, recruit participants, collect study data, and disseminate the study results back to their community. 12 Committee events such as these could also provide a mechanism for transparent mediation of power struggles between research stakeholders. Ideally, these external research ethics committee events should be more frequent than annual, especially during public health crises when the public is participating in vaccine and treatment clinical trials, and the pharmaceutical industry has a duality of priorities (i.e. producing safe and effective product and making profit for shareholders). Community Days and other stakeholder events can be held in virtual formats using teleconferencing technology when public health crises demand physical distancing.

In Iran, three main working groups have been set up to manage COVID-19 research, including (1) research on epidemiology and public health, (2) clinical research, and (3) basic science and virology research. 13 These committees are having an additional role in research monitoring, not just protocol review. Monitoring is usually a function performed by the research sponsor, but in this instance, the committees are potentially having additional impact in research quality by checking the conduct of research themselves. In the context of COVID-19 and vaccine research, decisions to pause or abort studies or pause distribution of emergency-authorized vaccines can have profound research and clinical implications. 14

Research ethics committees and associated data safety monitoring boards are the canaries in the mines who should be audible voices not bullied by sponsors or governments. Their advocacy for science and public safety as well as research integrity means viewing them in the research co-working space, as well as the regulatory/governance space. This lens shift allows for a change in tone in the research workplace, creating a culture which is more conducive to stakeholder collaboration and shared decision-making (rather than bullying). While various governance boards will ultimately render decisions, a shared decision-making approach from the lens of collaboration and co-working potentially fosters data sharing and dialog for public health benefit.

In situations of alleged research misconduct, research ethics committees should collaborate with journal editors and publishers to ensure that the investigative process is not delayed. Timely evidence sharing in tandem with fair and expert investigations will promote prompt retraction of research which has ethical and/or scientific misconduct, limiting its use and reuse. During these situations, it is vital that research ethics committee members are free from external pressures and are able to dialog without intimidation or conflict from research stakeholders. In the end, research outputs should be trusted scientific evidence for use by government policymakers, and health officers in their pursuit of public health and safety. 8

The time burdens and administrative strain of research ethics committees are well-known, thus the idea of more tasks may not be embraced. Widening the research ethics committee's current work area might at first seem burdensome, but with efficient planning and organization of events and communication channels, the broader benefits could prove worthwhile. It would be interesting to pilot an “enhanced” research ethics committee offering service lines for editors, community, and policy-makers.

In conclusion, cooperation between scientists, editors and policymakers is essential to promote the scientific integrity of COVID-19 research and public trust. Working together does not erode stakeholder autonomy, rather it gives the autonomy of each a voice which needs to be heard, especially during the urgency of a pandemic. Research ethics committees need freedom to perform their tasks without pressure from researchers, politicians, policymakers, and funders. In the setting of a pandemic, there are many stakeholders, scientific unknowns, and time pressure. With a multiplicity of competing interests, the setting can easily be a ‘boxing ring’ of personalities and agendas; however, a collaborative forum for perspectives, debate, and ethically-driven solutions is possible. This shifts the sometimes impression of research ethics committees as a scientific bottleneck 15 to a cooperative working space. 13 Research ethics committees evolve from gatekeepers, to also a forum where all stakeholders come together to speak up for the benefit of science and society.

Declaration of conflicting interests: Prof Chirico is Co-Founder and Co- Editor in Chief of the Italy-based journal, Journal of Health and Social Sciences

Funding: The author(s) received no financial support for the research, authorship and/or publication of this article.

ORCID iD: Francesco Chirico https://orcid.org/0000-0002-8737-4368

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Purpose of the Research Committee

The activities of the Research Committee of the Faculty of Economic and Management Sciences take place in terms of the directives for research at the University of Pretoria (see Rt 306/07; S4083/00; Rt 429/99; S3563/05). The aim is to coordinate and report in the prescribed format on research related activities of departments within the Faculty, whilst measures are put in place to support research by means of mentorship, training courses, as well as financial support.

A strategic objective of the Committee is the building of research capacity to increase both the quality and quantity of academic research, in order to be regarded as a leading Faculty not only in South Africa, but internationally.

