Community Committee July 2025 minutes

Chair:

Marian Knight (MK)

Community Committee Members:

Anne-Laure Donskoy (A-LD), Alisha Aman (AA), Christine Vial (CV), Eleni Chambers (EC), Louise Vale (LV), Margaret Cheng (MC), Sandra Duggan (SD), Sarah-Jayne Ambler (S-JA), Simon Kolstoe (SK), Stephanie Ellis (SE)

HRA Staff Attendees:

Alex Willis (AW), Becky Purvis (BP), Beth Hemming (BH), Clive Collett (CC), Eve Hart (EH), Georgia Copeland (GC), Jonathan Fennelly-Barnwell (JF-B), Kat Evans (KE), Naho Yamazaki (NY), Teagan Allen (TA)

HRA Guest Presenters:

Kirsty Edwards (KEs) – for item 2

Kirstie Shearman (KS) for item 3

Apologies:

Jan Speechley (JS)

Welcome and apologies:

MK welcomed the members to the meeting of the Community Committee and noted apologies.

BP gave the following verbal updates:

• Community Committee recruitment has been paused while work is taken forward to review the Committee’s ways of working
• staff will be in touch shortly to invite members to be part of work to review the way that we offer payments, informed by the discussion at the last meeting on 12th May
• reminded all attendees of the HRA ways of working together guidance to inform how they engage in this meeting Working together - Health Research Authority
• reminded members to approach GC as the first point of contact /support for the Committee

The Community Committee March Meeting Minutes (Paper B) were ratified.

Item 2

For review and advice: Paper and Slide Deck 1 – Simplified arrangements for consent

Guest: Kirsty Edwards, HRA Policy Manager

KEs presented slides setting out proposed work around simplified arrangements for consent. These noted:

• informed consent is both a legal and ethical requirement, defined by capacity, voluntariness, and full information
• the recent update to the UK law governing clinical trials will allow sponsors of certain clinical trials to use simplified arrangements for obtaining and evidencing consent, provided specific criteria are met
• the revised legislation provides little detail on what simplified arrangements might entail in practice, noting that further work is needed to better understand which simplified approaches could enhance the effectiveness of research, be trusted by the public, and remain consistent with existing statutory clinical trials regulations and broader common law
• HRA has surveyed views on one approach, which involved doctors recording consent directly in medical records. 55% of respondents were unsupportive, citing lack of takeaway information and concerns over inadequate consent. REC members were more open but noted power imbalances; whilst researchers were supportive of its potential to increase participation
• given the mixed feedback, a decision had been taken to rethink the approach and Community Committee were asked to provide guidance and advice on how we do this
• KEs outlined the proposal to form an advisory group including: REC and CAG members, trial participants, underserved community members, public contributors, researchers and academics and two members of the Community Committee. This group will advise and inform the project across two phases: idea generation and ongoing insight

A member queried the sample size for the pilot undertaken. KEs stated that there were 923 respondents, noting a significantly low response rate for research participants of only 23. KE advised that she would need to check the number of responses from REC members and researchers and agreed she could provide the figures.

The Committee were asked to review and provide advice on the proposal, including:

• the establishment of an advisory group
• the membership of the advisory group
• the scope of the advisory group
• the Community Committee’s role in providing advice and assurance

The Committee were given time within break out rooms to consider, with follow-up as a whole to consider the following questions:

• are we involving the right people in this initiative?
• are there others we should be involving?
• at what stages should we involve them?

Feedback from the breakouts included the following:

• approach: There was strong agreement on the importance of establishing an advisory group to explore simplified consent processes, with no objections raised to its formation. The group’s role should be clearly outlined in its Terms of Reference, focused on reviewing, collating, and synthesising existing knowledge, practice, and perspectives, rather than reinventing the wheel
• the process for selecting advisory group members should be transparent, with clear criteria for membership. There should also be clear communication channels to ensure the group reports back to the Community Committee to prevent siloed working. Clarification of the advisory group's scope and remit is also needed, what they are being asked to consider, and what decisions or recommendations they will influence
• scope: The group should explore how simplified arrangements might apply not only to initial consent but also to ongoing consent, noting that there is no legal barrier to this. The format for delivery of simplified consent, whether online, face-to-face, or a mix of both should also be considered
• there is extensive existing research on consent, particularly in relation to e-consent. It was stressed that the advisory group should build on this work, including relevant recent work undertaken (TransCelerate was cited as an example). Lessons from the National Data Opt-Out and public attitudes to data use should also inform the group's thinking, particularly in relation to layered consent approaches

