Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
Phase: NA
Conditions: Type 2 Diabetes
Sponsor: Kaiser Permanente

 
 
 
 
 
 
 
 
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes 
NCT ID not yet assigned 
September 7, 2022 

 
 
Kaiser Permanente Northern California
Institutional Review Board
FWA# 00002344    IRB# 00001045
 
1800 Harrison Street, 10th Floor
Oakland, CA 94612
(510) 625-4588
KPNC.IRB@kp.org
DATE:
September 7, 2022
 
 
TO:
Lisa Gilliam, MD, PhD
FROM:
Kaiser Permanente Northern California IRB
 
 
PROJECT TITLE:
[1857661-2] Overcoming therapeutic inertia among adults recently
diagnosed with Type 2 Diabetes
REFERENCE #:
 
SUBMISSION TYPE:
Amendment/Modification
 
 
ACTION:
RESEARCH - NOT HSR
DECISION DATE:
September 7, 2022
REVIEW TYPE:
Administrative Review
ADMINISTRATIVE CHECK-
IN DUE DATE:
Not applicable
 
 
Dear Dr. Lisa Gilliam:
On September 7, 2022, the Kaiser Permanente Northern California (KPNC) Institutional Review Board
determined that your project is Not Human Subjects Research as defined by federal regulations and
institutional policies (45CFR46.102).
The activity does not meet the regulatory definition of research at 45 CFR 46.102(d):
Research means a systematic investigation, including research development, testing and evaluation,
designed to develop or contribute to generalizable knowledge.
Note: The word "research" should not appear in any posters or publications resulting from this
project. Also, the word "clinical trial" should not appear in any posters or publications resulting
from this project. Lastly, the study team may not store any identifiable data or conduct any future
research use without IRB review and approval. 
This determination is based on the information provided to the IRB. If the scope or nature of the project
changes in a manner that could impact this review, you are required to notify the IRB Office prior to
implementing this change.
You are expected, however, to implement your study or project in a manner congruent with accepted
professional standards and ethical guidelines as described in the Belmont Report
(http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html).
- 1 -
Generated on IRBNet

 
Additionally, you are responsible for keeping a copy of this determination letter in your project files as it
may be necessary to demonstrate that your project was properly reviewed.
Provide this approval letter to the Physician in Charge (PIC), Area Manager, and/or Chief of Service, to
determine whether additional approvals are needed.
If you have any questions, please contact the KPNC IRB at KPNC.IRB@kp.org. Please include your
project title and reference number in all correspondence with this committee.
Sincerely,
 
Kaiser Permanente Northern California IRB
- 2 -
Generated on IRBNet