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The legacy of the Tuskegee syphilis experiments for emergency exception from informed consent.

In November 1996, the US Food and Drug Administration and the Department of Health and Human Services developed regulations allowing research to be performed with emergency exception to informed consent when the research participant is in a situation that is acutely life-threatening and a condition is being studied for which currently available treatments are untested or believed to be unsatisfactory. The regulations require the potential patient to be unable to consent because of the acute clinical condition, and there must not be time within the proposed therapeutic window to contact the legally authorized representative to obtain prospective consent. Furthermore, the possibility must exist that the patient will benefit from participation in the study. These regulations create a requirement for public notification and community consultation regarding the project before implementation.1 Public notification is meant to ensure that the community is aware of the study before implementation, whereas community consultation is intended to provide the local community an opportunity to provide input to the institutional review board about the acceptability of the proposed research.2 The rules were designed to balance the competing needs of respecting individual patient’s rights with performing resuscitation research to better treat the community. How well they succeed will depend on E T H I C S / E D I T O R I A L