Take Another Little Piece of My Heart1: Regulating the Research Use of Human Biospecimens

Gail H Javitt

This article reviews the history of the debate over use of biospecimens in research, the legal and ethical arguments that have been presented both in support of and in opposition to such use, court cases and judicial opinions involving disputes between specimen contributors, researchers, and institutions, and public attitudes regarding the use of biospecimens in research. The paper argues that proposed changes to the Common Rule are inadequate to resolve the legal and ethical concerns that have been raised with respect to the use of biospecimens. It argues that there is a need to distinguish between the dual roles - subject and donor - played by contributors of biospecimens.