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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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Research Ethics Review Committee

Review process

Recommended format for a 'research protocol'
Guidelines on submitting research proposals for ethics review
Guidance for submissions of documents
Summaries of research protocols: table 1
Summaries of research protocols: table 1 next
Summaries of template and guidance documents

To whom do I submit my proposal?

All research proposals involving human participants need to be submitted by the WHO staff member to the ERC Secretariat, using an online submission portal, ProEthos .

Each proposal undergoes a preliminary screening by the Secretariat to confirm that all necessary documentation has been submitted – i.e. the study protocol, informed consent forms, study instruments, local ethics approval etc. Only when all required documentation has been duly submitted, will the Secretariat forward the study for review by the ERC. A study will only receive final approval from the ERC when all core documentation has been satisfactorily submitted, including local ethics approval.

After the initial screening, what next?

Only when all required documentation has been duly submitted, will the Secretariat forward the study for review by the ERC. A study will only receive final approval from the ERC when all core documentation has been satisfactorily submitted, including local ethics approval.

What types of review are there?

Based on certain set of criteria, a proposal is submitted for one of the following types of review:

Full committee review of proposals

All research proposals that present more than minimal risk to human subjects are reviewed by two ERC members who present the proposal to the ERC followed by a general discussion and a consensus decision. WHO responsible officers for the proposal under review are invited to respond to queries raised and to provide clarifications and/or justifications.

Expedited review of proposals

A proposal is circulated for expedited review when the research procedures present no more than minimal harm to the research participants or communities. In this case, the proposal is sent to two ERC members who are required to provide their feedback to the secretariat within 10 working days. As appropriate, the proposal is then either approved or returned to the technical officer for further action.

Exemption from ERC review

Proposals are exempt from ERC review when there is no possibility of harm arising as a result of the conduct of the research project or when the information being collected is available from the public domain.

Accelerated review

In the event of a public health emergency, such as the investigation of a disease outbreak or a disaster relief operation, a protocol may be submitted for accelerated review.

Continuing review

Since ethics approvals are provided to studies for a limited time period, the ERC reviews the progress of the study at periodic intervals. In order to renew the approval, the WHO responsible officers should submit the necessary documentation to the ERC prior to approval expiry.

How is a proposal reviewed at an ERC meeting?

One of the two primary reviewers makes a brief presentation of the proposal under review, highlighting the ethical and other issues raised by the study and the documentation provided for review. The second primary reviewer supplements the presentation by his/her own review. After the presentation by the primary reviewers, the discussion is opened to the rest of the ERC members, who may raise additional questions.

The Secretariat invites the WHO responsible officer to attend the segment of the ERC meeting when discussions on his/her proposal are taking place. The responsible officer is given the opportunity to respond to all the queries and comments, and there is often a lively discussion on the proposal. When all the queries have been answered, the responsible officer will leave the meeting to enable the primary reviewers to make their overall recommendations, which the rest of the ERC may or may not endorse.

In the event of the latter, a debate will take place until the ERC agrees in unison what the final recommendation should be.

What if the Committee cannot agree on a final recommendation?

According to the erc rules of procedure:.

"A Committee decision on a research proposal shall be made by consensus. Where consensus cannot be reached, consideration of the proposal shall be postponed to a subsequent meeting in order to seek additional information or expert advice if so decided by a majority of members present and voting, or the proposal shall be considered not approved."

How is the outcome of the review communicated to the WHO responsible officer?

Whether a proposal has been submitted to a Full Committee or for an "expedited review", the outcome of the review will be communicated electronically to the Technical Unit. The Secretariat will provide an ERC Summary Review Form to the technical officer outlining the concerns, if any, raised by the ERC.

The ERC recommends that the responsible officer should not contact individual ERC members present at a meeting when their proposal was discussed. Any questions or concerns that a responsible officer might have with regard to his/her proposal should be referred directly to the Secretariat.

The review summary is sent electronically initially and is followed by the hard-copy only after the proposal is fully approved or if it is rejected.

What do the ERC recommendations mean?

The ERC may give any one of the following recommendations on a proposal:

Approved as submitted

The proposal is approved and no modifications are required. In this case, the responsible officer should prepare the Technical Service Agreement (TSA) if the study is being funded by WHO. If WHO is not funding the study, the Review Summary is the document required in order to begin the study.

