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• J Korean Med Sci
• v.38(25); 2023 Jun 26
• PMC10293659

Ethics Committees: Structure, Roles, and Issues

Pankti mehta.

1 Department of Clinical Immunology and Rheumatology, King George’s Medical University, Lucknow, India.

Olena Zimba

2 Department of Clinical Rheumatology and Immunology, University Hospital in Krakow, Krakow, Poland.

3 National Institute of Geriatrics, Rheumatology and Rehabilitation, Warsaw, Poland.

4 Department of Internal Medicine N2, Danylo Halytsky Lviv National Medical University, Lviv, Ukraine.

Armen Yuri Gasparyan

5 Departments of Rheumatology and Research and Development, Dudley Group NHS Foundation Trust (Teaching Trust of the University of Birmingham, UK), Russells Hall Hospital, Dudley, UK.

Birzhan Seiil

6 Department of Biology and Biochemistry, South Kazakhstan Medical Academy, Shymkent, Kazakhstan.

Marlen Yessirkepov

An Ethics Committee (EC) is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty. MEDLINE, Scopus, and Directory of Open Access Journals were searched for studies relevant to this topic. This review is focused on the types of research articles that need EC approval, the submission process, and exemptions. It further highlights the constitution of ECs, their duties, the review process, and the assessment of the risk-benefit of the proposed research including privacy issues. It’s pertinent for academicians and researchers to abide by the rules and regulations put forth by ECs for upholding of human rights and protecting research subjects primarily, as well as avoiding other issues like retraction of publications. Despite various issues of cost, backlogs, lack of expertise, lesser representation of laypersons, need for multiple approvals for multisite projects, conflicts of interest, and monitoring of ongoing research for the continued safety of participants, the ECs form the central force in regulating research and participant safety. Data safety and monitoring boards complement the ECs for carrying out continuous monitoring for better protection of research subjects. The establishment of ECs has ensured safe study designs, the safety of human subjects along with the protection of researchers from before the initiation until the completion of a study.

Graphical Abstract

INTRODUCTION

The journey of the role of ethics in biomedical research began with “The Doctor’s Trial” post-World War II in which 23 doctors and administrators were tried for war crimes, crimes against humanity, and conducting research without informed consent. This judgment, known as the “Nuremberg Code” was one of the first international ethical standards which gave a ten-point rule with respect to the protection of human research participants. The core principle was the requirement of voluntary consent of human subjects and respecting human autonomy. 1 , 2

However, some researchers continued to ignore the code and violations like the Willow Brook Hepatitis Study (1956), Jewish Chronic Disease Study (1963), and 22 others were highlighted by Beecher in 1966. 3 , 4 This led to the composition of the Declaration of Helsinki by the World Medical Association in Finland in 1964 with revisions at regular intervals. 5 This affirmed the principles highlighted in the Nuremberg Code stating that research should be conducted upholding the interests and rights of the human subjects. It proposed for the first time, the submission of a research protocol to an ethics committee (EC) before the initiation of the study ( Fig. 1 ). 6

EC refers to “Committees established by professional societies, health facilities, or other institutions to consider decisions that have bioethical implications. The role of these committees may include consultation, education, mediation, and/or review of policies and practices.” Committees that consider the ethical dimensions of patient care are Clinical ECs whereas committees established to protect the welfare of research subjects are Research ECs. 7 In this review, we will be using the terms ECs and Research ECs interchangeably.

It was in the 1960s that most nations developed guidelines regarding the formation of ECs with the main task of protection of human subjects. 8 EC is an independent body composed of members with expertise in both scientific and nonscientific arenas which functions to ensure the protection of human rights and the well-being of research subjects. ECs can be of two types—Institutional Review Boards (IRBs) or Institutional ECs (IECs) (referred to IRB or IEC by different countries) that are formally constituted by an institution to review research projects for that institute. An independent EC is an autonomous EC that is not part of any institute and performs the same functions independently. It is helpful for institutes that don’t have an IRB.

Despite these regulations, the unethical standards of the Tuskegee Syphilis study emerged in 1972 in which treatment was denied to the participants in order to study the natural course of the disease. This was followed by the conversion of the National Research Act in the USA into law (1974) and the setting up of the national commission of ‘International Ethical Guidelines for Biomedical Research Involving Human Subjects’ that submitted the Belmont report in 1979. The Belmont report described the role of assessment of risk-benefit of research involving human subjects, appropriate guidelines for selection of human subjects, and definition of informed consent. It was based on the three pillars of ethics- respect, beneficence, and justice. 9 , 10 It stressed the need for the approval of studies by an EC in accordance with the 1975 revision of the World Medical Association in Tokyo. Subsequently, countries like China, India, and South Korea adopted and legalized the need for submission of protocols to ECs from the 1980s onwards. 11 , 12 , 13 , 14

ECs function on six basic principles 15 :

• 1. Autonomy: respect the patient’s right to act on his/her own value and choice.
• 2. Justice: fair treatment of the research subjects.
• 3. Beneficence: work for the benefit of the patient.
• 4. Nonmaleficence: primum non-nocere or first do no harm to the patient.
• 5. Confidentiality: privacy protection.
• 6. Honesty: truthfulness in terms of the study.

