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

2. 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 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 Emphasis on informed consent as a process, not an isolated act

3. Informed Consent What is it? It is a particular kind of action by individual patients and subjects: an autonomous authorization 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...

4. Elements of Informed Consent A. Information Disclosure Nuremberg code states that the subject must have “sufficient knowledge” 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 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

5. 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

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

7. Subjects’ Rights Could investigator hold back information for “subject’s good”? Real concern should be on respecting subjects’ legally protected rights Real concern should be on respecting subjects’ legally protected rights “therapeutic privilege” is an exception only in clinical instances, not in research “therapeutic privilege” is an exception only in clinical instances, not in research

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

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

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

11. Competence 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

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

13. 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 Reasonable person standard Best interest judgment standard Best interest judgment standard

14. 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

15. Elements of Informed Consent C. Comprehension Focuses on subject’s understanding Focuses on subject’s understanding Subject’s competence partly depends on understanding Subject’s competence partly depends on understanding No understanding, no intentionality No understanding, no intentionality Autonomous authorization requires sufficient understanding Autonomous authorization requires sufficient understanding

16. Comprehension 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

17. Comprehension Its object Risks of study, real & potential Risks of study, real & potential Benefits Benefits Procedure to be used Procedure to be used Duration Duration Purpose (therapeutic???) Purpose (therapeutic???)

18. Comprehension Standard requirement? Substantial understanding, or Substantial understanding, or Full understanding Full understanding Substantial understanding – understands not only what one is authorizing, but essentially that it is the self issuing the authorization 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 Underscores subject’s exercise of autonomy

19. Elements of Informed Consent D. Voluntariness Focuses on influences which impair the subject’s right of self-determination Focuses on influences which impair the subject’s right of self-determination Such influences could be manipulative or coercive Such influences could be manipulative or coercive Subject acts voluntarily only when he/she acts free of others’ influence Subject acts voluntarily only when he/she acts free of others’ influence

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

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

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

23. 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?

24. Recap 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?