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February 21, 1996

Pathologists Enter Debate on Consent for Genetic Research on Stored Tissue

JAMA. 1996;275(7):503-504. doi:10.1001/jama.1996.03530310007001

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LAST FALL, a number of academic pathologists began to realize that an ongoing debate about informed consent and privacy issues prompted by the Human Genome Project had important implications for them as well as for geneticists.

Rumors abounded, faxes flew, and editorials and newsletters warned that some of the ideas being floated in drafts of proposals could impose unprecedented costs and administrative burdens on biomedical researchers. The investigators feared that some documents developed to address informed consent for genetic research—one of which has been offered as a guideline for state and federal legislation aimed at protecting "genetic privacy"—could lead to research-crippling restrictions on the collection and oversight of tissue samples, and perhaps even interfere with patient care.

"Pathologists are concerned about this because we are generally the legal custodians of tissue banks and of stored tissue specimens remaining from diagnostic evaluation," says Joe W. Grisham, MD, chair of the Department