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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 §414.755Designated Institutional Review Board (IRB)

(a) Each facility electing to participate in research must have a designated IRB. The designated IRB is responsible for reviewing, approving, and monitoring all research conducted at that facility, with the exception of research involving multiple facilities as provided by subsection (c) of this section.

(b) A facility may choose one of the following options for its designated IRB, which must be approved by the ORA as outlined in subsection (f) of this section.

  (1) Facility IRB. An IRB, established and operated by a facility, whose membership meets the requirements described in subsection (d) of this section.

  (2) Another facility's IRB. A facility IRB as described in paragraph (1) of this subsection.

  (3) University IRB. An IRB, established and operated by a university, whose membership meets the requirements described in subsection (d) of this section.

  (4) Central Office IRB. An IRB, established and operated by Central Office, whose membership meets the requirements described in subsection (d) of this section.

(c) A facility's CEO may request that the Central Office IRB act as the facility's designated IRB for a research study that involves multiple facilities.

(d) The membership of the IRB must comply with the requirements in 45 CFR §46.107, referenced as Exhibit A in §414.763 of this title (relating to Exhibits) and this subsection.

  (1) Facility IRB. Membership of a facility IRB must include at least three members who are familiar with the mental disorders or conditions and concerns of the population(s) served by the facility or facilities.

    (A) At least one of the three members described in this paragraph must be a professional in the field of mental health or mental retardation, as appropriate to the facility or facilities.

    (B) At least two of the three members described in this paragraph must be:

      (i) a person who is or has been in the mental health priority population or mental retardation priority population, as appropriate to the facility or facilities;

      (ii) a family member of a person who is or has been in the mental health priority population or mental retardation priority population, as appropriate to the facility or facilities; or

      (iii) an advocate for persons who are or have been in the mental health priority population or mental retardation priority population, as appropriate to the facility or facilities.

  (2) University IRB. Membership of a university IRB must include at least three members or ad hoc members who are familiar with the mental disorders or conditions and concerns of the population(s) served by the facility or facilities.

    (A) At least one of the three members described in this paragraph must be a professional in the field of mental health or mental retardation, as appropriate to the facility or facilities.

    (B) At least two of the three members described in this paragraph must be:

      (i) a person who is or has been in the mental health priority population or mental retardation priority population, as appropriate to the facility or facilities;

      (ii) a family member of a person who is or has been in the mental health priority population or mental retardation priority population, as appropriate to the facility or facilities; or

      (iii) an advocate for persons who are or have been in the mental health priority population or mental retardation priority population, as appropriate to the facility or facilities.

  (3) Central Office IRB. Membership of the Central Office IRB must include local representation from various regions of the state and at least three members who are familiar with the mental disorders or conditions and concerns of the population(s) served by TDMHMR.

    (A) At least one of the three members described in this paragraph must be a professional in the field of mental health and mental retardation.

    (B) At least two of the three members described in this paragraph must be:

      (i) a person who is or has been in the mental health priority population, a family member of a person who is or has been in the mental health priority population, or an advocate for persons who are or have been in the mental health priority population; and

      (ii) a person who is or has been in the mental retardation priority population, a family member of a person who is or has been in the mental retardation priority population, or an advocate for persons who are or have been in the mental retardation priority population.

(e) Each IRB must have written policies and procedures that are consistent with this subchapter and TDMHMR's rules governing the care and protection of individuals as described in §414.764(5) of this title (relating to References) and that address:

  (1) the functions and operations of the IRB as required by 45 CFR §46.103(b)(4) and (5);

  (2) the review or screening process to determine whether proposed research is exempt from the requirements of federal regulations made in accordance with 45 CFR §46.101(b), including required documentation, and any necessary approvals;

  (3) the process for ensuring that each IRB member and key researcher involved in an approved research study receives documented training in applicable ethics, laws, and regulations governing research involving human subjects; and

  (4) the process for disclosing and considering potential conflicts of interest, financial or otherwise, by IRB members and key researchers.

(f) ORA approval of a designated IRB.

  (1) A facility seeking approval for its own facility IRB, another facility's IRB, or a university IRB as its designated IRB, as described in subsection (b)(1), (2), or (3) of this section, must submit the following to the ORA:

    (A) IRB membership information in sufficient detail to determine compliance with subsection (d) of this section and which describes each member's chief anticipated contribution to IRB deliberations, and any employment or other relationship between each member and the facility, university, or Central Office, as appropriate;

    (B) the written policies and procedures described in subsection (e) of this section;

    (C) the written policy for the communication of IRB deliberations, recommendations, and decisions to the facility CEO and the ORA; and

    (D) if approval is for a university IRB or another facility's IRB, a copy of the written agreement in which the university IRB or other facility IRB accepts responsibility for reviewing, approving, and monitoring all research to be conducted at the facility seeking approval; and

    (E) if approval is for a university IRB, a detailed description of how the facility will collaborate with the university IRB to ensure compliance with any requirement in this subchapter that is unique to TDMHMR (i.e., the duties, activities, and responsibilities of both the facility and the university IRB).

  (2) A facility seeking approval for the Central Office IRB as its designated IRB, as described in subsection (b)(4) of this section, must submit a written request from the facility CEO to the ORA.

(g) The ORA shall review the information submitted by the facility and will approve, disapprove, or enter into negotiations to attain approval for the IRB as the facility's designated IRB. The ORA will provide written notice of approval or disapproval to the requesting facility.

(h) Any change in a designated IRB's membership, policies, or procedures must be reported to and approved by the ORA.

(i) The ORA may require that a designated IRB comply with additional requirements related to documentation and approval if the ORA determines that such requirements are necessary to ensure the protection of human subjects.

(j) The ORA may revoke approval of a designated IRB at any time the ORA determines the IRB fails to maintain standards in accordance with federal regulations and this subchapter.


Source Note: The provisions of this §414.755 adopted to be effective July 5, 2004, 29 TexReg 6093

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