Annual Report for Research Ethics Committees (RECs) in England 1 April 2022 to 31 March 2023

Seasonal RECs

A ‘Seasonal REC’ was created during the annual reporting period in order to be able to offer increased REC meeting slot availability at known peak times across the year (spring, summer and winter holiday periods), where demand for the REC service outweighs the capacity that will allow us to meet our Key Performance Indicators (KPIs) including legal requirement for CTIMPS. Several RECs understandably choose summer or the festive period in December to have one of their months without a scheduled meeting. This, combined with RECs preferring to limit the number of applications to four or five per meeting agenda to assist with the running of virtual meetings, means that there can be fewer available slots during these periods. This has led to applicants needing to wait longer for their ethics review. As a service improvement initiative, the Seasonal REC was set up. This is made up of a pool of 53 experienced REC members from across the service who have volunteered to be part of this initiative. The Seasonal REC has been recognised to review CTIMPs by the United Kingdom Ethics Committee Authority (UKECA) and 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

Seven face to face REC development days were held in 2022. These were held across the country and were attended by 324 REC members. There was also an online event for members who could not attend one of the face-to-face events. The development days provided members with an opportunity to meet in person and to network with members of other RECs and HRA staff. REC meetings will continue to be held virtually and we are mindful that offering opportunities to meet in person are important to many of our members. We have continued to provide face to face development days for 2023 and 2024 based on the positive feedback received from those who attended in 2022 to 2023. The HRA also enabled members to meet outside of their REC meetings for a networking event in order to build working relationships as committee members, with a £25 contribution towards a meal.

Proportionate review

A high number of applications that are submitted for proportionate review (PR) need to be transferred to a full REC meeting once they have been screened by staff. This is due to not meeting the criteria for proportionate review. This created delays and we heard from applicants that it can be frustrating. As a response, in September 2022, we created and published a standalone proportionate review toolkit in order to help applicants determine whether their study is suitable for PR and to help direct their study to the appropriate route during the booking process.

How REC members have supported the HRA’s other work

As well as attending the monthly REC meetings and reviewing proportionate review applications and substantial amendments outside of the meetings, our REC members and Chairs also give their time to support the HRA in other ways. In 2022 to 2023, some examples of these additional activities include:

• five REC members were part of the Advisory Group for the Think Ethics programme and participated in a number of meetings and workshops
• in August 2022, two REC members participated in a workshop which was held with a range of stakeholders to develop the new quality standards and design and review principles for participant information. A second related workshop was then held in January 2023 to test the draft standards and design principles which three REC members participated in. The implementation of the quality standards and design principles is planned to take place in Autumn 2023
• six REC members participated in a role play to help demonstrate what happens at a REC meeting as part of the HRA strategy launch. A number of REC members also attended the HRA strategy launch online and in person
• a focus group was held in January 2023 to understand how the ethics review form is used and if the form or how it is used could be improved to aid REC review. REC members discussed how they use the form and whether they think
• proposed changes to its use would be feasible and beneficial. 15 members from four RECs attended the focus group. Following the focus group, four RECs took part in a pilot of using the ethics review form in a new way, 41 REC Members participated in total. A recommendation to review and update the ethics review form is being taken forward
• methods of ethics review: 30 REC members from across the UK attended an online workshop to discuss strengths and weaknesses of potential changes to the ethics review process in this workstream of Think Ethics
• 25 REC members attended and joined in with workshops and presentations held during the Make it Public research transparency week in March 2022
• REC member interviews: 30 interview panels to help recruit new REC members were held during the annual reporting period. Each interview panel includes two REC members and a member of HRA staff
• Chairs meetings: Chairs and Vice-Chairs from each REC attended the bi-annual Chairs meetings held in Spring and Autumn each year
• there are 14 REC member mentors delivering training and supporting newly appointed members with the research ethics review process

REC member recruitment and retention

The recruitment of new REC members and retention of existing members has continued to be a large area of focus:

• recruitment campaigns for new lay plus members and for expert members were held during the annual reporting period
• a new online application form for people to apply to join a REC was launched in early March 2023 and has resulted in a substantial increase in applications (73 new applications received in March 2023 compared to 13 in January 2023 and 16 in February 2023)
• a REC member satisfaction survey to seek feedback from all existing members was undertaken in March 2023
• the REC Mentor Scheme continues to support new REC members in their role and is well received. A total of 18 new mentor groups were established during the reporting period each meeting three – four times over a period of six months
• a learning and development portfolio to support REC members wishing to progress to a REC officer role has been established and continued learning and development has been provided for REC officers in post

Membership

The membership of the 64 RECs is set out in figure 1 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. There were 799 members at the end of the annual reporting period.

