Confidential Data Request and IRB Approval Process

Step One:

• Email a brief summary of your research (1 paragraph) to CancerData@dshs.texas.gov. The TCR will provide feedback regarding feasibility.

Step Two:

• Complete the TCR Confidential Data Request Form, without signature pages, and email Word document to CancerData@dshs.texas.gov.
• TCR will review the form and provide feedback regarding recommended modifications and next steps.
• Review the IRB MOU Template and share with appropriate parties at your institution.

Step Three:

• Revise the TCR Confidential Data Request Form based on TCR feedback.
• Review IRB Initial Submission Checklist.
• Complete the Initial Submission IRB forms required by the checklist.
• Email unsigned drafts of documents to CancerData@dshs.texas.gov.

Step Four: 

• TCR screens applications and requests any missing documents. 
• Researcher provides missing documents, if necessary.
• TCR reviews application and provides feedback.

Step Five:

• Revise the forms, and once finalized (with TCR approval), sign, and email to CancerData@dshs.texas.gov.

For information on the status of your IRB application once it has been submitted to the IRB and RESC, email InstitutionalReviewBoard@dshs.texas.gov.

Any study or research that has been previously reviewed and approved by the DSHS IRB and requires approval renewal must complete a renewal IRB application.

Step One:

• Review Continuing Review of DSHS IRB-Approved Research Protocols
• Review IRB Renewal Checklist.
• Complete the Renewal Submission IRB forms required by the checklist.

Step Two:

• Q: Has study/research changed? Protocol, consent document, PI, recruitment materials, data requested (e.g., new years of data or variables).
  • A: NO
    • Skip to Step Three Below
     
  • A: YES
    • Review IRB Renewal with Amendment Checklist and complete IRB forms per checklist.
    • Complete the TCR Confidential Data Request Form, without signature pages, and save as Word document.
    • Email unsigned drafts of documents six weeks before the expiration date to CancerData@dshs.texas.gov.

Step Three:

• TCR screens applications and requests any missing documents. 
• Researcher provides missing documents, if necessary.
• TCR reviews application and provides feedback.

Step Four:

• Revise the forms, and once finalized (with TCR approval), sign, and email to CancerData@dshs.texas.gov.

For information on the status of your IRB application once it has been submitted to the IRB and RESC, email InstitutionalReviewBoard@dshs.texas.gov.

An amendment is required if any of the following have changed:  Protocol, consent document, PI, recruitment materials, data requested (e.g., new years of data or variables).

Step One: 

• Review IRB Amendment Checklist
• Complete Amendment Submission IRB forms required by the checklist.
• Complete the TCR Confidential Data Request Form, without signature pages, and save as Word document.
• Email unsigned drafts of documents to CancerData@dshs.texas.gov.

Step Two:

• TCR screens applications and requests any missing documents. 
• Researcher provides missing documents, if necessary.
• TCR reviews application and provides feedback.

Step Three:

• Revise the forms, and once finalized (with TCR approval), sign, and email to CancerData@dshs.texas.gov.

For information on the status of your IRB application once it has been submitted to the IRB and RESC, email InstitutionalReviewBoard@dshs.texas.gov.