The group also shared some thoughts on issues that should be considered in reviewing possible approaches to simplified arrangement for consent:

• the potential use of digital tools, such as the NHS App, was discussed, noting the benefits but also limitations, including digital exclusion, especially for older, poorer, and disabled populations. It was noted that many may lack access to such tools, and the risk of excluding marginalised communities was highlighted. Questions were raised about how individuals would know consent had been recorded in their medical record, and whether this might undermine transparency and inclusion
• the advisory group’s membership should reflect a wide range of expertise and lived experience. Suggested members include academic experts (e.g. ethicists), researchers, research delivery staff, sponsors, regulatory representatives (e.g. REC and CAG), public contributors (including underserved communities), and individuals with overlapping roles (e.g. someone who is who is a researcher and REC member or public contributor), which was seen to add value. Research delivery staff in particular were identified as key members due to their front-line experience with informed consent conversations and their understanding of how trust, culture, time, and training affect quality. Including sponsors will also help address concerns around participant information, format, and length. There was acknowledgement of the difference between NHS and industry with TransCelerate & ABPI suggested as potential sources of insight and representation from the pharmaceutical/industry sector
• it is important that the group considers accessibility of consent formats, and the importance of participants receiving information they can understand and keep. Long-standing concerns remain about participant information sheets being overly long and complex. Sponsors should be involved to help develop information that is clearer, more accessible, and includes summary versions. A physical record of consent was seen as important for some, as people may forget what they have agreed to
• while there was agreement that simplification can increase inclusion and accessibility, concerns were raised about the risk of reducing consent to a tick-box exercise. Member stated it was important that any simplified process maintains the core principles of genuinely informed consent. Training for research delivery staff was suggested to support them in delivering consent in a way that is both clear and reassuring to participants

The above feedback was shared and MK asked if any members had comments to add. A member highlighted more generally that 15 minutes to discuss the item in break out rooms did not feel like enough time, noting the lack of time for full discussions had been fed back previously. MK advised that the point could be discussed further in the later session on committee ways of working, acknowledging that the Committee not currently working effectively and noting the need to think about how it enables people to have the discussions needed to inform advice to the HRA.

KEs advised that the types of CTIMPs for which simplified consent would be applicable very specific and acknowledged a need to better express this. MK noted real examples would be much more helpful when thinking of the types of trials that this might include and suggested this be considered would be useful to aid understanding.

KEs thanked the Committee for their useful feedback and set out the next steps and timeline.

The next few weeks would be focussed on the criteria for the advisory group with a plan to go out to invite in the summer – noting it would be useful to come back to the Committee to discuss further as this work progresses.

BP advised that the legislation allowing for simplified consent would come into force in April 2026 at which point it will be possible for researchers to apply with simplified arrangements for consent, and for RECs to consider this. The aim of this work is to provide advice to researchers and RECs on what would be appropriate and that development of this advice would give confidence to take this forward. It was noted that doing this well might take more time. A member highlighted that if the advice was for use by RECs, it would be essential to involve the REC Chairs group in this work. BP reiterated the goal is for researchers to know what to do, REC to know how to assess, and for the public to be assured that they can trust simplified arrangements for consent that had been through this process.

Action – Information around invitation to advisory group for simplified arrangements for consent to come back to the Committee when available.

Action – KE to provide figures on the pilot work undertaken to be circulated to the Committee.

Item 3

Optional session – For information / advice: How we thank our REC and CAG members who leave us

Guest: Kirstie Shearman, HRA Member Engagement and Development Manager

KS sought Committee input on an appropriate thank you gift for departing REC and CAG members. Members provided the following feedback:

• recognition has been inconsistent and needs improvement
• personalised thank you letters seen as more meaningful than gifts
• importance of consistency and clarity across REC and CAG was stressed
• questions raised about what constitutes “leaving” (e.g., role changes)

Overall members agreed the gesture of recognition matters more than the specific item; future-proofing the approach is essential.

