Guthrie Cards in Scotland: Ethical, Legal and Social Issues

CHAPTER 6: STORAGE AND ACCESS

Key questions addressed by this chapter are:

• What kinds of uses should the collection be put to and which are lawful?
• Should access be allowed for health research?
• What other non-health research access is currently possible, and who is likely to request future access?

Key messages from this chapter are:

• The need for a clear, robust and transparent access policy for the Guthrie collection in Scotland is non-negotiable in terms of ethical and legal requirements; this must cover all current and foreseeable future uses of the resource;
• This policy should include guidance for decision-makers on relevant factors to take into account. This might include:
  • scientific or public value of the project;
  • ethical concerns both for individuals and society;
  • the pressing social need for the access;
  • whether consent can and should be sought for access;
  • any consequences of access for the resource; e.g. use of depletable samples, and
  • ways to minimise any adverse impact of the access.
• There should be some mechanism for prioritising research requests;
• A written protocol for the release of samples and information to the police be developed and made publicly available;
• Personnel within the NHS should act as gatekeepers with respect to access requests, and most notably and ideally Caldicott Guardians should be involved in all decisions;
• Given the existence of an opt-out system, consideration should be given to the mechanism for adequately informing people about withdrawing consent if the person no longer wants the blood spot card to be used for research or other purposes;
• Consideration should be given to the specific role of any Access Committee and/or oversight body in this regard (see further Chapter 7);
• Those responsible for the collection must clearly define the purposes of the collection and link these to justifiable periods of retention.
• Consideration needs to be given to the appropriateness of the physical environment in which the collection is held and the way in which it is archived.

DISCUSSION

6.1 There is a growing awareness that Guthrie card collections are potentially valuable sources of DNA for genetics research, and requests for access to the collections are increasing. Access to Guthrie cards for secondary uses raises numerous ethical issues, including privacy, confidentiality and genetic discrimination; these are compounded by the potential for requests for commercial access and access by non-health motivated parties, such as employers or insurers.

6.2 Storage and access are, of course, connected to issues of consent and anonymisation, which were discussed in the previous chapter. This chapter will focus on some of the ethical and practical considerations with regard to storage and access, and will make offer a number of points for consideration to improve current procedures.

A range of possible uses

6.3 As noted in Chapter 3 Figure 1, Guthrie cards are currently used for a number of purposes and might be used for other purposes in the future.

6.4 There are both practical and ethical issues to consider in terms of storage of, and access to, the Guthrie collection. One of the central concerns is that the indefinite or permanent retention¹⁰³ of the blood spots creates in effect, what could be viewed as, a de facto DNA database. This raises questions about how decisions are made regarding research access, how people's rights and privacy are protected, and how the involvement of commercial interests is taken into account in access decisions. Beyond this, concern lies with public perception of currently tightly controlled police access. (see Chapter 9 below).

Storage periods

6.5 The question of the legitimacy of retention periods for samples in the collection is important. In particular, it is noted that the current initial retention period of 1 year in Scotland - as detailed in the parental information leaflet¹⁰⁴ - is at odds with the UK NSPC guidance which suggests 5-years retention for quality assurance purposes. Data protection, in turn, requires that data are kept only so long as necessary for the original purposes for which they were gathered. This means that those responsible for the collection must clearly define the purposes of the collection and link these to justifiable periods of retention. What, for example, justifies one year and not a longer or shorter period of time? Clearly, different purposes can justify different retention periods, but as noted above, as the purposes move further away from individual health interests, the justification required is stronger.

Practical considerations

6.6 If the collection is to be retained indefinitely and is to be available for health-related research or indeed any other purposes, then it must be fit-for-purpose(s). Consideration thus needs to be given to the appropriateness of the actual physical environment in which the collection is held and the way in which it is archived. In this regard the importance of the NHS Scotland Guide on Records Management contains guidance on archiving collections. Also, the designation of the Guthrie collection as a national research collection means that it comes under NHS Research Scotland Guiding Principles for Governance of NHSScotland Tissue for Research. Such collections have NHS Research Ethics Committee approval to operate as a generic research tissue bank, and this means giving approval for research studies using human tissue. It should also be kept in mind that the European Court of Human Rights has indicated that the storage and use of cellular material interferes with an individual's right to respect for private life and that suitable mechanisms for storage and use must be in place (see Chapter 4 above).

