Committee objectives

The purpose of the External and Sponsorship Research Ethics Committee is to receive, consider and provide an ethics opinion on proposals for ethical approval for research being undertaken by staff and students.

The committee aims to provide a facilitative approach to supporting research conducted in and with the University of Bath.

Committee remit

With regards to sponsored projects

• To ensure that staff and student studies sponsored by the University of Bath comply with the requirements of the UK Policy Framework for Health and Social Care Research (2017) and/or the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, and to standards of Good Clinical Practice (GCP).

• The Committee also manages any reputational risk to the University that may arise as a result of the University acting as sponsor of research carried out within the NHS or social care and also for clinical trials conducted outside the UK.

• The Committee will review all staff and student applications for University sponsorship or co-sponsorship for studies that require sponsorship under the UK Policy Framework for Health and Social Care Research (2017). The Committee will also review applications for clinical trials carried out outside the UK, and provide appropriate sponsor oversight of sponsored studies on behalf of the University, ensuring compliance with sponsor responsibilities and other applicable legislative requirements.

With regards to projects which have gained an ethical opinion elsewhere

To confirm that the ethical review process carried out elsewhere is aligned with the standards, codes and principles expected by the University.

Committee duties

A. With regards to sponsored projects

• Receive and review sponsorship applications or associated amendments from University staff and students, and approve, conditionally approve, or reject applications;
• Receive and review sponsorship applications for clinical trials carried out outside the UK.
• Receive, and have oversight of, reports submitted by researchers in relation to University of Bath sponsored studies;
• Ensure that studies sponsored or co-sponsored by the University can be undertaken within the requirements of the UK Policy Framework for Health and Social Care Research (2017) and/or the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, and to standards of Good Clinical Practice (GCP);
• Provide oversight of the management of University’s Sponsored studies;
• Ensure that the projected financial plans for studies provide the necessary funding with which to deliver the study and are in line with the current costing attribution of the Department of Health;
• Ensure that studies have the necessary insurance cover from the outset;
• Ensure that studies receive appropriate peer review; and
• Ensure that a robust risk-assessment is carried out in order to inform the Committees decision on whether to issue Sponsorship approval.
• To conduct any audit visits to ongoing on and off-site projects in line with quality assurance and monitoring plans.

In reviewing applications, the Committee will have due regard for:

• Compliance with the UK Policy Framework for Health and Social Care Research (2017) and/or the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, and to standards of Good Clinical Practice (GCP), as applicable;
• Compliance with the University’s Sponsorship & Oversight Policy;
• The allocation of trial/study monitors, appropriate to the needs of the trial/study, and for international trials/studies, the availability of an International Trial Monitor to provide reasonable oversight;
• The allocation of staff resource and facilities required to deliver the study;
• Evidence of appropriate peer review of the scientific design and quality of the study;
• Evidence that the finances attached to the study are adequate to allow the University to discharge its sponsor responsibilities; and
• The results of the risk assessment any subsequent agreed actions for monitoring, managing or mitigating risk.

The Committee will receive the following regular reports:

• Progress against Quality Assurance Audit Plans for University sponsored studies
• Quality Assurance Audit and Monitoring reports completed since the last meeting
• Annual and End of Study REC reports submitted since the last meeting
• safety reports submitted since the last meeting
• Protocol and/or GCP violations/serious breaches, with any Medicines and Healthcare products Regulatory Agency (MHRA) reported serious breaches also being referred immediately to the Chair of the Committee.
• Suspected Unexpected Serious Adverse Reaction (SUSAR) line reporting, with immediate referral to the Chair of the Committee.
• Report on any SOPs that have exceeded their next review date
• Sponsor’s Office report of low-risk non-interventional studies approved via delegated procedures

The Committee will also receive the following annual reports:

• Quality Assurance Audit Plan
• Quality Assurance Audit Reports for external clinical trials units that manage a University sponsored study

B. With regards to projects which have gained an ethical opinion elsewhere

• Receive and review documents pertaining to research project and ethical review carried out elsewhere
• Confirm that the process followed elsewhere adhered to similar ethical standards in a similar legislative environment to that observed by Bath .
• Confirm that the scope of the external review is consistent with the University of Bath’s ethics policy.
• To accept the existing approval in lieu of a new University of Bath research ethics application upon confirming b) and d) above.
• To advise on how to get the project ethically appraised at Bath should the researcher be unable to demonstrate what process was followed elsewhere.
• To advise on how to get the project ethically appraised at Bath should the evidence provided shows that the standards applied fall short of those expected to be adhered to at this University.

Reporting lines and responsibilities of the Committee

This Committee reports to the Academic Ethics and Integrity Committee.

Procedural rules

Membership and appointment of Chair

See Senate Standing Order 16(i).

Membership of this Committee is constituted in the following way:

• A member to chair the committee
• A member to be deputy chair
• A member of the Research Governance and Assurance Team
• A representative from each primary research sub-discipline
• A lay member

This Committee should be multidisciplinary, represent diversity, and be constituted so that conflicts of interests are avoided. This means that such Committee would have at least 10 members, preferably 12, to ensure diversity of views and range of expertise.

Appointment of the Chair is for three years via an open call led by the Chair of Academic Ethics and Integrity Committee.

Co-option

See Senate Standing Orders 16(ii) and 16(iii). The committee may co-opt additional members to provide areas of specific expertise not offered by the Committee’s membership.

Alternates

See Senate Standing Orders 17(iv).

Quorum

The quorum for the Committee will be five members, There shall be a quorum at meetings of one-third of the membership of the Committee including the Chair, a representative of Research Governance and Assurance Team, and an academic representative. See Senate Standing Order 16(iv).

Rules for voting

See Senate Standing Order 8 and 9.

Minutes

Minutes are submitted to Academic Ethics and Integrity Committee.

Resources

• Research Ethics and Integrity
• Code of Ethics
• Code of good practice in research integrity
• Department Research Ethics officers

Adapted from: Research Ethics Support and Review in Research Organisations

Queries on the University's institutional ethics processes can be sent to Governance Office Queries on the University’s research ethics processes can be sent to research-ethics@bath.ac.uk

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