Attending a REC meeting

Contents

1. Purpose of this information
2. Scope
3. What happens before the REC meeting?
4. Who will be in attendance at the REC meeting?
5. How to join the REC meeting
6. Review of an application
7. Composition of a REC
8. Is attendance required?
9. Who should attend?
10. Time and venue
11. What will I be asked?
12. What happens after the meeting?
13. User feedback

1. Purpose of this information

This information provides guidance and advice for applicants who have submitted an application for Research Ethics Committee (REC) review and will therefore be attending a REC meeting in the near future. This guidance applies to full REC meetings. This information provides you with a greater insight into the process of attending a REC meeting in the UK and is designed to ensure you are more familiar with the procedure of ethics review. All full REC meetings are held via web-conference. The link to join the web-conference will be included in your meeting invitation.

2. Scope

This information is for study representatives including chief investigators, students, academic supervisors, research sponsors, patient and public representatives, observers and anyone else involved in the research who may be attending a REC meeting for the review of an application. This guidance applies to RECs within the UK Health Departments’ Research Ethics Service. All full REC meetings are held virtually via web-conferencing with the option to dial in via teleconference if required.

3. What happens before the REC meeting?

Submission of a valid application

On receipt of a valid application, a member of staff will email you an acknowledgement with the date of the REC meeting, the web-conference link and the dial in details (for teleconference) your allocated time slot and the web-conference link which you should use to join the meeting. Please also let us know, if you have any access needs relating to a disability, health condition or neurodiversity, and how we can accommodate these for you to assist with your attendance at the meeting.

If your study requires HRA and HCRW Approval then the HRA Initial Assessment letter will accompany the invitation email.

4. Who will be in attendance at the REC meeting?

Between seven and 15 volunteer members of the REC will be present at the meeting. HRA staff will also be in attendance at the meeting to take the minutes and to provide operational advice and support. It is a formal committee meeting, but the REC will wish to make this a positive, supportive, and helpful experience.

REC meetings are occasionally attended by external observers, who will have no vested interest in the applications under review and will take no part in the discussion. All observers are required to sign a confidentiality agreement. You will be advised if any observer is in attendance at the meeting and will be offered the opportunity to ask the observer to leave.

5. How to join the REC meeting

Please check the web-conference link and dial in details carefully, to ensure that you can access them both prior to the meeting date. We ask that you join the meeting a few minutes ahead of your timeslot in the event the committee is ready to review your application earlier than your allocated time.

Upon clicking the web-conference link you will be assigned to the virtual waiting room and invited into the meeting once the REC is ready to review your application. You should be prepared to wait beyond the allocated time if necessary, and we ask that you wait in the virtual waiting room until you are brought into the meeting. The REC will try and keep this to a minimum and inform you of any delays in a message sent to you while in the virtual waiting room. If you join via teleconference then you will be assigned to the waiting room until the REC is ready to review your application.

If you have made arrangements to dial into the meeting via telephone you will be emailed if there are any delays.

We ask that applicants switch on their video if possible in order to help with the discussion and improve the quality of the interaction. Where possible, we recommend that you have a good sized screen in order to be able to see the REC members when they ask questions. You will also be able to see the REC members as soon as you join the REC meeting.

The length of time you can expect to be in the meeting will vary depending on the type of study and any questions the REC may have; however, you can expect to be present in the meeting usually from anywhere between five and 20 minutes.

RECs find it very helpful to be able to meet and talk to researchers at the REC meeting to discuss any matters relating to the ethics of the application and HRA and HCRW Approval assessment queries, so we strongly encourage a member of the research team to attend if possible.

6. Review of an application

The REC will discuss any ethical issues in the application prior to inviting you into the meeting.

Once the REC has held its initial discussion, you will be invited into the meeting to answer any questions raised. The Chair will introduce themselves and you will be welcomed to the meeting and asked to introduce yourself, and members of your research team. The Chair will inform you who will be asking the questions about your study on behalf of the committee. Sometimes the Chair will ask all of the questions, or you may be asked questions by different members of the committee. All committee members will introduce themselves before asking questions.

The Chair may also explain that the REC uses a lead and second reviewer system which involves allocating one or two members to review the application in particular detail which supports the ethics review process. The committee will raise clear questions or queries related to the application and supporting documentation.

The REC will ask you questions regarding any ethical issues arising from the review of your application. You should be ready to provide clarification in respect of any ethical issues that the REC may raise with you. It is helpful if you have a copy of your application form and study documents to refer to when you attend the meeting.

Alongside any ethical issues raised, there may also be further queries raised by an HRA Approvals Manager or Approvals Specialist regarding the HRA Assessment element of your application. This review is for applications that require HRA and HCRW Approval.

Please note that you will not need to give a formal presentation as the REC members will have read your application documents.

You will not need to take notes as the Approvals Officer or the Approvals Administrator will take minutes, which will form part of the ethics opinion sent to you by email within 10 working days.

Please be aware of the following key considerations:

• as with all meetings, timings can overrun and therefore you must consider that the agreed time slot for the review of your application may be delayed and factor this in when planning your availability. Every effort will be made to stick to the agenda timings, but overruns can occur.
• it will be the Chair of the committee who welcomes you to the meeting and who will provide a brief overview of the format.
• please ensure that you are in a quiet, private, confidential environment when attending a REC meeting. If you have colleagues who would like to listen to the discussion, that is fine however, it is generally more practical if just one person provides the responses back to the committee. Please inform the REC in advance about who will be attending the meeting including any colleagues and other members of the research team.
• if you have requested to join the meeting by tele-conference, please ensure that you have confirmed your telephone number with the supporting REC staff so that it can be recognised when you dial into the meeting. The committee members themselves will be joining the REC meeting by web-conference.