Specific aims of the Research Committee are as follows:

· Formulation of research strategy

· Enhancement of the research culture of the Faculty

· Introduction of incentives to promote research endeavours

· Monitoring of progress with research programmes

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· Coordination of submissions to external organisations

· Organising of research colloquiums

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What is a Research Ethics Committee?

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Research ethics committees (RECs) are an important part of a healthy research culture. Their role is to consider the ethical implications of research. Traditionally this has focussed on the need to protect research participants (both human and animal), but in recent years their role in supporting researchers, and promoting research integrity more generally, has been increasingly recognised.

Two types of RECs

It is important to distinguish two types of research ethics committees. The first type is often set up to consider ethical issues that may be relevant to researchers working in specific areas. These might include the ethics of research into genetic modification, climate engineering, dual-use research (e.g., research with military applications), or research using potentially contentious methodologies such as “ human challenge ” trials (where participants are intentionally infected with diseases such as COVID). As these are difficult and complex areas, the main output is often in the form of guidance or position statements that can be applied by researchers, their institutions, funders, and ultimately policymakers. Consequently, these committees are convened at a fairly high level by organisations with an interest in the area of research being considered. They normally include scientific and legal experts alongside those with a specific interest in the topic under consideration (such as patient groups).

But the second, and far more common, type of research ethics committee is those set up by universities, research organisations, or health care providers (such as the NHS) to consider the ethical issues relating to individual, and often very specific, research projects. These Research Ethics Committees — abbreviated as RECs and referred to as Institutional Review Boards (IRBs) in the United States — provide a point-in-time review of a very detailed research protocol before the research is allowed to start. They aim to provide an opinion as to whether the research, if carried out in accordance with the detailed protocol, will meet accepted ethical norms. Exactly what these norms are, and how they can be addressed, is a complex question that may need to take into account guidance created by the first type of ethics committee described above. As such, although RECs still need to have suitably experienced individuals, it is more important that they are also suitably independent from the researcher (and their funder) to ensure they give an ethical opinion that is free from as many conflicts of interest as possible. Scientific or research expertise is important, but so is the voice of non-expert members. Quite often researchers will not be allowed to publish their work if they cannot prove it was reviewed by a REC before it started.

REC review supports research and researchers

REC review is criticised by researchers as being too lengthy, burdensome, or bureaucratic. This is often because it is confused with wider governance processes relating to issues such as data protection, health and safety, financial management, etc. While such issues are important, the fact that they are related to specific, often legally prescribed, arrangements means that they are governance issues that are the responsibility of the research institution (e.g., the university) to review and approve. The distinction between governance approvals , and ethics opinion , is extremely important if the aim is to create systems that provide robust, but proportionate, support to research and researchers. While in some contexts committees are expected to review both governance and ethics issues, there is an increasing recognition that governance is best handled separately by expert research officers, freeing RECs to consider the more complex ethical issues that may arise in any given research project.

Written by Dr Simon Kolstoe, UKRIO Trustee .

Research organisations and research ethics committees - ESRC

Our principles: research ethics committees.

All parties involved in research have an active role to play in creating and sustaining a culture of rigorous ethical reflection.

We acknowledge that RECs have many competing obligations, with duties to protect participants, researchers and research organisations which mean they are constantly working to achieve many goals; we encourage RECs to engage with researchers in all stages of a project’s research lifecycle.

The principles below should also be considered during any ongoing monitoring of ESRC-funded projects.

Research should aim to maximise benefit for individuals and society and minimise risk and harm

A REC review of a project should consider the ethical conduct of the research whilst also facilitating high quality ethical research; this includes high-impact activities and new forms of research, for example, co-production. The review should be proportionate to the potential benefits and level of risk of the proposed research. RECs should determine the degree of risk and potential harm that may be tolerable in relation to the potential benefits.

The rights and dignity of individuals and groups should be respected

The primary role of the REC review is to ensure that the research will respect the dignity, rights, welfare and, where possible, the autonomy of participants and all parties involved in and potentially affected by the research.

Wherever possible, participation should be voluntary and appropriately informed

The REC should consider the information provided by the researchers regarding consent and voluntary participation, and evaluate how researchers justify and mitigate risks associated with withholding information and the adequacy of any proposed debriefing.

