Annual Report for Research Ethics Committees (RECs) in England 1 April 2023 to 31 March 2024

Seasonal RECs

Seasonal RECs, which were introduced in 2022/23 as a service improvement to address periods of high demand continued to meet for the reporting period. The seasonal REC is comprised of a pool of existing members from across the service who volunteered to participate in seasonal REC meetings in addition to their usual REC meetings. Seasonal REC meetings are arranged to offer increased REC meeting slot availability at known peak times throughout the year (spring, summer and winter holiday periods) to avoid applicants having to wait too long for a meeting date.

There were 14 seasonal REC meetings held in the annual reporting year. 63 applications were reviewed by the seasonal REC. The median time to issue a final opinion was 31 days. The additional REC meetings have meant that we have been able to maintain the usual timelines between the date which an application has been submitted and the date of the REC meeting.

REC Member Development days

The REC development days are provided in response to members’ feedback, which has shown a demand for an opportunity to meet in person and to network with members of other RECs and HRA staff. Each year, the event and programme are changed to reflect feedback from previous years. The programme for the development days included a session on artificial intelligence in health research, and best practice for public involvement in health and social care research. Seven face-to-face REC development days were held from 1st April 2023 – 31st March 2024. These were held across the country and were attended by 396 REC members. There was also an online version of the development day attended by 51 members. This equates to roughly half our REC membership.

Chairs meetings

Chairs meetings are held twice a year and gives a chance for Chairs to discuss topics of interest. It also provides an opportunity for discussion on key developments. Chairs and Vice-Chairs from each REC attended the bi-annual Chairs meetings held in Spring 2023 and Autumn 2023. A face-to-face national training day for REC Chairs was held in December 2023. A key part of the agenda for the meetings was discussion and input on proposed changes to RECs relating to the new Clinical Trials Regulations that will come into effect in future.

Stepping into chairing courses

The HRA started running a ‘stepping into chairing’ course in January 2024. Two sessions have been held and 14 members have attended so far. This course was established to support and encourage REC members to progress into a REC Chair or REC Vice-Chair role. This course is designed for members who are considering applying to be a REC Chair or Vice-Chair to provide them with an opportunity to hear from existing Chairs and to find out more about what the role entails and what support is available.

REC mentors

The REC mentor scheme was introduced in 2021. The scheme has received overwhelmingly positive feedback and has become business as usual. New REC members are offered the opportunity to join a mentoring group as part of their onboarding. There are 12 REC member mentors delivering training and supporting newly appointed members with the research ethics review process. New members attend meetings with their mentor as a small group to learn and discuss how best to approach an ethics review, which aspects of a health and social care research application are within the REC to consider, and to find out about proportionate reviews and substantial amendment reviews.

NIHR Learn

In this reporting period, the HRA moved over to a new Learning Management System, called NIHR Learn. A transition to the new system was undertaken. In order to support this, the HRA learning team created step by step instructions for REC members on how to register for an account. There were also 11 informal drop-in sessions, providing answers to frequently asked questions, instructions and training for HRA staff, REC and Confidentiality Advisory Group (CAG) members.

79% of REC members registered with NIHR learn which is where REC member training materials and course dates are now available from. All REC members are encouraged to register for an NIHR Learn account by regular prompts in the monthly learning bulletin which is emailed to all members. New members are provided with information about using NIHR learn and details of what mandatory training needs to be completed as part of their onboarding.

Shared ethical debate

Shared ethical debate was originally developed in 2008 with a view to checking consistency among RECs. Over the years there have been several revisions to the procedure however, in terms of the format of the exercise, we identified that:

• it can be difficult to fit the shared ethical debate exercise into an already busy REC meeting
• the time lag between completing the exercise and RECs receiving the report is too long
• sourcing suitable applications to use as scenarios for the debate is challenging
• it is a lengthy process that involves many hours in preparing the proforma, managing the reviews, analysing the data and generating the report

Based on this review and feedback received from members, we tested a different approach to address these points between September and December 2023:

• the shared ethical debate exercise was run online (using a survey tool) with all REC members being invited to take part. This was a change in approach as the response would be from individuals as opposed to the REC
• the objective of the exercise would focus on building a consensus of opinion of ‘live’ research ethics related issues or dilemmas identified through queries to the approvals support quality and performance team, Chairs meetings and via staff
• reports from each exercise will be shared with all members and will focus on themes in opinion with clear outcomes, associated responsibilities, and timelines

207 members participated in our first new shared ethical debate on payments and incentives to young people and their families taking part in research. This compares to approximately 140 members who would have taken part in the previous shared ethical debates which were discussed as a REC meeting agenda item. Members were also invited to attend one of two live sessions to hear the results and to engage in the debate. A report and video to share the findings from the exercise is available on NIHR Learn. The findings of the exercise were able to be shared with the RECs much more quickly due to the use of the online survey tool. This helped to address REC member concerns with the previous format as previously several sets of REC meeting minutes needed to be analysed to report on the data which was time-consuming.

