Privacy Act Memo

DATE: November 19, 2019
TO:

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

FROM:

NIH Privacy Act Officer

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 2015, NIH launched an on-line application system for
researchers to request a CoC from NIH. Information is collected to allow confirmation of eligibility
for a CoC and to issue a Certificate. Eligible requestors will receive an electronic Certificate once
approved.
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 deemed 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 09-25-0156, “Records of
Participants in Programs and Respondents in Surveys Used to Evaluate Programs of the Public
Health Service, HHS/PHS/NIH/OD.” If you have questions, please contact me at (301) 402-6201.

Celeste Dade-Vinson
NIH Privacy Act Officer