1. C. RONALD KOONS, MD, FACP CLINICAL. PROF. MEDICINE, ETHICS UC IRVINE JULY 2014 Informed Consent; Why, Must We and How?

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3. “Information is abundant. Wisdom is Scarce.”

4. Consent from Whom? PATIENT:  Sick.  Wishes to get better.  Doesn’t know how to get better.  A Human being.  Respect.  Trust.  Walk their Path.  Professionalism.  Self - respect for your standards.

5. The BASICS of I.C. 1) MD decides management needed. 2) Capacity: Pt., surrogate (agent). 3) Competence of MD, Resident, Nurse Practitioner. 4) Pt. understands the illness. 5) Goal or nature of Proposed Treatment.

6. The BASICS of I.C. 6) All reasonable treatment options. 7) Include option, not to undergo Rx. 8) The most likely benefits and burdens for each of the reasonable options. 9) Your recommendation, and reasons. 10) (Did Pt. understand what you said?)

7. BASICS 11) MD’s financial and research interests. 12) Possible presence of Industry manufacture’s representative being present. 13) Both MD and Pt. sign and date. 14) Witness needed ONLY if signed with “X” or obtained telephonically. 15) Good for 90 days, or until situation changes.

8. When to Get Signed Informed Consent 1. Prior to all invasive or operative procedures. 2. For administration of blood. 3. For use of Investigational drugs or treatment. Research Unapproved use 4. When patient seems reluctant? 5. Before examining.

9. Signed consent NOT needed: Minor, everyday, routine procedures, i.e. blood drawing, lab. and x-ray, P.E. Medical emergency: immediate pain relief, immediate diagnosis and treatment if condition would lead to serious disability or death. Must put note in chart as to why you did what you did.

10. Who Signs the Consent? Adult patients. (≥ 18) Any emancipated minor. Legal Surrogate or Conservator. Family (spouse, children, parent, sibling, etc.) DOCTOR ! SIGN-DATE-HOUR

11. BEING HUMAN ! Honest & balanced information. YOU must be respected and trusted ! Patient’s comprehension & understanding. Time (Amount depends on the seriousness & importance of the decision, Pt. questions, fears & concerns, etc.) It’s NOT only the Science of Medical Care, but also the Art of Medical Care that counts. “Walk their path with them.” “See things through their eyes.”

12. Common Misunderstandings ► Consent that is not “fully” informed is not informed consent. ► Consent is not a piece of paper. (It is a process.) ► A signature on a form is informed consent. ► “Consenting a patient” is impossible. (it is the patient that must consent, not you.) ► The purpose of informed consent is to protect the Patient. (It is not for the benefit of the Doctor.)

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14. Two “Standards”  Some state laws adhere to “the reasonable person standard”: what would a reasonable person want to know?  Some state laws adhere to “the reasonable physician standard”: what does the professional standard of practice require you to divulge?  Forget legal concerns. Humanness & shared decision- making trumps.

15. The History of Informed Consent  Schloendorf, 1914: “Every human being of adult years and sound mind has a right to determine what shall be done with his own body” (Benjamin Cardozo)

16. The History of Informed Consent  Nuremberg Trial of Physicians, 1949 Principle One: “The voluntary consent of the subject is absolutely essential.” (American lawyers and judges)

18. Shared Decision-Making 1. Doctor, the expert on the disease, tells the Pt. about the disease, untoward effects, prognosis and recommended treatment. 2. Patient, the expert on the patient, tells the doctor what he/she would like to do. 3. If both are not going the same direction, try to find a common path or goal.

19. What you see as the disease...

20. PEOPLE MAY NOT REMEMBER EXACTLY WHAT YOU DID, OR WHAT YOU SAID. ~BUT~THEY WILL ALWAYS REMEMBER HOW YOU MADE THEM FEEL. Be A Team ROLE-MODEL “Patience & Wisdom”

21. PATIENCE AND WISDOM

22. My thanks for your attention. Now allow me to LISTEN to your thoughts & questions.

23. Californians’ Attitudes Almost 80% say they definitely or probably would like to talk with a doctor about end-of-life wishes, but only 7% have had a doctor speak with them about it. Two-thirds of Californians say they would prefer a natural death if they were severely ill. Only 7% say they would want everything done to prolong life. Coalition for Compassionate Care of California California HealthCare Foundation

24. Capacity CA probate Code-Health Care Decisions Law Section 4609: “Capacity” means a person’s ability to understand the nature and consequences of a decision and to make and communicate a decision, and includes in the case of proposed health care, the ability to understand its significant benefits, risks, and alternatives.

25. Barriers to Capacity Barriers (sedating meds., time, privacy, interpreter, serious illness) If Pt. has formed an opinion, what is the basis for that decision? Is decision stable over time? Are there underlying social issues? Are there underlying family issues?

26. Capacity Things that MAY NOT influence capacity:  IQ, Intelligence  Mental illness  Dementia  Severity of illness  Fear, apprehension  Age ( young, old.)

27. ? The American Journal of Bioethics Volume 12, Issue 3, 2012 Volume 12Issue 3 1) Saying Things the “Right” Way: Avoiding “Nocebo” Effects and Providing Full Informed Consent 2) Nocebo and Informed Consent in the Internet Era