Certificates of Confidentiality

Certificates of Confidentiality (CoC)

Certificates of Confidentiality (CoC) are issued to researchers by the National Institutes of Health and other Health and Human Services (HHS) agencies to help protect the privacy of human subjects enrolled in sensitive, health-related research. Certificates protect against compulsory legal demands for identifying information or identifying characteristics of a research participant, such as court orders and subpoenas.

CoC Application Process

All requests for a CoC must be made online. The online application can be initiated at the NIH Certificates of Confidentiality Kiosk website.

Generally, an application for a CoC is submitted after the Institutional Review Board responsible for its review approves the research project.

NIH recommends that applications for certificates should be submitted at least three months prior to the date on which enrollment of research subjects is expected to begin.

CoC Assurance Document

A Certificate of Confidentiality Assurance document is a required part of the CoC application. Investigators can follow the steps below to secure this documentation. Failure to include the assurance document will delay NIH’s review of your application.

1. Prepare a document on GW letterhead using the language copied verbatim from the NIH CoC website;
       • The name, title and address of the Institutional Official should be typed below the appropriate signature. Please use “Sheila Garrity, Associate Vice President, Research Integrity” and “Office of the Vice President for Research, 2121 I St NW, Suite 601, Washington, DC 20052”
2. Sign the document above “Signature of the Principal Investigator”
3. Send a scan of the signed document to resinteg@gwu.edu
4. The Institutional Official will sign and return an electronic version of the letter to you
5. Upload a scanned version of the signed document into the online CoC application

Questions About the CoC Process?

Questions about the CoC process can be answered by visiting the NIH Certificates of Confidentiality (CoC) Kiosk FAQs or by emailing resinteg@gwu.edu with “Certificate of Confidentiality” in the subject line.