Breaking the Stalemate: A Prospective Regulatory Framework for Unforeseen Research Uses of Human Tissue Samples and Health Information
Henry T. Greely
Stanford Law School
Wake Forest Law Review, Vol. 34, Pp. 737-766, Fall 1999
A vast quantity of human tissue samples and human health information currently exists after collection for either research or clinical uses. Those samples and records could be an enormously valuable scientific resource if they could be used for new research, not foreseen at the time they were collected. Such use is very tempting, but very controversial, at least since the December 1995 publication of an important article by Ellen Wright Clayton, et al. That article pointed out many serious ethical and legal questions about doing such research without getting new informed consent from the subjects, a difficult and sometimes impracticable task.
In spite of much discussion, and a report by the United States National Bioethics Advisory Commission, those questions remain largely unanswered. This has led continuing uncertainty about the use of these potential resources and, to some extent, has created a stalemate - no one knows whether those previously collected resources can or cannot be used. This article attempts to break that stalemate, at least for all such samples or information collected in the future.
It begins by discussing and criticizing current positions on such uses, including the recent report of the National Bioethics Advisory Commission, entitled Research Involving Human Biological Materials. It then proposes revisions to the existing human subjects regulations to create a new framework for unforeseen future uses of human tissue samples and health information collected in the future, which it argues would better protect the interests of the people who provide them. Such a framework, if adopted, would make clear under what conditions newly collected materials and information could be used for research not foreseen at the time of the collection. The article ends by suggesting a resolution for the problem of new uses of tissue and information collected before its regulatory scheme goes into effect.
JEL Classification: K29, K39
Date posted: July 25, 2000