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Informed Consent: Requirements. Ben Faneye, OP, DHCE West African Bioethics Training Program. 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

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Informed consent requirements

Informed Consent:Requirements

Ben Faneye, OP, DHCE

West African Bioethics Training Program

Informed consent
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

Informed consent1
Informed Consent

  • What is it?

    • It is a particular kind of action by individual patients and subjects: an autonomous authorization

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

      • A subject’s right which prevails . . .

Elements of informed consent
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

Information disclosure
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

Freedom of choice
Freedom of Choice

  • It is subject’s 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

Subjects rights
Subjects’ Rights

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

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

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

Subjects rights1
Subjects’ Rights

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

    • Investigator’s duty not to constitute hindrance or interference

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

Elements of informed consent1
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


  • 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 subject’s well-being could be posed in determining such boundary


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

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


  • Task/decision specific

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


  • 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

Competence determination
Competence Determination

  • Reasonable outcome of choice – paternalistic in approach

  • Ability to understand facts presented during the consent process

  • Rational capacity to apply information to one’s situation

  • An understanding of oneself being invited to be a subject and its implications

Elements of informed consent2
Elements of Informed Consent

  • C. Comprehension

    • Focuses on subject’s understanding

    • Subject’s competence partly depends on understanding

    • No understanding, no intentionality

    • Autonomous authorization requires sufficient understanding


  • Subject’s 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


  • Its object

    • Risks of study, real & potential

    • Benefits

    • Procedure to be used

    • Duration

    • Purpose (therapeutic???)


  • 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 subject’s exercise of autonomy

Elements of informed consent3
Elements of Informed Consent

  • D. Voluntariness

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

    • Such influences could be manipulative or coercive

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


  • Essence of Voluntary action

    • Individually willing an action

    • Act of will follows from self-intention

    • Intention flows from understanding of information


  • 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 Nuremberg’s intent in stressing “voluntary consent.”


  • Influences on Voluntariness

    • A. Coercion

      • Intention to control another’s will

      • By presenting what amounts to an irresistible threat

    • B. Manipulation

      • Intentional and successful control of another through the alteration of choices


  • 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?


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

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