The Institutional Review Board is housed within HHSC in State Hospital Central Administration. IRB2 reviews research in accordance with: current federal regulations, specifically, "the common rule" found in the Department of Health and Human Services regulation (45 Code of Federal Regulations 46), the TDMHMR Administrative Code (TAC Title 25, Chapter 414, Subchapter P), the Federal Privacy Rule (45 CFR 160 and 45 CFR 164, Subparts A and E), and Food and Drug Administration regulations (54 CFR 21 and 56 CFR 21). IRB2 provides oversight for any research that uses data on people served by community behavioral health services, community intellectual and/or developmental disorders services, state supported living centers, and/or state hospitals. The types of projects or studies reviewed by IRB2 include: surveys, interviews, observations or assessments of people served or agency staff. Additionally, IRB2 reviews data requests for research using secondary sources including information on people served by state hospitals or state supported living centers. IRB2 is not responsible for the delivery of data to researchers. Investigators are responsible for locating data sources independently and arranging a secure transfer.
Obtaining Approval for Research
Mandatory steps to obtain formal approval for research:
- Submit the "Approval-to-Apply" application (PDF) to the IRB2 coordinator, who will seek approval from executive leadership for the proposed research to continue with the IRB2 submission process.
- Once the Approval-to-Apply Application has been reviewed and approved by leadership, the IRB2 coordinator 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 are required. These materials are outlined on the checklist on the first page.
- IRB2 Application (PDF) — Required completion of Human Subjects Training Certificate from National Institutes for Health (Collaborative Institutional Training Initiative training also accepted)
- IRB2 Informed Consent Form Template (Word) (if needed)
- IRB2 Study Information Sheet Template (Word) (if needed)
- Once IRB2 approval is obtained, the following forms might be needed for annual renewal, study amendments to the approved protocol, or study closure.
IRB2 Contact Information
Before submitting any research for review, contact the IRB2 coordinator at IRB2@hhsc.state.tx.us to schedule a conference call to discuss the scope of any proposed research.