Informed Consent

1. Informed Consent Anthony Cozzolino, M.D. Chief Psychiatrist – Valley Medical Center Adjunct Clinical Faculty- Stanford University

2. Objectives • To review the history of the concept of informed consent • To understand the main components of informed consent • To review the process of informing patients in clinical practice • To understand the clinical applications of informed consent • To define the exceptions to informed consent • Discuss recent cases related to capacity to consent

3. General concepts • Competent individuals have a right to make informed treatment • decisions for themselves, including accepting or refusing treatment, free from coercion • You have a right to be told the major risks of any treatment and the alternatives • to the treatment • Concept of Battery • - unpermitted, intentional, or reckless contact with another person

4. Sample case of Battery by a physician: A physician has determined that a patient requires surgery on his right ear. The patient gives informed consent for the procedure. With the patient under anesthesia, the surgeon additionally operates on the patient’s left ear, which the surgeon deemed as necessary and explained to the patient at the followup appointment. Complications and damage occurred from the surgery. The patient sued and obtained a verdict of battery rather than negligence. J Contemp Health Law Policy. 2002;18:373–419

5. Historical Perspectives • Hippocrates • Concept of “benevolent paternalism” • Emphasis on benefit of individual and avoiding harm most important • Focus on patient care and outcomes rather than patient rights • Disclosure considered potentially harmful

6. Historical Perspectives Schloendorff v. Society of New York Hospital - 1914 - woman enters hospital with stomach pain, consented to ether examination - under ether, fibroid tumor resection performed - infection, gangrene, amputation of fingers resulted “In the case at hand, the wrong complained of is not merely negligence. It is trespass. Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault, for which he is liable in damages”. - Justice Benjamin Cardozo • What is sound mind? • How should the decision be made? University of Buffalo Center for Clinical Ethics and Humanities in Health Care

7. Historical Perspectives (cont.) • Salgo v. Leland Stanford JrUniversity Board of Trustees (1957) • 55 y.o male h/o arteriosclerosis, symptoms of lower extremity cramping, back, hip pain on exercise • - Surgeon recommended translumbar aortography, explained only that condition was serious • Patient agreed to procedure, developed permanent lower extremity paralysis • - Patient claimed not informed of risks prior to procedure • Holding of Court: • Physicians will be liable if they withhold facts that are “necessary to form the basis of an intelligent consent”. • Concept of informed consent first elaborated

8. Standards of consent “Reasonable Practitioner” standard: Natanson v. Kline (1960) - patient among the first in U.S. to receive cobalt radiation for breast cancer - patient claimed radiologist inadequately informed her of risks beforehand - was burned by cobalt irradiation following a mastectomy Court held necessary elements of disclosure includes: - nature of illness - nature of proposed treatment and its likelihood of success - risks of untoward outcomes - availability of alternative modes of treatment

9. How much should be disclosed? Natanson court established that the physician is required to disclose only that which the “reasonable medical practitioner” would disclose under similar medical circumstances. - assumed consensus within the medical profession regarding appropriate disclosure - began charge of negligence rather than battery

10. “Reasonable Person” standard: • Canterbury v. Spence (1972) • 19 y.o. with back pain agreed to laminectomy procedure • - surgeon informed no more dangerous than ordinary operation • - individual and mother consented • - resulted in paralysis- sued surgeon • challenged reasonable practitioner standard • shifted focus from what physicians generally do to what patients might want • to know • did not consider needs of particular patient, but what a • hypothetical reasonable person would want to know • court may have considered affect of increased malpractice liability that may follow

11. Components of Informed Consent 1- Disclosure 2- Lack of coercion- voluntariness 3- Competency

12. Disclosure: adequate information • Must inform of nature of illness, risks/benefits of recommended treatment • Discuss risks/benefits of alternative treatments or no treatment • Limits on confidentiality

13. 1- Would a rational person want to know all significant harms and benefits of a treatment? 2- How much disclosure is too much? 3- How likely must harm be to require disclosure (1/10, 1/1,000, 1/10,000)? - different or single standard? 4- Is type of harm relevant to decision (e.g. death vs. tinnitus)?

14. Lack of coercion – “Voluntariness” • Clear-cut only in extreme examples • Voluntariness vs. “appropriate persuasion” • - Is telling a suicidal patient that will be hospitalized if non-compliant coercive? • “Paternalism” • Is hospital environment “inherently coercive”? • - argued in case of Kaimowitz v. Michigan Department of Mental Health (1973) • - impossible to feel free of coercion when release from hospital depended on consenting to psychosurgery

15. Competency • Adults assumed to be competent - minors assumed to lack competency • Psychiatrist frequently called to assess competency in hospital settings for treatment refusal • Global vs. decisional competency: may lack competency for a specific decision but not others • Appreciation of information or understanding (e.g. delusional individual • believing is superman) • Question: • If an individual is actively psychotic is he/she not competent to make a decision?

