Bethune-CookmanUniversityInstitutionalReviewBoard
Policies and Proceduresfor ProtectingHumanSubjects fromResearchRisks
I.Introduction
Bethune-CookmanUniversity(B-CU)requiresthatallprogramsandgrantproposalsinvolvingHumanSubjectResearchbepresentedtoB-CU'sInstitutionalReviewBoard(IRB),unlessotherwiseexemptunderthesepolicies.ApprovalfromtheIRBmustbeobtainedpriortoinitiatingaResearchprojectinvolvingHumanSubjects,regardlessofwhethersuchprojectispartofaclassorclassrequirement.Failure to seekIRBapproval priorto conducting Human SubjectResearch isaviolation of federallaw and B-CU policy.
II.Purpose
ThepurposeofthisdocumentistoassistallB-CUfaculty,staff,students,andadministrators,oranyotherpartiesperformingResearchinconjunctionwithBCUB-CUinthepreparationandsubmissionof Researchproposals involvingHumanSubjectsfor review bytheIRB.
III.Definitions
Assurance:AdocumentnegotiatedbetweentheIRBandanInvestigator(or,whenfiledwithafederalagency,withtheinstitutionandsuchagency)thatstatesthattheResearchwillcomplywithallrequirementsregardingthe protection ofHuman Subjects.
Benefit: A valued or desiredoutcome.
ClinicalInvestigation:AnyExperimentthatinvolvesaTestArticleandHumanSubjects,theresultsofwhichareintendedtobesubmittedtotheFoodandDrugAdministration(FDA)aspartofanapplicationforresearch or marketingpermit. [21 CFR50.3(c)]
Experiment:Anyuseofadrugorchemical(includingthosecontainedinfoodproducts)otherthantheuseofa marketed(FDA approved) drugin the course of medicalpractice.
HumanSubject:AlivingindividualaboutwhomanInvestigator(whetheraprofessionalorstudent)conductingResearchobtains:(1)datathroughInterventionorInteractionwiththeindividual;(2)PrivateInformation;or(3)whoparticipatesinResearchastherecipientofaTestArticleorasacontrol. [45 CFR46.102(f) and 21 CFR 50.3(g)]
HumanSubject Research: ResearchthatinvolvesHumanSubjects.
IndividuallyIdentifiable:WheretheidentityoftheHumanSubjectisormayreadilybe(1)ascertainedbytheInvestigator;or (2)associated with the information. [45CFR46.102(f)]
InstitutionalOfficial(IO):TheIOistheuniversityofficialresponsibleforensuringthattheIRBhastheresourcesandsupportnecessarytocomplywithfederalregulationsandguidelinesthatgovernHumanSubjectsResearch.TheIOislegallyauthorizedtorepresenttheinstitution,shallsignoffonallAssurances,andassumestheobligationofanyAssurancesBCUB-CUfileswithafederalagency.TheIOisthepointofcontactforcorrespondencewhichaddressesHumanSubjectResearchfromanyfederalagency,includingbutnotlimitedtotheOfficeofHumanResearchProtections(OHRP)andtheFDA.TheIOshallbethePresidentofBCUB-CUorsuchdesigneeasthePresidentsoselects.
InstitutionalReviewBoard(IRB):AnadministrativebodythatmeetsthedefinitionofthistermassetforthintheDepartmentofHealthandHumanServicesRegulationsandthatisestablishedinaccordwithandforthepurposesexpressedinsuchregulationsorthatapprovesandconductstheperiodicreviewofResearchinvolvingHumanSubjectsperformedattheinstitutionassociatedwiththeIRBorother parties usingtheIRB. [45 CFR46.102(g), 21 CFR 56.102(g)]
Interaction:CommunicationorinterpersonalcontractbetweenanInvestigatorandHumanSubject.[45 CFR46.102(f)]
Intervention:Physicalproceduresbywhichdataaregatheredand/orthemanipulationofaHumanSubject'senvironment forthe purpose ofresearch.[45 CFR46.102(f)]
Investigator: Aperson (whether aprofessional ora student) who conducts Research.
