Preparing IRB Submissions for Human Subjects Research · Preparing IRB Submissions for Human...
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Preparing IRB Submissions for Human Subjects Research Tips for Preparing IRB Protocols IRB Educational Session-Psychological Sciences September 15, 2017 Post Approval Monitor-Joan Levine, MPH, CIP Research Compliance Services
Transcript of Preparing IRB Submissions for Human Subjects Research · Preparing IRB Submissions for Human...
Preparing IRB Submissions for Human Subjects
Research Tips for Preparing IRB Protocols
IRB Educat ional Sess ion-Psycholog ica l Sc iences
September 15, 2017 Pos t Approva l Mon i to r -Joan Lev ine , MPH, C IP
Research Compliance Services
research.uconn.edu
Objectives YouarereadytobeginthesubmissionprocesstotheIRB-whatdo
Ineedtoknow?• Describeandgiveexamplesofthe3levelsofIRBreview.• DiscusstheprocessforsubmiBngaprotocoltotheIRBusing
theweb-basedapplicaConsystem-InfoEd.• Protocolsubmissionprocess;FormsandlocaCons.infoed.uconn.edu/&InfoEdHowtoGuides• CommonpiMallswhencompleCngforms/submiBngtoIRB.
TipsforcompleCngasubmission.
DRAFT
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Is your study human subjects research? a. Isitresearch?• ResearchmeansasystemaCcinvesCgaCon,includingresearchdevelopment,
tesCngandevaluaCon,designedtodeveloporcontributetogeneralizableknowledge.AcCviCeswhichmeetthisdefiniConconsCtuteresearchforpurposesofthispolicy,whetherornottheyareconductedorsupportedunderaprogramwhichisconsideredresearchforotherpurposes.Forexample,somedemonstraConandserviceprogramsmayincluderesearchacCviCes.
b. Isithumansubjectsresearch?
• HumansubjectmeansalivingindividualaboutwhomaninvesCgator(whetherprofessionalorstudent)conducCngresearchobtains
(1) DatathroughintervenConorinteracConwiththeindividual,or(2) IdenCfiableprivateinformaCon.IfyestobothAandB,thenyouwillneedtosubmityourresearchtotheIRB.
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CITI Training CollaboraCveInsCtuConalTrainingIniCaCve(CITI)Theweb-basedtrainingmodulesinCITIprovidebasiceducaCononthehistoryandethicalprinciplesofresearch.Allresearchers,includingstudentswhoareworkingonthestudyandareconsidered“keypersonnel”mustcompletetheonline"CITITraining”coursefortheprotecConofhumanparCcipantsinresearchBEFOREtheIRBwillapproveastudy.Researchpersonnelmustrenewtheirtrainingeverythreeyears.KeypersonnelonstudiesconsideredtobeclinicaltrialsmustalsotakeGoodClinicalPracCcetraining.Also,availablefromCITI.
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Additional Training for NIH/NSF Research
TheNaConalScienceFoundaCon(NSF)requirestheresponsibleconductofresearch(RCR)trainingforallundergraduates,graduates,andpost-doctoralfellowswhoconductresearchsupportedbyNSFfunds.TheNaConalInsCtutesofHealth(NIH)requiresthatalltrainees,fellows,parCcipants,andscholarsreceivingsupportthroughanyNIHtraining,careerdevelopmentaward(individualorinsCtuConal),researcheducaCongrant,ordissertaConresearchgrantmustreceiveRCRtraining.Thisrequirementalsoappliestoallfaculty,includingnewfaculty,mid-careerfacultyandseniorfaculty,andprofessionalandscienCficemployeesreceivingfundingfromthesesources.PIsareresponsibleforensuringthateachundergraduatestudent,graduatestudentandpostdoctoralresearcherwhoparCcipatesintheirNSForNIHfundedresearchcompletesthetrainingduringthecourseoftheirparCcipaConintheproject.TheseRCRmodulescanbeaccessedthroughtheCITItrainingprogram.
