SECTION 925.5. Designated Institutional Review Board

(a) Each research project conducted involving Texas Health and Human Services Commission (HHSC) services must have a designated institutional review board (IRB). The designated IRB is responsible for reviewing, approving, and monitoring all research conducted.

(b) In accordance with 45 CFR §46.114, cooperative research, defined as projects that involve more than one institution, must rely on a single IRB to review and approve the portion of research conducted in the United States.

(c) The designated IRB will be one of the following:

(1) an external IRB with IRB2 approval; or

(2) the IRB2.

(d) The membership of the designated IRB must comply with the requirements in 45 CFR §46.107.

(e) In addition to 45 CFR §46.107, the IRB2 membership must include at least three members who are familiar with the mental disorders or conditions, intellectual or developmental disability (IDD), and concerns of the populations of individuals HHSC serves, including:

(1) at least one of the three members must be a professional in the field of mental health, IDD, or substance use; and

(2) at least two of the three members described in this paragraph must be:

(A) an individual with a serious mental illness, severe emotional disturbance, substance use disorder, or a person with IDD who is or has received HHSC services;

(B) a family member of a person described in subparagraph (A) of this paragraph; or

(C) an advocate for an individual described in subparagraph (A) of this paragraph.

(f) Each designated IRB must have written policies and procedures that are consistent with this chapter and HHSC's rules governing the care and protection of individuals as described in Texas Administration Code Title 25, Chapter 404, Subchapter E (relating to Rights of Persons Receiving Mental Health Services) and 40 TAC Chapter 4, Subchapter C (relating to Rights of Individuals with an Intellectual Disability) and that address:

(1) the review or screening process to determine whether proposed research is exempt from the requirements of federal regulations made in accordance with 45 CFR §46.104, including required documentation and any necessary approvals;

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

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

Source Note: The provisions of this §925.5 adopted to be effective November 27, 2022, 47 TexReg 7731