Legal Approach to the Use of Human Biological Materials for Research Purposes

Human Biological Materials (HBM) come from individuals in a variety of circumstances. The use of HBM for research purposes raises a host of difficult ethical questions. The law is important in this arena because, in most cases, legal principles significantly influence the making of ethical choices. Following a general overview of research regulation in the United States generally and a few comments on the relevance of international statements for this country, this article explores several specific legal issues, and their ethical implications, related to the obtaining and handling of HBM for research purposes, namely: informed consent; privacy; and commercial or ownership (property) interests in HBM. The article concludes that, although the realistic liability risks are low, the law's important role in characterizing the rights and responsibilities involved will be very influential in shaping the ways that the chasm between science and ethics is resolved within the context of the use of human tissue for research purposes.