Confidential Data Request and IRB Approval Process

Step One:

• Email a brief summary of your study (1 paragraph) to CancerData@dshs.texas.gov. TCR will evaluate for feasibility and provide feedback.

Step Two:

• If the study is determined to be feasible, complete the TCR Confidential Data Request Form and email to CancerData@dshs.texas.gov.
• TCR will review and provide feedback.
• Revise and resubmit the request form based on TCR feedback.
• Once TCR confirms the request form is complete, visit the DSHS IRB website and follow instructions for creating an IRB application within the DSHS OneAegis IRB System. Any questions about this system should be directed to institutionalreviewboard@dshs.texas.gov.

Step Three:

• TCR reviews the application within the DSHS IRB OneAegis System and provides feedback.
• Requester revises the application accordingly and resubmits within the DSHS OneAegis IRB System. Once the application is considered ready for the next level of review, TCR will route the application to legal and leadership for review.
• If legal or leadership have additional feedback, TCR will communicate this with the requester. Requester revises and resubmits.
• Once approved by leadership, TCR will submit the application to the IRB.
• For questions about the status of the application once it has been submitted to the IRB, please contact institutionalreviewboard@dshs.texas.gov. Some status information is also available in the DSHS IRB OneAegis System (e.g., Send Full Board Review, Send for MOU Processing, etc.).
• Review and approval of new IRB-approved applications is required by the DSHS Research Executive Steering Committee (R-ESC).
• The IRB will notify the PI after a determination is made. Investigators can view the status of the application in OneAegis.
• The DSHS IRB and Contracts Management Section will initiate the MOU process with the investigator. Once the MOU is executed, TCR will provide the data.

DSHS-IRB approved studies require renewal progress reports. IRB determinations expire 1-3 years after review depending on the risk level for the study/project. Please see the most recent IRB approval letter to identify the expiration date. Renewal reports should be submitted at least 10 weeks before the expiration date.

The DSHS IRB sends out renewal notification reminders to Principal Investigators 90, 60, and 30 days before their project’s expiration date.

Step One:

• Visit the DSHS IRB website and follow instructions for creating a renewal application within the DSHS OneAegis IRB System. Starting March 1, 2024, all renewal applications must be submitted within this system and must be separate from amendments.

Step Two:

• TCR reviews the application within the DSHS IRB OneAegis System and provides feedback.
• Requester revises the application and resubmits within the system.
• Once the application is considered ready for the next level of review, TCR will route the application to leadership.
• If leadership has additional feedback, TCR will communicate this with the requester. Requester revises and resubmits.
• Once approved by leadership, TCR will submit the application to the IRB.
• The IRB will notify the PI after a determination is made. Investigators can view the status of the application in OneAegis.

An amendment is required if any of the following have changed: protocol, consent documents; PI; recruitment materials; data requested (e.g., new data items or years of data); or research team members. This list is not exhaustive; investigators should reach out to the DSHS IRB to determine whether a study change requires an amendment.

Step One: 

• If you are not requesting new data items or years of data, skip to Step Two.
• If you are requesting new data items or years of data, email CancerData@dshs.texas.gov to confirm feasibility of your request. You will need to complete and submit the TCR Confidential Data Request Form to CancerData@dshs.texas.gov.
• TCR will review and provide feedback. Requester revises and resubmits. Once the form is considered complete, go to Step Two.

Step Two:

• Visit the DSHS IRB website and follow instructions for creating an amendment application within the DSHS IRB OneAegis System.
• There are three amendment applications: Changes to Research Team Amendment form, Legacy Amendment form, and Non-Legacy Amendment form. The DSHS IRB website has information on the appropriate form for your amendment.
• Starting March 1, 2024, all amendment applications must be submitted within this system and must be separate from renewals.
• TCR reviews the application and, if applicable, provides feedback.
• Requester revises the application and resubmits within the DSHS IRB OneAegis System.

Step Three:

• Once the application is considered ready for the next level of review, TCR will route the application to legal (if applicable) and leadership for review.
• If legal or leadership have additional feedback, TCR will communicate this with the requester. Requester revises and resubmits.
• Once approved by leadership, TCR will submit the application to the IRB.
• The IRB will notify the PI after a determination is made. Investigators can view the status of the application in the DSHS IRB OneAegis System.