Certificates of Confidentiality (CoC) are issued by the National Institute of Health (NIH) to help researchers protect identifiable research information from forced disclosures such as court orders and subpoenas. They allow researchers to refuse to disclose identifying characteristics about research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.
Please note, depending on the type of study, the NKU IRB may require that the researcher obtain a Certificate of Confidentiality.
Certificates of Confidentiality are issued for studies collecting sensitive information which, if disclosed, “...could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation".
To be eligible for a Certificate of Confidentiality, the research must:
The subject matter of the study must fall within a mission area of the NIH. Some research areas that are eligible for a CoC include research on HIV, AIDS, or other STDs:
NIH funded projects that meet the requirements for a CoC are automatically granted a CoC upon notice of award.
The review and approval period for unfunded projects, or projects not funded by the NIH, differ based on the agency reviewing the request. For example, if the study is collecting sensitive identifiable information about alcohol abuse, the researcher may contact a CoC coordinator for the National Institute on Alcohol Abuse and Alcoholism. A list of agencies and coordinator contact information can be found here.
Personally identifiable information protected by a CoC may be disclosed under the following circumstances:
As of October 1, 2017, NIH funded researchers will no longer have to request a CoC. The CoC will be issued automatically to NIH funded grants, cooperative agreements, and contracts, funded wholly, or in part, by the NIH, if the research collects or uses identifiable, sensitive information. Compliance with the requirements of the law will become a term and condition of award.
The researcher should visit the Certificate of Confidentiality Kiosk website: http://grants.nih.gov/grants/policy/coc/index.htm
Should contact the appropriate agency. Start by clicking here.
Researchers must tell their participants about the protections afforded by the Certificate of Confidentiality, and about any exceptions to these protections. For example, if there are any circumstances in which the researchers plan to voluntarily disclose identifying information about research participants (e.g. child abuse, harm to self or others, etc.), this must be explicitly included on the informed consent form.
The NIH recommends the following language be added to informed consent documents:
“To help us protect you and the information we will be collecting from you, this study has been given a Certificate of Confidentiality by [identify provider of certificate]. This Certificate means that the researchers cannot be forced, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, to disclose any information that may identify you. The researchers will use the Certificate to resist any demands of information that would identify you, except as explained below.”
“The Certificate cannot be used to resist a request for information from United States government employees if the request is for auditing or evaluation of federally funded projects. Include the following statement only if FDA regulated research: or for information that must be disclosed to meet the requirements of the federal Food and Drug Administration (FDA).”
“The Certificate does not stop you or a member of our family from voluntarily disclosing to any person information about yourself or your involvement in the study. If you give your written consent to release study information to an insurer, employer or other person, the Certificate cannot be used to withhold this information.”
“If any study information is placed into your medical records, the Certificate does not protect that study information.”
“If the researchers become aware of possible child abuse or elder abuse, or that you may cause serious harm to yourself or others, the researchers may report this to the appropriate authorities without your consent.”
“If the research shows that you have a reportable communicable disease (for example, tuberculosis [TB] or HIV/AIDS), the researchers may report this to state and/or federal public health authorities without your consent.”