Certificates of Confidentiality

• 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

"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.)

• Re-consent is not required for participants currently enrolled in ongoing studies.

• 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 provided below.)

• 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.

For ongoing or new research projects that have been issued a CoC, the following language must be included in the "Who will see my information?" section of the consent form:

"To help protect your privacy, a Certificate of Confidentiality will be obtained from the federal government. This Certificate means that the researchers cannot be forced (for example by court subpoena) to share information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.

The Certificate cannot be used to resist a demand for information from personnel of the U.S. government that is used for checking or evaluating federally funded projects.

The protection offered by the Certificate of Confidentiality does not prevent us from being required by applicable state law to report information about suspected or known sexual, physical, or other abuse of a child or older person, or a subject’s threats of violence to self or others. If any member of the research team is given such information, he or she will be required to make a report to the appropriate authorities. 

The Certificate, however, does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information. This means that you and your family should actively protect your own privacy.

If you are enrolled in the study after the expiration or termination of the Certificate, the protection afforded by the Certificate as described above will not apply."