selecting your review category · shenandoah university irb checklist rev. 1/2017 ... exempt vs....

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.



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.



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.



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.


Revisionsreturnedand

reviewedbyIRB.


AnnualReview


byPI.



reviewedbyIRB.


AnnualReview


byPI.



reviewedbyIRB.