Access

6.7 Requests for access to the Scottish Guthrie collection have been handled in the past on an ad hoc basis. However, with increased requests for access for a range of purposes, the potential for requests for commercial use of the collection, and increased attention to biomedical governance, it is imperative that robust mechanisms, policies and procedures are in place that are in accordance with the law¹⁰⁵ and in line with national guidance. This is important both for the protection of individuals whose samples/information are held as part of the collection, but also to assist the NHS Greater Glasgow & Clyde Biorepository staff in making decisions about requests for access to the collection. As we discuss in the next chapter, these decisions might involve the appropriate Caldicott Guardian and/or a suitable authorising body. The status of the Guthrie collection as a national research collection now means that any researcher who wants access must follow the nationally-agreed Access Policy. This includes provisions on ensuring that data are anonymised, that some of the bloodspot is retained for patient and family health screening, and that researchers share the data collected so that it can be used in future studies. In other words, there is a commitment to benefit sharing.

Considerations for access:

6.8 Research using Guthrie Cards for secondary purposes should not only be scientifically sound, but should also produce some "useful information" or clear health-related "benefit" even if this is to a broad (and/or future) category of persons.¹⁰⁶

6.9 In all likelihood, most interest in access to the Guthrie collection will be for genetic research as it represents a potentially very valuable resource. The use of the collection for genetic research is contested, however, because the actual benefits of any research using such a resource remain unproven and because of the spectre of discrimination for groups of persons on genetic grounds.¹⁰⁷ There are also fears about the collection being seen as de facto National 'DNA Database'.¹⁰⁸ All of these issues are potentially exacerbated by the prospect of requests for commercial interests, as we discuss in the next section.

6.10 Considerations are different depending on whether access is sought to information or samples. While information is an inexhaustible resource, the same is clearly not true for physical samples. Issues of prioritisation must be addressed. Moreover, while information might readily be subject to anonymisation processes, the same is not possible for a DNA sample which points to a single individual. In other words, privacy risks vary depending on the types of access sought. Indeed, even if consent for research is thought to be necessary, for example because the sample card will be accessed or the research is non-health related, it is vital that approaches to individuals and their families are handled in a sensitive and ethically appropriate manner. All of these considerations and more need to be considered in any access policy.

I: Commercial interests

6.11 The Newborn Blood Spot Screening Code of Practice for the Retention and Storage of Residual Spots, states that:

Newborn screening laboratories may not sell, or grant exclusive access to, residual newborn blood spots to commercial organisations. Some commercial partnerships may be required to develop screening methods that may benefit the screening service and public health more generally. These arrangements will be subject to scrutiny by the Programme Centre Board and will be documented in the Programme Centre's annual report.

6.12 The Code does not, however, address commercial access for research, and leaves it to the Board of each Centre to scrutinise arrangements for commercial partnerships individually. The proposed access provisions for the Scottish Guthrie collection envisage an Access Committee or Governance Board that would address such issues. The NHS Research Scotland guidelines make it clear that: "tissue should be made available to all legitimate researchers including commercial entities. Access should be as broad as possible."

6.13 Lysaught et al have commented that commercial use "is an area that has received the least attention".¹⁰⁹ They note that commercial access raises issues of ownership and profit-sharing, and suggest that release for commercial purposes could only be justified "in the context of an investigation explicitly designed to benefit public health, particularly the goals of newborn screening (i.e., diagnosis of conditions for which treatment will make a difference)".¹¹⁰ This in turn, however, raised issues of conflicts of interest,¹¹¹ which requires robust policies and procedures to monitor.

