Minutes of the meeting of 8 May 2019

The meeting was held between 11am and 3pm at Friends House, 173–177 Euston Road, London. NW1 2BJ

Expert group members

HRA staff

1.           Welcome and introductions

Professor Andrew George welcomed everyone to the Research Transparency Strategy Group meeting. All members were present and no apologies given.

2.           Strategy vision and outline

As agreed at the last meeting, the HRA secretariat had drafted a draft strategy vision and outline for comment between meetings. The Group discussed the vision and outline further, the structure of which is:

·        Vision: the future state we are aiming for (for all)

·        Mission: HRA’s ambitions in achieving that vision

·        HRA commitments: what the HRA will do to achieve the ambitions and contribute towards the vision

Vision

The Group agreed that the vision should be clear and concise and that it should focus on creating an accessible public record of health and social care research public. They agreed it should refer to all research within the HRA’s remit. It was felt that the vision should be broad, but the initial focus for most actions in the strategy should be focused on clinical trials.

Mission

The mission is focussed around four main roles for the HRA:

·        Championing research transparency

·        Lead improvement across the UK

·        Creating visibility around studies

·        Facilitating good transparency performance

It was noted that if part of the HRA’s mission is to create a public record of research, we need to carefully highlight the different types of reporting from studies and their relative reliability. The Group felt that the HRA’s job would be to gather information about individual studies and either publish it directly or signpost to where it is available (a journal article, for example), contextualising the information for the reader.

The Group discussed what the mission should include and agreed that as with the vision, our mission should be broad to reflect the HRAs remit, as set out in the Care Act. They also felt that the HRA’s mission should involve setting a standard, creating a framework for good transparency and being clear about expectations. It was also noted that educating should be part of our mission along with providing feedback on transparency performance.

HRA commitments

To achieve the mission and contribute towards the vision the strategy, we will set out a series of HRA commitments. The Group agreed this should include making it easy for transparency requirements to be followed, following up on requirements through monitoring and making information about studies public. The Group highlighted that it will be important for the HRA to be specific and clear about requirements, provide education and support and to work with the research community to achieve the mission.

Action

HRA to update strategy outline based on group discussions

3.           Potential policy changes

The HRA secretariat presented a paper proposing potential policy changes that the strategy could include to address areas of transparency that require improvement:

·        Registration of clinical trials (excluding trials of new medicines, which are already registered) – currently at only 68%

·        Reporting of results to the registry it was registered on – at only 50% for trials of new medicines and likely lower for other clinical trials

·        Giving participants information about the study results

·            Improving transparency behaviour more generally

For each of these areas the group were presented with options for addressing those problems with different policy, monitoring and compliance measures (including remaining with the status quo). The group reviewed the options and highlighted the advantages and disadvantages of each.

Policy options for registration of clinical trials

The Group discussed the following options for improving registration of clinical trials:

1.     All trials to be registered within maximum of 6 weeks of first recruit (status quo)

2.     Register by first recruit and report to HRA

3.     Applicants provide registration details at the time of applying for approval

4.     HRA registers study on behalf of sponsor (either by acting as a register or sending data to existing registers)

The Group agreed that the status quo is not desirable. They discussed the relative merits of the other options and agreed that they should form part of the consultation. This would be important not only to gather views about each option, but to test the feasibility and practicality of each one.

Policy options for reporting of results for clinical trials

The Group discussed the following options for improving reporting of clinical trials results:

1.     For clinical trials (excluding trials of new medicines, where there is an EU requirement), results should be made public in a timely manner and a final report to be sent to HRA 12 months after end of study (status quo)

2.     All clinical trials to report results where they registered within 12 months of study end, as a condition of ethical approval. A final report to be sent to HRA 12 months after end of study and compliance encouraged through automated reminders.

