Terms of Reference
1. Responsibilities of the UCL Research Ethics Committee
1.1. The UCL Committee is responsible for considering the ethics of human research (e.g. physical, psychological, attitudinal) carried out by UCL staff or students on the UCL premises and/or by UCL staff or students elsewhere.
1.2. The UCL Committee has the duty to provide guidance to researchers and to responsible authorities, such as UCL, to ensure that research involving persons is carried out safely, and with considered consent and respect to autonomy and privacy of the subjects, and with principles of distributive justice, and in accordance with the ethical principles, as set out in the Declaration of Helsinki, and other Guidelines. In particular, research must be based on valid science, risks must be commensurate with benefit to the individual, and commercial or political influence must not corrupt the progress of research for the benefit of humanity, and the advancement of knowledge. In addition, the Committee must ensure that requirements of the Law are met, for instance in matters such as Data Protection, and Controlled Drugs.
1.3. Subject to any general or particular direction that may from time to time be given by the Research Governance Committee, the Research Ethics Committee is charged:
- To review and approve, or withhold approval from, proposals for research on human participants or tissues (e.g. DNA) or databases of personal information to be carried out either by (a) UCL staff or (b) UCL students under the supervision of UCL staff:
- in UCL premises.
- where such research is to be conducted at a place where there is no ethics committee.
- overseas, subject also to the agreement of a research ethics committee in the host country.
- To review and approve, or withhold approval from, amendments to previously approved protocols.
- To monitor adverse events in research subjects.
- To undertake a regular review of the research (not less than once a year and more frequently as deemed appropriate).
- To report to the Research Governance Committee by submission to the Research Governance Committe officers of (i) the confidential Minutes of each meeting of the Research Ethics Committee, and (ii) an annual report outlining the work of the Committee in the preceding year.
- To allot an identification number and keep on file a copy of each application and associated correspondence.
- To record in a database administered by Academic Services all submitted proposals. Information recorded includes name and address of organisations carrying out the project, the financial sponsor, name and qualifications of the research team and research method and research question.
2. Constitution and Membership
2.1. Appointed – 6 lay members, not professionally concerned with research on human participants nor a member of UCL staff, appointed by the Committee (one to be the Chair).
2.2. Nominated – 6 academic staff of UCL, appointed by the Committee, covering areas of expertise such as medicine, psychology, law, statistics, anthropology (2 to act as vice-chairs)+.
2.3 Co-opted - 1 academic member of staff at UCL appointed by the Committee for the specialist review of clinical studies taking place in developing countries.
2.4 Secretary – Administrative Officer, Academic Services
3. Modus Operandi of the Committee
3.1. Chair – If neither the Chair or Vice-Chair is present at a meeting, the Committee may elect one of the other lay members present to act as Chair.
3.2. Term of Office of Members – The term of office is normally 3 years renewable once.
3.3. Quorum – a quorum of 6 is required, to include 3 of the 6 lay members.
3.4. Specialist Advice – The Chair may invite an individual to attend a particular meeting or meetings to give specialist advice to the Committee. Such individuals should not participate in the final decision-making of the Committee.
3.5. Declaration of Interest – Committee members must inform the Chair if they have a financial or personal interest in a project or with a project sponsor. The Chair will decide whether the interest disqualifies the member from the discussion.
The Committee Secretary will maintain a Register of Members' Interest which will be annually updated by members.
3.6. Meetings – The Committee will meet a minimum of ten times a year according to a publicised schedule. Dates for submission of proposals will be published. Closing dates for submissions will be three weeks prior to the meeting and will be strictly adhered to. The Committee aims to convey decisions to the applicants within 1 week of the meeting, or within four weeks of receipt of the application, unless there are queries to be made of the applicant, or a need for outside opinion. Applications can be sent to the Secretary of the Committee between meetings for circulation among Committee members, and decisions made by post or email, to be ratified at the next Committee meeting.
3.7. Powers of the Committee – The Committee may:
- authorise the research to proceed without requiring any amendment. Any such authorisation is granted on the basis of the project as stated on the research submission form. Any changes to personnel or to the protocol must be notified to the Committee.
- require clarification or modification of parts of the research submission. The Chair will normally be granted authority to approve the amendments without requiring further consideration by the full Committee.
- defer consideration of a submission to a subsequent meeting if substantial modification is required or where significant additional information is required.
- reject the research submission in whole or in part.
- revoke approval if dissatisfied with the conduct of the research or of the researchers.
The Committee will normally give reasons for requiring modification to proposals, rejecting them or revoking approval.
The Committee will maintain a record of all approved research submissions and may call for reports in the course of the research project or on its completion to help the Committee in formulating its guidance and so that the Committee can be assured that projects continue to conform to approved ethical standards.
3.8. Responsibilities of the Applicant Subsequent to Approval – The applicant is responsible for:
- reporting any adverse incident during the course of a study to the Committee, even if the incident is not directly related to the study (e.g. a complaint by a subject, an incident endangering a research worker taking a questionnaire out to a population study, etc.)
- notifying the Committee of any change in protocol and obtaining further ethical approval as appropriate.
- completing and returning to the UCL Ethics Committee the Continuing Review Approval Form on an annual or more frequent basis as deemed appropriate by the Committee.
3.9. Annual Report to the Research Governance Committee.
3.10. Indemnity for Members – UCL will maintain appropriate insurance cover, and will indemnify all members of the Ethics Committee, against any claims made against them which arise in respect of their membership of the Committee, provided that they have acted in good faith in reaching the decisions made.