The Informed The Informed Consent ProcessConsent Process

Jeremy Sugarman, MD, MPH, MAJeremy Sugarman, MD, MPH, MAPhoebe R. Berman Bioethics InstitutePhoebe R. Berman Bioethics InstituteJohns Hopkins University Johns Hopkins University Baltimore, Maryland USABaltimore, Maryland USA

OverviewOverviewEvolution of informed consent Evolution of informed consent Two senses of informed consentTwo senses of informed consentProcess of informed consentProcess of informed consentRelevant regulationsRelevant regulationsChallengesChallenges

The Evolution of ConsentThe Evolution of Consent

For Medical TreatmentFor Medical TreatmentPatient litigationPatient litigationLaws and regulationsLaws and regulations

For ResearchFor ResearchEarly consent practicesEarly consent practicesInfamous researchInfamous research

Medical Treatment andMedical Treatment andThe Right to LibertyThe Right to Liberty

SchloendorffSchloendorff v. Society of New York v. Society of New York Hospitals, 1914Hospitals, 1914

Medical Treatment and Medical Treatment and The Right to LibertyThe Right to Liberty

““Every human being of adult years Every human being of adult years and sound mind has a right to and sound mind has a right to determine what shall be done with determine what shall be done with his own body; and a surgeon who his own body; and a surgeon who performs an operation without his performs an operation without his patientpatient’’s consent commits as s consent commits as assault for which he is liable in assault for which he is liable in damages.damages.”” SchloendorffSchloendorff

Early Consent Practices for Early Consent Practices for ResearchResearch

Recognized as important for Recognized as important for research with volunteersresearch with volunteers

Not necessarily free and voluntaryNot necessarily free and voluntary

Yellow Fever ExperimentsYellow Fever Experiments

Conducted in Cuba following Conducted in Cuba following the Spanishthe Spanish--American WarAmerican WarWritten consent in Written consent in English and SpanishEnglish and SpanishConsent was witnessedConsent was witnessed

Yellow Fever ExperimentsYellow Fever Experiments

Ethical DifficultiesEthical DifficultiesExcessive compensationExcessive compensationNo ability to withdrawNo ability to withdraw

Infamous ResearchInfamous ResearchTuskegee Syphilis StudyTuskegee Syphilis StudyNazi experimentsNazi experimentsDeception researchDeception researchJewish Chronic Disease HospitalJewish Chronic Disease HospitalHuman radiation experimentsHuman radiation experiments

Human Radiation Human Radiation ExperimentsExperiments

Thousands of experiments Thousands of experiments conducted during the Cold Warconducted during the Cold WarMost conducted without Most conducted without informed consentinformed consent

Human Radiation Human Radiation ExperimentsExperiments

Researchers sought to minimize Researchers sought to minimize risksrisksConsistent with the norms at the Consistent with the norms at the time, physicians decided about time, physicians decided about enrolling their patients in researchenrolling their patients in research

OverviewOverviewEvolution of informed consent Evolution of informed consent Two senses of informed consentTwo senses of informed consent

Autonomous authorizationAutonomous authorizationSocial rules of consentSocial rules of consent

Process of consentProcess of consentRelevant regulationsRelevant regulationsChallengesChallenges

Autonomous AuthorizationAutonomous Authorization

Ethical principle of respect for Ethical principle of respect for personspersons

Autonomous AuthorizationAutonomous Authorization

Ethical principle of respect for Ethical principle of respect for personspersonsRight to libertyRight to liberty

Two Senses of Two Senses of Informed ConsentInformed Consent

Autonomous authorizationAutonomous authorizationSocial rules of consentSocial rules of consent

Social RulesSocial Rules

Consent of minorsConsent of minorsSpecial formsSpecial formsWitnessesWitnesses

OverviewOverviewEvolution of informed consent Evolution of informed consent Two senses of informed consentTwo senses of informed consentProcess of informed consent: Process of informed consent: Beyond consent formsBeyond consent formsRelevant regulationsRelevant regulationsChallengesChallenges

Informed Consent Informed Consent ProcessProcess

ThresholdThresholdDecisionDecision--making making capacitycapacity

Informed Consent Informed Consent ProcessProcess

For research with populations For research with populations likely to lack adequate decisionlikely to lack adequate decision--making capacity:making capacity:

Work with IRBWork with IRBFormal evaluation of capacityFormal evaluation of capacity

Informed Consent Informed Consent ProcessProcess

ThresholdThresholdDecisionDecision--making making capacitycapacityVoluntarinessVoluntariness

Informed Consent Informed Consent ProcessProcess

ThresholdThreshold

InformationInformation

DecisionDecision--making making capacitycapacityVoluntarinessVoluntariness

DisclosureDisclosureUnderstandingUnderstanding

Clarify TermsClarify Terms

““Medical experimentsMedical experiments”” vs. vs. ““medical studiesmedical studies””““Clinical investigationClinical investigation”” vs. vs. ““clinical trialclinical trial””

Informed Consent ProcessInformed Consent Process

ThresholdThreshold

AuthorizationAuthorization

InformationInformation

DecisionDecision--making making capacitycapacityVoluntarinessVoluntariness

DisclosureDisclosureUnderstandingUnderstanding

Indication of Indication of agreementagreementConsent forms:Consent forms:

