Completing a Request for Determination Click here to listen to the - PowerPoint PPT Presentation

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Completing a Request for Determination Click here to listen to the recording. Password: Knightcpp1 Completing a Request for Determination Form PI ( PrincipalInvestigator ) : personwhois responsibleforoversightofprojectactivities,

Completing a Request for Determination
Click here to listen to the recording. Password: Knightcpp1
Completing a Request for Determination Form PI ( PrincipalInvestigator ) : personwhois responsibleforoversightofprojectactivities, includingprotectionofhumansubjects ( participants )
RFD – Section One Hereyoucanpullfromproposalquestion1 . Descriptioncanbebrief ( 3 - 5sentences ) . Ifthisisacontinuation,it ’ shelpfultoreference thatthisprojectbuildsonapreviouslyfundedCPP project .
RFD – Section One Example : publishinanacademicjournal,share Generalizableknowledge : resultsareintendedto resultswithotherorganizations,presentata begeneralizedtoalargerpopulationbeyondthose nationalconference,prepareaninternalreport, involvedintheproject,orareintendedtobe etc . replicatedinothersettings .
RFD – Section Two Hereyoucanpullfromyour : Tier1 – methodologysection • Tiers2,3 – methodologyandevaluation • sections,projectobjectivestemplate
Example Typeofdata collectiontool Anonymous? Coded? Identifiable? Detailaroundwhat isbeingmeasured, how,andfrom who?
RFD – Section Two
RFD – Section Three If OHSU is not engaged in the project’s activities, data collection, or data analysis, sample language is provided on the template.
RFD – Section Four Selectthefirstboxunlessyourproject involvesgeneticresearch . Ifselecting thisbox,youcanskiptherestof sectionfourquestions .
RFD – Section Five Alistofthe18identifiersis providedontheRFD template .
RFD – Section Five Ifnoneoftheprovidedoptionsfit,select ‘ Other ’ anddescribe . Analystswillwanttoseedetailaround : • Accesstoprotectedhealthinformation ( PHI ) • Ifyouarewithahealthsystemorclinic,describewhether projectstaffhaveaccesstoPHIwithinregularscopeofclinical practice . Howwilldatacollectionforthisprojectbedifferent? • HowwillPHIbeusedspecificallyforthisproject ( identifying andrecruitingparticipants,trackingscreeningcompletion, etc . ) ?
Next Steps Ø CompleteRFDdraftforyourprojectandworkwithourteamtofinalize Ø OncesubmittedtotheIRB,twopossibleoutcomes : Ø No , your project is not considered human subjects research • NofurtherIRBactionneeded,unlessprojectdesignchanges Ø Yes , your project is considered human subjects research • SubmitadditionaldocumentsandinformationaboutprojecttotheIRB We will support your team through this multi-step process!
Thank You!

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