|Position||Vice Chair/Alternate Vice Chair|
|Time commitment required||In addition to time spent preparing and attending meetings as a member, an additional three hours per fortnight for sub-committee, including PRSC (Proportionate Review Sub-Committee) work, and additional time as and when required when deputising for the Chair|
|Remuneration||The position is voluntary; expenses will be met 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.
To take on officer responsibility for sub-committee work, in partnership and/or as agreed with the Chair.
To take on officer responsibility for some PRSC work in partnership and/or as agreed with the Chair.
To be aware of and keep up to date with HRA (Health Research Authority) policies, initiatives and Business Plans and gain, maintain and share a wider knowledge of Research and Governance.
At least once each year to chair the REC meeting (this may be in the absence of the Chair while deputising, or in the presence of the Chair for experience purposes) ensuring 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).
Ensuring that all ethical issues are explored, and clear decisions made and recorded. The chairing of the REC meeting may be whilst deputising for the Chair in his/her absence or in the presence of the Chair who can be called upon for support and guidance as or if required. The Vice Chair will work with the 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 deputise in the absence of the Chair, to attend, and participate in, regional Chairs meetings.
To provide mentorship for new REC members as agreed.
- Chair the REC meetings and allocated sub-committee, including PRSC meetings ensuring that they are quorate and 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.
- Ensure that during the meetings that a decision is reached and recorded and that the method of dealing with responses (chairs action, when deputising for the Chair, subcommittee/ main committee) is agreed.
- 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.
- Process all REC communications in line with due process and timelines.
- Be available to HRA staff (via email or in person) on a planned or ad hoc/daily basis, at least 2 hours per week as necessary, with additional time for PRS sub-committee work and 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 legislation (e.g. CTR, human tissue and mental capacity legislation) and other recognised guidelines are adhered to where applicable.
As required, provide general advice and guidance to HRA staff, Committee members and researchers.
Support for the role
The Health Research Authority values the important contribution the role of the Vice Chair/Alternate Vice Chair makes to the review of applications and in supporting the members, researchers and coordinators.
- Chairing skills training.
- National Chairs day.
- Access to the National Research Ethics Advisor 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.