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Certificates of Confidentiality


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.

REQUESTS FOR NEW CERTIFICATES REQUESTS FOR AMENDMENTS OR EXTENSIONS:

Link to Online Application**

OR

Link to Paper Process

 

**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.

Submit THREE months prior to expiration date.

Must be submitted by email (joanna.vivalda@nih.gov) OR Fax OR by mail (see contact information below).  To be included:

1) A cover letter with the following items:

  • the NINDS Certificate number
  • the reason for the extension or amendment request;
  • the study completion date;
  • the current PI’s contact information.

2) Copies of the IRB approval and current IRB-approved consent document.

NINDS Contact:

Joanna Vivalda
Certificate of Confidentiality Coordinator
National Institute of Neurological Disorders & Stroke
Neuroscience Center, Room 2215
6001 Executive Blvd., MSC 9520
Bethesda, MD 20892-9520
(For FedEx and courier: Rockville, MD 20852)
Phone: (301) 496-9135
Fax: (301) 480-1080
Email: joanna.vivalda@nih.gov

Last updated July 7, 2014