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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 .

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Methodology

• Ethical Considerations in Research | Types & Examples

Ethical Considerations in Research | Types & Examples

Published on October 18, 2021 by Pritha Bhandari . Revised on June 22, 2023.

Ethical considerations in research are a set of principles that guide your research designs and practices. Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.

The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways. What you decide to research and how you conduct that research involve key ethical considerations.

These considerations work to

• protect the rights of research participants
• enhance research validity
• maintain scientific or academic integrity

Table of contents

Why do research ethics matter, getting ethical approval for your study, types of ethical issues, voluntary participation, informed consent, confidentiality, potential for harm, results communication, examples of ethical failures, other interesting articles, frequently asked questions about research ethics.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe for research subjects.

You’ll balance pursuing important research objectives with using ethical research methods and procedures. It’s always necessary to prevent permanent or excessive harm to participants, whether inadvertent or not.

Defying research ethics will also lower the credibility of your research because it’s hard for others to trust your data if your methods are morally questionable.

Even if a research idea is valuable to society, it doesn’t justify violating the human rights or dignity of your study participants.

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Before you start any study involving data collection with people, you’ll submit your research proposal to an institutional review board (IRB) .

An IRB is a committee that checks whether your research aims and research design are ethically acceptable and follow your institution’s code of conduct. They check that your research materials and procedures are up to code.

If successful, you’ll receive IRB approval, and you can begin collecting data according to the approved procedures. If you want to make any changes to your procedures or materials, you’ll need to submit a modification application to the IRB for approval.

If unsuccessful, you may be asked to re-submit with modifications or your research proposal may receive a rejection. To get IRB approval, it’s important to explicitly note how you’ll tackle each of the ethical issues that may arise in your study.

There are several ethical issues you should always pay attention to in your research design, and these issues can overlap with each other.

You’ll usually outline ways you’ll deal with each issue in your research proposal if you plan to collect data from participants.

Voluntary participation means that all research subjects are free to choose to participate without any pressure or coercion.

All participants are able to withdraw from, or leave, the study at any point without feeling an obligation to continue. Your participants don’t need to provide a reason for leaving the study.

It’s important to make it clear to participants that there are no negative consequences or repercussions to their refusal to participate. After all, they’re taking the time to help you in the research process , so you should respect their decisions without trying to change their minds.

Voluntary participation is an ethical principle protected by international law and many scientific codes of conduct.

Take special care to ensure there’s no pressure on participants when you’re working with vulnerable groups of people who may find it hard to stop the study even when they want to.

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Informed consent refers to a situation in which all potential participants receive and understand all the information they need to decide whether they want to participate. This includes information about the study’s benefits, risks, funding, and institutional approval.

You make sure to provide all potential participants with all the relevant information about

• what the study is about
• the risks and benefits of taking part
• how long the study will take
• your supervisor’s contact information and the institution’s approval number

Usually, you’ll provide participants with a text for them to read and ask them if they have any questions. If they agree to participate, they can sign or initial the consent form. Note that this may not be sufficient for informed consent when you work with particularly vulnerable groups of people.

If you’re collecting data from people with low literacy, make sure to verbally explain the consent form to them before they agree to participate.

For participants with very limited English proficiency, you should always translate the study materials or work with an interpreter so they have all the information in their first language.

In research with children, you’ll often need informed permission for their participation from their parents or guardians. Although children cannot give informed consent, it’s best to also ask for their assent (agreement) to participate, depending on their age and maturity level.

Anonymity means that you don’t know who the participants are and you can’t link any individual participant to their data.

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, and videos.

In many cases, it may be impossible to truly anonymize data collection . For example, data collected in person or by phone cannot be considered fully anonymous because some personal identifiers (demographic information or phone numbers) are impossible to hide.

You’ll also need to collect some identifying information if you give your participants the option to withdraw their data at a later stage.

Data pseudonymization is an alternative method where you replace identifying information about participants with pseudonymous, or fake, identifiers. The data can still be linked to participants but it’s harder to do so because you separate personal information from the study data.

Confidentiality means that you know who the participants are, but you remove all identifying information from your report.

All participants have a right to privacy, so you should protect their personal data for as long as you store or use it. Even when you can’t collect data anonymously, you should secure confidentiality whenever you can.

Some research designs aren’t conducive to confidentiality, but it’s important to make all attempts and inform participants of the risks involved.

As a researcher, you have to consider all possible sources of harm to participants. Harm can come in many different forms.

• Psychological harm: Sensitive questions or tasks may trigger negative emotions such as shame or anxiety.
• Social harm: Participation can involve social risks, public embarrassment, or stigma.
• Physical harm: Pain or injury can result from the study procedures.
• Legal harm: Reporting sensitive data could lead to legal risks or a breach of privacy.

It’s best to consider every possible source of harm in your study as well as concrete ways to mitigate them. Involve your supervisor to discuss steps for harm reduction.