Approved conditionally; requires amendments and/or clarifications

The proposal’s approval is contingent upon an adequate response by the Principal Investigator to the satisfaction of the reviewers or the Chair on behalf of the ERC.

If amendments are required, they should be included in the proposal and the amended proposal submitted to the ERC Secretariat. The proposal will either be scrutinized by the Secretariat or by the Primary Reviewers as decided by the ERC.

Not approved; requires additional information and/or rewriting

The proposal should be improved and the revised version of the proposal should be re-submitted by the WHO responsible officer as a new submission to the ERC for re-review by the Committee.

The proposal is ethically unacceptable and may not be approved by the ERC, or supported by WHO. The Principal Investigator may submit a new proposal that takes into consideration the ethical issues raised by the Committee.

What is the time frame for the review of proposals by the ERC?

The initial screening is done on the first day of receipt of the proposal to ensure that all the documentation has been submitted. A more detailed technical screening at the Secretariat level is then carried out within 5 working days. If you do not receive any information or acknowledgement of the proposal, do not hesitate to contact the Secretariat.

Expedited review

Once submitted for expedited review, the proposal is reviewed within 10 days. Consequently, a responsible officer can expect a response from the Secretariat within 2-3 weeks of the initial submission.

Full Committee review

If a proposal is sent for regular review, it will be discussed at the next meeting to the date of receipt of a satisfactory submission. As a general rule ERC meetings take place on a monthly basis. The cut-off date for receiving a proposal for discussion at a particular meeting is listed on the ERC meeting dates and deadlines for submission of protocols.

The length of time for approval, with both expedited and regular reviews, depends on the promptness of the response from the responsible officers and the Principal Investigators to ERC concerns.

The ERC Secretariat is currently creating a system whereby you will be able to track the progress of the project through the review process.

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Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: World Health Organization; 2011.

Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants.

Iii standards and guidance for members of the research ethics committees.

The primary task of an REC is the ethical review of research protocols and their supporting documents. Approval or disapproval is based on the ethical acceptability of the research, including its social value and scientific validity, an acceptable ratio of potential benefits to risks of harm, the minimization of risks, adequate informed consent procedures (including cultural appropriateness and mechanisms to ensure voluntariness), measures to ensure protection of vulnerable populations, fair procedures for selection of participants, and attention to the impact of research on the communities from which participants will be drawn, both during the research and after it is complete. The review take into account any prior scientific reviews and applicable laws.

Standard 7. Ethical basis for decision-making in research ethics committees

The REC bases its decisions about research that it reviews on a coherent and consistent application of the ethical principles articulated in international guidance documents and human rights instruments, as well as any national laws or policies consistent with those principles. The REC makes clear the specific ethical guidelines on which it relies in making decisions and makes them readily available to researchers and the public. When an REC develops reliance agreements for review of research under its jurisdiction by another REC, it is the responsibility of the delegating REC to assure that the same ethical principles serve as the basis of the other REC's decision-making.

To aid in determining the ethical acceptability of research protocols, an REC may utilize a checklist to ensure that all relevant criteria are considered during review and that, as a general rule, similar protocols are treated similarly. When an REC determines that an approach it has taken on a particular ethical issue in the past is no longer appropriate, it provides an explicit rationale for its change in position. In communicating decisions about particular protocols to researchers, the REC explains its analysis of any significant ethical issues that arose in the review.

As articulated in more detail in international ethics guidelines and the research regulations of a number of jurisdictions, key criteria include, but are not limited to, the following.

1. Scientific design and conduct of the study

Research is ethically acceptable only if it relies on valid scientific methods. Research that is not scientifically valid exposes research participants or their communities to risks of harm without any possibility of benefit. RECs should have documentation from a prior scientific review, or should themselves determine that the research methods are scientifically sound, and should examine the ethical implications of the chosen research design or strategy. Unless already determined by a prior scientific review, RECs should also assess how the study will be conducted, the qualifications of the researcher(s), the adequacy of provisions made for monitoring and auditing, as well as the adequacy of the study site (e.g. availability of qualified staff and appropriate infrastructures).