Ethics approval is required for most research studies to uphold the above-mentioned principles, and protect the participants as well as the researcher. 16

In this narrative review, we aim to study the structure and function of ECs or IRBs with a focus on the composition, role, violations, and development perspectives of ECs.

Searches through MEDLINE (PubMed) and Scopus were performed in line with previously published recommendations. 17

Articles published till March 15, 2023 were reviewed using the following keywords: ("Ethics Committees, Clinical/classification"[Mesh] OR "Ethics Committees, Clinical/economics"[Mesh] OR "Ethics Committees, Clinical/ethics"[Mesh] OR "Ethics Committees, Clinical/history"[Mesh] OR "Ethics Committees, Clinical/legislation and jurisprudence"[Mesh] OR "Ethics Committees, Clinical/organization AND administration"[Mesh] OR "Ethics Committees, Clinical/standards"[Mesh] OR "Ethics Committees, Clinical/statistics and numerical data"[Mesh] OR "Ethics Committees, Clinical/trends"[Mesh]). Additional searches about subtopics were also carried out (“Data Safety Monitoring Boards” OR “Independent Data Review Committees”, “Institutional Review Boards” OR “Ethics Committees” and “Problems” OR “Issues”).

Articles in languages other than English, and reviews, conference proceedings, and editorials were excluded. Relevant articles searchable at the Directory of Open Access Journals and references of included articles were also processed for eligibility and inclusion for this narrative review. 18 , 19 , 20 , 21

RESEARCH, SUBMISSION PROCESS, AND EXEMPTIONS

IRB approval is required for most research to protect human rights and assess the scientific soundness of the research. For this, we first need to understand what research is. Research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” ( Table 1 ). 8

IRB = Institutional Review Board.

An EC approval is required for studies with more than minimal risk to the subjects where the intention is to publish findings or contribute to the scientific knowledge, studies involving the compilation or analysis of data containing patient identifying information, studies with any risk of physical or mental discomfort to participants or their families, and studies on vulnerable groups. 22 Minimal risk refers to the probability of discomfort posed by the research is not greater than that ordinarily encountered in routine daily life activities of an average healthy individual. 5 , 8 , 22

Thus, even surveys and archived data that contain patient identifying information (name, age, address) and sensitive information (illicit drug use, comorbidities, communicable diseases, e.g., HIV AIDS) need ethical approval to uphold the privacy and anonymity of the participants as well as protection the possibility of psychological discomfort to them. 10 , 23 , 24 , 25

Some studies may be exempted from ethical approval including most educational research, case reports on one to three patients (without any hypothesis testing), those that pose no risk to the participants, involve information freely available in the open domain for the community, analysis of open-source datasets or anonymized datasets obtained from other researchers with due informed consent taken at the time of primary data collection, research evaluating the public health programs or government public schemes. 26 , 27 However, a formal exemption is to be decided by the IRB and not the investigator. 8 , 28

For projects requiring an EC approval, the type of reviews includes expedited and a full board review. Expedited review is for research involving no more than minimal risk to the subjects, minor revisions of an already approved study, and is usually conducted by an experienced person or the chair of the IRB. A full board review on the other hand is for research with greater than minimal risk to the subjects or those involving vulnerable populations. This is reviewed extensively by a full IRB meeting.

The documents usually required for a full ethics review include the name of the applicant with designation, approval of the head of the department, research/trial protocol, ethical issues if any, and plans to address them, written informed consent form (and assent forms) in the language the participant understands, data collection tools, patient information sheet, regulatory clearances (e.g., Drug Controller General of India in India for drug trials), finance and funding details, Insurance, statement of conflicts of interest, information about payment or compensation to the subjects, scientific or departmental review board permission, Curriculum Vitae of the investigators, declaration of interests and any other relevant information. 29 , 30 Waivers of consent may be provided for no more than minimal risk to the subjects when the waiver will not endanger the rights and welfare of the subjects like retrospective studies, secondary analysis of data wherein consent had been taken previously, use of open access databases with anonymized data, and emergency research as seen fit by the EC. 31 , 32 In emergencies like the coronavirus disease 2019 pandemic, waivers may be provided if the patient is incapacitated or in life-threatening situations where there is no time for informed consent. Pandemics like these may even call for common documents for risk disclosure and audio/video/electronic consent. 33 , 34

EC PERSONNEL, THEIR EXPERIENCE, AND DUTIES

ECs have the primary responsibility of reviewing research and its alignment with the Good Clinical Practice (GCP) guidelines. 35 The research design must be scientifically sound and conducted in an ethical way to include human subjects with voluntary informed consent.

