With recent advances in molecular biology, human biospeci- mens have become enormously valuable for medical researchers. Biospecimens such as blood, surgical tissue, saliva, and urine con- tain genetic material that researchers analyze to identify gene variations associated with human diseases. By identifying the role that genes play in disease formation, researchers may be able to develop new diagnostic tests and targeted treatments for specific diseases and to investigate how genes interact with envi- ronmental factors. This research may also open the way to “per- sonalized medicine”—treatments that are customized to a per- son’s genetic profile (see chapter 29, “Personalized Medicine and Genomics”).

By 1999, over 300 million biospecimens were stored in the United States in a wide variety of public and private repositories. Most of these biospecimens were collected during routine clinical and surgical procedures. Over the last decade, several new public and private initiatives in the United States and elsewhere have been collecting and storing biospecimens for research purposes.

Institutions with biobanks in this country usually claim owner- ship rights over biospecimens. Legal challenges to this claim have been unsuccessful. Here is a sampling of significant cases.

Moore v. Regents of the University of California – In 1990, a California court ruled that individuals do not have an ownership interest in their cells after the cells have been removed from their bodies.

Greenberg v. Miami Children’s Hospital Research Institute, Inc. – In 2003, a federal district court in Florida ruled that individuals do not own their tissue samples.

Washington University v. Catalona – In 2008, the U. S. Supreme Court declined to review a biospecimen owner- ship case. The question was whether individual donors who provide biospecimens for research “retain an owner- ship interest allowing them to direct or authorize the transfer of such materials to a third party.” The court of appeals said, “the answer is no.