Appendix C IRB Outcome Letter

From:
Date: Fri, Nov 22, 2019 at 3:16 PM
Subject: NCR191796 Not Research Determination Notification
To: ,

Outcome Letter Notification

Regarding: #NCR191796 "Teaching Health Center Graduate Medical Education (THCGME) Cost Evaluation"
Submission Type: Submission Response for Initial Review Submission Packet
Attached is the outcome letter for this submission.
Thank You
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Memorandum
To: Regenstein, Marsha Joan, PhD
From: The George Washington University Office of Human Research
Date: November 22, 2019
Study Title: Teaching Health Center Graduate Medical Education (THCGME) Cost Evaluation
Re: Determination of Not Research

Regarding the Determination Worksheet submitted for the project entitled, “Teaching Health
Center Graduate Medical Education (THCGME) Cost Evaluation,” a determination has been made
that this project does not meet the definition of research. That is, a systematic investigation
designed to contribute to generalizable knowledge.
This determination is being made because this study is purely an evaluation of the Teaching Health
Center Graduate Medical Education program, which is a unique program. The purpose of the study is to
specifically inform the THCGME program. Per the PI, although results of the evaluation may be
published, there is no intention to contribute to knowledge outside of this research context.
Further review by the GW IRB is not required.
Should your study change in such a way that it does meet the definition of human subjects
research, please contact the Office of Human Research before proceeding.