Privacy Act Memo

DATE:

February 11, 2022

TO:

Pamela R Kearney, MD
Division of Human Subjects Research
Office of the Director (OD)

FROM:

NIH Senior Official for Privacy

SUBJECT:

Applicability of the Privacy Act: Electronic Requests for NIH Certificates of
Confidentiality (CoC) (OD)

I have reviewed the Electronic Requests for NIH Certificates of Confidentiality (CoC) (OD)
submission to OMB referenced above. In 2020, NIH launched a new on-line application system for
researchers to request a CoC from NIH. The information is now stored within a module of the NIH
Electronic Research Administration (eRA) system.
CoCs protect research participants, researchers, and institutions by prohibiting disclosure of
identifying information about participants to persons not connected to the research, with limited
exceptions. NIH, through its 24 funding Institutes and Centers (ICs), has issued Certificates of
Confidentiality since 1997 to researchers who request this protection. NIH-funded researchers are
now issued a Certificate upon award of NIH funding and no longer need to request a Certificate
through the system. Non-NIH funded researchers may continue to request a CoC through the online
system.
I have determined that the Privacy Act will apply to this data collection, which includes the collection
of personally identifiable information (PII) such as first and last name, phone number, address,
email and other identifiers stored in a system designed to be retrieved by a personal identifier.
The data collection is covered by NIH Privacy Act Systems of Record 09-25-0225, “NIH Electronic
Research Administration (eRA) Records, HHS/NIH/OD/OER.” If you have questions, please contact
me at (301) 402-6201.

Celeste Dade-Vinson
NIH Senior Official for Privacy