| (a) Proposed research must be submitted to the designated
institutional review board (IRB) and contain written information for
the IRB to determine whether the requirements described in 45 Code
of Federal Regulations (CFR) §46.111 are satisfied.
(b) Each designated IRB shall review all proposed research
in accordance with 45 CFR §46.109.
(c) Each designated IRB has the authority to approve,
require modifications to, or disapprove any proposed research. Approval
of proposed research shall be based on:
(1) consideration of the information described in 45
CFR §46.111;
(2) the designated IRB's verification that the requirements
in 45 CFR §46.111, §925.4 of this chapter (relating to General
Principles), and §925.8 of this chapter (relating to Informed
Consent) are met; and
(3) the designated IRB's verification that procedures
for obtaining and documenting authorization to use or disclose protected
health information (PHI) meet the requirements in 45 CFR §164.508,
unless:
(A) the designated IRB approves a waiver or alteration
of the authorization requirement as permitted in §925.9(b) of
this chapter (relating to Using and Disclosing Protected Health Information
in Research); or
(B) the designated IRB determines and documents that:
(i) the data needed for the research is contained in
a limited data set and the investigator will comply with the requirements
in 45 CFR §164.514(e), including the execution of a data use
agreement; or
(ii) the data needed for the research is limited to
decedents' PHI and documentation submitted by the investigator meets
the requirements in 45 CFR §164.512(i)(1).
(d) The designated IRB may take into consideration
deliberations and reviews from another IRB that has approved the protocol
for a specific research proposal, but the designated IRB is ultimately
responsible for approval of the proposed research.
(e) Research review and documentation process.
(1) External IRB as the designated IRB. The research
review and documentation process for research using an external IRB
is generally as follows.
(A) The IRB2 screens the research proposal and, if
determined appropriate for implementation, the investigator submits
the research proposal to the external IRB for review.
(B) The external IRB reviews the research proposal.
(C) The investigator informs the IRB2 of the external
IRB's approval or disapproval. The IRB2 informs the Texas Health and
Human Services Commission (HHSC) services authorized person of the
external IRB's approval or disapproval.
(D) Any approval by an external IRB is subject to HHSC
policy requirements.
(2) IRB2 as the designated IRB. The research review
and documentation process for research involving HHSC services using
the IRB2 is generally as follows.
(A) The principal investigator submits the proposal
to the IRB2.
(B) The IRB2 reviews the research proposal.
(C) The IRB2 informs the HHSC services authorized person
of the IRB2's approval or disapproval and recommendations, if any.
(D) If the research proposal is approved by the IRB2,
the HHSC services authorized person considers the IRB2's recommendations,
if any, and either approves or disapproves the research proposal for
implementation.
(f) In addition to approval by the designated IRB and
HHSC services authorized person, review and approval by the chief
medical officer or chief medical director of the state hospitals,
state supported living centers, or other entity primarily responsible
for the health and safety of the research subjects, as applicable,
is required for any research proposal involving:
(1) a placebo as the primary medication therapy;
(2) medication or doses of medication as the primary
medication therapy with an unknown effectiveness for the targeted
disorder or condition; or
(3) an investigational medication or device.
(g) The review process for proposed research may require
additional steps as necessary, (e.g., in the event a proposal is initially
rejected).
(h) The HHSC services authorized person is responsible
for ensuring that all investigators are qualified to perform any clinical
duties assigned to them and are knowledgeable of HHSC's rules governing
the care and protection of individuals as described in 25 TAC 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).
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