IRB ODDS & ENDSA DISCUSSION OF AN ASSORTMENT OF IRB TOPICS2015 IRB ANNUAL BOARD MEMBER TRAINING

IRB Administrators

GOALS FOR THIS PRESENTATION

Coverawiderangeofquestionswe’vereceivedthisyearfromboardmembers

Helpdirectyoutoresourcesavailableonline

Remindyouofimportantpoliciesandprocedures

Let’schat!

IRB SOPS AND GUIDANCE

What is a “Short Form Translation” and how is it used?

FDA GUIDANCE: NON-ENGLISH SPEAKING SUBJECTS

“Ifanon‐Englishspeakingsubjectisunexpectedlyencountered,investigatorswillnothaveawrittentranslationoftheconsentdocumentandmustrelyonoraltranslation.“Investigatorsshouldcarefullyconsidertheethical/legalramificationsofenrollingsubjectswhenalanguagebarrierexists.Ifthesubjectdoesnotclearlyunderstandtheinformationpresented,thesubject'sconsentwillnottrulybeinformedandmaynotbelegallyeffective.“IfinvestigatorsenrollsubjectswithoutanIRBapprovedwrittentranslation,a‘shortform’writtenconsentdocument,inalanguagethesubjectunderstands,shouldbeusedtodocumentthattheelementsofinformedconsentrequiredby21CFR50.25werepresentedorally.”

‐”AGuidetoInformedConsent”,FDA.gov

SHORT FORM CONSENT TRANSLATIONS

Q:Whenshouldtheshortformbeused?A:Weallowtheshortforminlimitedcircumstanceswhenafulltranslationisnotpractical,suchaswhenfundingistoolimited(e.g.non‐profitorcooperativegroupstudies),orwhenalargenumberofnon‐Englishspeakingparticipantsisnotanticipated.

Q:WhatwilltheIRBapplicationlooklikewhenashortformprocessisrequested?A:Lookfor1)atranslatedform,2)anEnglishversionoftheform,and3)aprocessdescriptionforuseoftheformonthe“ConsentProcessPage”oftheapplication.

SHORT FORM CONSENT TRANSLATIONS

Q:Whatistheprocessforobtainingconsentusingatranslatedshortform?A:

1. IntheeventthataparticipantdoesnotspeakEnglish,theoralpresentationwillbetranslatedwiththeuseofaninterpreter.

2. ThewrittensummaryoftheoralpresentationwillbetheIRBapprovedlongconsentdocument.3. Hospital‐based,professionaltranslationserviceswillbeprovidedtoallnon‐Englishspeakingstudy

participants.4. Consentwillbedocumentedusingashortform.5. Athird‐partywitnesswillbepresentduringtheoralpresentationandwillsignboththelongform

andtheshortform. ThewitnesswillbefluentinbothEnglishandSpanish.6. Thepersonobtainingconsentwillsignthelongform.7. Theparticipantwillsigntheshortform.8. TheparticipantwillreceiveacopyoftheconsentforminEnglishandthetranslatedshortform.

What are the rules for enrolling students and employees in studies?

BOARD MEMBER RESPONSIBILITIES

What are the responsibilities of secondary reviewers?

PRIMARY & SECONDARY REVIEWERS

IRBSOP202:“EachIRBmember’sprimarydutyistheprotectionoftherightsandwelfareoftheindividualhumanbeingswhoareservingasthesubjectsofthatresearch.”

IRBBoardMemberManual:“Aprimaryreviewerisassignedtoreviewtheprotocolandconsentprocess,andasecondaryreviewerisassignedtoreviewtheconsentprocessagainandinmoredetail.”

How do I update my board member profile in ERICA to show what

vulnerable populations I can represent?

