IRB Review

NCEZID Tracking Number: 071816HW

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

US-based migrant farm workers understanding and use of measures to prevent Zika
Project title transmission
Primary contact

Holly Williams, PhD

Division/Branch

Zika GM task
force

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.

Additional clearances
✔
☐

☐

OMB/PRA Contact
Lee Samuel
Chris de la Motte Hurst
Epidemiology Task Force

☐

Blood Safety Task Force

✔
☐

Global Migration Task Force

Nicky Cohen

☐

International Task Force

☐

Laboratory Task Force

☐

Medical Investigations Team

☐

Pregnancy & Birth Defects Task Force

☐

Puerto Rico Team

☐

State Coordination Task Force

☐

Vector Issues Task Force

✔
☐

Home Division/Unit

DGMQ

NCEZID Determination – Zika Response

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NCEZID Tracking Number: 071816HW
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 objective of this evaluation is to describe current knowledge, attitudes, and practices among US-based
migrant farm workers about Zika virus, its transmission, and its prevention. The purpose is to inform
targeted outreach and education measures tailored to a specific population that is particularly vulnerable
because of limited access to healthcare, prevention tools, and Spanish-language health education
materials. Focus groups and key informant interviews will be conducted with migrant farm workers in CA,
FL, GA, and TX, and will focus on current knowledge and concerns, perceptions about prevention
measures, and access to prevention measures and healthcare. Results of these activities will inform
targeted public health messaging efforts tailored to the specific needs of this population. As an activity
designed to gather information to tailor standard public health messages to the specific needs of a
particular group, this evaluation is consistent with the attributes of non-research program evaluation.
Additional considerations

Verbal informed consent will be obtained. Participants' names will not be recorded, and audio files will be
deleted following transcription. Participants will not be asked about their immigration status.

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

Title Human Subjects Advisor, NCEZID

Laura Youngblood
-S
Signature: _________________________________

7/18/16
Date: _______________

Digitally signed by Laura Youngblood -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC,
ou=People, 0.9.2342.19200300.100.1.1=1001704097,
cn=Laura Youngblood -S
Date: 2016.07.18 11:52:11 -04'00'

NCEZID Determination – Zika Response

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