6.14 The involvement of commercial interests, while a reality, has raised public concern. One of those concerns is that "research funded or undertaken by commercial companies is likely to give priority to potential profits and to what can be patented than to public health."¹¹²

6.15 In the 2005 Public Consultation on the Storage and use of newborn babies blood spot cards (Oliver et al, IOE London) (final report not publicly available), commercial access to the UK blood spot collection was included as a question: Do you have any comments about commercial companies using blood spot cards to develop equipment or tests? Interestingly, there was no question about commercial access for research purposes.

6.16 Evidence of public disquiet already exists. Dixon-Woods et al¹¹³ and Haddow et al¹¹⁴ have found that the attitudes of groups towards commercialisation can depend on their experience of ill-health. In particular, there can be marked differences between groups suffering from disease and their healthy counterparts both with respect to attitudes towards property claims and towards the prospect of others profiting from their contributions. Understandably, groups which have experienced ill-health are usually very supportive of research and can be more tolerant of its commercial aspects than healthy groups. The prospect of profit might not be a stumbling block in itself, but rather the idea of excessive profit; this raises a further concern about exploitation - or perceptions of exploitation - all of which should be considered in robust access policies before any access is granted.

II: Police Forensic Work

6.17 There is also public concern is some quarters about the prospect of police access/use to genetic resources. The human rights ruling in S and Marper v UK is a case in point. Notwithstanding, it should be noted at the outset that the police can get access to any form of evidence, held in a medical context or otherwise, so long as lawful procedures are followed. The Guthrie collection is no different in this regard. It does not follow, however, that the prospect of police access should not be discussed or communicated openly with patients. We suggest that information material and access policies with respect to the police make this clear.

6.18 Guthrie cards have been used by the police for two distinct purposes: to identify remains/deceased persons and for crime investigation. Two examples of the former use of Guthrie Cards are the identification of missing persons in the wake of the tsunami in Sri Lanka,¹¹⁵ and the identification of deceased persons.¹¹⁶ While these uses are relatively uncontroversial, of greater concern is the use of Guthrie Cards for evidential purposes in crime detection and prosecution. Indeed, the 2003 murder of Anna Lindh, Minister for Foreign Affairs in Sweden, in which a newborn blood spot card was used to positively identify the person suspected of the murder, created massive media attention and controversy.¹¹⁷ Similar police use led to the destruction of cards in Western Australia (para 2.21 above). In these instances, ethical considerations about protecting individual privacy often conflict with the provisions of the law; it is for this reason that procedures for police access need to be clear, and readily available to the public as well as those managing the resource. Once again, the distinction between the collection as information and the collection as tissue might have a bearing on the legal position.

III: Obtaining information from health records for police use

6.19 If Guthrie cards in Scotland are regarded as health records then guidance developed by the Scottish Government with the Association of Chief Police Officers on 'Information sharing between NHS Scotland and the Police'¹¹⁸ is relevant. In terms of access to information in a patient's records, the Guidance provides the following:

Type of request	Action by Police	Action by NHS Staff
Written request for information from a patient's medical record	Police officer will provide: Section 29 form to NHS or Signed 'consent' form completed by subject of the inquiry	NHS will provide information requested and retain Section 29 form, consent document
Procurator Fiscal Request	Procurator Fiscal will provide letter delivered by Police or Recorded Mail	NHS will provide requested information and retain PF letter and completed incident reporting form in accordance with local procedures
Sheriff Court Warrant	Court will provide Sheriff's Warrant delivered by Police or recorded Mail	NHS will provide requested information and retain Warrant and completed incident reporting form in accordance with local procedures

6.20 The role of the 'Section 29' form in this procedure is, in effect, to make an official request for information.¹¹⁹ The police are not entitled to this information without an official warrant from a court of law, but the effect of the guidance is that it operates as an agreement on the part of NHS Scotland to accede to requests. This does not mean, however, that scrutiny procedures can be laid aside. Personnel within the NHS should act as gatekeepers with respects to such requests, and most notably and ideally Caldicott Guardians should be involved in all decisions.¹²⁰ Moreover, in circumstances in which there is doubt as to the legitimacy of a police request, a refusal would mean that a court warrant would have to be sought.

