Research Determination

STARS Tracking Number: 0900f3eb822be99b

NCEZID Tracking Number:

012424LL

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title

Primary contact

Medical Tourism Surveillance Forms
Laura Leidel

Division/Branch

DGMH/TH

The purpose of this form is to document NCEZID’s determination that the above-listed protocol does not require
submission to CDC’s Human Research Protection Office. This authority is delegated to the CDC Centers, Institutes,
and Offices under CDC Policies SSA-2010-01 and SSA-2010-02.
Determination
Project is neither conducted nor supported by a Common Rule agency. IRB review is not required. [45 CFR 46.101(a)]
Project does not meet the definition of research under 45 CFR 46.102(l). IRB review is not required.

✔ Project is deemed not to be research under the following provision. IRB review is not required.
Public health surveillance activities, 45 CFR 46.102(l)(2)

Project does not involve human subjects under 45 CFR 46.102(e). IRB review is not required.
CDC’s role in the project does not meet the threshold requiring submission to HRPO. Investigator has provided documentation of
appropriate local review.
Rationale

The purpose of this project is to conduct surveillance of those taking part in medical tourism to
monitor the health risks involved. The surveillance will consist of surveying those patients who have
illnesses linked to medical tourism. The survey will be concerned with characterizing health threats
and risk factors. Results will be used to assess risk factors associated with medical tourism and may
be presented and published. As this activity involves a public health authority assessing risk factors
with an issue of public health importance, it is deemed non-research public health surveillance.

Additional considerations

Additional requirements

Changes in the nature or scope of this activity may impact the regulatory determination. Please discuss any changes with
your NC Human Subjects Advisor before they are implemented.
Reviewed by

James Peterson, PhD

signed by James M.
James M. Peterson - Digitally
Peterson -S
Signature S
Date: 2024.01.24 17:06:18 -05'00'

Title

Human Subjects Advisor

Date 1/24/2024