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Certificates of Confidentiality

Standard Operating Procedure Table of Contents

Purpose

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

Procedure

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.

Investigators

  • 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.

      Contacts

      NIAID inquiries, niaidcertificates@mail.nih.gov

      If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

      Links

      Certificates of Confidentiality: Background Information

      Certificates of Confidentiality Kiosk

       

    • Last Updated April 30, 2012

      Last Reviewed September 17, 2014