Current through Reg. 49, No. 52; December 27, 2024
(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).
