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How to Get a Certificate of Confidentiality?

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 Link to Non-U.S. Government Site - Click for Disclaimer

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 request extensions at least 3 months prior to the Certificate's expiration date and 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.  This includes major changes like a change in the primary institution where research will be conducted, and changes in the Principal Investigator/s.  
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.