The UK Biobank - A Question of Trust
Introduction
The Wellcome Trust (WT) and the Medical Research Council (MRC) commissioned People Science & Policy Ltd to conduct a public consultation about the ethical and management issues surrounding the proposed BioBank UK project.
Research Method
Three sessions were held in January 2002 in Hertfordshire, the West Midlands and Glasgow. Each session involved 20 people1 in the age group 45-69 (the proposed age of volunteers for BioBank UK). They were split into two groups of 10 for an introductory session of 1½ hours on a weekday evening. The groups were reconvened the following Saturday for a four hour interactive workshop session with PSP moderators and two members of the project team, one from the Wellcome Trust, the other from the MRC.
Everyone actively participated. People were willing to discuss the issues and all had thought about the project between the two sessions. Some useful practical ideas to support the development of the project were generated.
Recruitment
Motivation
Participants were very supportive and the great majority said they would take part on the basis that research was “a good thing” and that valuable information would come out of the study. However, participants may over-claiming their altruistic motivation in a group setting.
Potential barriers to participation
While most of the barriers to participation were practical, some have a more philosophical basis. For some participants the practical barriers were sufficient justification for not taking part. Others said that they would not take part because they were ethically opposed to the idea. Yet others may justify their inertia by citing ethical concerns or by saying that the study has not been thought through and will not provide reliable data.
Respondent burden
This consultation identified that inertia and apathy, lack of motivation, some reluctance to give blood and, for some, unclear benefits, are likely to reduce the response rate. There was general acceptance of the content of the initial examination and lifestyle questionnaire. Some participants recommended that lifestyle data should be up-dated more regularly than proposed.
The location, timing and content of the initial data collection are important factors in whether people will take part. Participants were also concerned about the time involved for monitoring, although it was understood that it was entirely through records and that “you would probably forget you were in the study”.
“Isn’t this already being done/known?”
There was a general sense that more is known about genetics than is actually the case. Some participants were therefore sceptical that BioBank would add anything to existing knowledge or current research.
Scale of the study and representativeness
Questions were asked about the scale of the project and why so many people were needed. Once there had been more discussion there was a feeling that perhaps it was not large enough. Questions were also raised the about how honest people would be in giving lifestyle data.
Age
There is limited understanding about the rationale behind the age group selected.
Impact on general practitioners
Some participants were concerned about the burden on GPs and the implications of this for healthcare delivery. Others looked for assurances that their GP would not have access to their lifestyle data.
Value for money
The question of whether or not this is the best use of the money was raised. The majority view was that it would be if it delivers what it promises.
Feedback
For many this is a real potential motivator. Participants saw the initial examination as an “MOT” and had high expectations of the feedback. They initially believed that their sample would be tested to ensure that they are well. The limitations of any testing must be made very clear.
Access and confidentiality
Access by users (both non-commercial and commercial); volunteers and their families; GPs; the police; insurance companies and employers; as well as illegal access, was covered.
It is clear that complete confidentiality at the individual level is important to potential volunteers. The need to re-link data with names in order to up-date data was understood.
There was little discussion about the role of academic researchers. However, there was a general assumption, despite some explanations to the contrary, that most of the research would be conducted by BioBank staff.
The idea of access by commercial organisations raised concerns. After some thought however, most participants realised that this is the only way medicines will be developed. Nevertheless, there remained concern that companies should address major healthcare issues and not just focus on “profitable diseases”.
Some participants were looking for ways in which they would benefit from taking part in the study. Access to personal health information that they might not otherwise have was the most obvious direct benefit. Some were also keen that their descendants should have access to the samples in case it could help with future family diseases that are found to be genetic.
Many did not want their GPs to have access to the lifestyle data and everyone was clear that employers and insurance companies should not have access to individual data. However, many realised that the general findings will be published and therefore accessible to anyone and that this might indirectly affect insurance premiums.
There was some ambivalence about whether the police should have access to the information. Where groups explored this in more detail they seemed content that if a court order was obtained access would be granted.
The generally pragmatic attitudes to illegal access were summed up by the quote:
“You don’t have to wait for BioBank to exist for people to hack into data about you.”
Uses
Participants were keen to know how the data would be used. Questions such as “Will certain diseases be given priority?” were asked.
There was little interest in whether the information might be used to study the genes of behaviour or personality, even though the moderators raised it with participants. This does not mean that use of the data is not an issue. This is what might be termed a second order issue that is likely to be discussed in more depth once more immediate concerns, such as confidentiality and general purpose, have been dealt with.
Arguments about the emergence of a “genetic underclass” were not picked-up either, although the impact on insurance premiums was an issue raised spontaneously. There was some concern that if direct access to samples, rather than just data, were to be allowed, that individual volunteers might be cloned.
Governance
Participants generally recommended that some form of oversight body should be established and that the body should be capable of acting independently of the users and sponsors. Two main models emerged.
The first was a fairly traditional stakeholder panel with users, funders, volunteers and the medical profession represented. Participants proposed that it should be headed by a well known person, maybe a retired judge. The individual members would be nominated or recruited through advertising. A role was also identified for people not directly involved in the project, and “with no financial interest” such as lawyers, clerics, etc.
The second model involves proactively seeking lay members with no vested interest in BioBank. They would be supported by professional staff and have the ability to consult more widely on specific issues as they saw fit. Some participants believe that “no one who wants to be on it [the oversight board] should be”.
Participants said that this oversight body should agree the rules for access, use, royalty payments, guarantee destruction of samples for those who wish to withdraw, and set sanctions for those who abuse their right of access. Generally, any such body should ensure that standards of behaviour and ethics were maintained and continued to reflect the public mood as the public consensus changes but within the original terms of the consent given by volunteers.
There were two minority views expressed. One held that “if it is that important the Government should be doing it”. The other was that as “the Wellcome Trust and MRC are reputable bodies, why can’t they do it?”.