Informed Consent: Requirements

Informed Consent:Informed Consent:RequirementsRequirements

Ben Faneye, OP, DHCEBen Faneye, OP, DHCE

West African Bioethics Training West African Bioethics Training ProgramProgram

Informed ConsentInformed Consent

What is it?What is it? A process by which a person authorizes A process by which a person authorizes

medical treatment or care once a provider has medical treatment or care once a provider has disclosed information regarding the nature, disclosed information regarding the nature, benefits and risks of treatmentbenefits and risks of treatment

Emphasis on informed consent as a Emphasis on informed consent as a processprocess, not an , not an isolated actisolated act

Informed ConsentInformed Consent

What is it?What is it? It is a particular kind of action by individual It is a particular kind of action by individual

patients and subjects: an autonomous patients and subjects: an autonomous authorizationauthorization

Emphasis on the patient/subject’s exercise of Emphasis on the patient/subject’s exercise of autonomy, which is an authorization done without autonomy, which is an authorization done without any external interferenceany external interference

A subject’s right which prevails . . .A subject’s right which prevails . . .

Elements of Informed ConsentElements of Informed Consent

A. Information DisclosureA. Information Disclosure Nuremberg code states that the subject must Nuremberg code states that the subject must

have “sufficient knowledge” have “sufficient knowledge”

This obliges the investigator to furnish human This obliges the investigator to furnish human subjects such information as nature, duration, subjects such information as nature, duration, purpose, method/means to be used, purpose, method/means to be used, inconveniences & risks that could be inconveniences & risks that could be reasonably expected reasonably expected

Information DisclosureInformation Disclosure

Merely presenting information does not Merely presenting information does not mean subject gives consent freelymean subject gives consent freely

Disclosure should empower subjects by Disclosure should empower subjects by helping overcome obstacles to choicehelping overcome obstacles to choice

Empowerment enhances right to self-Empowerment enhances right to self-determinationdetermination

Freedom of ChoiceFreedom of Choice

It is subject’s right, which imposes duty on It is subject’s right, which imposes duty on researcher to disclose. Its ensures that:researcher to disclose. Its ensures that: Subject has legal capacity to consentSubject has legal capacity to consent Situated as to exercise power of choice freely Situated as to exercise power of choice freely

(from fraud, deceit, force, etc.)(from fraud, deceit, force, etc.) Have sufficient comprehension to aid an Have sufficient comprehension to aid an

enlightened decisionenlightened decision Have sufficient knowledge to base decision Have sufficient knowledge to base decision

onon

Subjects’ RightsSubjects’ Rights

Could investigator hold back information Could investigator hold back information for “subject’s good”?for “subject’s good”?

Real concern should be on respecting Real concern should be on respecting subjects’ legally protected rightssubjects’ legally protected rights

““therapeutic privilege” is an exception only in therapeutic privilege” is an exception only in clinical instances, not in researchclinical instances, not in research

Subjects’ RightsSubjects’ Rights

Subjects have rights to exercise autonomy Subjects have rights to exercise autonomy without interference, which means thatwithout interference, which means that

Investigator’s duty not to constitute hindrance Investigator’s duty not to constitute hindrance or interference or interference

By giving pertinent information to subjects By giving pertinent information to subjects (complete Vs. substantial)(complete Vs. substantial)


B. CompetenceB. Competence Legal term indicating ability to perform a task, Legal term indicating ability to perform a task,

e.g., making a decisione.g., making a decision

Only an autonomous, i.e., competent person, Only an autonomous, i.e., competent person, can give informed consentcan give informed consent

It is a continuum concept, ranging from full It is a continuum concept, ranging from full competence to full incompetencecompetence to full incompetence

CompetenceCompetence

Threshold conceptThreshold concept

A minimum limit above which a subject is A minimum limit above which a subject is deemed competent, and below which deemed competent, and below which incompetence is declaredincompetence is declared

Questions peculiar to a study & in relation to Questions peculiar to a study & in relation to subject’s well-being could be posed in subject’s well-being could be posed in determining such boundarydetermining such boundary


For the competent person, the will power For the competent person, the will power serves as the source of authorization or serves as the source of authorization or refusal. An expression of one’s rightsrefusal. An expression of one’s rights

Social criteria of determining competence Social criteria of determining competence considers age, experience, maturity, considers age, experience, maturity, responsibility & welfareresponsibility & welfare


Task/decision specificTask/decision specific

Not a one-shot determination, which Not a one-shot determination, which underscores informed consent as a underscores informed consent as a processprocess


