INFORMED CONSENT

1. INFORMED CONSENT PATIENT PARTICIPATION IN HEALTH CARE

2. ADVANTAGES OF INFORMED CONSENT I • BOND OF MUTUAL TRUST BETWEEN PATIENT AND PHYSICIAN. • OPENING IMPORTANT PATHWAYS OF COMMUNICATION. • PATIENTS TAKE A GREATER MEASURE OF RESPONSIBILITY. • MORE EXTENSIVE KNOWLEDGE OF THEIR CONDITION. • IMPACT ON PERSONAL LIFESTYLE.

3. ADVANTAGES OF INFORMED CONSENT II • MORE EFFECTIVE CARING FOR PATIENTS. • INFORMATION ABOUT PATIENTS. • VALUE BASIS FOR GRANTING OR WITHHOLDING CONSENT. • REDUCES LIABILITY EXPOSURE. • MAINTAIN AVENUES OF COMMUNICATION WHEREBY CONFLICTS CAN BE RESOLVED WITHIN THE RELATIONSHIP WITHOUT THE COURTS.

4. GENERAL COMPONENTS OF INFORMED CONSENT I • CONDITION. • DIAGNOSIS. • PROGNOSIS. • AVAILABLE TREATMENTS.

5. GENERAL COMPONENTS OF INFORMED CONSENT II • PROPOSED TREATMENT. • NATURE. • PURPOSE. • RISKS. • BENEFITS. • REASONABLE ALTERNATIVES. • COST???

6. INFORMED CONSENT CONSIDERATIONS I:President’s Commission (1982) • INTEGRAL PART OF A PLURALISTIC SOCIETY WITH MULTIPLE VIEWS OF THE “GOOD LIFE.” • BASIC VALUES UNDERLYING INFORMED CONSENT. • PERSONAL WELL-BEING. • SELF-DETERMINATION. • SHARED DECISION MAKING --- MUTUAL RESPECT.

7. INFORMED CONSENT CONSIDERATIONS II:President’s Commission (1982) • PRESUMPTION OF CAPACITY TO MAKE DECISIONS. • CAPCITY IS SPECIFIC TO EACH DECISION. • CONSULTATION IN CASES OF INCAPACITY. • INFORMATIVE BUT NOT DETERMINATIVE.

8. LEVELS OF RECEIVING INFORMATION • FACTS. • PATIENT IS MERELY ACQUAINTED WITH A BODY OF FACTUAL KNOWLEDGE WHICH MAY BE FAIRLY DISCRETE AND UNRELATED. • UNDERSTANDING. • PATIENT HAS MASTERED THE FACTS AND IS ABLE TO SEE THE RELATIONS BETWEEN THEM “AT A DISTANCE.”

9. LEVELS OF RECEIVING INFORMATION • PROCESSING. • PATIENT HAS INTEGRATED FACTS INTO HIS/HER VALUE CONTEXT.

10. EXCHANGE OF POWER • INFORMATION EMPOWERS THE PATIENT. • CONSENT EMPOWERS THE PHYSICIAN. • DYNAMICS OF NEGOTIATION ARE ESSENTIAL TO RELATIONSHIPS OF POWER.

11. SURROGATE STANDARDS:SUBSTITUTED JUDGMENT I • DECISION THAT THE INCAPACITATED PERSON WOULD MAKE IF HE/SHE WERE ABLE TO MAKE A CHOICE. • DECISION THROUGH THE “VALUE EYES” OF THE INCAPACITATED PERSON.

12. SURROGATE STANDARDS:SUBSTITUTED JUDGMENT II • BASED UPON: • DIRECT STATEMENTS BY PATIENT. • INFERENCES FROM VALUE CHOICES OF PATIENT. • GROUNDED IN THE PRINCIPLE OF AUTONOMY. • SUBSTITUTED JUDGMENT STANDARD IS PREFERABLE BUT BEST INTEREST STANDARD IS PERMITTED AND OFTEN NECESSARY.

13. SURROGATE STANDARDS:BEST INTEREST I • “OBJECTIVE STANDPOINT.” • PROMOTE PATIENT’S GOOD. • REFERENCE TO THE INCAPACITATED PATIENT’S ACTUAL OR SUPPOSED PREFERENCES.

