How do I apply for a Certificate of Confidentiality?
FDA (Required if study involves a drug or device)
NIH Statement on Certificates of Confidentiality
Release Date: March 15, 2002
National Institutes of Health
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Certificates of Confidentiality may be granted for studies collecting information that if disclosed could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentility help achieve the research objectives and promote participation in studies by assuring confidentiality and privacy to participants.
Certificates constitute an important tool to protect the privacy of research study participants. Thus NIH would like to encourage their appropriate use. NIH is making information widely available to investigators working on sensitive biomedical, behavioral, clinical or other types of research.
Information on Certificates of Confidentiality is now available on the NIH web site at the CoC Kiosk. The Kiosk includes background information on Certificates, application instructions for extramural and intramural investigators, frequently asked questions, information on communicable disease reporting policy, and a list of contacts. For further information, please see the list of contacts at NIH Institutes and Centers at the CoC Kiosk.
Info on FDA Certificates of Confidentiality