To help protect the privacy of research participants National Institutes of Health (NIH) has for many years issued a Certificate of Confidentiality (CoC), upon request, to researchers collecting sensitive information about research participants. The CoCs protect researchers and institutions from being compelled to disclose information in response to legal demands that would identify their participants.
Section 2012 of the 21st Century Cures Act passed by Congress on December 13, 2016 authorized new provisions governing the authority of HHS to protect the privacy of research subjects. NIH’s new CoC policy, effective October 1, 2017, implements these statutory requirements.
The new policy includes the following:
•NIH-funded researchers will no longer be required to request a CoC. The CoC will automatically be issued for research funded wholly or in part by the NIH (including grants, cooperative agreements, and contracts) if the research involves the collection or use identifiable, sensitive information. Compliance with CoC will be included in the terms and conditions section of the award. NIH will not provide a separate CoC certificate.
•NIH-funded research that started or was ongoing on or after December 13, 2016 and is within the scope of this policy is automatically issued a CoC.
•Disclosure is no longer under the discretion of the investigator. Disclosure is only permitted if:
orequired by other Federal, State, or local laws, such as for reporting of communicable diseases
othe subject consents to the disclosure; or
ofor the purpose of scientific research that is compliant with human subjects regulations.
Note: the disclosure restrictions apply to all active CoCs, including those issued before December 13, 2016. Also recipients of CoCs are required to ensure that any investigator or institution who receives identifiable biospecimens and/or sensitive information protected by the policy understands that they too are subject to the disclosure restrictions, even if they are not funded by NIH.
•If your research is not supported by NIH, you may still apply for a CoC through the NIH Institute/Center that supports research in a scientific area similar to your project.
•For NIH-funded studies in which informed consent is sought, investigators are required to inform research participants of the protections and the limits to protections provided by the Certificate. For NIH-funded research that started on or after December 13, 2016 and is within the scope of this policy, investigators should submit a modification request to the IRB to add CoC language to the consent form. For additional guidance, visit the HRP CoC webpage. Thebiomedical and SBE consent template have been updated to include the CoC language.
•For more information go to the NIH Certificate of Confidentiality website or send an email to .