The composition of ECs varies depending on the country, center, volume, and nature of the research reviewed. However, there are some basic recommendations laid down by national authorities and GCP. 30

• a) Most countries in Europe, the USA, and South Korea have a requirement of at least five members whereas recommendations in China and India need a minimum of seven members and a maximum of 12–15 members. 14 , 36 , 37 , 38 , 39
• b) At least one member who is autonomous, independent of the institution or trial site. It is mandatory that the chairperson of the EC is not part of the institution where the research is to be conducted.

Others include a member secretary from within the institution and members from the scientific field. The composition should have an adequate gender and age representation with a blend of basic scientists, clinician scientists, one legal expert, one social scientist, one philosopher, and one layperson. Review of research involving vulnerable populations like children, pregnant women, handicapped, prisoners, etc., must involve one member with expertise in dealing with that population. 40 , 41 It is also desirable to have a member or expert advisor for special areas of research who has proficiency in that field.

Responsibilities

The chairperson has the primary responsibility of independent and smooth functioning of the EC, ensuring the participation of all members, seeking Conflict of Interests from all members, and handling complaints against the researchers and EC members. 39 It’s the responsibility of the member secretary to schedule EC meetings, handle documentation, organize an effective review of proposals, define and maintain adherence to standard operating procedures (SOPs), train EC members, and assess the need for expedited reviews/exemption from review. 39 The members of the scientific community have the primary responsibility of reviewing the research protocols and their scientific soundness. The non-scientist member is crucial to safeguard the human subjects and practical issues of the research. 40 , 41 However, studies have shown lesser participation by laypersons as compared to scientific members. A study conducted across 10 academic centers across the USA with 20 IRB meetings recorded noted that 29 community members were present in 17 of those meetings. They were primary reviewers in only two of the 93 submitted protocols due to refusal on grounds of lack of knowledge regarding medical research. Even as secondary and tertiary reviewers, they were less active and were more likely to focus on issues related to confidentiality. However, they played a greater role when they were not designated reviewers. 42

The EC or IRBs function to review and approve research protocols, monitor ongoing research involving human subjects with the aims of continual protection of human volunteers, advancement of research, and protecting the institute from litigation. Its main role is the protection of the human rights, autonomy, confidentiality, and welfare of the research subjects especially vulnerable populations. The GCP recommends the following for duties of the IRB ( Table 2 , Fig. 3 ) 35 :

e.g., An immunosuppressive drug “X” being evaluated for patients with Lupus Nephritis.

IRB = Institutional Review Board, SOC = standard of care, GCP = Good Clinical Practice, MMF = mycophenolate mofetil, CYC = cyclophosphamide, ICU = intensive care unit, SOP = standard operating procedure, RCT = randomized controlled trial.

• • The IRB should obtain and review all the necessary documents for the research/trial within a reasonable time and document its views following standardized operating procedures with clear identification of the dates for approval, modifications, disapproval, or termination of an ongoing trial that was initially approved in writing.
• • Qualification of the investigators should be considered for the proposed research.
• • Reviewing of ongoing research as appropriate to the risks involved (at least once a year).
• • Protocols indicating exemption of prior consent of the subject or their legally acceptable representative (e.g., emergency situations) should be assessed in detail for all the regulatory needs.
• • Review the sum and method of compensatory payment to subjects if required.
• • Functions should be performed as per written SOPs which should comply with the GCP guideline.

Most IRBs conduct meetings regularly (one–two per month depending on the number of protocols) and SOPs are followed as per the national governing authority.

An EC review is a continuous process and is needed before the initiation of research, before the extension of the approval period, prior to modifications to an already approved study, for monitoring of any adverse events, and until all the data collection and analysis is complete. 8 An oversight to the monitoring of trials (usually single center, early phase, less risky) is provided by the IRBs through annual reviews, adverse event monitoring, and reporting of undue events by the principal investigator (PI). However, complex clinical trials and/or multicenter, randomized controlled trials, interventional studies with pre-existing concerns about safety, or study participants who might need additional protection through an additional committee referred to as the Data Safety Monitoring Board (DSMB). 43 , 44

RISKS, BENEFITS, CONFIDENTIALITY, AND PRIVACY ISSUES IN RESEARCH PROTOCOLS

The role of the EC is not only to provide direct protection to human subjects from physical or mental harm but also to weigh the risks and benefits involved in the research. It must be assessed if the study is designed to add to the current scientific knowledge base and help society. 8

The research protocol is the document that includes the research question, aims and objectives, a critical literature review, methodology, and statistical plan. It is pertinent that the IRB reviews the protocol with respect to the clarity and focus of the research question; and whether the study design is suitable to answer the same. This is decided by the chair or a special departmental committee ( Table 2 , Fig. 3 ).

