The Human Tissue Act 2004 and Genetic Databases: some unanswered questions

The Human Tissue Act was passed in 2004 as the Government's response to the public concern and subsequent inquiries into the unauthorised retention of human material in numerous hospitals around the country, as highlighted in the Alder Hey inquiry report (Royal Liverpool Children's Hospital 2001) and the Bristol Interim Inquiry Report (2000). The Act has a very broad regulatory scope in relation to 'relevant  material', which includes most human material including organs, tissue, blood but excluding, for example, material already regulated under the Human Fertilisation and Embryology Act 1990 (Liddell and Hall 2005; McHale 2006; Price 2005).

The Human Tissue Act is predicated upon the consent principle in relation to use of human material (McHale 2006). It regulates organ transplantation, dealing with uncertainties in relation to the Human Tissue Act 1961 regarding use of material from cadavers - whether adults and children - use of bodies for anatomical examination, and it also for the first time places the use of material for research purposes within a coherent statutory framework. Failure to comply with the legislation may give rise to a criminal prosecution (see e.g. sections 5 and 8 Human Tissue Act 2004). What is notable however is what was left untouched by the legislation, and those issues which may give rise to challenges under the Human Rights Act 1998 in the future. This piece focuses upon the issue of consent to the long term storage and use of human material for research purposes which arises typically in the context of genetic databases, and highlights some uncertainties which remain.

One notable omission in the legislation is that it does not make any attempt to clarify, or indeed to engage with, the existing very complex case law concerning property in the body and its parts. Thus, huge uncertainty remains as to the extent to which human material can or indeed should be regarded as 'property' in English law and if so precisely whose property (Hardcastle 2007). There is the real prospect that a person may attempt to bring an action in property law through the tort of conversion, in a situation in which they are unhappy that human material has been used for research purposes without their consent. Researchers should be protected against the prospect of such litigation if they have obtained consent to the use of the material. But this means that what precisely constitutes 'consent' becomes particularly important.

Section 1 of the Human Tissue Act 2004 states that it is necessary to obtain 'appropriate consent'; however, what it does not do is define what this actually means (McHale 2006). The Human Tissue Act Code of Practice on Consent, published in 2006, suggests that consent may be 'general' or that it may be 'specific', or in some circumstances there could be general consent subject to some specific limitations (HTA 2006). Consent giving unlimited permission to use the sample of tissue in relation to a very specific research project may be seen as unproblematic. The individual participant, if given sufficient information, can decide whether they approve of a particular project and the use of their human material by researchers who are involved in that project.

In contrast, the position is much more complex when it is intended to store the material and make use of the material/related information over a long period - say for example, twenty years in a biobank. Over time a person's views may change. They may be unhappy about certain possible uses because of fundamental religious or cultural reasons (McHale 2004: McHale 2006). The Human Tissue Act Code of Practice does recognise that religious and cultural issues may give rise to particular sensitivities here, and alerts researchers to this issue (HTA Code 2006) but it nonetheless places the onus on researchers.

Long term storage and use of human material from children for research purposes will also pose particular additional challenges (McHale et al 2007). The Human Tissue Act provides that children may consent themselves if they have capacity to do so (section 2). Alternatively, in the case of young children, consent may be given by the person with parental responsibility. But what if the child's views change? It may simply be because in the case of a child they have grown up - and what they might have been happy with at the age of 15 would not now represent their views. The initial consent may have been given by their parents but now the child who has become an adult may have radically different views to their parents, with possibly even a different religious faith. Given this, would it be sufficient to rely on a general consent given by a child or a parent as to use of the material or should the child on reaching maturity be automatically approached to give subsequent consent to the use of their material for research purposes?

There is a danger  that if researchers rely on what is a very broad general consent then this may lead to human rights challenges in the future (McHale 2006: McHale  et al 2008). First, there is the prospect of challenges under Article 8 of the European Convention on Human Rights (ECHR). It could be argued that failure to obtain specific consent denied the right to autonomy and self-determination regarding use of their human material. Secondly, Article 9 of the ECHR could be used on the basis that adherence to a general consent for use of material has insufficiently safeguarded an individual's faith/belief, where material is later used for a purpose which is wholly incompatible with their personal religious beliefs.

Of course it can be argued that as long as researchers are sufficiently clear right at the outset as to the fact that they are obtaining broad general consent regarding the material they are seeking to use then this will be sufficient. The research participant will have been 'fully informed' that the future uses may be wide-ranging and uncertain. However that presumes that the consent process to the use of human material can be seen as in effect a 'one-off' transaction in this way. But is the research subject really simply handing over their material? Can and indeed should they be bound in this way in the future? Or should they have the prospect of changing their minds given that the material could be held for a long period of, say, up to two decades or even more? And even if we are prepared to accept general one-off consent for the adult can we - and indeed should we - apply these principles to children in the same way?  

It is somewhat disappointing that the Human Tissue Act 2004 did not attempt to grapple with these issues nor that of property in the body. The Human Tissue Act Code of Practice, while engaging persuasively with many of the issues in relation to consent, can do little more than simply present researchers with a range of alternatives. This puts a heavy onus on researchers undertaking the consent process to ensure that they are very careful in the information which they impart. They need to be conscious that they run the risk that general/generic consent may simply in the future not be enough to avoid the prospect of legal challenges.