On 7 September 2017, the National Institutes of Health (NIH) issued a new policy (Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality) that eliminates the need for NIH-funded researchers to apply for a CoC and outlines updated disclosure requirements.

This policy is effective 1 October 2017 for NIH-funded biomedical, behavioral, clinical, or other research that commenced or was ongoing on or after 13 December 2016 and that collects or uses identifiable, sensitive information.

Researchers should be aware of the grant recipient responsibilities outlined in the guidance.

  • New restrictions on disclosure
  • Requirements to comply with the CoC
  • Requirements to ensure others comply with the CoC when information is shared with other institutions or researchers
  • Informing subjects of the protections and limitations to protections provided by the CoC

Researchers who are not federally funded may still apply to the NIH for a CoC for specific research studies.

The CITI Program is current with this NIH policy.