Regulations for Committees Reporting Directly to Council or one of its Main Committees

Council Regulations 15 of 2002

Made by Council on 26 June 2002

Other Committees

Part 13: Central University Research Ethics Committee

Amended on 31 October 2002, 19 March 2008, 18 March 2010, 22 April 2010, 16 February 2012, 19 July 2012 and 2 August 2013

Renumbered on 28 July 2011

13.1. The Central University Research Ethics Committee shall consist of:

(1) a person appointed by Council who shall chair the committee;

(2) one of the Proctors or the Assessor as may be agreed between them;

(3) the chair of the Medical Sciences Interdivisional Research Ethics Committee;

(4) the chair of the Social Sciences and Humanities Interdivisional Research Ethics Committee;

(5) the chair of the Oxford Tropical Research Ethics Committee.

(6), (7) two external persons appointed by Council;

(8)–(13) up to six persons appointed by Council to ensure appropriate representation of areas of research involving human participants or personal data.

13.2. Appointed members shall serve for four years and shall be re-eligible.

13.3. The committee may co-opt up to four additional members, who may be internal or external, and who shall hold office for such period as the committee may determine.

13.4. The committee shall:

(1) establish, promote, implement, and keep under review policies and procedures for the consideration, approval, and monitoring of research projects involving human participants or personal data in order to meet the University’s requirement that all such research shall be the subject of ethical review;

(2) consider any matter of policy concerning the ethical approval of research involving human participants or personal data referred to the committee by the bodies set out in regulation 13.7 (1)-(3) below or any other relevant body;

(3) consider and advise on training provision for those involved in considering applications under this machinery and for those undertaking research involving human participants or personal data;

(4) consider any issues concerning the ethics of research referred to the committee by any other University body.

13.5. The committee shall establish, implement and keep under review a procedure for considering appeals against the exercise of the power under regulation 13.12 (3) by its subcommittees.

13.6. The committee shall report annually to Council on the matters set out in regulations 13.4 and 13.5 above, through the Research Committee of Council.

13.7. The committee shall have the following subcommittees:

(1) Medical Sciences Interdivisional Research Ethics Committee;

(2) Social Sciences and Humanities Interdivisional Research Ethics Committee;

(3) Oxford Tropical Research Ethics Committee.

13.8. The membership of each subcommittee established by these regulations shall consist of:

(1), (2) Two persons appointed as chair and vice-chair of the subcommittee by the General Purposes Committee of Council, ideally one of whom shall not currently be involved in research involving human participants or personal data. The person appointed as vice-chair may be external;

(3) One person, who may be external, appointed by the Central University Research Ethics Committee on the recommendation of the chair of the relevant subcommittee whose primary personal or professional interest is not in research involving human participants or personal data;

(4) One person, who may be external, appointed by the Central University Research Ethics Committee on the recommendation of the chair of the relevant subcommittee whose primary personal or professional interest is not in any particular research area;

(5)-(12) No fewer than three, and no more than eight, persons, one of whom may be external, appointed by the Central University Research Ethics Committee on the recommendation of the chair of the relevant subcommittee who have methodological and ethical expertise relevant to the proposals which each subcommittee will be expected to scrutinise.

13.9. Appointed members shall serve for four years and shall be re-eligible.

13.10. Each subcommittee may co-opt up to four additional members, who may be internal or external, and who shall hold office for such period as the subcommittee may determine.

13.11. Notwithstanding regulation 13.8(1), (2) above, the General Purposes Committee of Council may, but is not obliged to, appoint a second vice-chair of each subcommittee on the recommendation of the chair of the Central University Research Ethics Committee. For the avoidance of doubt, the second vice-chair may be external.

13.12. Each subcommittee shall:

(1) review the ethics of all proposals submitted to it for research involving human participants or personal data conducted by University employees or by University students or conducted by others on University premises unless the research falls within the remit of the National Research Ethics Service, in which case such research must meet the requirements of that Service;

(2) grant ethical approval on behalf of the University if it is satisfied that the research complies with the University’s policies and procedures on research involving human participants or personal data;

(3) have the power to withhold, suspend or withdraw approval of research (whether or not the approval was given by any body established by these regulations) if it is considered to be in contravention of the University’s policies and procedures on research involving human participants or personal data;

(4) establish and regularly review for approval by the Central University Research Ethics Committee:

(a) procedures for monitoring research approved by it to verify that the research continues to comply with the University’s policies and procedures on research involving human participants or personal data;

(b) procedures for ensuring that all research projects involving human participants or personal data are reviewed and approved, as appropriate, under the relevant subcommittee’s procedures; and

(c) standing orders.

(5) report annually to the Central University Research Ethics Committee and provide such other reports as are specified in its Standing Orders.