New Protocol Narrative for No Subject Contact

Institutional Review Board

Human Research Protections (HRP)

File:External link font awesome.svg - Wikimedia CommonsNo Subject Contact Protocol Narrative

Version April 17, 2020

To facilitate IRB review and approval, effective May 1, 2020, use of a new Protocol Narrative will be required for new applications in which researchers will access identifiable private information and / or identifiable biospecimens without contacting subjects. This includes data such as identifiable student records and protected health information (PHI).

The new Protocol Narrative will help researchers navigate whether Exempt 4 or Expedited 5 is the appropriate regulatory review category.  It will also help researchers understand when a waiver of informed consent (Appendix O) and/or a waiver of HIPAA authorization (Appendix T) is required.   

HRP is actively engaged in continuous improvement.  We value and seek your feedback on this new Protocol Narrative, as well as your ideas for other improvements!  Please share your feedback and thoughts by contacting the HRP Staff.

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