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Certificates of Confidentiality SOP

This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.


To protect investigators and institutions from being forced to release information that would identify research participants.


Certificates of Confidentiality can be used for biomedical, behavioral, clinical, or other types of research that are considered sensitive, i.e., disclosing identifying information that could have adverse consequences for subjects.

Sensitive research activities include collecting the following:

  • Genetic information.
  • Information on psychological well-being of subjects.
  • Data on substance abuse or other illegal risk behaviors.

Some projects are ineligible for a Certificate of Confidentiality, e.g., those that do not collect personally identifiable information; those that collect information which, if disclosed, would not significantly harm or damage the participant.

Anyone collecting sensitive information from human subjects may apply for a Certificate of Confidentiality.


  • Using this NIH Flow Chart, determine your eligibility for a certificate by finding the appropriate contact for applications and questions.
  • If you are eligible, get the certificate before you start to collect information from subjects.
  • Go to Application for Certificate of Confidentiality to fill out an application form.
  • Once you get a Certificate of Confidentiality, you must inform research subjects about the protections covered by the certificate and any exceptions.
  • Review language about confidentiality and data security that is routinely included in consent forms. Make sure it is consistent with the protections of the Certificate of Confidentiality.


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Certificates of Confidentiality: Background Information

Certificates of Confidentiality Kiosk

Last Updated April 30, 2012

Last Reviewed March 05, 2015