New NIH Policy for Certificates of Confidentiality


Effective October 1, 2017, NIH funded researchers will no longer have to request a CoC, nor will they receive an actual certificate (see NIH Notice NOT-OD-17-109). The CoC will be issued automatically to NIH funded grants, cooperative agreements, contracts and intramural research projects funded wholly or in part by the NIH that collects or uses identifiable, sensitive information. Compliance with the requirements of the law will become a term and condition of award. All research that was commenced or ongoing on or after December 13, 2016 and is within the scope of the new policy is issued a Certificate through this policy.
The CoC protects the privacy of subjects by limiting the disclosure of identifiable, sensitive information. Under the new policy, disclosure is not up to the discretion of the investigator. Disclosure is only permitted in the following circumstances:
  • if required by other Federal, State, or local laws, such as for reporting of communicable diseases
  • if the subject consents; or
  • for the purposes of scientific research that is compliant with human subjects regulations.
The restrictions on disclosures apply to all researchers or research institutions previously issued a CoC who are engaged in research.
More information about CoCs can be found here