| (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.
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