Guthrie Cards in Scotland: Ethical, Legal and Social Issues

CHAPTER 9 - SUMMARY OF POINTS, RECOMMENDATIONS AND FUTURE CONSIDERATIONS

General considerations

• 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.
• 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 stronger as the use becomes more about the public interest and less about each person's health interest.
• 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. While many aspects of the collection are now covered in this respect, all policies must be kept under regular review given the rapidly changing social and scientific landscape.

Legal Basis

• The Guthrie collection should be treated as both personal information and human tissue for the purposes of legal governance.
• The existing collection is lawful but careful attention must be paid to matter of future use and access.
• Consent to use is not an absolute requirement but should not be departed from lightly.
• Anonymisation can remove some legal obligations but not all obligations; moreover, it is not a complete answer to the challenges thrown up by the collection.
• Human rights are a consideration across all areas of law. All mechanisms, policies and procedures should be tested for human rights compliance.

Consent and anonymisation

• The law does not require that specific consent be sought from all persons whose samples or data are held in the Guthrie collection; it is for consideration none the less, whether such consent should be sought as a matter of good practice.
• If specific consent is not sought, all the more emphasise must be placed on the system of opt-out that exists. This is the principal means to respect persons whose samples/data are contained in the collection. It requires clear communication to the public about uses of the collection and details about the governance mechanisms in place. Vitally, citizens must be able to know easily how to exercise their right to opt-out and have the respected in a timely fashion.
• Because people consent to inclusion in the collection on the basis of broad consent, attention should be given to how they will be kept up-to-date with uses of the resource as and when these occur.
• It is for consideration whether a system of 'consent for consent' should be considered to facilitate access to the Guthrie collection for research purposes; caution should be exercised, however, about adopting a presumed consent approach.
• Specific consent should be sought from individuals if access is contemplated for non-standard purposes, e.g. non-health-related research.
• It is for consideration whether mature minors should be allowed to opt-out of the collection.
• Procedures should be developed for circumstances where access will be given without consent but subject to suitable authorisation.
• Procedures should be developed to decide whether and how access will be granted if neither consent nor anonymisation is possible.
• Consideration should be given to scrutiny mechanisms authorising access even when anonymisation is contemplated.
• A policy should be developed on whether and how feedback of individual results will be given.
• A decision should be taken on Open Access to the resource or results from the resource.
• A Privacy Impact Assessment should be carried out on the Guthrie collection.

Storage and access

• A clear, robust and transparent access policy should be kept under regular review for the Guthrie collection in Scotland to 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;
• If an opt-out system is thought to be desirable, consideration should be given to the mechanism for 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 an Access Committee and/or oversight body in this regard.

Governance

• The relationship between the Yorkhill Centre and NSS should be clarified within lines of accountability and framework for research governance. In particular, what is the relationship with:
  • the Caldicott Guardian,
  • Research ethics committees and
  • Privacy Advisory Committee?
• Robust and transparent policies should be development 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 for consideration whether the Scottish Guthrie collection requires its own Governance Board and/or Access Committee.
• It is for consideration whether the Guthrie collection requires an independent oversight body. It is recommended that models used by UK Biobank and Generation Scotland add considerable value in addressing the challenges of running a long-term resource into an uncertain future and could serve as possible models.
• Any governance mechanisms that are instituted 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.

Public attitudes and public engagement

• Previous research on public and professional attitudes does not suggest widespread distrust about the storage and use of newborn bloodspots but some degree of ambivalence was expressed by some.
• The issues of consent, access, appropriate use and regulation are relevant to parents and a variety of opinions are expressed about appropriate mechanisms.
• We recommend primary research on public and professional attitudes and concerns about the storage and further use of newborn bloodspots and a programme of public and stakeholder engagement for effective governance and policies.

Future considerations

The essential issue at the heart of all challenges relating to biomedical collections such as the Scottish Guthrie card collection is the question of time. The Guthrie collection was started at a time when ethical and social expectations were very different to those of today. Its potential value has become clearer over time and this forms the basis for arguments in favour of its retention; equally, only time will tell which kinds of request for future uses might arise and whether these will be granted. It is also very likely that public and individual expectations and attitudes will change. It would be unhelpful and unproductive to attempt to respond to speculative Frankenstein futures that can be imagined by the advent of developments such as cloud computing and genome-wide association studies. There is little doubt that the potential of biomedical collections will only increase, but we cannot say today what will be the appropriate responses of tomorrow. Notwithstanding, all of this speaks to the important of dynamic and robust governance that can respond to near-future challenges of storage, management and use as and when they arise. Given the cross-cultural and wide-ranging disciplinary issues at stake, it will be important to provide ample manoeuvre in developing appropriate responses to technological advances and which take into account the implications for science and society. For these reasons, as a final recommendation we suggest that jointly-funded AHRC and ESRC doctoral scholarships be pursued to examine the cross-cutting themes.