Att G - IRB Letter

Memorandum
Date:

August 15, 2022

From:

Wences Arvelo, MD, MSc
Associate Chief for Science
Division of Scientific Education and Professional Development
Center for Surveillance, Epidemiology and Laboratory Services
Office of Public Health Scientific Services

Subject:

Generic ICR for CDC Emergency Epidemic Investigations
2022 Request for Extension
Research Determination

To:

Jeffrey M. Zirger, PhD
Lead of the Information Collection Review Office
Office of Scientific Integrity
Office of the Associate Director for Science
Office of the Director

Based on the description and justification for the Generic Emergency Epidemic Investigations
(EEIs) activities and on the definition of research as defined by the Federal Policy for the
Protection of Human Subjects (45 CFR 46), IRB approval is not required for EEIs. These
investigations are usually considered public health emergencies and not a research based on
the definition provided by 45 CFR 46. For individual investigations, the appropriate CDC and
local health authority Human Subjects Review contact are consulted for an official research
determination.
Should there be any questions regarding this determination, feel free to contact me at (404)
498-6003 or [email protected].

Wences
Arvelo -S

Digitally signed by
Wences Arvelo -S
Date: 2022.08.03
11:47:47 -07'00'