IRB Determination - Not Human Research

NOT HUMAN RESEARCH DETERMINATION
November 27, 2018
Heather Kane
919-541-6738, x26738
hkane@rti.org
Dear Heather Kane:
On 11/27/2018, the IRB reviewed the following protocol:
Type of Review:
Title:
Investigator:
IRB ID:
Funding Source:
Customer/Client Name:
Project/Proposal Number:
IND, IDE, or HDE:

Initial Study
SMARTool Pilot Replication Project
Heather Kane
STUDY00020271
DHHS OASH
The MITRE Corporation
0214683.003.000.001
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

Page 1 of 1