The Ethics Committee is a multidisciplinary team composed of physicians, nurses, social workers, administrators, chaplains and other employees. The Committee has three main purposes. The Ethics Committee provides the requested consultation services, meets bimonthly to review any consultations that arise, receives updated information on any legal or ethical issues and acts as a resource by making recommendations on programs, education, process improvement and proposed policy and procedure changes. An ethics consultation is a review of circumstances brought to the committee where the
members provide information, suggestions and support to those involved in the case. The committee is not a decision making body but a consultative one, thus it provides recommendations and support to those involved. Anyone can request an ethics consult
with the knowledge of the patient’s care team. This can be done by the physician, the nurse or social worker on the unit, or by calling the Social Work office. The Ethics Committee is available seven days a week, and a consultation will be started within 24 hours of notification. 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:
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 reviewThis 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:
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:
*Healthcare professional is defined in the Regulations and includes the following:
- Art therapists - Chiropodists - Clinical scientists - Dieticians - Medical laboratory technicians - Occupational therapists - Orthoptists - Paramedics - Physiotherapists - Practising psychologists - Prosthetists and orthotists - Radiographers - Social workers in England - Speech and language therapists Qualities required for the role of lay and expert membersTo 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:
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:
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. Who are ethics committee members?Ethics Committee's Members. Chairperson/ Vice Chairperson (optional) Non-affiliated. ... . Member Secretary/ Alternate Member Secretary (optional) Affiliated. ... . Basic Medical Scientist(s) Affiliated/ non-affiliated. ... . Clinician(s) Affiliated/ non-affiliated. ... . Legal expert/s Affiliated/ non-affiliated.. Who may be included as members of the ethics committee quizlet?The committee is made up of a group of people who are ethicist, educators, legal advisors and political leaders. Their guiding force is to serve the best interest of community for the welfare of individuals residing in it. Some of the internal operational issues: 1.
Who makes up a research ethics committee?RECs consist of up to 15 members, a third of whom are 'lay' - their main professional interest is not in a research area, nor are they a registered healthcare professional. RECs review research proposals and give an opinion about whether the research is ethical.
What are the 3 functions of the ethics committee?The three primary functions commonly cited for an ethics committee are education, policy development and review, and case analysis.
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