IRB Determination - Project 1

NCEZID Tracking Number: 052616CP

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

Primary contact

Assessment of interventions intended to protect pregnant women in Puerto Rico from Zika infections
in Puerto Rico

Chris Prue, PhD, MSPH

Division/Branch NCEZID/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
As part of ongoing Zika response efforts in Puerto Rico, a number of standard interventions have been implemented
to minimize exposures for pregnant women. Interventions have included education and outreach, vector control in
and around the homes of pregnant women (indoor and outdoor residual spraying, larviciding), and distribution of
prevention kits (tote bags containing educational materials and PPE including insect repellant, condoms, bednets,
thermometers, and mosquito dunks). The purpose of the proposed activity is to assess whether these interventions
are reaching the target population, and to confirm they are having the intended effects. Pregnant women in Puerto
Rico will be identified through WIC clinics, and will be invited to take part in a telephone survey to assess 1) the reach
of interventions, and 2) the use and acceptability of interventions. As an activity designed to provide feedback to
improve an ongoing program, this assessment is consistent with the attributes of non-research program evaluation.

Additional considerations
Verbal consent will be sought from all survey respondents. Additional rounds of interviews or focus groups designed
to evaluate standard interventions targeting pregnant women in Puerto Rico may be considered under this
determination, pending consultation with the human subjects advisor.

Additional requirements
Please discuss any additional rounds of interviews or focus groups with the human subjects advisor prior to
implementation.

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

Laura
Youngblood -S

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: 2016.05.26 07:53:43 -04'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
5/26/16

Date: _______________