What is a Certificate of Confidentiality?
Certificates of Confidentiality (CoC) are certificates issued to protect the privacy of human subjects by limiting the disclosure of identifiable, sensitive information.
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 at https://grants.nih.gov/policy/humansubjects.htm.
Which projects are eligible for CoCs?
Certificates of confidentiality are only issued for research projects that are:
- Collecting or using identifiable, sensitive information (see below for more detail)
- On a topic that is within the HHS health related research mission
- Storing the research information collected or used in the US
- Research in which identifiable, sensitive information is collected or used, including research that
- Meets the definition of human subjects research, including exempt research in which subjects can be identified
- Is collecting or using human biospecimens that are identifiable or that have a risk of being identifiable
- Involves the generation of individual level human genomic data
- Involves any other information that might identify a person
Who must sign a non-NIH funded CoC request?
Both the PI and the Authorized Institutional Official must sign the application for a Certificate. Dr. Jennifer E. Woodward is the Authorized Institutional Official for CoC requests from the University.
How does a PI submit a non-NIH funded CoC request to the Office of Sponsored Programs?
The NIH will continue to consider requests and issue CoCs for research projects that are funded outside of the NIH, including non-Federally funded projects. First, visit the NIH online application system to review the instructions and requirements. Then submit the required application materials electronically to osp@pitt.edu for the application to be reviewed and signed by the Office of Sponsored Programs. We will return to Department for submission.