23867839 Informed Consent 1

8/8/2019 23867839 Informed Consent 1

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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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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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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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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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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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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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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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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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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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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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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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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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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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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

23867839 Informed Consent 1

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Transcript of 23867839 Informed Consent 1