Participants should, wherever possible, take part in research voluntarily and there should not be any coercion or inappropriate influence.

The REC should be confident that participants will be given sufficient information about the research to enable them to make an informed decision about their participation. REC members should also be aware that there may be instances where this is not practical or desirable (for example, for methodological reasons, or covert or crowd research).

Research should be conducted with integrity and transparency

RECs should ensure that they fulfil their role and responsibilities with integrity and record their decisions and feedback in a transparent way.

Lines of responsibility and accountability should be clearly defined

The remit and responsibilities of the RECs should be clear; RECs should be committed to training and development to enable them to fulfil their role. Where the REC feels that it does not have the expertise to review a proposal, it should seek the help of independent bodies or external members. The REC’s performance is subject to review by the research organisation.

The independence of research should be maintained, and where conflicts of interest cannot be avoided they should be made explicit

RECs should be able to conduct ethics review in a wholly independent and impartial manner without any conflicts of interest and with a focus clearly on the ethics of research proposals.

Independence can be achieved by a committee composed of members from a wide range of disciplines and includes external members, within a policy and governance structure that establishes the right of the REC to pass opinions free of influence.

Secondary RECs that comprise members from only one discipline or a small number of closely related disciplines may be regarded as too closely aligned with the interests of researchers.

Further information

Criteria for research ethics committee review

Conflicts of interest, complaints and appeals

Last updated: 15 October 2021

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Programs Climate Risk Committee

The purpose of Federal Housing Finance Agency’s (FHFA) Climate Risk Committee is to ensure the Agency makes strategic and tactically sound decisions concerning the impacts of and response to the risks posed by climate change in a coordinated, collaborative, and informed manner in furtherance of FHFA’s mission. The goal of the Climate Risk Committee is to better understand the impact of climate change on the housing and mortgage markets, including the disparate impacts on disadvantaged communities, and facilitate the sharing of climate-related financial risk data and information.

To this end, FHFA established an internal Climate Risk Committee, consisting of representation from the Agency's Divisions and Offices, with working groups staffed with experts from across the Agency on the following areas:

• Data and research;​​
• Assessing climate exposure;
• Reporting and disclosure;
• Governance; and
• Green bonds.

The Climate Risk Committee will build on the progress made by its predecessor, the Climate Change and Environmental, Social, and Governance (ESG) Steering Committee. In line with this and the Agency’s mission, FHFA will continue to integrate a consumer protection lens into its supervisory oversight and will foster interagency and regulated entity collaborations to keep abreast of emerging best practices for climate resiliency and sustainability.

A​dditional Steps Taken

In April 2023, FHFA joined the  Mitigation Framework Leadership Group (MitFLG) . MitFLG, led by the Federal Emergency Management Agency (FEMA), is focused on strengthening the nation’s disaster resilience by expanding mitigation awareness, coordination, and action.

In July 2022, FHFA joined the  Financial Literacy Education Commission (FLEC) . FLEC is a national interagency group focused on coordinating financial education efforts throughout the federal government.

On May 11, 2022, FHFA joined the  Network of Central Banks and Supervisors for Greening the Financial System (NGFS) . NGFS is an international group comprised of central banks and financial supervisors whose purpose is to help strengthen the global response required to meet the goals of the Paris agreement.

In February 2022, FHFA joined the Financial Stability Oversight Council’s (FSOC) Climate-related Financial Risk Committee (CFRC). The CFRC assists FSOC in gathering information on, conducting analysis of, and making recommendations to identify, assess, and mitigate climate-related risks to the financial system.

Econ Summits

FHFA will host an  Economic Summit  on climate risk on November 12, 2024. (Submissions Closed: Fall 2024 Econ Summit Call for Papers )

On October 3, 2023, FHFA hosted an Economic Summit on climate risk. The Summit included three sessions: climate change and insurance; land use regulations, disclosures, and risk modeling; and disaster risk and house prices. This blog post details the event and some key takeaways from the Summit and each of the 11 presentations.

On November 1, 2022, FHFA hosted an Economic Summit on climate risk, with sessions on climate stress testing and academic research on impacts to vulnerable communities.

