Certificate of Confidentiality (CoC)

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:

• Collect personally identifiable sensitive information,
• Have been approved by the Northern Kentucky University IRB.

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 Human Immunodeficiency Virus (HIV), Acquired Immune Deficiency Syndrome (AIDS), or other Sexually Transmitted Disease (STDs).

• Studies that collect information on sexual attitudes.
• Studies on the use of alcohol, drugs or other addictive products.
• Studies that collect information on illegal conduct.
• Studies that gather information that if released could be damaging to a participant’s financial standing, employability or reputation within the community.
• Research involving information that might lead to social stigmatization or discrimination if it were disclosed.
• Research on participants’ psychological well-being or mental health.
• Genetic studies, including those that collect and store biological samples for future use.
• Research on behavioral interventions and epidemiological studies.

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. Here is where a list of agencies and coordinator contact information can be found.

Personally identifiable information protected by a CoC may be disclosed under the following circumstances:

• Voluntary disclosure of information by study participants themselves or any disclosure that the study participant has consented to in writing, such as to insurers, employers, or other third parties.
• Voluntary disclosure by the researcher of information on such things as child abuse, reportable communicable diseases, possible threat to self or others, or voluntary disclosures provided that such disclosures are spelled out in the informed consent document.
• Voluntary compliance by the researcher with reporting requirements of state laws, such as knowledge of communicable diseases, provided such intention to report is specified in the informed consent document, or
• Release of information by researchers to DHHS as required for program evaluation or audits of research records or to the FDA as required under the federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.).

NIH Funded Projects

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.

Unfunded or Projects not Funded by the NIH

The researcher should visit the Certificate of Confidentiality Kiosk website: http://grants.nih.gov/grants/policy/coc/index.htm

Projects funded by CDC, FDA, HRSA, SAMHSA

Should contact the appropriate agency. Start by clicking here.