What is a Research Ethics Committee (REC)?
A Research Ethics Committee (REC) is an independent committee that considers the ethics of applications to conduct health or social care research in the UK. The studies will involve human participants, and most will take place within the NHS. The research proposal cannot proceed without the approval of the REC.
The key duty of a REC is to protect the interests of the research participants whilst at the same time facilitating ethical research. The committee reviews research applications and gives an opinion on whether the research is ethical and fair. REC members receive training in ethical review and have opportunities to debate challenging issues.
The Health Research Authority (HRA) is the appointing authority for RECs in England. RECs based in Scotland, Wales and Northern Ireland have different appointing authorities and their recruitment process for REC members might differ slightly. However, the information below is relevant to REC members in the UK.
Each REC consists of:
- a minimum of seven and a maximum of 18 volunteers;
- lay members (a term used to describe people who are not registered healthcare professionals and whose primary professional interest is not in clinical research). At least one third of members must be lay;
- expert members (a range of specialists including doctors, other healthcare professionals, statisticians with expertise in clinical research and others).
The definition of lay and expert members is defined in the UK Clinical Trials Regulations. Although there are different classifications (i.e. expert and lay), everyone’s role on the committee is the same.
There are currently 87 RECs in the UK and 64 in England. Between them they review approximately 6,000 applications to carry out research each year.
The process of ethics review
This process involves ensuring that any research project should fairly balance the likely benefits to the participant, or society at large, against the burdens involved and any risk of harm or actual harm to those taking part. It also means ensuring that the research proposal itself is necessary, properly designed, supervised and conducted and that the outcome will answer the research question.
An extremely important part of this is ensuring that patients or other participants are not unfairly pressured into taking part and that they are fully informed about the project and what it will mean for them. Central to this is ensuring participants have appropriate information before they agree to take part in the study (i.e. informed consent). Members undertake ethical review in line with the Standard Operating Procedures for Research Ethics Committees and other national and international legislation and guidance, such as the Clinical Trials Regulations, Mental Capacity Act and the Human Tissue Act.
There are three categories of RECs in the UK. All RECs review a wide range of different types of heath and social care research, but in addition some have special responsibilities:
- Type I REC – reviews applications for phase 1 trials in healthy volunteers within the UK (i.e. a clinical trial to study the effect of a new medicine when administered to humans for the first time).
- Type 3 REC – reviews applications for Clinical Trials of Investigation Medicinal Products (CTIMPs) within the UK (i.e. a clinical trial of a new medicine or an existing medicine being used outside of its licence).
- Authorised REC – is not permitted to review CTIMPs but reviews other types of research.
Some RECs may also be flagged to review research in special areas, such as medical devices, research tissue banks / databases, research involving children, social care, prisons and participants assessed under the Mental Capacity Act as being unable to consent for themselves.
REC meetings are held virtually by Zoom (web conferencing) and are not held in public, although meetings may be attended by observers with an interest in the work of RECs.
What is a lay member?
A lay member means someone who is not currently registered as a healthcare professional. Our lay members come from a wide range of professional backgrounds. For example, teachers / lecturers, students, research administrators at pharmaceutical companies or other clinical research bodies, medical ethicists, solicitors, barristers and administrative staff.
What is an expert member?
The definition of an ‘expert member’ is defined under the Medicines for Human Use (Clinical Trials) Regulation 2004. Under the Regulations, an expert member means a member who:
- is a ‘healthcare professional’ (see below) *
- has professional qualifications or experience relating to the conduct of, or use of statistics in clinical research, unless those professional qualifications or experience relate only to the ethics of clinical research or medical treatment
- is not a healthcare professional but has been a registered medical practitioner or a registered dentist.
*Healthcare professional is defined in the Regulations and includes the following:
- A doctor
- A dentist
- A nurse or midwife
- A pharmacist
- An ophthalmic optician registered under section 7 of the Opticians Act 1989
- A registered osteopath as defined by section 41 of the Osteopaths Act 1993
- A registered chiropractor as defined by section 43 of the Chiropractors Act 1994
- A person registered by the Health Professions Council under the Health Professions Order 2001, which includes the following:
- Art therapists
- Clinical scientists
- Medical laboratory technicians
- Occupational therapists
- Practising psychologists
- Prosthetists and orthotists
- Social workers in England
- Speech and language therapists
Qualities required for the role of lay and expert members
To help you decide if you'd like to apply to be a REC member, please look at the criteria below that we use when assessing candidates. To be considered, you must be able to demonstrate that you have the qualities, skills and experience to meet these.
We are looking for people:
- with a strong personal commitment to the interests of patients who take part (or are asked to) in health and social care research;
- with a strong personal commitment to ensuring the highest standards for health and social care research;
- who can read, understand and analyse complex issues from research proposals and weigh up conflicting opinions;
- who are able to take an objective stance, looking at a situation from several perspectives;
- who are good communicators and confident to voice their opinions;
- who are able to discuss issues with people who may not agree with them, including being able to influence others from a range of backgrounds;
- who are committed to the public service values of accountability, probity, openness and equality of opportunity;
- who are able to contribute to the work of the REC;
- who can be available monthly (approximately 10 meetings per year) with a commitment to attend at least 6 of the meetings;
- who are available to undertake the review of low risk studies (Proportionate Review applications) and substantial amendments electronically on a rota basis (approximately 2 to 3 meetings a year)
- who understand the requirement for confidentiality
- who will take part in the induction training and equality, diversity and human rights training in the first year of membership and then complete at least 5 hours training per year to equip you to carry out your role;
- who are IT literate and comfortable reviewing documents electronically. Access to a computer or tablet is desirable but if not, we can loan you a netbook to enable you to undertake REC work via email, Zoom and the member portal.
