Human Research Protection Program

The protections and limitations of the certificate of confidentiality must be clearly stated on the informed consent form, for example (amend as applicable):

To help protect your privacy, this research is covered by a certificate of confidentiality. This means that the researcher may not disclose or use information, documents or biospecimens that may identify you in any federal, state or local civil, criminal, administrative, legislative or other action, suit or proceeding, or be used as evidence — if there is a court subpoena, for example — unless you have consented to its use.

Information and documents protected by this certificate cannot be disclosed to anyone who is not connected with the research unless there is a federal, state or local law that requires disclosure, such as to report child abuse or communicable diseases; if you have consented to the disclosure; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects.

A certificate of confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider or any other person not connected with the research, you must provide consent to allow the researchers to release it.

Note that reference to an application for a certificate of confidentiality may not be included on the informed consent form if the CoC has not yet been approved.

All recipients of a certificate of confidentiality shall not:

• Disclose or provide, in any federal, State or local civil, criminal, administrative, legislative or other proceeding, the name of such individual or any such information, document or biospecimens that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document or biospecimens pertains.

• Disclose or provide to any other person not connected with the research the name of such an individual or any information, document or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

Disclosure is permitted only when:

• Required by federal, state or local laws (e.g., as required by the federal Food, Drug and Cosmetic Act, or state laws requiring reporting of communicable diseases to state and local health departments), excluding instances of disclosure in any federal, state or local civil, criminal, administrative, legislative or other proceeding.

• Necessary for the medical treatment of the individual to whom the information, document or biospecimen pertains and made with the consent of such individual.

• Made with the consent of the individual to whom the information, document or biospecimen pertains.

• Made for the purposes of other scientific research that is in compliance with applicable federal regulations governing the protection of human subjects in research.