Other FHFA Public Engagements

On March 13, 2024, the FHFA Multifamily team hosted a Multifamily Insurance Symposium. The symposium included sessions on insurance market risks and challenges, insurance and affordability, emerging solutions, and the Enterprises’ and HUD’s perspectives on insurance market challenges.

On November 14 and 15, 2023, the FHFA Single-Family team hosted a Single-Family Insurance Symposium. Day One included sessions on insurance commissioner perspectives, implications of growth in residual insurance markets, insurance industry perspectives, and the homeownership experience. Day Two included sessions on strengthening community resilience and insurability, empowering communities with information, wildfire solutions, building climate resilience across sectors, building codes and standards, and consumer perspectives.

Agency Documents

See FHFA’s guidance for managing climate-related risks to support a safe and sound operating environment within FHFA’s AB 2024-01: Climate-Related Risk Management Advisory Bulletin .

See FHFA’s ongoing research and staff working papers here .

See FHFA’s climate-related performance measures and targets for 2024 within FHFA’s  FY 2024 Annual Performance Plan .

See FHFA’s FY23 climate-related activities and plans for FY24 within FHFA’s  2023 Performance and Accountability Report .

See FHFA’s climate-related activities in 2023, 2022, and 2021 within FHFA’s 2023 Annual Report to Congress , 2022 Annual Report to Congress , and 2021 Annual Report to Congress , respectively

See FHFA’s climate-related performance measures and targets for 2023 within FHFA’s FY 2023 Annual Performance Plan .

See FHFA’s FY22 climate-related activities and plans for FY23 within FHFA’s 2022 Performance and Accountability Report .

Climate Blog Series

Read about the ongoing work and accomplishments of FHFA’s Climate Risk Committee Working Groups.

The Need to Address Climate Risk

August 28, 2023

Daniel E. Coates    

Deputy Director, FHFA Division of Research and Statistics

Chair, Climate Change and ESG Steering Committee

Executive Sponsor, Climate Change and ESG Working Groups

Understanding the Climate’s Impact on Vulnerable Populations

November 27, 2023

Authors:    

Leda DeRosa Bloomfield  

Branch Chief for Policy and Equity, Office of Fair Lending Oversight

Division of Housing Mission and Goals 

Sarah Friedman  

Examination Specialist, Office of Fair Lending Oversight

Division of Housing Mission and Goals

FHFA’s Fall 2023 Econ Summit on Climate Risk

January 22, 2024

November Wilson

Senior Economist,

Division of Research and Statistics

Incorporating Climate-Related Risks into Governance

April 22, 2024

Eric Kelley

Senior Strategic Analyst

Division of Conservatorship Oversight and Readiness

Anne Marie Pippin  

Deputy Director

La’Toya Holt    

Senior Risk Analyst, Governance and Management Risk Branch

Office of Risk Analysis

Policy and Guidance and Development

Division of Enterprise Regulation

Varun Joshi

Progress in Addressing Climate-related Disclosure Standards

April 23, 2024

Suzanne Crump  

Principal Accountant (Advisor)

Office of the Chief Accountant

Truc-An To  

Principal Accountant, Financial Disclosure Branch

Quinn McDonough

Accountant, Accounting Policy Branch

Lessons Learned from Assessing Exposure to Climate-Related Risks

May 1, 2024

Caroline Hopkins

Supervisory Financial Analyst,

Andrew Davenport

Principal Economist,

Barry Carroll

Senior Financial Analyst,

Stefan Szilagyi

Supervisory Economist,

Division of FHLBank Regulation

​Disaster Response and Assistance

In May 2019, FHFA formalized its agency-wide Disaster Response Team (DRT), which had been meeting informally for years prior. The DRT has experience coordinating with the regulated entities, other government agencies, external parties, and internal FHFA stakeholders during natural disasters. It is guided by a natural disaster response and recovery framework developed by FHFA in coordination with its regulated entities to support borrowers and renters affected by natural disasters. This framework incorporates forbearance and workout options for borrowers in areas impacted by natural disasters, tailoring options to their specific circumstances.

