1. Purpose
1.1. The Health Research Authority (HRA) is tasked to promote research transparency as a statutory function under clauses in the Care Act. The House of Commons Science and Technology Select Committee report, Research Integrity: Clinical Trials Transparency, published in October 2018, made recommendations to the HRA to improve transparency in clinical trials. A key recommendation of the report was that the HRA develop a transparency strategy to outline how research transparency in clinical trials will be achieved. The HRA has accepted this recommendation and will now work towards its creation. The Committee expects the strategy to be delivered by December 2019.
1.2. The Research Transparency Strategy Group is established to develop the transparency strategy and recommend it to the HRA Board for agreement. The Group’s role will be to:
· Use their knowledge and expertise to advise on contents of a strategy which will be both ambitious and feasible
· Highlight stakeholder priorities and motivators for compliance with transparency requirements to ensure the strategy will have buy-in from the community leading to long term compliance
· Highlight the concerns and needs of the public and patients surrounding research transparency to ensure the strategy inspires public confidence in research
· Develop the strategy to pre-agreed time points, allowing the draft strategy to be put out for consultation by summer 2019
· Assist in the engagement around the draft strategy, during the consultation period and beyond
· Take into account the findings of the consultation when finalising the strategy for recommendation to the HRA Board.
2. Members
2.1. The Group is chaired by Professor Andrew George, non-executive Board member of the Health Research Authority. The members of the group are:
· Marise Bucukoglu, Head of Research Governance, University of Edinburgh
· Professor David Edwards, Professor of Paediatrics and Neonatal Medicine, Kings College London
· Dr Cham Herath, Executive Medical Affairs Director UK and Ireland for Merck Sharp and Dohme
· Dr Simon Kolstoe, University of Portsmouth and research ethics committee chair
· Sile Lane, Head of Campaigns, AllTrials
· Alex Newberry, Head of NHS Research Governance and Informatics, Welsh Government
· Professor Sir Stephen O’Rahilly, Professor of Clinical Biochemistry, University of Cambridge and Director, MRC Metabolic Diseases Unit, University of Cambridge
· Dr Marina Parry, Senior Research Associate at UCL Cancer Institute
· Derek Stewart, public contributor/patient engagement
· Nisha Tailor, Head of Policy and Public Affairs, Association of Medical Research Charities
· Dr Matt Westmore, Operations Director, NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC)
· Dr Julie McCarroll, Programme Manager, Northern Ireland Public Health Agency
2.2. Members are not paid for their time, unless they are a patient or public contributor. All members are reimbursed for travel, subsistence and accommodation expenses associated with attending the Expert Group meetings or carrying out additional work for the group.
3. Meetings
3.1. Expert Group meetings will be face-to-face and normally held in London.
3.2. Members are on the group for their personal and professional expertise. Therefore, if members are unable to attend a meeting, they cannot send a deputy, unless agreed by the chair.
4. Secretariat, papers and minutes
4.1. The Group will be supported by Juliet Tizzard, HRA Director of Policy, and other members of HRA staff.
4.2. Papers for each meeting will be prepared by HRA staff and sent to Group members at least one week before the meeting.
4.3. Minutes of each meeting will be prepared by HRA staff and 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. These documents should not be shared beyond the group and HRA staff.
5. Openness and transparency
5.1. Information about the Group and the development of the strategy 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 research transparency strategy and is therefore expected to have a limited lifespan. However, once the strategy has been published, the HRA will discuss with members how to best oversee the implementation phase of the strategy.