IRB - GBS Case-Control Study

NCEZID Tracking Number: 022616TS

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

Primary contact

Epi-aid: Case-control investigation of etiologic agents associated with Guillain-Barré Syndrome -Puerto Rico, 2016

Tyler Sharp, PhD

Division/Branch DVBD/DB

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 investigate the recent cluster of GBS cases in Puerto Rico. Local transmission of
Zika virus in Puerto Rico was confirmed in December 2015, and a cluster of GBS cases has since been identified.
Increased numbers of GBS have been reported in other regions impacted by Zika virus. Co-circulation of dengue,
Chikungunya, and influenza further complicates the picture in Puerto Rico. Investigation of the etiology of GBS in
Puerto Rico is necessary to inform appropriate prevention and control measures. As an activity designed to identify,
characterize and control an immediate public health threat in Puerto Rico, this case-control investigation is consistent
with the attributes of non-research public health response, as described in current CDC policy. This activity is not
designed to develop or contribute to generalizable knowledge.

Additional considerations
Informed consent will be obtained from cases and controls prior to their participation. Retrospective medical record
review activities to describe the historic incidence of GBS were initiated the week of 2/15/16, after consultation with
the NCEZID Human Subjects Advisor.

Additional requirements
We acknowledge that outbreak investigations often evolve in the field. Please be reminded that some changes may
require additional review. Keep us apprised of any changes as this investigation unfolds.

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: 2016.02.26 12:40:40 -05'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
2/26/16

Date: _______________