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Minutes from our Ethics Review Advisory Group will be published on this page.

Our next meeting will take place on Friday October 15 2021 11-12:45pm.

Minutes for Ethics Advisory Group, 21 May 2021

This meeting was held between 2pm and 3.45pm via Zoom on 21 May 2021.

Advisory Group members

Name Organisation Attending/apologies
Professor Andrew George Non-Executive Director (HRA) In attendance
Dr Nicole Mather Non-Executive Director (HRA) In attendance
Dr Janet Messer Director of Approvals Service (HRA) In attendance
Juliet Tizzard Director of Policy and Partnerships (HRA) In attendance
Carys Thomas Head of Policy (R&D Division, Health and Social Care) (Welsh Government) In attendance
Dr Nicola Williams Director of Support and Delivery (Health and Care Research Wales) In attendance
Dr Janice Bailie Assistant Director, Health and Social Care R&D) (NI) In attendance
Gordon Watt Senior Research Policy Manager (Chief Scientist Office Scotland) In attendance
Dr Bryan Deane New Medicines and Data Policy Advisor (ABPI) In attendance
Chris Cannaby Senior Clinical Operations Manager (MSD UK) In attendance
Dr Rasha Al-Lamee Clinical Academic Interventional Cardiology Consultant (Imperial College Healthcare NHS Trust) In attendance
Professor Nalin Thakkar Vice President (University of Manchester) In attendance
Dr Mark Sheehan Oxford Biomedical Research Centre Ethics Fellow (Ethox Institute, University of Oxford) In attendance
Helen Lewis-White Research Operations Manager (North Bristol NHS Trust) In attendance
Dr Susan Kohlhaas Director of Research (Alzheimer's Research UK) In attendance
Tom Smith Public Involvement Network member (HRA) In attendance
Lynn Laidlaw Public Involvement Network member (HRA) In attendance
Marie Bardsley Research Ethics Committee member (HRA) In attendance
Sue Harrison Research Ethics Committee member (HRA) In attendance
Oliver Matias Research Ethics Committee member (HRA) In attendance
Joanne Doleman Research Ethics Committee member (HRA) In attendance
Dan Mace Research Ethics Committee member (HRA) In attendance
Professor Jo Rycroft Malone Programme Director, Health Services and Delivery Research Programme (NIHR Apologies
Professor Mary Dixon-Woods Director (THIS Institute, University of Cambridge) Apologies
Linda Cartwright Research Ethics Committee member (HRA) Apologies

HRA observers

Name Role/job title Attending/apologies
Dr Naho Yamazaki Head of Policy and Engagement In attendance
Will Griffiths-Stent Engagement Manager In attendance
Kirsty Edwards Policy Manager In attendance
Charlotte Allen Quality and Performance Manager In attendance
Alison Barbuti Communications Manager Apologies
Clive Collett Ethics Policy Manager In attendance
Martin Body Programme Manager In attendance

Item 1 - Welcome, introduction to the Group, and importance of ethics

The Chair, Andrew George (AG), welcomed everyone to the Group. He explained how he saw the importance of getting the process right, both as a researcher, a previous member of a REC and a research participant. AG outlined this opportunity to make a big step change in how we consider ethics in research. While there are many opportunities to make incremental changes, it would be disappointing if we did not have a major impact improving research ethics review, with benefit for participants, researchers and members of committee

Item 2 - Advisory Group member introductions

Members introduced themselves and shared their current role, experience and interest in research ethics and governance.

Item 3 - Overview of the Ethics Review Programme, activities and findings to date, and where we are now

Related Paper: ERAG 210521 (1)

A background slide deck was presented outlining the Ethics Review Programme. This covered the how Research Ethics Committees work and who makes up their membership, an overview of the fast-track ethics review pilot, and a summary of feedback from workshops held earlier in the year. This programme overview also outlined the programme roadmap, as well as HRA staff working across the different work packages, detailed in the table below.

Work package Aim Project Lead
Method of Review Proportionate review tracks for different types of research, including fast-track, light-touch review and self-assessment where appropriate. Encouraging researchers to think about ethical issues early on Kirsty Edwards
Information and Consent Significantly improved information for participants and a consistent and proportionate approach to review by RECs Leni Sivey
Streamlining Documentation Clarify questions for applicants regarding ethics review and ensure REC members get only the information they need for REC review Clive Collett
Decision Making and Committee Culture Collaborate with REC members to address issues around inconsistency, learning from the fast-track REC and consider how share good practice across the service Maria Brezitski
Committee Format and Membership A committee format which takes advantage of virtual working, but retains community within and between RECs. Supported through learning and development Jonathan Fennelly-Barnwell
Communications and Engagement (cross cutting) Engaging, interactive communications and engagement activity, supporting each work package to achieve strong engagement and involvement with their respective audiences Ali Barbuti

Will Griffiths-Stent

Item 4 - Breakout discussion

Group members were sent into three breakout groups. Each group worked through three discussion questions:

  • What is most important to you about this programme?
  • What do you think are some of the challenges with these work areas?
  • How should we engage stakeholders about this work?

