Human Subjects Determination: IRB Approval Not Required

STARS Tracking Number: 0900f3eb81bf1336

NCEZID Tracking Number:

100920JL

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

Primary contact

Myalgic EncephaloymelitisChronic Fatigue Syndrome KABs in the U.S. General Public

Jin-Mann Lin

Division/Branch

DHCPP/CVDB

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.
Select, if applicable

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 project is to perform a needs assessment of public KABs to inform public health
educational outreach for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). As ME/CFS affects
a large number of the population and is not well known, there is a need to provide public health educational
materials to raise awareness. WebMD will be prompting users to take a survey regarding their opinions and
knowledge of ME/CFS to evaluate the education outreach needs of the population. As the purpose of this
activity is to evaluate the needs of a target population to inform the implementation of a standard
programmatic activity, it is consistent with non-research program evaluation. This activity is not designed to
contribute to generalizable knowledge.
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: 2020.10.09 07:29:13 -04'00'

Title

Human Subjects Advisor

Date 10/9/2020