Contents

1. Assessment led REC Discussion
2. REC Annual Report 2021/2022
3. Apply to become a REC Chair, Vice-Chair or Alternate Vice Chair
4. Making reasonable adjustments at REC meetings for those with access needs
5. Using third party organisations for the payment of research participants’ expenses
6. Ethics Review of Combined Review CTIMPs

7. Contacting individuals who have declined to take part in a study

8. Joint Statement on the Application of Good Clinical Practice to Training for Researchers
9. National Data Opt Out
10. Staffing in the Approvals Operations Division and Approvals Support & Improvement Division
11. OpenAthens users

Assessment led REC Discussion

Following a successful pilot involving a sample of Research Ethics Committees (RECs) and a discussion at the most recent round of Chairs meetings, it has been agreed that from 1^st August the discussion of each HRA Approval application being reviewed at a full REC meeting will start with a summary of the assessment findings being provided by the Approvals Specialist.

The pilot found that raising the assessment findings first, helped to highlight what the Approvals Specialist had already considered as part of the HRA assessment, provided clarity of what issues the Approvals Specialist would be raising with the applicant, allowed members to focus on the ethics, and also increased REC members’ understanding of the role of the Approvals Specialist during the REC meeting.  

At the start of the review of each HRA Approval application, the Approvals Specialist will summarise their Initial Assessment Information for REC document– which typically takes around 1 minute to do. The Approvals Specialist will then pass back to the Lead Reviewer or members to undertake the ethics review.

An item will be added to your August or September REC meeting agendas to discuss this process. Any feedback on the item will be recorded in the minutes and shared with a senior member of the Approvals Operations team.

REC Annual Report 2021/2022

 The annual report for Research Ethics Committees (RECs) is now live on our website.

The annual report reflects on the last year and the work done to ensure we continue to deliver a high-quality service. Thank you all very much for helping this to happen! Between 2021 and 2022, we:  

• reviewed 2674 applications requiring full REC review with a median timeframe of 31 days, with 96% reviewed in less than 60 days
• reviewed 751 Proportionate Review applications with a median timeframe of 18 days  
• we started to deliver new, in person REC Development Days across England
• started our #StepForward recruitment campaign to attract new potential REC members
• provided training on and fully rolled out our combined review process for CTIMPs, which provides the REC opinion and MHRA authorisation delivered as a single UK decision.

Looking forward to 2023, our RECs want to continue doing great work. In 2023, we aim to recruit new members and increase diversity so that we can provide a service that is more reflective of the population it protects.

Apply to become a REC Chair, Vice-Chair or Alternate Vice Chair

If you are interested in developing your voluntary role within the REC service and you have at least one year’s experience as a REC member, why not consider applying to become a REC Officer (that is, a Chair, Vice Chair or Alternate Vice Chair)?

Benefits of a REC Officer role include developing and refining leadership skills which are transferable to the workplace.  Being a REC Officer is also recognised by some organisations as professional development and is recognised by schemes such as the National Clinical Impact Awards.   

In addition to working alongside their own REC members, REC Officers enjoy working with a number of other groups including HRA staff, research applicants and sponsors, and other REC Officers across the service to help promote ethical research.

To apply, please submit a written statement explaining why you are interested in the role and what you feel you can bring to the role (we suggest no more than one side of A4).  Please also provide an up-to-date CV and identify a referee – usually your current REC Chair.  This information should be sent via email to member.recruitment@hra.nhs.uk  Please include the title of the officer role that you are interested in applying for (Chair/Vice-Chair/Alternate Vice-Chair)  along with the name of your current REC in the subject header.

Candidates shortlisted will be invited to an interview and if successful following the interview, will join a bank of appointable REC Officers.   Those on the bank will be approached about REC Officer opportunities as and when they arise.

To learn more about the different REC Officer roles why not have a look at the role descriptions available on the HRA website?  We can also arrange for you to speak to an experienced REC Officer and/or Louise Braley, the Membership Development Manager, if you would like to learn more about the roles and the support available to REC Officers.  If you would find this helpful, please contact Louise at Louise.Braley@hra.nhs.uk

Making reasonable adjustments at REC meetings for those with access needs

We have received feedback that we could make the ethics review process more accessible to those with a disability, health condition, or neurodiversity by making a few simple changes. In order to respond to this, we have recently updated our REC meeting invitation email to include a request that the applicant lets us know if they have any access needs and how we might meet them. These accommodations/changes are described as “reasonable adjustments”.

We have identified a few adjustments that could be made available when needed without a significant burden to the Committee or staff:

1. The applicant could elect to not attend the meeting (as a reasonable adjustment). In this circumstance, we will make it clear that their non-attendance will not affect the final outcome of their application.
2. Offering a pre-meeting discussion with either a staff member or the Chair to talk through the ethics review process and to provide a friendly face on the day.
3. Bring a “buddy” to provide support at the meeting.
4. Brief the Committee on communications challenges that the individual may face (with the individual’s agreement), in order that the Committee may take these into consideration in their approach during the meeting.

