Institutional Review Board (IRB2)

Mental Health, Substance Use and Intellectual/Developmental Disabilities Institutional Review Board (IRB2)

The Institutional Review Board is housed within HHSC in State Hospital Central Administration. IRB2 reviews research in accordance with federal regulations and provides oversight for any research using data on people served by community behavioral health services, community intellectual and/or developmental disorders services, state supported living centers, and/or state hospitals. IRB2 is not responsible for the delivery of data to researchers. Investigators are responsible for locating data sources independently and arranging a secure transfer.

Research utilizing identifiable or de-identified patient data from any Texas State Hospital must receive agency review prior to applying for IRB2 approval.. Investigators may begin drafting their IRB2 application while agency review is underway. Do not submit the IRB2 approval-to-apply document for review until the agency review is completed. To inquire about State Hospital data requests email State_Hospital_Research@hhsc.state.tx.us.

An overview of the IRB2 review and approval process can be found here (PDF).

Obtaining Approval for Research

Mandatory steps to obtain formal approval for research:

1. Submit the "Approval-to-Apply" application (PDF) to the IRB2 Administrator, who will seek approval from executive leadership for the proposed research to continue with the IRB2 submission process.
2. Once the Approval-to-Apply Application has been reviewed and approved by leadership, the IRB2 Administrator will direct you to complete the longer IRB2 Application (PDF) for committee review, and superintendent review (if proposed research concerns research at an SSLC or state hospital). The IRB2 application should be read carefully as supplemental materials may need to be emailed to the IRB2 Administrator. These materials are outlined on the checklist on the first page.
   • IRB2 Application— Required completion of Human Subjects Training Certificate from: Office for Human Research Protections, National Institutes for Health, Protecting Human Research Participants or the Collaborative Institutional Training Initiative. Researchers are financially responsible for any costs associated with securing Human Subjects Training.
   • Disclosure of Potential Conflicts of Interest (PDF)
   • IRB2 Informed Consent Form  (Word) (if needed)
   • IRB2 Study Information Sheet (Word) (if needed)
3. Once IRB2 approval is obtained, the following forms might be needed for annual renewal, study amendments to the approved protocol, or study closure.
   • IRB2 Continuing Review or Study Closure Form (PDF)
   • IRB2 Amendment Form (PDF)
   • Protocol Deviation or Noncompliance Report (PDF)
   • Adverse Event and Unanticipated Problem Report (PDF)

IRB2 Contact Information

Before submitting any research for review, contact the IRB2 coordinator at IRB2@hhs.texas.gov to schedule a conference call to discuss the scope of any proposed research.

Resources

• NIH Decision Tool: Am I Doing Human Subjects Research?
• OHRP Human Subject Regulations Decision Charts: 2018 Requirements

Regulatory References

• "Research in TDMHMR Facilities" Texas Administrative Code
• Belmont Report website
• Common Rule 45 CFR 46 website