Research Determination

August 13, 2024
Brianna Eiter
[email protected]
RE:

Approval of Exempt Research Protocol 7507, “Developing a Framework to Identify and
Address Hazards Unique to Women Mine Workers”

Dear Brianna Eiter:
On August 13, 2024, the CDC Human Research Protections Office (HRPO) reviewed your
submission of research study, “Developing a Framework to Identify and Address Hazards Unique to
Women Mine Workers,” 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 7507.
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 informed consent form. This protocol may
be tracked using OSIRIS.
If the research is not complete within one year, you must submit Form 1259, Study Progress Report
Form, by August 12, 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 I via email at [email protected], or telephone at 404-639-8379.
Sincerely,

Robert Chirila, Lead
Human Research Protections Office
cc: NIOSH HSRB Office
[email protected]