CDC Determination: IRB Approval Not Required

STARS Tracking Number: 0900f3eb81c7d96e

NCEZID Tracking Number:

021021ZM

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

Primary contact

CryptoNet Case Report Form
Zach Marsh, 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. This authority is delegated to the CDC Centers, Institutes,
and Offices under CDC Policies SSA-2010-01 and SSA-2010-02.
Determination
Project is neither conducted nor supported by a Common Rule agency. IRB review is not required. [45 CFR 46.101(a)]
Project does not meet the definition of research under 45 CFR 46.102(l). IRB review is not required.

✔ Project is deemed not to be research under the following provision. IRB review is not required.
Public health surveillance activities, 45 CFR 46.102(l)(2)

Project does not involve human subjects under 45 CFR 46.102(e). IRB review is not required.
CDC’s role in the project does not meet the threshold requiring submission to HRPO. Investigator has provided documentation of
appropriate local review.
Rationale

The purpose of this activity is to collect data on exposures associated with Cryptosporidium cases
using the CryptoNet case report form. Data collected will be used to monitor for and inform response
to increased cases of cryptosporidiosis. Summaries and analysis of data may be published and
presented. As the purpose of this activity is to collect data to monitor a condition of public health
importance, it is consistent with non-research public health surveillance.

Additional considerations

Additional requirements

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

James Peterson, PhD

signed by James M.
James M. Peterson - Digitally
Peterson -S
Signature S
Date: 2021.02.10 09:11:19 -05'00'

Title

Human Subjects Advisor

Date 2/10/2021