Approvals staff will let the Committee know where reasonable adjustments have been requested/put in place for the applicant. Where an adjustment requires changes to the Committee operation or might have an impact on the running of the meeting this will be discussed with the Chair in advance.

Using third party organisations for the payment of research participants’ expenses

At one of the Chairs meetings held during the Spring, some RECs expressed concern about electronic expense payment systems (e.g. Greenphire, versions of Visa etc. ) increasingly being used by sponsors for studies involving patients.

Expense payment systems managed by third parties are frequently used for Phase 1 studies in healthy volunteers and in June 2021 guidance for REC members was included in an Information Exchange to state that this was an acceptable approach.

However, some RECs have expressed concerns with electronic payment systems being used in studies involving patients (rather than healthy volunteers) who might be very unwell or who might struggle to use the system due to their condition.

During the meeting, it was discussed whether RECs could request that an alternative should be provided for patients who might find submitting expenses via an electronic system difficult due to being physically or mentally unwell (e.g. by submitting expense claims to the local research team instead with paper receipts etc.). There were mixed views within the group as other RECs felt that electronic expense payment systems offered practical and efficient methods of organising expenses and the additional resource need to process hard copy expense forms could cause delays.

We decided to discuss this issue with some research site staff to see what the impact would be on sites if RECs specified that an alternative method of submitting expenses was made available. The feedback from those asked was that they were supportive of patients being provided with a choice. Therefore, if a REC is concerned about how patients are expected to submit their expenses, it is reasonable to specify that an alternative option should be available for patients who might not be well enough to use an electronic system.

Ethics Review of Combined Review CTIMPs

We have been asked what RECs should do if they have a concern regarding the trial safety or methodology for combined review CTIMPs as although both of these areas will be reviewed by the MHRA medical assessor, members wanted to know what they could do if they still had a particular concern relating to these aspects of the trial.

We would like to take this opportunity to clarify that RECs can raise issues regarding the safety or trial methodology however, these issues should ideally be raised with the MHRA first so that there is a co-ordinated approach before points to be addressed are presented to the sponsor. REC members should ideally highlight any concerns before the REC meeting so that any specific concerns can be raised with the MHRA medical assessor assigned to the application. In some cases the MHRA medical assessment report will be available in the Member Portal, in which case you can review this and see what the MHRA has raised, or you can raise concerns during the meeting which can then be raised with the MHRA  after the meeting – either directly by e-mail or as a Part 1 issue which Approvals staff submit in the HARP database.  The MHRA medical assessor will review the issue being raised and may respond to it by providing further information and justification  to the REC for this position, they may accept the issue in principle but request a change to how the issue is presented, or it may be accepted in full.

The MHRA undertakes a comprehensive review of the safety and methodology and is primarily responsible for the assessment of these particular areas and the MHRA Medical Assessors have the qualifications and experience to undertake these assessments. However, we recognise that some individual REC members will also have such qualifications and/or experience which means that they inevitably will see and question things which are also being reviewed by the MHRA. These concerns can be raised, but this should be as a co-ordinated approach with the MHRA as specified above.

Contacting individuals who have declined to take part in a study

The following topic was discussed at the Chairs meetings held in the Spring as some RECs reported that they were receiving more of these requests:

‘A number of researchers are including strategies in their application for following up people who had chosen not to participate in the study. Amendments to go back and contact people who have declined to take part in order to find out why they made this decision have also been submitted. Some members have viewed this as inappropriate and potentially coercive. However, for feasibility studies this level of insight could make a real difference to informing the main study. When asked to provide further rationale, some researchers have provided a strong case for needing to go back and contact ‘decliners’.

Chairs were asked to comment on what factors are considered by their REC when reviewing these requests. The following points of consideration were identified and it was agreed to share these with all REC members:

• The appropriateness of contacting people who had declined to take part needed to be considered on a case by case basis depending on the particular study and the reasons why the information was needed.
• Researchers need to provide evidence and rationale as to why they require this information.
• Views on contacting ‘decliners’ should be sought as part of the public involvement. Early public involvement could also prevent the need to contact people who have declined to take part by helping to identify and mitigate barriers to recruitment at an earlier stage.
• The method of following up was important. For example, an email or letter is less intrusive than a telephone call. There should also only be one attempt to make contact.
• The person contacting the individual who had chosen not to take part should be a different person to who had originally provided them with information about the study.
• The Participant Information Sheet should inform potential participants that they might be contacted if they chose not to take part to help provide information about their reasons but there should be an opt-out or additional statement on the consent form available for people who do not wish to be contacted.
• Finding out why people have chosen not to take part is valuable information for feasibility studies to help improve the main study.

