Non-Research Determination

NCEZID Tracking Number:

032216NT

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Prevalence Survey of Healthcare-Associated Infections and Antimicrobial Use in U.S. Nursing
Homes
Primary contact Nicola Thompson, PhD

Division/Branch DHQP/ERIB

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

This activity proposes to conduct a survey of nursing homes in the United States to monitor the rates of hospital
acquired infections and antimicrobial use. Currently, surveillance data is lacking for HAIs and antimicrobial use in
nursing homes and this activity will provide data to inform policy makers and public health programs. As the
purpose of this activity is to inform public policy and programs by collecting information about a specific condition
or public health issue, it is consistent with non-research public health surveillance as per CDC policy. This activity is
not designed to contribute to generalizable information.
Additional considerations

None.

Additional requirements

The data collected for this activity may generate hypotheses regarding causes of HAIs or antimicrobial misuse. Any
further analysis of these hypotheses would need to be reviewed and may be found to be research.

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.

Human Subjects Advisor

Reviewed by James Peterson, PhD

Title

James M.
Peterson -S
Signature: _________________________________

3/22/2016
Date: _______________

Digitally signed by James M. Peterson -S
DN: c=US, o=U.S. Government, ou=HHS, ou=CDC,
ou=People, 0.9.2342.19200300.100.1.1=0014247152,
cn=James M. Peterson -S
Date: 2016.03.22 13:00:01 -04'00'