The UK Biobank - Ethical & Governance Framework
Conducted on behalf of The Wellcome Trust and The Medical Research Council
Executive Summary
Introduction and method
People Science & Policy Ltd (PSP) has established a panel of 64 lay people aged between 45 and 69, the age group that will be invited to contribute to the UK Biobank. All panel members have previously participated in briefing and discussion sessions about the UK Biobank and are familiar with its broad purpose and the early plans proposed for its operation. The panel is not large enough to provide statistically representative data but it provides a cross-section of the population of interest. This panel has been recruited independently and membership is in no way connected to any future invitation to contribute to the UK Biobank.
An Interim Advisory Group (IAG) appointed by the Wellcome Trust and the Medical Research Council (MRC) produced an Ethical and Governance Framework (EGF). Before finalising their report to the UK Biobank team the IAG, supported by the Trust and the MRC, wished to consult with the panel on the draft EGF and the various options under discussion. In all, 47 panel members took part in this consultation between 15 May and 12 June 2003.
I. Relationship between UK Biobank and Participants
A. Understandings and consent.
1. Recruitment
a. Selection for participation
There were some questions about the power of GPs in selecting people for the UK Biobank. Some panel members wanted to be able to opt-in and give permission for access to their records, irrespective of the views of GPs about the project.
b. Procedure for recruitment
Recruitment was seen as a process with initial letters of invitation coming from the GP. Even if the administration were to be undertaken by the UK Biobank, it was thought that this would generate the best response rate. It was not thought to be misleading, as the GP must endorse the study by granting access to the medical records they hold. Moreover, letters coming from a largely unknown organisation could appear as a breach of confidence before the project has started.
Following the initial letter there might be a fuller information pack and the opportunity to attend local meetings to ask questions before attending the session with the research nurse. After the session with the research nurse, there might be a cooling-off period before the data is processed. It was thought that this process would help to minimise later drop-out, which it was recognised would be expensive as well as having an adverse impact on the scientific quality of the project.
2. Consent
The central issues in obtaining consent from potential volunteers were identified as confidentiality, security of data, the uses to which the data will be put and who will have access to the information. The UK Biobank will need to be able to provide detailed answers to operational questions.
3. Collection of data from medical records
Participants appreciated the necessity of access to past and future medical records and were more concerned about the potential absence of full records and inaccuracies that might be present.
4. Feedback of health information to participants
a. At enrolment (including initial blood analyses)
Participants were happy about the amount of feedback they would receive at the recruitment session.
b. After enrolment
The reasons that feedback will not be provided at an individual level are appreciated. However, many thought that it would motivate some to volunteer, whilst acknowledging that others might not want this feedback. The panel members have already had extensive discussions about individual feedback at earlier sessions.
5. Ongoing dialogue with participants
The panel members found it difficult to think of how they might “actively participate” after recruitment beyond providing more blood samples and up-dating lifestyle information. A paper newsletter that would provide information on who was using the data and for what purposes was popular. Some were concerned that producing and distributing a newsletter might divert money from research and preferred the option of a website. However, most people recognised that access to, or familiarity with, the Internet would mean that this option would not be appropriate for all the volunteers.
The opportunity to sit on the Oversight Body, the ability to ask questions and to feed in comments were other ideas put forward on how continuing dialogue with the volunteers might be achieved.
6. Expectation of recontact
The panel members understood the need for recontact to collect more information. Indeed in the original sessions questions had been asked about whether the data would be sufficiently reliable if it was only up-dated once in ten years.
There was no expectation that volunteers should receive information from the UK Biobank about the research being conducted or the operation of the project but it was of some interest to most of the panel. Keeping volunteers informed about the progress that the project was making was felt to be a good way of keeping the volunteers engaged and interested.
7. Right to withdraw
While some panel members were adamant that volunteers should not be allowed to withdraw, the majority believed that it was an essential right. There was also the view that being able to withdraw would reassure volunteers about the bone fides of the project.
8. Respect for incapacitated and deceased participants' wishes
There was a strong feeling that volunteers should be asked their views at the time of recruitment about their wishes in the case of death or mental incapacity during the ten years and that these wishes should be paramount.
Respect for relatives after death is essential and the UK Biobank will need to ensure that death records are processed quickly so that contact is not made with relatives after death.
