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 on the UCL premises and/or by UCL staff.

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. The UCL Committee is not responsible for considering the ethics of research which falls under the remit of Department of Health approved ethics committees who abide by Governance Arrangements for NHS Research Ethics Committee:

If the research involves:

participants identified from, or because of, their past or present use of NHS or social care services for which the UK Health Departments are responsible, including participants recruited through these services as healthy controls;
participants identified because of their status as relatives or carers of users of these services;
the collection of tissue (i.e. any material consisting of or including human cells) or information from users of these services; and
use of previously collected tissue or information, from which past or present users of these services could be identified from the tissue/information on its own or through combination with other tissue/information.

then the ethics of such human research MUST be referred to the appropriate Department of Health approved ethics committee. If it is a multi-centre study (i.e. involving more than one research site), Multi Research Ethics Committee (MREC) approval may be necessary.

Further details and information on how to apply is available from the National Research Ethics Service (NRES) but please also contact the Joint Research Office who can give the appropriate advice.

Please note that NHS REC approval is no longer required for research involving NHS staff or NHS premises unless it is also required by one of the above criteria. NHS REC approval is not required for research involving previously collected, non-identifiable human tissue samples (e.g. from NHS patients), unless one of the following conditions applies: (1) consent has not been given or the research is outside the scope of the consent; (2) the material is not held on premises covered by an HTA licence; (3) the project also involves the use of new samples gathered from the living or the deceased; or (4) the research also involves the use of identifiable information held with the samples.

It should also be noted that:

Under the Mental Capacity Act (2005), research with participants over the age of 16 who are deemed unable to make their own decisions, for example, because of learning difficulties, brain injury or mental health problems, must obtain ethical approval from a REC operating under the National Research Ethics Service (i.e. an NHS REC).
If your study involves human tissue it may need to be approved by an NHS Research Ethics Committee depending on the type of tissue activity involved. The UCL Research Ethics Committee can only currently grant ethical approval for studies involving human tissue under certain circumstances. → Further information.

1.4. 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 the Graduate School 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.

1.5. Ethical clearance at UCL involves a two-stage process.

Completed applications are first submitted for departmental endorsement. Departmental endorsement can be via a departmental ethics/research committee or via the head of department. Departmental endorsement ensures:

Awareness by the department of proposals being put forward by departmental staff and students.
Compliance with the Data Protection Act.
Completion of a formal signed Risk Assessment Form.
An opportunity for modification of the ethics application before it reaches the UCL Ethics Committee if alterations are deemed necessary and desirable to expedite ethics approval.

Departmental endorsement also offers the department the opportunity to recommend to the UCL Ethics Committee that an application be considered by Chair's action. Such recommendations may be used as appropriate by the Ethics Committee to facilitate its role in making its decision in relation to ethical approval. A recommendation for Chair's action will be deemed appropriate if the research involves minimum risk as defined below:

Applications where there are NO contentious issues such as genetic research or research on illegal substances.
Applications where NO invasive or traumatic procedures are involved including the administration of pharmacological agents.
Applications where participants are NOT children or other vulnerable subjects (e.g. participant suffering from mental disorder, prisoners).
Applications that potentially DO NOT put the investigators at risk.

2. Constitution and Membership

2.1. Appointed – 5 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 – 5 academic staff of UCL, appointed by the Committee, covering areas of expertise such as medicine, psychology, law, statistics, anthropology.

2.3 Secretary – Administrative Officer, Graduate School

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 5 is required, to include 3 of the 5 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 five 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 Goverance Committee, Aacdemic Board and the Council

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.