Mental Health and Substance Abuse Research Administration Institutional Review Board (IRB#2)

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The Institutional Review Board (IRB#2) reviews research, studies, and projects 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), when applicable.

 

Under the authority of the TDMHMR Administrative Code (TAC Title 25, Chapter 414, Subchapter P), DSHS Institutional Review Board (IRB) #2 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 (e.g. Clients Assignment and Registration System [CARE]).
  • Individuals receiving services from a DSHS or DADS facility (State Hospital or State Supported Living Center).

 

The types of projects or studies reviewed by IRB#2 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 in MHSA such as CARE.
  • 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, program evaluation). 

Obtaining Approval for Research, Studies, and Projects

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

  • Approval to submit a formal application to IRB#2 (granted by the Mental Health and Substance Abuse Assistant Commissioner [for DSHS projects] or the Assistant Commissioner for State Supported Living Centers  [for DADS projects]).
  • Approval of the formal IRB#2 application package by DSHS IRB#2 (full board or expedited) and facility superintendent.

    • Full Board review can require two or more meetings of the IRB.
    • Expedited reviews are conducted by the Chair or his designee and are ongoing.
  • 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 IRB#2.

 

Approval at all three steps is required for formal approval of research, studies and projects.  Title 45 Code of Federal Regulations Part 46.112 states, “Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials if the institution.  However, those officials may not approve the research if it has not been approved by an IRB.” 

 

Contact the IRB#2 staff to arrange a brief conference call to discuss the scope of the project and request an Approval to Apply form.  IRB#2 staff will submit the completed Approval to Apply form to the Assistant Commissioner. 

IRB#2 Staff Contact Information

Abigail Cameron, PhD (512)206-5730
Email: IRB2@dshs.state.tx.us

Resources

 

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Last updated October 15, 2014