Ethics Review Advisory Group - Minutes

Minutes for Ethics Advisory Group, 21 May 2021

This meeting was held via Zoom on 21 May 2021.

Advisory Group members

HRA observers

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.

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 to 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

HRA Observers

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

HRA Observers

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

Minutes for Ethics Advisory Group, 15 October 2021

This meeting was held between 11am and 1pm via Zoom on 15 October 2021.

Advisory Group members

Item 1 - Welcome and apologies

The Chair, Andrew George (AG), welcomed everyone to the Group. AG updated the Group on changes to membership. Alex Newberry has joined, replacing Carys Thomas representing Welsh Government. Andrew Toft is replacing Gordon Watt from Chief Scientist Office Scottish Government. Jennifer Harris is replacing Bryan Deane from ABPI. AG then shared apologies of those unable to attend and outlined basic housekeeping for the meeting.

Item 2 - Review of minutes and actions

AG reviewed the minutes from the previous meeting, all agreed these were a true reflection. There were no outstanding actions from the previous meeting.

Item 3 - Programme update

Juliet Tizzard (JT) gave an update on the Ethics Review Programme since the last Advisory Group meeting. JT presented the Programme Plan, a grid giving an overview of the programme outlining for each workstream in the programme, what work has been completed and what is due to be completed when. JT asked the Group if they found this a helpful tool to keep them updated. The Group felt that seeing the Programme Plan at each meeting would be a useful way to track progress and more detail can be requested when needed.

Ali Barbuti (AB) updated the Group on the public launch of the programme. AB explained that launch had been well received and presented reactions from across the research landscape. AB thanked members of the Group for their contributions to the launch by providing quotes and blogs and informed them that more of their quotes will be used as we continue to update the community about the work in the ethics review programme (known publicly as Think Ethics).

Item 4 - Streamlining Documentation- what do we need to conduct an ethics review?

Clive Collett (CC) spoke to the Group about the large amount of information members of a Research Ethics Committee (REC) must read as part of ethical review. Currently, REC members review a large number of answers to questions submitted to them as part of the IRAS application along with many associated study documents. Not all of these questions and documents directly support ethics review. In addition, they add to the burden of reviewing applications, unnecessarily prolong meeting time, and broaden the potential for inconsistency.

CC explained that as part of the Streamlining Documentation workstream it is important to define which documents are required by the REC to allow them to undertake an ethical review. This will help to highlight any documents that are not required, or that can be checked elsewhere in the system- reducing the volume of information/documentation REC members need to read.

Interactive session

The Group were split into two virtual breakout groups, one for REC members and the other non-REC members. In each group members were asked to review and discuss the list of documents currently received by REC members and decide whether each document-

• needs to be reviewed by the REC to be able to conduct an ethics review,
• is not required for review by the REC directly, providing assurance is given to the REC that the check has been done elsewhere or,
• is not needed by the REC at all

IRAS application form – both groups decided that the IRAS form is required but that it could be improved to be more efficient and lead to less accompanying documents being required.

Initial assessment – REC members differed on whether they use this routinely or not but decided to keep it as part of the document set. The non-REC members were undecided, it was queried whether this document should go to the REC if the initial assessment highlights no issues. Some did feel even if no issues are found it is useful to allow the REC to be reassured that other things have been checked elsewhere and it helps steer RECs away from looking into non-ethical considerations.

Cover letter - the REC members decided this was not required. They felt it could be useful for HRA staff but felt they do not need to see it. The non-REC group had a similar discussion, highlighting that this letter can help to fill in gaps in the IRAS form but that it is better for HRA staff to triage this.

Protocol – the non-REC group agreed that the protocol is required to complete a REC review. In the REC group there was a split in opinion. Some members felt strongly that the protocol provides necessary detail that allows queries to be answered. Others felt the protocol is not required and commented that it contains too much irrelevant information and can lead REC members to look at issues they do not need to. The REC members agreed that there were some studies where the protocol is needed and others where it is not. Both groups remarked that much of the information in the protocol is also in the IRAS form and felt there was an opportunity to improve the protocol related questions in IRAS.

CVs – the non-REC members felt the RECs should receive assurance that the CVs have been reviewed elsewhere. The REC members agreed for the summary CV of a Chief Investigator but were undecided about student and supervisor CVs with some feeling that for student studies it would be important for the REC to see the supervisor CV.

Advertisements – the REC members felt assurance that these have been checked by R&D departments would be sufficient as there are guidelines and templates for these materials. The non-REC group decided that the REC should review these, to check consistency of how a study is discussed across patient-facing documents.

Letters of invitation – both groups felt these were required for REC review.

Participant information sheet – both groups agree these are needed, the REC members highlighted that they do not necessarily need to see all versions.

Validated questionnaires – all REC members agreed they do not need to see these.

Non validated questionnaires – REC members agreed that they could receive assurance that these have been checked elsewhere.

Interview schedule – REC members agreed these could also be checked by others.

Neither group was able to review the full list of documents in the time allocated due to the amount of discussion generated around some of the documents.

Item 5 - Break

Item 6 - Group discussion

The Group came back together and discussed the exercise. It was noted that if in future we decide that some information should be reviewed by others (and the REC given assurance that it had been reviewed), this could impact on workload elsewhere in the system, for example HRA staff. The REC members in the Group felt that if they were to no longer see all documents they would like to be able to escalate concerns to HRA staff if it is not possible to reconcile a query with the information they have. A general discussion was had about being clear who is responsible for what; it was remarked by a REC member that they can feel responsible for everything and that by giving their ethical opinion they are saying everything is ok with the study. This can lead to double checking things that are not part of ethical review. A non-REC member added that because the REC receives all of these documents, do they consequently assume responsibility for checking everything – even when it is outside of their remit. The suggestion was given that by removing unnecessary documents we then remove the possibility of REC members assuming responsibility/feeling responsible for things outside of the remit of a research ethics committee.

Item 7 - Any other business

AG and JT asked the Group how they feel the meetings are working and if they have any suggestions to improve them. Members of the Group would like to be updated when opinions are being gathered more widely as the programme moves forward and a summary of what those opinions are. The Group would also like to be reminded what the different workstreams are looking at now they are progressing and how they can get involved, beyond meetings, if they wish to. It would also be helpful to have a list of who from the Group is engaged in which workstream.

Item 8 - Meeting close

AG thanked members for their contributions and discussion.

Date of next meeting: Friday 12 November 2021, 11am-1pm

Minutes for Ethics Advisory Group, 12 November 2021

This meeting was held between 11am and 1pm via Zoom on 12 November 2021.

Advisory Group members

HRA observers

1. Welcome and apologies

The Chair, Andrew George (AG), welcomed everyone to the Group. AG shared apologies of those unable to attend and outlined basic housekeeping for the meeting. AG let the Group know that there will be a Group discussion held later in the meeting that will be recorded to allow full notes to be taken. The recording will be deleted once notes have been made, there were no objections to a recording being made.

2. Review of minutes and actions

AG reviewed the minutes from the previous meeting, all agreed these were a true reflection. There were no outstanding actions from the previous meeting.

3. Programme update

Juliet Tizzard (JT) gave an update on the Ethics Review Programme since the last Advisory Group. JT explained how the programme has progressed since the last meeting informing the Group that a provider has been selected to support the collection of public opinions on research ethics review through the public dialogue project. JT informed the Group that presentations and updates on the programme have been delivered at Research Ethics Committee (REC) Chair’s meetings and member training sessions throughout October and November.

Clive Collett gave a recap on the Streamlining Documentation project reminding the Group that the aim of the project is to improve REC-specific IRAS questions in order to better support REC review and to reduce the volume of information going to REC members to allow them to focus their time most effectively. The current focus of the project is understanding which documents are needed to undertake ethics review and gathering REC member views on this. CC discussed with the Group how best to gather these views.

Maria Brezitski gave a recap on the Method of Review project reminding the Group that the aim of the project is to explore the possibility of redesigning proportionate review, introducing self-assessment, widening the remit of the fast track and providing pre-application support for researchers. The current focus of the project is to analyse the background research that has been collated and then develop options for service improvement. MB explained that the findings of this analysis will be presented at the December Advisory Group meeting to seek the Groups feedback.

4. Information and consent: what is the evidence telling us

Leni Sivey gave a recap on the Information and Consent project reminding the Group that the project is looking to improve the quality of participant information and improve the consistency of how participant information is reviewed by ethics committees. The current focus of the project is gathering stakeholder attitudes and mapping priorities. The next step is to develop initial options for improvement.

LS presented the findings of background research that has been completed for the Information and Consent project. The research falls into five categories relating to participant information

• length,
• content,
• function,
• readability,
• format

LS asked that the Group give their opinions on what the evidence from this research tells us.

