Human rights, privacy and medical research: analysing UK policy on tissue and data

'Human rights, privacy and medical research', a new report published by the Genetic Interest Group, traces the impact that the right to privacy is having on the regulation of medical research and clinical practice, with a particular focus on implications for human genetics. Less than 15 years ago, English law categorically rejected the right to privacy, and professional guidelines encouraged researchers to see research using health data as their moral duty (without necessarily seeking consent or research ethics committee approval). However, in the five years since the implementation of the Human Rights Act 1998 and the Data Protection Act, the situation has changed beyond recognition.

This report analyses the directions that government policy has been taking, and suggests some responses. It argues that the right to privacy is being given too much weight in the context of medical research and clinical genetics, with insufficient reference to wider rights law and court decisions.

It begins (Section 1) by examining the most recent legislative implementation of the right to privacy - the Human Tissue Act 2004. In particular, it highlights some of the Parliamentary debates that convey the government's spirited and sometimes perplexing defence of an individual's right to privacy regarding the analysis and use of their tissue, cells and DNA. Section 2 outlines how some writers and campaigners interpret existing laws on the use of data analogously to the legislative scheme implemented for tissue. Some want to go further still, questioning the effectiveness of anonymisation for the protection of privacy rights. These interpretations have gained wide currency and have had a significant impact on research and clinical practice, leading some scientists and institutions to adapt practice to privacy-centric interpretations of data laws.

Section 3 compares the recent legislative developments on tissue with those around 2000 in relation to data protection. The differences between the law on data and tissue demonstrate that the right to privacy, at least in the government's mind, has been growing more, rather than less, important. The differences also demonstrate, contrary to some recent rhetoric, that the data protection laws were cast so as to balance the right to privacy on the one hand, and the public interest in research and the health needs of other individuals on the other.

A legal basis for a less privacy-centric approach is reinforced by recent judicial decisions (Section 4). This part of the analysis is not straightforward, since the courts have not yet been asked to decide a case concerning clinical genetics or medical research. That said, it is clear that although the courts consider the Human Rights Act 1998 to have crystallised the value of autonomy and dignity in the law of confidentiality (thereby expanding individuals' right to protect 'private' information), they have at the same time been careful to point out the limits of the right to privacy. It is qualified by certain public interests, including the protection of health, the investigation of crime, and the rights of others (including the right to free expression). In short, the important message from the courts is that the right to privacy is extensive, but also extensively qualified.

The concluding section summarises the predicament facing researchers. The government wishes to cement support for some of its flagship policies using the rhetoric of consumer choice and patient-centred care. Like many others, it has drawn tenuous conclusions from the Alder Hey organ retention controversy, to the effect that researchers are not trusted and that research (unlike audit) is an optional frill in evidence-based care. The key question for the research and genetics communities is how to react. Professionals critical of the government's policy are aware that they have a powerful and important story to tell, and a degree of public support for their case, but they remain uncomfortable with the position in which they find themselves - out of favour with sections of the government and their values questions - and wary of presenting their own concerns too forcefully in public. Difficult though it may be, there is a pressing need to take the issues into political and public arenas; to make the case for the value of research and to explain the means as well as the ends of research to a wider audience.

To obtain a copy of the report contact the Genetic Interest Group