Certificates of Confidentiality

Certificates of Confidentiality (CoC) are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Certificates of Confidentiality may be granted for studies collecting information that if disclosed could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by assuring confidentiality and privacy to participants.

Sources for additional information

Tools and Information Provided by the NIH

NIH is making information widely available to investigators working on sensitive biomedical, behavioral, clinical or other types of research.

Examples of such studies include (but are not limited to) research on HIV, AIDS, and other STDs; studies on the use of alcohol, drugs, or other addictive products; studies that collect information on illegal conduct; research on participants' psychological well being or mental health; and genetic studies, including those that collect and store biological samples for future use.

Procedures for Obtaining a CoC for the NIH at CHOP

  • A CoC application requires the inclusion of Assurances which are signed by the Principal Investigator and the Institutional Official. The Institutional Official at CHOP, Bryan Wolf MD, PhD, has delegated signature authority to Matthew Hodgson, AVP, Research Compliance and Regulatory Affairs.

  • An application for a CoC requires an IRB-approved study. Please note that while the IRB will issue approval of a study with a pending certificate of confidentiality application, the IRB will not release the consent including the CoC template language until the certificate has been obtained.

  • When a researcher obtains a Certificate of Confidentiality, the research subjects must be told about the protections afforded by the certificate and any exceptions to that protection. That information must be included in the informed consent form. The NIH provides examples of appropriate language. Researchers may adapt the language to the needs of the research participants and to the subject matter of the study. However, the language used must cover the basic concepts of a CoC and be substantially similar to the language provided by the NIH and provided below.

Researchers should also review the language about confidentiality and data security that is routinely included in consent forms to be certain that it is consistent with the protections of the Certificate of Confidentiality.

Obtaining a CoC from the FDA

The FDA is authorized to issue a Certificate Confidentiality for studies with an IND or IDE that do not have any other HHS funding.

For all investigational new drug products associated with an IND :

Sherry George
Program Analyst
Food and Drug Administration
Division of Safety Compliance- Human Subjects Protection Branch
10903 New Hampshire Avenue
White Oak, Building 51, Room 5331
Silver Spring, MD 20993
Phone: (301) 796-3403- Direct line
Main Line: (301)796-3150
Fax: (301)847-8748

Email: sherry.george [at] fda.hhs.gov (Sherry George, Office of Compliance, CDER)

Download instructions for CDER CoC: Certificate of Confidentiality Instructions (CDER)

For all investigational new drug products associated with an IND :

Anthony Hawkins
Consumer Safety Officer
Food and Drug Administration
CBER/Office of Compliance and Biologics Quality
10903 New Hampshire Avenue, Building 71, Room 5132
Silver Spring, MD 20993-0002
Phone: 240-402-8950 or 240-402-9159

Email: anthony.hawkins [at] fda.hhs.gov (Anthony Hawkins, Office of Compliance and Biologs Quality, CBER)

or OCBQ-DIS-BMB-VMAIL

Download instructions for CBER CoC: Certificate of Confidentiality Instructions (CBER)

Example Consent Language:

The NIH has suggested language for the Certificate of Confidentiality Section of the consent form (see below). To learn more, visit their Suggested Language page.

To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, 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.

(Use the following language as applicable) The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of Federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). You should understand that a Certificate of Confidentiality 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, medical care provider, or other person obtains your written consent to receive research information, then the researchers will not use the Certificate to withhold that information.

Optional Language:

The researchers should include language such as the following if they intend to make voluntary disclosure about things such as child abuse, intent to hurt self or others, or other voluntary disclosures.

The Certificate of Confidentiality does not prevent the researchers from disclosing voluntarily, without your consent, information that they are required by law to disclose to government authorities. For example, researchers must comply with laws requiring the reporting of suspected child abuse and neglect and communicable diseases.

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