Guthrie Cards in Scotland: Ethical, Legal and Social Issues

CHAPTER 3 - CORE CONSIDERATIONS FOR THIS REPORT: PERSONS, PURPOSES AND PROCEDURES

3.1 It is important to identify the core concerns associated with the collection, storage and use of Guthrie cards in Scotland in order to inform adequately the discussion and recommendations in this report and the future policies applied to the collection. We suggest that the core considerations relate to: Persons, Purposes and Procedures.

Key questions to ask of the collection are:

• Which persons are affected by the collection and how?
• What purposes are envisaged for the collection, now and in the future, and how legitimate are these purposes?
• What procedures are required to respect persons and to legitimate purposes?

Key messages from this chapter are:

1. It is essential to consider the full range of people affected by the collection. Different people might be affected in different ways and different legal rules might apply to them.

2. It is essential to consider the full range of purposes for which the collection might be used, both now and in the future. Although a range of purposes might be justified, the case for each use must be clearly made. The justifications must be all the stronger as the use becomes more about the public interest and less about each person's health interest.

3. It is essential that clear, transparent and robust policies are in place for every aspect of the collection from initial taking of consent and samples, to storage, quality assurance, access and contingency planning.

DISCUSSION

Persons

3.2 We have already indicated that the long-term nature of this collection in Scotland and its prospective expansion raise particular issues and it may not be the case that a one-size-fits-all approach is possible or desirable. From the perspective of persons affected by their inclusion in the collection, we suggest that there are at least five (5) discrete categories of persons to consider. These are:

1. Persons who are now adults and for whom consent was never given (1965-1997)

2. Persons who are still children but for whom consent was never given (1997-2003)

3. Persons who are still children and whose parental consent has been given (2003-now)

4. Persons who have died since the collection began

5. Future persons and whether and how their samples should be obtained and retained.

3.3 The relevance of this categorisation turns around the crucial date of 2003 when informed consent procedures were introduced. It does not necessarily follow, however, that because consent is now obtained that it should be sought from all of those for whom consent was never sought or who might now be in a position to consent for themselves. The relevance of death is also legally significant, for example, because the requirements of the Data Protection Act 1998 do not apply to deceased persons (although the common law duty of confidence continues after death). Furthermore, as regards future persons it may be the case that current consent procedures can be improved. Overarchingly, while explicit consent might not be necessary or practicable, it is nonetheless important to offer an opt-out system for all who would choose it. This is now provided for by NHS Research Scotland National Guiding Principles for Governance of NHSScotland Tissue for Research.

Purposes

3.4 It is important to consider current and future purposes of the resource because legal and ethical legitimacy of the collection is framed around the purposes for which samples and taken, stored and used.⁴² Different purposes will have a different impact on different categories of persons. What, then, is the range of current purposes and what are future purposes likely reasonably to be? What possible impact might these various purposes have on different categories of persons and their interests?

3.5 It is helpful to consider the range of purposes in the form of a series of concentric circles, with the individual and his or her health interests at the centre of that circle - indicating what should be the primary focus of our attention - and wider societal interests occupying the outer circles - indicating that as we move further away from the individual stronger justification of purposes is required.

Figure 1:

3.6 The list of current purposes includes:

• the immediate health benefit of the child (PKU etc.)
• the longer-term interests of individuals and their families (e.g. causes of infant or childhood death or disease; the identification of familial genetic conditions; the identification of deceased persons)
• the monitoring and improvement of the newborn screening programme (i.e., for the interests of newborns and families generally)
• the monitoring of the health of the general population (e.g. rates of HIV infection, genetic markers in childhood diseases etc).

The list of possible future purposes includes:

• Health-related research generally (which might include linkage to other information leading to, or increasing the risk of, identifiability of specific individuals)
• Non-health related research, e.g., proposals for access by insurers or employers (should this ever be contemplated)
• Forensic police work: There are two broad purposes under this category: (i) the identification of dead or missing individuals, (ii) the detection and prosecution of crime.