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 unconnected with the conduct of clinical research and not be registered health and social care professionals (lay plus). In order to make sure sufficient clinical and expert input, the HRA tries to make sure 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 64 England RECs is set out in figure one. Although GAfREC allows for up to 18 members to be appointed to each REC, 15 members is the operational target. There were 799 members at the end of the reporting period.

Figure one shows the numbers of the membership per member category: Expert (50%), Lay (27%) and Lay Plus (23%)

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.

As shown in figure two below, a greater number of members have left the service than we have been able to appoint, particularly in the lay plus member category. In Spring 2023, to help address this, the HRA initiated a lay plus member recruitment campaign. This involved developing new advertisement material, obtaining quotes from existing lay plus members, creating a series of tweets, and revising the HRA’s #Stepforward ‘Become a REC Member’ webpage. This, supported by the move to an online application process, resulted in a high number of applications.

The majority of members (77%) who left the service during the annual reporting period resigned as opposed to leaving at the end of their first or second term of office. The term of office for REC members is five years, which may be renewed for a second term of five years. Members can either decide to leave at the end of their first term of office after having served five years or they can choose to resign at any time. After ten years, members can either decide to leave, or can transfer to join a different REC. The most frequently cited reasons for leaving were increased workload or personal commitments which meant that they 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. Although identifying members to co-opt to attend REC meetings which are at risk of being inquorate has been made easier with online meetings, we have noticed a change over the last 12 months. The number of requests to co-opt members from different RECs to attend REC meetings which do not have enough members attending has increased significantly. Initial analysis has shown that the requests are not confined to RECs with lower membership and further work is underway to identify the reasons for this. Results will allow us to develop a more efficient process for ensuring that meetings are quorate.

Figure two: number of members appointed and leaving the service between 2022 and 2023

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Figure two shows the number of members (in each category type) appointed and leaving the service between 2022 and 2023.

As shown in figure two, a greater number of members have left the service than we have been able to appoint particularly in the lay plus member category.

The most frequently cited reasons for leaving were increased workload or personal commitments which meant that they no longer had time to volunteer as a REC member.

Figure three: how people applying to join a REC heard about us

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Figure three shows how the people (in each membership category type) are applying to join a REC, the chart shows the varying ways in which people have been informed or referred.

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 decreased by 11% compared to the previous year. 2418 applications were reviewed at a full REC meeting in 2022 / 2023 in comparison to 2674 in the previous year.

All RECs continue to schedule ten full REC meetings for the financial year with either four or five application slots available for each meeting.

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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.

Table one also shows the percentage of applications in each application type reviewed in less than 60 days (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).

Applications reviewed by Proportionate Review sub-committees

The number of Proportionate Review (PR) applications reviewed in 2022 to 2023 decreased by 9% in comparison to the previous year (692 in 2022 to 2023 compared to 751 in 2021 to 2022). Each REC in England schedules seven PR meetings per year with two agenda slots available at each meeting.

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Table two shows the total number of Proportionate Review allocation types reviewed in 2022 and 2023 and includes the median review time.

Substantial amendments

The number of substantial amendments reviewed by Research Ethics Committees in England has reduced by 9% this year (6612 in 2022 and 2023 compared to 7175 substantial amendments in 2021 and 2022).

(*The clinical trials regulations specify that the ethics committee must give its opinion on an amendment within 35 days).

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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, 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).

Modified amendments

Modified amendments can be submitted after an unfavourable opinion of a previous substantial amendment and have a 14-day ethics review timeline. The data in table four does not include any modified amendments for combined review CTIMP applications as these are just re-submitted as a new substantial amendment.

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Table four shows the total number of modified amendments reviewed in 2022 and 2023 and includes the median review time.

Modified amendments can be submitted after an unfavourable opinion of a previous substantial amendment and have a 14-day ethics review timeline. The data in table four does not include any modified amendments for combined review CTIMP applications as these are just re-submitted as a new substantial amendment.

Section 30 amendments

These are amendments to include adults lacking capacity in the study for the first time and have a 60-day ethics review timeline. These types of amendments are reviewed at a full Committee meeting in order that the REC can consider whether to approve the study under the Mental Capacity Act.

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Table five shows the total number of section 30 amendments reviewed in 2022 and 2023 and includes the median review time.

These are amendments to include adults lacking capacity in the study for the first time and have a 60-day ethics review timeline. These types of amendments are reviewed at a full Committee meeting in order that the REC can consider whether to approve the study under the Mental Capacity Act.

Fast track ethics review

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

• any Clinical Trial of an Investigational Medicinal Product (CTIMP) led from the 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 one or phase one / two CTIMP in healthy volunteers or patients

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Table six shows the total number of fast track applications reviewed in 2022 and 2023 and includes the median review time.

