<<Prev Rule

Texas Administrative Code

Next Rule>>
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 §414.757Review and Approval of Proposed Research
Texas Register

(a) Proposed research must be submitted to the facility's designated IRB and contain adequate written information for the IRB to determine whether the requirements described in 45 CFR §46.111, referenced as Exhibit A in §414.763 of this title (relating to Exhibits), are satisfied, including the following:

  (1) A complete description of how the research protocol will be implemented at the facility or facilities, including:

    (A) the process for recruiting, screening, and selecting human subjects;

    (B) procedures for obtaining and documenting informed consent;

    (C) how many subjects are required at the facility or facilities;

    (D) the process for and level of clinical monitoring of human subjects throughout the research period;

    (E) procedures for obtaining and documenting authorization to use or disclose protected health information (PHI) or a request for a waiver or alteration of authorization with justification; and

    (F) appropriate and sufficient information to enable the facility to provide an accounting of disclosures as required in 45 CFR §164.528(b), if the proposed research includes a request for a waiver or alteration of authorization to use or disclose PHI or the proposed research involves using or disclosing decedents' protected health information without an authorization.

  (2) A thorough justification of the research protocol and proposed analyses, including;

    (A) a description of the procedures designed to minimize risks to subjects; and

    (B) the scientific rationale for targeting the proposed population(s) as human subjects.

  (3) If the proposed research would extend a human subject's use of an investigational medication or device as the primary treatment after the subject is discharged from the facility, then the research proposal must also contain a memorandum of agreement between the principal investigator and the local authority responsible for the subject's continuity of care which states that, before the conclusion of the subject's participation in the research study, the local authority agrees:

    (A) to make face-to-face contact with the subject to determine whether the subject will need medication services when the subject's participation in the research study has ended; and

    (B) to arrange for the provision of needed medication services for the subject when the subject's participation in the research study has ended.

(b) Each designated IRB shall review all proposed research at the facility in accordance with 45 CFR §46.109, concerning IRB review of research.

(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 subsection (a)(1) - (3) of this section;

  (2) the IRB's verification that the requirements in 45 CFR §46.111, concerning criteria for IRB approval of research, §414.754 of this title (relating to General Principles), and §414.758 of this title (relating to Informed Consent) are met; and

  (3) the IRB's verification that procedures for obtaining and documenting authorization to use or disclose PHI meet the requirements in 45 CFR §164.508, unless:

    (A) the IRB approves a waiver or alternation of the authorization requirement as permitted in §414.760(b) of this title (relating to Using and Disclosing Protected Health Information in Research); or

    (B) the IRB determines and documents that:

      (i) the data needed for the research is contained in a limited data set and the researcher 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' protected health information and documentation submitted by the researcher meets the requirements in 45 CFR §164.512(i)(1)(iii).

(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) Facility IRB as the designated IRB. The research review and documentation process for a facility IRB, as described in §414.755(b)(1) and (2) of this title (relating to Designated Institutional Review Board (IRB)), is generally as follows.

    (A) The research proposal is reviewed by the facility IRB and, if approved, forwarded to the CEO of the facility where the research is to be conducted.

    (B) The facility CEO is informed of the facility IRB's approval or disapproval and recommendations, if any.

    (C) If the research proposal is approved by the facility IRB, the facility CEO considers the facility IRB's recommendations, if any, and either approves or disapproves the research proposal for implementation at the facility.

    (D) If the research proposal is approved, the ORA is notified in writing of the CEO's and IRB's approval including copies of the IRB's meeting minutes concerning the review of the proposal, the proposal itself, and the CEO's and IRB's documentation of approval.

  (2) University IRB as the designated IRB. The research review and documentation process for a facility using a university IRB is generally as follows.

    (A) The research proposal is screened by the facility CEO and, if determined appropriate for implementation at the facility, forwarded to the university IRB for review.

    (B) The research proposal is reviewed by the university IRB.

    (C) The facility CEO is informed of the university IRB's approval or disapproval and recommendations, if any.

    (D) If the research proposal is approved by the university IRB, the facility CEO considers the university IRB's recommendations, if any, and either approves or disapproves the research proposal for implementation at the facility.

    (E) If the research proposal is approved, the ORA is notified in writing of the CEO's and IRB's approval including copies of the IRB's meeting minutes concerning the review of the proposal, the proposal itself, and the CEO's and IRB's documentation of approval.

  (3) Central Office IRB as the designated IRB. The research review and documentation process for a facility using the Central Office IRB is generally as follows.

    (A) The research proposal is screened by the facility CEO and, if determined appropriate for implementation at the facility, forwarded to the Central Office IRB.

    (B) The research proposal is reviewed by the Central Office IRB.

    (C) The facility CEO is informed of the Central Office IRB's approval or disapproval and recommendations, if any.

    (D) If the research proposal is approved by the Central Office IRB, the facility CEO considers the Central Office IRB's recommendations, if any, and either approves or disapproves the research proposal for implementation at the facility.

    (E) If the research proposal is approved, the ORA is notified in writing of the CEO's and IRB's approval including copies of the IRB's meeting minutes concerning the review of the proposal, the proposal itself, and the CEO's and IRB's documentation of approval.

  (4) Central Office IRB as a facility's designated IRB for research studies involving multiple facilities. When a facility's CEO requests that the Central Office IRB act as its designated IRB for a research study involving multiple facilities, pursuant to §414.755(c) of this title, then the research review and documentation process is generally as follows.

    (A) The research proposal is reviewed and approved by:

      (i) each facility CEO;

      (ii) the Central Office IRB; and

      (iii) the appropriate Central Office director(s), (i.e., director of state mental health facilities or director of state mental retardation facilities).

    (B) If the research proposal is approved by the facility CEOs, the Central Office IRB, and the appropriate Central Office director(s), the ORA is notified in writing of the approval, including copies of the IRB's meeting minutes concerning the review of the proposal, the proposal itself, and documentation of approval of the CEOs and the Central Office IRB.

(f) In addition to approval by the designated IRB and facility CEO, review and approval by the TDMHMR medical director 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 which are known to be ineffective 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 facility CEO or designee is responsible for ensuring that all key researchers are qualified to perform any clinical duties assigned to them and are knowledgeable of TDMHMR's rules governing the care and protection of individuals as described in §414.764(5) of this title (relating to References).


Source Note: The provisions of this §414.757 adopted to be effective July 5, 2004, 29 TexReg 6093

Link to Texas Secretary of State Home Page | link to Texas Register home page | link to Texas Administrative Code home page | link to Open Meetings home page