The National Institutes of Health has issued Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (NOT-OD-17-109).
A Certificate of Confidentiality (Certificate) protects the privacy of research participants enrolled in biomedical, behavioral, clinical or other research. The Certificate prohibits disclosure in response to legal demands, such as a subpoena
In the past NIH provided Certificates of Confidentiality to PIs carrying out human subjects’ research. NIH has just issued guidance that they will no longer do this
Effective October 1, 2017, certificates of confidentiality will issue automatically for applicable NIH awards as part of the award terms and conditions
NIH will not determine applicability; that is now the responsibility of the awardee institution and investigators
Also, NIH will no longer provide a paper certificate. NIH has indicated that:
Documentation of NIH funding or support (i.e., the award notice), the NIH Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (NOT-OD-17-109), the NIH Grants Policy Statement (See 126.96.36.199) subsection 301(d) of the Public Health Service Act, and any additional future guidance issued by NIH, will serve as documentation of the issuance of a Certificate for a specific study.
The policy applies to research commenced or ongoing on or after December 13, 2016. The NIH CoC website has now been updated and includes updated consent language and FAQs.