Guthrie Cards in Scotland: Ethical, Legal and Social Issues

CHAPTER 7: GOVERNANCE

Key questions addressed by this chapter are:

• Who is (or should be) responsible for the governance of the collection?
• Who is legally liable if things go wrong?
• Can existing oversight bodies, such as research ethics committees or the Privacy Advisory Committee, assist with the governance challenges of the Guthrie collection?
• Can lessons be learned from other countries or other biomedical collections?
• What does good governance look like?

Key messages from this chapter are:

• The relationship between the Glasgow Southern General Hospital - as immediate custodian of the initial sample collections for the first two years - and other entities such as Greater Glasgow & Clyde Health Board, National Services Scotland, NHS Research Scotland, and Health Improvement Scotland should be clarified within lines of accountability and framework for research governance. Ultimately, it is Greater Glasgow & Clyde Health Board that bears the responsibility of management of the collection but the input and influence of national bodies could be explained further.
• Robust and transparent policies should be kept under constant review with respect to all aspects of the resource. Valuable lessons can be learned from the Danish model of research and access governance for newborn blood spot cards.
• It is suggested that models used by UK Biobank and Generation Scotland to provide independent oversight of biomedical collections add considerable value in addressing the challenges of running a long-term resource into an uncertain future and could serve as possible models. Governance mechanisms for the Guthrie collection could learn useful lessons in this regard.
• Governance mechanisms must include policies and procedures for raising awareness of the collection and engaging with the public and other stakeholders, such as the research community.
• It is for consideration whether an education campaign like that envisaged by the Confidentiality and Security Advisory Group for Scotland (CSAGS) should now be undertaken in Scotland.

DISCUSSION

7.1 Good governance in healthcare has become a topic of significant interest in recent years. In the United Kingdom alone, numerous projects are underway with respect to information governance. Novel models of governance have been instituted for large-scale longitudinal genetic resource projects such as UK Biobank and Generation Scotland; the Scottish Health Informatics Programme (SHIP) has been launched with involvement of NHSScotland; the Ministry of Justice has published a report on Data Sharing and the UK Government has issued its response and Scottish Government has held various consultations on improving research infrastructure in Scotland and which culminated in the publication of its Guiding Principles for Data Linkage.¹³⁰ A growing number of examples of good practice are emerging as lessons are learned from experience.¹³¹ In this regard, we should also consider foreign experiences, not just the cautionary such as those outlined in Chapter 2, but also the positive and especially that of the Danish Newborn Screening Biobank. In sum, there is much experience on which to drawn when considering the governance challenges of the Guthrie collection in Scotland. This chapter lays out those challenges as identified in this report and makes suggestions as to how these can be met.

Governance challenges

7.2 The following governance challenges face the Guthrie collection:

• Although the Scottish Newborn Screening Laboratory sits under the auspices of Greater Glasgow and Clyde Health Board and NSS, it would be helpful to clarify how its operation should dove-tail with other branches of the work of NSS, such as Privacy Advisory Committee, and how/whether there should be a role for research ethics committees, for example in applications for access. The input from other agencies, such as NHS Research Scotland that has produced tissue research Guiding Principles, and Health Improvement Scotland, which is responsible for monitoring compliance under its Accreditation Scheme, further complicates matters.
• More particularly, the role of the Caldicott Guardian with respect to the collection and the Scottish Newborn Screening Laboratory could be more explicit.
• A Governance Board and/or an Access Committee has been established for the Guthrie collection and this is welcomed. Notwithstanding, its role and relationship to other bodies also needs further elucidation with respect to all of the points raised in previous chapters.
• Independent oversight will be provided by Healthcare Improvement Scotland in monitoring the Guiding Principles. It is for further consideration whether this is sufficient for all aspects of the resource, especially given its potential high profile and public concerns that we discuss in the next chapter. Other large biomedical collections now benefit from such monitoring and advice.
• There has been little effort to engage the wider public about the collection and its uses. Consideration should be given to the need for consultation.

