IRB Approval

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control

and Prevention (CDC)

M emorandum

Date

d

December 10, 2020

From

Jerrell Little

IRB-Committee Administrator

Human Research Protection Office

Subject

CDC IRB Approval of New Protocol 7310.0, "Availability, use, and public health impact of emergency supply kits among disaster-affected populations." (Expedited)

To

Amy Schnall, MPH, BA, CPH

NCEH/DEHSP

CDC's IRB-Committee 1 has reviewed the request for approval of new protocol 7310.0, “Availability, use, and public health impact of emergency supply kits among disaster-affected populations.”. The protocol was reviewed and approved on 11/23/2020 in accordance with the expedited review process outlined in (45 CFR 46.110(b)(1)), category 7.  This study does not require continuing review, and this approval will not expire. You should close out expedited protocols this study as soon as CDC staff are no longer engaged in the research activity.  The Human Research Protection Office (HRPO) may follow up with you periodically to check the status of CDC’s engagement in this research activity.

The IRB determined that the study poses minimal risk to subjects. The IRB approves the inclusion of pregnant women (45 CFR §46.204).

If other institutions involved in this protocol are being awarded CDC funds through the CDC Office Financial Resources (OFR), you are required to send a copy of this IRB approval to the CDC OFR award specialist handling the award.  You are also required to verify with the award specialist that the awardee has provided OFR with the required documentation and has approval to begin or continue research involving human subjects as described in this protocol.

Any problems of a serious nature should be brought to the immediate attention of the IRB, and any proposed changes to the protocol should be submitted as an amendment to the protocol for IRB approval before they are implemented.

If you have any questions, please contact your National Center Human Subjects Contact or the CDC Human Research Protection Office at (404) 639-7570 or email at [email protected]).

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