Privacy and confidentiality are a part and parcel of every physician-patient relationship. Needless to say, this must be maintained in a researcher-human subject relationship as well. It helps build trust, curbs participant anxiety, maintains their dignity, and above all their autonomy. 10 The International Committee of Medical Journal Editors recommends that authors must ensure that nonessential information like names, initials hospital record numbers, etc., are omitted during data collection, storage, and publication whenever possible. 45 However, there’s an extent to which this confidentiality can be maintained. Information required for scientific purposes (e.g., clinical photographs) or those with mandated legal reporting may breach participant privacy. This needs to be explained to the participant and recorded in written informed consent ( Table 2 ).

The role of the IRB with respect to privacy and confidentiality is to:

• • Review the consent document and assess the sensitivity of the information, the duration for which it will be held, the usefulness of the information, and the ability to protect it.
• • For multicenter projects, review the measures taken by the research team to maintain the privacy of the research subjects including the number of personnel with access to the information, data storage, and transfer.
• • An ongoing review of the research must include monitoring of confidentiality issues to check for maintenance of the same and the need for a revised privacy protection plan.
• • Educate researchers and IRB members regarding the data privacy and protection process. 46

Review of informed consent by IRBs is especially important in low-middle-income countries. There are various issues related to the lack of understanding of the information provided, maintaining privacy due to interference by family members, and the inability to assess risk and benefit by the research participant. IRBs have an additional responsibility to ensure that studies have minimal/no risk to the participant, the consent forms are clear and simple to understand and ensure the proper process of obtaining informed consent is being followed without undue pressure or coercion to participate in the study. 47

VIOLATIONS OF ETHICS APPROVAL RULES AND REGULATIONS

Violations of IRB approval rules like lack of approval, lack of approval of modifications to the protocol, and lack of informed consent can result in dire aftermaths for the authors. It can result in the withdrawal of the article if it’s still in press, retraction if it’s already published, and even removal if it has legal consequences. The number of papers retracted as searched on the retraction database 48 is steadily increasing by the decade from 474 in the 1990s to 6120 in the 2010s. The most common reason for retraction is plagiarism whereas violation of IRB rules accounts for 4–5% of all retractions. 49 , 50 When consultations for ethical inquiries to the Korean Association of Medical Journal Editor were analyzed, the most common reason was duplicate publications (12 of 80) with issues with IRB approval (5 of 80) and informed consent (6 of 80). 51 Some of the examples of types of studies and their reasons for retractions have been summarized in Table 3 .

Violations can be assessed before the studies are published for those with IRB approval. It is the responsibility of the IRBs to monitor whether ongoing studies are abiding by the ethical regulations and whether the approved protocol is being followed. A study conducted in India by an IRB at a tertiary care hospital in Mumbai monitored 12 clinical trials from 2011–2017. The most common violations were related to informed consent, followed by a lack of understanding of protocol and protocol deviations. This was corrected by re-taking of the informed consent and retraining in GCP by the IRB. 52 A similar study in Uganda done from 2007–2010 with monitoring of 40 research projects also found a similar frequency and reasons for violations. 53

Journal editors routinely check if a statement mentioning whether ethics approval was sought has been mentioned in the manuscript. Depending on the journal and type of article, further details of the EC approval can be sought by the journal editorial board. 54

ISSUES AND ONGOING DEVELOPMENTS

ECs were developed to provide ethical oversight to clinical research. But here are various issues associated with the functioning of IRBs.