For more information on disaster response and assistance: See  https://www.fhfa.gov/homeowners-and-homebuyers/mortgage-assistance/disaster-assistance

RFI: Climate and Natural Disaster Risk Management at the Regulated Entities

Link to Comments

Link to RFI Synopsis

Listening Session

On March 4, 2021, FHFA held a public listening session on Climate and Natural Disaster Risk Management at the Regulated Entities.

March 4, 2021 Listening Session

March 4, 2021 Agenda

March 4, 2021 Listening Session Transcript

March 4, 2021 Listening Session Presentations

Statements, Remarks, and External Engagements

Jessica Shui, Project Coordinator for the Climate Change and ESG Working Groups at FHFA, discussed FHFA’s climate risk management initiatives on April 19, 2024, at the Americatalyst Housing and Finance Leadership Summit.

Anju Vajja, Executive Sponsor of the Climate Change and ESG Working Groups at FHFA, discussed climate-related financial risks at the American Savings Education Council Panel hosted by the Bipartisan Policy Center on April 11, 2024.

Daniel E. Coates, Executive Sponsor of the Climate Change and ESG Working Groups at FHFA, discussed FHFA and its regulated entities’ actions to address climate change in an interview with The Economist on March 27, 2024.

Daniel E. Coates, Executive Sponsor of the Climate Change and ESG Working Groups at FHFA, delivered closing remarks addressing climate change at the joint GSE Climate Risk Forum held on March 20 and 21, 2024 at the Freddie Mac Headquarters.

Daniel E. Coates, Executive Sponsor of the Climate Change and ESG Working Groups at FHFA, delivered remarks on FHFA and its regulated entities’ actions to address climate-related risk during the Ceres webinar, Charting Progress: Regulator Actions on Climate Financial Risks, on December 18, 2023.

Daniel E. Coates, Deputy Director for the Division of Research and Statistics at FHFA, discussed the impact of climate change on the housing finance sector at the Insurance Information Institute (III) Town Hall held on November 30, 2023.

Daniel E. Coates, Deputy Director for the Division of Research and Statistics at FHFA, participated in a panel on Climate-Related Risk for Housing Finance at the Financial Services Conference organized by the Consumer Federation of America on November 16, 2023.

Jessica Shui, Climate Change and ESG Branch Manager for the Division of Research and Statistics at FHFA, delivered remarks on FHFA’s progress in advancing climate resiliency at the Financial Literacy and Education Commission  Public Meeting  held on November 15, 2023.

Jessica Shui, Climate Change and ESG Branch Manager for the Division of Research and Statistics at FHFA, delivered remarks addressing climate risk at CoreLogic’s DC Government Forum held on November 13, 2023.

Sandra L. Thompson, Director of FHFA, delivered  remarks  addressing climate change at the Financial Stability Oversight Council’s Climate-related Financial Risk Advisory Committee Meeting on October 20, 2023.

Daniel E. Coates, Deputy Director for the Division of Research and Statistics at FHFA, delivered remarks on FHFA’s work to address climate change during an interview with National Mortgage Professionals on October 12, 2023.

Daniel E. Coates, Deputy Director for the Division of Research and Statistics at FHFA, delivered closing remarks addressing climate change at the joint GSE Climate Risk Forum held on October 10, 2023.

Sandra L. Thompson, Director of FHFA, participated in a climate change Q&A organized by the National Association of Federally Insured Credit Unions (NAFCU) on September 13, 2023.

Daniel E. Coates, Deputy Director for the Division of Research and Statistics at FHFA, delivered remarks which also touched upon climate change at the 2023 American Real Estate and Urban Economics Association (AREUEA) National Conference held on June 1, 2023.

Daniel E. Coates, Deputy Director for the Division of Research and Statistics at FHFA, participated in a panel discussion on climate risk hosted by CoreLogic on May 10, 2023.

Daniel E. Coates, Deputy Director for the Division of Research and Statistics at FHFA, delivered remarks on FHFA’s actions to address climate-related risk during the Ceres webinar, The Climate Risk Scorecard: Assessing U.S. Financial Regulator Action, on December 6, 2022.

Sandra L. Thompson, Director of FHFA, delivered  remarks  during the Financial Literacy Education Commission (FLEC) Public Meeting on November 17, 2022, which also touched upon climate.