A full summary of feedback from this discussion is found under Item 6.

Item 5 - Break

Item 6 - Summaries of breakout discussions

What is most important to you about this programme?

  • Streamlining the process: a consistent theme from each discussion was the need for streamlining to make the approvals process simpler, clearer and more efficient. Within this, reducing duplication, clear scope of activity and roles, simplifying documentation - particularly for patients - and ensuring use of lay language were some of the key areas highlighted for improvement.
  • Standardisation and consistency: importance of the need to ensure consistency between RECs, but also a recognition of what can realistically be standardised (operational processes and decision outcomes are already consistent for example).
  • Meaningful patient involvement: patient involvement and engagement was another consistent theme. Researchers and applications that undertake meaningful patient involvement, and can provide clear assurances of this, benefits numerous ethical and practical aspects of the research, including further streamlining the process.
  • Recognise and continue with what is being done well: this programme will introduce changes, but we also need make sure we keep what is working well.
  • Increasing communication: whether to spread the word of RECs to encourage more recruitment, to increase the ways RECs and applicants can speak around REC meetings, or to bring a wider range of organisations and patients into discussions

What do you think are some of the challenges with these work areas?

  • Getting the right balance between streamlining and maintaining quality: need to maintain the high quality and rigor of ethics review, whilst introducing measures to streamline and speed the process. Any changes that are introduced should enable and not negatively impact on REC’s ability to give independent ethical opinion.
  • Activity in the context of a wider system: other issues can dominate compared to ethical issues, so we need to be conscious of the wider system and how we mitigate external issues that may impact on our activity.
  • Implementation of changes: the need for change is often vocalised, however it can be difficult to actually get people to move away from what they are familiar with.
  • Programme complexity and crossover: need for strong communication to prevent duplication and ensure cohesion and consistency across different internal working groups. Also essential to ensure that key stakeholders, including RECs, understand the parameters of what we are trying to achieve.

How should we engage with stakeholders about this work?

  • For patients, as the end users, we need to offer reassurance that our quality and focus on ethics is being maintained. We also need to engage about the balance between protection and autonomy. We also need to ensure that patient and public are represented in the various work packages running as part of the programme.
  • For applicants, we need to regular engage them throughout the programme, to show the strength and benefit of the process, and to celebrate success.
  • For sponsors, we need to bring them along to show the important balance between speed and consistency, as well as how the changes this programme will implement with strengthen the UK as a great place for research.

Item 7 - Review and sign-off

Group members approved the Advisory Group Terms of Reference, Paper: ERAG 210521(2). HRA staff described the webpage being established for the group on the HRA website, which will include information about the programme, the work of the Advisory Group and a short profile of each member.

Action: Each Group member to send basic information (name, role, experience), along with a photograph to HRA.

Item 8 - Close, next steps and confirmation of next meeting date

AG summarised the discussion, highlighting the energy and quality of initial discussions that had taken place, and thanking group members for their contributions.

Action: HRA to send slides from the meeting to Group members, as well as minutes from the last meeting and a calendar invite and Zoom details for the next meeting.

Date of next meeting: Friday 18 June 2-3.45pm.

Minutes for Ethics Advisory Group, 18 June 2021

This meeting was held between 2pm and 3.45pm via Zoom on 18 June 2021.

