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September 10, 1997

Genetic Testing and Informed Consent-Reply

JAMA. 1997;278(10):821-822. doi:10.1001/jama.1997.03550100047034

In Reply.  —The purpose of our article was not to advance the debate about informed consent for the use of stored DNA. Our goal was to outline what should be done prospectively when obtaining informed consent for nonanonymous cancer susceptibility tests when the results will be disclosed to individual patients. Drs Page and Jensen overlook 2 important distinctions: one between existing samples and those being obtained in new projects, and the other between identifiable and "anonymized" samples.Are Page and Jensen suggesting that genetic testing on identifiable samples be permitted without specific consent? The authors support institutional review board review of protocols as an alternative to the guidelines emerging from multidisciplinary panels. However, the Office of Protection From Research Risks 1993 guidelines for institutional review boards states in the "Human Genetic Research" section: "Particular attention should be paid to protecting the confidentiality of the data and obtaining consent from the participants for