Transplant research and deceased donors: laws, licences and fear of liability

Abstract

Transplantation research on samples and organs from deceased donors in England, Wales and Northern Ireland is under threat. The key problems relate to difficulties encountered in gaining consent for research projects, as distinct from consent to donation for clinical transplantation. They are due partly to the terms of the Human Tissue Act 2004 (the 2004 Act), and partly to its interpretation by the Human Tissue Authority (HTA). They include excessive interaction with donor representatives regarding ‘informed consent’ to research projects, uncertainty as to the scope and duration of a donor's ‘authority’ over an organ, and restrictions caused by the apparent need for licensing of transplantation research under the 2004 Act, combined with lack of certainty, or guidance, as to the distinction between ‘research’, which requires a licence, and ‘service development’, which does not. In our view this confusion hinders and deters Specialist Nurses for Organ Donation in approaching donor representatives and discussing possible research projects with them. It has also, as we have reported elsewhere, led to abandonment of research projects for fear of liability, despite both Research Ethics Committee (REC) approval and donor consent. Such problems do not seem to occur under the transplant laws of most other comparable jurisdictions. The Transplantation Ethics Symposium, ‘The ethics of organ retrieval: goals, rights and responsibilities’, hosted by the MRC Centre for Transplantation at King's College London in December 2010, revealed that many senior clinicians and researchers, administrators, and lawyers are both unclear and in disagreement concerning the effects of the 2004 Act and the extent to which it is adhered to or ignored in practice. In this paper we examine the difficulties encountered and suggest solutions based on a less restrictive interpretation of the 2004 Act, or, more probably, a regulatory change under its authority. We propose that, in the long term, a law which includes consent for REC-approved research within the general consent for organ donation and transplantation seems preferable to the present system, both ethically and in practical terms.