Informed Consent: Requirements

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Informed ConsentRequirements

• Ben Faneye, OP, DHCE
• West African Bioethics Training Program

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Informed Consent

• What is it?
• A process by which a person authorizes medical
  treatment or care once a provider has disclosed
  information regarding the nature, benefits and
  risks of treatment
• Emphasis on informed consent as a process, not an
  isolated act

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Informed Consent

• What is it?
• It is a particular kind of action by individual
  patients and subjects an autonomous
  authorization
• Emphasis on the patient/subjects exercise of
  autonomy, which is an authorization done without
  any external interference
• A subjects right which prevails . . .

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Elements of Informed Consent

• A. Information Disclosure
• Nuremberg code states that the subject must have
  sufficient knowledge
• This obliges the investigator to furnish human
  subjects such information as nature, duration,
  purpose, method/means to be used, inconveniences
  risks that could be reasonably expected

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Information Disclosure

• Merely presenting information does not mean
  subject gives consent freely
• Disclosure should empower subjects by helping
  overcome obstacles to choice
• Empowerment enhances right to self-determination

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Freedom of Choice

• It is subjects right, which imposes duty on
  researcher to disclose. Its ensures that
• Subject has legal capacity to consent
• Situated as to exercise power of choice freely
  (from fraud, deceit, force, etc.)
• Have sufficient comprehension to aid an
  enlightened decision
• Have sufficient knowledge to base decision on

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Subjects Rights

• Could investigator hold back information for
  subjects good?
• Real concern should be on respecting subjects
  legally protected rights
• therapeutic privilege is an exception only in
  clinical instances, not in research

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Subjects Rights

• Subjects have rights to exercise autonomy without
  interference, which means that
• Investigators duty not to constitute hindrance
  or interference
• By giving pertinent information to subjects
  (complete Vs. substantial)

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Elements of Informed Consent

• B. Competence
• Legal term indicating ability to perform a task,
  e.g., making a decision
• Only an autonomous, i.e., competent person, can
  give informed consent
• It is a continuum concept, ranging from full
  competence to full incompetence

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Competence

• Threshold concept
• A minimum limit above which a subject is deemed
  competent, and below which incompetence is
  declared
• Questions peculiar to a study in relation to
  subjects well-being could be posed in
  determining such boundary

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Competence

• For the competent person, the will power serves
  as the source of authorization or refusal. An
  expression of ones rights
• Social criteria of determining competence
  considers age, experience, maturity,
  responsibility welfare

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Competence

• Task/decision specific
• Not a one-shot determination, which underscores
  informed consent as a process

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Competence

• When subject is deemed incompetent, a proxy
  consent is allowed but no more than minimal risk
  to subject allowed
• Standard followed
• Reasonable person standard
• Best interest judgment standard

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Competence Determination

• Reasonable outcome of choice paternalistic in
  approach
• Ability to understand facts presented during the
  consent process
• Rational capacity to apply information to ones
  situation
• An understanding of oneself being invited to be a
  subject and its implications

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Elements of Informed Consent

• C. Comprehension
• Focuses on subjects understanding
• Subjects competence partly depends on
  understanding
• No understanding, no intentionality
• Autonomous authorization requires sufficient
  understanding

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Comprehension

• Subjects understanding cannot be ascertained
  merely by asking do you understand?
• Focus questions rather on the information given,
  which concerns the particular research study
• Understanding to be determined by how subject
  relates to specific information given

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Comprehension

• Its object
• Risks of study, real potential
• Benefits
• Procedure to be used
• Duration
• Purpose (therapeutic???)

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Comprehension

• Standard requirement?
• Substantial understanding, or
• Full understanding
• Substantial understanding understands not only
  what one is authorizing, but essentially that it
  is the self issuing the authorization
• Underscores subjects exercise of autonomy

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Elements of Informed Consent

• D. Voluntariness
• Focuses on influences which impair the subjects
  right of self-determination
• Such influences could be manipulative or coercive
• Subject acts voluntarily only when he/she acts
  free of others influence

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Voluntariness

• Essence of Voluntary action
• Individually willing an action
• Act of will follows from self-intention
• Intention flows from understanding of information

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Voluntariness

• Acting voluntarily means acting solely on your
  own initiative, free from fear, force, violence,
  ignorance, etc
• Consent that is given by a competent subject
  involuntarily is invalid an indication of
  coercion
• Such violates Nurembergs intent in stressing
  voluntary consent.

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Voluntariness

• Influences on Voluntariness
• A. Coercion
• Intention to control anothers will
• By presenting what amounts to an irresistible
  threat
• B. Manipulation
• Intentional and successful control of another
  through the alteration of choices

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Voluntariness

• Certain populations of people highly dependent
  cannot give voluntary consent, e.g., prisoners,
  psychiatric pts, other institutionalized
  persons (dependency compromises autonomy)
• Patients under physicians care
• Old/poor people?

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Recap

• Informed consent underscores the subjects right
  of self-determination, without which the person
  loses ones dignity
• In light of the Nigerian Factor, what measures
  could investigators take to ensure subjects give
  not only informed, but voluntary consent?