3.7 Factors which might complicate the issues surrounding these purposes include the prospect of access by those with commercial interests, e.g. research undertaken by large-scale pharmaceutical companies. While this is a reality, it could raise broader concerns. For example, some public attitude surveys suggest a degree of discomfort among some sectors of the public when public health resources are used to generate excessive private profit.⁴³

3.8 While the importance of an individual's interests is fundamental, those interests, or indeed their individual rights, are rarely (if ever) absolute. That is, while individuals can claim certain rights, such as the right to respect for private life, it is often the case that exceptions exist and rights can be interfered with so long as just cause is shown. In the language of human rights, for example, interference with the individual's right to respect for private life is justifiable if that interference is necessary, proportionate and is reasonably likely to further other legitimate social ends. These include: "...the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others."⁴⁴

3.9 The core lesson here from a legal perspective is that likely interferences with individual rights must be fully explained and justified. The same is true from an ethical perspective, viz, purposes, policies and procedures must be robust and defensible even if they are not necessarily accepted by all persons affected. Furthermore, for those persons who disapprove of particular purposes it is prudent, and indeed necessary, to offer an opt-out system which at the same time as respecting their individual choice does not necessarily undermine the public interest in the resource itself (see now the NHS Research Scotland Guiding Principles).

Procedures

3.10 It is important to consider procedures because transparency, accountability and trust can, in large part, be built around well thought-through and well-executed processes for decision-making, quality assurance, governance and public engagement. Central to this is the value of Standard Operating Procedures (SOPs). Which exist? How fit for purpose are they? Which need to be introduced? Why and how?

3.11 The UK Newborn Screening Programme Centre (UK NSPC) has a range of existing procedural documents covering many aspects related to initial taking and storage of blood spots. For example, these include information about communicating with parents, ensuring high quality blood spots, laboratory quality assurance guidelines and implementation and reporting guidance with respect to UK-wide policies on newborn screening.⁴⁵

3.12 In August 2008, the Centre produced updated Standards and Guidelines for Newborn Blood Spot Screening, and stated that: "Central to the development of policies are standards that underpin the performance management of the blood spot screening programme. Their purpose is to assure the quality of the screening process and ensure that babies who may have one of the conditions for which screening is offered receive timely medical treatment."⁴⁶ These were subject to a recent consultation exercise, the report on which was published in March 2013.⁴⁷ 133 responses were received, including from parents, parent representative groups, health professionals and professional bodies. Scotland was included in the recent consultation.

3.13 NHS Quality Improvement Scotland has developed Clinical Standards for Pregnancy and Newborn Screening (2005)⁴⁸ reflecting the above and which require in particular that "All women/parents/carers receive clear information (written or in other formats) to help them to make an informed decision about newborn bloodspot screening" [Statement 4b].

3.14 These procedures focus, rightly, on the health interests of each infant and the quality of the samples and data collected. As we have seen, however, longer-term storage for a wider range of purposes have different impacts. First and foremost, these impact on the quality of the consent that is obtained and the degree and quality of information given to parents. Both England and Scotland have documentation available to parents which mention (in superficial detail) the possibility of research but not the possibility of police access;⁴⁹ and while the range of possible uses is contained in the UK NSPC 2005 Code of Practice and on its website, it is not entirely clear how well lines of communication between health professionals and parents join up in practice. The UK NSPC Health Professional Handbook 2012 details procedures to discuss and record decisions about research, but again makes no mention of police or commercial access/uses.⁵⁰ Robust procedures can address this.

3.15 More broadly, the contemplation of other purposes beyond individual health interests need both to be articulated and communicated clearly and to be handled appropriately. This turns on procedures with respect to access. In research terms, there already exist detailed governance frameworks within the health service which can be deployed to guide researchers in seeking access to the resource and which also could act as a safeguard for patient rights and interests. The NHS Research Scotland Guiding Principles mentioned in para 2.2 are a suitable locus for details on access terms and conditions.

3.16 In police terms, it can matter very much whether the Guthrie collection is seen as part of the medical record in Scotland or is sui generis (of its own kind). Different procedures might apply depending on whether the request for access is to "information" or to a physical object (e.g. a blood sample). Finally, as for future un-contemplated requests for access - for example, non-health related research - clear procedures and lines of authority and accountability can help to ensure that these are dealt with timeously and appropriately and can provide decision-makers with guidance as to the relevant factors and considerations to be taken into account in making a final decision. A commitment to openness about these procedures and any uses that are made of the collection can also help to dispel concerns as well as facilitate an opt-out option for those who wish to use it.