The NHS Research and Development (R&D) strategy is committed to involving members of the public in the work it undertakes - not as "subjects" of research, but as active participants in the research process. Members of the public have already played an important role in some areas of R&D in the NHS, but there is room for improvement.
Various organisations have been set up to encourage the public to become more involved in research. The aim of these is to improve the way in which research is prioritised, planned, conducted and how the information obtained is communicated and used.
It is now acknowledged that research which is directed towards the public need is more likely to produce useful results which can then be used to improve practice in health and social care.
As part of that commitment, EPIC-Norfolk wishes to actively promote greater participant involvement in our research. For this reason, in 2010 we set up an EPIC-Norfolk Participant Panel to act as a consultation group to advise us on our research. We see the formation of this Panel as a partnership between EPIC participants and us as researchers.
Members of the EPIC-Norfolk Participant Panel can be involved in the designing of health questionnaires, writing of lay summaries, participant information, dissemination of results and providing a lay perspective on potential projects we may be considering for the future.
This was a busy meeting with thirteen Panel members and three members of the research team.
Matters arising from previous minutes
The minutes of the previous meeting were reviewed and updates given.
The Panel were updated on the mailout of the FU6 Questionnaire, Food Frequency Questionnaire 4 and the DietWebQ letter. The documents and process have been approved by the Ethics committee as a substantial amendment to the EPIC Study as a whole. There will be two further invitations for participants to undertake the DietWebQ, one which will be sent out with the 5HC invitation pack and the other which will be given at the Health Check.
The revised Consent form has been resubmitted and approved by Ethics.
There had been a lot of positive feedback regarding the talk at the previous meeting on measurements of obesity by Dr Emanuella de-Lucia-Rolfe. The work described has recently been published in Nature Genetics.
Information on opt outs
Robert Luben (Head of Bioinformatics – EPIC-Norfolk) gave a talk about patient Opt-Out including the history, the story of care.data and the possible implications of Opt-Outs for EPIC-Norfolk and other studies like it.
EPIC-Norfolk participants were flagged with the Office of National Statistics (ONS) from the beginning of the study in the early 90s and this ensured death and cancer notifications were given to the study. In addition, EPIC-Norfolk also receives Hospital Episode Statistics (HES).
EPIC-Norfolk obtained Confidentiality Advisory Group (CAG) Section 251 exemption for consent.
The Health and Social Care Information Centre (HSCIC) was set up to manage the data and send them out as appropriate.
Care.data was an initiative designed to collect data from GP records and health services, which could then be shared with health services planners, businesses and research studies. However, it was dropped in 2016.
No distinction seems to have been made between research studies and other commercial companies and on how data might be used. Some concerns were raised around privacy, non-identifiable data being sold to third parties, patients not being open with GPs for fear of data being released and re-identification risks. A leaflet was sent to households in the UK and an ‘Opt-Out’ offered. Some 700,000 people opted out and the care.data initiative was dropped in 2016.
A report by Dame Fiona Caldicott suggested two options for Opt-Out questions that could be used. Legal action was taken against HSCIC for not processing and recognising Opt-Out requests. They are now doing this and so provide no death certificate or cancer registrations for anyone who has opted out.
Opt-outs trump Section 251 meaning that EPIC-Norfolk does not get death or cancer data for people who have opted out via their GP. The rate of Opt-Outs is approximately 2 to 3% in EPIC-Norfolk Practices and this could introduce bias into the data being received. Many participants may not know the implications of opting out in terms of research as the wording varies between GP surgeries and some do not mention medical research at all.
The 5HC is a good opportunity to inform participants about opt-out implications. The next newsletter will describe opt-outs and ask people to phone in if they would like more information.
Suggestions from the Panel included a letter to GPs to highlight the effect of opt-outs on medical research. The distinction between research and companies making a profit is important to people. The consent received by EPIC has always followed the law and regulations of the time and is updated at each opportunity such as a health check.
Other cohort research projects have complained of similar frustrations.
If people change their mind regarding opt-outs, they should contact their GP practice.
Writing to the newspapers on the subject was suggested because the issue could severely affect medical research and people are not aware of this.
Fifth Health Check (5HC) update
5HC recruitment and appointments are working well and Panel members should now have received their 5HC appointment invitations.
The website coding update is continuing. The EPAP pages are now fully up to date and in a format which will make updates much easier to manage. The Summary Findings pages are currently being worked on.
Any other business
The Panel discussed a current news item regarding overcooked starch (eg burnt toast, roast potatoes).
The new meeting length and format was discussed. Each meeting will be tailored to the content to ensure leaving time for talks when needed as well as regular business.
These will be at the Assembly House, Norwich, starting at 11am. The next will be in April with a talk on Dementia and Definitions. The AGM will be in July and there will be an Ethics Committee member speaker. In October’s meeting, there will be a talk on results from the EPIC-Norfolk eye study.
AGM meeting 2011
Scoping meeting, March 2010
For more information about the Panel please contact Nichola Dalzell at firstname.lastname@example.org or on 01603 218165.