Observing a Research Ethics Committee meeting

About the Health Research Authority

The Health Research Authority (HRA) is here to protect the rights, safety, dignity and wellbeing of people who take part in research (research participants) and to facilitate and promote ethical research that is of potential benefit to participants, science and society.

Our vision is for high quality health and social care research today, which improves everyone’s health and wellbeing tomorrow. We help realise this by making it easy to do research that people can trust.

We have a duty to provide an efficient and robust ethics review service that is a core part of the research regulation in the UK. Our service also helps to maximise UK competitiveness for health research and maximises the return from investment in the UK, while protecting participants and researchers.

Our objectives, taken from our strategy are:

• supporting UK growth in life sciences – so the UK is the easiest place in the world to do excellent health and social care research that people can trust
• health and social care research is done with and for everyone, meaning that we can all benefit from research findings, helping reduce health inequalities
• health and social care research is streamlined, efficient and encourages and supports success, increasing the impact of money invested

Our website is a great place to find out more about what is going on in the HRA.

If you’d like to, you can also sign up to receive HRA Latest which provides ongoing information about our current and future work.

What is a Research Ethics Committee?

Research Ethics Committees (REC) review research applications when their is a legal or policy requirement, for example, when the study is testing a new medicine or taking place in the NHS or adult social care. Their focus is to protect the rights, safety, dignity and wellbeing of research participants. The other UK nations also provide a research ethics review service, which runs in a similar way. Managing the Research Ethics Committees in England is one of the HRA’s core functions.

Our RECs review research proposals and give an opinion about whether the research is ethical, including participant involvement in the research. The committees are entirely independent of research sponsors (the organisations responsible for the management and conduct of the research), funders and the researchers themselves. This enables them to put people (participants) at the centre of their ethics review.

Who can observe a REC meeting?

Anyone is welcome to observe a REC meeting. Observers might include:

• members of HRA staff including new starters
• members of the public
• people who would like to apply to volunteer as a REC member
• representatives from patient, carer and voluntary sector organisations
• representatives from the research community

How do I register to observe a meeting?

Please complete an observer request form if you would like to register your interest in observing a REC meeting.

If you have a particular interest in a research area, we will try to match you to a REC reviewing relevant studies.

The REC directory page is a place where you can find a list of meeting dates for all Research Ethics Committees (RECs) across the UK. If you would like to observe a specific committee after looking at this list, do let us know. It would be helpful if we could have at least a month’s notice to arrange an observation so that we can ensure we can book you onto one of the limited slots available for each meeting.

How does observing a meeting work?

All of our REC meetings are held online. Once we know which meeting you will be joining, you will be sent information about the meeting, the agenda and a link to join the meeting. We encourage you to put your camera on when you join the meeting, so that the Chair knows that you have arrived and can introduce you to the REC.

Are meetings confidential?

Public observers will be asked to sign a confidentiality agreement ahead of the meeting and prior to receiving the agenda for the REC meeting. This is because the information being discussed is confidential. Because of this, it is important that when joining, you are in a private area where the meeting discussion cannot be overheard.

How old do I need to be to observe a REC meeting?

If you are under the age of 16 and would like to observe a REC meeting, we recommend that you attend with an adult relative, tutor or guardian.

We might also get in touch with you to check what you would most like to gain from observing a REC so we can provide you with the appropriate information and support.

Can I take part in the discussion?

When you initially join the meeting, before researchers (applicants) join, the Chair will welcome you and say a few words. However, from that point, we request turning your camera off.

As an observer, you will be able to listen to the business of the meeting, however you will not be able to take part in the REC’s discussions. Observers aren’t expected to ask questions relating to topics not covered on the agenda, take part in voting or put their own views to the REC.

What should I do if I have a question?

At the end of the meeting, if there is time, you can check with the Chair or the member of staff who has been in touch with you before the meeting about whether you can ask a question relating to items on the agenda.

If you have specific questions ahead of or, following the REC meeting, these can be directed to the member of staff co-ordinating your observation request.

How do the meetings run?

At the start of the meeting the Chair will introduce you to the REC. The Chair will then move on to the business of the meeting which are detailed in the agenda and will include the following items:

• noting any apologies
• reviewing the minutes from the previous meeting
• considering if any members have a conflict of interest with any of the applications on the agenda (in which case a decision is made about whether they might need to leave the meeting)

The meeting will then turn to the applications that have been submitted for REC review. The REC will discuss the application and supporting documents and agree the key questions that will be asked of the applicant.

Each study review works as follows:

• once the lead reviewer has provided their comments, other members of the REC will be invited to raise any further points
• the REC will agree what questions they will ask of the applicant and who will be asking the questions - this could be one of the lead reviewers, or the Chair or it might be shared out across members
• the applicant is then invited to the meeting and will answer the questions raised by the REC
• the applicant will then leave the REC meeting and the REC will agree its decision.

Each agenda item slot is allocated approximately 30 minutes, however, sometimes the discussion may take longer depending on the questions and the level of discussion. Applicants are told of the outcome of the review within 10 working days of the REC meeting.

