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.
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2. In Section 6.a 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, indicate “Yes.”
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Please note that if DHS patient data will leave DHS premises for transfer or further analysis (i.e. entering PHI into REDCap in a Keck environment), you may need a Full HIPAA Waiver.
11. In Section 36.1, indicate that you will be using a Partial Waiver. Then, for Section 36.With both 2, answer “Both” that you will be obtaining both authorization from participant in addition to a Full Waiver.
With a partial waiver, you may have access to PHI for study recruitment purposes. However, once the participant agrees to participate, they must ALSO consent to sign the full authorization in order for you to use/retain any of the data accessed from the partial waiver.
11. In Section 36.1, indicate that you will be using a Partial Waiver. Then, for Section 36.2, answer “Both” that you will be obtaining both authorization from participant and a Full WaiverThe Full Waiver is also needed if patient data will be obtained from the CDW at DHS.
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12. In Section 42, indicate which Clinical Data Warehouse(s) you will be requesting request research data from.
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13. In your Methods and Procedures section, specify a plan how the DHS Investigator will take responsibility for all DHS data storage, transfer, and management. Patient PHI files will be kept within the DHS Intranet, encrypted, password-protected, and behind DHS firewalls. (check section 24.5.1 B). Include how data management and /transfer will be handled (i.e. de-identifying all DHS PHI before external data transfer).
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