Charitable trusts and human research genetic databases: the way forward?*

Human genetic research databases cast a new light on the controversial issue of which uses of the human body are morally permissible. More specifically, banking human tissue raises issues relating to the ownership of the samples that the participants have donated, to the ownership of the data that are derived through processing the donated samples, and to the management arrangements that better balance the interest of genetic research with the protection of participants’ rights. Winickoff & Winickoff suggest that the charitable-trust model is a superior legal arrangement for biobanking compared with private biobanking. This paper critically assesses Winickoff & Winickoff’s claim by highlighting some areas of implementation where such a model could be problematic. The charitable trust is certainly an advantageous arrangement because (1) it favors the separation between control and use of the samples, (2) it provides a procedural mechanism that facilitates the participation donor groups in the biobank management and (3) it mediates the different interests that are affected. On the other hand, the charitable-trust model leaves unresolved several issues—among them the ownership of the sample, the right of withdrawal, access and funding mechanism. I conclude that further theoretical and empirical analysis is required in the area. 1 The Challenges of Genomic Biobanking Large collections of human tissues cast a new light on the controversial issue of which uses of the human body are morally permissible. The technical possibilities of automatized data analysis of large collections of DNA samples and their bioinformatics processing have developed dramatically over the last few years and are constantly being improved. The protection of genetic data that is collected in human genetic research databases has consequently emerged as a highly complex ethical issue that urgently needs to be addressed. In its summary of the most pressing issues raised by advances in genetic research, the 2002 Report of WHO’s Advisory Committee on Health Research on Genomics and World Health points out that “[t]he planned development of large-scale genetic . . . databases offers a series of hazards and ethical issues which have not been encountered before”, and it then outlines, as possible hazards, the “many ambiguities regarding access and control . . . the potential harm to individuals, groups and communities . . . risks . . . arising from access to genetic information, both by individuals themselves and by third parties.” 1 Furthermore, the Report lists access by “health insurance companies, government bodies, or the legal profession and police” as well as “the effect of stigmatizing entire countries or particular groups of individuals, and there are concerns about commercial exploitation without adequate compensation” as pressing ethical issues. Ethical issues become even more acute when genetic data are combined with information on individuals’ health, lifestyle or genealogy. Furthermore, human genetic research databases raise specific issues of ownership of samples that the participants have Genomics, Society and Policy, Vol.1 No.2 (2005) ISSN: 1746-5354 © CESAGen, Lancaster University, UK. Genomics, Society and Policy 2005, Vol.1, No.2, pp.41–49. 42 donated, ownership of the data that are derived through processing the donated samples, and of management arrangements that better balance the interest of genetic research with the protection of participants’ rights. In recent years, per-profit companies have been increasingly involved in genetic research and in the creation of large genetic databases. However, commercial biobanking has raised even more substantial questions about the conditions under which genetic databases can be established, kept, and made use of in an ethically acceptable way. To address some of the growing concerns, scholars have proposed arrangements that are alternative to commercial biobanking. In a 2003 paper, David and Richard Winickoff proposed the charitable trust as a model for genomic biobanks superior to commercial biobanking. This paper critically analyzes Winickoff & Winickoff’s article, concluding that the charitable trust model in itself does not solve many of the open questions. My basic argument is that the charitable trust model provides an interesting governance model, but many of the issues can only be solved at level of rules that are governing the trust rather than in the model itself. The following sections lay out my critique of Winickoff & Winickoff first by describing their proposal (Section 2) and then by critically assessing and illustrating the critical aspects of their proposal (Section 3). Finally, I present my conclusion and provide some indication for further policy research of biobanks (Section 4). 2 The Charitable Trust Model A biobank organized as a charitable trust would be created by a trust agreement under which the participant in the research project (or settler), “formally expresses a wish to transfer his or her property interest in the tissue to the trust.” By donating the tissue samples to the biobank, the donor contextually appoints the recipient as trustee of the property, who has legal fiduciary duties to keep or use the property for the benefit of the beneficiary. Winickoff & Winickoff suggest that in genetic biobanking the general public acts as the beneficiary of the charitable trust. Figure 1 The Charitable Trust Model