Advisory Group members

Name Organisation Attending/apologies
Andrew George Chair In attendance
Bryan Deane ABPI In attendance
Carys Thomas Welsh Government In attendance
Dan Mace Research Ethics Committee In attendance
Fiona Watt Chief Scientist Office Scotland In attendance
Janet Messer HRA In attendance
Janice Bailie HSCNI In attendance
Joanne Doleman Research Ethics Committee In attendance
Juliet Tizzard HRA In attendance
Lynn Laidlaw Public Involvement Network In attendance
Marie Bardsley Research Ethics Committee In attendance
Mark Sheehan Ethox Institute, University of Oxford In attendance
Mary Dixon-Woods THIS Institute, University of Cambridge In attendance
Nalin Thakkar University of Manchester In attendance
Nicola Williams Health and Care Research Wales In attendance
Nicole Mather HRA In attendance
Rasha Al-Lamee Imperial College Healthcare NHS Trust In attendance
Sue Harrison HRA In attendance
Susan Kohlhaas Alzheimer's Research UK In attendance
Chris Cannaby MSD UK Apologies
Helen Lewis-White North Bristol NHS Trust Apologies
Jo Rycroft Malone NIHR Apologies
Linda Cartwright Research Ethics Committee Apologies
Oliver Matias Research Ethics Committee Apologies
Tom Smith Public Involvement Network Apologies

HRA Observers

Name Role/Job title Attending/apologies
Naho Yamazaki Head of Policy and Engagement In attendance
Will Griffiths-Stent Engagement Manager In attendance
Kirsty Edwards Policy Manager In attendance
Charlotte Allen Quality and Performance Manager In attendance
David Nguyo Programme Manager In attendance
Clive Collett Ethics Policy Manager In attendance
Leni Sivey Public Involvement Manager In attendance

Item 1 - Welcome and apologies

The Chair, Andrew George (AG), welcomed everyone to the Group, shared apologies of those unable to attend, and outlined basic housekeeping for the meeting.

Item 2 - Review of minutes and actions

AG ran through a list of outstanding actions. Will Griffiths-Stent (WGS), Engagement Manager, provided an update and detail against each of these. These were then updated by WGS on the Hub Action Log.

Item 3 - Programme update

Related Paper: ERAG 180621 (1)

Juliet Tizzard (JT) presented slides that outlined relevant updates on the Ethics Review Programme since the last meeting. A key discussion item was the public name of the programme ‘Think Ethics’ and the proposed strapline, ‘Creating a culture of ethical health and social care research with patients at the heart’. Comments from the group were largely positive, though some touched on the wording, including how best to include the word ‘culture’, as well as comments around capturing both current and future patients.

Item 4 - Workstream update

Method of Review – Workstream overview and group discussion

Kirsty Edwards (KE) presented a brief slide deck on the proposed activity for this workstream. The Group was asked for comments on the workstream ambition, its detailed impact and outcomes, and if this description captured the change we wanted to deliver appropriately.

Themes and discussion from the Group in relation to this update covered:

  • Clear project structure: need for a clear timeline and milestones for project activity, and for further clarity of the rationale, proposed scale, and the desired outcomes for the process outlined in the update
  • Recognition of difference between public and patient opinion: and the importance of this in any engagement activity done by the workstream
  • Reducing REC member workload: the importance and potential benefits this project in reducing the burden on REC members, as well as applicants
  • Cross-sector engagement: early in the project, particularly with sponsors because of their experience of the process as a whole

Decision-making and culture – Workstream overview and group discussion

KE and Maria Brezitski (MB) jointly presented a second brief slide deck on the proposed activity for this workstream. KE stated a key feature of this workstream was how we carry good practice across RECs, and what elements we want to encourage within REC culture (empathy, leadership, for example). MB added that consistency in how decisions are made, without constraining how REC members make decisions, is the overarching theme of this workstream. MB stated there would also be a need for a framework to make decision-making standardised to some degree.

Themes and comments from the group around this workstream included:

  • Appropriate and inappropriate consistency: there is a need to distinguish between what is inappropriate inconsistency from appropriate inconsistency
  • Acknowledging differences in REC opinion: like the previous workstream, recognition of the difference in opinion within RECs between members with and without lived experience of conditions that research may be addressing, and the need for proper contextualisation of that when making decisions
  • Consistency: need to focus on consistency in requests for further information
  • Transparency of opinion: with regards to culture, specific comments were raised around the importance transparency and openness with RECs, as a means of creating a positive and progressive culture within the REC and between RECs

Item 5 - Break

Item 6 - Scoping public dialogue – activity overview and group discussion

Naho Yamazaki (NY) presented a brief slide deck on potential public dialogue activity, which provided an overview of possible topics for this activity to look at. Suggested topic areas included:

  • Focus of ethics review – protecting participants vs enabling informed choice
  • Nature of ethics review – what needs to be reviewed
  • Co-designing research – how important is this for patients and the public

Comments from the group included:

