|Time Commitment required||In addition to time spent preparing for and chairing meetings, at least three hours per week.|
|Remuneration||The position is voluntary; a Chairs allowance and expenses will be paid under the terms of the Appointing Authority policy.|
Protecting the rights, safety, dignity and well-being of research participants and facilitating and promoting ethical research that is of potential benefit to participants, science and society.
The main purpose of this role is to Chair the Research Ethics Committee (REC) to ensure that all study applications seen by the committee receive ethical review within the guidelines of Governance Arrangements for Research Ethics Committees (GAfREC), the European Clinical Trials Directive 2001/20/EC (EUD) (1) , the Medicines for Human Use (Clinical Trials) Regulations 2004 (CTR) and Standard Operating Procedures for Research Ethics Committees (SOPs). The Chair as leader of the committee is responsible for the committee function, ensuring that all ethical issues are explored and clear decisions made and recorded. The Chair will work with Approvals Operations staff, recognising their separate but complementary responsibilities in managing the REC functions; they will receive support from the Approvals Specialist on all issues of process, which are governed by SOPs.
To be aware of and keep up to date with Health Research Authority policies, initiatives and Business Plans and gain, maintain and share a wider knowledge of Research and Governance.
To attend, and participate in, regional Chairs meetings.
To contribute when required to specific projects including the development of guidelines through initiatives such as Shared Ethical Debate, and to challenge continued applicability of guidance.
- Chair the monthly REC meetings and sub-committee meetings ensuring that ethical issues are explored and debated. Responsible for reading the applications and meeting documents, taking part in the ethical review, assuming lead reviewer role where necessary and to be responsible for the time management of the committee meeting.
- Process all REC communications in line with due process and timelines.
- Be aware of the HRA ‘Guidelines for inviting researchers to attend REC meetings. Promote the courteous treatment of all researchers attending the meeting.
- To be aware of, and undertake training in, Equality and Diversity and ensure that applicants to the REC, members and potential members, are treated fairly and equally regardless of gender, race, disability, sexual orientation, religion/belief or age.
- Chair, or assist HRA Operations staff in ensuring that PRSCs (Proportionate Review Sub-committees) are set up and managed in accordance with SOPs.
- Ensure that during the meetings a decision is reached and recorded and that the method of dealing with responses (Chair’s action / HRA staff / sub-committee / main committee) is agreed and appropriate.
- Promote the effective working of the committee as a cohesive group. Work with the HRA with regards to the development of the committee and members; for example, review decision making data and implement change where necessary, work with the VC and AVC and help succession planning for officers within the committee and help members to develop in their role.
- According to agreed methods review and deal with responses from applicants who have received a provisional opinion and the consideration of protocol amendments in a timely manner.
- Be available to the HRA staff (via email or in person) on a planned or ad hoc/daily basis, at least 2 hours per week as necessary, to include the following:
- Check and approve the Minutes (drafted by the Approvals Officer or Approvals Administrator) in a timely manner to allow decision letters to be sent within timelines; these will provide a comprehensive and accurate record of all the detailed amendments/queries agreed at the meeting.
- Approve more technical responses to new REC applications and amendments, including agreeing issues related to provisional opinions under delegated authority of the committee.
- Electronically authorise the Minutes
- Ensure SOPs, GAfREC, relevant regulations (e.g. CTR, human tissue and mental capacity legislation) and other recognised guidelines are adhered to where applicable.
- Ensure effective communication of HRA updates at REC meetings.
- Provide general advice and guidance to HRA staff, Committee members and researchers.
- Offer support, and mentorship as required to the Vice-Chair, Alternate Vice Chair and members.
- Support the Appointing Authority in managing the membership of the committee in collaboration with the HRA staff, including:
- Assisting with recruitment and selection of new members.
- Providing guidance to committee members regarding potential conflicts of interest.
- Ensure lead reviewers are identified as per agreed process for new applications and protocol amendments.
- Ensuring that own, and members training is up to date.
- Addressing issues of poor performance, poor attendance or conduct issues in the first instance in line with Member Management Procedures
- Attend regional Chairs meetings.
- To feed back to the Appointing Authority on any administrative issues or concerns which affect the efficient running of the REC.
- Be aware of outcomes of accreditation audit of the REC and assist the HRA Approvals Support Team with the completion of actions regarding REC member training and attendance.
Support for the role
The Health Research Authority values the important contribution the role of the Chair makes to the review of applications and in supporting the members, researchers and coordinators. The following are provided to support the Chair's role:
- Chairing skills training.
- National Chairs day.
- Access to the National Research Ethics Advisors Panel.
- Regional Chairs meetings.
Web link reference documents:
(1) DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 4 APRIL 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.