Quality standards for participant information

The Participant Information Quality Standards (QS) and Design and Review Principles (DRP) were developed as part of the Think Ethics Programme. The HRA held a series of workshops with REC members, applicants, research participants, patients and the public to create the QS and DRP, to achieve the following purposes:

• improve participant information; how it’s developed ethically, proportionately, and reviewed
• make research ethics review even more consistent, proportionate and focussed on ethics
• continue to build trust in the service, for participants, applicants and the public,
• continue to attract innovative research to the UK.

The QS and DRP were launched in July 2023 and were implemented for use by REC staff and members from September 2023. Compliance with the QS and DRP became mandatory for all applications submitted from 1 December 2023.

The rollout and implementation of the QS and DRP was supported by an extensive communications plan, to ensure all key audiences were appropriately informed and prepared, which included training staff across the HRA and devolved administrations. A training module was also prepared for REC members.

The aims and objectives of the QS and DRP rollout and implementation plan were to achieve the following by 1 December 2023:

1. develop a staff-led process to review participant information materials for compliance against the QS at the REC application validation stage UK wide
2. embed the DRP as the framework for the ethics review of participant information materials across all RECs UK wide

Both objectives were achieved and use of the QS and DRP is now established as the business-as-usual practice for review of participant information materials for all new REC submissions across the UK.

REC Membership

The membership of the 64 RECs is set out in figure one below. Although the Governance Arrangements for Research Ethics Committees (GAfREC) allows for up to 18 members to be appointed to each REC, 15 members is the operational target in order to ensure that the number of members present at meetings is not too large, and so that we can effectively support our members. There were 883 members at the end of the annual reporting period.

RECs are made up of a variety of people who bring different skills and experiences:

• lay members - people who are not registered healthcare professionals and whose primary professional interest is not in clinical research, for example retired healthcare professionals (excluding retired doctors) and those involved in the management or administration of clinical research
• lay-plus members - members of the public who have never worked in healthcare or research and have never been a member of a health service body
• expert members - registered healthcare professionals, clinical trial statisticians and other experts in research

The constitution of Research Ethics Committees is defined in GAfREC and requires a minimum of a third of the membership to be lay. For RECs reviewing CTIMPs, half of the lay members should be lay plus. To ensure sufficient clinical and expert input, the HRA tries to ensure that at least 50% of the members of each REC are expert.

Figure one: REC membership

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Figure one alt text:

The membership of the England RECs is set out in figure one. There were 883 members at the end of the reporting period.

Figure one shows the numbers of the membership per member category: Expert (418 equating to 47%), Lay (249 equating to 28%) and Lay Plus (216 equating to 24%)

Note: Expert members are defined as currently registered health care professionals, individuals with professional qualifications or experience in clinical research or a previously registered doctor or dentist. Lay members are people who are not registered healthcare professionals and whose primary professional interest is not in clinical research, for example retired healthcare professionals (excluding retired doctors) and those involved in the management or administration of clinical research, and Lay Plus members are members of the public who have never worked in healthcare or research and have never been a member of a health service body. They should also not be a registered health and social care professional and should be unconnected with the conduct of clinical research.

Incredible progress has been made in terms of how many new members were recruited in this annual reporting period. In the previous annual reporting period, a greater number of members left the service than we had been able to appoint particularly in the lay plus member category. Figure two demonstrates the significant turnaround which has been made relating to this.

The increase in the number of members being recruited was achieved as a result of the following:

• a wider pool of staff participating in REC member interview panels so that more interview dates could be held at more frequent intervals (61 interview panels were held during the annual reporting period)
• the application form to join a REC is now available as an online form as opposed to potential members needing to contact the HRA to request a form
• the language used in the online application form has been improved to make it clearer that no specific qualifications are needed to apply to join a REC as a lay member
• new members being appointed to a REC more quickly after interview due to more effective vacancy planning
• a restructure in the Approvals Support & Improvement team provided dedicated resource for member recruitment

The most frequently cited reasons for leaving were increased workload (not related to REC work) or personal commitments which meant that members no longer had time to volunteer as a REC member.