VULNERABLE POPULATIONS REPRESENTATION

Amembershouldhaveextensive background,education,orexperiencewiththepopulation. Thismayinclude:

Adirectaffiliationtothepopulation

Workorlifeexperiencewiththepopulation

Researchexperiencewiththepopulation

Holdingacertificationorlicensurethatpermitsthetreatment,counseling,orotherdirectrelationshipwiththepopulation

VULNERABLE POPULATIONS REPRESENTATIONWiththistypeofbackground,amemberwouldhavemeaningfulexperienceaddressing,understanding,orworkingwithintheparametersofthepopulation’sspecificvulnerability. Children/Neonatesarevulnerablebecausetheylackfullmaturityandpsychologicalcapacitytoprotecttheirowninterests.

Cognitively‐impairedadultsarevulnerablebecausetheylackthefullpsychologicalcapacitytoprotecttheirowninterests.

Fetusesarevulnerablebecausetheyaresubjecttotheenvironmentoftheirmothers,whichmaynotbeconducivetoprotectionofthefetuses’interests.

Prisonersarevulnerablebecausetheylacksomesocialandlegalrightstoactforthemselvestoprotecttheirowninterests. Additionally,theyaresubjecttotheauthorityofothersformuchoftheiractionandbehavior,thusincreasingtheirvulnerabilitytocoercion.

Economicallyoreducationallydisadvantagedpersonarevulnerablebecausetheymaylackthesocial,financial,andeducationalresources,increasingtheirvulnerabilitytocoercion.

How specific should my “Approve with Changes” revisions be so

an IRB Chair can sign-off?

DEFINITIONS

What is the difference between Privacy and Confidentiality?

What is the difference between compensation and reimbursement?

What is the new definition of “Serious Non-Compliance”? How is it

different from the old definition?

OLD VS. NEWFORMER

SeriousNon‐Complianceis“anactoromissiontoactthatresultedinincreasedphysical,psychological,safety,orprivacyriskthatcompromisedtherightsandwelfareofresearchparticipants.”

SeriousNon‐Complianceis“anactoromissiontoactthatresultedsignificantharminincreased (physical,psychological,safety,orprivacy)orsignificantlyincreasedthepossibilityofharmriskthatcompromised to therightsandwelfareofresearchparticipants.”

UPDATED

SeriousNon‐Compliance is“anactoromissiontoactthatresultedinsignificant harm(physical,psychological,safety,orprivacy)orsignificantlyincreasedthepossibilityofharmtotherightsandwelfareofresearchparticipants.”

How have we changed how we review new risks in IBs as they relate to

UP determinations?

TheIRBdefinesanUnanticipatedProblem(UP)asfollows:

Anyincident,experience,oroutcome thatmeetsallofthefollowingcriteria:

1. Unexpected (unforeseenbytheresearcherortheresearchparticipant)intermsofnature,severity,orfrequency,giventheresearchproceduresandthesubjectpopulationbeingstudied;and

2. Relatedorprobablyrelatedtoparticipationintheresearch,oriftheeventorproblemprobablyordefinitelyaffectsthesafety,rightsandwelfareofcurrentparticipants;and

3. Suggeststhattheresearchplacessubjectsorothersatagreaterriskofharm(includingphysical,psychological,economicorsocialharm)thanwaspreviouslyknownorrecognized.

IB updated with meta-analysis from several sites/studies ≠ UP

THE FDA

What is a combination device? How can I tell if a study has one?

The study I’m reviewing includes a Humanitarian Use Device (HUD).

How should I review this? Is it research?

HUMANITARIAN USE DEVICES (HUD)AnHumanitarianUseDevice(HUD)isadevicethatisintendedtobenefitpatientsbytreatingordiagnosingadiseaseorconditionthataffectsorismanifestedinfewerthan4,000individualsintheUnitedStatesperyear.

ToobtainapprovalforanHUD,anhumanitariandeviceexemption(HDE)applicationissubmittedtoFDA.

AnHDEissimilarinbothformandcontenttoapremarketapproval(PMA)application,butisexemptfromtheeffectivenessrequirementsofaPMA.AnHDEapplicationisnotrequiredtocontaintheresultsofscientificallyvalidclinicalinvestigationsdemonstratingthatthedeviceiseffectiveforitsintendedpurpose.