MinimalRisk:ARiskisMinimalwheretheprobabilityandmagnitudeofharmordiscomfortanticipatedintheResearcharenotgreater,inandofthemselves,thanthoseordinarilyencounteredindailylifeorduringtheperformanceofroutinephysicalorpsychologicalexaminationsortests.[45CFR46.102(i)]
PrivateInformation:IndividuallyIdentifiableinformationaboutbehaviorthatoccursinacontextinwhichanindividualcanreasonablyexpectthatnoobservationorrecordingistakingplace,and/orIndividuallyIdentifiableinformationwhichhasbeenprovidedforspecificpurposesbyanindividualandwhich the individualcan reasonablyexpect will not be made public. [45 CFR46.102(f)]
Research:ASystematicInvestigation,includingresearchdevelopment,testingandevaluation,designedtodeveloporcontributetogeneralizableknowledge.ActivitieswhichmeetthisdefinitionconstituteResearchforthepurposesofthispolicy,whetherornottheyareconductedorsupportedunderaprogramwhichisconsideredresearchforotherpurposes.Forexample,somedemonstrationsandserviceprogramsmayincludeResearchactivities.Researchmayalsoincludeoralhistories,interviews,surveys,andparticipantobservations. [45 CFR46.102(d)]
Risk:theprobabilityandmagnitudeofharmordiscomfort,including butnotlimitedto physical,psychological,social, oreconomic harm, which mayariseasresult of participation in Research.
SystematicInvestigation:Anymethodicalcollectionofdata,whetherquantitativeorqualitative,incorporatedintoaResearchplan,includingbutnotlimitedtosurveys,tests,observations,orExperiments.
Test Article: A TestArticle is a drug,device, food, or other article includinga biologicalproductused in ClinicalInvestigations involvingHumanSubjects or their specimens.
IV.InstitutionalAuthority
TheIRBoperatesundertheauthorityofBCUB-CU'sBoardofTrustees,whoshallregularlyreceiveinformationregardingIRBminutes.ResearchthathasbeenreviewedandapprovedbytheIRBmaybesubjecttofurtherreviewanddisapprovalbytheBoardofTrusteesorotherBCUB-CUofficials.NoResearch shall be approvedif rejectedbytheIRB.
TheIRBshallconductitsactivitiesinaccordancewiththeexistingguidelinesoftheCodeofFederalRegulationsestablishedbytheOHRP andFDA. [45 CFR 46, 21 CFR 56]
V.InstitutionalResponsibilities
BeforeanyHumanSubjectResearchisconducted,theInvestigatormustapplyforapprovalfromtheIRB.TheIRB,afterapprovinganyResearchtobeperformedunderagrantfromtheDepartmentofHealthandHumanServices(HHS),shallsubmitawrittenAssurancetotheHHSonbehalfoftheInvestigatorconfirmingthattheResearchorExperimentwillcomplywiththerequirementsof allpoliciesgoverningHumanSubjectResearch.AllAssurancessubmittedtotheHHS orother federal agencyshall be signedbytheInstitutionalOfficial.
Any HumanSubjectResearchconducted(1)atBCUB-CU;(2)by orunderthedirectionofanyemployeeoragentofBCUB-CUinconnectionwithhisorherinstitutionalresponsibility;(3)bystudentsofBCUB-CUinconnectionwiththeirinstitutionalresponsibilities;or(4)byorunderthedirectionofanyemployeeoragentofBCUB-CUusing anypropertyorfacilityowned byBCUB-CUorinvolving non-publicinformationcollectedbyBCUB-CU shall be reviewedbytheIRB.
VI.GoverningPrinciples
ItisthedutyoftheIRBtoreviewandapproveResearchonlyifitcomplieswiththeethicalprinciplesoftheBelmontReport,attachedheretoasExhibitA.ToensurethatallResearchcomplieswiththeBelmontReport,InvestigatorsshallberequiredtoobtaininformedconsentformsfromanyHumanSubjects, or theirparent/guardian, involved in Research.
