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Certificates of Confidentiality
The privacy of participants involved in research is protected through the COC. These certificates are issued by The National Institutes of Health (NIH) and various health and human service agencies; OHRP does not issue a COC. This certificate allows the researchers who have access to research records, to refuse to disclose identifying information on research participants in civil, criminal, administrative, legislative, or other proceedings, whether federal, state, or local. COC may be granted for studies collecting information that, if disclosed, could have adverse consequences for participants, such as damage to their financial standing, employability, insurability, or reputation. By protecting researchers and institutions from being compelled to disclose information that would identify research participants, COC help to minimize risks to participants by adding an additional level of protection for maintaining confidentiality of private information.
COC protect participants from compelled disclosure of identifying information but do not prevent the voluntary disclosure of identifying characteristics of research participants. Researchers, therefore, are not prevented from voluntarily disclosing certain information about research participants, such as evidence of child abuse or a participant's threatened violence to self or others.
However, if a researcher intends to make such voluntary disclosures, the consent form should clearly indicate this. Furthermore, COC do not prevent other types of intentional or unintentional breaches of confidentiality. As a result, investigators and IRBs must ensure that other appropriate mechanisms and procedures are in place to protect the confidentiality of the identifiable private information to be obtained in the proposed research. (OHRP, DHHS Guidance on COC, Feb. 25, 2003)
For more information contact the IRB Office at 797-0567.