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How to Get a Certificate of Confidentiality?

How to Get a Certificate of Confidentiality?

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


  Get your CoC

 

Step 1: Identify the Funding Source for Your CoC Request

Note: Any project receiving NIH funding that collects or uses identifiable, sensitive information is automatically deemed issued a CoC. NIH awardees do not need to request a CoC.

  
Funder Next Step Contact  Information
The National Institutes of Health (NIH) No need to request 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 through the NIH online CoC system For general questions about Certificates of Confidentiality, Certificates for non-NIH funded research, or NIH policies related to Certificates of Confidentiality, see our CoC FAQs.

Contact the NIH Office of Extramural Research, Division of Human Subjects Research CoC Coordinator with other questions. 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)

To request a CoC, you need to provide the following information:

  1. Project details, including research title, start date, projected end date, and description.
  2. Institution and performance site (if applicable) details, including institution and performance site(s) names and addresses, and institutional official name, email address, and phone number.
  3. Principal Investigator name, phone number, email address, degree, position.
  4. Key personnel names, degrees, and positions
  5. Name(s) of drugs that will be administered, route of administration, and dosage
  6. The following document to upload, if applicable:​
    1. a copy of the DEA certificate(s)/registration for studies in which a controlled drug will be administered
       
Note: An email will be sent to the Institutional Official listed on the CoC request. The Institutional Official will need to review the CoC request information for accuracy and affirm the online Institutional Assurance Statement by checking each box and then submitting the CoC request. 
 

If you have technical difficulties with the CoC system, please contact the eRA Service Desk. See also our list of compatible browser versions.

If you have process or policy-related questions, contact the NIH CoC Coordinator 

 

Is your Certificate Expiring or Has There Been a Significant Change in the Research?

Expiring Certificates If your non-NIH funded research project activities, including the collection of new data and enrolling new participants, will extend beyond the current expiration date on your Certificate, you will need to submit a request for a new CoC through the Online CoC System. 

NOTE: if your study has completed all enrollment and data collection, there is no need to request a new Certificate. Sensitive, identifiable research information that is collected or used when the Certificate is in effect, is permanently protected.
Significant Change If there is a SIGNIFICANT change in your non-NIH funded research project after the Certificate has been issued, you need to request a new Certificate through the NIH online CoC system. Significant changes include a change in the primary institution where research will be conducted, and a change in the Principal Investigator.  For the purpose of the Certificate, minor changes, such as the addition of a new survey instrument or clinical test, or adding a participating research site to a multisite study, are not considered a significant change, and do not require a new Certificate. 
Contact the NIH CoC Coordinator if you have a question whether the changes in your research project are significant and you need to request a new Certificate.
NIH-funded Research If your NIH-funding will or has ended and the recruitment of new research participants will continue without NIH-funding, you 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 permanently protected.

Please contact NIH CoC Coordinator if you have additional questions.
 
This page last updated on March 25, 2020
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