Length: Information sheets seem to be getting longer and the longer they are, the less likely a participant will read all of the information. If you ask people hypothetically if they would like more information, they tend to say yes. However, research shows that people do not actually use much information to help them decide whether to take part in a study and in some instances, they use no information at all. Research shows that a participant’s understanding of a study seems to be similar irrespective of length of the information sheet.

Points raised in discussion:

• ethically there should be enough information included in an information sheet to allow the reader to have all the information to make a decision about participating – even though it is ultimately their choice whether they choose to read it.
• information sheets for commercial studies are particularly long and that this is linked to some information being legally required.
• we need to be clear on what is legally required and to be aware that this may differ between countries and there may be times when things are not legally required in this country but are still being included in information sheets.

Content: Research shows that potential participants tend to focus on information that relates to what will happen to them during the study. Participants also tend to concentrate on things within the information sheet that build trust.

Points raised in the discussion:

• information sheets should outline a participant timeline clearly.
• there is growing thought clinically that tailoring information to each patient may be the most effective way to provide study information. With this approach, providing information on every aspect of a study is not necessarily effective as it is more important to understand what each patient needs to make a decision and give them that.
• however, if many variations of information and consent documentation are provided it may not be feasible for a REC to review all of these.
• information sheets can often come from a defensive standpoint by making sure people have all possible information in case something goes wrong. However, isn’t genuinely informed consent a better defence against legal issues?
• only those who understand what is involved in the research should take part.
• trust underpins the whole idea of informed consent. In practice it is the conversations with the doctors, nurses and research delivery staff that patients base the decision to participate on - it is this part of the process that builds trust. This might mean looking at consent as a process rather than a point in time, with ethics committees involved in reviewing the process rather than just the documentation. This is an area the project is looking at - to see if there is a way that we can get assurances in other ways about the information and consent process.

Function: There is a need to focus on how people use information sheets in practice. There is research that shows people use information sheets in quite different ways. Points from the discussion:

• motivation to take part in a study can differ greatly from person to person meaning so too would use of information sheets. Although all information is not used to make a decision about taking part in a study, the information may be revisited for reference at a later date.
• the participant has a choice to not read the information sheet, though participants will be asked to sign a form to say they have read it before they can take part. The system at present does not allow for people who actively do not want to read the information.
• one role of the information sheet is in protecting the researcher legally. It was suggested that where there is a legal requirement for certain information to be read this should be explicitly explained to participants. This will allow the participant to understand they are required to do so for the benefit of the study.
• if information sheets contain elements that are not being used by participants but are important to other people in the process, such as legal assurances for commercial studies, where should this information go? At present the information sheet seems to be about a conversation between sponsors, researchers and regulators rather than about research delivery staff and potential participants.

Readability and format: Participant information is often written using vocabulary and layouts which aren’t easy to understand. Factors that influence this are readability score, syllables per word and sentence length. Often discussions around readability tend to focus on the participant’s reading level, but there are many other reasons they are difficult to understand. Public Involvement in writing consent forms can make a big difference in the information that people retain. Points from the discussion:

• there is a need to understand when readability makes a document poor quality and when this is actually becomes an ethical issue. Often readability of information sheets is low and if this was always seen as an ethical issue it would take up a lot of committee time.
• there has been a lot of conversation over recent years about using different methods to communicate study information, such as videos, slideshows and interactive online tools rather than a paper document. The research seems to be mixed on the benefit of this on understanding, although different formats do tend to make a difference on people’s satisfaction with the process. This might be important for trust and building relationships through the information and consent processes.
• the difference between understanding and satisfaction is important to make if we need to ensure consent is actually informed.
• we need to be aware of health and digital literacy – people have different experiences and ability to understand/use different forms of information. We need to ensure how information is delivered is proportionate to who we are trying to reach.

5. Break

6. Group discussion

Throughout the discussion the Group raised the potential impact of information and consent on retention of participants in studies. It is assumed that the more engaged a participant is the more likely they are to fulfil their commitment to a study. A member of the Group noted that it is important to keep in mind that by producing information in one way you are only engaging one kind of participant. There are different ways of engaging different people- we need to improve diversity in research and so need to diversify how we engage people and give them choice of how they want to be informed.

One of the public contributors noted that they do not want to feel like a passive participant in the information and consent process. If there are instances when information is poor, as a participant is there a process to feed this back, is the HRA checking back with participants to ensure information and consent is ethical. During the discussion LS remarked that we should not only be looking at how researchers and the REC approach information and consent differently but how can participants approach this differently. For example, providing tools and guidance to assist members of the public going into a research situation giving them information on what they can expect and questions they may want to ask. These things do exist but are not currently imbedded in the regulatory process. A member of the Group also felt that ensuring participants understand what it means to take part in a study could positively impact study retention.

JT discussed with the Group the need to think about other areas in the system where we can influence good practice in the community- beyond just ethical review. One of the public contributors questioned who decides what is good patient information. Should it be the REC and researchers. When public contributors and those with lived experience have been involved in the design of information and consent how important is their opinion. The Group agreed this was an important point. JT discussed this point and the need to understand if RECs are reviewing how good the document is or is it about making sure the right people are involved in making sure they are right. We need to understand what RECs role is in this and it is equally important to understand what participants expect the RECs role to be.

7. Any other business

No other business was raised.

8. Meeting close

AG thanked members for their contributions and discussion.

Date of next meeting: Friday 17 December 2021, 11am-1pm

Minutes for Ethics Advisory Group, 17 December 2021

This meeting was held between 11am and 1pm via Zoom on 17 December 2021.

Advisory Group members

HRA staff

1. Welcome and apologies

The Chair, Andrew George (AG), welcomed everyone to the Group. AG shared apologies of those unable to attend and outlined basic housekeeping for the meeting. AG let the Group know that there will be a Group discussion held later in the meeting that will be recorded to allow full notes to be taken. The recording will be deleted once notes have been made, there were no objections to a recording being made. AG introduced Shaun Eglen (SE) to the Group, who has replaced David Nguyo (DN) as Programme Manager for the Ethics Review programme.

2. Review of minutes and actions

AG reviewed the minutes from the previous meeting, all agreed these were a true reflection. Linda Cartwright (LC) questioned why HRA staff are listed as ‘observers’ in these meetings when they contribute to the meetings. AG explained that this is to reflect that members of HRA staff are not part of the Advisory Group and if it was ever necessary to have a formal vote on a matter HRA staff would not be included. It was agreed to review this wording. There were no outstanding actions from the previous meeting.

3. Programme update

Juliet Tizzard (JT) gave an update on the Ethics Review Programme since the last meeting. JT spoke about a change of focus to the Streamlining Documentation project, which will shift focus from looking the at individual documents that are reviewed as part of ethics review to the frameworks and approaches surrounding the review of documentation. This project will also link to the Decision Making and Committee Culture project. JT informed the Group that Clive Collett (CC), the project lead, will provide an update on the project at the next meeting. JT informed the Group that engagement activities will be taking place in the new year for the Information and Consent and Method of Review projects. JT thanked members of the Group for the additional work they have been doing to support the projects in the Ethics Review programme.

Naho Yamazaki (NY) provided the Group with an update on the Public Dialogue. NY informed the Group that an Advisory Group has been established specifically to support the Public Dialogue. The Public Dialogue Advisory Group is Chaired by Lynn Laidlaw (LL) and its purpose is to help steer the project and develop materials for use in the workshops being facilitated by Hopkins Van Mil. NY explained that the Group have had a productive initial meeting to set the over-arching themes the workshops should cover. NY will continue to keep the Group updated on this work.

4. Method of Review: options for change

Maria Brezitski (MB) reminded the Group of the background of the Method of Review project by outlining the current methods of ethics review: full committee review, proportionate review and fast track review. MB went on to discuss the reasons that have prompted the HRA to explore areas for improvement-

Full Committee Review

• Not all studies have sufficient ethical risk to warrant this level of rigor
• Requires significant resource

Proportionate Review

• Places burden on REC members
• Same amount of information required in the application as full committee review
• Resolving issues can take up staff and REC member time

Fast Track Review

• Only 1 REC does this
• CTIMPS and Phase I are the only studies that can use this method

MB explained that options for change have been developed, to be tested with a wide range of stakeholders soon. Mark Sheehan (MS), who has been working on the project, presented the options for discussion.

Option 1: Approved Research Templates - a template to be used as a tool for researchers to check their study meets agreed and approved ethical standards.

Approved research templates could cover certain types of research and could deal with ethical issues in an agreed way and so provide the basis for expedited review. The Group discussed the pros and cons of this approach, including the possibility that people might change their research to fit the template if it was seen as a route to getting ethics approval more quickly. A member of the Group felt post-approval follow up would be important if this approach were adopted in future.