Item 4

Optional session – For information: HRA Strategy – Share pre-embargoed copy of the strategy before launch on 9 July.

BP shared a pre-embargoed copy of the HRA strategy. Although the sharing of the strategy was not a formal part of the business, it was noted as important to bring it back to the Committee given the role they had played in shaping it.

Members asked if they could give feedback on the strategy post-launch. It was confirmed that feedback would be welcomed to help inform implementation.

Members proposed having a mechanism to give feedback before the September Committee meeting. MK supported the idea and emphasised the importance of addressing “how” questions as the strategy shifts to the delivery phase.

Action – Members are welcome to provide feedback on the strategy to GC who will ensure that this is shared appropriately to inform the HRA’s work to implement this. Agenda item at September meeting to discuss HRA strategy and how it is implemented.

Item 5

For review and advice: Paper 2 - Community Committee: Future Ways of Working

MK introduced the session by referencing the paper circulated in advance to support thinking. As a relatively new member of the HRA and recently appointed Chair of the Committee, MK acknowledged this was a challenging time to begin, especially with the recent effectiveness survey.

After reflecting on previous meetings and concerns about the Committee’s current operation, MK emphasised the importance of making best use of members’ time. With the HRA’s new strategy in place, MK explained this is seen as a timely opportunity to reassess how the Community Committee works with the HRA Board to provide the most valuable advice and ensure the Committee is operating effectively.

MK reminded members that the Committee’s role is to provide strategic advice to the Board, with the core aim of strengthening the HRA’s ability to make research easier to do in ways people can trust. It was noted that all members bring different perspectives, and that this session aimed to begin exploring how to better support the strategy’s delivery through the Committee’s structure and processes.

MK commented that the session had been added to the agenda at the request of the Board. It was not expected to resolve all issues, but aimed to identify next steps. MK explained that the discussion would feed into a planned autumn meeting. Four questions were posed to Committee members:

1. What are the key issues affecting the Committee’s effectiveness?
2. Are there specific people the Committee would like to hear from?
3. What background or context would be helpful in advance of the autumn session?
4. What input or feedback should be considered when organising the future meeting?

MK encouraged members not to use this session to raise individual access requirements, noting she did want members to feel pressured to disclose and these would be picked up separately. It was noted that the Committee does not feel as though it is working well for many members, —and, if so, it is also not serving the HRA effectively. BP acknowledged MK’s framing and confirmed it reflected both what had been heard previously and what the Board had asked to be explored.

MK invited initial reflections on how the autumn session could be structured, what issues should be covered, and who the Committee would like to hear from.

A member highlighted the importance of early notice for the autumn session, including date, location, and format, in order to maximise attendance. MK confirmed that no logistics had yet been planned, pending this conversation, but recognised the importance of providing a date for the session as soon as available. Another member asked whether hybrid access would be available.

BP discussed the relationship between RECs across the UK. It was noted that the Committee provides a valuable opportunity to strengthen connections with other nations. A member in attendance who was also a member of a Scottish REC provided insight into some of the operational challenges they faced in their role. Meetings are held online and documentation is available digitally, which improves accessibility. However, meetings typically last three and a half hours without a break, resulting in a significant mental load. Additionally, the number of sub-committees contributes to an intense workload. Many members wish to contribute but also work full-time, which makes full engagement difficult. There appears to be an expectation that full-time workers comment on every study, raising the question of whether this is also the case for English RECs.

There was a suggestion that it would be beneficial for the upcoming autumn meeting to be held in a hybrid, citing accessibility. MK commented on the practical issues with hybrid meetings, observing that they tend to favour one group, either in-person or remote participants, while the other group often feels excluded or ends up communicating only amongst themselves. While acknowledging the accessibility benefits raised, MK suggested that careful thought was needed to determine whether hybrid meetings support the kind of conversations the Committee needs to have. A member reiterated that their preference for hybrid meetings was influenced by personal accessibility considerations, including sensory sensitivities and limited social energy. They noted these factors contribute to their view that hybrid options may provide a more inclusive environment.

