| (a) Each designated institutional review board (IRB)
shall:
(1) follow its written policies and procedures as described
in §925.5(f) of this chapter (relating to Designated Institutional
Review Board);
(2) function in accordance with 45 Code of Federal
Regulations (CFR) §46.108;
(3) ensure proposed research is reviewed and approved
in accordance with §925.7 of this chapter (relating to Review
and Approval of Proposed Research);
(4) exercise appropriate oversight to ensure:
(A) its policies and procedures designed for protecting
the rights, privacy, and welfare of human subjects are being applied;
and
(B) research is being conducted in accordance with
the approved protocol;
(5) maintain records of its operations in accordance
with 45 CFR §46.115;
(6) maintain documentation of its continuing review
of all approved and active research protocols; and
(7) maintain documentation of any unanticipated serious
problems or events involving risks to the human subjects or others.
(b) Each designated IRB will suspend or terminate research
that is not being conducted in accordance with the IRB's requirements
or that has been associated with significant unexpected harm to human
subjects. If an IRB suspends or terminates research, the IRB must
promptly notify the following in writing of the suspension or termination
and include a statement of the reasons for the IRB's action:
(1) the principal investigator;
(2) the appropriate HHSC services authorized person;
and
(3) the IRB2.
(c) When IRB2 is not the designated IRB for a research
protocol, a reliance agreement will be signed by the IRB2 chair outlining
all oversight responsibilities and obligations in order to ensure
the protection of human subjects.
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