When subject is deemed incompetent, a When subject is deemed incompetent, a proxy consent is allowed but no more than proxy consent is allowed but no more than minimal risk to subject allowedminimal risk to subject allowed

Standard followed:Standard followed: Reasonable person standardReasonable person standard

Best interest judgment standard Best interest judgment standard

Competence DeterminationCompetence Determination

Reasonable outcome of choice – Reasonable outcome of choice – paternalistic in approachpaternalistic in approachAbility to understand facts presented Ability to understand facts presented during the consent processduring the consent processRational capacity to apply information to Rational capacity to apply information to one’s situationone’s situationAn understanding of oneself being invited An understanding of oneself being invited to be a subject and its implicationsto be a subject and its implications


C. ComprehensionC. Comprehension

Focuses on subject’s understanding Focuses on subject’s understanding Subject’s competence partly depends on Subject’s competence partly depends on

understandingunderstanding No understanding, no intentionalityNo understanding, no intentionality Autonomous authorization requires sufficient Autonomous authorization requires sufficient

understandingunderstanding

ComprehensionComprehension

Subject’s understanding cannot be Subject’s understanding cannot be ascertained merely by asking “do you ascertained merely by asking “do you understand?”understand?”Focus questions rather on the information Focus questions rather on the information given, which concerns the particular given, which concerns the particular research studyresearch studyUnderstanding to be determined by how Understanding to be determined by how subject relates to subject relates to specificspecific information information givengiven


Its objectIts object Risks of study, real & potentialRisks of study, real & potential BenefitsBenefits Procedure to be usedProcedure to be used DurationDuration Purpose (therapeutic???)Purpose (therapeutic???)


Standard requirement?Standard requirement? Substantial understanding, orSubstantial understanding, or Full understandingFull understanding

Substantial understanding – understands not Substantial understanding – understands not only what one is authorizing, but essentially only what one is authorizing, but essentially that it is the self issuing the authorizationthat it is the self issuing the authorization

Underscores subject’s exercise of autonomyUnderscores subject’s exercise of autonomy


D. VoluntarinessD. Voluntariness

Focuses on influences which impair the Focuses on influences which impair the subject’s right of self-determinationsubject’s right of self-determination

Such influences could be manipulative or Such influences could be manipulative or coercivecoercive

Subject acts voluntarily only when he/she acts Subject acts voluntarily only when he/she acts free of others’ influencefree of others’ influence

VoluntarinessVoluntariness

Essence of Voluntary actionEssence of Voluntary action

Individually willing an actionIndividually willing an action

Act of will follows from self-intentionAct of will follows from self-intention

Intention flows from understanding of Intention flows from understanding of informationinformation

Voluntariness Voluntariness

Acting voluntarily means acting solely on Acting voluntarily means acting solely on your own initiative, free from fear, force, your own initiative, free from fear, force, violence, ignorance, etcviolence, ignorance, etc

Consent that is given by a competent Consent that is given by a competent subject involuntarily is invalid – an subject involuntarily is invalid – an indication of coercionindication of coercion

Such violates Nuremberg’s intent in Such violates Nuremberg’s intent in stressing “voluntary consent.”stressing “voluntary consent.”


Influences on VoluntarinessInfluences on Voluntariness A. CoercionA. Coercion

Intention to control another’s willIntention to control another’s will

By presenting what amounts to an irresistible By presenting what amounts to an irresistible threatthreat

B. ManipulationB. ManipulationIntentional and successful control of another Intentional and successful control of another through the alteration of choicesthrough the alteration of choices


Certain populations of people highly Certain populations of people highly dependent cannot give voluntary consent, dependent cannot give voluntary consent, e.g., prisoners, psychiatric pts, & other e.g., prisoners, psychiatric pts, & other institutionalized persons (dependency institutionalized persons (dependency compromises autonomy)compromises autonomy)

Patients under physicians’ carePatients under physicians’ care

Old/poor people?Old/poor people?

RecapRecap

Informed consent underscores the Informed consent underscores the subject’s right of self-determination, subject’s right of self-determination, without which the person loses one’s without which the person loses one’s dignitydignity

In light of the Nigerian Factor, what In light of the Nigerian Factor, what measures could investigators take to measures could investigators take to ensure subjects give not only informed, ensure subjects give not only informed, but voluntary consent?but voluntary consent?

Informed Consent: Requirements

Documents

Transcript of Informed Consent: Requirements