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InfoEd InfoEdisthewebbasedapplicaConsystemusedtodevelopandsubmitresearchprotocolstotheIRB.InfoEdsessionsareofferedonaregularbasis.TheIRBstronglyencouragesallresearcherstoa`endasessionpriortosubmiBngaprotocol.StudentshaveaccesstoallfeaturesintheInfoEdsubmissionsystem.However,afacultymentormustbelistedasthePrincipalInvesCgatorofthestudy.ThePIisulCmatelyresponsibleforensuringprotecConofhumanparCcipants.Tips:Beforeclickingsubmit,allstudiesthatareunfundedmustberoutedtothedepartmentheadandPIforsignoff.Forfundedstudies,rouCngmustgotothePI.IfyouareunsurewhoyourDepartmentHeadis,pleasecontactRCS.TherearesomeDHswhodelegatethistasktoothers.Don’tforgettoclick“submit”!!
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The Common Rule OfficeforHumanResearchProtecCons(OHRP)-The“CommonRule”isthefederalpolicyfortheprotecConofhumansubjectsinresearch.Itwasfirstpublishedin1991andknownas45CFR46.TheCommonRuledescribesthedetailoftheIRBoperaConsandthetypesofresearchthataresubjecttoregulaCon.Thereare4subpartsforaddiConalprotecConsforpregnantwomen,humanfetuses,andneonates,prisoners,andchildren.UConnrequiresaddiConalprotecConsforstudentswhotakepartinresearch.ChangestotheregulaConshavebeenapprovedbythepreviousadministraCon.However,thechangesarepresentlyinreviewbythecurrentadministraCon.
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Level of IRB Review Whatlevelofreviewismystudy?
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Level of Review cont. 1. Exemptresearchisconsidered“lessthanminimalrisk”andfitsinto
oneofsixcategories.MostoftheresearchhereatUConnfallsunderCategory2:anonymoussurveyresearch.TheseapplicaConsareacceptedonaconCnualbasis.TheIRBChairordesigneereviewsandapproves.IRB-5ApplicaConandProtocol
Examples:anonymoussurveyscollectedthroughQualtrics/SurveyMonkey-manystudiesuseMechanicalTurk,orthePsychologyParCcipantPooltocollectdata.ThedataarenotlinkedtoanyidenCfiers.2. Expeditedstudiesinvolvenogreaterthanminimalriskandfitinto
oneof9categories.IRB-1ApplicaConandProtocolExamples:SurveyresearchwithidenCfiabledata,focusgroups,collecConofdatathroughnon-invasiveproceduresormeans(MRI,EEG,buccalswab),secondarydataanalysesofidenCfiabledatasets.OneIRBmemberreviewsthisresearch.Typically,anIRBmemberwillreviewprotocolsatleastonceperweek.
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Level of Review cont. 3. Fullcommi`eeresearchisconsideredtobemorethanminimalrisk.
Thesestudiesincluderesearchthatinvolvesphysicalorpsychologicalrisks,orthecollecConofidenCfiabledataconsideredtobesensiCveinnature.ThefullboardreviewsthesestudiesatafullyconvenedmeeCng.MeeCngsonceevery3weeks.DatesarelistedontheIRBweb-site.Theseprotocolsaredue3weekspriortotheIRBmeeCngdate.ThisprovidesCmeforaRCSmembertopre-reviewthestudytoensureallofthedocumentshavebeensubmi`ed,andfortheIRBmemberstoreadthroughandbepreparedfordiscussionduringthemeeCng.
IRB-1ApplicaConandProtocolExamples:researchwithdrugs/supplements,biologics,manydevicesprotocols,researchthatincludespsychological,physical,orlegalrisk.AtCmes,researchersareinvitedtotheIRBmeeCngtoclarifyprocedures.*CallRCSpriortosubmiBngyourprotocoltoensurethatyouaresubmiBngunderthecorrectcategoryandhaveallnecessaryformscompleted.CommonFinding-protocolssubmi7edunderincorrectcategory-exemptvs.expedited
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IRB Criteria for Approval 45 CFR 46 1. Riskstosubjectsareminimized2. RiskstosubjectsarereasonableinrelaContoanCcipatedbenefits,ifany,to
subjects,andtheimportanceoftheknowledgethatmayreasonablybeexpectedtoresult.