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

• any Clinical Trial of an Investigational Medicinal Product (CTIMP) led from the 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 one or phase one / two CTIMP in healthy volunteers or patients

REC meeting decisions

Figure four: ethics opinions issued at full REC meetings

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Figure four shows the ethical opinion decision types issued at full REC meetings in 2022 and 2023 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. Please note, this decision cannot be issued for combined review CTIMPs (including Phase one CTIMPs) at the time of the first review
• favourable opinion with conditions: no outstanding ethical issues, minimal specific changes not requiring further review by the REC. Please note, this decision cannot be issued for combined review CTIMPs (including Phase one CTIMPs) at the time of the first review
• provisional opinion: ethical issues to be addressed or further information needed to allow the REC to make a decision
• unfavourable opinion: significant, unresolved ethical issues. Please note, this decision cannot be issued for combined review CTIMPs (including Phase one CTIMPs) at the time of the first review

Figure four demonstrates that the majority (73%) 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 decision rate was 74%. Studies taking place in the NHS require HRA and HCRW Approval and the provisional opinion from the REC, will also be accompanied by a request for further information for the purposes of the HRA assessment as well in order that the applicant can provide a full response.

The decision outcomes for CTIMPs have not been included in figure four 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 662 CTIMPs which were issued a provisional outcome at the first review, 458 (69%) subsequently received a favourable opinion and 30 (5%) received an unfavourable opinion.

Of the 106 Phase one CTIMPs which were issued a provisional outcome at the first review, 100 subsequently received a favourable opinion, two unfavourable and four are awaiting a final outcome from the MHRA.

Figure five: 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

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Figure five shows the ethical opinion decision types issued at a Proportionate Review sub-committee in 2022 and 2023.

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 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.

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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 seven shows the number of new submissions and amendments reviewed in 2022 and 2023 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. For example, constitution (review of member expert / lay capacity), officer appointments, appointment / terms and conditions, training and attendance, along with final REC meeting products (minutes and decision letters). This scheme runs on a two-year rolling cycle of audits.

No committees failed to achieve accreditation. For those committees that had to complete an action plan before achieving accreditation the most common action related to REC members not having completed their annual training requirement. To help address this, the support and improvement team has submitted a request for change to HARP to allow members to view their training on the member portal and enter their self-directed learning. The format of the training records will also be updated so that members can see how many learning credits they have completed. This will support the proactive monitoring of training for our members.

Figure six: audit outcomes

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Figure six 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 six shows the audit outcome option types and the percentages for those RECs reviewed during 2022 and 2023:

• full accreditation
• accreditation with conditions
• full accreditation following successful completion of an audit action plan
• provisional accreditation with an audit action plan

Appeals

If an application 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.

Nine appeals against an unfavourable opinion for applications were received; all were allowed resulting in the following outcomes:

• six applications were issued favourable opinions (three received a provisional opinion followed by a favourable opinion)
• two applications received an unfavourable opinion again
• one application is currently on a provisional opinion and awaiting a final decision

Five appeals against an unfavourable opinion for substantial amendments were received; two of which were then submitted as a new application following consultation with the REC. Two were subsequently submitted as modified amendments following discussion with the REC and one appeal was allowed resulting in a second unfavourable opinion following re-review.

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 ethical issues, such as the information provided to participants and any impact on consent previously given.

Figure seven: breaches

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Figure seven shows the number of breaches submitted to the HRA per month during 2022 and 2023.

Figure eight: category of breaches

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Figure eight shows the total number of breaches submitted and reviewed to/by the HRA by category type for 2022 and 2023.

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

• investigational medicinal product
• consent / participant information sheet / recruitment
• record keeping
• safety reporting
• no approval
• tissue
• data protection
• other (does not fit into any of the other categories)
• breach of ethical opinion

Conclusion

We are 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.

There will be a number of changes which will affect the work and membership of research ethics committees and the research ethics review process in 2023 and 2024 which we look forward to taking forward in order to further enhance the service:

• the proposed legislative changes for clinical trials means that we have the opportunity to make changes to how REC members are classified and how RECs are described in the legislation. We are working with our REC members on some of the proposed changes
• a significant review of GAfREC and the Standard Operating Procedures for Research Ethics Committees will be undertaken to align with the new clinical trials regulations but also, to update our guidance and expectations for REC membership and REC review for other types of health and social care research
• our work in the HRA to attract and recruit new REC members with an emphasis on increasing diversity continues. We will also be collaborating with charities and communities to invite members of the public to observe our REC meetings to increase awareness of RECs amongst the public
• we will be using the results from our REC member satisfaction survey to inform further retention initiatives in order to retain existing members. We are working to consider ways to address feedback provided about the level of commitment and workload which the role of a REC member entails