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Ethical, Legal and Social Implications NCHGR/CDC Workshop on Informed Consent for Genetics Research Using Stored Tissue Samples

National Institutes of Health
Bethesda, Md.

July 7-8, 1994

This workshop, which was co-sponsored by the Centers for Disease Control and Prevention (CDC) and the National Center for Human Genome Research (NCHGR), brought together a group of scientists, ethicists, lawyers and consumers to examine the current policies regarding the use of stored tissue samples for genetic studies and to develop guidance for use by institutions and state and federal agencies in formulating their own policies regarding the use of such samples. The primary focus of this meeting was obtaining informed consent for the use of stored tissue samples for genetics research.


  1. Informed consent is required for all genetic research using linkable samples unless conditions for limitation or waiver are met.

  2. Informed consent is not required for genetic research using anonymous samples but may be considered if identifiers are to be removed from currently linkable samples.

  3. Institutional review boards could usefully review all protocols that propose to use samples for genetic research.

  4. Further work regarding these issues is warranted.

For a more complete discussion of the recommendations see: Clayton, E.W. et al. "Informed Consent for Genetic Research on Stored Tissue Samples." JAMA. December 13, 1995: 274(22); 1786-1792.

Last updated: October 01, 2012