Attachment 9 - IRB Non-research Determination

NCEZID Tracking Number: 042313BC

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

Primary contact

Evaluation of the TravAlert electronic messaging system

Blanche Collins, PhD

Division/Branch DGMQ/QBHSB

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
The purpose of this project is to optimize the placement of TravAlert monitors in airports, verify that the messages
being presented are being understood, and inform ongoing messaging strategy for international travelers. Neither
the message content nor the communication method are novel. This activity is not designed to further the
understanding of health communication methods. This activity is consistent with the attributes of routine
non-research program evaluation, per 2010 CDC policy, as well as OHRP guidelines regarding non-research quality
improvement activities. As such, this activity does not meet the regulatory definition of research.

Additional considerations
Verbal consent will be obtained from respondents. Questions are not sensitive in nature. This project also underwnt
ethical review by the IRB at ORAU, and was similarly determined not to meet the regulatory definition of research.

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.
Reviewed by Laura Youngblood, MPH, CIP

Signature:

Laura
Youngblood
_________________________________
Digitally signed by Laura Youngblood
DN: c=US, o=U.S. Government, ou=HHS,
ou=CDC, ou=People, cn=Laura
Youngblood,
0.9.2342.19200300.100.1.1=1001704097
Date: 2013.04.23 07:50:36 -04'00'

Title Human Subjects Advisor, NCEZID
04/23/13

Date: _______________