SECTION 925.4. General Principles

(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.

Source Note: The provisions of this §925.4 adopted to be effective November 27, 2022, 47 TexReg 7731