Make sure to disclose all possible risks of harm to participants before the study to get informed consent. If there is a risk of harm, prepare to provide participants with resources or counseling or medical services if needed.

Some of these questions may bring up negative emotions, so you inform participants about the sensitive nature of the survey and assure them that their responses will be confidential.

The way you communicate your research results can sometimes involve ethical issues. Good science communication is honest, reliable, and credible. It’s best to make your results as transparent as possible.

Take steps to actively avoid plagiarism and research misconduct wherever possible.

Plagiarism means submitting others’ works as your own. Although it can be unintentional, copying someone else’s work without proper credit amounts to stealing. It’s an ethical problem in research communication because you may benefit by harming other researchers.

Self-plagiarism is when you republish or re-submit parts of your own papers or reports without properly citing your original work.

This is problematic because you may benefit from presenting your ideas as new and original even though they’ve already been published elsewhere in the past. You may also be infringing on your previous publisher’s copyright, violating an ethical code, or wasting time and resources by doing so.

In extreme cases of self-plagiarism, entire datasets or papers are sometimes duplicated. These are major ethical violations because they can skew research findings if taken as original data.

You notice that two published studies have similar characteristics even though they are from different years. Their sample sizes, locations, treatments, and results are highly similar, and the studies share one author in common.

Research misconduct

Research misconduct means making up or falsifying data, manipulating data analyses, or misrepresenting results in research reports. It’s a form of academic fraud.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement about data analyses.

Research misconduct is a serious ethical issue because it can undermine academic integrity and institutional credibility. It leads to a waste of funding and resources that could have been used for alternative research.

Later investigations revealed that they fabricated and manipulated their data to show a nonexistent link between vaccines and autism. Wakefield also neglected to disclose important conflicts of interest, and his medical license was taken away.

This fraudulent work sparked vaccine hesitancy among parents and caregivers. The rate of MMR vaccinations in children fell sharply, and measles outbreaks became more common due to a lack of herd immunity.

Research scandals with ethical failures are littered throughout history, but some took place not that long ago.

Some scientists in positions of power have historically mistreated or even abused research participants to investigate research problems at any cost. These participants were prisoners, under their care, or otherwise trusted them to treat them with dignity.

To demonstrate the importance of research ethics, we’ll briefly review two research studies that violated human rights in modern history.

These experiments were inhumane and resulted in trauma, permanent disabilities, or death in many cases.

After some Nazi doctors were put on trial for their crimes, the Nuremberg Code of research ethics for human experimentation was developed in 1947 to establish a new standard for human experimentation in medical research.

In reality, the actual goal was to study the effects of the disease when left untreated, and the researchers never informed participants about their diagnoses or the research aims.

Although participants experienced severe health problems, including blindness and other complications, the researchers only pretended to provide medical care.

When treatment became possible in 1943, 11 years after the study began, none of the participants were offered it, despite their health conditions and high risk of death.

Ethical failures like these resulted in severe harm to participants, wasted resources, and lower trust in science and scientists. This is why all research institutions have strict ethical guidelines for performing research.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Normal distribution
• Measures of central tendency
• Chi square tests
• Confidence interval
• Quartiles & Quantiles
• Cluster sampling
• Stratified sampling
• Thematic analysis
• Cohort study
• Peer review
• Ethnography

Research bias

• Implicit bias
• Cognitive bias
• Conformity bias
• Hawthorne effect
• Availability heuristic
• Attrition bias
• Social desirability bias

Ethical considerations in research are a set of principles that guide your research designs and practices. These principles include voluntary participation, informed consent, anonymity, confidentiality, potential for harm, and results communication.

Scientists and researchers must always adhere to a certain code of conduct when collecting data from others .

These considerations protect the rights of research participants, enhance research validity , and maintain scientific integrity.

Research ethics matter for scientific integrity, human rights and dignity, and collaboration between science and society. These principles make sure that participation in studies is voluntary, informed, and safe.

Anonymity means you don’t know who the participants are, while confidentiality means you know who they are but remove identifying information from your research report. Both are important ethical considerations .

You can only guarantee anonymity by not collecting any personally identifying information—for example, names, phone numbers, email addresses, IP addresses, physical characteristics, photos, or videos.

You can keep data confidential by using aggregate information in your research report, so that you only refer to groups of participants rather than individuals.

These actions are committed intentionally and can have serious consequences; research misconduct is not a simple mistake or a point of disagreement but a serious ethical failure.

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The key role of ethics committees

Rapid response to:

Should research ethics committees police reporting bias?

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• Rapid responses

Rapid Response:

We read with great interest the head to head on reporting bias and the possible role of ethics committees in its control and the 3 accompanying responses available at this time.

Many interesting points have been addressed such as the need for resources, the complex issue of sanctions, the “waste” of research, the necessity to improve the information available in the data base and so on. Still the main question remains, “Should research ethics committee records be used to detect reporting bias?” as Simon E Kolstoe points out.