TheIRBshalldeterminewhetherResearchisapprovedbybalancingtheRisksandBenefitsoftheResearch.SolongastheRisksarereasonableinrelationtotheanticipatedBenefits,andinformedconsentisobtained,theResearchshallbeapproved.ThefactorsthattheIRBmayconsiderwhenbalancingtheRisksandBenefitsinclude(1)risksofinjury ordiscomforttotheindividual,includingbutnotlimitedtophysical,psychologicaland/orsocialrisks;and(2)potentialbenefitstothe individual, a group towhich the individualbelongs,and/or society.
TheIRB'sgoalisnottoreviewthescientificdesignoftheResearchsubmittedforapproval,buttodeterminewhethertheBenefitsofanyproposedResearchoutweightheRisks.However,iftheIRBdeterminesthatthedesignoftheResearchisnotadequatetoattaintheResearch'spurpose,theIRBmaydetermine thatno Benefitcanbe derived,and the Researchwillnot be approved.
VII.Duties ofInvestigators
NoResearch,includingbutnotlimitedtoInteractionorInterventionwithHumanSubjects,maybegin until the Researchhas been reviewedand approvedbytheIRB,ora determinationhasbeenmade,ingoodfaith,thattheResearchdoesnotconstituteHumanSubjectsResearchorthattheResearchisotherwiseexemptfromthispolicy.AnInvestigatormaysubmitaResearchproposaltotheIRBforadeterminationastowhetherornottheResearchisconsideredHumanSubjectResearchoris otherwise exempt.
IntheeventthatanInvestigatorfailstosubmitaprojectorstudytotheIRB,andtheprojectorstudyqualifiesasHumanSubjectResearch,thenanydataorinformationcollectedforthestudypriortoreceivingIRBapprovalmaynotbepublished,presented,orused.TheIRBmayrefusetoapproveResearchthatwasstartedbyanInvestigatorwithoutseekingprior-approvalfromtheIRB.InvestigatorsshoulderronthesideofcautionandseekIRBreviewandapprovalforanyResearchthatcouldpotentiallyinvolveHumanSubjects,evenifsuchinvolvementisconditionaloranticipatedat afuture date.
InvestigatorsshouldattempttoforwardallmaterialsintheResearchproposaltotheIRBinatimelymanner.ItistheintentionoftheIRBthatmembershaveaccesstheResearchproposalmaterialstwoweeks priortoa scheduled IRBmeetingsothat theyhavetheopportunityto reviewsuchmaterials.
VIII.Membership in theIRB
TheIRBshallhaveaminimumoffivemembers,includingaChairmanasdesignatedbytheIO,fromvaryingbackgrounds.ThemembersoftheIRBmustbequalifiedintheirparticularareaofexperienceandexpertise.MembershiptotheIRBshouldincludeconsiderationsofdiversity,includingbutnotlimitedtorace,genderandculturalbackgroundaswellassensitivitytoissueswithin the communityand safeguardingthe welfare of HumanSubjects.EverynondiscriminatoryeffortwillbemadetoensurethattheIRBdoesnotconsistentirelyormenorentirelyofwomen,solongas no selection is made solelyon the basis ofgender.
TheIRBshould includepersonsfamiliar with theResearchactivitiesthatcome before theIRBforapproval,butnomembershallparticipate intheIRB'sinitialorcontinuingreviewforanyprojectinwhichthememberhasaconflictinginterestorisotherwiseinvolvedintheResearch.IntheeventthattheIRBregularlyreviewsresearchinvolvingavulnerablecategoryofsubjects,includingbutnotlimitedtochildren,prisoners,pregnantwomen,ordisabledpersons,theIRBshallattempttoincludeatleastonememberwhopossessesknowledgeandexperienceregarding thesesubjects.
