The third meeting of the Research Transparency Strategy Group took place on 29 May 2019. Minutes can be found below.
The meeting was held between 11am and 3pm at Skipton House, 80 London Road, London. SE1 6LH.
Expert group members
| Marise Bucukoglu | Head of Research Governance, University of Edinburgh | Attending via phone |
| Professor David Edwards | Professor of Neonatology, St Thomas’ Hospital London | Apologies |
| Professor Andrew George | HRA non-executive director (Chair) | In Attendance |
| Dr Cham Herath | Director of Healthcare and Medical Affairs UK, AstraZeneca | Apologies |
| Dr Simon Kolstoe | University of Portsmouth and Research Ethics Committee chair | In Attendance |
| Sile Lane | Head of Campaigns, AllTrials | In Attendance |
| Dr Julie McCarroll | Northern Ireland Public Health Agency | Attending via phone |
| Alex Newberry | Head of NHS Research Governance and Informatics, Welsh Government | In Attendance |
| Professor Sir Steve O’Rahilly | Professor of Clinical Biochemistry, University of Cambridge and Director, MRC Metabolic Diseases Unit, University of Cambridge | Attending via phone |
| Dr Marina Parry | Senior Research Associate, UCL Cancer Institute | In Attendance |
| Derek Stewart | Public contributor/patient engagement expert | Attending via phone |
| Nisha Tailor | Head of Policy and Public Affairs, Association of Medical Research Charities | Apologies |
| Dr Matt Westmore | Operations Director, NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) | Apologies |
HRA staff members
| Teagan Allen | Policy Officer | Attending via phone |
| Clive Collett | Ethics Policy Manager | In Attendance |
| Nicola Gilzeane | Engagement Officer | Attending via phone |
| Eve Hart | Head of Communications | Apologies |
| Juliet Tizzard | Director of Policy | In Attendance |
1. Welcome and apologies
Professor Andrew George welcomed everyone to the Research Transparency Strategy Group meeting and noted apologies.
2. The strategy
The HRA secretariat had refined the draft strategy, taking in comments made in the last meeting, and presented this to the Group. The Group reviewed the updated draft strategy and agreed with the ambition and pitch of the overall strategy as it was presented, but noted it was important that the vision/mission encompassed the ambition to change the culture of health and care research in the UK to put transparency at its core. The Group worked through the updated draft strategy, and discussed the plans and proposals of the strategy which were set out in three sections-
· Changes we will make
· Changes we’d like to make
· Changes we could make
Changes we will make
This section outlines changes that the group have agreed will be made in supporting good practice and making compliance easier, making performance clear and clarifying HRA’s expectations around sharing the results of research studies with the patients who took part. The Group explored how to make performance clear and whether it should be the researcher or sponsors performance that is considered and whether this should be done privately or publicly. It was also raised that the HRA should be clear about its own performance, being open about progress. The Group discussed how to consult on these changes, as we are committed to making them, it was agreed that the consultation will be used to help prioritise these changes for implementation.
Changes we’d like to make
This section of the draft strategy outlines areas where change is needed, but the approach is not yet determined, and so proposals are made on the possible changes that could be made and that we will consult on. It is proposed that requirements in relation to monitoring sponsors’ and researchers’ transparency performance on clinical trials should be strengthened. In particular; that the HRA will strengthen requirements on sponsors to report results at the end of a study and increase its monitoring and prompting of sponsors. The Group considered how impactful this change would be and raised several points to consider, these included
· What time frame will results be expected after end of study, e.g. within 12 months of end of study
· What kind of results information will be expected – full results, an overall conclusion, or just an outline of what happened
· Reasons why researchers may want to delay reporting results, such as publication and intellectual property
The Group discussed how these issues should be addressed in the strategy and approached during the consultation. This section of the strategy also highlights registration as an area requiring change. The strategy proposes three ways to achieve 100% registration of clinical trials, these are:
1. Researchers have to register their study before seeking approval
2. HRA supplies data directly to a registry
3. HRA becomes a registry itself
The Group agreed that we will seek opinions on these options during the consultation.
Changes we could make
This section of the draft strategy outlines further changes that could be made if the other changes we plan to make do not dramatically improve transparency performance-
· Imposing sanctions under existing legislation
· Considering the past performance of applicants
· Asking the Government to extend our legal powers
The Group felt that imposing sanctions and extending legal powers should be part of the same action and so agreed to join these points together. The Group discussed how past performance would be used and that there would have to be guidance produced on how, and by who, past performance should be used to ensure consistency and fairness across the system. A discussion was had about whether we should consider making some of these changes part of our initial plan. It was agreed that we will seek opinions on how appropriate these measures are during the consultation. HRA secretariat staff noted that if it was decided that we pursue these measures a further consultation would be done on the specific measures that could be used prior to implementation.
Action
HRA to update the strategy as discussed and circulate to the Group for comment
3. Consultation survey questions
The HRA secretariat presented a draft question set for the online survey that will be used during the consultation to gather feedback on the strategy from the research community, public and patients. The Group refined the question set and agreed it was important that the questions elicit responses that would give a clear indication of opinions on the strategy whilst also ensuring it is concise to allow as many people as possible to complete it. They therefore felt the mixed approach of qualitative and quantitative questions was appropriate and that no more than 10-12 questions should be used. The Group agreed to the use of different measurement scales being used with the survey.
Action
HRA to update survey questions as discussed and circulate to the Group for comment
4. Consultation plan
HRA secretariat staff updated the group on the plan to consult the research community, public and patients to gain feedback on the draft strategy. The HRA confirmed for the group that the consultation will launch the on 17 June 2019 and run for 12 weeks. The updated plan for the consultation includes the following events
· Online survey launch: 17 June
· Open workshop: 16 July, London
· Open workshop: 25 July, Manchester
· Open workshop: (date TBC), Cardiff
· Patient and public focus group: (date TBC), Nottingham
· HRA staff focus groups: (date TBC), HRA regional offices
· REC member webinar (date TBC)
The Group agreed to offer their support to workshops and engaging the community where possible.
Action
HRA to provide Group with details of workshops and events
5. Plan for next meeting
The next meeting will be on 23 September and will be used to review interim analysis of feedback gathered during the consultation.
Minutes from the first meeting, held on 3 April 2019, can be found here
Minutes from the second meeting, held on 8 May 2019, can be found here