SECTION 925.6. Designated Institutional Review Board Functions and Operations

(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.

Source Note: The provisions of this §925.6 adopted to be effective November 27, 2022, 47 TexReg 7731