Option 2: Staff Review – a new role for expert staff in carrying out ethics review of studies with no material ethical issues.

Expert staff could carry out ethics review of studies which no material ethical issues, instead of Research Ethics Committee members. This could include studies which would fall under the Approved Research Templates in Option 1.

The Group discussed the pros and cons of this option, including the cost implications, needing a mechanism to escalate studies and whether this model would work UK wide as there are different staffing arrangements in place in different countries.

Option 3: Institutional Self-Assessment - HRA and Devolved Administrations could delegate ethics approval for certain types of study to institutions who satisfy a pre-specified set of standards.

This could include studies currently eligible for proportionate review and/or sub-studies within clearly defined research programmes. Audit processes could be put in place to check compliance.

The Group wondered whether institutions have the resources or research infrastructure in place to support this. The Group also discussed how this option would impact on trust in ethics review. It was felt that a level of independence would need to be maintained and an audit system would be required. There was concern this could lead institutions to avoid riskier studies to maintain their self-assessment status. Several Group members wondered whether this option would make the system recreate the gap between ethics and governance. However it was noted by some that this option could work well for certain studies, such as sub-studies.

Option 4: Researcher Self-Assessment - HRA and Devolved Administrations delegate approval for certain types of study to individual researchers who have pre-specified training and/or a particular level of experience in research ethics.

The Group questioned whether self-assessment could be used for certain areas of the application rather than all of it. It was noted that this would require a change on the IRAS application form. It was also suggested that self-assessment could be a way of improving the quality of applications that come to committees rather than obviating the need for REC review. Several members of the Group generally felt that with the implementation of rigorous processes, support and levels of auditability self-assessment could be a good option.

Option 5: Pre-Application Support - HRA and Devolved Administrations staff would have one-to-one or small group consultation with researchers who are developing their application.

The Group discussed the pros and cons of this option, including that it would help people think ethically earlier on, the need to avoid this option creating a situation where people are taught to ‘get through’ ethics and assessing whether the positive impact is worth the resource implications. It was suggested that more general pre-application support maybe be useful. This could be done through pre-recorded interviews/case studies and examples of best practice in different types of studies.

Option 6: Fast Track Service Revision - widen the eligibility criteria for fast-track ethics review beyond CTIMPs and Phase 1 studies

It was raised that we need to understand what the benefit is against the resource that is used.

Overall, the Advisory Group was content that the group of options should be taken to the next stage of engagement.

5. Information and consent: shaping up the options

Leni Sivey (LS) explained to the Group that they had compiled a long list of ideas for improving participant information and consent. These are grouped into 6 broad themes

• Collaboration
• Assurances
• Remit
• New requirements
• Accountability
• Templates and guidance

Group members were split into breakout rooms to discuss the advantages and disadvantages of each of the ideas within the 6 themes. Each Group member was then asked to indicate which ideas would be their top 3. The most popular ideas were:

Participant information design principles – as opposed to providing templates or stipulating topics to include. These would be mirrored in participant information review principles for REC.

A toolkit for people considering taking part in research – including what to expect from an information sheet, research participant rights, general research information and what questions it might be useful to ask research delivery staff

Minimum requirements for participant information readability, accessibility, content, length, and public involvement – defined and agreed in collaboration with other bodies with expertise in these areas

Applicants having to seek and report participant feedback on the suitability of the participant information – this will be done once the study has begun and would be incorporated into IRAS questions, standard conditions of REC opinion and annual progress report

Following the prioritisation task Group members were asked to feedback on whether they felt any options or considerations were missing. One REC member remarked that it is important to keep in mind the vast range of different types of research and that one size will not always fit all. It was also pointed out that information does different jobs for different people. Members of the Group discussed that there are tensions between the wants and needs of different perspectives and that we need to be upfront about these to do our best to ensure everyone gets what they need out of information and consent.

It was also remarked that being in a study is a relationship, not a moment in time and things can be dealt with at different times. Behaviours of researchers at the time of taking consent is therefore just as important as the documentation and should be taken into consideration in ethics review. Others also cautioned the need to be careful about being prescriptive about documentation and behaviour so as not to hinder innovation. Researchers need some freedom to do this in a different way, if we put minimum standards in place it may become a tick box exercise.

6. Any other business / Items for next meeting

AG discussed with the Group if they are happy with the level of communication between meetings and questioned whether they would benefit from update videos between meetings. The Group felt happy with the current level of engagement between meetings.

7. Meeting close

Before bringing the meeting to a close AG thanked everyone for their contribution to the meeting and to the programme throughout the year.

Date of next meeting: Wednesday 23 February 9am – 11am.

Minutes for Ethics Advisory Group, 23 February 2022

This meeting was held between 9am and 11am via Zoom on 23 February 2022.

Advisory Group members

1. Welcome and review of minutes

The Chair, Andrew George (AG), welcomed everyone to the meeting. AG shared apologies of those unable to attend and outlined basic housekeeping for the meeting. AG informed the Group that due to increased commitments Oliver Matias (OM) has decided to the leave the Group he sent his thanks to the Group for welcoming him and added that he found this work very interesting. AG remarked that we are grateful for Oliver’s contribution to the Group. AG let the Group know that the meeting will be recorded to allow full notes to be taken. The recording will be deleted once notes have been made, there were no objections to a recording being made.

2. Programme update

Shaun Eglen (SE) updated the Group on how the programme has progressed since the last meeting. SE referenced the Advisory Group update paper that was circulated to the Group in lieu of the January meeting, confirming that Clive Collett (CC) and Kirsty Edwards (KE) have joined Maria Brezitski (MB) on the Method of Review project to provide additional resource to the project. The document also outlined that the Streamlining Documentation project has been rescoped in response to input from colleagues and stakeholders. The project will now include elements of the planned work on how committees make decisions and will aim to increase clarity on how to carry out ethical review. The project has been renamed Refocusing Ethics Review and will commence in Spring 2022.

3. Public dialogue update

Suzannah Kinsella (SK) and Henrietta Hopkins (HH) from Hopkins Van Mil joined the meeting to present the summary findings of the Public Dialogue. SK informed the Group that 46 members of the public took part in the public dialogue and attended a webinar and three workshops. SK explained that the dialogue had been guided by the HRA project team and Advisory Group which was chaired by Lynn Laidlaw (LL).

In advance of the dialogue Hopkins Van Mil gathered information through interviews with a range of stakeholders. Across the webinar and workshops participants heard from 11 different speakers who gave them an insight into the different aspects of research ethics.

To inform the Think Ethics Programme the main questions the public dialogue participants were encouraged to consider were –

• What would make research ethical?
• Who is trusted to be on a research ethics committee?
• What changes to the review process would the public support?

Key findings

Support for alternative ethics review methods – there was widespread support for diversifying methods of review to allow Research Ethics Committees (RECs) to focus on the most complex and ethically challenging health and care research.

Calls for more diverse REC membership – it mattered to participants that ethics committees are diverse, inclusive and cover a wide range of backgrounds and lived experience. The participants discussed compensating REC members as one way of achieving this.

Increase visibility of the research ethics service - participants called for the HRA to increase its visibility as an organisation and of the ethics review process. They felt this would increase trust in research and democratise ethics by making it wider known, understood and championed.

Ongoing monitoring of ethics – there is a need to provide reassurance that once ethics approval is received, that the ethical aspects of research are being adhered to. Participants felt that researchers should be held accountable throughout each stage of the research.

HH explained that very few participants had heard of the HRA prior to the dialogue and two thirds had not heard of ethics committees, however people did have broad knowledge of the range of organisations that are involved in research and the variety of health and care areas that research explores. As the dialogue developed an appreciation grew of the HRA’s role in research- there was a relief that a body like the HRA and its equivalents in Wales, Scotland and Northern Ireland exists.

SK explained that the full report of the public dialogue is being finalised and will be delivered to the HRA in early March. The report will contain considerations for the Think Ethics Programme. Following the presentation Naho Yamazaki (NY) thanked SK and HH for all of their work on the project.

4. Information and Consent update

Leni Sivey (LS) updated the Group that their input in the December Advisory Group meeting helped to take the original 25 ideas for improving participant information down to 10 ideas for further engagement with stakeholders. These ideas fall into three broad themes (that are not mutually exclusive) which explore the different changes we can make.