TheIRBshallincludeatleastonememberwhoseprimaryconcernsareinscientificareasandatleastonememberwhoseprimaryconcernsarenotinscientificareas.TheIRBshallincludeatleastonememberwhoisnototherwiseaffiliatedwithBCUB-CU,norisanimmediatefamilymemberofapersonaffiliatedwithBCUB-CU.
TheIRBmay,initssolediscretion,inviteindividualswithcompetenceinspecialareastoassistwiththereviewofanyResearchprojectwhichrequiresexpertisebeyondtheknowledgeoftheIRB,butsuchpersonmaynotvoteontheapprovaloftheResearch.AnyindividualthatisinvitedtoassistwiththereviewofaResearchprojectmustagreetokeepanyinformationsuchindividuallearnsattheIRBmeetingconfidential,andmayberequiredtosignaconfidentialityagreementensuringthe same.
TheChairmanshallnominatequalifiedindividualstoserveasIRBmembers.AllIRBmembersmustreceivetheirfinalappointmenttotheIRBfromtheIO.EachmemberoftheIRBshallservefortwoyearterms(excludingcertaininitialmembers,aslistedbelow,whowillservetermsof
2.5years,inordertoallowfortermstobestaggered.Aftertheinitialtermof2.5years,allmembersshallservetermsof2years.)MembershipintheIRBmayberenewedforadditionaltermsatthediscretion oftheIO.
Alist ofthe currentmembers is available on Exhibit B,attached hereto.
AllmembersoftheIRBmustcompleteanorientationasdesignatedbytheIRBChairman.Amember mayresign from theIRB atanytimebyprovidingwrittennotice to theIRB Chairman orIO,asapplicable.TheIOmayremoveamemberoftheIRBfor anyreasonatanytime.
IX.DutiesofMembers
MembersshouldattendallIRBmeetings,orprovidetheChairmanwithadvancenoticeiftheyareunable to do so. Members should ensure thatanyandallinformation provided byInvestigators inResearchproposalstotheIRBremainsconfidential,andreturnanyandalldocumentstheMembersaregiveninordertoevaluatetheResearchtotheChairmanupontheIRB'sfinaldecision.AllMembersarerequiredtoreporttotheChairmanorIO anyinstancesof whichtheyareawarethatinvolveauseordisclosureofconfidentialorPrivateInformationobtainedbyanothermemberviahis or her position with theIRB.
X.RecordKeeping
TheChairmanwillensurethattheIRBprepareandmaintainadequatedocumentationofallitsactivities,includingbut not limited to copies of allResearch proposals, minutes ofIRBmeetings,recordsofcontinuingreviewactivities,correspondencereceivedfromInvestigators,andstatementsofsignificantfindings.TheIRBshallalsomaintainandupdatethispolicyasrequired,andkeepanupdatedmembership list atalltimes.
MinutesofIRBmeetingswillbekeptinsufficientdetailtoshowattendanceatthemeetings;actionstakenbytheIRB;thevoteontheseactionsincludingthenumberofmembersvotingfor,against,andabstaining;thebasisforrequiringchangesinordisapprovingresearch;andawrittensummaryofthediscussion of controversialissuesandtheir resolution.
AllIRBrecordswillberetainedbytheIRBforatleastthreeyears.RecordsthatpertaintoResearchthatisapprovedwillberetainedforaminimumofthreeyearsafterthecompletionofsuchResearch.All IRBrecordswillbeaccessibleforinspectionandcopyingforauthorizedrepresentativesoftheHHS,applicable federalagencies, orInvestigator atreasonable timesand in a reasonable manner,providedthat thesecurityof allsuchdocuments ismaintained.
XI.Dutiesofthe IRB
TheIRBshallapprove/disapproveanyResearch,andmayterminate,suspend,orplacerestrictiononanyResearchthatcomesbeforeit,evenaftersuchResearchhasbeenapproved,shouldsuchResearchcauseharmtoHumanSubjects.TheIRBshallalsoprovidetrainingandeducationalinformationforInvestigatorsinordertoassistInvestigatorsinobtainingapprovalfortheirResearch.
