IRB Approval

October 1, 2024
Kristen Cibelli
[email protected]
RE:

Approval of Exempt Research Protocol 7512, “NHIS Diabetes Study”

Dear Kristen Cibelli:
On October 1, 2024, the CDC Human Research Protections Office (HRPO) reviewed your
submission of research study, “NHIS Diabetes Study,” 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 7512.
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, to HRPO by September 30, 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: Amanda Titus
Kathy O’Connor