3.     All clinical trials to report results where they registered within 12 months of study end, as a condition of ethical approval. A final report to be sent to HRA 12 months after end of study and compliance enforced (mechanism to be explored further)

The Group agreed that we need to tighten up the requirement here as it is crucial that registered studies report their results. However, the Group felt that discussing firmer sanctions was premature and that before that it explored we should do much more to facilitate compliance through better systems, collaboration with funders, data sharing and making information public.

The Group agreed that rather than giving options, the strategy reflect this approach of starting with an enabling approach but consider the use of sanctions if this does not prove effective.

Policy options for sharing study results with participants

The Group discussed the following options for improving the sharing of results with participants:

1.     Ask applicants whether they will inform participants of results (status quo)

2.     Ask firmer: how will you inform participants of results?

3.     Include in the final report a field that asks for confirmation this has been done

The Group agreed that it is important that study participants are told about the results of the research, to acknowledge their input and encourage future participants. Although there can be practical issues with feeding back to participants, particularly for longitudinal studies, the default should be to do so.

The Group raised the possibility of using the HRA as a central place to provide this information to participants – meaning a standard link could be put in the participant information sheet. It was noted that this type of information is provided elsewhere - for example to funders – and the Group underlined the need to avoid duplication and where possible facilitate processes where researchers only need to record information once.

It was agreed that it would be best to set out a commitment in this area in the strategy consultation and seek feedback, rather than to test particular options.

Policy options to improve transparency performance of sponsors and researchers

The Group discussed the following options for improving the overall transparency performance of researchers and sponsors by considering past performance at the time of ethics review for a new study:

1.     No information on performance is gathered or referred back to (status quo)

2.     Ask HRA Approval applicants to provide details on past studies voluntarily with no specific action set in response to this

3.     HRA to gather this information and previous non-compliance must be rectified before approval process can progress for a new application  

The Group discussed the current lack of equity between commercial and non-commercial research in respect of sanctions and whether considering past performance might be a way of creating better parity. The Group agreed that past performance is worth exploring in the consultation, but careful consideration must be given to who is held responsible: the sponsor or the researcher. Consideration would also need to be given to who would act on this information: would it be the ethics committee or at a more organisational level within the HRA?

The Group agreed to discuss this idea in the consultation, but not to test particular options at this stage.

Action

HRA to update policy options based on discussion

4.           Consultation plan

HRA secretariat staff presented an outline for how they will consult the research community, the public and patients to ensure we are using a collaborative approach to create a strategy that is feasible and achieves research transparency. A 12 week consultation period is planned to begin in the summer 2019.

The HRA will use a variety of methods to engage the community and gain feedback-

·        An online questionnaire that is open to all and will run for 12 weeks  

·        A series of workshops  

·        Direct engagement with key stakeholders and partners

·        Attending existing forums and groups to engage the community

The Group agreed to assist with workshops and engaging the community where possible.

Action

HRA to canvas the group on availability to assist with consultation workshops

5.           Engagement update

The HRA gave an update on the engagement that has been done around the strategy. Individual meetings have been held with:

·        TranspariMed

·        Centre for Evidence-based Medicine

·        Academy of Medical Sciences

·        ISRCTN registry

Meetings are planned with:

·        Department of Health and Social Care

·        Science & Technology Committee clerks

·        Medicines and Healthcare products Regulatory Agency

·        Cancer Research UK

We are presenting information about the strategy to:

·        NHS R&D Forum annual conference (14 May)

·        HRA Board (15 May)

·        Transparency Forum (22 May)

6.           Communications update

The HRA Communications Team want to make our work about transparency more easily understandable and recognisable for the community and the public. The team presented new a strategy and campaign name to the Group, who felt it captured the spirit of transparency well. The HRA asked the group to review the proposed wording and provide suggestions to help refine it before it is signed off.

Action

HRA to circulate options for wording for the communication that will surround this work

7.           Plan for next meeting

The next meeting will be on 29 May and will be used to finalise the draft strategy. This will be a meeting in London, with the option to dial in.  

Minutes from the first meeting, held on 3 April 2019, can be found here