Daniel E. Coates, Deputy Director for the Division of Research and Statistics at FHFA, served as the keynote presenter for the September 30, 2022, Climate Adaptation Forum (CAF).

Sandra L. Thompson, Director of FHFA, addressed climate change during the National Association of Federally Insured Credit Unions (NAFCU)’s Congressional Caucus event in September 2022.

Daniel E. Coates, Deputy Director for the Division of Research and Statistics at FHFA, addressed climate change in a podcast on climate change risk organized by the National Association of Federally Insured Credit Unions (NAFCU) in August 2022.

Remarks of Sandra L. Thompson, Director of FHFA, at Financial Stability Oversight Council Principals Meeting on July 28, 2022.

Federal Housing Finance Agency Announces Membership in the Network of Central Banks and Supervisors for Greening the Financial System (NGFS)​ on May 11, 2022 .

FHFA Acting Director Sandra L. Thompson's Statement on Climate Change on December 27, 2021 .

Prepared Remarks of Sandra L. Thompson, Acting Director of FHFA, at Financial Stability Oversight Council Principals Meeting. on October 21, 2021 .

Regulated Entities

On March 20 and 21, 2024, the Enterprises hosted a joint GSE Climate Risk Forum. The event included panel sessions, presentations, and individual speakers covering topics on the low-carbon transition and housing.

On October 10, 2023, the Enterprises hosted a joint GSE Climate Risk Forum. The event included panel sessions, presentations, and individual speakers covering topics on climate resilience and the housing market.

In June 2023, the Federal Home Loan Banks released an inaugural  Corporate Social Responsibility Report  highlighting their commitment to robust and prudential risk management and governance in order to continue to meet the demands of their member districts.

The ESG website of the  Federal Home Loan Bank of Dallas  describes their ESG strategy and includes a link to their  2022 ESG Report , published in April 2023.

Fannie Mae  and  Freddie Mac's  ESG websites describe their ESG strategies and include links to their most recent Sustainability and ESG Reports.

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Official development assistance (ODA)

Official development assistance (ODA) is government aid that promotes and specifically targets the economic development and welfare of developing countries. ODA has been the main source of financing for development aid since it was adopted by the OECD’s Development Assistance Committee (DAC) as the “gold standard” of foreign aid in 1969. The OECD is the only official source of reliable, comparable, and complete statistics on ODA.

• Preliminary 2023 ODA statistics
• How is ODA data collected?

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Key messages, supporting the economic development and welfare of low- and middle-income countries.

ODA is financial support from official providers to aid recipients (low- and middle-income countries) in areas such as health, sanitation, education, and infrastructure. It mainly consists of either grants or “soft” loans and it makes up over two thirds of external finance for least-developed countries.

Defining which countries and territories are eligible to receive ODA

The DAC List of ODA-eligible recipients shows all countries and territories meeting the criteria to receive ODA. These consist of all low- and middle-income countries based on gross national income (GNI) per capita as published by the World Bank, with the exception of former G8 members, EU members, and countries with a firm date for entry into the EU. The list also includes all of the Least Developed Countries (LDCs) as defined by the United Nations (UN). It is reviewed every three years by the OECD’s DAC.

Monitoring ODA for better targeting and results

The DAC tracks and monitors ODA so that individual donor efforts are measured alongside the broader development finance landscape. The OECD ensures that providers adhere to the primary objective of ODA (the economic development and welfare of aid recipients) and inform them about where their ODA should go relative to existing needs.

International aid rises in 2023 with increased support to Ukraine and humanitarian needs

International aid from official donors rose in 2023 to a new all-time high of USD 223.7 billion, up from USD 211 billion in 2022, as provider countries increased aid flows to Ukraine and directed more humanitarian assistance to developing countries. This aid amounted to 0.37% of DAC countries’ combined gross national income.

ODA for gender equality dropped for the first time in a decade

The share of development finance for gender equality decreased after a decade of progress—from 45% in 2019-20 to 43% in 2021-22. Less than 1% of ODA is aimed at ending violence against women and girls.

What is ODA and how is it reported?

Frequently asked questions on ODA

Related data, related publications.

Related policy issues

• ODA eligibility and conditions
• ODA standards
• ODA trends and statistics

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