Throughoutthereviewprocess,theIRBshalldocumentalldecisionsitmakesinregardstotheResearch,includingdocumentationofanyfindingsregardingtheRisksandBenefitsoftheproposedResearch,ethicalconsiderations,scientificmerit,PrivateInformation,andcompliancewithanyregulationsrequiredbyfederalagencies.TheIRBshallalsomonitorongoingResearchafterithasbeenapproved to ensure that it complieswith the terms ofits approval.
A.TypesofReview
1.ExemptResearch
CertaincategoriesofHumanSubjectsResearchareexemptfromIRBapproval.Suchresearchincludes:
(a)Researchconductedinestablishedorcommonlyacceptededucationalsettings,involvingnormaleducationalpractices,including but not limitedto:
(1)Research onregular andspecialeducationinstructionalsettings; or
(2)Researchontheeffectivenessoforthecomparisonamonginstructionaltechniques,curricula,or classroommanagementmethods.
(b)Researchinvolvingtheuseofeducationaltests(cognitive,diagnostic,aptitude,achievement),surveyprocedures,interviewprocedures,orobservationsofpublicbehaviorunless:
(1)informationobtainedisrecordedinsuchamannerthatHumanSubjectscan be identified,directlyor throughidentifierslinked to the HumanSubjects;and
(2)anydisclosureoftheHumanSubjects'responsesoutsidetheResearchcouldreasonablyplacesuchHumanSubjectsatriskofcriminalorcivilliabilityorbedamagingtothe Human Subjects'financialstanding,employability, orreputation.
(c)Researchinvolvingtheuseofeducationaltests(cognitive,diagnostic,aptitude,achievement),surveyprocedures,interviewprocedures,orobservationofpublicbehaviorthatisnotexempt under (b) above if:
(1)theHumanSubjectsareelectedorappointedpublicofficialsorcandidates forpublic office; or
(2)federalstatue(s)require(s)withoutexceptionthattheconfidentialityoftheIdentifiableInformationwill be maintainedthroughout the Researchand thereafter.
(d)Researchinvolvingthecollectionorstudyofexistingdata,documents,records,pathologicalspecimens,ordiagnosticspecimens,ifthesesourcesarepubliclyavailableoriftheinformationisrecordedbytheInvestigatorinsuchamannerthattheHumanSubjectsparticipatingin suchResearchcannotbe identified viaanyinformationreported in theResearch.
(e)Researchanddemonstrationprojectswhichareconductedbyorsubjecttotheapprovalofdepartmentoragencyheadsandwhicharedesignedtostudy,evaluate,orotherwiseexamine:
(1)public benefit or serviceprograms;
(2)proceduresfor obtaining benefits or services under suchprograms;
(3)possiblechangesinoralternativestothoseprogramsorprocedures;or
(4)possiblechangesinmethodsorlevelsofpaymentforbenefitsorservices underthose programs.
(f)Taste andfood qualityevaluationandconsumeracceptance studies,if:
(1)wholesome foods without additivesareconsumed or;
(2)ifafoodisconsumedthatcontainsafoodingredientatorbelowthelevelandforausefoundtobesafe,oragriculturalchemicalorenvironmentalcontaminantatorbelowthelevelfoundtobesafe,bytheFDAorapprovedbytheEnvironmentalProtectionAgencyorthe Food SafetyandInspectionServices oftheU.S.Department of Agriculture.
Notwithstandinganyexemptionscontainedherein,anyResearch(1)dealingwithsensitiveaspectsofthebehaviorof aHumanSubject,including butnotlimitedtoillegalconduct,drugsoralcoholuse,orsexualbehavior;or(2)usingHumanSubjectsthatareunder-agechildren,mentallyorphysicallyimpaired,pregnant,prisoninmates,orsufferingfromanillness,isnotexemptunderthissection.
