To request review of a “Limited Data Set with Data Use Agreement” from Privacy Board, complete a new application in eResearch Regulatory Management (eRRM). Fill out system-required sections, including:
- Question 1.8 (project summary): explain the purpose of the project, and why this requires access to PHI.
- Section 01-1: “Activities Not Regulated…”;
- Section 02: Link to any applicable Unfunded Agreements (UFAs), even if still in "Create Record" state
- Section 04-1: “Research Involving Coded Private Information”;
- Section 04-2: Yes to “limited data set?”
- Section 24: fill out a separate line item for each data source, including
- Question 24.5: Upload a copy of the DUA if not provided elsewhere in the application (or linked in a UFA).
- Section 25-1: fill out, including
- 25-1.3 “HIPAA authorization will not be obtained from any subjects”
- 25-1.3.2: “Limited data set(s)”
- Section 25-4: provide required assurances.
- Note that if PHI will be disclosed outside U-M, the eResearch system will force a DUA upload in this section (even if provided elsewhere)
Once completed and submitted, the application will be reviewed by IRBMED Staff for clarity and completeness, then assigned to the Privacy Board for determination.
Update Approved by IRBMED Chairs and Director: October 14, 2011
Website Updated: July 10, 2018