Theapplication,however,mustcontainsufficientinformationforFDAtodeterminethatthedevicedoesnotposeanunreasonableorsignificantriskofillnessorinjury,andthattheprobablebenefittohealthoutweighstheriskofinjuryorillnessfromitsuse,takingintoaccounttheprobablerisksandbenefitsofcurrentlyavailabledevicesoralternativeformsoftreatment.

ANCILLARY COMMITTEES

How many ancillary committees are there? What do they review?

ANCILLARY COMMITTEES

IRB

HCI PRMC

RDRC

RGE (UPDB)

CoI

IBCPCH

Privacy Board

VA

CCTS

OSP

uTRAC

TheUniversityHumanResearchProtectionProgram(HRPP)includesseveralcommitteesthatspecializeinregulatingaspecificaspectofhumansubjectresearch.

AlloftheancillarycommitteesareautomatedinERICAtosomedegree.

TheIRBisthelaststopofthisreviewprocess.

ANCILLARY COMMITTEES

HCI PRMC

“HuntsmanCancerInstituteProjectReview&MonitoringCommittee”(formerlytheCCIC)

ThePRMCwasestablishedtoprovidescientificreviewforallcancertrialsasrequiredby(NCI)CancerCenterSupportGrant(CCSG)guidelines.

AllclinicaltrialsattheUniversityofUtahthatinvolvecancerpatientsorsubjectsatriskforcancer(screeningorpreventionstudies)mustundergoaninitialreviewbythePRMC.

Tworeviewerswithnoinvolvementinthetrialunderreview,abiostatistician,aresearchpharmacist,aresearchnurse,andapatientadvocateprovidewrittenreviews.

ANCILLARY COMMITTEES

RDRC-HUS

“RadiologicalDrugResearchCommittee&HumanUseSubcommittee”

TheRDRCisrequiredtoevaluateandtoapproveordisapproveallresearchanddevelopmentalusesofradioisotopesonorinhumans.

AsrequiredbyUtahDivisionofRadiationControl,theHUSevaluatesandapprovesordisapprovesallproposedusesofionizingradiationsourcesonorinhumansforinvestigationalornon‐routineclinicalprocedures.

ANCILLARY COMMITTEES

RGE

“UtahResourceforGenetic&EpidemiologicResearch”

TheRGEwasestablishedbyExecutiveOrderoftheGovernorofUtahonJuly14,1982,asa“dataresourceforthecollection,storage,study,anddisseminationofmedicalandrelatedinformation”for“thepurposeofreducingmorbidityormortality,orforthepurposeofevaluatingandimprovingthequalityofhospitalandmedicalcare.”RGEgovernsaccesstothe UtahPopulationDatabase(UPDB),whichincludesfamilyhistoryrecords,vitalrecords,cancerregistryrecords,driverlicenserecords,andothers.Theserecordsarelinkedtogethertoformmulti‐generationalpedigreesaswellaslongitudinalperson‐leveldata.

ANCILLARY COMMITTEES

CoI

“ConflictofInterest”The CoIOffice supportstheUniversitycommunityinidentifyingandmanagingfinancialconflictsofinterestinthreeareas:ResearchandScholarlyActivitiesProcurementIntellectualProperty

CoIworkswithfaculty,staff,postdoctoralfellows,studentsandotherswhoarerequiredtodiscloseexternalfinancialintereststotheUniversityforevaluation.TheyalsoworkwiththeIndividualConflictofInterestCommittee toreviewandmanagefinancialintereststhatcreateconflictsofinterest.