Change what we expect

1. Maximum length of information – layer information elsewhere
2. Minimum quality standards of information
3. Require public involvement in design

Change how we respond

1. Monitoring after ethics review – receiving feedback on how effective information is
2. Use other informed consent assurances – consent conversations
3. Review principles for RECs – clarifying how to respond to participant information

Change how we support

1. Design principles for applicants – more explicit and consistent principles for those creating participant information
2. Toolkit for participants – create resources to make it clearer for participants what to expect
3. Public Involvement service – a new service providing support on a sponsor basis to develop public involvement infrastructure
4. Tailored guidance generator – moving away from templates and using algorithms to create tailored guidance

We have held engagement events to gather feedback on the acceptability, feasibility and impact of these ideas. In January we held a webinar for REC members and in early February two external stakeholder workshops. A wide range of stakeholders attended the workshops including public contributors, research delivery staff and sponsors. During the workshops attendees were split into small mixed groups to discuss the ideas in more detail. Most recently the ideas have been discussed with HRA Approvals staff and those who work closely with ethics committees have been invited to sessions to provide feedback on the feasibility and impact of the ideas.

LS presented some interim, high level findings of the engagement activities. They explained that during the REC webinar there was generally more support for more quantifiable ideas such as pinning down design principles, review principles, quality standards and requiring public involvement. More open ideas had less support, however LS reflected that this could relate to the level of detail we were able to offer around these ideas at this early stage.

In the workshops attendees were asked which idea within each theme would have the most positive impact. Within ‘changing what we expect’, the idea of imposing a maximum information length had the least support. There was concern that this could lead to focus on word count rather than what is useful for the participant. In the second theme, ‘change how we respond’, stakeholders favoured more clearly outlined review principles. In the third theme, ‘change how we support’, there was a strong preference for clear design principles followed by a public involvement service.

A member of the group asked how this works on an international level- would this mean we are moving further away from what is happening elsewhere? If so, does this make the UK a more a less attractive place to do research? LS explained this something that we will be exploring and was something raised in workshops. Others added that if we can prove the benefits and show how to implement them others are likely to follow.

LS explained that they are currently reflecting on all of the feedback to decide which ideas should be developed into full options to present to the Think Ethics Programme Board in March.

5. Method of Review

CC discussed with the Group the options report that has been developed for the Method of Review project and was circulated to the Group in advance of the meeting. CC explained that the report presents initial ideas that are in the early stages of development. More work is required to understand feasibility. CC reminded the Group that these ideas need to be compatible with systems and practices across the UK and reassured them that we are involving the Devolved Administrations throughout this work.

CC outlined that under the current methods of review around 3,500 applications a year go through full Research Ethics Committees. Studies with no material ethical issues go through a proportionate review sub-committee - around 1,400 applications a year. Alongside ethical review, staff in England and Wales, the HRA and Health Care Research Wales (HCRW) respectively, conduct a desk-based assessment to review applicable legal and governance standards. This is being rolled out across the UK and it is important to think about how any changes to ethics review are integrated into this work.

The Method of Review project is looking to build upon the current methods by streamlining and redirecting some studies to new review pathways to make better use of staff and committee member expertise and time. We hope this would lead to improved committee member satisfaction by allowing their expertise to be used in the most complex cases. It is also hoped that applicant satisfaction will be improved by giving quicker approval times.

The proposals within the options report are based on a risk adapted framework, minimising regulation and oversight where there is little need for it. Whilst ensuring appropriate requirements for those studies that need it. In practice this means any application submitted should receive the level of scrutiny it warrants and should not receive full review if there really are no ethical issues.

The proposals represent a single pathway for applications with increasing levels of ethical scrutiny. As the application passes through each level of the review process it will be checked that the ethical complexity and the risks are appropriate for that level of review. If more rigor is required, the application would move to the right level of scrutiny. For example, a clinical trial involving adults lacking capacity would move to the highest scrutiny - at a full Research Ethics Committee. By contrast, a simple questionnaire study could exit the ethics review pathway at a much earlier level.

We will continue to develop and refine the proposals for discussion at a future Ethics Review Advisory Group meeting.

6. Meeting close

Before bringing the meeting to a close AG thanked everyone for their contribution to the meeting.

Date of next meeting: Tuesday 22 March 2pm – 4pm.

Minutes for Ethics Advisory Group, 22 March 2022

This meeting was held between 2pm and 4pm via Zoom on 22 March 2022.

Advisory Group members

1. Welcome and review of minutes

The Chair welcomed everyone to the meeting. Apologies were noted. The minutes of the previous meeting (23 February 2022) were approved. There were no outstanding actions from the previous meeting.

2. Programme update

Juliet Tizzard (JT) informed the Group that, following the presentation of the proposed options for the Method of Review project at the last meeting, the team have been working on the level of detail needed to make the proposals ready for public consultation. Kirsty Edwards (KE) said that the project team are gaining a deeper insight by using internal data and case studies to explore ethical issues associated with each proposal.

JT and Andrew George (AG) informed the Group that this would be Maria Brezitski’s last meeting as she is leaving the HRA. JT and AG thanked Maria for her great contribution to Method of Review and the Think Ethics programme.

3. Information and Consent: options and recommendations

Kirstie Shearman (KS) presented the recommended options for the information and consent project. KS reminded the Group of the project aim to improve the quality of participant information and the consistency of how research ethics committees review it. KS explained that engagement activities with key stakeholders have been carried out. Focus groups with patients and the public, a UK wide ethics committee member webinar, external stakeholder workshops and discussions with HRA Approvals staff have helped to refine 10 options for improving participant information down to four recommendations.

The 10 options that were presented during stakeholder engagement were

Change what we expect

1. Maximum length of information – layer information elsewhere
2. Minimum quality standards of information
3. Require public involvement in design

Change how we respond

1. Monitoring after ethics review – receiving feedback on how effective information is
2. Use other informed consent assurances – consent conversations
3. Review principles for RECs – clarifying how to respond to participant information

Change how we support

1. Design principles for applicants – more explicit and consistent principles for those creating participant information
2. Toolkit for participants – create resources to make it clearer for participants what to expect
3. Public Involvement service – a new service providing support on a sponsor basis to develop public involvement infrastructure
4. Tailored guidance generator – moving away from templates and using algorithms to create tailored guidance

From the stakeholder engagement some quantitative data from quick votes was collected and then more qualitative data from conversations and feedback was taken. The data was analysed to explore the perceived advantages, disadvantages and considerations for implementation. Using this information each of the options was appraised focusing on

1. The impact each option would have on improving information
2. The acceptability of each option in the community and how feasible they would be to implement

Some options were easily ruled out as it was clear they would not be workable in practice or would not result in improved information.

Option 4. Real world monitoring: there was little support for this option across stakeholder groups. It was thought to be impractical- creating a lot of work for researchers and sponsors. Many told us they do assess their information and make changes accordingly so were already doing this.

Option 5. Focus on informed consent assurances: there was a universal agreement that consent is more than information and consent forms and that a holistic approach is important. However, it was questioned whether this measure would actually improve information itself and about what falls in the research ethics committee remit. The decision was therefore made to incorporate this idea into the overall package but not as a discrete option.

Option 8. Toolkit for participants: stakeholders felt this option would not improve participant information or how it is reviewed, so it was felt that to address the aims of this project the impact would be low. Stakeholders also thought there were already good resources available.

Option 9. Public involvement service: here were concerns that this would be repeating work other organisations are doing such as the NIHR and stakeholders also considered that again in this particular project this option is not necessarily going to improve participant information.

There were two options that were considered in more detail as they required further unpacking

Option 1: Maximum length of information: this was a key aim of this project as one key issue with participant information is that it is too long, and getting longer. The idea of putting a limit, either in pages or words, was therefore tempting. But there were two main problems with this:

Option 10. Tailored guidance generator: the main benefit to the generator is that it would standardise information and would ensure researchers know exactly what they need to include. However, stakeholders wanted us to encourage and facilitate the use of media aside from a hard copy sheet, and the use of a generator doesn’t send the right message. There was a worry here that researchers would think using the generator meant their work on information was done, or use it prescriptively, when we want to encourage researchers to think about their individual group and tailor their information accordingly. The generator therefore might make information more measurable for research ethics committees but was unlikely to improve information in a way that benefits participants.

Resultantly we decided that the remaining four options would be taken forward as recommendations for improving participant information and ethics committee review of it.

Recommendations

Option 3. Require public involvement in design

One of the areas ethics committees currently most vary on is whether and how they encourage applicants to develop participant information with people with similar lived experience to the intended participants so that it makes sense to them, addresses what matters to them honestly and clearly, and is respectful and inclusive.

Alongside this requirement the HRA will make it much clearer what is expected and what high-quality public involvement looks like in practice. We will provide detailed guidance for researchers and applicants on designing high quality public involvement. The HRA will also provide research ethics committees the information they need to evaluate public involvement in design and the assurances they can take from it.

We expect this measure to increase participant information quality and research ethics committee confidence that it will be fit for purpose.