With respect to mental incapacity, relatives might feel that a volunteer is too ill to be recontacted and this will need to be accommodated.
9. Expectation of financial gain
There was no expectation of financial gain for the volunteers. It was accepted that the data would be used by commercial companies, particularly pharmaceutical companies, for profit but it was thought that these types of organisations should pay for access to the UK Biobank.
B. Confidentiality
1. Commitment to maintaining confidentiality
The commitment to confidentiality was seen as paramount.
2. Anonymisation
It was important to the panel members that researchers should not know the identity of the individuals with whose data they are working.
3. Re-identification
The need for re-identification was understood by everyone who took part. Some groups recommended the use of high-level encryption and encoding to remove the need for anyone to be able to access the full dataset for any individual. Others recommended that two or more people should hold part of the “key” and that it should be people within the UK Biobank structure – perhaps the Chairs of the Oversight Board, the Scientific Committee, the Ethics Committee or the Chief Executive.
4. Security
While it was acknowledged that the data is not a matter of “national security”, it was assumed that security would be tight. Some panel members were unconcerned about who saw their medical records but others were much more wary.
II. Relationship between UK Biobank and Research Users
A. Stewardship of data and samples
It was assumed that the professionals recruited to work at the UK Biobank would have professional codes of conduct that would be enforced.
B. Research access to data and samples
1. General terms of access
It was agreed that access should be for medical research, which would include the identification of the causes of illness and cures as well as investigating what is detrimental to health. It was envisaged that most users would be academics and the pharmaceutical industry.
Use by the food industry to develop healthy foods or foods that would protect health, was sanctioned, where it arose. Access by insurance companies was ruled out by everyone. Access by tobacco and alcohol companies, who might claim to be able to make products that were safer, was also raised by some panel members, but seen as a more ambiguous area.
Access by non-UK organisations was accepted but it was suggested that more rigorous checks might be needed for non-UK companies.
2. Specific terms of access
Panel members recommended that there be a fee for access to the information in the UK Biobank. Furthermore, any organisation likely to make a profit from their research results should be charged more than others, probably through a profit-sharing formula.
3. Requirement of data sharing and broad release of findings
The philosophy that all results will be published and that information will be fed back to the UK Biobank as a condition of access was widely supported.
III. Relationship between UK Biobank and Society
A. Internal Governance
1. UK Biobank Board of Directors
This body was thought to be responsible for the day-to-day running of the UK Biobank. It was assumed that it will comprise suitably qualified and experienced professionals.
2. Oversight Body
The Oversight Body should perhaps consider another name as “oversight” is commonly associated with an error.
There was consensus that there should be some independent professionals on the Oversight Body.
The main function of the Oversight Body should be to oversee the workings of the UK Biobank, to ensure that the rules are being abided by, to agree changes in policy, particularly with reference to the ethical and governance framework, and to act as an arbiter of last resort on operational and access matters.
It was thought an Oversight Body that meets a few times a year, paying members’ expenses or a small allowance and receiving staff reports, should be able to meet this aspiration, provided that it is given the authority to challenge the reports laid before it. However, it was suggested that thought should be given to an external auditing procedure to ensure that not only are the finances being correctly managed but that operating systems are being adhered to.
The Nolan principles were recognised as having weaknesses but the transparency of the process largely reassured the more sceptical participants. The independent assessor will be an important figure and, it was suggested, could be one of the volunteers or a GP.
B. External Governance
1. NHS ethics review
This was discussed in some groups and the existing processes provided reassurance to the panel members. Some within these groups thought that this process rendered the proposed UK Biobank Ethics Committee redundant.
2. Department of Health Research Governance Framework for Health and Social Care
Participants believed that where there are existing relevant codes of conduct, these should be applied, whether they had originated in the UK or overseas.
C. Benefit sharing and intellectual property
The panel members see the final outputs as benefiting society as a whole through better diagnosis and treatment of disease. They recognised that individual companies exist to make a profit and are therefore unlikely to invest in research if they cannot protect their intellectual property rights. It was suggested that one way to address this might be to recover some proportion of profits in the case of medicines being developed as a result of the UK Biobank data.
D. Contingency in event of closure of UK Biobank
This was not discussed in this consultation.
IV. Adoption, implementation and revision of the EGF
An EGF should be adopted by the funders initially and subsequently up-dated and revised by the Oversight Body.