Certificates of Confidentiality are an important tool to protect the privacy of research study participants (see NIH Guide Notice 03/15/2002). This Kiosk web site provides information about Certificates of Confidentiality for those involved with the conduct of sensitive biomedical, behavioral, clinical or other types of research, including investigators, IRB members, and Institutional Officials.
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. 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 helping assure confidentiality and privacy to participants.
Are you new to the Certificate process and are not sure where to start? If, so, please use this FLOW CHART
CERTIFICATE OF CONFIDENTIALITY ON-LINE APPLICATION UPDATE: The following NIH Institutes/Centers (ICs) are using an on-line application process: NCCIH, NCATS, NHLBI, NIAAA, NIAID, NICHD, NIEHS, NIMH, NINDS, NINR. To access the on-line system for one of the IC's, please click on one of the IC's listed or go to the IC listing on the Contacts List: http://grants.nih.gov/grants/policy/coc/contacts.htm NOTE: When seeking to amend or extend an existing CoC, please contact the issuing IC staff to determine if the on-line system can be used for this purpose.
Certificates of Confidentiality Information:
Frequently Asked Questions - Listing of Frequently Asked Questions on Certificates of Confidentiality that will be updated as new questions are received. Please check back periodically for new questions and answers.
- FLOW CHART – to determine eligibility for a Certificate and appropriate contacts
- Key information for Investigators, Institutional Officials, and IRB members
- Contacts List - NIH staff who you can contact for additional information. Also lists contacts at other HHS agencies that issue Certificates.
- NIH Guide Notice (03/15/2002) - NIH Announces Statement on Certificates of Confidentiality.
- Background Information (07/21/2003) - Detailed Background Information on Certificates of Confidentiality.
- Extramural Projects - Application Instructions (03/15/2002) - Detailed Application Instructions for Certificate of Confidentiality for research conducted by investigators outside of NIH.
- Intramural Projects - Application Instructions (03/15/2002) - Detailed Application Instructions for Certificate of Confidentiality for research conducted by NIH staff investigators.
- Slide Presentation (05/03/2002) - Slide presentation on Certificates of Confidentiality, in HTML and PowerPoint formats.