IRB Determination - Project 2

NCEZID Tracking Number: 061616LA

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

Primary contact

Association of Zika prevention kits with Zika virus prevention among pregnant women in Puerto Rico

Laura Adams, DVM, MPH

Division/Branch DVBD/DB

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 evaluation is to assess the use of Zika prevention kits, and to identify prevention behaviors that
are effective in the context of the ongoing outbreak in Puerto Rico. Of the women who have received ZPKs, those
who have subsequently tested positive or negative for Zika virus will be interviewed about their knowledge, attitudes,
and practices surrounding Zika virus and the prevention tools provided as part of the ZPKs. Identification of any
factors that are associated with Zika prevention will help to inform improvements or refinements to the ZPKs, as well
as outreach and educational efforts, and prioritization of resources. As an activity designed to evaluate the use and
effectiveness of standard interventions for the purpose of controlling an ongoing outbreak, this activity is consistent
with the attributes of non-research public health evaluation and response. This activity is not designed to develop or
contribute to generalizable knowledge.

Additional considerations
Verbal informed consent will be obtained prior to interview.

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

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: 2016.06.16 17:09:54 -04'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
6/16/16

Date: _______________