• • Composition: Most studies indicate a skewed gender representation in the structure IRBs. Further, the participation of laypersons on the board is minimal. 14 , 42 , 55 , 56 , 57
• • Overburdened IRBs, delays, and operational costs: The IRB reviews have been associated with delays from over 4 to 7 months on average from surveys conducted across the USA. 58 , 59 A delay in biomedical research can translate into more than monetary loss as biomedical research saves lives and a delay in the approvals can result in greater loss of life. 60 An older survey conducted across 63 institutions (with 20 being low volume, 24 intermediate volume, and 19 being high volume centers) in the USA in 2005 reported the median amount spent by academic medical centers on IRB was $750,000/year with an average of $559 per review. The main costs are divided across staff salary, board salary, space, outsourcing of the reviews, travel, supplies, and equipment. 61 Over the years, there is a definite increase in the number of ongoing research projects thus increasing these costs further. Furthermore, documentation of Food and Drug Administration (FDA) warning letters to IRBs was predominantly related to paperwork stressing on documentation of reviews and meetings rather than ethical issues. 62 Increasing paperwork further results in delays and added costs. These deficiencies are more marked in developing nations like India and China dealing with issues like lack of regulation, informal ethics reviews, lack of supervision, and insufficient ethics review capacity. 63 , 64
• • Multi-site projects: With multicenter projects on the rise, a single protocol is often reviewed by multiple IRBs. In a review of 17 articles reported from UK, USA and Europe, which underwent multiple IRB reviews of the same protocol there were discrepancies in the judgment. Five of 26 reported rejection at some and acceptance by some IRBs. However, there were great differences in the protocol revisions, consent, patient information sheets, risk-benefit assessment, and compensation arrangements. 65 Keeping these issues in mind, the Common Rule in the USA was revised in 2017 with IRB approval required only from one center for multisite projects. 66 This may be extrapolated to other nations or consideration of an expedited review at other sites when fully reviewed at one IRB can be considered.
• • Independent EC and IEC: Independent ECs have inherent tissues of limitation of knowledge about the local community and use of these may promote IRB shopping. Whereas, local IRBs can have conflicts of interest as colleagues of investigators may be on the review board. Thus, a central IRB can alleviate some of these concerns by avoiding repetitive reviews, minimizing conflicts, and establishing a centralized adverse event reporting system. 67 , 68 , 69 A central IRB can be formed by experts on a particular subject or by a group of institutes like the National Cancer Institute’s Central IRB and the Biomedical Research Alliance of New York respectively. 70 , 71
• • Scientific expertise of the IRB reviewers: The IRB reviewers may lack the scientific expertise to review sophisticated research projects that may affect the quality of the research. 11 , 14 , 57 , 72 Regular training in research ethics and GCP along with adequate consultations with external experts is needed. This can be done at a national, regional, and international level. First, by identifying core issues and then solutions for them by focused training. 73 Training of EC members is conducted across Central Asia and Eastern Europe under the framework of Forum for Ethics Committees in the Confederation of Independent States and Strategic Initiative for Developing Capacity in Ethical Review program that train members regarding GCP, bioethics, the establishment of an EC, review processes and SOPs, choosing independent consultants, and confidentiality agreements. 74
• • Review of studies involving complementary and integrative medicine (CIM) is a challenge due to the lack of quality evidence to support the basis for their use. Moreover, most international regulatory bodies and research regulations do not address CIM, thus leaving the review process and decision-making to the IRBs. However, it is to be emphasized here studies irrespective of the type (modern or CIM) must be reviewed using the same principles of respect, beneficence, and justice. Well-designed studies on CIM are essential to ascertain the health and safety of patients. 75

DSMB is defined by the FDA, USA as “a group of individuals with pertinent scientific expertise that review research data of an ongoing trial on a regular basis, advises the sponsor/or researcher regarding the continuing safety of research subjects and those yet to be recruited into the research trial, and advises as to the continuing validity and scientific merit of the trial.” 76 It’s an autonomous entity independent of the researchers, sponsors, and the IRB so as to control data sharing and protect the authenticity of the clinical trial from unfavorable impact. 35 It was first developed in the USA in the 1960s as the NIH began sponsoring multicenter trials, the first trial was the Coronary Drug Project which used a DSMB for monitoring. 77 Over time, it became a common practice for the sponsors to have experienced scientific personnel serving on these committees. Although the FDA does not mandate DSMB for all trials, DSMBs are generally recommended for large, multi-site studies evaluating treatments that intend to reduce mortality and morbidity.

DSMBs are usually constituted for:

• • The study outcome is such that a highly encouraging or detrimental result is a possibility in an interim analysis that may require an early termination of the study on ethical grounds.
• • When the safety concerns are high, e.g., invasive therapy is administered.
• • Previous data suggesting serious toxicity with the study treatment.
• • Studies involving vulnerable populations.
• • Studies including subjects at an increased risk of death or serious outcomes.
• • Large, multisite, long-duration studies.

In India, it is recommended by the Indian GCP guidelines that the sponsor may establish a DSMB to assess the progress of the trial, and in 2006 Indian Council of Medical Research (ICMR) mandated a DSMB to review data emerging from research on interventions in the emergency setting. 39 These were updated in 2012 by the ICMR to include all stem cell research involving human subjects. The SOPs for the constitution and responsibilities of the DSMB are laid down by the World Health Organization and are similar across USA, Europe, and South Korea. 78 , 79

DSMBs are constituted by scientific members and are appointed by the funding agency, before the recruitment of the first subject in the trial. It can consist of as few as three members and is typically constituted of clinicians and at least one biostatistician. Others that may be included are medical ethicists, other scientists, etc. The most important requisite is that the members should be independent of the sponsors, investigators IRBs, regulatory authorities, and site or study staff. They should have no conflicts of interest with the sponsors, researchers, or study staff.

