Research use of human tissues is increasingly controversial. Current policy in the UK and elsewhere is that tissue samples should be treated as "gifts" to research. This approach has been criticised for demanding altruism from tissue donors, but potentially allowing commercial exploitation of the donated material. However, there is very little evidence about how people with serious illnesses from whom tissue is removed as part of diagnosis and treatment feel about tissue donation, and even less about the views of people who seek consent to tissue donation. These issues are particularly important and interesting in relation to research use of tissues from children. Our project aimed to review issues of law, ethics, and governance relating to the use of children's tissue for research; to investigate media representations of using children's tissue for research; and to explore through interviews and surveys the views of children with cancer and their families and the views of professionals involved in treating childhood cancer.
Our media analysis found that media reporting of the organ retention scandal had a significant impact on the rate of registrations of tissue in the childhood cancer tumour bank. At the height of the controversy, registrations of tissue halved over their previous level. Media reporting imposed a "template" on all issues concerning use of children's tissue for research, often implying that the interests of the research and medical community were opposed to those of families. We also found that the mass media themselves "commodified" children's body parts, by using them as a source of sensational stories.
Our legal and ethical analysis identified that many issues relating to the use of children's tissue for research remain unresolved, notwithstanding the Human Tissue Act 2004. It is still the case that many aspects of the removal and use of human material are governed by a combination of common law and statutory principles from a range of areas, including tort, family law, and property law. What is clear that is separate consent is required for taking the tissue from the body (e.g. during a biopsy) and for storing or using the tissue for research. A notable feature of the Human Tissue Act is that, for the first time in English law, provision is explicitly made for children to consent to the use of their material for therapeutic or research purposes. However, it is not clear how straightforward the implementation of the Human Tissue Act will be in practice. For example, it is not clear how easy it will be to assess the capacity of a child to consent. Many issues will be left for Research Ethics Committees to decide upon. And issues such as whether there is property in the tissues and if so how owns it, whether open-ended consent to tissue banking is sufficient, and whether people are entitled to feedback, all remain unsettled.
Our interviews with 79 family members (including 20 children) and 54 professionals at seven childhood cancer treatment centres in the UK found that there was very strong support for using tissue samples left over after operations and biopsies for research. No family member said that they would not consent to such use. In explaining why they would consent, family members described themselves as belonging to a well-defined community. They saw themselves as being indebted not only for the treatment received, but to past generations of families whose participation in childhood cancer research had led to the striking improvements in survival seen in the last 30 years. They felt committed to securing further improvements in survival and treatment for future generations. However, their consent was conditional on there being no risk to the child, and given, that they tended to see the tissue samples as having an alien or intruder status and as "waste", the saw the costs of consenting as very low. A community ethic was thus very important in explaining consent to tumour banking.
It is important to recognise that the clinical staff involved in tumour banking who seek consent can also be understood as involved in behaviour that has some altruistic features, since they mostly gained no personal reward participants saw everyone in the childhood cancer community - families, clinical staff, and researchers - as committed to the same values and aspirations. High levels of trust were expressed.
Our findings suggest that using the "gift relationship" model to describe tissue donation is thus problematic in several ways. The model was developed originally by the social policy theorist Richard Titmuss in relation to blood donation, but it appears ill-suited to tissue donations.. Many family members and staff were very negative about describing tissue samples as "gifts", pointing to its inappropriateness as a metaphor. While blood is generally much valued, participants in our study expressed contempt or fear of the tumour samples. Titmuss' model emphasised a rather demanding form of altruism. In this study, family members' consent to tumour banking could be seen as altruistic in so far as it was motivated by a wish to promote the public good and in no expectation of reward, but it was a limited form of altruism because families did not feel they were giving up anything valuable or accepting risks. Their behaviour, in sociological terms, could perhaps more appropriately be described as reciprocity rather than altruism. These findings have important implications for regulation, ethics, and governance.
The high level of trust expressed by family members and the particular features of this community mean that an approach to governance that rested on donors retaining individual property rights over tissue samples might be problematic. The possibilities of a charitable trust model for tissue banking, though unlikely to be without its own problems, should be explored.
We also conducted a survey of professionals and parents. We are still awaiting the return of some questionnaires from parents. Our analysis of 330 responses from professionals suggests that they would prefer that both child and parent(s) be asked for consent to tumour banking (rather than one or the other), but over half (55%) felt that assessing capacity to consent in children would be difficult.