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Informed ConsentInformed Consent
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Informed ConsentInformed Consent
DefinitionsDefinitions
ProcessProcess
Special situationsSpecial situations
Elements of informed consentElements of informed consent
RetentionRetention
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Definition of Informed Consent: ICHDefinition of Informed Consent: ICH
GCP 1.28GCP 1.28 A process by which a subjectA process by which a subject voluntarilyvoluntarily
confirms his or her willingness to participateconfirms his or her willingness to participatein a particular trial, after having beenin a particular trial, after having beeninformedinformedof all aspects of the trial that areof all aspects of the trial that are
relevant to the subjects decision torelevant to the subjects decision toparticipateparticipate
Informed consent is documented by meansInformed consent is documented by meansof a written, signed, and dated informedof a written, signed, and dated informed
consent formconsent form
Cornerstone of ethical conduct in clinicalCornerstone of ethical conduct in clinicalresearchresearch
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Informed Consent of Trial SubjectsInformed Consent of Trial Subjects
In obtaining and documentingIn obtaining and documentinginformed consent, theinformed consent, the
investigator should comply withinvestigator should comply withthethe applicable regulatoryapplicable regulatoryrequirementsrequirements and adhere toand adhere to GCPGCPand to the ethical principles thatand to the ethical principles that
have their origin in thehave their origin in theDeclaration of HelsinkiDeclaration of Helsinki
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Informed Consent DocumentInformed Consent Document
Prior to the beginning of a trial,Prior to the beginning of a trial,the investigator must obtainthe investigator must obtainfrom thefrom the IRB/IEC writtenIRB/IEC written
approval/favorable opinionapproval/favorable opinion ofofthe written informed consentthe written informed consentform and any other writtenform and any other writteninformation to be provided toinformation to be provided tosubjectsubject
Revisions will also need reRevisions will also need re--
approval and reapproval and re--consentingconsenting
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Informed Consent ProcessInformed Consent Process
Intention is to transmit study information fromIntention is to transmit study information frominvestigator to subject/legal representativeinvestigator to subject/legal representative
Assumes subjectAssumes subject clearly understandsclearly understands RisksRisks
Alternative treatmentsAlternative treatments
BenefitsBenefits Their obligations as a subjectTheir obligations as a subject The study involves researchThe study involves research
Reading and signing a consent does not assureReading and signing a consent does not assurecomprehensioncomprehension
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ProblemsProblems
Not being doneNot being done VsVs not done correctlynot done correctly
The timing of the consent may notThe timing of the consent may not
be correctbe correct Proper signatures are not alwaysProper signatures are not always
obtainedobtained
Consent form is poorly writtenConsent form is poorly written There are missing required elements.There are missing required elements.
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Informed Consent ProcessInformed Consent Process
Subject is to be treated as anSubject is to be treated as anautonomousautonomous agentagent
Subject must be allowed to make aSubject must be allowed to make avoluntary decisionvoluntary decision without coercionwithout coercion
Consent must be obtainedConsent must be obtained priorprior to anyto anystudy related proceduresstudy related procedures
Consent should not contain anyConsent should not contain anylanguagelanguage waivingwaiving the subjects legalthe subjects legalrightsrights
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Informed Consent ProcessInformed Consent Process
Giving subjectGiving subject adequateadequate informationinformation
Providing an opportunity for subject toProviding an opportunity for subject toconsiderconsider optionsoptions
A
nsweringA
nswering questionsquestions
EnsuringEnsuring comprehensioncomprehension
ObtainingObtaining voluntary agreementvoluntary agreement
SupplyingSupplying ongoing informationongoing information
DocumentingDocumenting subjects agreement tosubjects agreement toparticipateparticipate
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Informed Consent ProcessInformed Consent Process
Consent form must beConsent form must be approved by theapproved by theIRB/IECIRB/IEC
InvestigatorInvestigator is ultimatelyis ultimately responsibleresponsible forforobtaining consentobtaining consent
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Informed Consent ProcessInformed Consent Process
All oral and written information mustAll oral and written information mustbe understandable to the subjectbe understandable to the subject
Language in which subject is fluentLanguage in which subject is fluent
Medical terms versus lay termsMedical terms versus lay terms
Subject is to beSubject is to be provided a copyprovided a copy of theof theconsent documentconsent document
If amended, consent needs to be reIf amended, consent needs to be re--approved and reapproved and re--signed by allsigned by allongoing subjectsongoing subjects
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Special SituationsSpecial Situations
Trials which have no anticipatedTrials which have no anticipateddirect clinical benefit to thedirect clinical benefit to thesubject should be conducted insubject should be conducted insubjects who can personally givesubjects who can personally giveconsent and who can sign andconsent and who can sign anddate the written informeddate the written informed
consent formconsent form
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Special SituationsSpecial Situations
Trials which have no anticipatedTrials which have no anticipateddirect clinical benefit may bedirect clinical benefit may beconducted in subjects with consent ofconducted in subjects with consent of
a legally acceptable representativea legally acceptable representativeprovidedprovided
The objectives of the trial cannot be metThe objectives of the trial cannot be metby means of a trial in subjects who canby means of a trial in subjects who can
give informed consent personallygive informed consent personally
The risk to the subjects is lowThe risk to the subjects is low
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Special SituationsSpecial Situations
The negative impact is minimalThe negative impact is minimal
