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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 ethical 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.

The move to virtual meetings during the Covid-19 pandemic meant that more applicants were able to attend REC meetings without the need to travel. With this is mind and feedback received from applicants and REC members, we have agreed to take advantage of virtual working and the benefits it provides. Therefore, all full REC meetings will be held virtually under this new model, as a permanent arrangement. All full REC meetings will be held via web-conferencing (using Zoom) with the option to dial in via teleconference.

3. Submission of a valid application

On receipt of a valid application the REC staff will email you an acknowledgement with the date of the REC meeting, your allocated time slot and the web-conference link.

All the REC designated email addresses can be found on the Search Research Ethics Committee Directory.

4. What happens at a REC meeting?

Between seven and 15 volunteer members of the REC will be present at the meeting, together with HRA staff attending for minute taking and to provide technical advice and support. It is a formal committee meeting, but the REC will wish to make this a positive and helpful experience.

REC meetings are occasionally attended by observers, who will have no vested interest in the applications under review and will take no part in the discussion. If this is the case the Chair of the REC will inform you and ask if you have any objections to their presence. All observers are required to sign a confidentiality agreement form. 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. This does not apply to HRA staff who may be in attendance to observe the meeting.

The REC will ask you questions surrounding ethical issues arising from a review of your application to seek reassurance that all ethical issues have been addressed (see point 11). 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.

You will not need to take notes as the Approvals Officer or the Approvals Administrator will take minutes, which will form part of the ethical decision sent to you via a status update email.

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. If you are not able to attend via web-conferencing, then it is possible to make arrangements for you to dial into a REC meeting by telephone (teleconference). 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. Once you click on the Zoom web-conference link you will be placed into a waiting room until the committee is ready to review your application. You will be informed if the meeting is overrunning. Please note that your time in the meeting will vary from 5 minutes up to 20 minutes and would depend on the review of your application.
  • It will be the Chair of the committee who introduces you.
  • 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 who shall be attending the meeting including any colleagues and other members of the research team.
  • If you choose to attend via teleconference then you will be placed into the waiting room and then brought into the meeting when the committee is ready to review your application. Committee members can hear the questions being raised and your responses. This is to support the committee in their ethical decision making. Often, but not exclusively, questions will normally be raised by the Chair of the committee who will introduce themselves to you and clearly raise the ethical issues that require clarification. The lead and second reviewer may also ask questions who will also introduce themselves to you.
  • If requested, please ensure that you have confirmed with the supporting REC staff your most appropriate telephone number from which you will be dialling from 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.

5. Composition of a REC

A REC is comprised of seven to 18 members (the optimum maximum membership is 15 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, whilst lay members are often people with no affiliation with the National Health Service. Lay members come from a wide range of different backgrounds. Examples include carers, solicitors, members of the clergy and teachers to name a few.

An email acknowledging the receipt of a valid application will be sent to you by REC staff. The email will advise of the date of the REC meeting, your time slot at the REC meeting and the web-conference dial in details. If your study requires HRA and HCRW Approval then the HRA Initial Assessment letter will accompany the status update email.

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 ethical review decision email that is issued following the REC meeting.

6. Is attendance required?

While attendance at a REC meeting is not compulsory, it is strongly recommended. We also strongly advise that students are accompanied by their academic supervisor. If you are unable to attend the meeting by web-conference, it is possible for you to dial in by telephone (teleconference). The teleconference number will also be included in the email sent to you.

As mentioned above, you are recommended to attend the meeting as 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 review more quickly.

Please ensure that you are in a quiet and confidential place when joining the meeting. You should ensure that you have good quality internet connection, and that you have access to a copy of the application documents with you. Where possible, we recommended that you have a good sized screen in order to be able to see the REC members when they ask questions.

If you are unable to attend either via web-conferencing or over the telephone by dialling in, the REC will make its ethical decision based on the information in the application form and supporting documentation. If you or another person attending the meeting has a disability that would affect the attendance at a virtual meeting please contact the Approvals Manager or Approvals Specialist prior to the meeting to allow appropriate arrangements to be made. The contact details for the Approvals Manager or Approvals Specialist will be detailed in the email sent to you inviting you to the meeting.

7. Who should attend?

The chief investigator should attend; whilst 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. Applicants should have a copy of the REC application form and supporting documents to hand when attending the REC meeting. For eligible student applications, it is strongly recommended that the academic supervisor attends the meeting with the student. Please note that you will not need to give a formal presentation as the REC members will have read your application documents.

8. 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 ethical review it is strongly recommended that you review the scheduled REC meeting dates on the Search Research Ethics Committee Directory; this may help to avoid any delay to the planning and commencement of your study.

The date of the full REC meeting, the web-conference link and the dial in details (for teleconference) will be emailed to you upon receipt of a valid application.

You will be given an approximate window of time for the discussion of the application however, whilst RECs do try to keep to time, this can be difficult dependent upon the discussions required for individual applications. 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 keep you informed of any delays in a message sent to you while in the waiting room.

If you have made arrangements to dial into the meeting via telephone (see point four) you will be emailed of a delay.

Please note it may not always be possible to give those applicants that are attending via telephone an update for any unforeseen delays and therefore we would greatly appreciate your understanding that contact may not be made at the exact time agreed and you should be prepared to wait beyond the allocated time given to you.

9. Attendance at 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. The date of the REC meeting including the Zoom web-conference link and dial in details will be emailed to you in a status update upon receipt of a valid application. We ask that you join the meeting a few minutes early in the event the committee are ready to review your application earlier than your allocated time.

Upon clicking the Zoom web-conference link you will be assigned to the waiting room and invited into the meeting once the REC is ready to review your application. We ask that applicants switch on their video so the REC members can see you. You will also be able to see the REC members as soon as you join the REC meeting. If you join via teleconference then you will be assigned to the waiting room until the REC is ready to review your application. As soon as you are brought into the meeting the REC will be able to hear you.

10. 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 their initial discussion, you will be invited into the meeting to answer any questions which may have been 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 question. 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 and this supports the ethical review process (see point 11). The committee will raise clear questions or queries related to the application and supporting documentation.

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 review applications in line with Standard Operating Procedures (SOPs) and refer 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.

Some of the considerations the Committee will review are as follows.

  • Are the applicant and supporting staff suitably qualified and do they have experience relevant to the proposed research?
  • Are the facilities and arrangements suitable?
  • Have any conflicts of interest been considered?
  • Has the safety of the research team been considered?

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 ethical 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.

Any questions the REC has could be directed from the Chair alone, a member who has led the review of the study or any other member of the committee. This varies by REC. If your research involves the NHS and is lead from England or Wales, a member of HRA Approvals staff may ask you questions to help with the HRA assessment of the application.

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 for anywhere between five and 20 minutes.

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 make an ethical decision and send the chief investigator (copying the sponsor) and attendees to the meeting the outcome of the review of your application via email. This email will outline the ethical decision and assessment queries (if your study requires HRA and HCRW Approval) within a maximum of 10 working days of the meeting. Please wait to receive the email outlining the outcome of the REC review before making any changes to your study documentation.

after

12. What happens after the meeting?

The REC may not be able to ask you all of their questions at the meeting therefore, further information may be requested as part of a request for further information after the meeting. The status update will list any requests for further information from the REC and any further information needed for the HRA Approval assessment (if your study requires HRA and HCRW Approval).

You will be notified of the REC’s decision via a status update 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 (Fast Track REC) will receive the status update sooner.

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.

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 on the HRA websitefor details on how the HRA handles your data.

The HRA has a complaints policy if you request that any aspect of the processing and review of the application is investigated 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.

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