Some questions you may have:
What kind of person would make a good REC member?
REC members have a very real interest in protecting patients' interests and in supporting health and social care research. They take a balanced view of the likely harms and benefits of a research project and are confident about expressing and supporting their own opinions, whilst also taking into consideration the opinions of colleagues on the committee. Members have the ability to understand the sometimes complex issues involved in reaching ethical decisions. They are flexible, have excellent communication skills and possess a desire to make a difference.
Who would I be representing?
Members of a REC do not represent any interest group. The mixture of members that makes up a committee give as wide a perspective as possible. Lay members will bring their own valuable perspective to the committee’s deliberations through a variety of experiences, contacts and networks, and reflect current public views and concerns. Expert members will also bring to the discussion their knowledge and experience of working within the healthcare system and / or conducting research.
What experience should I have?
REC members come from all walks of life and bring differing experiences to the committees. It is not necessary to have been involved in committee work before, but some of our members have experience gained via involvement in business, industry, community groups, school representative bodies, voluntary organisations and charities. We will provide you with training to undertake the role.
What would I be expected to do?
REC members work as part of a committee, using their skills and personal experience to reach decisions about research applications. Prior to the meeting they read the meeting papers electronically via our member portal. At the meetings, the proposals will be discussed, and it may be possible to ask questions directly to the researchers themselves, before a decision is taken by the committee. As the meeting papers are reviewed electronically, it is important that you are comfortable using a computer or a tablet to review the documents.
How much time is involved?
We ask our members to commit to four to five hours per month for each REC meeting, plus five to six hours reading in preparation for each meeting. There are usually ten meetings of each committee each year, and we ask all members to commit to attending at least six of these. After six months as a member, we ask you to participate in the review of Proportional Review (PR) applications as part of a sub-committee. PR applications are lower risk studies containing no material ethical issues. You may also be asked to take part in sub-committees on a rota basis. These committees review amendments to studies, which have already received a favourable ethical opinion. At the moment all meetings are being held virtually although sub-committees may be held by email.
Will I be able to carry out the role of a REC member alongside my current job?
Some employers allow REC members time to attend meetings, recognising this activity as professional development or via supporting it as part of their corporate social responsibility. Many organisations appreciate the valuable work of committees, without which research in the NHS could not be carried out. Please check whether your organisation offers this support. We can send a letter to your employer asking them to support your application to join a REC, should you feel this would be helpful.
The majority of REC meetings are held during the day but we do have some meetings in the evening.
If you would find it difficult to fit REC membership around existing work commitments (for example clinics) you might like to consider sharing REC membership with a colleague. This would require each of you attending at the very minimum three REC meetings and participating in one to two sub-committees each year.
For healthcare professionals, REC membership is recognised as Continuing Professional Development (CPD) and can count towards Clinical Excellence Awards.
If you are not a healthcare professional, it is important to acknowledge the work you undertake and the skills you have developed as a result of being a REC member during your work appraisal.
Will I get paid for being a REC member?
This is a voluntary position and as such, does not accrue employment rights under employment legislation. You will not be paid for this role but the HRA will reimburse any travel costs or other agreed expenses, such as childcare, incurred whilst undertaking REC duties. All payments are made by BACS and in line with the HRA’s Committee Member Expense Policy.
If you are self-employed, you might be eligible for payment of loss of earnings, for example if you are a GP and need to arrange for a GP locum to cover your clinic. You will need to get prior approval from our member support team and submit an invoice. There is a maximum amount that can be claimed, and this arrangement only applies to cover provided in the UK. More information can be obtained from the HRA’s Committee Member Expense policy.
If you are in receipt of certain state benefits you may wish to get independent advice about whether your planned involvement in our work affects your continued entitlement. We want to support people receiving benefits to take part in our work.
We may be able to adjust our offer to you, to comply with your benefit conditions if requested.
Who else is on a REC?
Rec members include:
- General Practitioners
- Hospital medical staff
- Lay people
- Other health service professionals
- Research professionals
Our membership includes people in all walks of life who are representative of the community and general population, whether employed, unemployed or retired.
Where will REC meetings be held?
Our REC Directory lists all of our committees along with their meeting dates, time and venues. You can search for a specific committee or committees in a region. By clicking on one of the individual committees listed, you will be able to see the time and location of the meetings. If you have a preference, please indicate this on your application form. Please note, during the COVID-19 pandemic our RECs are currently holding meetings by video-conference.
What is the legal position of a REC member?
Any member acting responsibly within the committee is ‘indemnified’ by the HRA (or the appropriate appointing authority if you become a member of a committee based in Wales, Scotland or Northern Ireland). The indemnity provided will differ slightly across the UK but for members based in England, this means the HRA will protect members against civil action that might arise from the business of the committee. This is with the condition that the member informs the HRA and co-operates with them in respect of any claim made against them, and has not acted in bad faith, wilfully defaulted on their responsibilities or been grossly negligent.
How long would I serve?
A term of office is generally five years. Terms of appointment may be renewed, but normally not more that two terms of office are served consecutively. You may resign at any point during your membership, but members can, and many do, stay on for a maximum of 10 years.
Who can I discuss this with in greater detail?
Applicants often find it helpful to attend a REC meeting as an observer, to better understand how a REC works before applying. This can be arranged by contacting the Member Support Team using one of the email addresses detailed above.
How do I apply?
You will need to request our application pack and complete the application form in it We also ask that you complete a REC members equal opportunities monitoring form in addition to submitting an application form. This allows the HRA to assess how well it is meeting its responsibilities contained within the Equality Act 2010.
If you’re shortlisted we will invite you to complete a short assessment and attend an interview.