3. SelecConofsubjectsisequitable.4. InformedconsentwillbesoughtfromeachprospecCvesubjectorthesubject's
legallyauthorizedrepresentaCve,inaccordancewith,andtotheextentrequiredby§46.116
5. Informedconsentwillbeappropriatelydocumented,inaccordancewith,andtotheextentrequiredby§46.117
6. Whenappropriate,theresearchplanmakesadequateprovisionformonitoringthedatacollectedtoensurethesafetyofsubjects.
7. Whenappropriate,thereareadequateprovisionstoprotecttheprivacyofsubjectsandtomaintaintheconfidenCalityofdata.
8. Whensomeorallofthesubjectsarelikelytobevulnerabletocoercionorundueinfluence,suchaschildren,prisoners,pregnantwomen,mentallydisabledpersons,oreconomicallyoreducaConallydisadvantagedpersons,addiConalsafeguardshavebeenincludedinthestudytoprotecttherightsandwelfareofthesesubjects.
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Forms
• CompletetheIRB-1orIRB-5(ifExempt)electronicapplicaConinInfoEd.
• CompletethecorrespondingIRB-1orIRB-5StudyProtocolanduploadtoInfoed
• IncludeanAppendixAform(personnelform)ifyouhaveaddiConal“keypersonnel”thatwillbeworkingonyourstudy.EachpersonlistedonAppendixAmustcompletetherequiredCITIcoursespriortoIRBapproval.Ifapersonhasnotcompletedthetraining,thiswillholdupIRBapproval.CommonFinding-personnelhavenotcompletedCITI
• Pleasebesurethattheprotocolsandotherforms,suchastheconsentform,parentalpermissionform,informaConsheet,etc.,arethemostrecentlyupdatedformsthatareontheIRBweb-site.Sugges?on:createfolderonyourcomputerwithallnecessaryforms.Whencomplete,uploadtoInfoEd.
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Forms Cont.
• InyourIRB-1orIRB-5ApplicaConorProtocol,pleasebesuretoprovidearesponsetoeachquesCon.
• TheIRBreliesontheinvesCgatortoprovidenecessaryinformaCon.• Whenreadytosubmityourprotocol,pleasecheckfor
completenessandaccuracy.• Itmaybehelpfulforsomeonetoproofreadtheconsentform.Are
theproceduresclear?IfIwereaparCcipant,wouldIunderstandtheresearch,howthedataarestoredinaconfidenCalmanner,thecompensaCon,whotocontact?
• Useanappropriatereadinglevelintheconsentform.• Avoidjargon.Iftheproposalcan’tbeeasilyunderstood,thenthe
IRBcan’tadequatelyassesstherequiredelements.Sameforconsent.
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Common Findings During Initial Review • Screeningproceduresarenotclearlydefinedinprotocol.• Considerscreening,ifpossiblepriortoconsent.Ifdoingso,
completethewaiverquesConsintheconsentsecConforscreening.CommonFinding:notcomple?ngthewaiverques?ons
• InconsistenciesbetweenIRBprotocolandconsentform-incenCves,privacy/confidenCality,procedures.
• RecordretenCon-notconsistentwithregulaCons(3yearsaserstudycompleCon).
• Studymeasures-inconsistencybetweenwhatissubmi`ed,whatisincludedintheprotocol,andwhatisdescribedintheconsentform.
• Eligibilitynotclearlydefined-ormissingcomponents.Forex:notexcludingpeoplewithcertaincondi?ons.Forex:ifMRI-mustexcludethosewithmetalinbody,etc.
• MoredetaileddescripConofproceduresneededintheICF.• **Forge@ngtoclickonsubmit!!!
