The amendments to 21 CFR Part 50 and 45 CFR Part 46 were published in
the Federal Register on October 2, 1996 and became effective on November
1. The regulations weren't really relaxed, FDA just changed their rules
to match those at HHS. The exemptions are restricted significantly, but
they will allow some easier implementation of protocols in
life-threatening situations when the patient is comatose or otherwise
unable to give consent. References are:  comments on rule changes and
FDA response - 61 FR 51497; final rule - 61 FR 51528.

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* Bill Caskey                                  *
* Director, Research & Grants Administration   *
* The Children's Mercy Hospital                *
* 2401 Gillham Road                            *
* Kansas City, MO  64108                       *
* Voice:        (816) 234-3879                 *
* Fax:          (816) 855-1982                 *
* E-mail:       xxxxxx@cmh.edu                *
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