Confidential Data Request and IRB Approval Process

The flowchart below outlines the process of requesting TCR confidential data and the subsequent DSHS IRB approval process. Please review the TCR Data Dictionary for information detailing which variables are considered confidential.

Applications are reviewed in the order in which they are received. However, applications that have missing components or require significant revisions will delay the review process.

Type of Confidential Data Request

New/Initial	Renewal	Amendment

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

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


	Q: Has study/research changed? Protocol, consent document, PI, recruitment materials, data requested (e.g., new years of data or variables).

• 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.

	A: NO • Skip to next box. A: YES • Review IRB Amendment Checklist and complete Amendment Submission IRB forms per checklist, *in addition to the renewal IRB forms*. • 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.







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




• Revise the forms, and once finalized (with TCR approval), sign, scan, and email to CancerData@dshs.texas.gov. • Ensure the forms are in the correct order, as shown on the applicable IRB checklist. • Please be advised that the review process (from submission to TCR until IRB and Research Executive Steering Committee approval) may take 2-4 months, or possibly longer if significant revisions are required. Due to COVID-19, IRB and RESC approvals may be delayed. For information on the status of your IRB application once it has been submitted to the IRB and RESC, email InstitutionalReviewBoard@dshs.texas.gov.