Consistent with Consistent with disclosuredisclosureReadableReadable

Consent vs. AssentConsent vs. Assent

Consent = informed, voluntary Consent = informed, voluntary decision to participate, decision to participate, culminating from a process of culminating from a process of disclosure and understandingdisclosure and understandingAssent = expression of Assent = expression of willingnesswillingness

OverviewOverviewEvolution of informed consent Evolution of informed consent Two senses of informed consentTwo senses of informed consentProcess of informed consentProcess of informed consentRelevant regulations: Relevant regulations: 45 CFR 46, Parts 116 & 11745 CFR 46, Parts 116 & 117ChallengesChallenges

Relevant RegulationsRelevant Regulations45 45 CFRCFR 4646

Part .116 Part .116 -- Requirements for consentRequirements for consentRequired elements to be disclosedRequired elements to be disclosedConditions for waiver of elements of Conditions for waiver of elements of consentconsent

Part .117 Part .117 -- DocumentationDocumentationRequirements for documentation of Requirements for documentation of consent consent Conditions for waiver of documentation Conditions for waiver of documentation of consentof consent

Required Elements of Required Elements of ConsentConsent

Nature of the proposed intervention:Nature of the proposed intervention:purpose of the researchpurpose of the researchduration of participationduration of participationprocedures to be followedprocedures to be followedprocedures which are experimentalprocedures which are experimental

Required Elements of Required Elements of ConsentConsent

Nature of the proposed intervention:Nature of the proposed intervention:purpose of the researchpurpose of the researchduration of participationduration of participationprocedures to be followedprocedures to be followedprocedures which are experimentalprocedures which are experimental

Potential risks and benefitsPotential risks and benefitsAlternative proceduresAlternative proceduresProtection of confidentialityProtection of confidentiality

For research involving greater For research involving greater than minimal risk: compensation than minimal risk: compensation and treatment, if any, for and treatment, if any, for possible injurypossible injuryContact informationContact informationAssurance that participation is Assurance that participation is voluntaryvoluntary

Required Elements of Required Elements of ConsentConsent

Additional ElementsAdditional ElementsWhere AppropriateWhere Appropriate

Unforeseeable risksUnforeseeable risksTermination of participationTermination of participationCosts to subjectsCosts to subjects

Additional ElementsAdditional ElementsWhere AppropriateWhere Appropriate

Unforeseeable risksUnforeseeable risksTermination of participationTermination of participationCosts to subjectsCosts to subjectsConsequences of withdrawalConsequences of withdrawalNew findingsNew findingsNumber of subjectsNumber of subjects

Conditions for Waiver of Conditions for Waiver of Required ElementsRequired Elements

1. Minimal risk;1. Minimal risk;2. Would not adversely affect the rights 2. Would not adversely affect the rights

and welfare of the subjects;and welfare of the subjects;3. Could not be practicably carried out 3. Could not be practicably carried out

without the waiver; ANDwithout the waiver; AND4. Subjects provided with additional 4. Subjects provided with additional

information after participation.information after participation.

Requirements for DocumentationRequirements for DocumentationWritten consent Written consent

embodies required elementsembodies required elementssigned by the subject or the signed by the subject or the subjectsubject’’s legally authorized s legally authorized representativerepresentative

Short formShort formstates the required elements states the required elements have been presented orallyhave been presented orallywitness neededwitness neededIRB approves summary IRB approves summary signed by witnesssigned by witnesscopy of short form and copy of short form and summary to subjectsummary to subject

Conditions for Waiver of Conditions for Waiver of Required DocumentationRequired Documentation1. The only record linking the subject 1. The only record linking the subject

to research would be the consent to research would be the consent document, and the principal risk document, and the principal risk relates to breach of confidentiality;relates to breach of confidentiality;

Conditions for Waiver of Conditions for Waiver of Required DocumentationRequired Documentation1. The only record linking the subject 1. The only record linking the subject

to research would be the consent to research would be the consent document, and the principal risk document, and the principal risk relates to breach of confidentiality;relates to breach of confidentiality;

Or,Or,2. No more than minimal risk and 2. No more than minimal risk and

involves no procedures for which involves no procedures for which consent is required outside of the consent is required outside of the research context.research context.

OverviewOverviewEvolution of informed consent Evolution of informed consent Two senses of informed consentTwo senses of informed consentProcess of informed consentProcess of informed consentRelevant regulationsRelevant regulationsChallengesChallenges

Challenges to the Process Challenges to the Process of Informed Consentof Informed Consent

Recommendations, persuasion Recommendations, persuasion vs. coercionvs. coercion

Challenges to the Process Challenges to the Process of Informed Consentof Informed Consent

Recommendations, persuasion Recommendations, persuasion vs. coercionvs. coercionResearch with minorsResearch with minors

SummarySummaryRespect for personsRespect for persons is manifest in the is manifest in the expectations of informed consent processexpectations of informed consent processUS regulations emphasize need for US regulations emphasize need for written written informed consentinformed consent and the and the elements to be elements to be includedincluded in the consent processin the consent processWhen aimed at enhancing protection of When aimed at enhancing protection of subjects, subjects, modifications modifications to the informed to the informed consent process consent process can be authorizedcan be authorized by the by the IRBIRB