| (a) Participation in research that can advance scientific
knowledge of mental disorders, substance use disorders, and intellectual
or developmental disability supports the mission of the Texas Health
and Human Services Commission (HHSC).
(b) HHSC's guiding principle for all research involving
human subjects is the protection of the personal rights, safety, well-being,
privacy, and dignity of the subjects to:
(1) ensure the protection of human subjects involved
in research, HHSC promulgates this chapter and adopts by reference
45 Code of Federal Regulation (CFR) Part 46, Subparts A, B, C, and
D;
(2) ensure ethical principles are maintained when research
involving human subjects is conducted, HHSC adopts by reference "The
Belmont Report: Ethical Principles and Guidelines for the Protection
of Human Subjects of Research, Report of the National Commission for
the Protection of Human Subjects of Biomedical and Behavioral Research"
(April 18, 1979);
(3) ensure all research undertaken is conducted with
a fundamental commitment to high ethical standards regarding the conduct
of scientific research, HHSC adopts by reference 42 CFR Part 93;
(4) ensure research subjects' participation is voluntary;
and
(5) protect the privacy of human subjects involved
in research, HHSC adopts by reference the Federal Standards for Privacy
of Individually Identifiable Health Information, 45 CFR Part 160 and
Part 164, Subparts A and E, promulgated by the U.S. Department of
Health and Human Services pursuant to the Health Insurance Portability
and Accountability Act of 1996.
(c) HHSC is committed to research conducted in a manner
that is consistent with the best interests and protection of personal
rights and the welfare of human subjects involved in the research.
(1) An investigator may not approach an individual
to participate in a research study if the research conflicts with
the individual's treatment goals.
(2) No research involving human subjects may be conducted
unless the risks to human subjects are minimized and are reasonable
in relation to the anticipated benefits.
(3) No undue influence or coercion may be used to influence
an individual to participate in a research study.
(4) Unless scientifically justified, an individual
may not be excluded from participating in research based on personal
characteristics, such as race, color, ethnicity, national origin,
religion, sex, age, or ability.
(5) Human subject participation in research studies
must be equitable, with measures taken to ensure the research sample
is representative of the population of interest. Within the population
of interest, subject selection procedures must offer equitable opportunity
for access to participation in research and access to potential benefits
of participation.
(6) An investigator may not approach an individual
receiving HHSC services under an order of protective custody pursuant
to the Texas Health and Safety Code Chapter 574 about participation
in a research study involving an investigational medication or device
prior to the entry of an order for temporary or extended mental health
services.
(7) Research may not be conducted with a human subject
who is involuntarily committed if the research involves:
(A) placebos as the primary medication therapy;
(B) medication or doses of medication as the primary
medication therapy which are known to be ineffective for the targeted
disorder or condition; or
(C) an investigational medication or device that is
proposed to be undertaken when previous research on the medication
or device with 100 human subjects or fewer has provided minimal or
no documentation of the efficacy and safety of the medication or device
for the population with the targeted disorder or condition.
(8) Research may not be conducted if the protocol:
(A) extends the use of a placebo or washout period
beyond what has been approved by the institutional review board (IRB);
(B) deprives the human subject of reasonable relief
in consultation with the subject; or
(C) extends a human subject's use of placebos as the
primary medication therapy after the subject is discharged.
(9) Unless otherwise provided for in this chapter,
research involving human subjects may not be conducted unless:
(A) the designated IRB reviews and approves the research
in accordance with §925.7 of this chapter (relating to Review
and Approval of Proposed Research);
(B) the HHSC services authorized person agrees to the
research being conducted; and
(C) the necessary assurance and certification has been
submitted to the appropriate federal agency, (e.g., Health and Human
Services, Food and Drug Administration) if required, and the agency
has indicated its approval.
(10) Research conducted may not hinder the ability
of the research site or program to accomplish its primary purpose.
(d) Right to file a complaint.
(1) An individual involved in research or the individual's
legally authorized representative (LAR) is entitled to file a complaint
about alleged mistreatment or other concerns relating to the research
with an HHSC rights officer or through any other applicable complaint
mechanism.
(2) An individual or the individual's LAR is entitled
to file a complaint about violations of the Federal Standards for
Privacy of Individually Identifiable Health Information as provided
by 45 CFR Part 160 and Part 164, Subparts A and E with the Office
for Civil Rights at the U.S. Department of Health and Human Services
or refer to the HHSC Health Insurance Portability and Accountability
Act policy, which can be found at https://hhs.texas.gov/laws-regulations/legal-information/hipaa-privacy-laws,
as set forth in the Notice of Privacy Practices.
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