Learning from experience: Danish Newborn Screening Biobank (NBS-Biobank)

7.3 This example has been chosen as the most closely analogous to the position in Scotland. Since 1982, residual dried blood spot samples from virtually all newborns in Denmark, Greenland and the Faroe Islands have been stored in the Danish Newborn Screening Biobank (NBS-Biobank). There are approximately 1.8 million samples in the bank.¹³² The purpose of the storage is:

• Diagnosis and treatment of congenital disorders including documentation, repeat testing, quality assurance, statistics and improvement of screening methods;
• Diagnostic use later in infancy after informed consent;
• Legal use after a court order;
• The possibility of research projects after approval by the Scientific Ethical Committee System in Denmark, the Danish Data Protection Agency and the NBS-Biobank Steering Committee.¹³³

Parents may "opt-out of biobank storage at the time of blood sampling by marking the data card, or at any time later, either by a written letter to the department or by registering in the central 'Use of Tissue Register' (www.Sundhedsstyrelsen.dk/vaev)".¹³⁴

7.4 New Biobank Regulations were introduced in 2004 and incorporate the terms of the EU Data Protection Directive (which is also the basis of the Data Protection Act 1998 in the UK). A Task Group on biobank regulation determined in 2002 that a biobank may be regarded as a 'manual register' and is, therefore, subject to the legislation in data protection. This provides some support for the Scottish position that Guthrie Cards are "medical records" and the conclusion in this report that they are subject to the Data Protection Act 1998. The Task Group also made recommendations which led to changes in the law:

• The establishment of a central opt-out register for the use of tissue (the Central Use of Tissue Register), which allows people to opt-out of non-treatment-related use of biological material, and a right to destruction or the conditional surrender of donated biobank material;
• The approval of all research projects using biobank material by a science-ethical committee.¹³⁵

The new regulations on biobanks, published by the Ministry of Health in September 2004, made the following provisions:

1. The biobank and register must be registered and accepted by the Danish Data Protection Agency with information about purpose, operation, data-responsible authority, biobank-responsible person, etc. (Act on processing of personal data). The equivalent in the United Kingdom is the Information Commissioner's Office.

2. Accordance with the Act on Patients' Rights which is concerned with 'self-determination' for a clinical biobank concerning informed consent and the right to 'opt out', to 'destruction' or to 'retrieval' of the biobank material. There is no equivalent Act in Scotland or the United Kingdom, although the general legal position embodies a right to self-determination with a right to refuse.

3. Procedures for use of biobank material for research must always be accepted by the Scientific Ethical Committee System according to the Act on Scientific Committee (www.cvk.im.dk). The Guthrie collection in Scotland currently has no such oversight.

4. According to the Act on Health, the biobank-responsible person(s) is/are responsible according to general rules for personal health care concerning secrecy confidentiality, etc. Complaints concerning biobanks can be directed to the Health Care Patients Complaints Authority, Danish National Board of Health. As established above, the equivalent lines of accountability for the Scottish Guthrie collection lead to NSS within NHS Scotland.¹³⁶

Steering Committee for Scientific Use of the NBS-Biobanks

7.5 A Steering Committee for Scientific Use of the NBS-Biobank (SCSU) was set up in 2005 to administer the use of the samples for research and, in particular, to prioritise the use of the residual blood spots to ensure that enough blood is left to serve the most important purposes, which are, first, the analysis of the residual blood spots for the benefit of the child and family and, second, the development of new methods for newborn screening analyses.¹³⁷

7.6 Once the proposed project has received approval from the Danish Data Protection Agency and the Scientific Ethics Committee System, the SCSU "evaluates the scientific value of the projects and the appropriateness of the proposed analytical technology", ensuring that "there is always enough blood left of each sample to complete the necessary medical analyses directly related to the original purpose of storage", that being medical analyses for the benefit of the child and family.¹³⁸ This is a very good example both of priority setting with respect to the use of a depletable resource and of robust mechanisms for assessing the scientific/public value of proposed uses. A further consideration for such a body might be an assessment of the likely privacy impact on individuals of granting any particular application for access and recommendations as to whether this is acceptable or might be minimised.

7.7 In Scotland, the Greater Glasgow & Clyde Health Board Biorepository Governance Board acting as Access Committee could scrutinise applications in this way. Alternatively, or additionally, a research ethics committee or a body such as the Privacy Advisory Committee in Scotland could have such responsibility or even a wider oversight role. At the time of writing a consultation was underway on the need for a National Privacy Advisory Committee. In this respect, lessons might be learned closer to home from the UK Biobank project and the Generation Scotland project and existing guidelines/principles for tissue collections¹³⁹.

Learning from experience: UK Biobank and Generation Scotland

7.8 The purpose of the UK Biobank project is to build a resource for research in the public good with the specific aim of improving the prevention, diagnosis and treatment of illness and promoting health throughout society. Recruitment took place between 2007 and 2010 and the resource now contains health and lifestyle data and biological samples from over 500,000 individuals aged 40-69 at time of enrolment. Participants give broad consent to participate in UK Biobank and grant permission to UK Biobank to access to their health records, provide some biological samples (e.g. blood and urine) and information about their lifestyle. The cohort will be followed up for decades, capturing all major health episodes and eventual death.

