Human Subjects Determination

STARS Project ID Number:

0900f3eb824755af

NCEZID Tracking Number:

102424SG

STARS Accession Number: NCEZID-SEA-10/22/24-755af

Determination of Non-applicability of Human Subjects Regulations

National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Risk factors, clinical course, presence and persistence of virus in various bodily fluids,
Project title
and risk of sexual transmission among U.S. adults with Oropouche virus disease
Primary contact

Sarah Guagliardo

Division/Branch

DVBD/ADB

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 overarching purpose of this project is to evaluate the presence and persistence of Oropouche Virus
(OROV) in bodily fluids and the risk of sexual transmission. Specific objectives of this project are to assess
potential risk factors for OROV disease; describe the clinical course and outcomes of OROV disease among
U.S. travelers; assess the prevalence and duration of OROV, viral RNA, and OROV-specific neutralizing
antibodies in various bodily fluids; and evaluate the evidence for sexual transmission of OROV. These
activities, conducted by CDC and STLT health departments, are necessary for identifying and assessing risk
factors for OROV disease and disease transmission. Findings will inform public health messaging regarding
clinical recognition and management of patients with OROV, and to inform prevention recommendations.
Additional considerations

This investigation involves the collection and use of information and biospecimens to address OROV disease. It is conducted
by CDC and other STLT health departments, and it is limited to activities that are necessary to identify and monitor risk factors
for OROV disease and possible transmission. As such, it is deemed not to be research under 45 CFR 46.102(l)(2).
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

Signature:

Laura Youngblood
Digitally signed by Laura
Youngblood -S
Date: 2024.10.25 11:34:11 -04'00'

Title

Human Subjects Advisor

Date:

10/25/24