26 Tex. Admin. Code § 925.9 - Using and Disclosing Protected Health Information in Research
(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).
Notes
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