Data on current and predicted vacancies is routinely collected to aid improved succession planning and targeted recruitment.

Figure two: number of members appointed and leaving the service during 2023/24

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Figure two shows the number of members (in each category type) appointed and leaving the service between 2023 and 2024.

Appointed between 2023 and 2024:
128 total Expert REC members - 69 total Lay REC members - 94 total Lay plus REC members
Leaving between 2023 and 2024:
81 total Expert REC members - 31 total Lay REC members - 49 total Lay plus REC members

As shown in figure two, a greater number of members have been appointed than those that have left.

Ensuring a positive experience for members

Focused discussions took place with members at the REC development days in this reporting period, focusing on concerns raised around recruitment and retention of members. Work has been undertaken to collate and analyse the feedback and a plan developed to address relevant points. The key themes include:

• Workload
• Recognition and thanks
• Communication and training
• Knowing how members are making a difference

Regular updates are now being provided for reassurance on membership levels.

Work continues to address the feedback on workload. In addition, other feedback was actioned, for example exploring whether members could have access to NHS discounts and other aspects that recognise their service and commitment to the work that they do with us as volunteers.

We have also made a commitment to publish more content that highlights the work that our members do, responding to the need for recognition and knowing how members make a difference in their critical role in the research pathway in the UK.

Some of our REC members have expressed a desire for more face-to-face interactions. Work is in progress to explore ways to enhance interaction within our online meetings. This includes creating dedicated opportunities for members to connect, using the opportunity created by a reduction in meeting slots across RECs. Additionally, we will incorporate activities that aim to address these needs within the programmes for future REC development days, which continue to be our main opportunity for in person networking and learning for our members.

Communication with members over the past year has aimed to clarify that we are not returning to face-to-face REC meetings.

In order to gauge the level of demand, a specific question was asked in the recent community survey to understand members’ experience of online working, to gauge demand, and to seek views about what they feel is missing with meetings being online. The results of the community survey more widely have provided some helpful insights and are being used to inform the development of an action plan to address some of the feedback received, in discussion with the HRA Community Committee.

The survey responses provided helpful evidence that shows that most respondents appreciate the flexibility and convenience of online meetings, which was supported by positive comments. Some members stated that they could not be a member of a REC if the meetings were held in person. However, a minority of members feel that in-person interactions are needed for networking and learning. They miss the chance to build relationships with fellow committee members and engage more deeply.

Work continues to ensure that being a REC member is as positive an experience as possible.

Reviews undertaken

Applications reviewed at full REC meetings

Table one shows the number of applications reviewed at a full REC meeting. The number of applications reviewed at full REC meetings increased very slightly (1%) compared to the previous annual reporting year. 2445 applications were reviewed at a full REC meeting in 2023/24 in comparison to 2418 in the previous year.

All RECs continued to schedule ten full REC meetings per annual reporting year. In 20234/24 there were either four or five application slots available for each meeting.

Download a csv file for table one.

Table one alt text:

Table one shows the total number of applications reviewed at a full REC meeting broken into four application types CTIMP, Non-CTIMP, Research Database, research tissue bank. Table one also shows the median review time from submission to final opinion.

The clinical trials regulations specify that the ethics committee must give its opinion in 60 days. The data for CTIMPs reflects the timeline for the ethics review only. It is not the timeline for the combined review outcome which also includes the decision from the MHRA. The median time is used in performance reports in order that the data is not skewed by any outliers.

Applications reviewed by Proportionate Review sub-committees

Proportionate review is a lighter-touch ethics review process for research proposals which do not contain any material ethical issues. The number of proportionate review applications reviewed in 2023/24 increased by 12% in comparison to the previous year (790 in 2023/24 compared to 692 in 2022/23).

Download a csv file for table two.

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Table two shows the total number of Proportionate Review allocation types reviewed in 2023 and 2024 (790 total) and includes the median review time (21 days).

Substantial amendments

The number of substantial amendments submitted for REC review has reduced by 7% this year (6181 in 2023/24 compared to 6612 in 2022/23).

Download a csv file for table three.