Option 7. Design principles for applicants

This option was very popular with stakeholders. The HRA has existing participant information guidance and previously had templates, but templates have proven to be a very double-edged tool in supporting high quality participant information development

- Applicants save and use out of date templates making it difficult to disseminate up to date guidance and have clear shared expectations

- Applicants receive varied feedback from ethics committees which is then sometimes used to adapt sponsor templates – contributing to the cycle of participant information getting longer and more complex

- Very difficult to create a participant information sheet template suitable and proportionate for all research – real risk that it will stifle creativity and innovation (particularly if e.g. excellent public involvement has identified a better way to communicate effectively)

So instead we suggest principles that can be adapted to specific studies. The challenge would be balancing making them specific enough to be useful with general enough to be adaptable, the aim is to shift from a template of topics to thinking about what the intended reader really needs and encouraging innovation

Option 2. Minimum quality standards of information

As well as looking at what gold standard best practice looks like, we want ethics committees, regulatory staff, and applicants to have a far clearer shared understanding of what minimum good practice looks like. For example, stakeholders have highlighted that it is not clear what the HRA (and others) expect in terms of participant information readability, or public involvement in designing participant information.

There are some evidence-based resources that have been developed that help to quantify this, so bringing that together in one place and making sure everyone is working towards the same standards is key. Any standards would be co-develop with ethics committee members, participants, and research delivery staff to ensure they are going to be effective on the ground.

Option 6. Review principles for research ethics committees

This recommendation would provide clarity on research ethics committees remit in reviewing participant information – understanding what they don’t need to look at so they can focus their expertise. This would be broader thank training, we want to equip and empower ethics committees by giving them support – this could include guidance/decision tools/training. This would be developed in collaboration with REC members.

In the same way the introduction of design principles will encourage innovation and thinking about information provision throughout the process over time, the introduction of review principles will support ethics committees to take assurances from other aspects of research design and delivery of the whole process.

The Advisory Group welcomed the recommended policy measures and agreed that they should be put to the Four Nations Policy Group for consideration as a new UK policy for the development and review of participant information. The Group also agreed that members of the Advisory Group not present at the meeting should be given an opportunity to comment before the recommendations to the Four Nations Policy Group are finalised.

The Group discussed some of the recommendations in more detail. They agreed that quality standards should be developed through co-production. However, it was noted that any co-production working groups would require diverse representation from across the research landscape to prevent unintended consequences on the ground. They wondered whether the requirement for public involvement in information design should apply to all study types. If there are to be any exceptions the HRA will need to be clear on the details of how and when these would apply. The Group encouraged the HRA to promote the many benefits of public involvement to attract research to the UK by being an example of how to do high quality ethical research.

A discussion was had around whether the four recommendations should be implemented incrementally or simultaneously. The benefits of each approach were discussed, and the overriding wish was for the HRA to allow space for practicalities to be worked through during the implementation phase. The Group were mindful of how the effectiveness of the recommendations in achieving the project aims will be measured. KS explained that this is something that will be explored as the project moves to the next phase.

Next Steps

• Present the four recommended policy measures for consideration by the Four Nations Policy Group
• If the Group agrees the policy measures, start the process of developing/co-producing new guidance, processes and tools to implement them
• Consider whether all four measures will be introduced together or at different times
• Consider how we will evaluate these measures to ensure we have met our objectives

4. Meeting close

Before bringing the meeting to a close AG thanked everyone for their contribution to the meeting and to those who have given additional input to the information and consent project.

Date of next meeting: Thursday 28 April 1pm-3pm

Minutes for Ethics Advisory Group, 28 April 2022

This meeting was held between 1pm and 2.45pm via Zoom on 28 April 2022.

Advisory Group members

1. Welcome and review of minutes

The Chair welcomed everyone to the meeting. Apologies were noted. The minutes of the previous meeting (22 March 2022) were approved. There were no outstanding actions from the previous meeting.

2. Programme update

Juliet Tizzard (JT) presented a programme update.

Information and consent: The recommendations for improving information and consent have been accepted by the Four Nations Policy Group. The new policy surrounding these is due to be announced. We are currently developing an implementation plan which includes creating a new steering group.

Public dialogue: The findings from the public dialogue are being shared with Research Ethics Committee (REC) members at REC member regional meetings. We are also preparing to share the full report of the findings on our website.

Refocussing ethics review: Work is still being planned in this area.

Programme change: Juliet Tizzard will be leaving the HRA in early July, a new programme lead will be identified shortly. Andrew George (AG) thanked Juliet for all of her work on the programme.

Ethics Review Advisory Group: This Group has given a really helpful steer for the programme so far and some members have been further involved in certain projects. It feels like an appropriate time to review the Group and how it is working. Group members were asked to consider-

• is the Group too large for productive discussions and a shared sense of purpose?
• is the Group too virtual?
• is the Group membership correct- are there enough public contributors and researchers?

Members of the Advisory Group gave the following feedback:

• Members were positive about their experience of being on the group and that having a range of perspectives has been really valuable
• there have been instances when discussions may have benefitted from more of the ‘on the ground’ perspective. More researchers or research managers would help address this
• more in person meetings would be helpful.

JT and AG agreed to discuss these comments further and update the Group.

3. Method of Review Proposals

Kirsty Edwards (KE) presented the proposals for Methods of Review. She explained that the proposals are looking to embed more proportionate approaches to ethics review, making it easier for research ethics committees to focus on ethical issues that are high risk and complex or for which there is no precedent.

Project Aims:

• Make better use of REC members time and expertise
• Improve REC members’ satisfaction with their experience of ethics review
• Utilise staff time and expertise
• Improve the applicant experience with the potential to speed up (lower risk) applications
• Improve the quality of applications through the use of an application support tool

The proposals set out a vision of a pathway which is more integrated and proportionate in approach. Every application would receive the appropriate level of ethics scrutiny and review depending on its risk and complexity. Studies with a lower risk/complexity would be able to exit the ethics review pathway at earlier stages. KE outlined the proposals and emphasised that these are just ideas at this stage.

Proposal 1: Think Ethics – application support tool

Option 1: all applicants complete the tool

All applicants would complete an application support tool to determine ethical complexity and define the appropriate route through which their applications will be reviewed.

• Applicants can reflect on the ethical issues raised by their research- providing a teachable moment.
• Provides a timely means to identify ethical issues and to support an accurate and consistent estimation of the “ethical complexity” of research proposals.
• Applicants receive a favourable opinion where answers indicate very low risk equivalent to current “no material ethical issues”.

Proposal 2: staff assessment of ethical issues

Option 1: code consistency review

Approvals staff would apply established and applicable codes/guidance to the ethical review of applications

• ‘Ethics checklist’ with no ethical deliberation, simply checking that it meets existing codes/guidance.
• Codes/guidance could be defined and agreed in partnership with expert REC members, approvals staff, stakeholders and public involvement representatives.
• Sub-committee support: where conflict among code provisions exists a sub-committee of experienced and diverse REC members can be set-up.

Sub-option: code consistency plus ethical judgement required

This would be a hybrid approach. Staff would undertake code consistency review but also engage in making decisions about ethical acceptability where conflict among code provisions exists or there is no applicable codes/guidance.

• This would mean staff validating, providing governance review and advice to applicants.
• Staff would take on new, well defined, responsibility for ethics review (currently only undertaken by REC members).
• Staff would need to be provided with ethics training, and policies would need to be updated.
• Staff could still trigger the sub-committee option.

Proposal 3: Institutional Self-Assessment

Option 1: institutional approval for a programme of research

The HRA would delegate research ethics review for a programme of research to institutions who satisfy a specific set of standards.

• This would include an audit process to check compliance.
• This would involve studies which would initially receive appropriate HRA REC approval, but when the need arises to conduct sub-studies, instead of making separate IRAS applications, researchers would be able to submit their research application for review within their institution to which the HRA have agreed set criteria.
• Low to moderate risk/burden programmes of research with well understood ethical issues that can be managed through standard procedures.

Sub-option: institutional approval for certain types of research

The HRA would delegate research ethics review for certain types of research to institutions who satisfy a specific set of standards.

• This option would include an audit process to check compliance.
• Types of research could include those currently going through proportionate review.
• Low to moderate risk applications. Well defined and understood ethical issues that can be managed through standard procedures.
• Research institutions would be required to adopt standard processes/SOPs that include appropriate ethics review.
• Has the potential to improve researcher experience (time and cost saving).

4. Method of Review Proposals: group discussions

Members discussed what the felt were the benefits and barriers for each of the proposals.

Proposal 1:

Benefits – there was support for this proposal, members felt that it could help to improve efficiency and speed up the process. They saw benefit in offering a teachable moment particularly for student researchers. It was suggested that this should be extended through the life of a study to include amendments.

