Informed Consent for Genetic Research on Stored Tissue Samples

Objective.-To develop recommendations for obtaining adequate informed consent in the future when gathering tissue samples that may be used for genetic studies and defining the circumstances under which it is necessary to obtain fur ther consent if tissue samples already in hand are to be used for such research. Participants.-Scientists, ethicists, lawyers, and consumers selected by the National Center for Human Genome Research and the Centers for Disease Con trol and Prevention to represent a wide array of opinions. Evidence.-Statutes, regulations, and cases and articles on law and ethics. Consensus Process.-Initial workshop, followed by circulation of several drafts of this document with opportunities for comment by workshop participants and oth ers as well as smaller meetings involving participants with widely differing views. Conclusions.-Genetic research using stored tissue samples poses an array of benefits and risks to individuals, researchers, and society. As a result, thework shop participants conciudethat (1) informed consent is required for all genetic re search using linkable samples unless conditions for limitation or waiver are met; (2