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Table three shows the total number of substantial amendments reviewed at a REC sub committee meeting broken into four application types CTIMP, Non-CTIMP, Research Database and research tissue bank. Table three also shows the median review time from submission to final opinion.

Table three also shows the percentage of substantial amendments in each application type reviewed in less than 35 days (the Clinical Trials Regulations specify that the ethics committee must give its opinion in 35 days).

Fast-track ethics review

Fast-track ethics review is open to global clinical trials and phase I trials, whether the sponsor is commercial or non-commercial. This includes:

• any Clinical Trial of an Investigational Medicinal Product (CTIMP) led from UK with at least one other country participating
• any CTIMP led from outside the UK which could be placed in any country and the UK is competing for participation (including any only taking place in the UK)
• any phase I or phase I/II CTIMP in healthy volunteers or patients

Download a csv file for table four.

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Table four shows the total number of fast track applications reviewed in 2023 and 2024 and includes the median review time. Table four shows the type of submission (fast track research ethics review) that has 179 reviewed with a median time to final opinion of 26.

REC meeting decisions

Figure three: ethics opinions issued at full REC meetings

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Figure three shows the ethical opinion decision types issued at full REC meetings in 2023 and 2024 in three application categories: research tissue banks, Research Databases and Non-CTIMP studies.

Ethical Opinion Decision Types:

• favourable opinion: no outstanding ethical issues and no changes needed.
• favourable opinion with conditions: no outstanding ethical issues, minimal specific changes not requiring further review by the REC.
• provisional opinion: ethical issues to be addressed or further information needed to enable the REC to make a decision.
• unfavourable opinion: significant, unresolved ethical issues.

Figure three demonstrates that the majority (70%) of non-CTIMP applications reviewed at a full REC meeting are issued a provisional opinion at the time of the first review. This is comparable to the previous year where the provisional opinion decision rate was 73%.

The decision outcomes for CTIMPs have not been included in figure three as for CTIMPs, the REC is only able to issue a provisional opinion at the time of the first review in order that the applicant receives both the MHRA and REC decisions as a combined final outcome. Of the 608 CTIMPs which were submitted for REC review during the annual reporting period and which were issued a provisional outcome at the first review, 574 (94%) subsequently received a favourable opinion and 27 (4%) received an unfavourable opinion.

Of the 84 Phase 1 CTIMPs which were issued a provisional outcome at the first review, 81 (96%) subsequently received a favourable opinion and three (4%) received an unfavourable opinion.

Figure four: applications reviewed by Proportionate Review sub-committee

• no opinion: a Proportionate Review sub-committee can issue ‘no opinion’ when an application submitted for Proportionate Review contains material ethical issues which requires a review at a full Research Ethics Committee meeting.

Download a csv file for figure four.

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Figure four shows the ethical opinion decision types issued at a Proportionate Review sub-committee in 2023 and 2024.

In addition to the ethical opinion decision types available to full REC Committee meetings, a Proportionate Review sub-committee can issue a ‘no opinion’ decision type when an application submitted for Proportionate Review contains material ethical issues which requires a review at a full Research Ethics Committee meeting.

Generic Review Committee

This is a small committee of two members which provides an ethics opinion on generic recruitment documents for Phase 1 trials. As well as new submissions, the Generic Review Committee also receives amendments to previously approved submissions. Excellent feedback about the service which the Generic Review Committee provides continues to be received from the Phase 1 Advisory Group.

Download a csv file for table five.

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The Generic Review Committee is a small committee of two members which was established to provide an ethics opinion on generic recruitment documents for phase one trials. As well as new submissions, the Generic Review Committee also receives amendments to previously approved submissions.

Table five shows the number of new submissions and amendments reviewed in 2023 and 2024 and the median review time to final opinion.

Accreditation scheme for the audit of RECs

The accreditation scheme audits on the standards that relate directly to RECs as set out in GAfREC and the research ethics service standard operating procedures. The standards checked as part of the audit include a review of the constitution of the REC, member and officer appointments, member training and member attendance, and a quality check of REC meeting outputs (minutes and decision letters). The scheme runs on a two-year rolling cycle of audits.

All RECs audited during the annual report period achieved their accreditation. For RECs which had to complete an action plan before achieving accreditation, the most common action related to REC members not having completed their annual training requirement (all REC members must obtain eight learning credits related to research ethics each year). New functionality has recently been added to the reviewer portal to prompt members to complete and record their training.

