IRB Approval Landscape

19BOI Att 7 IRB Approval Landscape Ass Final.pdf

National Diabetes Prevention Program Introductory Session Project

IRB Approval Landscape

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NOT HUMAN RESEARCH DETERMINATION
February 13, 2019
Deborah Porterfield
919-630-0532
[email protected]
Dear Deborah Porterfield:
On 2/13/2019, the IRB reviewed the following protocol:
Type of Review: Initial Study
Title: Landscape Assessment and Evaluation of
Introductory Sessions to Inform and Increase
Enrollment in the CDC-Recognized Lifestyle Change
Program, 0213618.024.000.002
Investigator: Deborah Porterfield
IRB ID: STUDY00020491
Funding Source: CDC NCCDPHP
Customer/Client Name: CDC PGO
Project/Proposal Number: 0213618.024.000
IND, IDE, or HDE: 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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