Certificate of Confidentiality

March 2020 Announcement:

Notice of Transition to New System for Issuing Certificates of Confidentiality for Non-NIH Funded Research (NOT-OD-20-075):  https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-075.html  

  • NIH is transitioning to a new online system request a Certificate of Confidentiality (CoC) for non-NIH funded research. We will update the resource information and links to the online system on this page when they become available. 
  • NIH will no longer accept CoC requests through the current kiosk system effective March 11, 2020.
  • Current users who need a copy of their Certificate or documentation should access and download these items before March 13, 2020. The last day to access the kiosk is March 12, 2020. 
  • The new system is designed to streamline and simplify the CoC request process.
  • The new system requires direct submission by an authorized institutional official rather than by the investigator or other research team member.

 

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.
  

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

Examples of Federally-Funded Research Automatically Covered by a CoC

Examples of Research Automatically Covered by a CoC Include:

  • Biomedical, behavioral, clinical or other research, including exempt research, except when the information obtained is recorded in such a manner that participants cannot be identified, or the identity of the participants cannot be readily ascertained, directly or through identifiers linked to the individual participant. 
  • The collection or use of biospecimens that are identifiable to an individual; or there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen and other available data sources could be used to deduce the identity of an individual. 
  • The generation of individual level, human genomic data from biospecimens; or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can readily be ascertained.
  • Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, 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. 
     

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 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 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.  (Be sure to use approved CoC language provided in the OUHSC Consent Template)
       

Is re-consent required?

The IRB and NIH do not expect participants to be notified or re-consented as described below:

  • For studies that were previously issued a CoC (and notified participants of the CoC in the consent form):
    • Re-consent is not required for participants currently enrolled in ongoing studies.
  • For studies that did not previously have a CoC, but were issued one as a result of the NIH Policy:
    • Update your consent form to add CoC language and submit to the IRB at the time of Continuing Review or Modification. Contact the IRB Office if you have questions regarding whether this will apply to your study or not. (Be sure to use the approved CoC language available in the OUHSC Consent Template)
    • Re-consenting previously enrolled participants is not required.
       

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

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

Certificate of Confidentiality (CoC) Links:


Additional information regarding CoC is available in HRPP SOP 1002: Privacy and Confidentiality, located in the Policies & Procedures Section of the IRB website.

 

 

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