Clinical Research Operations

Application for Certificate of Confidentiality

Purpose: Provide additional protection for sensitive information obtained during the conduct of biomedical, behavioral or clinical research.

Step 1: Collect and prepare necessary documents

The application for a Certificate of Confidentiality is Institute specific. The general intramural instructions can be found at http://grants.nih.gov/grants/policy/coc/appl_intramural.htm .

• Applicants should read NIH's background information and instructions on Certificates of Confidentiality, which are available at http://grants.nih.gov/grants/policy/coc/background.htm. See also Frequently Asked Questions http://grants.nih.gov/grants/policy/coc/faqs.htm .
• The application requires an IRB-approved protocol. 
• Prepare the protocol and consent (initial IRB application or amendment) with the required wording
• Obtain "conditional" IRB approval with an IRB (iRIS) approval memo.
• Obtain the PI and Scientific Director’s signature on the cover letter of the application.
• Submit the application with the IRB approval memo, protocol and consent to the IC Certificate Coordinator (http://grants.nih.gov/grants/policy/coc/contacts.htm).
• Upon approval of the application, submit approval in iRIS. 

Resources for additional information: 

   http://grants.nih.gov/grants/policy/coc/index.htm 

   http://grants.nih.gov/grants/policy/coc/appl_intramural.htm 

   http://www.hhs.gov/ohrp/policy/certconf.pdf 

Current IC Certificate Coordinator for NCI Intramural 

Samson Adepoju
National Cancer Institute
9609 Medical Center Drive, Room 3W262
MSC 9711
Rockville, MD 20850
Phone: 240-276-5660
Fax: 240-276-7912
Email: adepojus@mail.nih.gov