Ethical issues relating to supply of human tissue to the commercial biomedical sector

Demand for an ethical supply of human tissue for research in the commercial biomedical sector is increasing substantially. This article sets out to review ethical issues specifically relating to acquisition of tissue from patients in a publicly funded national health service (NHS), for research use in a commercial setting. Some of the background to recent high profile Inquiries in England is discussed and is used to illustrate legal and ethical differences between living and dead people. Issues relating to patient consent are investigated and the case is made for a clear distinction between tissue acquisition and tissue processing. Future possibilities for regulation are discussed. This revised version was published online in July 2006 with corrections to the Cover Date.