Notice Number: NOT-OD-20-075

Key Dates
Release Date: February 28, 2020

NOT-OD-17-109

NOT-OD-02-037

Issued by
Office of The Director, National Institutes of Health (OD)

Purpose

The purpose of this Guide Notice is to inform the research community that NIH is updating its Certificate of Confidentiality online system that is used to request an NIH-issued Certificate of Confidentiality (CoC) for non-NIH funded research.

NIH considers requests for Certificates of Confidentiality for non-NIH funded research to protect identifiable, sensitive research information from disclosure. Section 2012 of the 21st Century Cures Act amended subsection 301(d) of the Public Health Service Act (42 U.S.C. 241) to require the Department of Health and Human Services to minimize burden, streamline the process, and reduce the time it takes to comply with the requirements associated with applying for a Certificate. As part of its efforts to implement these requirements, NIH has updated its Certificate of Confidentiality request process for non-NIH funded institutions through a new CoC online system.

Note: This notice does not apply to biomedical, behavioral, clinical, or other research, funded wholly or in part by the NIH. All NIH-funded research that was commenced or ongoing on or after December 13, 2016 within the scope of the NIH Policy for Issuing Certificates of Confidentiality is deemed to be issued a Certificate through the Policy. See NOT-OD-17-109 for full details of the NIH policy.

Key Changes

• NIH will no longer accept Certificate of Confidentiality requests through the current system as of March 11, 2020.

• Current users who need a copy of their Certificate or associated documentation should access the Certificate of Confidentiality system to download these files prior to March 13, 2020. Users will no longer have access to the current Certificate of Confidentiality system as of March 13, 2020.

• The new system streamlines and simplifies the Certificate of Confidentiality request process by utilizing self-certification statements and shortened text fields, rather than attachments

• The new CoC system requires direct submission by the authorized institutional official, rather than by the investigator or another research team member.

Resources

Additional information, such as new FAQs, is available at the NIH Certificates of Confidentiality website at https://humansubjects.nih.gov/coc/index.

Inquiries

Please direct all inquiries to:

Office of Extramural Research
Division of Human Subjects Research
Email: [email protected]