Informed Consent: Requirements

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 • 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 • 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” • 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 • 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

7. 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

8. 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)

9. 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

10. 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 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 • 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 • Subject’s competence partly depends on understanding • No understanding, no intentionality • 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 • Benefits • Procedure to be used • Duration • Purpose (therapeutic???)

18. 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 subject’s exercise of autonomy

19. 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

20. Voluntariness • Essence of Voluntary action • Individually willing an action • Act of will follows from self-intention • 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 • 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

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?