2.ExpeditedReview
TheIRBmayreviewcertaintypesofResearchunderanexpeditedreviewprocedure.SuchResearch includes:
(a)AnyResearchfoundbytheIRBtoinvolvenomorethanaMinimalRisktotheHumanSubjectsparticipatingin suchResearch;
(b)AnyResearchthathasbeenpreviouslyapprovedbytheIRBwithinthelastcalendaryear andwhichcontainsonlyminor changes; or
(c)Anyother categoriesapprovedbythe HHS.
ExpeditedreviewmaybecarriedoutsolelybytheChairmanorbyanyIRBmembersthattheChairmansodesignates.ResearchshallnotbedisapprovedunlesstheResearchundergoesafullreview,asprovidedforbelow.AllIRBmembersshallbenotifiedwhenResearchsubjecttoexpeditedreview comesbefore theIRB.
3.FullReview
AllResearchnotfallinginto(1)or(2)aboveshallbefullyreviewedbytheIRB.AfullreviewshallbecarriedoutatameetingoftheIRBinwhichamajorityoftheIRBmembers,includingatleastonenon-scientist,arepresent.Membersmaynotparticipateinafullreviewbymail, butmayparticipate bytelephone.Research shall not be approvedwithout amajorityvoteofthemembersparticipatinginthefullreview.Anyabstentionfromvotingshallberecordedasadisapproval.
Anymemberwithaconflictofinterest,orwhomshallparticipateintheResearchupforreviewbeforetheIRBmaynot participateinthemeetingreviewing suchResearch.AfterpresentationofallmaterialsubmittedbytheInvestigatorproposingtheResearch,followedbyadiscussionamongsttheIRBmembersregardingthepotentialRiskstheResearchmaycauseto
HumanSubjects,theChairmanshallmoveforavotetodeterminewhatcategorytheResearchshould be placed in, as set forthbelow.
B.Actions ofthe IRB
At a review meeting,proposals will be voted uponbytheIRBandcategorized into oneoffive categories.Suchcategoriesare:
1.Approved.TheResearchisapproved.UponreceiptofanapprovalletterfromtheIRB, theInvestigator maybegin the study.
2.Approvedcontingentuponmodifications.TheInvestigatorwillbenotifiedinwritingastothenatureofthemodificationsrequiredbytheIRB.OncetheInvestigatorhascompliedwillallrequiredmodifications,andsentwrittennoticetotheIRBconfirmingcompliance,theIRBwillsendtheInvestigatoranapprovalletter.UponreceiptofanapprovalletterfromtheIRB, theInvestigator maybegin the study.
3.Deferred.ThiscategoryindicatesthattheIRBhasnotcompletedafullreviewoftheResearchandthattheIRBdesirestocontinuereviewinganddiscussingtheResearchatanadditionalmeeting.Researchmaybe placed into the Deferred categorymore thanonce.
4.Tabled.ThiscategoryindicatesthattheIRBrequiresadditionalinformationand/orhasaseriousconcernregardingtheproposedResearch.TheChairman,oramemberappointedbytheChairman,willcontacttheInvestigatortolearnmoreinformationregardingtheResearch.TheChairmanmay,inhisorhersolediscretion,requiretheInvestigatortocometoameetingoftheIRBandfurtherdiscusstheResearchinfrontoftheIRBmembers.Afterreceivingadditionalinformation, theIRBwillagainreview anyTabledResearchand placeit into a new category.
5.Disapproved.IfaResearchproposalisdisapproved,theInvestigatormaymakemodificationstotheResearchandresubmittheResearchforreview.Researchmaynotbedisapprovedunless afullreview is performedbytheIRB.
