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IRB

IRB

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Published by Paul Frey

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Published by: Paul Frey on Dec 13, 2011
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FORM:
Human Research Determination
NUMBERFORM DATEPAGE
F30908/01/20111 of 6
No handwritten forms will be accepted.P
ROJECT
T
ITLE
:
UAMC Guideline for Acute Spinal Cord Injury
I
NVESTIGATOR 
Principal Investigator Name, Degree(s):Paul Frey, Patrick Hryshko, Zac Johnson, Holly Paddock Status/Rank:Department/Center/Section:College:University of Arizona College of PharmacyContact phone: 520-626-1427Fax:Email:Mailing address:(Campus PO Box/Mailstop)1295 N MartinPO Box 210202 Tucson AZ 85721
A
DVISOR 
 
CONTACT
 
INFORMATION
(R 
EQUIRED
 
FOR 
 
ALL
 
STUDENTS
 
AND
 
RESIDENTS
)
 Name, Degree(s):Kara SnydeContact phone: 520-694-4822Fax:Email:Kara.snyder@uahealth.comMailing address:(Campus PO Box/Mailstop)1501 N Campbell AvePO Box 245015 Tucson AZ 85704
A
LTERNATE
/C
OORDINATOR 
 
CONTACT
 
INFORMATION
 Name:Terri WarholaContact phone: 520-626-4240Fax:520-626-5518Email:warholak@pharmacy.arizona.eduMailing address:(Campus PO Box/Mailstop)1295 N MartinPO Box 210202 Tucson AZ 85721
HSPP USE ONLY
Date received:Received by:
 
FORM:
Human Research Determination
NUMBERFORM DATEPAGE
F30908/01/20112 of 6
The purpose of this form is to help you to determine whether your project should be classified as Human Research,as defined by OHRP.
 
Upon completion, sign and submit to the designated Scientific/Scholarly Reviewer. If theScientific/Scholarly Reviewer agrees that the proposed activity does not constitute Human Research, forward thedocuments to the HSPP Office. (Click  hereto review the OHRP Human Subject Regulations Decision Charts, in  particular 
Chart 1
)
Contact HSPP staff about how to proceed if your project includes Native Americans or InternationalIndigenous Populations.
If you have any questions on how to answer the items on this form, please contact the HSPP at (520)626-6721.
If at any point your answers lead you to the conclusion that your project does constitute Human Research, please
STOP
filling out this form and complete the appropriate HSPP initial application form. If this form indicates thatyour project does not constitute Human Research and will not require IRB review, please proceed with thefollowing:
Attach a project summary, along with materials supporting the answers that led to that conclusion.
SeeSECTION 2
of this document to provide specific details of the project protocol.
Speed up review by
providing an explanation to support your answers
to the subsequent questions.
Submit this form and supporting materials to your 
(internal)
designated Scientific/Scholarly Reviewer.
Following Departmental approval, submit all materials to the
HSPP
for 
FINAL
approval.
NOTE: PROJECTS INVOLVING DRUGS OR MEDICAL DEVICES WILL ALWAYS REQUIRE IRBREVIEW AND APPROVALIs the project a Systematic Investigation designed to develop or contribute to generalizable knowledge?
Systematic
: having or involving a system, method or plan.
Investigation
: a searching inquiry for ascertaining facts; detailed or careful examination.
Generalizable
: generalizability is the extent to which research findings and conclusions from a studyconducted on a sample population can be applied to the population at large. Please note that use for a thesis,dissertation, publication, or poster presentation does not automatically mean that the work is generalizable
.NoSTOP: Go no further!
The project isnot considered research; IRB review isnot required.
Yes - Go on to question #2Provide Explanation:The project is not generalizable to the population at large due to theguidelines that are being developed will only to be used in hospitalsetting at The University of Arizona Medical Center.Does the research involve obtaining information about living individuals?
This includes secondary data analyses of existing data that was
not
obtained by the investigator of the proposed project.
NoSTOP: Go no further!
The project isnot considered Human Research; IRBreview is not required.
Yes - Go on to question #3Provide Explanation:Will the research obtain data through intervention or interaction with individuals (including use of surveyswhere the investigator and the participant never meet or talk)?
When there is an intervention or interaction with a living individual for the primary purpose of obtainingdata regarding the effect of the intervention or interaction, the data are considered to be about the living
 
FORM:
Human Research Determination
NUMBERFORM DATEPAGE
F30908/01/20113 of 6
individual.)
YesSTOP: Go no further!
The project
IS
considered Human Research and IRBreview
WILL BE
required. Completethe appropriate Human Research Form.
No - Go on to question #4Provide Explanation:Can individual identities be readily ascertained (or associated with the data), by the PI or project staff?
Examples of items that would
make an individual readily identifiable
include,
but are not limited to
,any of the following: first and last name, social security number, current street address, telephone number,email address, driver’s license number, medical record number,
**see thiswebsiteand45 CFR  §164.514(b) for the full list of HIPAA identifiers
.**
YesSTOP: Go no further!
The project
IS
considered Human Research and IRBreview
WILL BE
required. Completethe appropriate Human Research Form.
No - Go on to question #5Provide Explanation:Is the data collected considered “private” information?
Is it specific information/data that the individual can reasonably expect will not be made public, or is it in acontext in which the individual would otherwise expect that no observation or recording was taking place?Review this OHRP
 on research involving coded private information.
NoSTOP: Go no further!
The project isnot considered Human Research; IRBreview is not required.
Yes - Go on to question #6Provide Explanation:Do individual records have a unique identification number?
(Review this 
and contact HSPP staff for confirmation.)
No
The project may not involve humansubjects and may not require IRBreview; confirm with HSPP staff.
Yes - Go on to question #7Provide Explanation:Is the identification code attached to or replacing any data items that make the individual readilyidentifiable?
This includes cases where there exists a master list connecting individuals and unique identificationnumbers, which is called “coded information.”
NoSTOP:
 
Go no further!
The project isnot considered Human Research; IRBreview is not required.
Provide Explanation:

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