1. Informed Consent

2. Informed Consent vs. Informed Refusal A)Informed Consent:For treatment For research 1)voluntary and informed conditions __________________ ___________________________ 2)proxy consent

3. Informed Consent vs. Informed Refusal B)Informed Refusal 1)voluntary and informed conditions __________________ ___________________________ 2)proxy consent 3)advance directives: instructions living wills medical directives durable power of attorney for health care

4. Informed Consent vs. Informed Refusal Informed consent and informed refusal presuppose decision making capacity Advance directives usually apply when there is no decision making capacity The more serious the procedure, the higher the standards for information Information standards are relative to the capacities of the patient Consent vs. Assent

5. Informed Consent for Treatment 1)Risks/Benefits 2)Alternatives (if no treatment?) 3)Second opinion 4)Competence of doctor, team, institution 5)Nature of procedure 6)Life after: Recuperation, bodily, psychological changes

6. 7)Cost 8)Who is involved in treatment (teaching hospital concerns) 9)Patient's role in procedure, recovery 10)Conflicts of interest Informed Consent for Treatment

7. 1)Consent Intentional, the result of deliberation Free, without coercion Authentic, from one's own values and desires 2)Conditions for Informed Consent Information about: * Nature of the research * Therapeutic or non-therapeutic * Risks * Benefits Informed Consent - Research on Human Subjects

8. 2)Conditions for Informed Consent (cont.) Information about: * Who's doing it, competence of investigators * What will be done to subject * Privacy and confidentiality of information * Right to withdraw without penalty * Provisions for adverse circumstances Informed Consent - Research on Human Subjects

9. 2)Conditions for Informed Consent (cont.) Information about: * Amount and level of information is relative to the subject's ability to understand * The greater the risk the higher the standards of information * Are the standards different in therapeutic and non-therapeutic research? Informed Consent - Research on Human Subjects

10. 3)Competence/Decision Making Capacity Informed consent presupposes competence Competence is determined in relation to the task at hand Legal competence/moral competence Conditions for competence: * some degree of self-knowledge and self- awareness * able to process information Informed Consent - Research on Human Subjects

11. 3)Competence/Decision Making Capacity (cont.) Conditions for competence: * able to comprehend information * able to restate information in one's own terms * able to act from stable set of values * free from: acute anxiety acute depression denial Informed Consent - Research on Human Subjects

12. 4)Obstacles to Informed Consent: * Difference in the knowledge base of the doctor and patient * Patients are compromised by illness, anxiety, etc. * Language of probabilities is unfamiliar to lay-persons * Takes too much time * Some patients just don't want to know Informed Consent - Research on Human Subjects

13. 5)Justification for Informed Consent: * Respects autonomy/persons autonomy as a value autonomy as a goal * Respects the right to control what happens to one's body * Respects the right to control access to the self * Promotes greater social goods Informed Consent - Research on Human Subjects

14. 5)Justification for Informed Consent (cont.): * Promotes trust between doctor and patient * Reduces liability and malpractice claims * Can be justified at least on utilitarian, deontological, and rights grounds, also on virtue ethics grounds Informed Consent - Research on Human Subjects