ANCILLARY COMMITTEES

IBC

“InstitutionalBiosafetyCommittee”AnIBCisrequiredatinstitutionsthatreceivefundingfromtheNationalInstitutesofHealth(NIH)forresearchinvolvingrecombinantorsyntheticnucleicacidmolecules.Allnon‐exemptrecombinantDNAandsyntheticnucleicacidresearchattheU,regardlessoffundingsource,mustbeconductedinaccordancewiththe NIHGuidelinesforResearchInvolvingRecombinantorSyntheticNucleicAcidMolecules andmustberegisteredwiththeIBC.AttheU,asatmanyotherinstitutions,theIBCalsohastheresponsibilityofreviewingavarietyofexperimentationthatinvolvesbiologicalmaterials,suchasriskgroup(RG)2orhigherpathogens,andotherpotentiallyhazardousagents,suchasbiologicaltoxins.

ANCILLARY COMMITTEES

PCH

“PrimaryChildren’sHospital”PrivacyBoard

ThePCHPrivacyBoardreviewsresearchthatincludesPCHasastudysitetoensurethatthestudy: AlignswithPrimaryChildren'sMission,Vision

andValues ReceivesapprovalfromthePrimaryChildren's

resourcesimpacted(e.g.: lab,radiology,infantunit,etc.);and

IdentifiesPrimaryChildren'sstudyrelatedchargesfromstandardofcarecharges

ANCILLARY COMMITTEES

CCTS

“CenterforClinical&TranslationalScience”CCTSbuildsontheUniversity'sstrengthsingeneticsandbioinformaticstotranslatepromisingbenchscienceintopracticesthatimprovehumanhealth.TheCenterservesasanacademichomeforclinicalandtranslationalresearch,developinginnovativehealthservicesforthecommunityandhealthresearchers,andtraininganewgenerationofclinicalandtranslationalinvestigators.The ClinicalServicesCore(CSC),locatedonthefifthflooroftheUofUMedicalCenter,servesastheCCTSvenueforinpatientandoutpatienthumansubjectsstudies.Studiesarereviewedby,andmustbeapprovedbyboththeIRBandtheCCTSbeforetheymaybegin.Inadditiontohumansubjectsafetyandrisk,theCCTSevaluatesandscoresprotocolsonscientificmerit,feasibility,statisticalrigor,likelyacademicbenefittotheinstitutionandinvestigator,andutilizationofCCTSresources.

ANCILLARY COMMITTEES

OSP

“OfficeofSponsoredProjects”

OSPisresponsibleforpreparing,interpreting,negotiating,andexecutingagreementsonbehalfoftheUforprojectsfundedbyfederalandstateagencies,foundations,andotherpublicandprivatesources.

Theyalsodraft,negotiate,andexecuteawardsandsubawards forcollaborativeresearch.

ANCILLARY COMMITTEES

TVC

“Technology&VentureCommercializationOffice”(formerly

TCO)

TCOisdedicatedtocommercializingnewtechnologiesandinventionsfromdiscoveriesmadeanddevelopedattheUniversityofUtah.

Theyapplyastage‐gated,milestone‐drivenprocessthathasasanend‐goaloflicensingintellectualproperty,buildingbeneficialcommercialpartnerships,supportingourcommunityandeducatingstudents.

ANCILLARY COMMITTEES

VA

“Veteran’sAffairs”(SaltLakeCityHealthCareSystem)

TheVAResearch&DevelopmentprogramseekstoimprovethelivesofVeteransandallAmericansthroughhealthcarediscoveryandinnovation.

SLCVAR&DpersonnelreviewVAresearchproposalstoensureVArequirementsaremet.

ANCILLARY COMMITTEES

uTRAC

“UniversityTrackingofClinicalResearch”uTRAC servestoassistresearcherswithcreatingaprotocolbillinggridandbudgetfortheirproject.Ifstudiesintendtobillinsuranceforanystudy‐relatedprocedures,aMedicareCoverageAnalysis(MCA)mustbeperformedinuTRAC.AllclinicalresearchstudiesarerequiredtouseuTRAC.Astudyisclinicalifitinvolvesoneormoreprospectiveclinical procedures,services,orotheritems.Byinstitutionalpolicy,noexceptionscanbemadetothisrule.