The functions of the DSMB are:

• • To uphold participant safety.
• • Ensure credibility and integrity of the trial for future subjects.
• • Ensure the timely conclusion of the study so that the results can be disseminated.
• • Identify protocol violations if any.
• • Identify unexpectedly high dropouts and evaluate for the same.
• • Ensure the validity of the results.

The above functions are carried out by an initial organizational meeting to understand the protocol and safety monitoring plan followed by an early safety review meeting to review early safety information. Continuing periodic reviews to assess safety, efficacy, and the progress of the trial are then carried out with reporting of serious adverse events. 44 A final meeting is to be held at the termination of a study. DSMBs function independently of the IRBS but the PIs must submit DSMB reports or minutes to the IRB.

Dramatic instances in which trials have been stopped prematurely on the recommendation of the DSMB include the withdrawal of rofecoxib and celecoxib in two trials on the prevention of colonic polyps due to increased cardiovascular events. 80 , 81

We have come a long way from the horrific ethical compromises in clinical studies in history to establishing adequate safety for the human subjects participating in clinical research today. The establishment of the IRB or EC has ensured safe study designs and the safety of human subjects right from before the study initiation until its completion. This is further supplanted by additional boards like DSMBs. However, we still need studies assessing the outcomes of the ECs on a global basis and addressing various issues that are still pertinent to the working of the ECs. 82

Disclosures: The authors have no potential conflicts of interest to disclose.

Author Contributions:

• Conceptualization: Mehta P, Zimba O, Gasparyan AY, Seiil B, Yessirkepov M.
• Data curation: Mehta P.
• Writing - original draft: Mehta P.
• Writing - review & editing: Mehta P, Zimba O, Gasparyan AY, Seiil B, Yessirkepov M.

Research organisations and research ethics committees - ESRC

Governance arrangements for research ethics committees, rec independence.

Research organisations (ROs) are responsible for ensuring that the research ethics committees (RECs) within their organisation act, and are seen to act, independently.

They should be free from bias and undue influence from:

• the RO in which they are located
• the researchers whose proposals they consider
• the personal or financial interests of their members.

The independence of a REC is founded on its membership, on strict rules regarding conflict of interests, and on regular monitoring and accountability for decisions made by the REC (see also Conflicts of interest, complaints and appeals ).

RECs should be constituted and operate in accordance with ESRC guidelines.

Authority and mandate

The authority of a REC should be delegated through the research organisation’s (RO) usual governance mechanisms.

It should report to the appropriate RO authority. In defining a REC’s mandate and authority, the organisation should make clear the jurisdiction of a REC and its relationship to other relevant bodies or authorities both within and outside the RO.

ROs should ensure that there is a principal REC for their organisation, but may establish secondary RECs (for example faculty, school or department-based) if required.

Where more than one REC is established, the area of responsibility of each should be clear; it would normally be defined by an area of substantive and methodological expertise. There should be clear procedures to establish the relationship between RECs and to facilitate co-operation and common standards, including arrangements to escalate deliberations to a principal REC where necessary.

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; ROs should therefore ensure the independence of these RECs and transparency of their procedures and decisions.

Principal RECs should also be wholly independent and impartial and are likely to be multidisciplinary, and apart from the requirement of at least one external member could include individuals from outside the RO, as well as those with the requisite skills and experience to evaluate more complex and ambitious research proposals.

Principal RECs are also likely to be more broadly based, leaving the work of reviewing proposals to RECs in faculties, schools or departments and to concentrate on policy matters and oversight of the secondary RECs.

Remit and responsibilities

RECs are responsible for reviewing all research involving human participants and personal data conducted under their auspices and undertaken by individuals employed by the organisation that does not come under the remit of the UK Health Departments and Health Research Authority . This REC responsibility may also include research that intends to re-use data from previous research.

RECs should review research proposals in a way that is independent, competent and timely. Ethics reviews should strive to notify a decision within a month of receiving a submission, and researchers and the research process should not be disadvantaged by RECs which are not sufficiently resourced to comply. Research organisations (ROs) have a duty to make sure their RECs are functioning appropriately, and are resourced to do so. Ethics review timeframe should not exceed 60 days unless there are circumstances beyond the control of the RO.

RECs should provide supportive, reflexive governance to researchers and operate a system of ongoing monitoring and supportive reflection that promotes mutual learning for researchers and REC members.

In some circumstances RECs may authorise other sub-committees or their chair to conduct reviews on research involving minimal risk. There should be no conflict of interest by anyone authorised by a REC to review research. A sub-committee or the REC Chair will be accountable to the REC and the appropriate organisational authorities for the decisions they make.

An organisation-wide REC might advise on broad strategy for ethics review and monitor performance overall, rather than consider individual proposals. Wherever they are located, RECs should follow the guidance of this framework, even at department level if this is where the decision to review a project is to be taken. If checklists are used to identify the type of review required, the checklists may be overseen by an independent review body at faculty, school or department level.

