Information for Participants in the FlowDx Research Study

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25 Νοε 2013 (πριν από 3 χρόνια και 6 μήνες)

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Information for Participants in the FlowDx Research Study

Principal Investigator: Treister, Adam S. (541) 201
-
0022


Introduction:
You are being asked to participate in
a
research study.

The study is called Clinical Cytometry
Analysis Software with Automa
ted Gating. FlowDx LLC will use the findings of the study to develop a software
application to isolate populations of interest in flow cytometry data using mathematical algorithms in the place of
conventional methods of manual gate definition
., The resul
ting commercial software program will be called
FlowDx. We anticipate a two
-
year development period and may ask again for your participation during that time.


Purpose:
We need a body of manually drawn gates as a standard by which to measure the success of

clustering
algorithms. Working from a written procedure, you will perform a series of familiar analytic steps in the FlowJo
software program. A single analysis procedure should take no more than an hour. The study will collect and
codify the gating choice
s you make, to establish baseline, or consensus gates for a given data set. The present step
requires (need to provide #)__ sessions, lasting about (need to provide #_____ hrs.


Procedures:
You will be asked to

perform a familiar software analysis task in
FlowJo so that the data you
identify can be similarly identified in software.


Risks:
There are minimal risks to participation in this research, similar to those you encounter in the regular
performance of your job.


Benefits:
The chief anticipated benefit

of success in this study is the potential development of a software
application to effectively reducte the repetitive labor necessitated by large
-
scale studies with high throughput.


Reimbursement/Compensation for Illness/Injury During Study:
There is no
reimbursement or compensation
for your participation in this research.


Confidentiality:
Data will be de
-
identified as the work is performed and before it is handed over for use by the
FlowDx study. However, the following groups may gain access to informat
ion that identifies you by name: your
lab director; the U.S. Food and Drug Administration (FDA); the Office for Human Research Protections (OHRP);
and UAB’s Institutional Review Board (IRB). The results of the study will be published for scientific purpose
s.
These results could include your analysis data. Once the study is completed, personal information connected with
the data and held by the cooperating lab will be destroyed.


Legal Rights/Patient Consent:
You are not waiving any of your legal rights by s
igning this informed consent
document.

Voluntary Participation/Withdrawal:
Your participation is voluntary.


Whether or not you participate will not
affect your relationship with your employer or FloxDx LLC.


You are free to withdraw from the study at any
time
without penalty.


Researchers reserve the right to end the study or your participation at any time.


Research Subjects Rights:

If you have any questions, concerns, or complaints about the research or a research
-
related injury, please contact Principal

Investigator Adam S. Treister, FlowDx LLC
-

541 201
-
0022. 340 A Street,
Ashland, OR 97520


If you have questions about your rights as a research participant, or concerns or complaints about the research,
you may contact the Southern Oregon IRB, 541.789.46
26, 2825 East Barnett RD, Medford, OR 97504. Office
hours of the IRB are 8:00 a.m. to 5:00 p.m. PT, Monday through Friday. You may also call this number in the
event the research staff cannot be reached or you wish to talk to someone else.