There were twelve participants together with seven EPIC Researchers and administration staff present at the EPIC Participant Advisory Panel’s Annual General Meeting held at the Assembly House, Norwich.
Being the AGM, the opportunity was taken for EPAP members and EPIC group staff to introduce themselves and give a brief overview of their backgrounds, Panel membership and roles.
There have been no Panel member resignations or starters since the last AGM in July 2015.
Matters arising from previous minutes
The health and lifestyle (FU6) questionnaire and the DietWebQ have been finalised and an ethics application is being prepared. As this pack is being sent to all remaining EPIC participants, a newsletter will also be included in the questionnaire pack.
An additional point has been added to the 5HC consent form covering the use of tissue.
The views of the Panel on the collaboration proposal considered at the previous meeting were reported to the EPIC management committee. No further decisions will be made until the group carrying out this research have received ethics permission.
The wrist monitors shown to the Panel at the previous meeting have been included in the 5HC. Two colours will be purchased so that couples will be able to distinguish between them.
EPIC and BREXIT statement
The Panel asked about the effect of Brexit on research and the EPIC Study.
Professor Kay-Tee Khaw provided a statement regarding research funding following the BREXIT vote.
5HC update ‐ consent
NJD informed the Panel that the 5HC application had been reviewed by the ethics committee in June and that a small number of queries had been received. These are being addressed and a response forwarded to the committee by their 5 August deadline.
The 5HC administration processes are ready to go and it is hoped that approaches to participants will be sent in August following Research Governance approval.
One of the ethics points raised was regarding the consent form. The Panel were asked for their views on the suggested consent form revisions and the resulting Panel discussion will be fed back to the EPIC Management Committee for further consideration.
Overview on 5HC preparations
The Research Assistants present at the meeting provided an overview on the practical preparations for the 5HC covering topics such as system modification and testing, documentation review, posters, practice run through of appointments with staff from other sites and appointment modifications based on feedback.
Panel members were given information about patient opt-out.
Participants in EPIC gave permission when they joined the study ‘to provide information from my medical records’. Section 251, which EPIC has been granted, allows access to medical records without permission. EPIC utilise every opportunity to inform individuals that they follow up on participants using their medical records – this is important scientifically and to ensure that participant data is not wasted.
NHS patients can ask for their personal information to be prevented from leaving their GP practice and for the prevention of identifiable health and social care data being released by HSCIC (now known as NHS Digital). Both of these apply for uses other than direct patient care. Data can be used by HSCIC for healthcare planning, commissioning services, payment by results, developing national policy, improving public health and university research (this is where EPIC comes in) but if a patient opts-out via their GP practice, their data cannot be used for any of these secondary uses.
EPIC-Norfolk links to medical records and HSCIC to enable updates of participant data (health, death and contact information). Where possible, the preferred option is to obtain updated informed consent at the ongoing Health Checks. However, some participants may not be able to attend a Health Check for a number of reasons such as transport problems and ill health. However, they may still be taking part in the study and providing or have provided data in other ways, such as questionnaires. In these circumstances, Section 251 would apply.
EPIC follow ‘fair processing’ – informing participants, including those who do not attend Health Checks that they follow up on their health using records and access data.
Nationally 1 in 45 people are opting-out of their GPs giving information to HSCIC. EPIC would not be able to follow up using GP or HSCIC information when people have registered an objection with their GP. HSCIC have informed EPIC that having obtained Section 251 does not override this. Therefore, the EPIC sample could become biased and this could result in EPIC attempting to contact people who have died and could cause upset to families.
Informed consent does override an opt-out registered via the GP but this does not take into account people who are unable to come to EPIC Health Checks and for whom EPIC cannot gain consent at this point.
Q. Do people understand that if they have a registered an objection via their GP, that their data cannot be used/useful in any research studies that they have been taking part in?
Q. Is this point being made clear in any information relating to opting out and is there a mechanism to opt back in?
A full discussion took place and EPAP members’ views were that they had not heard of it. They suggested talking to practice managers as GPs may not have time, lobbying at a higher level and asking whether people were having the consequences of opt-out and research explained to them.
There was overall agreement that Panel members could approach their own GP practice to enquire what is happening with patient objection.
Election of posts
The Panel were asked whether anyone wished to put themselves forward for the three posts up for re-election. The following were re-elected unopposed:
- Chair – Nichola Dalzell
- Minute-taker – Stephanie Moore
- Website summary – Ron Brewer