IV: Obtaining samples for police use

6.21 If the physical parts of the collection are seen as tissue in Scotland then, under the common law,¹²¹ a warrant would always be required.¹²² This reflects the position in England.¹²³

6.22 In England, the police require an access order to obtain samples for the purposes of a criminal investigation from existing collections held by third parties. Access orders may be sought by a constable pursuant to s.9(1) of the Police and Criminal Evidence Act 1984 (PACE) (which does not extend to Scotland) for 'human tissue or tissue fluid which has been taken for the purposes of diagnosis or medical treatment and which a person holds in confidence', provided certain conditions are met.¹²⁴

6.23 In Scotland, there is no statutory equivalent to the provisions in PACE for obtaining samples from third parties. Legislation in Scotland, such as the Criminal Procedures (Scotland) Act 1995 (CPA), deals mainly with the taking of samples from arrested, detained or convicted persons (see for example ss.18 & 19 of the CPA). In Scotland, powers of search and seizure are governed by the common law. At common law, the police cannot enter a private premises without a warrant to search for evidence,¹²⁵ unless consent has been given or in situations of urgency.¹²⁶ The normal procedure is that police officers in Scotland who wish to obtain a search warrant make a report to the Procurator Fiscal who will then prepare the application for a warrant to the appropriate magistrate, most commonly the Sheriff.¹²⁷ Warrants to search premises must be specific as to the articles the search is intended to locate and the place(s) to be searched. A warrant that is too wide and indefinite is illegal.¹²⁸ When carrying out a search under warrant in Scotland, police officers should follow what is considered 'appropriate procedure' in their area.¹²⁹

V: Missing persons

6.24 With regard to the identification of missing or deceased persons, current practice in Scotland is that the police will obtain a letter from the Procurator Fiscal for release of the blood spot card.

VI: Accessing children, parents and families

6.25 The above analysis suggests that in the future it will be important to seek consent from parents or persons themselves about uses of the samples or data. Examples include where the proposed use exceed the bounds of what a reasonable citizen would expect, where a research use might be particularly controversial, where the sample or use involves identification of individuals and/or where an access or ethics committee otherwise deems consent to be necessary. In all such cases, the procedures for tracing and contacting people become very important. It is not acceptable, for example, for researchers simply to be given contact details in order to approach people 'out of the blue'. Rather, approaches must be carried out sensitively and be proportionate in relation to the privacy implications. In such cases, it is important to identify a suitably-responsible intermediary to make the approach. This might be a senior official in National Services Scotland or National Registers for Scotland or from the Health Board under whose auspices the collection in held (Greater Glasgow & Clyde). Any approach should first be subject to ethical oversight by a suitable ethics committee or the Privacy Advisory Committee.

POINTS TO CONSIDER AND RECOMMENDATIONS FROM CHAPTER 6:

• A clear, robust and transparent access policy for the Guthrie collection in Scotland should cover all current and foreseeable future uses of the resource;
• This policy should include guidance for decision-makers on relevant factors to take into account. This might include:
  • Determining the scientific or public value of the project;
  • Assessing ethical concerns both for individuals and society;
  • Establishing the pressing social need for the access;
  • Deciding whether consent can and should be sought for access;
  • Identifying any consequences of access for the resource; e.g. use of depletable samples, and
  • Implementing ways to minimise any adverse impact of the access;
• There should be mechanisms for prioritising research requests and requiring return of results to the resource in the spirit of benefit sharing;
• A written protocol for the release of samples and information to the police be developed and made publicly available;
• Personnel within the NHS should act as gatekeepers with respect to such requests, and most notably and ideally Caldicott Guardians should be involved in all decisions;
• Given the existence of an opt-out system, consideration should be given to the mechanisms for adequately informing people about withdrawing consent if the person no longer wants the blood spot card to be used for research or other purposes;
• Consideration should be given to the role of any Access Committee and/or oversight body in this regard (see further Chapter 7);
• Those responsible for the collection must clearly define the purposes of the collection and link these to justifiable periods of retention;
• Consideration needs to be given to the appropriateness of the actual physical environment in which the collection is held and the way in which it is archived;
• Appropriate processes must be established for contacting people when seeking consent to use of samples and data.