Appendix E RTI IRB Exempt Correspondence 11-28-2022

EXEMPT DETERMINATION
October 15, 2022
Erik Crankshaw
919-316-3809, x23809
ecrankshaw@rti.org
Dear Erik Crankshaw:
On 10/13/2022, the IRB reviewed the following submission:
Type of Review: Initial Study
Title: Online Survey of Risk Factors of Lithium-Ion
Batteries Used in ENDS
Investigator: Erik Crankshaw
IRB ID: STUDY00022187
Funding Source: FDA CTP
Customer/Client Name: FDA CTP
Project/Proposal Number: 0217597.007.000
Contract/Grant Number: 75F40120A00017
IND, IDE, or HDE: None
The IRB determined that this study meets the criteria for exemption from IRB review
under Category (2)(iii) Tests, surveys, interviews, or observation (identifiable); and for
which limited IRB review was conducted via expedited review.
Ongoing IRB review and approval by this organization is not required. This
determination applies only to the activities described in the IRB submission and may not
apply should any changes be made. If changes are made and there are questions about
whether these activities impact the exempt determination, you should contact the IRB to
discuss whether a new submission and determination is necessary.
Sincerely,
The RTI Office of Research Protection

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