Non-Research Determination

NCEZID Tracking Number: 051716CP

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

Primary contact

Formative evaluation of CDC autocidal gravid traps 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
The purpose of this evaluation is to assess the acceptability and sustainability of CDC autocidal gravid ovitraps
(CDC-AGO) for vector control in Puerto Rico. Focus group discussions will be held in Caguas, the location of the
planned initial distribution, to assess overall knowledge and attitudes about Zika virus, opinions about AGO -including willingness to use and maintain them, and preferred communication and distribution channels. CDC-AGO
is an accepted vector control measure, although it will be unfamiliar to many communities in Puerto Rico. As an
activity designed to gather feedback to tailor an accepted intervention to the needs of a specific community, and to
inform implementation logistics, this activity is consistent with the attributes of non-research formative evaluation, as
described in current CDC policy. This activity is not designed to develop or contribute to generalizable knowledge.

Additional considerations
Verbal informed consent will be obtained prior to initiating the focus group discussion. Although the protocol is
specific for CDC-AGO, this determination may be used to cover additional formative evaluations (focus groups or key
informant interviews) of other accepted vector control interventions, pending consultation with the Human Subjects
Advisor.

Additional requirements
If you wish to use this determination for additional formative evaluations of accepted vector control interventions or
strategies, please consult with the Human Subjects Advisor prior to initiating FGDs or KIIs, and provide a copy of the
discussion/interview guide.

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: 2016.05.17 07:05:07 -04'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
5/17/2016

Date: _______________