SLIDE 1
Completing a Request for Determination Click here to listen to the - - PowerPoint PPT Presentation
Completing a Request for Determination Click here to listen to the - - PowerPoint PPT Presentation
Completing a Request for Determination Click here to listen to the recording. Password: Knightcpp1 Completing a Request for Determination Form PI ( PrincipalInvestigator ) : personwhois responsibleforoversightofprojectactivities,
SLIDE 2
SLIDE 3
Completing a Request for Determination Form
PI(PrincipalInvestigator): personwhois responsibleforoversightofprojectactivities, includingprotectionofhumansubjects (participants)
SLIDE 4
RFD – Section One
Hereyoucanpullfromproposalquestion1. Descriptioncanbebrief(3-5sentences). Ifthisisacontinuation,it’shelpfultoreference thatthisprojectbuildsonapreviouslyfundedCPP project.
SLIDE 5
SLIDE 6
RFD – Section One
Example: publishinanacademicjournal,share resultswithotherorganizations,presentata nationalconference,prepareaninternalreport, etc. Generalizableknowledge: resultsareintendedto begeneralizedtoalargerpopulationbeyondthose involvedintheproject,orareintendedtobe replicatedinothersettings.
SLIDE 7
RFD – Section Two
Hereyoucanpullfromyour:
- Tier1–methodologysection
- Tiers2,3–methodologyandevaluation
sections,projectobjectivestemplate
SLIDE 8
Example
Typeofdata collectiontool Anonymous? Coded? Identifiable? Detailaroundwhat isbeingmeasured, how,andfrom who?
SLIDE 9
RFD – Section Two
SLIDE 10
RFD – Section Three
If OHSU is not engaged in the project’s activities, data collection,
- r data analysis, sample language is provided on the template.
SLIDE 11
RFD – Section Four
Selectthefirstboxunlessyourproject
- involvesgeneticresearch. Ifselecting
thisbox,youcanskiptherestof sectionfourquestions.
SLIDE 12
RFD – Section Five
Alistofthe18identifiersis providedontheRFD template.
SLIDE 13
RFD – Section Five
Ifnoneoftheprovidedoptionsfit,select‘Other’ anddescribe. Analystswillwanttoseedetailaround:
- Accesstoprotectedhealthinformation(PHI)
- Ifyouarewithahealthsystemorclinic,describewhether
projectstaffhaveaccesstoPHIwithinregularscopeofclinical
- practice. Howwilldatacollectionforthisprojectbedifferent?
- HowwillPHIbeusedspecificallyforthisproject(identifying
andrecruitingparticipants,trackingscreeningcompletion, etc.)?
SLIDE 14
Next Steps
Ø CompleteRFDdraftforyourprojectandworkwithourteamtofinalize Ø OncesubmittedtotheIRB,twopossibleoutcomes: ØNo, your project is not considered human subjects research
- NofurtherIRBactionneeded,unlessprojectdesignchanges
ØYes, your project is considered human subjects research
- SubmitadditionaldocumentsandinformationaboutprojecttotheIRB
We will support your team through this multi-step process!
SLIDE 15