7.9 UK Biobank operates within an Ethics and Governance Framework (EGF). The EGF is a public document which contains the express commitments of UK Biobank to its participants, to the public and to other stakeholders, such as researchers. The EGF affirms the right to withdraw at any time; makes a commitment to protect the confidentiality of both samples and data; confirms the role of UK Biobank as a steward of the resource (albeit, probably also its legal owner); describes the principles which will govern access to the resource and describes the benefit sharing arrangements that will be required of those who use the resource - these include the obligatory publication of findings (including negative results), return of data to UK Biobank, and the accessible storage of findings for future use.

7.10 UK Biobank is monitored by the independent Ethics and Governance Council (EGC).¹⁴⁰ The EGC is a permanent and independent body to oversee the project and to monitor and advise on its operation.¹⁴¹ Current challenges facing UK Biobank and the EGC are the development of access policy and procedures and the possible input of the EGC into the work of any Access Committee which might be established by UK Biobank.

7.11 Generation Scotland (GS) has a similar scientific focus to UK Biobank in that it is concerned with gene/environment interaction in the onset of disease; it is entirely complementary, however, in that it seeks to recruit families and not unrelated individuals. GS also has governance parallels with UK Biobank in that it has been overseen by the Generation Scotland Advisory Board which performed a similar function to the UKB Ethics and Governance Council.¹⁴² This was disbanded in due course once the resource was firmly established, albeit the on-going issues continue to arise as access has got underway.

7.12 In both cases, the rationale for an independent advisory body is related to the long-term nature of each project - which could extend for many decades - and the known unknowns surrounding the kinds of research that might be carried out using each resource and the kinds of researchers who will carry it out. Thus, such oversight bodies provide on-going scrutiny and input as the projects develop and change. This role has not been undertaken by any body to date in the UK with respect to life sciences research. Equally, Scotland must not succumb to the vagaries of unwarranted regulatory burden. What is important here is that the function, not necessarily the form, of such entities is built into governance arrangements. That is, these functions might be picked up by the Greater Glasgow & Clyde Biorepository Governance Board and there might be no need to establish a new one so long as the key features of this role are discharged.

7.13 A further issue relates to the nature of the consent which is sought from participants and which arguably requires a different approach to that which has traditionally governed the involvement of individuals in research. This is broad consent as outlined above. This is used because it is not possible to give people full information prior to participation. Rather, the ethical (and legal) obligation is to inform people as the projects progress on matters such as access, research use, benefit sharing, commercialisation etc. In this way consent is constructed far more robustly as a process including an on-going obligation to engage with participants throughout the life of the project and not a one-off event prior to launch. Participants have a right to withdraw at any time and for any reason.

The parallels here with the Guthrie collection should be self-evident. They require on-going and robust engagement about the management and use of the Guthrie collection.

Public engagement

7.14 We address specific questions about public attitudes and engagement in the next chapter. Here we simply to point to the numerous junctures in this report, and in the experience of other collections, which suggest that a robust policy of public engagement is valuable and an increasingly essential feature of good governance. The English consultation on Guthrie cards contemplated the possibility of a public scrutiny panel and regular public consultation exercise.¹⁴³ At the time of writing the report remains unpublished. In Scotland, the Confidentiality and Security Advisory Group for Scotland (CSAGS)¹⁴⁴ recommended in 2002 a public education campaign about uses of health information but no such campaign has taken place. We recommend that this issue be given serious reconsideration.

POINTS TO CONSIDER AND RECOMMENDATIONS FROM CHAPTER 7:

• While it is Greater Glasgow & Clyde Health Board that has the principal responsibility for governance of the Guthrie collection, the relationship with, and influence of, other entities such as National Services Scotland, NHS Research Scotland, and Health Improvement Scotland could be elucidated further.
• Robust and transparent policies must be kept under review with respect to all aspects of the resource, especially because access requests are only likely to increase in the future. Valuable lessons can continue to be learned from the Danish model of research and access governance.
• It is for consideration whether the Guthrie collection requires its own independent oversight body. The important feature, however, is not the form of this governance but the fact that the key features are incorporated into arrangements. Thus the NHS Greater Glasgow & Clyde Biorepository Governance Board might learn valuable lessons from existing independent bodies such as the UK Biobank Ethics and Governance Council.
• Governance mechanisms must include policies and procedures for raising awareness of the collection and engaging with the public.
• It is for consideration whether an education campaign like that envisaged by CSAGS should now be undertaken in Scotland.