Exempt Research Determination

July 8, 2024
Amanda Wilmot
[email protected]
RE:

Approval of Exempt Research Protocol 7500, “Cognitive Decline”

Dear Amanda Wilmot:
On July 3, 2024, the CDC Human Research Protections Office (HRPO) reviewed your submission of
research study, “Cognitive Decline,” and has determined that it meets the criteria for exemption
under 45 C.F.R. 46.104(d)(2)(ii). Therefore, HRPO approved your research study for exemption, and
assigned it CDC Protocol Number 7500.
You have selected to apply the Assurance of Confidentiality to this study.
If the research is not complete within one year, you must submit Form 1259, Study Progress Report
form, by July 2, 2025, 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:

Kathy O’Connor
Amanda Titus