Please note that once the applicants are invited into the meeting, the Chair will let them know that an observer is present and are given the opportunity to object to an observer being present for the review of their application. We will inform them of the presence of an observer before the meeting. If the applicant would prefer not to have an observer present, we have to respect this and so you will be asked to leave the meeting for the question and answer stage of the review of that particular application and you can join again once the discussion has ended.

What documents will I be provided with?

The meeting agenda will be made available to you. We do not share the application documentation with observers so that we can maintain confidentiality for those applying to us for an ethical opinion on their studies.

You may hear the committee talk about a number of forms that they have used to review the study paperwork before the meeting. We list them here for your awareness. RECs use an Ethics Review Framework which helps to structure their review; there are other forms you might hear them refer to depending on the study type.

There is the main Ethics Review Form and then others depending on whether studies involve Adults Lacking Capacity to Consent for themselves , are for Research Tissue Banks and finally one for Research Database applications.

Most RECs assign two people to take a more in-depth look at all the study documents and feed back the main points to the rest of the committee. This helps the committee consider all the studies they will cover at their meeting. They can review up to four studies at each meeting. We refer to the people tasked with doing this detailed work as the lead reviewer and second reviewer, which you will hear mentioned in the meeting.

What are the potential outcomes of a meeting?

There are set outcomes and decisions available to the REC for each application. These are:

• favourable opinion with standard conditions - the study has been approved
• favourable opinion with additional conditions - the study has been approved with some very minor changes to documentation.
• unfavourable opinion (This is an option for non-CTIMPs only. For CTIMPs, an unfavourable opinion can only be issued following a request for further information in the first instance)
• Request for further information - Where necessary, the REC can issue a request for further information. For CTIMPs, where the REC cannot issue a favourable opinion (with or without additional conditions), it will issue a request for further information in the first instance
• Request for further information pending consultation with referee - The Committee may decide that a final opinion cannot be made until they are able to get further advice and expertise has been sought from a referee. A REC may seek the advice of a referee on any aspects of an application that are relevant to the formation of an ethical opinion, and which lies beyond the expertise of the members or on which the Committee is unable to agree. These referees may be specialists in ethics, specific diseases or methodologies, or they may be representatives of communities, patients or special interest groups.

Please note that once the applicants are invited into the meeting, the Chair will let them know that an observer is present and are given the opportunity to object to an observer being present for the review of their application. We also inform them of this before the meeting. If the applicant would prefer not to have an observer present, we have to respect this and so you will be asked to leave the meeting for the question and answer stage of the review of that particular application and you can join again once the discussion has ended.

The length of the meeting will vary depending on how many applications need to be reviewed; however, they usually run for around three to four hours.

Who will be at the meeting?

Our committees are all made up of volunteers. They are people from all walks of life and this means that we see a variety of people who bring different skills, experiences and points of view. This is really important as it means that we have insight from different perspectives. Everyone’s view is equally important in the committee regardless of whether they are professionally involved in the NHS, social care or research more widely; or not.

To comply with regulations, five members present at a meeting, although the aim is always to have seven members where possible.

The REC meeting will include at least the following:

• A Chair person (this can be a Chair, Vice Chair or Alternate Vice Chair)

• At least one lay member

• At least one member with a healthcare designation. (For social care applications, this can be a member with a social care designation). The REC membership will collectively reflect the qualifications and experience to review the science, medical aspects and ethics of the research applications.

You can find more information on REC member roles and designations here on our website

The meetings are also attended by members of HRA staff who review the studies from other perspectives (for example making sure they have the right insurance in place, that data protection requirements are being followed). You may see up to three HRA staff members at the meeting. They will summarise the review they have completed on the studies. They will also take the minutes of the meetings and ensure that the outcome letters reach the applicants in a timely way.

The meetings are also attended by the applicants who have submitted their research for review at the meeting – they are invited to join the meeting once the REC have discussed the application. Sometimes the applicants attend the meeting on their own and some will bring other colleagues along to answer specific questions, for example someone who specialises in statistics or a patient who’s been working with them to develop the proposed research study.

How long are meetings?

The length of the meeting will vary depending on how many applications need to be reviewed; however, they usually run for around three to four hours.

Do I have to stay for the entire meeting?

No. You don’t have to stay for the entire meeting. It is helpful if you can let us know in advance how long you’ll be staying.

What if I have accessibility requirements?

If you have any specific accessibility requirements or if you need any adjustments, we’re keen to ensure that we can support you in any way we can.

Please email member.support@hra.nhs.uk in advance of the meeting so that we can make the necessary arrangements for you.

Can I record the meeting?

The details of all meetings are confidential.

Because of this, audio or video recording, live reporting and taking screen shots of REC meetings is not allowed by observers. You will be agreeing to this when you sign the Observer Confidentiality Agreement.

We pride ourselves on running a trusted service and so we ask our observers to respect confidentiality and ensure that they don’t disrupt the meetings.

What if I don't understand some of the terminology?

You may hear a few words being used at the meeting that you’re not familiar with - don't worry if you don't understand a term though!

If you aren't sure about a term that has been used, please do ask. You can find further acronyms under the glossary section of our Standard Operating Procedures.