In orderfor theIRBto approve Research it must determine that:
(a)Risks to HumanSubjectsare minimized;
(b)The Researchdesign is sound andhasscientific merit;
(c)There is anappropriate Risk to Benefit ratio;
(d)The selection ofHumanSubjects to participate in the Research is equitable;
(e)AppropriateproceduresarefollowedbytheInvestigatorforobtaininganddocumentinginformedconsentorwaivingoralteringinformedconsentdocumentationorproceduresin anappropriate manner;
(f)TheResearchplanhasadequateprovisionsformonitoringthedatacollectedtoensureHumanSubjectsafety;
(g)There are adequate provisions to protect Human Subject privacy and dataconfidentiality;and
(h)Additionalsafeguardsareincludedtoprotecttherightsandwelfareofanyvulnerablepersonsinvolved in the Research.
C.InformedConsent
InordertoobtainapprovalfromtheIRB,theInvestigatormustobtainlegallyeffectiveinformedconsentfromtheHumanSubjectortheHumanSubject’slegallyauthorizedrepresentative,suchasaparentorotherlegalguardian(inthecaseofaminor),unlesstheconditionsforawaiveroralterationofinformedconsentareapprovedbytheIRBuponreview.Informedconsent(orawaiveror alteration) must beobtained prior to conducting anyResearch. Acopyofthe informed consentformorprocedures,oranexplanationastowhythesameshouldbewaivedoraltered,mustbesubmittedbytheInvestigator for review bytheIRB.
The informed consent document must include:
1.A clear statementthat thestudyinvolvesResearch;
2.Anexplanation ofthe purposes ofthe Research;
3.The expected duration ofthe HumanSubject'sparticipationin the Research;
4.Acompletedescriptionoftheprocedurestobefollowed,includinganexplanationofthestandardtreatmentthattheHumanSubjectwouldreceiveifnotinvolvedintheResearch(ifapplicable)and howthis treatment is different from thatperformed in theResearch;
5.AdescriptionofthereasonablyforeseeableRisksordiscomfortsthattheHumanSubject mayexperienceduringthe Research;
6.AdescriptionofanyBenefitstotheHumanSubjectortoothersthatmayreasonablybe expectedfrom the Research;
7.Adisclosureofappropriatealternativeproceduresorcoursesoftreatmentthatmightbe advantageous to theHuman Subject;
8.AstatementdescribingtheextenttowhichconfidentialityofrecordsidentifyingtheHumanSubjectandprivacywillbemaintained,includingastatementastowhatinformationwillorwill not be included in the HumanSubject'smedicalrecord(if applicable);
9.ForResearchinvolvingmorethanaMinimalRisk,anexplanationastowhetheranycompensationisavailableandanexplanationastowhetheranymedicaltreatmentsareavailableifinjuryoccursand,ifso,whatsuchtreatmentsconsistofandwhereadditionalinformationonsuchtreatmentsmaybeobtained;
10.Anexplanationofwhomtocontactfor(a)answers topertinentquestionsabouttheResearch,(b)injuriesrelatedtotheResearch,and/or(c)complaintsorconcernsabouttheResearch;
11.AnexplanationofwhomtocontactattheIRB(asanalternativetothepersonlistedin10 above) in orderto obtainanyofthe informationlisted in 10 above;
12.Astatementthatparticipationisvoluntary,thatrefusaltoparticipateatanypointduringtheResearchwillnotresultinalossofbenefitsthattheHumanSubjectisotherwiseentitledto receive,andthat theHuman Subject maydiscontinue participationat anytime;
13.ForResearchregulatedbytheFDA,thattheFDAhastherighttoinspecttheResearchmaterialsatanytime;and
14.Anyofthe additionalelements, if applicable:
(a)AstatementthattheparticularResearchmayinvolveRiskstotheHumanSubject(orfetus, should the HumanSubject be pregnant) which arecurrentlyunforeseeable;
(b)AnticipatedcircumstancesunderwhichtheHumanSubject'sparticipationmaybeterminatedwithoutregard to the HumanSubject'sconsent;
Research;
(c)AnyadditionalcoststotheHumanSubjectthatmayresultfromparticipationinthe
(d)TheconsequencesofaHuman'sSubject'sdecisiontowithdrawfromtheResearchandprocedures fororderlytermination ofparticipation bythe Human Subject;
(e)AstatementthatsignificantnewfindingsdevelopedduringtheResearchwhichmayrelatetotheHumanSubject'swillingnesstocontinueparticipationintheResearchwillbeprovidedto the HumanSubject;
(f)The approximate numberof HumanSubjectsinvolved in the Research; or
(g)AnyadditionalinformationthattheIRBrequirestobeplacedontheinformedconsentform.
