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INSTITUTIONAL REVIEW BOARD FOR HUMAN SUBJECTS RESEARCH
ShenandoahUniversityIRBChecklist Rev.1/2017
HUMANSUBJECTSRESEARCHPOLICY
ShenandoahUniversity'spolicyrequiresreviewandapprovalofallactivitiesthatinvolveusinghumansubjectsinresearch. The Institutional Review Board (IRB) is responsible to the Vice President for Academic Affairs.ApprovaloftheIRBmustbeobtainedpriortoinvolvementofhumansubjects.FailuretohavehumansubjectsresearchreviewedbytheIRB,includingthoseprotocolsbelievedtobeexempt,isaviolationofUniversitypolicyandwillbereportedtotheVicePresidentforAcademicAffairsfordisciplinaryaction.Allforms,linksandinformationregardingsubmittingaproposalcanbefoundontheSUIRBwebsite.____________________________________________________________________________________________________
SelectingYourReviewCategory:
IFYOURPROJECTMEETSALLOFTHEFOLLOWINGCRITERIA,YOUSHOULDSELECT“EXEMPT”REVIEW:❑ Researchconductedinestablishedorcommonlyacceptededucationalsettings❑ Researchinvolvingtheuseofeducationaltestsifsubjectscannotbeidentified❑ Researchinvolvingsurveys,interviews,orobservationsofpublicbehaviorthatdonotdealwithsensitive
orcriticalresponses.Allresearchusingsurveyorinterviewproceduresisexemptwhentherespondentsareelectedorappointedpublicofficialsorcandidatesforpublicoffice.
❑ Theprojectwillnotinvolvesubjectsinhighriskgroups(SeeFormA,Item11).❑ Researchinvolvingthecollectionorstudyofexistingdataorspecimensthatareeitherpubliclyavailable,
ornotindividuallyidentifiable.IFYOURPROJECTMEETSANYOFTHEFOLLOWINGCRITERIA,YOUSHOULDSELECT“EXPEDITED”REVIEW:
❑ Collection of hair, nail clippings, dental plaque and calculus, or teeth in a non-disfiguringmanner, or
secretions.❑ Recording of data from subjects 18 years of age or older using noninvasive procedures routinely
employedinclinicalpractice.❑ Collectionofsmall(≤550mlper8weeks,and≤2samplesperweek)amountsofbloodbyvenipuncture
fromhealthy,non-pregnantsubjects18yearsofageorolderandweighatleast110pounds.❑ Voicerecordingsmadeforresearchpurposessuchasinvestigationsofspeechdefects.❑ Moderateexercisebyhealthyvolunteers.❑ Studyofexistingdata,documents,records,pathologicalspecimens,ordiagnosticspecimens.❑ Researchonindividualorgroupbehaviorwheretheinvestigatordoesnotmanipulatesubjects'behavior
andtheresearchwillnotinvolvestresstosubjects.❑ Research on drugs or devices for which an investigational new drug exemption or an investigational
deviceexemptionisnotrequired.NOTE: IF YOURPROJECTDOESNOTMEETALLOF THECRITERIA FORANEXEMPTREVIEWORANYOFTHECRITERIAFOREXPEDITEDREVIEW,YOUMUSTSELECTFULLREVIEW.
