Judith Carrithers and Jeremy Sugarman, co-chairs of the NIH Collaboratory’s Ethics and Regulatory Core, recently published an article in the journal Learning Health Systems that examines the NIH’s Certificate of Confidentiality (CoC) policy for NIH-funded human subjects research. Since October 1, 2017, the CoC is issued automatically and applies to all biomedical, behavioral, clinical, and other research funded wholly or in part by the NIH that “collects or uses identifiable sensitive information.”

In their review of the CoC policy, the authors describe unanticipated challenges of applying the policy to pragmatic clinical trials, where the focus is on embedding research interventions in clinical care and which relies on existing data in electronic health records (EHRs). The authors identify 3 issues that are especially problematic in embedded pragmatic clinical trial (ePCT) settings and which may jeopardize the progress of learning health systems:

• Whether the EHR may be populated with research data that may be sensitive or stigmatizing without explicit consent from subjects
• Incomplete protections for sensitive data in the EHR
• Requirements for notifying subjects about the policy’s provisions

The authors urge the NIH to provide formal guidance on the CoC policy as it pertains to ePCTs. Read the full publication online.

“Special attention should be paid to pragmatic research that populates the electronic health record with research data as well as research conducted without explicit consent.” – Sugarman and Carrithers