IRB Letter

NOT HUMAN RESEARCH DETERMINATION
August 19, 2020
Jennifer Duke
919-485-2669, x22669
jduke@rti.org
Dear Jennifer Duke:
On 8/19/2020, the IRB reviewed the following protocol:
Type of Review:
Title:
Investigator:
IRB ID:
Funding Source:
Customer/Client Name:
Project/Proposal Number:
Contract/Grant Number:
IND, IDE, or HDE:

Initial Study
Hornik Study
Jennifer Duke
STUDY00021223
FDA Ctr Tobacco Products
FDA Ctr Tobacco Products
0215534.001
HHSF223201610032I
None

The IRB determined that the proposed activity is not research involving human subjects
as defined by DHHS regulations.
Although RTI IRB oversight of this activity 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 the nature or scope of the activity changes and there are questions
about whether the revised activities constitute human subjects research, 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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