On September 7, 2017, the National Institutes of Health (“NIH”) released a Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (NOT-OD-17-109) (“the Policy”). This Policy flows from the Cures Act’s changes to when and how a Certificate of Confidentiality (“Certificate”) is issued, see Pub. Law 114-255, Section 2012 (December 13, 2016), and applies to research “in which identifiable, sensitive information is collected.” The Policy goes into effect on October 1, 2017, with retroactive implications; all NIH-funded research that was “commenced or ongoing on or after December 13, 2016” will be deemed to have been issued a Certificate pursuant to the Policy. NIH has indicated that guidance on the Policy is imminent; when issued, it will likely appear on the NIH’s Certificates of Confidentiality (CoC) Kiosk.
We have identified the following preliminary questions and concerns with the Policy and will be monitoring the forthcoming guidance to see whether and how it addresses them. Institutions also may want to assess the guidance against these concerns to formulate further questions to NIH to the extent troubling aspects of the Policy remain unclear. (more…)