Changes in the policy on certificates of confidentiality go into effect October 1st, 2017. Learn more about the changes in policy.
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 Confidentiality 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. The National Institute of Neurological Disorders and Stroke (NINDS) issues Certificates of Confidentiality for studies that are pertinent to the mission of the Institute and meet the requirements for issuing a Certificate.
Information on Certificates of Confidentiality is 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 contact information.
For additional information, please visit the NIH Certificates of Confidentiality webpage.
REQUESTS FOR NEW CERTIFICATES:
Link to Online Application**
**NOTE: The electronic application must be completed all at once: You cannot save a partial application and complete it later. Please read the background information and have all the information ready to complete the on-line application.
REQUESTS FOR AMENDMENTS OR EXTENSIONS:
Submit THREE months prior to expiration date.
Must be submitted by e-mail to: (Ellen Rosenberg at firstname.lastname@example.org)
To be included:
- Current IRB-approved informed consent form including the suggested consent CoC language.
- Current IRB protocol approval letter. If the protocol was amended with new information, please attach it with a list of the changes.
- A memo with the reason for the extension (for example: continued enrollment) and a new estimated closure date signed by the PI. Please reference the study name & CoC number on the memo.
- A new assurance document signed by the Principal Investigator and an Institutional Official. Please reference the study title or number on the assurance.
- An updated list of key personnel.