7. Composition of a REC

A REC comprises of seven to 18 members and at least seven members will be present at the meeting. Each REC is made up of expert and lay members. Expert members could include hospital consultants, nurses, academics, health care professionals, clinical trial statisticians, and pharmacists. Lay members come from a wide range of different backgrounds. Examples include carers, solicitors, members of the clergy and teachers to name a few.

Whereas every effort is made to ensure that each REC has a broad range of expertise, it is not possible for RECs to be specialists in all research topic areas, nor is this necessary. However, RECs have the option to request expert advice from a specialist referee (either a member of a different committee or an external referee), if the members feel that they would benefit from additional guidance. If advice from a referee was sought before or after the meeting, this will be communicated to you in the decision email that is issued following the REC meeting.

8. Is attendance required?

While attendance at a REC meeting is not compulsory, it is strongly recommended to assist with the speed of the review of your application. It is also important that students are accompanied by their academic supervisor.

Some issues the REC may identify, along with HRA assessment queries regarding your application, could be resolved if you are present to provide an explanation. Attending a REC meeting may avoid the need for questions to be raised via correspondence following the meeting which will allow you to receive the final outcome of the ethics review more quickly.

We strongly recommend that a suitable member/s of the research team attends the meeting. However, if no one is available to attend, the REC will make its decision based on the information in the application form and supporting documentation.

9. Who should attend?

The chief investigator should attend; while any other key investigators or a representative of the sponsor are also welcome to attend. Any representative who does attend the meeting should have a good understanding of the proposed research to be able to answer any questions.

10. Time and venue

Please note all REC meetings are held via web-conference

Individual full REC meetings take place 10 times a year via web- conferencing. Should you have a preferred REC that you wish to apply to for ethics review it is strongly recommended that you review the scheduled REC meeting dates on the Search Research Ethics Committee Directory - Health Research Authority (hra.nhs.uk); this may help to avoid any delay to the planning and commencement of your study.

11. What will I be asked?

You should be prepared to answer questions from the REC including questions regarding the science/methodology of the study.

The committee reviews applications in line with Standard Operating Procedures (SOPs) and refers to a lead reviewer form that outlines the main ethical domains.

The committee will need to consider the suitability of the applicant and the supporting staff as part of the ethics review and therefore, the committee may ask questions about the qualifications and experience of the chief investigator and research team if it is not clear from the submission documents.

REC members will consider your application with reference to the following ethical domains:

1. social or scientific value; scientific design and conduct of the study
2. recruitment arrangements and access to health information, and fair participant selection
3. favourable risk benefit ratio; anticipated benefits/risks for research participants (present and future)
4. care and protection of research participants; respect for potential and enrolled research participants’ welfare & dignity
5. informed consent process and the adequacy and completeness of research participant information
6. suitability of the applicant and supporting staff
7. independent review
8. suitability of supporting information
9. other general comments

There is a lead reviewer form for committee members to use when undertaking a full ethics review. There is also a separate lead reviewer form for studies requiring approval under the Mental Capacity Act (England), Research Databases and Research Tissue Banks. These documents are used when reviewing the application to ensure all aspects of the ethical review are considered.

Once all the REC’s main queries have been answered, you will be given an opportunity to raise any brief queries you may have, then you will be thanked for attending and asked to leave the web-conference (if you attend by teleconference then the telephone call will be terminated). The REC will then discuss the application further, taking into account the answers that you provided.

At the end of the discussion the REC will issue an ethics opinion and send the chief investigator (copying the sponsor) and attendees to the meeting the outcome of the review via email within a maximum of 10 working days of the meeting. This email will also provide the details of any assessment queries (if your study requires HRA and HCRW Approval). Please wait to receive the email outlining the outcome of the REC review before making any changes to your study documentation.

On occasions, the REC may find all aspects of the project completely satisfactory and there may be no need to ask you any questions. However, if you have attended the meeting the REC will still, out of courtesy, invite you into the meeting in case you have any questions.

12. What happens after the meeting?

Further information may be requested after the meeting via an email and will list any information needed from the REC and for the HRA assessment (if your study requires HRA and HCRW Approval).

You will be notified of the REC’s opinion via email, usually within 10 working days, and will receive one of the following decisions:

• favourable opinion with standard conditions
• favourable opinion with additional conditions
• provisional opinion with request for further information
• provisional opinion pending consultation with referee
• unfavourable opinion

Detailed information on what these decisions mean can be found in the REC Standard Operating Procedures

Applications submitted via the expedited review process will receive the status update sooner.

13. User feedback

The HRA website offers you the opportunity to provide feedback on the service received when making an application for ethical review. Applicants and sponsors are invited to complete the online feedback survey and rate a number of aspects including the website, the Integrated Research Application System (IRAS), helpfulness of the correspondence they have received and their views of the committee meeting they attended. Any comments received will help to inform the operational system and improve the service the HRA provides.

In addition to feedback provided by you post-review, the HRA may also approach you to provide feedback on the service you have received. Please refer to the Privacy Statement for details on how the HRA handles your data.

Requests can be made to investigate any aspect of the processing and application review on a more formal basis.

If you wish to raise a complaint about the HRA, including complaints about the standard or quality of services provided by the HRA, any divergence from procedures or the behaviour of our directly employed staff, secondees, agency workers, contractors and volunteer members, please email complaints@hra.nhs.uk. Your complaint will be managed in accordance with the HRA’s complaints policy and procedure.