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Certificate 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. CoCs can be used for biomedical, behavioral, clinical, or other types of research that is sensitive and could adversely affect or damage an individual's financial standing, employability, insurability, or reputation. 

Institutional Official Information

The NIH CoC System requires that an authorized Institutional Official (IO) is listed when filling out a CoC request. The appropriate IO is listed below - please do not list the IRB Office, staff, or members as the IO. 

  • Name: Scott Davis
  • Email: Scott-Davis@ouhsc.edu 
  • Phone: 405-271-2090

NIH Policy

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. 

NIH Policy

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 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
  • fingerprints, voiceprints, photographs
  • genetic information
  • tissue samples
  • data fields that when used in combination with other information may lead to identification of an individual

How does the NIH policy affect ongoing research already 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: non action 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 consent form (if applicable to the research).
    • At the time of Continuing Review or Modification, the HSC IRBs will evaluate NIH-funded research on a case-by-case basis and request investigators revise their consent forms to add CoC language if necessary. Investigators should use approved CoC language provided in the OUHSC Consent Template. 

Is re-consent required?

Can I obtain a CoC if my research is not funded by NIH (or other federal sources)?

Yes, the IRB may require investigators obtain (apply for) a CoC for non federally-funded research that will collect, use, and/or disclose sensitive information. 

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

These requests require an application submission to NIH. Links are provided on this page. 

IRB Submissions and CoCs

If you are submitting a new study to the IRB and you plan to apply for a CoC from NIH or you automatically received a CoC as a condition of NIH funding: 

  1. Answer 'yes' to the CoC question in your IRB application and 
  2. Include the approved CoC language in your consent form. This language is provided in the OUHSC Consent Template. 
 

If you did not initially receive or plan to obtain a CoC, and the IRB requires you apply for or obtain a certificate: 
  • Revise your IRB application to answer 'yes' to the CoC question
  • Add approved CoC language to your consent form that is available in the OUHSC Consent Template.