IRB Determination

April 18, 2024
Katherine Moran
NCCDPHP/OSH
[email protected]
RE:

CDC IRB Initial Approval of CDC Research Study 7493, “Evaluation of Local Policies
that Restrict Sales of Menthol-Flavored Tobacco Products”

Dear Katherine Moran:
On April 12, 2024, the CDC Institutional Review Board (IRB) reviewed and approved the
research study titled “Evaluation of Local Policies that Restrict Sales of Menthol-Flavored
Tobacco Products," and assigned it CDC Protocol Number 7493. The approval is effective as of
April 12, 2024. The CDC IRB made the following findings in accordance with 45 C.F.R. Part
46:
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The research study was reviewed and approved in accordance with the expedited review
process outlined at 45 C.F.R. §46.119(b)(1)), category 7
Determined the research study does not involve more than minimal risk to subjects
Determined the research study does not require continuing review. However, the CDC
Human Protections Office requires an annual progress report, which is due by April 11,
2025.
Approved the inclusion of pregnant women, human fetuses, and neonates
Approved a waiver of informed consent documentation
A Certificate of Confidentiality applies to this research study to protect the privacy of
individuals who are subjects of this study, pursuant to subsection 301(d) of the Public
Health Service Act

Please note that any changes to the research study including the protocol, informed consent
process or materials, or any other aspect of the research study or research materials must be
reviewed and approved by the CDC IRB before they can be implemented. Failure to obtain CDC
IRB’s approval may result in the suspension or termination of the research study. Unanticipated
problems or noncompliance of a serious or continuing nature should be promptly reported to the
CDC’s Human Research Protections Office in accordance with CDC policies and procedures.
We appreciate your commitment to responsible conduct of research and your cooperation with
the IRB review process.

If you have any questions or concerns regarding the conduct of the research study or the IRB
review process, please do not hesitate to contact your Center Human Subjects Contact or Felecia
Peterson, IRB Administrator, at 404-639-4961, or via email at [email protected].
Sincerely,

For Robert Chirila, Lead
Human Research Protections Office