Certificates of Confidentiality

Certificates of Confidentiality (CoC) are issued by the National Institutes of Health (NIH) or the FDA 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.

CHOP-Approved Certificate of Confidentiality Language

The NIH's CoC language is written at Grade 20+ and will therefore, not be understandable to all but a few individuals. The CHOP IRB has revised the CoC language so that it is more approachable (Grade 8.4 - 10.4 depending on the reading assessment tool). The CHOP IRB encourages investigators to use its version of the CoC in consent forms. An MS Word version of the CoC can be downloaded from the Informed Consent page or by using the download link.

CHOP Certificate of Confidentiality Language

A Certificate of Confidentiality (CoC) covers this research. A CoC helps protect your identifiable information and biological samples.

A CoC protects your private information from all legal proceedings. Unless you consent, information from this research study that identifies you will not be shared outside this research.

  • No one can be forced to share your identifiable information or biological samples for a lawsuit.
  • Your information can't be used as evidence even if there is a court subpoena.

If you consent, your information can be shared for:

  • your medical treatment and/or for use by your insurance company;
  • other purposes not connected with this research.

The CoC does not prevent some disclosures.

  • The researchers can't refuse requests for information from those funding this research. The [Funding Agency] may need information to assess this project. (if applicable add) Also, the US Food and Drug Administration (FDA) may need information.
  • You can still share information about yourself. You can also freely discuss your involvement in this research.
  • The researchers must disclose things required by law. This includes suspected child abuse or communicable diseases.
  • Some information from this study must go in your medical record.
  • Your information and biological samples may be shared for other research.

NIH-Funded Research

As of October 1, 2017, all studies funded by the NIH that involve human subjects research will automatically be issued a Certificate of Confidentiality. The change is the result of the 21st Century Cures Act, passed in 2016. All investigators who receive funding for human subjects research should familiarize themselves with the new policy and must ensure that all consent forms include a CoC section.

Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality

Sources for additional information

Tools and Information Provided by the NIH

For more information and tools related to Certificates of Confidentiality:

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 from the NIH at CHOP

Studies that are NIH-funded automatically receive a CoC. For non-NIH funded studies, follow the procedures outlined below.

  • 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)

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