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April 10, 1996

Informed Consent for Genetic Research-Reply

Author Affiliations

Vanderbilt University Nashville, Tenn

JAMA. 1996;275(14):1086. doi:10.1001/jama.1996.03530380027021

In Reply.  —Our article represents the best efforts of a diverse group of people who attempted to reach some agreement about emerging ethical and legal issues surrounding informed consent for genetics research using stored tissues.The Centers for Disease Control and Prevention was one of the conveners of the meeting that led to the writing of this article. As a result of their guidance, the authors and supporters of the document directly considered concerns about epidemiologic research as raised by Dr Kelsey. Current federal regulations require that institutional review boards (IRBs) review all proposals that use identifiable tissue samples for research, not just protocols involving genetics.1 However, IRBs are directed to require investigators to obtain informed consent from subjects (including identifiable individuals from whom samples were obtained) unless the IRB determines that all four criteria for waiving or limiting consent are met.2 The recommendations included in our article