| (a) Except as provided by this section, to use or disclose
protected health information (PHI), an authorization is required that:
(1) conforms with the requirements of 45 Code of Federal
Regulations (CFR) §164.508 and, if applicable 42 CFR Part 2;
and
(2) includes a statement that the subject's right to
access his or her PHI created or obtained during research may be temporarily
suspended while the research is in progress, and will be reinstated
upon completion of the research, if the research includes treatment.
(b) During the review of proposed research, the designated
institutional review board (IRB) has the authority to approve a waiver
or alteration of the authorization requirement in accordance with
45 CFR §164.512(i).
(c) The designated IRB has the authority to approve
the use or disclosure of PHI for purposes preparatory to research
if the IRB obtains from the investigator adequate representations
as required by 45 CFR §164.512(i)(1)(ii).
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