Barriers – there was concern it could add time to the process and highlighted the importance of getting the triage right so this isn’t just an additional step. This would still require staff time to support the process to ensure it is working correctly. This should be done through an agile approach with piloting to refine the process.

Proposal 2:

Benefits – utilising existing knowledge in this way was seen as a positive and it was suggested that staff and REC members discuss what ethics is and where the balance is between technical and ethical considerations. They highlighted the need to also increase understanding of how RECs reach ethical decisions.

Barriers – concern was raised for the potential burden on staff if they will be making ethical decisions in isolation. Extra time and expertise for staff to undertake this will be required and so this would require an analysis of the cost impact of moving a portion of work from volunteers to staff. Code consistency could be taxing – depending on whether it can build on precedent, which will be determined by the capabilities of IT and data systems. Need to be clear who is responsible for reviewing which aspect of an application to avoid duplication.

Proposal 3:

Benefits – there was support for institutional self-assessment for programmes of research.

Barriers – for the sub option of institutional approval for certain study types there were concerns with pushing elements of regulation back on to institutions. It was felt that decentralisation, after the HRA has in recent years centralised approvals, could lead to greater inconsistency. Additionally, Institutions with less infrastructure may be disadvantaged and unable to benefit. Research may be limited if there are particular departments that are risk adverse.

Next steps

KE informed the Group that there will be a public consultation period where people will be given a variety of ways to provide feedback on these ideas. The comments made by the Group in this meeting will help us to give a fair presentation of the ideas during the consultation by outlining concerns raised about acceptability and feasibility.

5. Meeting close

Before bringing the meeting to a close AG thanked everyone for their contribution to the meeting and for those who have provided additional input to Method of Review.

Minutes for Ethics Advisory Group, 30 June 2022

This meeting was held between 1oam and 12pm via Zoom on 30 June 2022.

Advisory Group members

1. Welcome and review of minutes

The Chair welcomed everyone to the meeting, noting that Jonathan Fennelly-Barnwell (JFB) is now Senior Responsible Officer for the programme. Apologies were noted. The minutes of the previous meeting (28 April 2022) were approved. There were no outstanding actions from the previous meeting.

2. Project updates

2.1 Information and consent

The project is planning the development of quality standards and design and review principles. Discussion is ongoing as to whether these should be tested in tandem or at different times. A formal implementation plan is being developed and a reference group is being put together for oversight. A workshop with key stakeholders will be used to ensure what is being developed can apply to all types of research. Project lead, Kirstie Shearman (KS) explained that co-production will be used to develop principles and standards, the Group discussed that co-design could be a more appropriate approach. Group members, Lynn Laidlaw (LL) and Mary Dixon-Woods (MDW) who have experience of co-design agreed to advise on the process.

2.2 Method of Review

On 13 June the 14-week public consultation on rethinking ethics review launched. Stakeholders are being invited to feedback on our ideas to:

• introduce a tool to support researchers to think more ethically
• use ethics review by expert Research Ethics Service staff
• delegate ethics review for studies within a programme of research

There have been over 400 responses to the online survey so far, we have started some initial familiarisation with the survey data. Alongside the online survey the project lead Kirsty Edwards (KE) has been attending internal and external stakeholder meetings to provide information on the consultation. A series of engagement events will take place across the summer including a UK wide REC member workshop, staff engagement events and a multi-stakeholder workshop to include sponsors and researchers. Alison Barbuti (AB) noted that the social media launch resulted in over 589,000 impressions on Twitter and a bespoke launch article was sent to 16,700 subscribers of HRA Latest which had an above average open rate. Think Ethics webpages received over 1,189 views.

A thematic analysis will be conducted on the data gathered from the consultation, generating codes to draw-out key themes. These themes will provide the foundations for the final recommendations. An iterative approach will be taken through the consultation to better understand the potential benefits and concerns of stakeholders. In late autumn a set of recommendations will be developed to test and pilot in the next phase. Group members questioned what methodology will be used to go from survey responses to recommendations to implementation. There was particular concern if responses are too similar and there is no clear direction. It was discussed that workshops will be used to explore responses more deeply to get a better understanding of opinions. Issues may be highlighted but that does not necessarily mean a particular idea is discounted, rather that there are things to be aware of for implementation. JFB noted that it may be useful to do some light testing of some elements of the ideas, to help understand the survey data.

KE suggested that for the next phase of the project it would be useful to increase the membership of the established working group with interested members of the Advisory Group. This will make best use of Group member’s time and expertise to help develop the set of final recommendations.

2.3 Refocusing Ethics Review

Clive Collett (CC) outlined that there is an active programme of continuous improvement at the HRA so there are elements of the Refocusing Ethics Review project that could, or already do fall into that. To avoid duplication work is being done to determine what should be looked at within this project. Areas that are currently being explored are:

Scope

REC members have expressed there is some uncertainty around what their focus should be and what they should consider in an ethical review. Some committees consider typographical issues or issues reviewed elsewhere whilst other committees do not. When members join a REC they need clarity on role and remit via the induction process. This should be aligned to guidance so that applicants have the same understanding of the scope of ethics review.

Experience

Looking at the diversity of experience on a committee and the demographic spread of membership to explore who should be on the committee and what roles individuals play.

Consistency

Applicants need clarity on what can be expected in terms of consistency, where decisions should be consistent and when there should be reasonable difference. Currently precedents are not used, but clarity on when certain opinions should be used could offer support to Chairs in issuing decisions.

Next steps

Internal data at the HRA is being collected to understand what issues are being addressed elsewhere and we will hold an internal workshop to agree what to take forward and how. A new policy manager is being recruited to lead this work.

Observer comment: Holly Fernandez Lynch (HFL), Assistant Professor of Medical Ethics at University of Pennsylvania and member of The AEREO (Advance Effective Research Ethics Oversight) Consortium.

HFL explained that in the United States of America there is no centralised system for ethical review, only institutional review boards. The AEREO Consortium are asking institutions to share precedents. There are concerns about the practicalities surrounding this as there are no processes in place so to use precedents relies on individuals and their knowledge. The issue with this reliance is that information can be easily lost when people leave an institution. They have piloted staff making summaries but this created a large amount of work. To address these issues the Consortium are looking at ways in which using technology could help but to do this there will need to be consistency of language and categorization. There will also need to be a decision on what makes an opinion worthy of being used as a precedent. There were major reforms in the United States five years ago which took some types of research out of review completely and moved them to staff. In the United States ethics is not always included in study review and so in some cases only regulation is considered. There has not been a lot of discussion on who sits on ethics review and the participant perspective is not often included. HFL will be watching the progress of Think Ethics closely due to the overlaps with the work of the AEREO Consortium.

3. Programme update

The programme update outlined what has been achieved so far by the Ethics Review programme:

Information and consent – alongside stakeholders ideas were formulated and through workshops and engagement events refined to recommendations. Recommendations signed off by the programme Board and Advisory Group and subsequently accepted by the Four Nations Policy Group. The new policy for participant information has been publicly announced. New project lead and workstreams established, the project has now moved to process and workstream mapping.

Public Dialogue – members of the Advisory helped to inform and support the dialogue. Public dialogue successfully completed and the findings have fed into the wider Ethics Review programme. Full results of the dialogue have been reported publicly through various communications and engagement routes.

Method of Review - case studies and internal data sampling and analysis completed. Significant engagement was conducted with stakeholders to develop ideas. Following consensus with stakeholders and the Advisory Group ideas for consideration in public consultation were finalised and signed-off by the programme Board. The public consultation launched with a good response rate.

Refocusing Ethics Review – restructuring of the remaining elements of the programme to form this project, initial scoping exercise to frame the project complete.

JFB informed the Group that the programme has been extended from March 2022 to March 2023. Planning and use of resource for the next phase will be important. From August the programme will be without a programme manager so a more iterative approach will be taken to some elements of the programme.

Shaun Eglan (SE) outlined advisory work that the programme will require in the next quarter:

Method of Review, Early review of consultation findings and potential recommendations - August-September

Refocusing Ethics Review, Prioritisation and design of areas of focus coming out of exploratory phase - August-September

Information and Consent, Review of first stage piloting, proposed implementation of changes - September

Method of Review, Review of draft recommendations - November

Method of Review, Sign off recommendations - December

4. Ethics Review Advisory Group next steps

Andrew George (AG) discussed that during the next phase of the project things will happen incrementally, but the goal of the programme remains to be transformational. The role of the Advisory Group will be to ensure the programme is held to its overarching transformational vision. AG suggested that the Group meet less frequently, moving to quarterly meetings. There will be an advance plan of what the meetings will focus on to ensure the programme keeps moving and milestones can be reached. JFB added that using this iterative approach there will need to be checks and testing, however we do want to be pragmatic with Group member’s time and also include voices that are yet to be heard. To allow for this, members were encouraged to delegate if necessary and where appropriate. Members of the Group expressed support for this approach and appreciated the benefits of a more pragmatic approached.