14. SURROGATE STANDARDS:BEST INTEREST II • WEIGHING BENEFITS AND BURDENS. • “REASONABLE” PERSON LOOKING AT CLINICAL OUTCOMES. • SELF-REFLECTIVE. • RELATIVELY UNBIASED. • ATTEMPTING FACT-BASED OBJECTIVITY. • SETTING ASIDE SELF-INTEREST. • GROUNDED IN THE PRINCIPLE OF BENEFICENCE.

15. MODELS OF IMPLEMENTING INFORMED CONSENT:EVENT MODEL • DISCRETE ACT. • MINIMAL LEGAL REQUIREMENT. • CONSENT FORM AS A SYMBOL. • HOW MUCH DO PATIENTS TRULY UNDERSTAND?

16. MODELS OF IMPLEMENTING INFORMED CONSENT:PROCESS MODEL I • ACTIVE PATIENT PARTICIPATION IN DECISION MAKING. • ROLE EXPECTATIONS OF PHYSICIANS AND PATIENTS. • IMPORTANCE OF PATIENT’S PERSONAL AND VALUE HISTORY.

17. MODELS OF IMPLEMENTING INFORMED CONSENT:PROCESS MODEL II • PATIENT RESPONSIBILITY. • MUTUAL MONITORING. • CONTINUAL DIALOGUE. • CONTINUAL RUMINATION AND REORDERING OF KNOWLEDGE IN LIGHT OF NEW INFORMATION AND EXPERIENCE.

18. STRATEGIES FOR PROCESS MODEL I • DEFINE PROBLEM. • ESTABLISH RESPONSIBILITY. • PERSONAL AUTONOMY. • NORMAL PART. • GETTING WELL. • MANAGING A DISEASE. • SET GOALS FOR TREATMENT. • SELECT APPROACH TO TREATMENT.

19. STRATEGIES FOR PROCESS MODEL II • SET GOALS FOR TREATMENT. • SELECT APPROACH TO TREATMENT. • FOLLOW-UP IN EXTENDED TREATMENT. • SOLICIT PATIENT REFLECTIONS.

20. COMMUNICATION ANDINFORMED CONSENT I • ACCURATE INFORMATION. • INFORMATION IN AN UNDERSTANDABLE WAY. • PROCESSING INFORMATION WITHIN PATIENT’S VALUES AND GOALS.

21. COMMUNICATION AND INFORMED CONSENT II • EXPLORING FEELINGS. • SHARING RESPONSIBILITY. • AVOIDING EUPHEMISMS AND DOUBLE MESSAGES. • SUPPORTING PATIENT IN THE DECISION.

22. PROBLEMS IN INFORMED CONSENT I • COMMUNICATION. • TIME. • EFFICIENCY. • LANGUAGE. • UNCERTAINTIES. • PROBABILITIES.

23. PROBLEMS ININFORMED CONSENT II • TRUST. • IN PHYSICIAN. • IN PATIENT. • PATIENT’S VALUE CONTEXT. • WHAT PATIENT CONSIDERS BENEFICIAL. • PATIENT’S TOLERANCE LEVEL FOR RISKS --- MORBIDITY, MORTALITY. • PATIENT’S FEAR LEVEL.

24. PROBLEMS IN INFORMED CONSENT III • INEQUALITY OF PATIENT AND CAREGIVER. • KNOWLEDGE BASE. • VARIABILITY OF VALUES. • EXPERIENCE. • VULNERABILITY. • PRESUMING TOO MUCH KNOWLEDGE FROM PATIENT. • SPECIFICITY IN CONSENT FORM.

25. PROBLEMS ININFORMED CONSENT IV • TESTING UNDERSTANDING. • REPEATING WORDS. • SIGNIFICANCE FOR LIFESTYLE. • ROLE OF SURROGATES. • DECISIONAL CAPACITY. • VARYING WISHES OF PATIENTS AND SURROGATES.

26. PROBLEMS ININFORMED CONSENT V • ROLE OF CAREGIVERS. • PROVIDE INFORMATION. • PROCESS INFORMATION. • RESOURCE ISSUES. • STANDARDS. • REASONABLE PHYSICIAN. • REASONABLE PATIENT.