Storage and use of Guthrie cards

Additional Submission from NZORD on the storage and use of Guthrie cards - October 2008.

In June 2007 NZORD submitted a response to the National Screening Unit’s consultation on Guthrie Cards. Our key messages at that time in relation to storage and use of the cards advocated limited retention for primary use (age 21 as provided for in the discussion paper options), provision for people from age 18 to make choices for either return of the card, donation to research, or destruction, and in the event that other arrangements were made for storage and use, a second layer of scrutiny after approval by an ethics committee of any research proposal.

After numerous further discussions in stakeholder groups, the newborn metabolic screening advisory group, and with some support group leaders with a particular interest in this topic, we now provide you with an additional submission that clarifies some of our earlier points and revises our position on others. Those extensive discussions added new dimensions to the topic as we appreciated it then.

1. The interests and benefits to immediate family should be considered to be as important as the interests and benefits of the individual, and the arguments for a minimum period of storage should be extended to allow secondary uses from which the individual or their remaining family might directly benefit. These uses would include determining cause of mortality and morbidity, and identification of victims. This would justify very long term storage up to the life of the individual.

2. We no longer advocate actively seeking individual decisions from age 18 for return, donation for research, or destruction. This original suggestion of ours has “ideal world” aspects to it, but further consideration shows that it would be a task of such complexity and cost to organise that it simply would not be practical. It would not achieve the desired outcome of a clear mandate for what is to happen to individual cards as it is extremely unlikely that clear responses could be obtained from a sizeable proportion of the population, leaving considerable dilemma about what to do with cards for which no choice has been exercised. In addition, the value of a research resource arising from such choices would be very limited from a public health research perspective. For that purpose there would need to be a very high proportion of the population donating and that is highly unlikely to be achievable. Another problem is that selection bias inherent in our earlier proposal would mean much high quality public health research would be unachievable.

3. A decision will need to be made about use of the cards for public health research without the consent of individuals whose cards are sought. That is, whether the cards could be used to gain knowledge of benefit to society as a whole. In raising this question we take it as a given that any card may be used in research if appropriate institutional and ethics approvals are given in addition to the consent of the person entitled to give it. Likewise, it is also a given that cards may be requested back at any time. The critical question is public health research without specific consent.

4. Any decisions to continue storage of the cards long term, or to allow public health research on the Guthrie cards without consent from individuals, should be made at the highest level, meaning a government decision by Cabinet. We suggest legislation to support that decision and to regulate access to the cards. We advocate that a guardianship group should be appointed to protect the public interest in the card collection. Though public health research without specific consent is permitted in theory by Right 7 (10) of the HDC code and by our ethics committee framework, there has been none in fact because of the programme advisory group recognising the sensitivity and importance of the collection, and not allowing access to the cards even if ethics approval has been obtained.

5. The guardianship role should be vested in a small group of people appointed for this purpose by government in order to ensure supreme public confidence in the process. We advocate this in line with the Kaitiaki regulations for cervical screening information, and similar to guardianship roles for a variety of public interests such as Lake Manapouri, New Zealand Superannuation fund, and others. This suggestion is made as we believe there is not sufficient public understanding of the health research ethics system to enable public confidence of adequate protections solely by those committees, for such a sensitive and significant collection as the Guthrie cards. Despite their significant lay membership, ethics committees may be seen as part of the health research system and not sufficiently independent to provide the highest level of public confidence required. Nor is there a sufficiently wide brief for the ethics committees in these circumstances to consider important matters such as protection of the Guthrie cards as a special resource, or protection of the newborn metabolic screening programme itself.

6. We acknowledge a variety of views among health and disability consumer groups on these matters and in considering what weight to give to various consumer stakeholder interests we ask that special consideration is given to the interests of families who actually bear the burden of genetic and metabolic diseases in our community. Our interests differ from others because of our lived experience and because we appreciate the importance for society of gaining knowledge about disease causes and incidence. We seek these provisions with appropriate protections, rather than the more restrictive positions advocated by some other consumer groups, because we are more conscious of the actual impacts of these diseases on our families, compared to the abstract concerns of others leading them to see theoretical risks and individual interests as paramount.

7. The essence of the newborn metabolic screening programme is one that exists to save lives and reduce harm. This theme should be carried through into the total policy framework governing storage and use, and thus should support secondary uses and public health research that will continue to enhance the ability to save lives and reduce harm. Other concerns about privacy and use of personal material without consent, should be dealt with by providing protections and safeguards as we have proposed, rather than any blanket prohibition or restrictions that would particularly disadvantage certain groups in society, and more generally disadvantage society as a whole.

8. In the analysis of ethical considerations by different groups, those who advocate greater restriction on storage and use are more likely to appeal to arguments of autonomy and consent as the basis of restriction - that is, advocating there should be no long term storage or no access for research without specific consent from the individual. We argue that there are wider issues of justice to be considered and in particular the need for systems to allow for the particular needs of disadvantaged groups. In this context, for families affected by genetic and metabolic diseases, there is clear disadvantage inherent in any decision to restrict the length of storage or secondary uses.

9. In arguments put forward by those advocating restriction on use in public health research, it is clear that objection to Right 7 (10) of the code, or to any use without specific informed consent, is the fundamental positions adhered to. Yet this is in conflict with established public policy and regulation devised to ensure that steps can be taken to obtain important public health knowledge that would otherwise be unachievable. Analysed in this way it shows that the restrictive arguments are about changing the status quo. However the lack of actual research because of sensitivity about this particular collection, demonstrates that if the status quo is to remain and be allowed to actually operate, it will need official blessing at the highest levels of decision making.

10. The restrictive arguments also do not adequately consider social good considerations such as the Nuffield Council’s description of collective responsibility in its “stewardship model” (Nuffield Council, Public Health: ethical issues, 2007) nor that Council’s view that a restrictive or “do nothing” approach would need to have its own justification within ethical frameworks. In other words, if a decision was made to deny public health research without specific consent, or even more restrictively to mandate destruction of the cards at a certain point in time, the decision would need to be justified by showing how the consequent harm to families and societal interest can be justified.

11. Finally, we note that the decisions are sensitive social and political ones. We suggest that advice to government should ensure there is full appreciation of the harms a restrictive decision would imply.

NZORD hopes this additional commentary will assist you with assessment of all the relevant matters.

John Forman
Executive Director, NZORD