IRB Determination

NCEZID Tracking Number: 020215AR

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

Primary contact

Healthcare facilities granting State Health Departments access to electronic health record data during
a healthcare-associated infection outbreak: a retrospective assessment

Anjanette Raber, PhD, MSN

Division/Branch DHQP

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 project is to identify and describe the challenges faced by healthcare facilities in granting
electronic health record access to health departments during the investigation of the fungal meningitis outbreak in
2012. This project builds on a previous assessment of health departments' experiences in collaborating with
healthcare facilities during this outbreak. Together, the results of these projects will be used to develop a toolkit to
help State health departments address the needs and perspectives of healthcare facilities in their jurisdictions when
investigating healthcare-associated infections. As an activity designed to assess the implementation of a public
health response activity in order to inform improvements to standard public health practice, this activity 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
None.

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: 2015.02.02 14:47:43 -05'00'

Signature: _________________________________

Title Human Subjects Advisor, NCEZID
2/2/15

Date: _______________