The research projects evaluated by ethics committees often lack in definition of outcomes, as well as in precise reporting about the interventions to be done and the population to be enrolled. This lack of fundamental informations makes almost impossible the monitoring and the detection of reporting bias, regardless of who is the actor of the monitoring process.

Population, interventions, comparators and outcomes definition, are the essential information to guarantee a valid and reliable judgement process.

The response of Michelle van der Vecht to the head to head recalls the availability of structured tools for the evaluation of research protocols ( http://www.spirit-statement.org ). These instruments, also inspired to Good Clinical Practice ( http://www.ich.org ), are also designed for the purpose of reporting bias control and are aligned to similar tools ( http://www.consort-statement.org ) adopted by all major biomedical journals.

The ethics committee of the Tuscany region is organized in four sections, one exclusively dedicated to clinical research in pediatrics, has adopted the SPIRIT Statement as an evaluation tool for interventional research protocols. The availability of a management software will allow the creation of a database of research projects including a clear definition of outcomes, interventions and populations to be enrolled. This database could be used for the monitoring and detection of reporting bias (and probably Publication bias).

We believe that the role of ethics committees could be crucial in the control of reporting bias since they are in a privileged position to begin the monitoring process. However, the availability of robust evidence to identify the reporting bias can be guaranteed only by an evaluation system of the ethical committees that use validated and standardized tools.

Competing interests: No competing interests

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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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.

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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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UCL Research Ethics

About the UCL Research Ethics Committee

To support our reforms, the Research Innovation and Global Engagement Committee (RIGEC) has approved a new governance structure for research ethics at UCL. Find out more below.

Research ethics is fundamental to UCL's mission as a world-class institution dedicated to the continued pursuit of original knowledge and scientific advancement to benefit humanity and the world of the future. Research ethics committees play a central role in ensuring that research meets the highest standards of academic rigour, transparency, accountability and ethics, to safeguard and empower participants

These high standards are essential for ensuring the highest quality research and maintaining the continued trust and confidence of the wider research community and the public.

What does the UCL REC do?

From spring 2024, the UCL Research Ethics Committee (UCL REC) will be established as a strategic committee with overarching responsibility for research ethics policy, guidance and processes at UCL. There will be 3 subcommittees, including 2 to review both high and low-risk applications* (from non-LREC areas):

• Life and Medical Sciences Research Ethics Committee (LMS REC) : Brain Sciences, Life Sciences, Population Health Sciences and Medical Science
• Humanities, Arts and Sciences Research Ethics Committee (HAS REC) : Arts and Humanities, Bartlett, Institue of Education, Laws, Social and Historical Sciences, Mathematical and Physical Sciences and Engineering Sciences
• The LREC Chairs Group: For the Chairs of the 24  Local Research Ethics Committees (LRECs) operating in faculties and departments, to facilitate the sharing of best practice and developing consistent approaches to emerging ethical issues.

Our 2 central reviewing committees will be multi-disciplinary with cross-UCL faculty representatives working in different fields and disciplines.

We are working with faculties on the membership of these committees. If you are enthusiastic about promoting ethical research practices and contributing to the advancement of knowledge at UCL, find out more about joining an ethics committee on our Become an ethics committee member  page.

* High-risk applications submitted for the March 2024 deadline will undergo review by the existing UCL REC. Low-risk applications will continue to be considered on a rolling basis with applications being reviewed in order of submission.

Constitution and membership

Terms of reference.

• To maintain strategic oversight of research ethics at UCL. 
• To develop and review institutional policy and processes on research ethics to ensure they remain fit for purpose and respond to evolving research and ethics.  
• To ensure that ethics policy and processes and are in line with the principles set out in the UCL Code of Conduct for Research, UCL’s commitments to equality, diversity, and inclusion, and best practice in governance. 
• To oversee the work of the reviewing subcommittees and to review and recommend any required changes to the research ethics governance structure. 
• To review and approve proposals for the establishment of new low-risk LREC Chairs Group.  
• To receive and discuss reports from reviewing committees on complex ethical issues, recommending approaches, approving and implementing UCL-wide guidance and commissioning expert guidance where required. 
• To monitor and audit practice through the receipt of annual reports and to conduct other audits as required. 
• To review and suggest improvements required to the research ethics IT system. 
• To ensure that appropriate training and advice is available for staff, supervisors and students on good practice in relation to the ethics of their research.  
• To develop, implement and review the system of appeals, complaints and adverse events or incidents reported regarding ethically approved research.
• To report on an annual basis to UCL Research, Innovation and Global Engagement Committee an overview of the effectiveness of current ethics policy, practices and procedures in that reporting year.

The UCL REC membership will comprise Chairs from the reviewing committees, LREC Chairs Group (representing LRECs) and a range of experts to inform and support the ongoing development of research ethics review policy and process.

Page last updated: March 2024