Ethical and Legal Debates in Irish Healthcare: Confronting Complexities by Mary Donnelly & Claire Murray

Author:Mary Donnelly & Claire Murray [Donnelly, Mary & Murray, Claire]
Language: eng
Format: epub
Tags: Business & Economics, Business Ethics, Law, Health, Social Science, Disease & Health Issues
ISBN: 9780719099465
Google: mk3IyAEACAAJ
Goodreads: 26722589
Publisher: Manchester University Press
Published: 2016-01-15T08:37:24+00:00

III

REGULATING RESEARCH

9

Retention and use of human biological samples: the Guthrie card example

Deirdre Madden

Introduction

The retention and use of human biological samples raises interesting and challenging ethical and legal issues including compliance with principles of autonomy and privacy as well as the provisions of data protection law. However, in addition, there are wider competing public interests in this context due to the potential value of such samples for diagnostic purposes, clinical research and innovation and public health and epidemiology. This chapter will explore these issues through the lens of one specific example of the use of biological samples, namely the acquisition, retention and use of newborn screening cards, also known as Guthrie cards.

In 2009, a complaint was made to the Irish Data Protection Commissioner in relation to the retention of the newborn screening cards without consent, contrary to the Data Protection Acts of 1988 and 2003. The Commissioner upheld the complaint and a new policy in relation to the cards was subsequently agreed between the Health Service Executive, Department of Health and Data Protection Commissioner to the effect that, in the future, specific consent should be obtained for the retention of the cards for a ten-year period after which they would be disposed of. In relation to the existing archive of cards, it was agreed that the retention of samples without consent clearly contravened both EU and national data protection legislation and those cards must therefore be disposed of. The Minister for Health subsequently ordered the destruction of the cards unless individuals requested them back. There were calls from clinicians and researchers to retain the cards as a valuable medical resource for diagnosis and research as a result of which the Minister paused the destruction order pending advice from the Attorney General. At the time of writing, approximately 30,000 cards have been returned to those who requested them and the Attorney General’s advice has not been made public. The future of the existing archive therefore remains uncertain.

This chapter will consider the ownership of newborn screening cards and the blood spots retained on them, the role of consent to the use of these cards and relevant data protection provisions which have resulted in challenges to their retention. The issues raised here also have relevance for biobanks and other existing archives of retained biological samples in hospitals and research facilities as similar questions arise in relation to those collections. The chapter concludes by recommending that legislation be introduced to exempt the newborn screening card collection from data protection legislation and to put in place a clear and robust governance framework to ensure that individual rights are protected to the greatest extent possible. These recommendations are also relevant to other collections of biological samples in which a strong argument exists for their retention for diagnostic purposes as well as for public health.

Use of newborn screening cards in clinical diagnosis and research

Newborn screening for Phenylketonuria (PKU) was introduced in Massachusetts in the United States in 1962 and less than four years later Ireland started its national newborn screening programme for PKU.

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