Research Determination

October 22, 2024
Zachary Smith
[email protected]
RE:

Approval of Exempt Research Protocol 7513, “RANDS 11”

Dear Zachary Smith:
On October 21, 2024, the CDC Human Research Protections Office (HRPO) and the CDC
Institutional Review Board (limited review) reviewed your submission of research study, “RANDS
11,” and have determined that it meets the criteria for exemption under 45 C.F.R. 46.104(d)(2)(iii).
Therefore, HRPO approved your research study for exemption, and assigned it CDC Protocol
Number 7513.
The Program has selected to apply the Assurance of Confidentiality (AOC) to this research study.
If the research is not complete within one year, you must submit Form 1259, Study Progress Report
form, by October 20, 2025, for continuing review 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: Amanda Titus
Kathy O’Connor