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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 414RIGHTS AND PROTECTIONS OF PERSONS RECEIVING MENTAL HEALTH SERVICES
SUBCHAPTER PRESEARCH IN TDMHMR FACILITIES
RULE §414.756IRB Functions and Operations

(a) Each designated IRB shall:

  (1) follow its written policies and procedures as described in §414.755(e) of this title (relating to Designated Institutional Review Board (IRB));

  (2) function in accordance with 45 CFR §46.108, referenced as Exhibit A in §414.763 of this title (relating to Exhibits);

  (3) ensure proposed research is reviewed and approved in accordance with §414.757 of this title (relating to Review and Approval of Proposed Research);

  (4) except when an expedited review is used as described in 45 CFR §46.108(b), ensure proposed research is reviewed and approved only at meetings in which at least one of each of the following members are present, participating, and voting:

    (A) a member who satisfies the requirements of §414.755(d)(1)(A), (2)(A), or (3)(A) of this title, as appropriate to the IRB; and

    (B) a member who satisfies the requirements of §414.755(d)(1)(B), (2)(B), or (3)(B) of this title, as appropriate to the IRB, and in the case of the Central Office IRB, as appropriate to the facility or facilities for which the research is proposed.

  (5) exercise appropriate oversight to ensure that:

    (A) its policies and procedures designed for protecting the rights, privacy, and welfare of human subjects are being effectively applied; and

    (B) research is being conducted at the facility or facilities in accordance with the approved protocol;

  (6) maintain records of its operations in accordance with 45 CFR §46.115;

  (7) submit to the ORA documentation of its continuing review of all approved and active research protocols; and

  (8) immediately notify the ORA of any unanticipated serious problems or events involving risks to the human subjects or others.

(b) Each designated IRB has the authority to 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, then 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) appropriate facility or facilities officials; and

  (3) the ORA.


Source Note: The provisions of this §414.756 adopted to be effective July 5, 2004, 29 TexReg 6093

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