5. Meeting close

Before bringing the meeting to a close AG informed the Group that Shaun Eglan and Alison Barbuti are leaving the HRA and this will be their last meeting. AG thanked them both for their contribution to the Ethics Review programme.

6. Next meeting

Thursday 6 October 2022, 10am-12.00pm via Zoom

Ethics Review Advisory Group

This meeting was held between 10am and 12pm via Zoom on 6 October 2022.

Advisory Group members

1. Welcome and review of minutes

The Chair welcomed everyone to the meeting. Apologies were noted. The minutes of the previous meeting (6 October 2022) were approved. There were no outstanding actions from the previous meeting.

2. Programme update

The Group were informed that since the last meeting there has been a stocktake on the programme and greater clarity around what the deliverables are for the programme. We now have a really clear picture of what effect we want Think Ethics to have.

The programme team presented a ‘deep dive’ of the programme to the HRA Board outlining where the programme is, what it has done to this point and timescales moving forward. From the Board there was a sense that when the programme finishes there will be work to do to transition those deliverables into business as usual. We will also be looking ahead to what is next for the organisation to embed ‘think ethics’ into the centre of what we do.

For the next quarter the three projects will be drafting recommendations and piloting and testing proposals. Immediate next steps for the programme is closing the consultation for Methods of Review and analysing the data that has been collected. We are working with our Business Change Lead and the Continuous Improvement Lead to prepare for various possible recommendations to ensure that any changes do not come out of the blue for teams to operationalise. For example, early stage testing is being carried out to look at staff review of studies that have no material ethical issues under the current Proportionate Review criteria to understand where the gaps and opportunities are.

3. Project update and group discussion - Ethics in Focus

The initial focus of this project was on matters concerning the inner workings of the ethics committee, such as consistency of processes and experiences. This project has now changed from ‘Refocusing Ethics Review’ to ‘Ethics in Focus’ in order to address some of the findings of our Think Ethics Public Dialogue exercise. In particular, the finding that the public want the HRA to increase visibility of RECs and engage the public in the research process. As a result, the project now has three workstreams:

• Increase visibility of the HRA and RECS
• Engage and inform the public meaningfully in the research process
• Increase REC consistency of process and experience

The project is now moving from the discovery phase to formalising the project plan. One of the early things the project will look at is increasing public engagement with research ethics. To do this we are looking to have members of the public visible on the HRA website talking about what ethics means to them and why it is important. Mark Sidaway (MS), the project lead, will be working with the HRA Communications team to produce these videos.

Another area of focus to help increase visibility and engage the public will be around observers at REC meetings. At present observers do attend REC meetings, but to help make RECs more accessible and transparent to the public work will be done to adopt a more systematic approach to this. We want to look at how observers are selected, how observers are briefed prior to meetings, what an observation entails and what feedback the HRA receive afterwards. The aim is for this to become business as usual, as the public have expressed that they wish to be more informed and involved. This work will be kept close to the ambitions of the HRA strategy and feedback from the Public Dialogue and so diversity, inclusion and transparency will be central considerations.

The Group discussed this approach and REC members of the Advisory Group discussed their experiences of observers at REC meetings. They noted that there are regularly observers at meetings and that the observers are usually involved in research in some way. There was a feeling that the observers usually find the experience interesting and useful but that there is no formalised way for them to feed back to the HRA on their experience and so there is a missed opportunity to gather valuable insights and feedback.

The Advisory Group discussed the suggested approach of becoming more systematic with the observer system and diversifying who observes meetings. Some members of the Group felt there would be a need to consider whether opening meetings up to the general public would impact on the ethical discussions in the meeting as members may feel they are under scrutiny. There was also a discussion over confidentiality where commercially sensitive information is being shared. Others felt that holding a REC meeting in public would be the best way to raise visibility and awareness and noted other organisations are already doing this, and so we could learn from their methods. The group noted that this seems to be two separate issues as systematising REC meeting observation may not sufficiently achieve increased visibility and public engagement. The suggestion was that two should be seen as two different tasks

1. improving the observer process and getting feedback,
2. making meetings more publicly accessible.

Jonathan Fennelly-Barnwell (JFB) added that we want to build up a bank of feedback and insights to help improve our service and that along with members of the public we are aware of others who it would beneficial to have observe a meeting and gather their feedback. This project is a piece of this larger work.

The team are considering what the consistency workstream should address. This issue has been around for some time and this project will be looking more closely at the comments we hear about ‘inconsistency’ and what these comments are referring to. We could be looking at a framework for a consistent approach to ethical issues in research ethics committees. There is also an issue around consistency of output and what the researcher receives following their REC meeting. From the REC development days feedback has been gathered on how RECs get to ethical opinions that will help this part of the project.

4. Project update and group discussion Information and Consent

A workshop was held on Friday 26th August, six public contributors were recruited for the workshop. These are public contributors who have not worked on the Think Ethics and so are bringing fresh perspectives. In the workshop key themes that have been previously identified were agreed-

• Quality of information participants receive
• Language that is used in participant information
• Content, what is included in participant information and why
• Format of information, not relying solely on hard copy information
• Patient and public requirement for participant information

The workshop generated at lot of discussion and useful advice and suggestions were gathered from attendees. From this feedback Kirstie Shearman (KS) will start to draft the quality standards and design and review principles. Once these are drafted a second workshop is planned with REC members and members of the Public Contributor Network to test the design and review principles to ensure they function as intended. There were some issues that generated a lot of discussion in the workshop, the Advisory Group gave their input on these.

International Public Involvement- where studies are based in another country and have done public involvement in that country would we still require public involvement to be carried out in the UK?

For sponsors this would mean additional work, but the public contributors in the workshop gave reasons why it would be important to also do that work in the UK

• differences in health systems in other countries
• differences in terminology

The Group discussed whether PI should be required for participant information if it has already been carried out in other countries. One Group member noted that there can be instances when only a very small number of patients are recruited in the UK and this could be inhibitory for studies choosing the UK, so a proportionate approach may be required. For example, this would only be required if the public involvement in another country is deemed to be not representative or sufficient then for UK participants. Another member of the Group highlighted that the focus should be on the patients’ perspective and that what is deemed proportionate could be subjective. It was also highlighted that documents are often signed off at a global level and so lawyers and compliance teams are in different countries and so this could be a barrier to changing them in the UK. Another member noted that despite the wish for good quality public involvement the commercial trials can be competitive and so any UK specific public involvement would need to be very quick.

Public involvement in Phase 1 Healthy Volunteer studies – in the workshop, the public contributors felt that public involvement was still important as healthy volunteers still may have accessibility and inclusions barriers and concerns that need to be addressed and taken into account and that these issues are likely to be broader than in a cohort of a particular patient group.

The Advisory Group felt that involvement should be included in these studies but that the application of the requirement could differ, for example using public involvement on templates for an organisation rather than individual studies.

Participant information explaining that involvement has been carried out – this would be something additional to what is already included and has the potential to make information even longer.

A REC member in the Group explained that they do often ask for information on involvement to be included in an information sheet, briefly. However, for committees it is more important for the REC to have a clear understanding from the application what involvement has been done. KS explained that this may fall into the quality standards. It was suggested that a standard sentence would be a better approach than adding lots of this information into the form as people will differ on what they understand about involvement and this could cause confusion. The Group agreed a layered approach would be better, to give those who want more information on involvement an opportunity to get it.

Reading age score – a lot of participant information sheets are way above the average reading age in the UK. There has been a suggestion that information sheets go through a reading age check when they are submitted to IRAS.

One of the Group felt reading age is important to encourage more diversity in participants and to encourage those who do not have English as a first language. This could be included in the guidance for researchers to run their information through an online check themselves rather than it being on the IRAS form. The Group also cautioned that a reading age may not help those who take information more visually or are unable to read at all. KS explained that the push for improved reading score is not in place of encouraging more multimedia approaches, but to ensure that anything that is hard copy is accessible.

5. Programme and Advisory Group next steps

As the projects move closer to the delivery phase the project leads will come to the Group for feedback either via email, through discussion in a full Advisory Group meeting or directly to individuals. They will then all go to the Ethics Review Programme Board for approval.

For Methods of Review, if the data from the consultation shows that we should explore some of the options more we will spend January to March 2023 planning a pilot to run from April to understand whether a permanent change should be made. This will be done in collaboration with our colleagues in the Devolved Administrations to ensure our REC service continues to be UK wide.

For Information and Consent recommendations will be shared with the Four Nations Policy Leads after the Programme Board have agreed them. This will help us to understand whether these are UK wide standards or HRA standards. We will then develop an implementation plan to ensure that any change is communicated effectively so that people can be prepared and that we allow a reasonable time for the transition.

