Guide to the IRB at DSHS

IRB applications typically begins with a researcher request for data from DSHS or HHSC. The program reviews that data request and determines the most appropriate pathway for the release of the data. 

The following DSHS programs require a data request form (available from the program) when reviewing researcher requests for their data:

• Texas Cancer Registry
• Center for Health Statistics Data Management Team

Data may be publicly available (ie. on the website), publicly releasable, or program staff may determine that an IRB application is required before data can be released. If a data release requires an approved IRB application, then program staff will refer the researcher to the IRB for information on how to submit an application.

For Researchers Requesting Data From HHSC: Researchers are advised to submit an Open Records Request if requesting data from HHSC. The HHSC website contains information on how to submit an Open Records Request to HHSC. 

Researchers should not begin the IRB submission process until they have contacted a DSHS program. DSHS programs will provide information to researchers on whether or not an IRB application is necessary.

Researchers submit IRB application to DSHS through the DSHS IRB OneAegis System. The system at DSHS is web-based and accessed through IAMOnline, which is our single sign-on system at the Health and Human Services.

The following applications are submitted through the DSHS IRB OneAegis System:

• initial applications
• amendments
• renewal applications
• study closure materials
• adverse or unintended event reports

Submitting an IRB application requires researchers to:

1. Create an IAMOnline account
2. Request access to OneAegis
3. Create the application
4. Submit the application

Information on accessing OneAegis through IAMOnline and how to create an IRB application are available on the IRB website.

If you have trouble with your IAMOnline account, please contact the IAMOnline Help Desk. The Help Desk is available 7:00 AM to 7:00 PM Central Time, Monday-Friday by phone at 855-435-7181 (toll free) or 512-438-4720.

IRB applications are reviewed by appropriate programs who will review the application for completeness, obtain all legal and executive reviews of the application before approving the application. Programs typically require modifications to an IRB application before an application is approved.

Program Level Review: Criteria for Review

• Conducts initial scientific review of study’s validity
• Ensures DSHS has the data being requested
• Ensures the program has resources to meet the data request without compromising agency functions
• Review which variables are being requested and how it relates to study review data management and destruction plans

Data or biospecimens requests from multiple programs go through program review for each program.  Each program may or may not require legal review and associate commissioner review depending on the legal requirements of each dataset. 

Legal Review: Criteria for Review

• Provides legal guidance and answers questions from program staff
• Approves  or disapproves release of data based on statute

Associate Commissioner Review: Criteria for Review

• Conducts division level pre-IRB review of IRB applications for studies or data requests

The IRB administrator will determine how to route an application for IRB review. There are three types of IRB reviews:

• Full board reviews are conducted at convened monthly meeting (except in August when there is no meeting).  Initial applications are always referred to the full board.
• Expedited Reviews are conducted outside of the full board meetings by a designated board member or the Chair. To qualify, the request must be minimal risk and meet the criteria outlined in the Common Rule. Administrator expedited reviews consist of research team log changes and can be approved by the IRB administrator with subsequent review by the IRB chair.
• Exempt Reviews are for proposals that are considered exempt under the federal regulations, such as projects deemed to be public health practice. These are also conducted outside of the monthly meetings. 

DSHS IRB reviews based on the federal regulations set by the Common Rule.  We also abide by legislation set forth by the State of Texas. IRB criteria for review:

• Reviews proposed research involving human subjects
• Ensures risks to subjects are minimized and reasonable in relation to any benefit from study or importance of knowledge that may result
• Selection of subjects is fair and equitable
• Participation is voluntary and informed consent is obtained or there is sufficient justification for a waiver of informed consent
• Research plan provides for monitoring the data to ensure the safety of the subjects
• Adequate provisions in place to protect privacy and maintain confidentiality of data

All IRB approved initial applications that utilize DSHS data are referred to the Research Executive Steering Committee (R-ESC). The Committee includes the Assistant Deputy Commissioner, the Office of General Counsel Director, and the State Epidemiologist or their Designees and typically meets monthly.

It is the policy of the ESC to consider public health purpose and benefit when reviewing and approving proposed research applications. The R-ESC is delegated by the DSHS Commissioner and has the authority to approve, require modification of, place restrictions on, or disapprove proposed research applications. 

Upon approval by the Research Executive Steering Committee, the IRB will package IRB application documents and send them to the Contract Management Section. The Contract Management Section will work with the researchers and their institution to get an MOU signed and approved. When all MOU documents are signed, the Contract Management Section will contact the IRB who will send approval letters to the researchers and program staff.

Each institution represented in the research team log will need a Vendor Information Form submitted with an IRB application. Each institution conducting DSHS IRB research will need a signed & executed MOU/DUA. New research studies will be added to an institution’s MOU through an amendment process. All MOU amendments must be approved by all parties (DSHS & the research institution)

The Contract Management Section will contact the researcher's institution when an MOU needs renewal (typically every 5 years).

Programs in the table below can be contacted to obtain information on how to access their respective data systems. This table does not include all data systems at DSHS.

Information on various HHSC programs and services are available on the HHSC Data and Statistics webpage. Available datasets include:

• Childcare licensing data and statistics
• Enrollment in the Children's Health Program (CHIP), Medicaid, Medicaid Managed Care, and Women's Health
• Induced Terminations of Pregnancy
• Medicaid and CHIP Financial Statistical Reports
• Medicaid CHIP Quality and Efficiency Improvement
• SNAP
• TANF
• YES Waiver

Researchers requesting non-publicly available data from HHSC are advised to submit an Open Records Request before submitting an IRB application.