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Suggested Consent Language Describing the CoC Protections

When a CoC is obtained, the research subjects must be told about the protections afforded by the Certificate and any exceptions to that protection. That information should be included in the informed consent form. Sample consent language describing the CoC is below. 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 points noted below. 

In addition, researchers should review boilerplate language about confidentiality and data security that is routinely included in consent forms to ensure that it is consistent with the protections of the Certificate of Confidentiality and the intentions of the researchers to use these protections as necessary.

Your consent form must be submitted as part of the application and will be reviewed for accuracy.

Sample Consent Language: (Click the box below to select all, then copy)

(You may Click the box below to select and copy all the text. Note that the text in [brackets] is instructional and not part of the consent language)

To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. 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 federal or state government agency sponsoring the project and that will be used for auditing or program evaluation of agency 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.

[language such as the following should be included if researcher intend to make voluntary disclosure about information obtained in the research such as child abuse, or intent to hurt self or others.] The Certificate of Confidentiality will not be used to prevent disclosure to state or local authorities of [list what will be reported, such as child abuse and neglect, or harm to self or others].

 

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