Determination: IRB Approval not Required

NCEZID Tracking Number:

081716KM

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Information Collection for Tuberculosis Data from Referring Entities to CureTB
Primary contact Kathleen Moser

Division/Branch DGMQ/OD

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. Under existing institutional policy,
authority to determine whether a project is research involving human subjects or whether CDC is
engaged in human subjects research is delegated to the National Centers.
Determination
■

Project does not meet the definition of research under 45 CFR 46.102(d). IRB review is not required.
Project does not involve human subjects under 45 CFR 46.102(f). IRB review is not required.
CDC is not engaged in the conduct of human subjects research per 2008 OHRP engagement
guidance. CDC IRB review is not required. Investigator has provided documentation of appropriate
local review.

Rationale

This activity involves collecting information on tuberculosis (TB) patients for the purposes of continuity of care
after migration or travel. Contact and TB treatment data will be collected and used to ensure that patients are
linked to the necessary care after migration or travel. As this project is consistent with non-research public health
practice, IRB review is not required per CDC policy. This project is not designed to contribute to generalizable
knowledge.

Additional considerations

None.

Additional requirements

None.

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.

Human Subjects Advisor

Reviewed by James Peterson, PhD

Title

James M.
Peterson -S
Signature: _________________________________

08/17/2016
Date: _______________

Digitally signed by James M. Peterson -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC,
ou=People, 0.9.2342.19200300.100.1.1=0014247152,
cn=James M. Peterson -S
Date: 2016.08.17 15:34:58 -04'00'