Research Determination

November 29, 2023
Meghan Holst
[email protected]
RE:

Approval of Exempt Research Protocol 7479, “Outbreak Prevention and Response
Study”

Dear Meghan Holst:
On November 29, 2023, the CDC Human Research Protections Office (HRPO) reviewed your
submission of research study, “Outbreak Prevention and Response Study,” and has determined that it
meets the criteria for exemption under 45 C.F.R. 46.104(d)(2)(i). Therefore, HRPO approved your
research study for exemption, and assigned it CDC Protocol Number 7479.
Please note that a Certificate of Confidentiality (COC) applies to this study, and the recommended
COC language has been added to the study’s protocol, and will be included in the verbal informed
consent.
If the research is not complete within one year, you must submit a Progress Report Form to maintain
exempt status for the research. Any changes to this protocol may not be implemented until they are
reviewed by HRPO and determined to be consistent with the exemption categories.
Please note that investigators remain responsible for the ethical conduct of this research and for
ensuring appropriate human research protections even for research that is exempt from the
regulations governing the protection of human subjects in research.
If you have any questions, please contact your Associate Director for Science, your National Center
Human Subjects Contact, or me via email at [email protected], or telephone at 404-639-8379.
Sincerely,

Robert Chirila, Lead
Human Research Protections Office
cc: Alfonsina De Leon Salazar
Shirley Ding