IRB Approval Evaluation

19BOI Att 8 IRB Approval Evaluation Final.pdf

National Diabetes Prevention Program Introductory Session Project

IRB Approval Evaluation

OMB: 0920-1300

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NOT HUMAN RESEARCH DETERMINATION
March 25, 2019
Deborah Porterfield
919-630-0532
[email protected]
Dear Deborah Porterfield:
On 3/22/2019, 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
Landscape and Effectiveness Study - Phase 2
Deborah Porterfield
STUDY00020512
CDC NCCDPHP
CDC PGO
0213618.024.000
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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