For Ethics in Focus anything relating to consistency in RECS will be taken to the UK wide Operations Lead and Policy Lead Groups to ensure a UK wide approach is agreed.

6. Next meeting date

Wednesday 7 December 10am to 12pm

Ethics Review Advisory Group

This meeting was held between 10am and 12pm via Zoom on 7 December 2022.

Advisory Group members

1. Welcome and review of minutes

The Chair welcomed everyone to the meeting and introduced Nzinga Cotton the new Communications lead for the Ethics Review Programme and Ioannis Anagnostopoulos as the new Programme Manager. Apologies were noted. The minutes of the previous meeting (6 October 2022) were approved. There were no outstanding actions from the previous meeting.

2. Programme update

The programme is running approximately one month behind due to unavoidable delays in the Autumn. This is not expected to impact on the timing of key deliverables. The Methods of Review project is on track to deliver a draft recommendations report in December and then final recommendations in January 2023. Information and Consent is on track to deliver an advance draft of the Quality Standards to the Programme Board meeting in January 2023. A comprehensive delivery plan has been put in place for Ethics in Focus, as this project had a later start than other projects in the programme. Progress is being made in all three workstreams of Ethics in Focus- consistency, Research Ethics Committee (REC) meeting observations and communications work focussing on ‘what is ethics’.

3. Ethics in Focus update

Consistency

A task and finish group has been set up with colleagues in the Approvals Directorate. At REC Development Days members have been giving feedback on how they reach an ethical opinion and how they use the ethics review form. A focus group will be held in January with 2-3 Research Ethics Committees to ask what they find helpful about the ethics review form and what is not helpful to get a better understanding of how it is used. From this information a pilot will be run in selected REC meetings in February to understand where the process can be tightened and more formalised to make review more streamlined and efficient and to focus on key issues.

The Chair asked how success in improving consistency will be measured, the project lead suggested that the use of the review form could be used to help do this. A member of the Group felt that the form could be used to frame how success is measured rather than being the measure itself. Another Group member noted that use of the form should not be rigid and should be used more as a guide because committees have to be agile enough to be able to review novel studies. The project lead noted that there is no intention for the form to become mechanistic. The ethics review form is being looked at in this workstream because when it is used consistently it tends to lead to a better review.

REC observations

The charity Dementia Voices will take part in REC meeting observations in January and early February. It will be key to understand what observers want from REC meetings and how they find the experience of observing. This information will feed into HRA business as usual.

Communications

Blogs that focus on ethics will be written by a variety of voices from the HRA and externally and will be amplified by the Communications team.

4. Information and Consent update

The first draft of the quality standards is close to completion and will be reviewed by internal colleagues at the HRA by the end of December. Staff from Operations and Approvals will review them to make sure they are in the right format for the people who will use them. The design and review principles are taking longer because they need to be able to apply to different study types, different study designs and different populations meaning there are more things to consider and explain.

The design and review principles will be tested by the working group and in the second planned workshop with public contributors and REC members. The testing will be done on real information sheets to see if any changes are needed. Final drafts will be ready for the February Advisory Group meeting, this will allow for any further comments from this Group to be included before the programme officially ends in March.

5. Methods of Review consultation findings

The public consultation is closed, and the data collected via the online survey and 7 stakeholder engagement events has been coded and analysed

Survey respondents

- 744 respondents

- 75% from England, 17% Scotland, 5% Wales 2% Northern Ireland and 1% from outside the UK

- 40% researchers in higher education institutions and the NHS

- 20% research ethics committee members

- 19% patients and individuals who have taken part in health and social care research

- 13% sponsors from higher education institutions and the NHS

A paper of the analysis of the data and consultation findings has been drafted. The first draft of the recommendations report has been started and when complete will be taken to the programme board.

Think Ethics Tool consultation findings –

Online survey analysis found that 61% of respondents thought the Think Ethics Tool could be an acceptable method of review, however few respondents thought the tool could be successful in bringing the benefits the tool would be expected to achieve. This could be a reflection that we consulted very early with ideas, rather than detailed plans. Respondents across all three ideas felt unable to indicate the level of success of the ideas without more information on how they would be applied.

The response to the Think Ethics Tool was generally positive in the survey and workshops and there was an appreciation that thought was being given to support early career researchers to give them an understanding of what is expected. A member of the Group explained that supporting early career researchers in this way does not work unless ‘thinking ethically’ it is supported in their institution. They suggested it may be more beneficial to focus on the Principle Investigators to create a culture change.

One concern for respondents was that applicants could game the system. It was suggested in the Group that this issue may have come up in relation to respondents’ experiences with the amendment tool. They noted that in their experience how the amendment form is filled in will dictate the level of review required. This is not necessarily because people are gaming the system but because the categories of research on the tool do not fit with more novel types of research.

A Group member also wondered if the essence of the idea of the Think Ethics Tool had not been fully understood in the consultation. The intention is that the tool would help people to ‘think ethically’ and therefore it is not something that could or should be gamed. It was suggested that naming it a ‘tool’ in the consultation may have made people think more about process than the principle.

Staff review consultation findings-

61% of survey respondents thought staff review could be an acceptable method of review for studies with lower ethical risks. REC members raised a wide range of concerns including risk of harm, accountability and lack of diversity in decision making. Research ethics service staff saw the possible opportunity in diversifying their role but had concerns about accountability and training. Patients and those involved in research were worried about the loss of lay member and expert voices. Sponsors had concerns about added bureaucracy and the need for trust and researchers thought it might increase risk of harm but that it could offer better support to researchers.

Many respondents seemed unable to endorse the idea because the consultation did not give a clear definition of what studies would be deemed to be ‘low risk’. There was also concern that there are occasions when a study appears to be low risk when in practice it is not.

A member of HRA staff suggested that a lower risk option could be to expand on the types of substantial amendments that are reviewed by staff rather than introducing staff review on studies. Members of the Group who work with RECs supported this suggestion as committee members do comment on the additional workload of amendments.

It was noted by a member of the Group that for staff review to be implemented consideration would need to be given about the differences in staffing structure across the Devolved Administrations and how staff review would be applied in each country. The project lead assured the Group that this had been raised during the consultation engagement and would form part of any recommendations.

Programme of research consultation findings –

51% of respondents thought delegated ethics review for studies within a programme of research could be an acceptable method of review for studies with lower ethical risks.

This idea received the most challenge in the survey and during engagement events. However, members of the working group for this project have pointed out much of this may be due to the limited detail that was provided about this idea in the consultation. Respondents may have interpreted the idea of ‘delegation’ differently because of this. Additionally, the lack of detail around any parameters that would be in place could have impacted on support for this idea as there are very different types of sub study and some carry much more risk than others.

For this idea, an application would be seen by the REC and they would give an ethical opinion and within agreed parameters, set at the time of ethical approval, future sub-studies would then gain approval within the institution. Respondents were concerned that sub-studies can look very different from how they are initially planned at the start of a study and that researchers would not always come back to get a new ethical opinion from the REC to address this. Other challenges from respondents included concerns that this would be adding bureaucracy and that there was potential for conflicts of interest. REC members felt this was decentralisation of ethics review. Sponsors in higher education institutions in particular were concerned about the burden this would place on institutions.

There was some surprise in the Group that this idea received a higher level of challenge as during COVID-19 some forms of delegation were used. It was questioned whether this was deemed acceptable because it was an unprecedented situation. Members of the Group felt that some people living with life limiting illnesses could have the same feeling of urgency for research to commence as was felt societally during the pandemic.

Additional consultation findings –

Although the lack of detail surrounding the ideas may have made it difficult for respondents to give definitive answers to some of the consultation questions it allowed space for people to comment more widely. This has given a really rich dataset which highlights additional things we could do better or differently which will be used to feed into other areas of work.

6. Programme next steps

Once the projects have delivered recommendations to the programme board decisions will be made about what will be taken to the next level of testing or will be highlighted for discussion with colleagues in the Devolved Administrations to be taken forward on a UK wide level.

The Think Ethics programme was discussed at the HRA Board with a view to Think Ethics becoming a long-term campaign and way of working. The initial aim of the project was to put ethics at the heart of everything we do and so should not be restricted to a fixed programme of work. In discussion with the director of policy Becky Pervis, the work of Think Ethics will be used to help fulfil the HRA strategic priority to ‘include’ everyone in research. The projects have highlighted service improvements that can start to be acted on as part of business as usual. How the programme itself will be closed and brought into the business as usual is still in discussion and recommendations on how we take this forward as a HRA commitment will be made in the new year. Members of the Group were very supportive of the essence of the programme continuing.

7. Date of next meeting

Monday 6th February 2023 1pm – 3pm