Non-Research Determination

Att. 3 - Non-research determination.pdf

Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery

Non-Research Determination

OMB: 0920-1050

Document [pdf]
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NCEZID Tracking Number: 020118RC

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

Primary contact

MosquitoNet Focus Group
Roxanne Connelly, PhD

Division/Branch DVBD/ADB

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 activity is to gather feedback about the MosquitoNET surveillance system from individuals
working in mosquito control, in order to improve user acceptability and identify barriers to use, prior to expanding the
surveillance system nation-wide. The activity will include focus groups of adult mosquito control professionals, during
the annual meeting of the American Mosquito Control Association. As an activity designed to gather feedback to
improve an existing public health surveillance program, this project is consistent with the attributes of non-research
program evaluation, as described in current CDC policy. This activity is not designed to develop or contribute to
generalizable knowledge.

Additional considerations
Information about the nature and scope of the project, including voluntariness, is provided via recruitment e-mail, as
well as in the scripted introduction to the focus group sessions.

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: 2018.02.01 09:20:22 -05'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
02/01/2018

Date: _______________


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