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Tips when Preparing Protocols
RecruitmentmethodsAreyouusingrecruitmentmaterial(flyers,Ads,emails,le`ers)?Ifyes,mustincludethefollowing:Ø Astatementthatincludes“research”Ø TitleØ PurposeØ Majorprocedures.Whatistested?LengthofCmetocomplete.Ø Majorinclusion/exclusioncriteria.Ø Benefits.Ø CompensaCon.Ø LocaCon,contactinformaConofSIandPI,Department.Ø Noboldstatements,orcompensaConinCAPS.
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Preparing Protocols cont. • Whenusingacronyms,pleasespellthemoutfirst.Also,provide
clarificaConwhereneededwhenusingscienCficterminology.• Howarethedatamaintained?UITSguidelines-DataSecurity
AssessmentForm?• ArethereaddiConalregulaConstoconsider-FERPA,FDA?Are
thereotherinsCtuConsinvolvedintheresearch?• ReviewpracCcalguidanceintheResearcher’sGuidesecCon.
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Other Regulations to Consider ConsideraConsforenrollingcollegestudents:• FERPAconsideraCons-DefiniCon:TheFamilyEducaConalRightsandPrivacyAct(FERPA)(20U.S.C.§1232g;34CFRPart99)isaFederallawthatprotectstheprivacyofstudenteducaConrecords.FERPArestrictsresearchers’accesstostudentrecordswithoutwri`enpermissionfromparents.However,withinFERPA[20U.S.C.1232g(b)(1)(F)],therearecondiConsunderwhichstudentrecordscanbedisclosedwithoutparentalconsent:“OrganizaConsconducCngcertainstudiesfororonbehalfoftheschool”.InvesCgatorsmustcontacteachinsCtuConandfollowthatinsCtuCon’sFERPApolicy,inaddiContotherequirementsofUConnIRB.Finally,ProtecConofPupilRightsAmendment(PPRA)outlines8categoriesofprotectedinformaConforsurveyresponsesandrequiresthatparentsbeaffordedtherighttoinspectsurveysbeforetheyaregiventostudents(formoreinformaCononFERPAandPPRA,seethelinkattheendofthissecCon).**ContactthePrivacyOfficeratUConnifyouplanonobtainingeducaConaldatafromstudentsatUConnorotherschools.RachelKrinsky-Rudnickrachel.krinsky@uconn.edu
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Research in Other Countries • ResearchconductedinforeigncountriesremainsunderUConn
purviewandguidelines.Adjustmentsmaybemadetorespectculturaldifferences,butstandardsfortheprotecConofhumansubjectsinresearcharenotrelaxed.
• TheIRBmayrequiretheresearchstudytobeapprovedbythelocalequivalentboardorgroup,withsubmissionofdocumentaConofapproval.
• TheIRBmayseekguidancefromtheOfficeforHumanResearchProtecConsInternaConalCompilaConofHumanSubjectsProtecConsormaycontactOHRPtodeterminewhetherproceduresbyforeigninsCtuConaffordequivalentprotecConstoU.S.regulaCons.
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Research with Other Institutions
• IfyourresearchwilltakeplaceatanotherinsCtuCon/facility,pleaseincludeinformaConthatwillbeinformaCveandhelpfulfortheIRBreviewer.
• AgreementswithConnecCcutChildren’sMedicalCenter(CCMC),
HarMordHospital(HH),andUConnHealth(UCH).**CallIRBfirst-thismaysaveyouaconsiderableamountofCmewhencompleCngyoursubmission.
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Informed Consent Howisconsentgoingtobeaddressedinyourstudy?UConnRCShastemplatesonweb-sitefortheInformedConsentForm,InformaConSheet,&ParentalPermissionForm.Thereisrequiredlanguageineach.• Signedconsent• InformaConSheet-nosignature.Thisrequiresa“WaiverofSigned
Consent”(mustmeet4criteria).• ParentalPermissionForm-minorscannotprovideconsent.This
formissignedbytheparent/softhechild.TheIRBwilldetermineifthechildalsosigns(assents)thisform.AgefactorsintothisdeterminaCon.
• Minors-aseparateassentform(nosignature)• “Waiverofconsent”-IRBdeterminesawaiverundercertain
circumstances(screening).
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Informed Consent Cont.