The trial is not prohibited by lawThe trial is not prohibited by law
The IRB/IEC has given writtenThe IRB/IEC has given writtenapproval/favorable opinion ofapproval/favorable opinion ofthe trialthe trial
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Special SituationsSpecial Situations
In an emergency situation when priorIn an emergency situation when priorconsent of the subject is not possibleconsent of the subject is not possible
The consent of a legally acceptableThe consent of a legally acceptable
representative should be requested if onerepresentative should be requested if oneis availableis available
If a legally acceptable representative isIf a legally acceptable representative is
not available, the subject can still benot available, the subject can still beenrolled if it is to the subjects bestenrolled if it is to the subjects bestclinical interestclinical interest
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Special SituationsSpecial Situations
When subjects can only be included inWhen subjects can only be included ina trial with the consent of aa trial with the consent of arepresentative (e.g., minors, orrepresentative (e.g., minors, or
persons with severe dementia)persons with severe dementia) The subject should be informed about theThe subject should be informed about the
trial to the extent of his/hertrial to the extent of his/herunderstandingunderstanding
If capable, the subject should sign andIf capable, the subject should sign anddate the informed consent formdate the informed consent form
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Special SituationsSpecial Situations
Subject or representative isSubject or representative isunable to readunable to read An impartial witness should beAn impartial witness should be
present during the entire informedpresent during the entire informedconsent discussionconsent discussion
After the subject has orallyAfter the subject has orally
consented the subject and/orconsented the subject and/orrepresentative should sign and daterepresentative should sign and datethe consent form if they are capablethe consent form if they are capable
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Special SituationsSpecial Situations
Impartial witness signs attesting thatImpartial witness signs attesting that
all trial information was clearlyall trial information was clearly
explained to theexplained to the
subject/representativesubject/representative
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Elements of Informed ConsentElements of Informed Consent
FormForm
The trial involves researchThe trial involves research Purpose of the trialPurpose of the trial
Possibility ofPossibility ofrandom assignmentrandom assignment
Trial procedures that will be necessaryTrial procedures that will be necessary Experimental aspects of the trialExperimental aspects of the trial
Possible risksPossible risks
Reasonably expected benefitsReasonably expected benefits
Alternative proceduresAlternative procedures
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Elements of Informed ConsentElements of Informed Consent
FormForm
Available compensation in the event ofAvailable compensation in the event ofinjuryinjury
Payment, if any, to the subject forPayment, if any, to the subject for
participation in the trialparticipation in the trial
Anticipated expenses, if anyAnticipated expenses, if any
State that the subjects involvement in theState that the subjects involvement in thetrial is voluntary and the subject maytrial is voluntary and the subject maywithdraw at any timewithdraw at any time
The persons who will be granted directThe persons who will be granted directaccess to the subjects medical informationaccess to the subjects medical information
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Elements of Informed ConsentElements of Informed Consent
FormForm
The identification of the individualThe identification of the individualsubjects will be kept confidentialsubjects will be kept confidential
The subject and/or representativeThe subject and/or representativewill be informed when any newwill be informed when any newinformation becomes availableinformation becomes available
A person to contact for furtherA person to contact for furtherinformation on the trial and in theinformation on the trial and in the
event of an emergencyevent of an emergency
Reasons why the subject may beReasons why the subject may beterminated from the trialterminated from the trial
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Elements of Informed ConsentElements of Informed Consent
FormForm
Expected duration of the trialExpected duration of the trial
Approximate number of subjects thatApproximate number of subjects that
will be included in the trialwill be included in the trial Subject agrees that the data collectedSubject agrees that the data collected
will be reported and transferred aswill be reported and transferred aspart of trial analysispart of trial analysis
The subject will not be uniquelyThe subject will not be uniquelyidentified and their data will be usedidentified and their data will be usedeven if subject withdrawseven if subject withdraws
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Document RetentionDocument Retention
A master copy of each version of theA master copy of each version of theinformed consent form should be filed alonginformed consent form should be filed alongwith its approval with the trial documentswith its approval with the trial documents
The signed completed informed consentThe signed completed informed consentforms should be filed with the subjects trialforms should be filed with the subjects trialfile or medical records, as appropriatefile or medical records, as appropriate
According to ICH, all trial documents mustAccording to ICH, all trial documents mustbe retained 2 years after the last approval ofbe retained 2 years after the last approval ofa marketing applicationa marketing application
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The consent processThe consent process
Have someone read the consent form.Have someone read the consent form.
Presenter summarizes importantPresenter summarizes importantpoints.points.
Ask if there are questions.Ask if there are questions.
Never convince a subject toNever convince a subject toparticipate.participate.
Ask the subjects questions to assessAsk the subjects questions to assesscomprehension.comprehension.
Give adequate timeGive adequate time
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Schedule Y appendix VSchedule Y appendix V
Checklist for Subjects informedChecklist for Subjects informedcomnsent documentscomnsent documents
Essential elementsEssential elements
Additional elementsAdditional elements
Format of informed consent formFormat of informed consent formfor subjects participating in afor subjects participating in aclinical trialclinical trial