Observing a Confidentiality Advisory Group 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 guiding principles, taken from our strategy are:

• to include, so that health and social care research is done with and for everyone
• to accelerate, so that research findings improve care faster because the UK is the easiest place in the world to do research that people can trust

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 the Confidentiality Advisory Group?

The Confidentiality Advisory Group (CAG) is an independent body which provides expert advice on the use of confidential patient information, without consent, and outside the direct care team. This includes providing advice to the Health Research Authority for research uses. It also provides advice to the Secretary of State for Health for non-research uses.

CAG advises on whether applications to access confidential patient information without consent should or should not be supported under the Health Service (Control of Patient Information) Regulations 2002, specifically Regulation 5. The Regulations enable the common law duty of confidentiality to be temporarily lifted so that confidential patient information can be processed without being in breach of the common law duty of confidence.

The key purpose of CAG is to protect and promote the interests of patients and the public, while at the same time facilitating appropriate use of confidential patient information for purposes beyond direct patient care, by ensuring the purpose is in the public interest.

The Confidentiality Advice Team (CAT) are the HRA employed secretariat to the CAG. You will have corresponded with a member of CAT whilst arranging observing the CAG meeting.

Who can observe a CAG meeting?

Anyone is welcome to observe CAG meetings. Observers might include:

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

How do I register to observe a CAG meeting?

If you would like to register to observe a CAG meeting please email member.support@hra.nhs.uk

On the CAG meetings dates page you can find a list of the upcoming CAG meeting dates. If you would like to observe a specific date, 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 CAG meetings are run online on Zoom. Once we know which meeting you will be joining, and approximately one week before the meeting date, you will be sent the agenda and a link to use to join the virtual 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 CAG.

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 CAG 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 CAG meeting?

If you are under the age of 16 and would like to observe a CAG 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 CAG meeting so we can provide you with the appropriate information and support.

Can I take part in the discussion?

When you initially join the meeting, the Chair will welcome you and say a few words. However, from that point, we would recommend 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 CAG 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 CAG.

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 CAG meeting, you can ask by emailing member.support@hra.nhs.uk

How do the meetings run?

At the start of the meeting the Chair will introduce you to the CAG. 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
• acknowledging if the HRA or Secretary of State decision makers agreed with CAG advice from a 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)
• commenting on the publication status of minutes from recent meetings

The meeting will then turn to the applications that have been submitted for CAG review. The CAG will discuss the application and supporting documents. If the applicant is attending, CAG will agree the key questions that will be asked of the applicant. If the applicant is not attending, which is usual for CAG currently, the Chair will sum up the CAG recommendation.

So that you can follow the general flow of the meeting, you might find it helpful to know that each study review works as follows:

• once the lead and other reviewers have provided their comments, other members of the CAG will be invited to raise any further points
• if an applicant is attending, the CAG 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 CAG
• the applicant will then leave the CAG meeting and the CAG will agree its decision - if there is no applicant attendance, this is completed after the first step
• each agenda item slot is allocated approximately 30 to 45 minutes, depending on the complexity of the application – however, sometimes the discussion may take longer

All CAG meetings have two Chairs attending. One Chair is assigned to each application. One CAG member is assigned as a ‘lead reviewer’ to each application, and they are expected to briefly present the application and discuss any areas they feel necessary.

Three other CAG members are also assigned to each application as ‘reviewers’, to take an in-depth look at all of the study documents and feed back their main points to the rest of the committee.

Members of the committee are not expected to read applications they are not assigned to, unless they are interested. CAG can review up to six applications at each meeting.

If there are applicants attending, 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.

What documents will I be provided with?

The meeting agenda will be made available. This will be sent to you approximately one week before the meeting. 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 whilst reviewing the study paperwork before the meeting.

The CAT complete a CAT assessment form prior to the CAG meeting, which contains detail on relevant parts of the application, including any areas that the CAT have identified as needing CAG scrutiny. The CAT will ask queries of the applicant prior to the meeting, and the query responses will also be provided.

There are other forms you might hear CAG refer to, such as the CAG application forms, which are different for research and non-research. For more detail on what CAG expect from an application, please see the guidance for CAG applicants page.

What are the potential outcomes of the meeting?

Applicants are told of the outcome of the review within 10 working days of the CAG meeting.

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

• fully supported – the application has a legal basis to access identifiable patient information within the boundaries of the application - the application will be subject to standard conditions of support
• conditionally supported – the application has a legal basis to access identifiable patient information within the boundaries of the application. The application will be subject to standard conditions of support and is also subject to some specific conditions which will need to be actioned within the timeframe provided in the outcome letter. Support is in place from the date of the letter, and the applicant does not have to provide a response to the conditions prior to beginning the activity
• provisionally supported – CAG may decide that they cannot advise support until further information or clarification has been provided by the applicant
• deferred – the application does not contain enough information for the CAG to advise the decision maker and the applicant may submit a new application for CAG to consider
• rejected – the application contains sufficient information and CAG have advised that the activity should not be supported

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, information governance; or not.

The make-up of the CAG committee includes one Chair, one Vice-Chair and two Alternate-Vice Chairs. There are currently 23 CAG members.

To comply with regulations, we need to have at least seven members present (including the two Chairs) at the meeting, to include at least one lay member and one expert member.

The different roles depend on the member's experience and you may hear them referred to following titles during the meeting:

• lay member - those with an interest in and experience of healthcare; as a patient, a service user or a carer
• expert member - those with professional expertise as a health professional, in health research or information governance

The meetings are also attended by the CAT, who are members of HRA staff. CAT review the applications prior to the meetings. You may see up to six CAT members at the meeting. They will take the minutes of the meeting and ensure that the outcome letters reach the applicants in a timely way.

You may also see other observers at the meeting. The meetings are also occasionally attended by the applicants who have submitted their application for review at the meeting – they are invited to join the meeting once the CAG have discussed the application. There can be up to three applicants attending per application.

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 between 2 and 4 hours. You do not have to stay for the entire meeting; it is helpful if you can let us know in advance how long you will be staying.

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 the meetings are confidential.

Because of this, audio or video recording, live reporting and taking screen shots of CAG meetings is not allowed by observers. You will be agreeing to this when you sign and return 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!

To help, we’ve put together a glossary of terms or acronyms you might hear used at CAG meetings. If you aren't sure about a term that has been used, please do ask.