NoinformedconsentmayincludeanyexculpatorylanguagebywhichtheHumanSubjectorhis/herlegallyauthorizedrepresentativeismadetowaiveorappeartowaiveanyoftheHumanSubject'slegalrights,orwhichreleasesorappearstoreleasetheInvestigator,theIRB,BCUB-CUoranyof their respective agents or employees from liabilityfor negligence.
Informedconsentmaybe documented by awrittenconsentformapprovedby theIRB,orobtainedorallybyfollowinga writtenscriptapprovedbythe IRB.SuchscriptmustbereadtotheHumanSubjectinthepresenceofawitnessthatcanverifyanddocumentthatthescriptwasappropriatelyfollowed.TheInvestigatorisresponsibleforcollectingandmaintainingallwritteninformedconsentforms,ordocumentationoforalconfirmationofinformedconsentasverifiedbythewitness.IntheeventthatinformedconsentisobtainedfromapersonthatdoesnotspeakEnglish,suchconsentshall betranslated into a language inwhich the Human Subject is fluent.
Informedconsentmaybe waivedbythe IRBwhere(1)theonlyrecordlinkingtheHumanSubjectandtheResearchwouldbetheinformedconsentdocumentationandthemainRiskinvolvedintheResearchconsistsofabreachofconfidentialityoftheinformedconsentdocument.Insuchacase,theHumanSubjectwillbeaskedwhetherhe/shewantsdocumentationlinkinghim/herwiththeResearchandtheHumanSubject'swisheswillgovern;or(2)theResearchpresentsnomorethanaMinimalRiskofharmtotheHumanSubjectandinvolvesnoproceduresforwhichconsentisnormallyrequiredoutsideoftheResearchcontext.InsituationswheretheIRBwaivesinformedconsent,theIRBmaystillrequirethattheInvestigatorprovidetheHumanSubjectsparticipatinginthe Researchwithwritteninformationregardingthe Research.
XII.ResearchApplications
A complete researchapplicationshallinclude:
A.A complete resource development checklist,as provided for bythegrantsoffice;
B.Professionalqualifications ofthe PrincipalInvestigator;
C.A cover letter;
D.AsummaryoftheHumanSubjectResearchproject,writteninlanguageunderstandablebytheIRB;
E.Acopyoftheinformedconsentform,proceduresforobtainingoralinformedconsent,oranexplanationas to whyinformedconsent should bewaived or altered;
F.CopiesofanyadvertisementsorbrochuresusedbytheInvestigatortorecruitHumanSubjects;
G.CopiesofanysurveyinstrumentsordatacollectionformstobeusedaspartoftheResearch;
H.DocumentationshowingtheprincipalInvestigatororotherswhoaredirectlyinvolvedintheHumanSubjectsResearchhavereceivedtraininginResearchmethodsandtheprotectionofHumanSubjects;and
I.AnyothermaterialsthatmayassisttheIRBwhendeterminingwhethertoapprovetheResearch.
XIII.AfterApproval
OncetheIRBhasapprovedtheResearch,itisthedutyoftheprincipalInvestigatorofsuchResearchtotrainandsupervisetheethicalconductofallpersonsperformingsuchResearchtoensurethatallHumanSubjectsareprotectedthroughouttheResearch.TheprincipalInvestigatormustalsoensurethatanychangesinthedesignoftheResearch,whichwerenotsubmittedintheoriginalapproval,arepresentedtotheIRB.TheprincipalInvestigatormustalsocollectanyandallrequiredforms,includingbutnotlimitedtoHIPPAauthorizationandinformedconsents,requiredtocomplete the Research.