From September 2023, a new way of issuing REC accreditation was tested. This was done in order to provide a true picture of quality and adherence to standards, without preparation for the audit interview. An increase in audit findings were anticipated as the approach was changed. Themes were highlighted in the early stages and this allowed corrective and preventative action to be taken. The trends continue to be reviewed through management reporting and regular review and discussion of the findings.

Figure five: audit outcomes

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A further 17 RECs achieved full accreditation, following the successful completion of an action plan.

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Figure five shows the percentage totals outcomes from the HRA internal Quality Assurance audit process standards established to make sure a REC is constituted, managed and operating in accordance with adherence to both internal and external standards and regulations, including Clinical Trials Regulations, the Governance Arrangements for Research Ethics Committees and HRA Standard Operational Procedures. This accreditation scheme runs on a two-year rolling cycle of audits.

Figure five shows the audit outcome option types and the percentages for those RECs reviewed during 2023 and 2024:

• full accreditation (9 REC members - 26%)
• accreditation with conditions (17 REC members - 48%)
• provisional accreditation with an audit action plan (9 REC members - 26%)
• a further 17 RECs achieved full accreditation, following the successful completion of an action plan

Appeals

If an application requiring REC review receives an unfavourable opinion, there is an option available for the applicant to appeal the decision. This means that the same application will be reviewed by a second REC.

Seven appeals were received during the annual reporting period. All the requests to appeal were allowed resulting in the following outcomes:

• four applications were issued a favourable opinion from the second REC (three of these received a provisional opinion first followed by a favourable opinion)
• one application received a second unfavourable opinion
• two applications were allowed to appeal however, the applicants were advised to resubmit as a new application due to the number of changes requested because they were originally proportionate review applications.

Breaches

A “serious breach” is defined as a breach of the protocol or of the conditions or principles of Good Clinical Practice (or equivalent standards for conduct of non- CTIMPs) which is likely to affect to a significant degree the safety or physical or mental integrity of the trial subjects, or the scientific value of the research.

It is a condition of the REC favourable opinion for the sponsor to notify the REC and relevant regulatory bodies of a serious breach in any study within seven days of the matter coming to their attention.

When reviewing breaches, the REC will consider what corrective and preventative actions have been taken and will consider the ethics, such as the information provided to participants and any impact on consent previously given.

Figure six: breaches

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Figure six shows the number of breaches submitted to the HRA per month during 2023 and 2024.

Figure seven: category of breaches

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Figure seven shows the total number of breaches submitted and reviewed to/by the HRA by category type for 2023 and 2024.

The breaches submitted to the HRA are assessed and assigned into one of the following categories:

• breach of ethical opinion - 8
• other (does not fit into any of the other categories) - 37
• data protection - 32
• tissue - 6
• no approval - 12
• safety reporting - 11
• record keeping - 15
• consent/PIS/recruitment - 46
• investigational medicinal product - 22

Conclusion

The HRA is extremely thankful for the significant and valuable contributions which REC members provide in terms of making the UK an excellent place to conduct health and social care research. REC members play a pivotal role in helping the HRA achieve its strategic objectives and give their time freely and generously to enable high quality research to take place in the UK. REC members do not just do this by taking part in the review of applications and the significant workload of amendments, but also in helping us understand how we can run the service even more effectively.

We have already implemented changes in 2024/25 to help with the work and membership of RECs to ensure that ethics reviews take place quickly, proportionately, and to a high standard. We also want to focus on what we can do to ensure that being a member of a REC is as enjoyable and rewarding as possible by introducing initiatives such as long service awards and access to NHS discounts for our volunteers.

So far in 2024 we have already been able to reduce the number of applications reviewed at full REC meetings by adjusting our proportionate review screening procedures. RECs which review CTMPs have four application slots per meeting and RECs which do not review CTIMPs have three application slots per meeting and review more proportionate review applications. This has been well received by members in terms of reducing the length of their meetings.

A significant amount of work has taken place across the United Kingdom Research Ethics Development Group (UKREDG) and a number of stakeholders (including all REC Chairs), to develop a new approach for how different types of REC members are described, changes to the meeting quoracy, and changes to our REC membership requirements to make it easier for a more diverse range of people to be involved in the work of RECs. We look forward to implementing these changes when the new clinical trials regulation comes into place to work towards achieving our aim to deliver a more transparent, flexible, and adaptable research ethics service.