  • Existing research: before beginning the exercise, there is a need to review existing literature and research around these areas, so we ensure the final version of the dialogue that is taken forward is of premium value to the programme and addresses gaps in existing knowledge
  • Ensuring breadth of responses: ensuring patients as well as wider public could respond, and ensuring the dialogue helps inform as its asks, so it is able to generate informed opinion. A further emphasis was placed taking the work to people we want to engage with, rather than asking those people to come to us
  • Interest in an emphasis on format: and potential design principles for engaging online, as more research moves in that direction, and the benefits of this form of research and engagement in increasing inclusion, accessibility and diversity of opinion and experience

Item 7 - Valuing our Volunteers – survey review and group discussion

Related Paper: ERAG 180621 (2)

JT presented slides with the questions and results from the recent survey of HRA volunteers, including Research Ethics Committee members. The findings show a strong sense of satisfaction and pride amongst REC members. However, the heavy workload is a theme throughout. The survey also showed that amongst REC members there is a higher proportion of women and people over 55 than in the general population. Finally, there is a strong sense of community within individual committees, but less sense of community across the committees.

Item 8 - Any other business / Items for next meeting

No other business covered or raised by Group Members. JT stated that presentations and discussion on the remaining workstream areas would take place at the next meeting.

Item 9 - Meeting close

AG thank members for their contributions and discussion. The HRA would follow-up from the meeting various documents, including minutes, slides, and a calendar invite and Zoom details for the next meeting. WGS would also begin sending invites for subsequent meetings, so they are in people’s calendars earlier.

Date of next meeting: Thursday 5th August 10-11:45am

Minutes for Ethics Advisory Group, 5 August 2021

This meeting was held between 10am and 11.45am via Zoom on 5 August 2021.

Advisory Group members

Name Organisation Attending/apologies
Andrew George Chair In attendance
Carys Thomas Welsh Government In attendance
Chris Cannaby MSD UK In attendance
Dan Mace Research Ethics Committee In attendance
Fiona Watt Chief Scientist Office Scotland In attendance
Helen Lewis-White North Bristol NHS Trust In attendance
Joanne Doleman Research Ethics Committee In attendance
Jo Rycroft Malone NIHR In attendance
Juliet Tizzard HRA In attendance
Linda Cartwright Research Ethics Committee In attendance
Lynn Laidlaw Public Involvement Network In attendance
Marie Bardsley Research Ethics Committee In attendance
Mark Sheehan Ethox Institute, University of Oxford In attendance
Mary Dixon-Woods THIS Institute, University of Cambridge In attendance
Nicola Williams Health and Care Research Wales In attendance
Oliver Matias Research Ethics Committee In attendance
Susan Kohlhaas Alzheimer's Research UK In attendance
Tom Smith Public Involvement Network In attendance
Bryan Deane ABPI Apologies
Fiona Watt Chief Scientist Office Scotland Apologies
Janice Bailie HSCNI Apologies
Mary Dixon-Woods THIS Institute, University of Cambridge Apologies
Nalin Thakkar University of Manchester Apologies
Nicole Mather HRA Apologies
Rasha Al-Lamee Imperial College Healthcare NHS Trust Apologies
Sue Harrison HRA Apologies

HRA Observers

Name Role/Job title Attending/apologies
Ali Barbuti Communications Manager In attendance
Charlotte Allen Quality and Performance Manager In attendance
Clive Collett Ethics Policy Manager In attendance
David Nguyo Programme Manager In attendance
Leni Sivey Public Involvement Manager In attendance
Maria Brezitski Policy Manager In attendance
Naho Yamazaki Head of Policy and Engagement In attendance
Nicola Gilzeane Engagement Manager In attendance
Will Griffiths-Stent Engagement Manager In attendance

Item 1 - Welcome and apologies

The Chair, Andrew George (AG), welcomed everyone to the Group. AG updated the Group on HRA staff changes to the group, with Nicola Gilzeane and Jonathan Fennelly-Barnwell now members, representing HRA Engagement and Approvals respectively. The Chair then shared apologies of those unable to attend, and outlined basic housekeeping for the meeting.

Item 2 - Review of minutes and actions

Will Griffiths-Stent (WGS), Engagement Manager, provided an update on outstanding actions from the last group meeting. These were then updated by WGS on the Hub Action Log.

