IRB Determination

Attachment D. NCIPC Non Research Determination Form.pdf

Evaluation of the Field Triage Decision Scheme: The National Trauma Triage Protocol

IRB Determination

OMB: 0920-0844

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Form Version Date 05.12.08

NCIPC Determination of Applicability of Human Subiects Re~ulations,
Request to Classify Proiect as Not 1~volvin.HumanSubiects or Research
Project Titlemaluation of the Field Triage Decision Scheme Educational Initiative
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Science Officer(~):V
Telephone: 770-488-38 16

/

M

Division: NCIPC/DIR
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Ethics verification number:--

Project Officer(~)Kelly Sarmiento, MPli
Division: NCIPCIDIR- Telephone: 7 7 0 - 4 8 8 - B
Ethics veritication number: 9256
Proposed Project Dates: Start: 05 /I 512009 Ending: 05/01/2010
Categories of data collection that do not constitute human subjects research
engaged are listed below. Please check appropriate category:

do involve human subjects but CDC not

X_ I. Activity is not research. Primaq intent is public health practice: diseaselinjury control, surveillance,
improvement of programs or services. Objectives focused on a specific population.
- -A. Epidemidendemic diseaselinjury control activity; collected data directly relate to immediate disease
control needs.
-B. Routine diseaselinjury surveillance activity; data used for disease control program or policy purposes
for a specific health conditionldisease in a specific population and setting. (Includes disease reporting)
X C. Program evaluation activity; data are used primarily for assessing, monitoring or improving a program
in a specific populationJsetting.
Justification: Data collected from participants will be used to improve the educational materials developed as part of
the Field Triage Decision Scheme Educational Initiative. Please attach for project goalslaims, objectives, design, setting
and participants, methods, and data sources.

-0R11. Activitv is research but does NOT involveidentifiable human subiects. Primary intent is to develop or
;%ribUte to generalizable knowledge.
-A. Activity is research involving collection/analysisof data about health facilities or other
organizations or units, which are not individual persons ....or...
--- B. Activity is research involving data andlor specimens from deceasedpersons.

Justification:

-111. Activity
is research involving human subiects but CDC - includine em~lovees.visit in^ scientists, fellows,
and on-site contractors (but not off-site contractors or other collaborators~- will NOT obtain data bv
intervening or interactine with ~articipantsand will NOT have access to identifiable (including coded)
private data or blolo~icals~ecimens.
Justification:

-I

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