ROs should establish and publish working procedures and systems of documentation in relation to REC responsibilities.

These should include:

• terms of reference and responsibilities of RECs
• scope of the authority of RECs and supervisory arrangements where review is delegated
• what researchers can expect from their REC/ethics review; how long such a review will normally take; how to appeal against a decision which is considered unfair
• procedures for reporting decisions to the main REC where a review has been delegated
• training arrangements for REC members – successful framework implementation requires the development of minimum standards of training and competence, which should be kept up to date with the changing social science landscape.

Composition

The membership composition of a REC is fundamental to ensuring that it has the range of expertise and the breadth of experience necessary to provide competent and rigorous ethics review of the submitted research proposals, and to do so from a position that is independent of both the researchers and the RO in which it is located.

Its composition and independence are important in establishing the legitimacy of the opinions expressed and the decisions made, in the eyes of the community and wider society as well as the researchers and funders of research.

Principal RECs

Principal RECs should be multidisciplinary and comprised of both men and women. They should include at least one external member with no affiliation to the RO in question. There should be a chair and members who have broad experience and expertise in the areas of research regularly reviewed by the REC, and members who have the confidence and esteem of the research community.

Principal RECs would also benefit from including individuals who reflect ethnic diversity, users of specialist health, education or social services (where these are the focus of research activities), individuals with experience of professional care or counselling, and individuals with specific methodological expertise (for example, quantitative or qualitative methods) relevant to the research they review.

A principal REC should include among its membership people who are collectively familiar with a range of philosophical approaches to research ethics and with the different perspectives seen in individual research proposals. Taking all of this into account, good practice would suggest that a ROs principal REC would need at least seven members.

Seeking advice outside the committee

A REC may seek advice and assistance from experts outside the committee in considering a research proposal. When this happens, the chair should establish that the experts have no conflict of interest in relation to the proposal.

Research organisations (ROs) should establish research ethics committee (REC) procedures that are sufficiently flexible to cause minimum delay to the progress of research, for example through triaging proposals for review for risk level so that proportionate review can take place, and offering informal consultation pre-application where necessary.

What RO policies and procedures should address

RO polices and procedures should address the criteria for identifying research which involves more than minimal risk and therefore requires full ethics review.

They should also address clear procedures and forms for submitting proposals for light-touch, expedited and full review.

The presentation of research proposals and supporting documents

While a basic set of standard information should be required for all research proposals, ROs should consider whether the required proposal information might vary between RECs in light of the research they review.

Research paradigms differ between disciplines and a ‘one size fits all’ approach is not always appropriate. Application forms and procedures should be kept as brief as possible and could be tailored to the requirements of particular disciplines.

The point at which research proposals should be submitted for review

It is inappropriate and wasteful for organisations that fund research to require that ethics review be completed before a proposal for funding is submitted, as a significant proportion of proposals are not funded.

ROs and funding agencies should be flexible about the point at which a REC review is required.

In the majority of cases the point at which research proposals should be submitted for review will be immediately after notification of funding, but it could also be prior to a pilot study so that participants’ interests are protected; prior to seeking the agreement of potential research sites and gatekeepers so they can be assured of its good standing; or prior to the main data collection.

Methods of decision-making, rationale and recording decisions

REC decisions and feedback to researchers should be clearly recorded and open to scrutiny. ROs’ procedures should ensure openness and accountability of REC decisions while maintaining confidentiality where this is required.

REC meeting administration and transparency

RECs should publish details of administration procedures, including:

• dates of REC meetings
• deadlines for submission of proposals to be considered at each meeting
• the procedure for preparation of agendas and distribution of papers to members in advance of meetings
• distribution of minutes following meetings
• minimum attendance for a quorum and procedures when meetings are not quorate
• details of procedures developed by the REC, for example electronic review.

Prompt notification of decisions

ROs should publish a timetable for completion of light-touch and full ethics review by RECs and a commitment to providing a decision within a timeframe, which should usually be around one month and should not exceed 60 days unless there are circumstances beyond the control of the RO.

Procedures for reporting

Reporting procedures should be agreed with the researchers regarding any unforeseen events that might challenge the ethics conduct of the research or which might provide grounds for discontinuing the study.

Last updated: 23 February 2023

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Research ethics committee

Below you will find information relating to the Research Ethics Committee. For guidance on the research ethics review process, please visit the research ethics policy and procedures webpage. Please note that applications for ethics approval are reviewed electronically as and when they are received - they do not need to wait until a meeting of the Committee.

The LSE Research Ethics Committee has U.S. Department of Health and Human Services IORG status (IRB00004908, and Federal Wide Assurance FWA00025801).

