Research Determination

NCEZID Tracking Number: 112817JP

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

Primary contact

Developing a framework for a Quality Management Systems training curriculum for CDC
research laboratories
Justine Pompey, PhD

Division/Branch DHCPP/CVDB

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 survey is to assess CDC laboratorians' needs and preferences with respect to training content,
format, and delivery, with respect to quality management systems. The results of this survey will inform internal
training programs for CDC staff. As an activity designed to gather feedback from a target audience to tailor routine
training courses for the specific needs of the audience, this project is consistent with the attributes of non-research
program evaluation. This activity is not designed to develop or contribute to generalizable knowledge.

Additional considerations
Survey links will be distributed via e-mail. The recruitment e-mail clearly articulates the nature and purpose of the
survey, and it clearly identifies the survey as voluntary. Identifiers will not be recorded, although it may be possible to
deduce some respondents' identities. However, the nature of the questions would not reasonably place any
respondent at risk, should his or her identity be revealed.

Additional requirements
Project team has consulted with Lee Samuel re: PRA applicability.

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: 2017.11.28 07:27:23 -05'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
11/28/17

Date: _______________