Research Determination

Attachment E: IRB Exempt Determination

EXEMPT DETERMINATION
DATE:

24 Feb 2023

TO:

Carolyn Kopf

PROJECT:

Department of Health and Human Services - 00067314 / 00067314 75D30120F09670, Public Health Communications Messages and Materials
Testing Focused on Antimicrobial Resistance Among the U.S. General
Population Pilot Data Collection Project Protocol
Prepared for the Centers for Disease Control and Prevention, Antimicrobial
Resistance Coordination & Strategy Unit (Pro00067314)
DOCUMENTATION REVIEWED:

Protocol Version(s):



Protocol (Not Dated)

Consent Form(s):



PARTICIPANT INFORMATION SHEET & INFORMED CONSENT
FORM (Not Dated)

Other Material:





Recruitment Screener (Not Dated)
Interview Discussion Guide (Not Dated)
Technology Check (Not Dated)

Using the Department of Health and Human Services regulations found at 45 CFR 46.104(d)(2), the IRB determined
that your research project is exempt from IRB oversight. The IRB also completed the necessary additional limited
review considerations as set forth under the Revised Common Rule, 45 CFR 46.104(d). All study related documents
will be removed from our active files and archived.
Note: You will still be able to access this study via the Advarra CIRBI Platform under the "Archived" tab on your
Dashboard for three years. After three years, the study will be removed from the system in accordance with IRB
regulations.
The IRB granted this exemption with an understanding of the following:
1. The research project will only be conducted as submitted and presented to the IRB, without additional
change in design or scope.
2. Should the nature of the research project, or any aspect of the study, change such that the nature of the study
no longer meets the criteria found in 45 CFR 46.104(d)(2), you will resubmit revised materials for IRB
review.

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3. It is the responsibility of each investigator to ensure that the project meets the ethical standards of the
institution. Specifically, the selection of subject is equitable, there are adequate provisions to maintain the
confidentiality of any identifiable data collected, and when there are interactions with research subjects,
they will be informed: that the activity involves research; of a description of the procedures; that
participation is voluntary; and of the contact information for the researcher.
The IRB will evaluate the new information and make a determination at that time regarding the research project’s
status.
This project is not subject to requirements for continuing review.
If you wish to appeal the IRB’s determinations and/or imposed modifications, please submit supporting
documentation to address the IRB’s concerns by creating an Appeal Modification in CIRBI.
If you have any questions or concerns, please use the Contact IRB activity on the Advarra CIRBITM Platform.
Thank you for selecting Advarra IRB to review your research project.

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