In the U.S., under the Revised Common Rule, can an Agency or Department head waive both the IRB review requirement [at policy part .109], and informed consent [at policy part .116], under policy part .101(i), for a particular human research project, involving physical interventions upon the human body (or brain)?  I am asking this question because: Under the Revised Common Rule, at .101(i), it appears that there is a new requirement that an Agency Head waiver of all or part of the Revised Common Rule must be consistent with the Belmont Report. And it appears that the Belmont Report states the Informed Consent of the human subject is required by the principle of human autonomy / respect for persons. So, how could an Agency Head waive Informed Consent under the new Belmont Report related restrictions at .101(i) of the Revised Common Rule? The letter h should appear at least 26 times.
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