Certificates of Confidentiality

Certificates of Confidentiality (CoC) are issued by the National Institutes of Health (NIH) to safeguard the privacy of research participants by protecting identifiable sensitive research information from forced disclosure. CoCs allow investigators and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Certificates can be used for biomedical, behavioral, clinical or other types of research that is sensitive and could adversely affect or damage a subjects' financial standing, employability, insurability, or reputation.

 

NIH Policy Update:

Effective October 1, 2017, the NIH will automatically grant a CoC to studies funded wholly or in part by the NIH, that was commenced or ongoing on or after December 13, 2016, and collects or uses identifiable, sensitive information.

Additional Information

What is "identifiable sensitive information?"

  • Identifiable sensitive information means information about an individual that is gathered or used during the course of biomedical, behavioral, clinical, or other research whether the following may occur:

    • An individual is identified; or

    • For which there is at least a very small risk that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.
       

  • Examples of identifiable, sensitive information includes but is not limited to name, address, social security or other identifying number; and fingerprints, voiceprints, photographs, genetic information, tissue samples, or data fields that when used in combination with other information may lead to identification of an individual

How does this new policy affect ongoing research that has already been approved by the IRB?

"Ongoing" refers only to research that was commenced or ongoing as of December 13, 2016. The updated policy does not affect research that was commenced or ongoing prior to this date.

  • Ongoing research that already has a CoC: No action is required.

  • Ongoing research that did not previously have a CoC and now receive one as part of the new policy:

    • CoC language must be added to the informed consent form (if applicable to the research).

    • At the time of Continuing Review or Modifications, the IRB will evaluate NIH-funded research on a case-by-case basis and request investigators revise their consent forms to add CoC language if necessary.  (Be sure to use approved CoC language provided below.)

Is re-consent required?

Can I obtain a CoC if my rearch is not federally funded?

  • The NIH will continue to consider requests for CoCs for non-federally funded research in which identifiable sensitive information is collected or used.

  • This will require an application submission to NIH. Please see links below to access the CoC Kiosk for more information.

What language must I include in my consent form?

Note:

If you obtained a certificate of confidentiality and are providing identifiable, sensitive information to outside researchers or organizations (regardless of whether the research is federally funded), the outside researcher or organization must also comply with the requirements associated with a certificate of confidentiality. Please contact the HRPP office if you believe this situation applies to you: 405-325-8110 or irb@ou.edu.

Certificate of Confidentiality (CoC) Links:

Additional information regarding CoC is available in HRPP SOP 301: Research Submission Requirements, located in the Policies & Procedures Section of the IRB website.

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