1. Purpose
1.1. The Ethics Review Advisory Group supports the development of improvements to research ethics review in the UK. The Group’s role will be to:
- Advise on the prioritisation, design and implementation of changes to research ethics review.
- Consider how proposals for change fit within the wider research system.
- Consider how proposals for change impact upon research participants, researchers, sponsors, research ethics committees and wider society.
- Assist in communications and engagement activity to ensure that stakeholders have an opportunity to shape changes to the service.
2. Members
2.1. The Group is chaired by Professor Andrew George, Non-Executive Director, HRA.
2.2. Members of the group are:
- Dr Nicole Mather, Non-Executive Director, Health Research Authority
- Dr Janet Messer, Director of Approvals Service, Health Research Authority
- Juliet Tizzard, Director of Policy and Partnerships, Health Research Authority
- Carys Thomas, Head of Policy (R&D Division, Health and Social Care), Welsh Government
- Dr Nicola Williams, Director of Support and Delivery, Health and Care Research Wales
- Dr Janice Bailie, Assistant Director, Health and Social Care R&D Division, Health and Social Care Northern Ireland
- Gordon Watt, Senior Research Policy Manager, Chief Scientist Office Scotland
- Dr Bryan Deane, New Medicines and Data Policy Director, Association of the British Pharmaceutical Industry
- Chris Cannaby, Senior Clinical Operations manager, MSD UK
- Professor Jo Rycroft Malone, Programme Director, Health Services and Delivery Research Programme, National Institute for Health Research
- Dr Rasha Al-Lamee, Clinical Academic Interventional Cardiology Consultant, Imperial College Healthcare NHS Trust
- Professor Mary Dixon-Woods, Director, THIS Institute, University of Cambridge
- Professor Nalin Thakkar, Vice President, University of Manchester
- Dr Mark Sheehan, Oxford Biomedical Research Centre Ethics Fellow, Ethox Institute, University of Oxford
- Helen Lewis-White, Research Operations Manager, North Bristol NHS Trust
- Dr Susan Kohlhaas, Director of Research, Alzheimer’s Research UK
- Lynn Laidlaw, HRA Public Involvement Network member
- Tom Smith, HRA Public Involvement Network member
- Marie Bardsley, HRA Research Ethics Committee member
- Sue Harrison, HRA Research Ethics Committee member
- Oliver Matias, HRA Research Ethics Committee member
- Joanne Doleman, HRA Research Ethics Committee member (Deputy)
- Linda Cartwright, HRA Research Ethics Committee member (Deputy)
- Dan Mace, HRA Research Ethics Committee member (Deputy)
2.3. Members are not paid for their time, unless they are a patient or public contributor. All meetings of the group are scheduled to take place virtually, over Zoom. Should members be required to travel or have subsistence and accommodation expenses associated with attending the Advisory Group meetings or carrying out additional work for the Group, these will be reimbursed by the HRA.
3. Meetings
3.1. Advisory Group meetings will be held once a month for the first two months, and then transition to a regular meeting once every two months.
3.2. Advisory Group meetings will be held virtually over Zoom.
3.3. Members are on the group for their personal and professional expertise. If members are unable to attend a meeting, a deputy should be sent.
4. Secretariat, papers and minutes
4.1. The Group will be supported by the HRA’s Policy and Engagement team.
4.2. Papers for each meeting will be sent to Group members at least one week before the meeting.
4.3. Minutes of each meeting will be sent within one week of the meeting to Group members for sign-off.
4.4. Papers and other documents will be available to Group members on a password-protected workspace.
5. Openness and transparency
5.1. Information about the Group and the development of the new research ethics review model will be published on the HRA website. This information consists of:
- Names and biographies of the Group members
- The Group terms of reference
- The agenda of each meeting, to be published two working days before the meeting
- The minutes of each meeting, to be published within two weeks of the meeting.
5.2. Other information, such as background papers and blogs about the group’s work may also be published on the HRA website.
6. Review
6.1. The Group has been established to help develop the HRA’s Ethics Review Programme and is therefore expected to have a limited lifespan. However, once the proposed model has been agreed, the HRA will discuss with members how to best oversee the detailed design of the research ethics review process.