Approval Letter

NOT HUMAN RESEARCH DETERMINATION
July 6, 2020
Jennifer Duke
919-485-2669, x22669
jduke@rti.org
Dear Jennifer Duke:
On 7/2/2020, the IRB reviewed the following submission:
Type of Review:
Title:
Investigator:
IRB ID:
Funding Source:
Customer/Client Name:
Project/Proposal Number:
Contract/Grant Number:
IND, IDE, or HDE:

Initial Study
Monthly Monitoring Study
Jennifer Duke
STUDY00021152
FDA Ctr Tobacco Products
FDA Ctr Tobacco Products
0215534.001.001.008
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