Attachment A12 - IRB Decision Letter

11200 ROCKVILLE PIKE, SUITE 320 | NORTH BETHESDA, MD 20852 | 301.495.1080
JBSINTERNATIONAL.COM

January 8th, 2024
To:

Amanda Gmyrek
Principal Investigator
JBS International, Inc.

From: Katelyn Franke, Ph.D.
IRB Co-Chair
JBS International, Inc.
Maia Hyary, Ph.D.
IRB Co-Chair
JBS International, Inc.
Re:

JBS IRB #AG23-01
Approved by Expedited Review

Dear Dr. Gmyrek:
Your protocol HRSA MCHB PMHCA Program National Impact Study (JBS IRB # AG23-01)
has been approved by expedited review by the Institutional Review Board. This study fulfills
the criteria for expedited review under 45 CFR 46.110, category #7.
The IRB has determined that Continuing Review is not required. As the Principal Investigator,
you have the ultimate responsibility for the conduct of the study, the ethical performance of the
project, the protection of the rights and welfare of human subjects, and strict adherence to any
stipulations imposed by the IRB. You must abide by the following principles when conducting
your research:
1. Perform the project by qualified personnel according to the approved protocol.
2. Do not implement changes in the approved protocol or consent form without prior IRB
approval (except in a life-threatening emergency, if necessary, to safeguard the wellbeing of human subjects). This includes changes to the research design or procedures that
could introduce new or increased risks to human subjects and thereby change the nature
of the research.
3. Promptly report any adverse reactions or unanticipated reactions within five working
days of occurrence. All fatal or life-threatening events or events requiring hospitalization
must be reported to the IRB in writing within 48 hours after discovery.
The investigator(s) identified above are required to retain an IRB protocol file, including a record
of IRB-related activity, data summaries and consent forms. This file is to be made available for
review for internal procedural (audit) monitoring.

If you have any questions, please contact kfranke@jbsinternational.com and
mhyary@jbsinternational.com
Expedited Review Approved By:
Katelyn Franke, Ph.D.
IRB Co-Chair
Maia Hyary, Ph.D.
IRB Co-Chair