| Subject: | FDA Seeks Comments on Proposed Exceptions from Informed Consent Requirements for Emergency Research |
| Category: | Food and Drug Administration (FDA)
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| Published: | Tue, 5 Sep 2006 - 12:00 am |
| The FDA seeks comments on draft guidance titled “Guidelines for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research.” When finalized, the guidance is intended to assist Institutional Review Boards (IRBs), clinical investigators and sponsors in the development and conduct of emergency research.
The draft guidance also describes specific human subject protection requirements for emergency research,... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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