INSTITUTIONAL REVIEW BOARD FOR HUMAN SUBJECTS RESEARCH
ShenandoahUniversityIRBChecklist Rev.1/2017
RequiredDocuments:
IFYOUSELECTEDANEXEMPTREVIEW,YOUMUSTSUBMITTHEFOLLOWINGITEMS:❑ FormA❑ FormB❑ FormE❑ Explanationofstudyforsubjects/researchproposal❑ Methodofconfidentialstorageofdataisfullydescribed❑ Informedconsentform(ifapplicable)❑ Appendices(surveys,questionnaires,ortests)(ifapplicable)❑ Consentforphotographicorvoicerecording(ifapplicable)❑ Letter of approval from each cooperating organization’s institutional review board or administrative
representative(ifapplicable)IFYOUSELECTEDEXPEDITEDORFULLREVIEW,YOUMUSTSUBMITTHEFOLLOWINGITEMS:❑ FormA❑ FormB❑ Informedconsentform❑ Methodofconfidentialstorageofdataisfullydescribed❑ Appendices(surveys,questionnaires,ortests)(ifapplicable)❑ Consentforphotographicorvoicerecording(ifapplicable)❑ Letter of approval from each cooperating organization’s institutional review board or administrative
representative(ifapplicable)❑ Electricalequipmentsafetycheckmemo(ifapplicable)____________________________________________________________________________________________________
CheckforCompleteness:
BEFOREYOUSUBMITYOURPROPOSAL,PLEASECHECKTHEFOLLOWINGITEMSFORCOMPLETENESS:❑ AllsignaturesareobtainedonFormEand/orFormA❑ Allcorrespondingdocumentation is included(requireddocuments listedabovewithintheappropriate
category,surveys,researchproposals,etc.)❑ Startdatewillallowsufficienttimeforreviewtobecompletedbeforeinvolvingsubjectsandendtime❑ Currentformsarebeingused(themostcurrentversionsarelocatedontheSUIRBwebsite)**NOTE:Iftherearemissingsignatures,documents,orinformation,yourIRBapplicationwillbereturnedto
youuntilallmissingitemsarereceived.Thiswilldelayyourapplicationprocess.
INSTITUTIONAL REVIEW BOARD FOR HUMAN SUBJECTS RESEARCH
ShenandoahUniversityIRBChecklist Rev.1/2017
EstimatedTimeframeForReview:
§ “Exempt”reviewsgenerallytakeatleast4-6weeks.§ “Expedited”reviewsgenerallytake6-8weeks.§ “FullBoard”reviewswillgenerallytakeanywherefrom8-10weeks.
The timeof review varies dependingon the complexity of the research and if any revisions are requested. Pleaseplanaccordingly.____________________________________________________________________________________________________
ITISVERYIMPORTANTTHATYOUALWAYSPROVIDEYOURPROTOCOLIDENTIFICATIONNUMBER
(ex.#12-1234)WHENCORRESPONDINGWITHTHECOMPLIANCECOORDINATOR.
INSTITUTIONAL REVIEW BOARD FOR HUMAN SUBJECTS RESEARCH
ShenandoahUniversityIRBChecklist Rev.1/2017
RESEARCHREVIEWPROCESSAllresearchinvolvinglivinghumansubjectsand/ortheirrecordsmustbereviewedandapprovedbytheSUIRBPRIORTObeginningresearch.Researchisclassifiedatthreelevelsofreview:exempt,expedited,andfull.Thefinaldeterminationofexemptvs.non-exemptisdeterminedbytheIRB.
EXPEDITEDREVIEW
ReviewedbytwoIRBmembers.
FULLREVIEW
ReviewedbyfullIRB.
EXEMPTREVIEW
ReviewedbyoneIRBmember.
PrincipalInvestigator(PI)preparesIRBproposalapplicationpacket.PIsendsapplicationpackettotheirsponsor/advisorforreviewandapproval.Receivessignaturesofadvisor/
sponsorandtheirdepartment/divisionchair.
PIsubmitsapplicationpackettoSU’sIRBonlineprotocolsubmissionsystem,AxiomMentor,forprocessing.Packetisreviewedandanyneededadditional
informationorclarificationisobtainedfrominvestigators.
ApprovallettersenttoPI.
AnnualReview
Revisions,ifnecessary,made
byPI.
ApprovallettersenttoPI.
Revisionsreturnedand
reviewedbyIRB.
ApprovallettersenttoPI.
AnnualReview
Revisions,ifnecessary,made
byPI.
ApprovallettersenttoPI.
Revisionsreturnedand
reviewedbyIRB.
ApprovallettersenttoPI.
AnnualReview
Revisions,ifnecessary,made
byPI.
ApprovallettersenttoPI.
Revisionsreturnedand
reviewedbyIRB.