How to Get a Certificate of Confidentiality?

Step 1: Identify the Appropriate Agency for Your CoC Request
Step 2: Use the Online Certificate of Confidentiality System to provide the required information

Get your CoC

The required Institutional Assurance language provided by NIH must be used verbatim when requesting a CoC. See Step 2 below.

Step 1: Identify the Appropriate Agency for Your CoC Request

Note: Any research/study receiving NIH funding automatically receives a CoC. NIH awardees no longer need to request a CoC.

Funder	Next Step	Contact Information
The National Institutes of Health (NIH)	No need to obtain a CoC
Centers for Disease Control and Prevention (CDC), Substance Abuse and Mental Health Services Administration (SAMHSA), Health Resources and Services Administration (HRSA), or Indian Health Service (IHS)	Contact the Agency CoC Coordinator	CDC Office of Scientific Integrity Centers for Disease Control and Prevention Atlanta, GA 30333 Phone: 404-639-7570 Click here for more information on CDC Assurances of Confidentiality. SAMSHA Summer King, Statistician CBHSQ/DEASR Substance Abuse and Mental Health Services Administration (SAMHSA) 1 Choke Cherry Road, Room 2-1057 Rockville, MD 20857 Phone: 240-276-1243 Email: summer.king@samhsa.hhs.gov HRSA Lisa Wright-Solomon Office of Planning, Analysis, and Evaluation Health Resources and Services Administration 5600 Fishers Lane, Room 14N-39 Rockville, MD 20857 Phone: 301-443-1984 Email: lwright-solomon@hrsa.gov IHS Rachael L. Tracy Research Director, Division of Planning, Evaluation, and Research Office of Public Health Support 5600 Fishers Lane, MS 09E10D Rockville, MD 20857 Phone: 301-443-2029 Email: rachael.tracy@ihs.gov Heather H. McClane IHS Privacy Officer Phone: 301-945-3040 Email: heather.mcclane@ihs.gov
Agency for Healthcare Research & Quality (AHRQ)	Contact AHRQ	AHRQ has its own privacy regulations which may apply, and NIH will not issue a CoC for projects covered by AHRQ’s regulations; click here to contact AHRQ
Department of Justice (DOJ)	Contact the DOJ Project Officer	The Department of Justice has its own privacy regulations for research that they fund and NIH will not issue a CoC for DOJ funded projects; click here for more information
None of the above but is under the authority of the Food and Drug Administration (FDA) operating under IND or IDE	Contact the FDA CoC Coordinators	For all investigational new drug products associated with an IND: Kimberly Price, Program Analyst Food and Drug Administration - CDER Compliance Enforcement Branch 10903 New Hampshire Avenue White Oak, Building 51, Room 5333 Silver Spring, MD 20993 Phone: 301-796-3724 - Direct line Main Line: 301-796-3150 Fax: 301-847-8748 Email: Kimberly.Price@fda.hhs.gov CDER-CoC-Requests@fda.hhs.gov Anthony Hawkins, Consumer Safety Officer FDA/CBER/Office of Compliance and Biologics Quality 10903 New Hampshire Avenue, Building 71, Room 5132 Silver Spring, MD 20993-0002 Phone: 240-402-8950 or 240-402-8975 Email: anthony.hawkins@fda.hhs.gov or CBERBIMONotification@fda.hhs.gov Soma Kalb, Director, IDE Program FDA/CDRH/Office of Device Evaluation 10903 New Hampshire Avenue, Building 66, Room 1534 Silver Spring, MD 20993-0002 Phone: 301-796-6359 Email: Soma.Kalb@fda.hhs.gov
None of the Above	Submit your request online to the NIH Office of the Director	For general questions about Certificates of Confidentiality, Certificates for non-NIH funded research, or NIH policies related to Certificates of Confidentiality contact the NIH Office of Extramural Research Email: NIH-CoC-Coordinator@mail.nih.gov

Step 2: Use the Online Certificate of Confidentiality System

You can use this system to:

Request new Certificates of Confidentiality (CoC)
View and track requests submitted through this system

To obtain a CoC, you will need:

1. To Login with NIH Single Sign-on using the steps below:

CoC requestors (who are not HHS employees) must set up an account using Google or PayPal for CoCs. We recommend setting up a separate Google or PayPal account.
Access the CoC system through the Social Login/OpenID option from the Account type drop down menu.
Enter your account username and password. [Note: NIH does not have access to requestor login credentials. You must work with Google or PayPal to re-set/retrieve login credentials]

2. Your Institution Federal wide Assurance (FWA) number from OHRP; Click here for information on obtaining an FWA

3. The following documents to upload:

A copy of final IRB approval OR approval contingent ONLY on getting a CoC
A copy of the IRB approved consent form with appropriate language about the CoC. Example consent language is available here.
A copy of the DEA certificate/registration for studies in which a controlled drug will be administered
A signed institutional assurance document. Click here for required institutional assurances language

Note: The required institutional assurances language must be used verbatim or your request will be returned for resubmission.

4. Choose "NIH Office of the Director (OD)" as the NIH Institute or Center (IC) to submit your request.

If you have technical difficulties with the CoC system, please send an email to NIH-COC-help@mail.nih.gov.

For process or policy-related questions, contact NIH-CoC-Coordinator@mail.nih.gov.

Need to Extend or Amend an Existing Certificate of Confidentiality?

Extensions	If your non-NIH funded research project will extend beyond the current expiration date on your Certificate you should request an Extension. Please contact NIH-CoC-Coordinator@mail.nih.gov to request an extension and receive additional instructions at least 3 months prior to the Certificate's expiration date. Include the reason for the extension in your request (for example, we are continuing to enroll new subjects). NOTE: if your study has completed all enrollment and data collection, there is no need to extend the Certificate. Sensitive, identifiable research information maintained by investigators during any time a Certificate is in effect, is protected permanently.
Amendments	If there is a SIGNIFICANT change in your non-NIH funded project after the Certificate has been issued, you should request an Amendment by contacting NIH-CoC-Coordinator@mail.nih.gov. This includes major changes like a change in the primary institution where research will be conducted, and changes in the Principal Investigator/s. Minor changes such as the addition of a new survey instrument or clinical test do not require an Amendment to your Certificate.
NIH-funded Research	If your NIH-funding will or has ended but the recruitment of new research participants will continue without NIH-funding, you will need to request a CoC for continuity of protections using the CoC system. If your NIH funding will or has ended but your study has completed all enrollment and data collection, there is no need to extend the Certificate. Sensitive, identifiable research information maintained by investigators during any time a Certificate is in effect, is protected permanently.

Please contact NIH-CoC-Coordinator@mail.nih.gov if you have additional questions about extensions or amendments.

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