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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 414RIGHTS AND PROTECTIONS OF PERSONS RECEIVING MENTAL HEALTH SERVICES
SUBCHAPTER PRESEARCH IN TDMHMR FACILITIES
RULE §414.754General Principles

(a) Participation in research that can advance scientific knowledge of mental disorders and conditions is integral to the mission of TDMHMR.

(b) TDMHMR's guiding principle for all research involving human subjects at its facilities is the protection of the personal rights, safety, well-being, privacy, and dignity of the subjects.

  (1) To ensure the protection of human subjects involved in research at its facilities, TDMHMR promulgates this subchapter and adopts by reference Title 45, Code of Federal Regulations, Part 46 (Protection of Human Subjects), Subparts A, B, and D, referenced as Exhibit A in §414.763 of this title (relating to Exhibits).

  (2) To ensure ethical principles are maintained when research involving human subjects is conducted at its facilities, TDMHMR 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), referenced as Exhibit B in §414.763 of this title.

  (3) To ensure all research undertaken at its facilities is conducted with a fundamental commitment to high ethical standards regarding the conduct of scientific research, TDMHMR adopts by reference 42 CFR Part 50, Subpart A, (Responsibility of PHS Awardee and Applicant Institutions for Dealing With and Reporting Possible Misconduct in Science), referenced as Exhibit C in §414.763 of this title.

  (4) To protect the privacy of human subjects involved in research at its facilities, TDMHMR adopts by reference the Federal Standards for Privacy of Individually Identifiable Health Information, Title 45, Code of Federal Regulations, 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 (HIPAA).

(c) TDMHMR is committed to research conducted in a manner that is consistent with the best interests and protection of personal rights and welfare of human subjects involved in the research.

  (1) An individual may not be approached 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 inducement or coercion may be used to influence human subjects to participate in a research study.

  (4) Unless scientifically justified, individuals may not be excluded from participating in research on the basis of personal characteristics, such as race, color, ethnicity, national origin, religion, sex, age, disability, sexual orientation, or political affiliation.

  (5) Human subject participation in research studies must be equitable with measures taken to ensure the research sample is adequately 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) Individuals receiving mental health services under an order of protective custody pursuant to the Texas Health and Safety Code, Chapter 574, may not be approached 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 human subjects who are 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 at a facility if the protocol:

    (A) extends the use of a placebo or washout period unreasonably;

    (B) deprives the human subject of reasonable relief; or

    (C) extends a human subject's use of placebos as the primary medication therapy after the subject is discharged from the facility.

  (9) Unless otherwise provided for in this subchapter, research involving human subjects may not be conducted at a facility unless:

    (A) the research has been reviewed and approved by the facility's designated IRB in accordance with §414.757 of this title (relating to Review and Approval of Proposed Research);

    (B) the facility CEO has agreed to have the research conducted at the facility; and

    (C) if required, the necessary assurance and certification has been submitted to the appropriate federal agency, (e.g., Health and Human Services, Food and Drug Administration) and the agency has indicated its approval.

  (10) Research conducted at a facility may not hinder the facility's ability to accomplish its primary purpose.

(d) Right to file a complaint.

  (1) A human subject involved in research or his/her LAR is entitled to file a complaint about alleged mistreatment or other concerns relating to the research with the facility's rights officer or with any other applicable complaint mechanism in place.

  (2) An individual or his/her LAR is entitled to file a complaint about violations of the Federal Standards for Privacy of Individually Identifiable Health Information (45 CFR Part 160 and Part 164, Subparts A and E) with the facility's privacy coordinator, the TDMHMR Consumer Services and Rights Protection/Ombudsman Office, or the Office for Civil Rights at the U.S. Department of Health and Human Services, as set forth in the Notice of Privacy Practices.


Source Note: The provisions of this §414.754 adopted to be effective July 5, 2004, 29 TexReg 6093

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