Certificates of Confidentiality

Important: New NIH Policy

  • Effective October 1, 2017 CoCs will be issued automatically for any NIH-funded project using identifiable, sensitive information that was on-going on/after December 13, 2016
    • The CoC will be issued as a term and condition of award
    • There will be no physical certificate issued
  • All CoCs issued in the past or in the future, regardless of funding sources, must comply with the requirements of the CoC policy, especially the new disclosure requirements and restrictions. 
    • The new disclosure requirements prohibit disclosure of the name of research subjects or any identifiable research information, document, or biospecimen to anyone not connected with the research except under very specific circumstances as detailed in the CoC policy.

General Information

Certificate of Confidentiality (CoC) is issued by the National Institutes of Health (NIH) to safeguard the privacy of research study participants by protecting identifiable research information from forced disclosure. A CoC allows 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. More background information and FAQs are available on the NIH website.

Obtaining a Certificate

To obtain a CoC for a non-NIH funded project, the PI will need to apply for a CoC.  Applications for a CoC require an Institutional Signature before submission. The application should be sent to the FIU Office of Research Integrity (MARC 414) for signature by the Vice President for Research. Detailed instructions for applying for a CoC are available at the Certificates of Confidentiality Kiosk.

Investigators are required to use the FIU formatted Certificate of Confidentiality Assurance Template as part of the CoC application process.

Language in Consent Forms

Investigators are required to include additional language in the Consent Form to outline the protections of the CoC. Template language is provided below.

Certificate-Obtained Language

(Include the following text in your Informed Consent Form if you have successfully obtained the Certificate, if you have an NIH funded study that will automatically receive a Certificate, or if you do not plan to begin recruitment and consenting until after you have obtained the Certificate):

To help us protect your privacy, we have a Certificate of Confidentiality from the National Institutes of Health (NIH). With this Certificate, we can’t be forced by a court order or subpoena to disclose information that could identify you in any civil, criminal, administrative, legislative or other proceedings.

There are circumstances where the Certificate doesn’t protect against disclosure of your personally identifiable information:

  • when the US government is inspecting or evaluating federally-funded studies
  • when information must be disclosed to meet FDA requirements
  • if you give someone written permission to receive research information or you voluntarily disclose your study information
  • if the researcher reports that you threatened to harm yourself or others
  • in cases of child abuse reported by the researcher
  • if the investigator reports cases of contagious disease (such as HIV) to the state

Certificate-Pending Language

(Include this paragraph in your Informed Consent Form if you wish to begin subject recruiting and consenting before you have actually obtained the Certificate):

To help us protect your privacy, we have applied for a Certificate of Confidentiality from the National Institutes of Health (NIH). We will let you know right away if we do not get it.  With this Certificate, we can’t be forced by a court order or subpoena to disclose information that could identify you in any civil, criminal, administrative, legislative or other proceedings.

There are circumstances where the Certificate doesn’t protect against disclosure of your personally identifiable information:

  • when the US government is inspecting or evaluating federally-funded studies
  • when information must be disclosed to meet FDA requirements
  • if you give someone written permission to receive research information or you voluntarily disclose your study information
  • if the researcher reports that you threatened to harm yourself or others
  • in cases of child abuse reported by the researcher
  • if the investigator reports cases of contagious disease (such as HIV) to the state