2. Risks and potential benefits

In ethically acceptable research, risks have been minimized (both by preventing potential harms and minimizing their negative impacts should they occur) and are reasonable in relation to the potential benefits of the study. The nature of the risks may differ according to the type of research to be conducted. REC members should be aware that risks may occur in different dimensions (e.g. physical, social, financial, or psychological), all of which require serious consideration. Further, harm may occur either at an individual level or at the family or population level.

3. Selection of study population and recruitment of research participants

Ethically acceptable research ensures that no group or class of persons bears more than its fair share of the burdens of participation in research. Similarly, no group should be deprived of its fair share of the benefits of research; these benefits include the direct benefits of participation (if any) as well as the new knowledge that the research is designed to yield. Thus, one question for research ethics review to consider is whether the population that will bear the risks of participating in the research is likely to benefit from the knowledge derived from the research. In addition, ethically acceptable research includes recruitment strategies that are balanced and objectively describe the purpose of the research, the risks and potential benefits of participating in the research, and other relevant details.

4. Inducements, financial benefits, and financial costs

It is considered ethically acceptable and appropriate to reimburse individuals for any costs associated with participation in research, including transportation, child care, or lost wages. Many RECs also believe that it is ethically acceptable to compensate participants for their time. However, payments should not be so large, or free medical care or other forms of compensation so extensive, as to induce prospective participants to consent to participate in the research against their better judgement or to compromise their understanding of the research.

5. Protection of research participants' privacy and confidentiality

Invasions of privacy and breaches of confidentiality are disrespectful to participants and can lead to feelings of loss of control or embarrassment, as well as tangible harms such as social stigma, rejection by families or communities, or lost opportunities such as employment or housing. RECs should therefore examine the precautions taken to safeguard participants' privacy and confidentiality.

6. Informed consent process

The ethical foundation of informed consent is the principle of respect for persons. Competent individuals are entitled to choose freely whether to participate in research, and to make decisions based on an adequate understanding of what the research entails. Decisions for children or adults who lack the mental capacity to provide informed consent should be made by an authorized surrogate decision-maker.

RECs should examine the process through which informed consent will occur, as well as the information that will be provided. RECs may waive the requirement of informed consent only when doing so is consistent with international guidelines and national standards.

While informed consent to research is important, the fact that a participant or surrogate may be willing to consent to research does not, in itself, mean that the research is ethically acceptable.

7. Community considerations

Research has impacts not only on the individuals who participate, but also on the communities where the research occurs and/or to whom findings can be linked. Duties to respect and protect communities require examining by the REC and, as far as possible, are aimed at minimizing any negative effects on communities such as stigma or draining of local capacity, and promoting, as relevant, positive effects on communities, including those related to health effects or capacity development. Researchers should actively engage with communities in decision-making about the design and conduct of research (including the informed consent process), while being sensitive to and respecting the communities' cultural, traditional and religious practices.

Standard 8. Decision-making procedures for research ethics committees

Decisions on research protocols designated for review by the convened REC are based on a thorough and inclusive process of discussion and deliberation. Protocols involving no more than minimal risk and burden to research participants may be reviewed on an expedited basis by one or more members (rather than the full committee), if the REC has established written procedures permitting such a procedure.

During meetings of the REC, members engage in discussions to elicit all concerns and opinions related to the protocols and the associated documents under consideration. The REC's rules ensure that the discussions are respectful of all opinions and allow for varied beliefs to be aired. The Chair fosters a respectful and inclusive tone and allows adequate time for deliberation, during which only REC members participate and decisions are made only by those who were present during the entire discussion. The Chair is responsible for the decision-making process, in particular for determining when consensus is needed to achieve the decision. Researchers, funders, or others directly associated with the protocol in question are not present during committee deliberations.
REC members recognize the limitations of their knowledge and seek external input when necessary, particularly in relation to research that involves people whose life experiences may differ significantly from those of the committee members.
Decisions are arrived at through either a vote or consensus. Consensus does not require that all REC members support the decision, but that all members consider the decision at least acceptable and no member considers the decision unacceptable. A pre-defined method determines when votes will be taken and how many favourable votes will be needed for a proposed research to be approved.

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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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Committees: Research Ethics Committees

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First Online: 01 January 2022
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Ana Borovecki 2

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

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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.

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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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