Mental Health and Substance Abuse Institutional Review Board (IRB2)

The Institutional Review Board (IRB2) reviews research in accordance with current Department of Health and Human Services regulation (45 CFR 46), the TDMHMR Administrative Code (TAC Title 25, Chapter 414, Subchapter P), the Privacy Rule (45 CFR 160 and 45 CFR 164, Subparts A and E), and Food and Drug Administration regulations (54 CFR 21 & 56 CFR 21).


IRB2 Contact Information

Contact the IRB2 Coordinator to schedule a conference call to discuss new IRB submissions: 


Under the authority of the TDMHMR Administrative Code (TAC Title 25, Chapter 414, Subchapter P), IRB2 reviews the following:

  • Resources of the Mental Health and Substance Abuse Division (MHSA), including staff, property, and non-public information; this includes, but is not limited to, centralized client databases.
  • Individuals receiving services from an HHSC or DADS facility.

The types of projects or studies reviewed by IRB2 include:

  • Surveys, interviews, observations, or assessments of clients, patients, or staff.
  • Requests for release of client-patient data/records from State Hospitals or State-Supported Living Centers.
  • Requests for release of client-patient data from centralized databases.
  • Use of client-patient level data or data collection for the purposes of contributing to generalizable knowledge (e.g., Master’s thesis, Doctoral dissertation, conference presentation, journal article, federal reports, legislatively mandated reports). 

Obtaining Approval for Research:

Mandatory steps to obtain formal approval for research, studies, and projects:

1. Approval to submit a formal application to IRB2:

        HHSC projects
        DADS projects

2. Approval of the formal IRB2 application package by IRB2 (full board or expedited) and facility superintendent.

  • Full Board review
  • Expedited reviews are conducted by the Chair or his designee and are ongoing.

        IRB Application Packet
        Required Human Subjects Training from NIH (CITI Training also accepted)
        IRB Informed Consent Form Template

3. Approval by the DSHS Research Executive Steering Committee (R-ESC) required by DSHS Policy Number PA-4002.  R-ESC approval is not required for DADS applications submitted to IRB2.

Other IRB2 Forms:

        IRB2 Continuing Review, Amendment, and Closure Packet
        Protocol Deviation or Noncompliance Report
        Adverse Event and Unanticipated Problem Report



Last updated August 16, 2017