• Haveyoubeentrainedonhowtoadministerconsent?• Howisprivacyaddressedduringtheconsentprocess(referringto
theindividual-notdata)?• Whatsafeguardsareinplaceifyouareenrollingvulnerable
populaCons?Howareyougoingtoassentminors?• AlthoughtheregulaConsdonotrequireconsentinresearchthatis
Exempt,UConnpolicyistoprovideparCcipantswithanInformaConSheet.
*CalltheIRBofficeforguidancebeforeyousubmityourprotocol.
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Time Frames for Review
Ø ForExemptReview,allow2-3weeksfortheIRBtotakeaniniCallookattheprotocol.TheIRBChairdelegatedIRBstafftoassumethereviewresponsibility.
Ø ForExpeditedReview,allow3-4weeksfortheIRBtotakeaniniCallookattheprotocol.IRBstaffconductanadministraCvereviewfollowedbyanIRBmemberwhoconductsascienCficreview.
Ø ForFullBoardReview,allow3weeksastheIRBmeeCngstakeplaceeverythreeweeksduringmuchoftheyear.IRBstaffconductanadministraCvereviewfollowedbyanIRBmemberwhoservesasprimaryreviewer.ThefullIRBalsoreviewstheprotocol.
Ø Overall,theIRBadvisesthatresearchersallowforanapproximate4weekapprovalprocess.
Ø NotethattheseCmeframesareapproximateanddependupontheCmeofyear.ProtocolsarereviewedintheorderinwhichtheIRBreceivesthem.
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Common Rule-Not Official*** • Issuedin1991• ChangesincludefocusofIRBreviewonhigherriskresearch,lessonlowerrisk
procedures.• EffecCvedate:January19,2018• KeychangesthatinfluenceSBER:-Changestoconsent-informaConmustbepresentedtofacilitatesubjectunderstandingofwhyorwhynottoparCcipate.Couldbedetailedinasummaryintheform-ConCnuingreviewnotrequiredifExpedited,“LimitedReview(new)”,oropenfordataanalysesand/oraccessingfollow-upclinicaldataincertaincircumstances.-EstablishesnewExemptcategoriesbasedonlevelofrisk-now8categories-benignbehavioralintervenCons,storage,maintenance,&useofsecondaryuseofidenCfiableprivateinformaCon&idenCfiablebiospecimens-where“broadconsent(prospecCveconsenttounspecifiedfutureresearch)”isobtained-U.S.insCtuConengagedin“cooperaCveresearch”–singleIRBreview-researchintheU.S.-compliancedate2020,similartoNIHpolicy
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Links/Resources 1. HumanSujectsRegulaCons-OfficeforHumanResearchProtecCons(OHRP)45CFR46:
h`ps://www.hhs.gov/ohrp/regulaCons-and-policy/regulaCons/45-cfr-46/index.html2. LinktoIRBhelpsessions,InfoEdsessions,IACUCCtraining,IRBformsworkshops&other
relatedIRBevents:h`p://research.uconn.edu/news/upcoming-events/
3. InfoEd“howtoguides”:h`p://research.uconn.edu/irb/esubmissions/4. IRBweb-site:h`p://research.uconn.edu/irb/5. UConnIRBCITIprogramhowtopage:h`p://research.uconn.edu/irb/ciC-training/
6. ReviewtheresourcesUConnprovidestosecuredata.h`p://research.uconn.edu/irb/researcher-guide/computer-and-internet-based-research-involving-human-parCcpants/
7. RevisionstotheCommonRule:h`ps://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf
8. FERPAUConn:h`p://ferpa.uconn.edu/
9. InfoEdSupport:PleaseemaileRA-support@uconn.eduorcall860-486-7944tobeconnectedtoamemberoftheeRAHelpdesksupportteam.ThehelpdesklineisstaffedMonday-Friday(exceptholidays)from8:30AM–4:00PM.
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IRB Office DougBradway,M.A.,CIP,[email protected]
JerryMcMurray,[email protected]
JoanLevine,MPH,[email protected]
DanaWine,[email protected]
PamelaErickson,Ph.D.,IRBChair,[email protected]