Item 3 - Programme update

Juliet Tizzard (JT) presented slides that outlined relevant updates on the Ethics Review Programme since the last meeting. These included the creation of the Think Ethics webpage and HRA intranet page, and further development on the programme’s refreshed comms and engagement strategy. JT also updated on each of the projects within the Think Ethics programme:

  • Method of review project: the project scope has been established and project plan drawn up. Meetings have been held with subject matter experts and the first project group meeting will be held in September. Maria Brezitski (MB) has taken over the project to cover maternity leave.
  • Information and consent project: presenting at today’s meeting (see item 4.1)
  • Streamlining documentation project: presenting at today’s meeting (see item 4.2)
  • Decision making and committee culture project: the first project group meeting has been held and subject matter experts are currently identifying gaps in learning. The findings will be discussed at the September project group meeting.
  • Committee format and membership project: transferred out of this programme for implementation by the Approvals Directorate

Item 4 - Workstream update

Information and Consent – Workstream overview and group discussion

Leni Sivey (LS) presented a brief slide deck on the proposed activity for this workstream. The Group was asked for comments on the workstream scope, proposed outputs, and level of ambition for change in this area.

Themes and discussion from the Group in relation to this update covered:

  • Templates versus guidance: difference in opinion as to whether a more structured template or looser guidance is the best way forward regarding completion of Patient Information Sheets (PIS). Guidance potentially allows for more flexibility in the information provided.
  • Concise patient information: length and complexity of PIS is a key issue. Group discussion covered that many PISs are too difficult to be used effectively, both in terms of complexity and in length, and therefore do not ultimately lead to ‘informed’ consent. PIS are often treated as legal contracts or a set of clauses, rather than serviceable information for patients and people
  • Variation in types of PIS: discussion included options of splitting out different types of studies with different PIS, and exploring the issues that global companies have, namely developing participant information at a global level and submitting applications to different systems in each country. How can this work help these global companies overcome this issue, in a way that does not create too much variation?
  • Delivering information: examples were raised on alternative ways that patient information can be delivered. Examples of video and written information combined for complex studies.

Streamlining REC Documentation – Workstream overview and group discussion

Clive Collett (CC) presented a slide deck on proposed activity for this workstream. The Group was again asked for comments on the workstream scope, proposed outputs, and level of ambition for change in this area. Specifically, the group was asked about the usefulness of question A6-2, which asks applicants: ‘Please summarise the main ethical, legal, or management issues arising from your study and say how you have addressed them.’ This question has recently been withdrawn from the IRAS question as part of work to harmonise with European requirements, but the group was asked about how, where and if this should be reinstated now that we are redeveloping questions for the UK.

Themes and comments from the group included:

  • Sponsor perspective: representatives from sponsors raised that A6-2 is very useful and encourages applicants to think about the ethics. However, a form of steer or guidance would be valuable to support applicants and researchers in completing this appropriately. The SBAR framework, used by the NHS elsewhere, is a suitable, related guidance framework that could be adopted in some form.
  • Filtering of documentation: discussions included options for filtering documentation by the HRA for RECs, as lots of information applicants provide may not be relevant to REC members and the decisions they are responsible for. It was further raised that REC members feel obligated to read these additional materials, but may struggle to do so either because of time or technical language.
  • Single or multiple questions around ethics: a closing discussion was had around whether ethical questions could be weaved throughout the IRAS form, rather than a single open question. This may encourage consistent thinking throughout about the ethical implications.

Item 5 - Break

Item 6 - Public contributor update

Tom Smith (TS) and Lynn Laidlaw (LL), as public contributors, raised points in this open section. In this update, TS and LL raised the wider need to go back to patients and the public that were involved in research. This gives contributors an opportunity to continue to engage in the research, and to feedback on how they thought and felt their contributions were used and valued.

Item 7 - Programme narrative and roadmap – overview and discussion

JT presented and summarised the written programme narrative, recently seen by the HRA Board. This narrative summarises the need and purpose of the programme, its objectives, and progress to date. The group were asked for comments of tone, content, length, and ambitiousness of the narrative, as well as how this could be taken forward and communicated externally. They were also asked about the usefulness of the roadmap, and its level of detail.

  • Summary of roadmap: it was agreed that a summary of the roadmap would beneficial
  • Sharing the narrative and roadmap externally: in terms of sharing the information in the narrative externally, the group raised the importance of using visual and audio, such as illustrations, videos, and audio, alongside more typical written webpages and blogs, to enhance the narrative.

Item 8 - Any other business / Items for next meeting

No other business covered or raised by Group Members.

Item 9 - Meeting close

AG thanked members for their contributions and discussion. The HRA will follow-up from the meeting with various documents, including minutes, slides, and a calendar invite and Zoom details for the next meeting. WGS would also begin sending invites for subsequent meetings, so they are in people’s calendars earlier. Meetings will take place on six-weekly basis moving forward.

Date of next meeting: Friday October 15 2021 11-12:45pm
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