Joint Statement on the Application of Good Clinical Practice to Training for Researchers

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.

Researchers can sometimes be required, inappropriately and often disproportionately, to undertake GCP training when they do not conduct research in the field of clinical trials of investigational medicinal products (CTIMPs) or where their involvement in the trial is minimal and entirely within their professional expertise.

The HRA and MHRA published a joint statement regarding the expectations for GCP training and REC members are reminded that they should not be suggesting that researchers undertake GCP training or request evidence that they have completed it.

National Data Opt Out

In May 2018 the National Data Opt Out (NDO) was announced in England. This provided patients in England the option to opt out of their information being used for research and planning. Importantly, the NDO only applies where confidential patient information (that is identifiable patient information) without consent, and where an application to the Confidentiality Advisory Group (CAG) was necessary.

Due to COVID, implementation of the NDO has been pushed back. However, from the 31 July 2022 it has been mandatory for organisations in England to apply the NDO for activities undertaken with Section 251 support, following CAG advice. Due to its recent increased prominence, REC members considering applications may see references to the NDO – please be reassured that CAG will be ensuring that the NDO will be applied as part of their considerations and it is not necessary for REC to review the NDO requirements of the study.

Further, please note that the NDO only applies to activities under section 251 support. For other application types (e.g. consented studies, use of anonymised data only), the use of the NDO is not required and should not be applied. Full details on when the NDO should be applied can be found in the operational guidance. Note that the NDO only applies in England, and it not relevant for patient data use in Northern Ireland, Scotland or Wales.

Please speak to your Approvals Specialist for support where necessary.

Staffing in the Approvals Operations Division and Approvals Support & Improvement Division

REC members who have already attended one of our face-to-face development days will have received some information regarding the structure and areas of responsibilities of the Approvals Operations Division and Approvals Support and Improvement Divisions. We are sharing this with all members in response to feedback that it would be useful to have further information about who to contact in the organisation.

Approvals Support & Improvement Division - what we do

The Support & Improvement Division is led by Reshma Raycoba (email: Reshma.Raycoba@hra.nhs.uk) who has been appointed as the Head of Approvals Support & Improvement. The contribution and commitment of our REC members is critical to the HRA. The Support team provides dedicated support to members of RECs. Having a centralised team, with fixed points of contact for REC members, allows us to undertake the planning and logistics of scheduling REC meetings, manage member expenses, and plan and oversee the recruitment of members more efficiently.

The Support & Improvement Division has primary responsibility for:

• Logistics for REC meetings, including venue and facilities
• Processing member expense claims
• Accreditation of RECs
• REC Officer and Member Recruitment
• REC Member Development and training (in liaison with the HRA Learning team)
• Matters relating to the constitution of RECs and co-opting of Members
• Quality and performance reporting (in liaison with the Quality Assurance and Operations teams)
• Appeals and Breaches
• UK-wide Research Ethics Service delivery
• Generic Document Review Committee

Approvals Operations Division - what we do

The Approvals Operations Division is led by Matthew Harris, Head of Approvals Operations (email: Matthew.Harris@hra.nhs.uk) who is responsible for the running of the Approvals Operations Division and the HRA Approval service, which brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent ethics opinion undertaken by a REC.

Each REC is supported by either an Approvals Specialist or Approvals Manager (but not both), an Approvals Officer and/or Approvals Administrator. The role of Specialists and Managers will be the same in relation to the REC meeting, but Approvals Managers also have a role in managing teams of staff.

• The Approvals Specialist or Approvals Manager will attend the monthly REC meetings. They will be responsible for assisting the REC with any queries related to the information detailed in the Initial Assessment for REC form (for HRA Approval studies) and will validate Full and Proportionate Review applications. They are also able to advise the REC on REC SOP’s.
• The Approvals Administrator/s or Approvals Officer assigned to your REC will set the REC meeting agenda, check that the meeting is quorate, and attend the monthly REC meeting to take the minutes.
• The Approvals Administrator/s also process amendments, facilitate Sub-Committee meetings, and assist with post approval work.
• The Approvals Officers also support Pharmacy Assurance, Audits, Actively Managing Applications across multiple RECs and REC Member Development days.
• The Workflow Administrators undertake general administrative duties to manage the flow of applications. They also process and acknowledge report submissions (including but not limited to; Safety, Progress, and End of study reports).

OpenAthens users

REC members with OpenAthens accounts will be prompted to change their password in the coming months if it does not meet the new password requirements.  If the HRA has previously provided you with an OpenAthens account and you have any questions about it please contact training@hra.nhs.uk