A member observed that the Committee should seek clarity on what matters most to the communities it represents. The member reflected on the earlier item on simplified consent, suggesting that had prior engagement occurred, in the form of earlier discussions with RECs for examples, the discussion might have been more focused. A proposal was made to use the future session to collectively identify priority issues.

MK added that more thought is needed on how the Committee intersects with other groups, such as the REC Chairs or other advisory bodies, and when they may be better placed to advise the Board on certain topics.

A member raised a point about making better use of the existing skills within the Committee, both from individuals and from community-specific expertise (e.g. REC, CAG, public contributors). They suggested that, for example, the recent audit questionnaire process might have benefited from better allocation of roles based on existing skills.

Some members expressed a desire for clearer communication from the Board about its expectations for the Committee. The lack of face-to-face interaction and an explicit brief from the Board were seen as contributing factors to the disconnect. Members recommended inviting a senior Board member to participate in the autumn session, as MK was still a relatively new member of the Board. MK acknowledged the point but highlighted that she and BP are senior members of the Board. Members pointed out that, while this was the case BP had been closely involved with the Committee and part of the group since its inception.

Other members raised a concern about the lack of joined-up communication between the Committee and other groups that its members sit on. A member cited the strategy project group as an example, two Committee members were involved, yet there was no mechanism for feedback or updates to the broader Committee. It was suggested that all future meetings should include a standing agenda item to enable feedback and discussion from members involved in other groups. This would help members better understand developments across the organisation and allow them to support one another more effectively. MK agreed, linking this to the forthcoming advisory group for the work around simplified arrangements for consent and noted the importance of developing a consistent way to keep members informed.

BP explained that the HRA has a staff Community Group that includes oversight of Community Committee discussions and aims to support joined up thinking across different areas (Approvals, Communications, CAG, Public Involvement, etc.). BP also noted a member comment that there is a risk of always discussing new issues without completing the loop on earlier ones. BP agreed this ties in with a general sense that discussions feel fragmented, and efforts to join the dots have not yet been fully successful.

MK summarised that the Committee would value hearing directly from senior Board members, (particularly the Chief Executive or the Chair), to clarify the Committee’s role in relation to the new strategy.

Members asked whether an external facilitator would be brought in for the autumn session and emphasised that given the presence of powerful emotions and deeper structural issues, an external facilitator—someone neutral and without committee history—would be of great value. MK agreed this was strong framing and agreed to discuss and consider this further with BP.

A member raised that, as the only CAG representative on the Committee, she often feels disconnected. She asked whether minutes from these meetings are shared with CAG and questioned how communication can be improved. BP responded that the HRA is working to improve consistent communication across its community-facing work, and that multiple staff observers attend from across teams to help with alignment.

A member asked generally whether use of the Zoom chat function was appropriate. MK confirmed it was allowed but that it was personally difficult to monitor chat while also chairing the discussion. The need to look at how meetings are run to ensure inclusivity was reinforced.

MK summarised that several themes had emerged:

• the need to hear directly from the HRA Board about expectations for the Committee
• the importance of early planning and communication about the autumn session, including format
• a request for an external facilitator to support deeper conversations
• a proposal for clearer feedback loops between Committee members and the other groups they serve on
• a broader understanding of the organisational landscape the Committee fits within (e.g. the Community Group and other advisory forums)
• the value of identifying when the Committee is not the right group to advise, and how to direct issues more efficiently
• a strong interest in understanding whether hybrid or in-person formats are most inclusive and effective
• better understanding the priorities for the different communities that are represented on the Committee

BP confirmed and reiterated the importance of hearing from the Board and understanding Committee priorities.

MK suggested that the chosen facilitator could advise on meeting format (hybrid vs in-person) in a neutral way, as opposed to a decision based on preference that might not best serve the discussion. It was noted that planning will begin shortly, and suggested dates will be circulated as soon as possible.

Action – HRA staff to take forward plans for a meeting in the autumn, informed by this discussion.

Item 6

AOB including any reflections on the effectiveness of this meeting.

None

MK thanked everyone for joining and contributing to the meeting.

Next meeting: 08 September 2025, 10:00 am to 13:00 pm (Zoom).