IRB determination

NCEZID Tracking Number:

032717JH

Determination of Non-applicability of Human Subjects Regulations
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Project title Understanding Strategies to Improve Sexual Health Messaging to Prevent
Multidrug-resistant Shigella Infections among Men who have Sex with Men
Primary contact Jacqui Hurd, MPH

Division/Branch DFWED/WDPB

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 assess the needs and inform the development of sexual health messaging
targeted to prevent the spread of multidrug-resistant Shigella among men who have sex with men. This evaluation
will consist of focus groups to develop effective messaging and review messaging acceptability in the targeted
population. Results will be used to develop and finalize public health messaging. As an activity to evaluate the
needs of a population targeted by standard public health messaging, this is consistent with non-research
evaluation per CDC guidance. This activity is not designed to contribute to generalizable knowledge.
Additional considerations

None.

Additional requirements

Georgia State University will be leading the focus groups and submitting for local human subjects research
determination. Please provide documentation of GSU human subjects research review when it is available.

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: _________________________________

3/27/2017
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: 2017.03.27 10:37:51 -04'00'