The Research Ethics Committee is currently recruiting for two MPhil/PhD students to assist the Committee for 2024-25. Please see the advert (pdf) for details. Closing date is 9th September.

Schedule of meetings 2024-25

Please note that applications for ethics approval are reviewed electronically as and when they are received - they do not need to wait until a meeting of the Committee.

Weds 30 October 2024, 12:00 - 14:00 pm, room VAR

Thur 20 February 2025, 14:00 - 16:00 pm, room SAL B.07

Weds 11 June 2025, 14:30 - 16:30 pm, room SAL B.07

REC review time-frame

Applications are reviewed as and when they are received - they do not need to wait until a meeting of the Committee. All researchers must ensure that they have ethics approval before they commence any data collection. The following timeframes are given as a guide:

The Committee aims to review applciations and send initial feedback to the researcher within two weeks of receiving the application. (Students need to allow time for review by the supervisor first.) The researcher may then be asked to provide some additional details, clarification or amendments before approval can be confirmed. Thus researchers should typically allow four weeks for the REC review process. However, complex applications may require longer and/or further iterations with the researcher, and thus the review process could take up to 5-6 weeks.

Expedited review:  where there is a genuine case for urgency due to circumstances which could not have been anticipated and which are outside of the researcher’s control (for example, in the case of fast-track funding to address global or national emergencies), the Research Ethics Committee will expedite the review process as quickly as possible; researchers should email  to request this. Please do not expect, however, that urgency will pre-empt the full extent of the review process.

For further guidance, please visit the  Research ethics policy,   procedures and guidance webpage.

Membership 2024-25

Terms of Reference

The Research Ethics Committee (REC) is a sub-committee of Research Committee. The current  Terms of Reference of the REC  can be found here.

Annual Reports

 2016-17 Annual Report  

2017-18 Annual Report

2018-19 Annual Report 

2019-20 Annual Report

2020-21 Annual Report

2021-22 Annual Report

2022-23 Annual Report

For any queries regarding the Research Ethics Committee, please contact Lyn Grove in the first instance.

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Guidance and policy for REC members

Governance Arrangements for Research Ethics Committees (GAfREC) outlines the policy of the UK Health Departments, describing what is expected from the research ethics committees that review research proposals relating to areas of the departments’ responsibility. An updated edition of the policy has been published and was implemented in July 2021.

Standard Operating Procedures for Research Ethics Committees (SOPs)

There are Standard Operating Procedures (SOPs) for Research Ethics Committees (RECs) within the UK Health Departments’ Research Ethics Service. RECs are required to act in accordance with the SOPs. 

The SOPs are divided into 15 chapters, which each cover a different aspect of the ethical review process from booking and submitting applications, giving an ethical opinion, and reviewing amendments to studies which have previously been issued an ethical opinion. 

It is helpful for all REC members (and essential for REC Officers) to have an awareness of the SOPs and what the expected processes are. A copy of the SOPs is available for you to have a look at and to refer to when you need to. 

If you have questions or require any further help using the SOPs, please contact your REC Manager in the first instance.

Peer/Scientific review and the role of RECs

A framework of questions (and considerations that would arise) RECs might ask when satisfying themselves of the adequacy of peer review of applications. 

Ethics Review form

There is a lead reviewer form  for use when undertaking an ethical review. There is also a separate lead reviewer form for studies requiring approval under the Mental Capacity Act . Additionally, there are also separate forms for Research Tissue Banks and Research Databases . REC Members should use these documents when ethically reviewing applications to support and lead the discussions about the application at the meeting. The forms can also be used when REC members cannot attend a meeting and wish to provide comments in support to the ethical review of an application, in this situation the forms should be sent to the REC support staff in advance of the meeting to be shared with the Chair. Alternatively, members can also complete the ethics review form directly in the HARP Member Portal.

HARP Member Portal

The HARP Member Portal is available for all members to access. This allows full applications, proportionate review applications and substantial amendments to be accessed electronically through the portal. All REC members need to use the HARP Member Portal to access the applications and amendments which have been submitted for an ethics review.

There is a YouTube video  which provides a demonstration of the HARP member portal:

Download a transcript of the HARP Member Portal Demonstration video.

We recommend that you read both the HARP member portal user manual and our frequently asked questions document, which can both be accessed from the ‘Help’ section of the Member Portal’ 

National Research Ethics Advisors’ Panel (NREAP) 

NREAP was established by the Research Ethics Service (RES) under Governance Arrangements for Research Ethics Committees (GAfREC) as a resource to the RES and the appointing authorities of RECs within that service to help optimise research ethics review and so improve the research environment in the UK. 

NREAP provides advice and support to RECs and appointing authorities in exercising their responsibilities under GAfREC and SOPs. 

Terms of reference, minutes of NREAP meetings, Panel members’ biographies and a library of NREAP guidance may be found within the NREAP area on our website .

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