Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Include the following on your IRB application for your DHS research request. If you are filing an amendment to an existing IRB application, use this as a guide.

...

2. In Section 6.a.1 check the specific DHS facilities that are applicable to your research study. This checkbox triggers the DHS research Oversight Board (ROB) research categorization process. To learn more about this process, click here.

         

3. In Section 6a.4, select “Yes” to indicate that this research will potentially benefit DHS patients in the future.

...

11. In Section 36.1, if this will be a recruitment study, indicate that you will be using a “Partial Waiver.” Then, for Section 36.2, select “Both” to indicate that you will be obtaining both HIPAA authorization from participant , in addition to a Full Waiver (since their PHI will be obtained).

**With a partial waiverPartial Waiver, you may have access to DHS PHI for study recruitment purposes. However, for recruitment studies, once the participant agrees to participate, they must ALSO consent to sign the full HIPAA authorization in order for you to use/retain any of the data accessed from the Partial Waiver.

**The Full HIPAA Waiver is also needed if any patient data will be obtained from the CDW at DHS, even if it is not a recruitment study.

...

12. In Section 42, select which Clinical Data Warehouse(s) you will request research data from.

       

...