Human Research Determination
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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
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
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.
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
designated Scientific/Scholarly Reviewer.
Following Departmental approval, submit all materials to the
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?
: having or involving a system, method or plan.
: a searching inquiry for ascertaining facts; detailed or careful examination.
: 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
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