16. Levels of competency: • Simple choice- least restrictive, lowest level • Demonstrated understanding • Reasoning • Appreciation

17. Competency (cont.) Competent if: 1- Pt evidences a choice (least restrictive criterion) - may be appropriate for low-risk decisions 2- Evidences a choice that the clinician believes would lead to a reasonable outcome 3- Has ability to understand the information disclosed 4- Actually understands the information disclosed 5- Applies rational reasoning in the decision 6- Demonstrates consistency of reasoning over time Roth, Meisel and Lidz review: Tests of competency to consent to treatment. Am J Psych 1977; 134:279-284

18. Competency (cont.): • Not competent if: • Unable to express a decision or preference for treatment • Unable to understand current clinical situation and consequences • Unable to understand information necessary to make a choice • Unable to offer reason for decision or preference • Cannnot explain risks and benefits of treatment options

19. Competency (cont.) • 1- A mental disorder should not preventa patient from understandingwhat s/he consents to. • 2- A mentaldisorder should not prevent a patient from choosingdecisivelyfor/against the intervention. • 3- A mental disorder should notprevent a patient from communicatinghis/her consent (presumingthat at least reasonable steps havebeen taken to understandthe patient's communication if presentat all) • 4- A mentaldisorder should not prevent a patient from acceptingthe needfor a medical intervention. J Med Ethics 2003;29:41-43

20. Case example: Competency Mr. Taylor is a 65 year-old, retired farmer, with a h/o CAD s/p stroke and mild memory impairment. One year prior he had a skin lesion found to be malignant melanoma, and was treated with surgery and chemotherapy. Recently, his cancer has recurred, and is now more widespread than before. At the time of his current admission, he is informed by his doctors that he is terminally ill. His doctors are recommending further debulking surgery and chemotherapy, explaining that these procedures are likely to prolong his life by several months and relieve much of his pain. Mr. Taylor has refused these treatments, stating that he simply prefers to go home and await his death. Psychiatric consultation is ordered and obtained and he is found to not have depression. He demonstrates mild cognitive deficits including an inability to perform serial sevens and recalls one of three simple words after five minutes. He appears to understand his medical situation adequately, knows the facts about his illness, and the risks of not receiving treatment. Should the patient’s wishes be overruled?

21. Process of informing 1- One-time disclosure at initiation of treatment or intervention 2- Process model - continue to update and inform over time - e.g. following remission of psychotic symptoms - encourage patient to ask for additional information at time points Printed forms most commonly used for documenting disclosure, or chart documentation - not a substitute for direct discussion

22. Clinical applications • Hospitalization • Medications • ECT • Psychotherapy • Human subjects research

23. Human Subjects Research • Nuremberg trial (1946) • Medical atrocities by Nazi personnel- 23 physicians and scientists • Thousands of concentration camp victims used for experiments without consent • Resulted in deaths or disability • Nuremberg Code - human subjects protection • - origin of modern ethics in experimental research • - drafted by Dr. Andrew Ivy • - 10 principles of medical ethics related to research • - approved by AMA 1946 • - subsequently amended - adopted worldwide www.forensic-psych.com/catProfEthics.html

24. Human Subjects Research (cont.) • Necessary components of consent • Statement that is research study, explanation of nature,purpose of study • Expected duration of participation • Description of procedures • Description of which interventions are experimental • U.S. Office for Human Research Protections (OHRP) Code of Federal Regulations

25. Human Subjects Research (cont.) • Review of reasonably foreseeable risks or discomforts and benefits • - if “more than minimal risk” procedure, explain treatment or compensation if injury occurs • - more than minimal risk defined as greater than that encountered in daily life • Explain methods of maintaining confidentiality • Explain who to contact for questions • Statement that participation is voluntary and may be withdrawn at any time- refusal to participate will involve no penalty U.S. Office for Human Research Protections (OHRP) Code of Federal Regulations

26. Consent and psychotherapy: A double-edged sword1 • Pros: • 1- Psychotherapy is a valid medical treatment therefore therapists have same obligations • 2- allows patients greater autonomy and input into care • 3- decreases dependency and allows a shared liability between therapist and patient • Cons: • 1- Risks nor the benefits clearly known at the outset - unpredictability • 2- Disclosure may hamper progress of therapeutic process • 3- Appearance of legalistic approach rather than therapeutic • Should discuss: • 1- mode of psychotherapy, potential risks, benefits, and alternatives to recommended treatment “as early as feasible”2 • 2- cost, negative transference, regression, depression, limitations on confidentiality 1-Gutheil, Thomas: American Journal of Psychiatry 2001 2-American Psychological Association, 2002, p. 1072

27. Exceptions/variations of informed consent • 1- Implied consent • - individual enters doctor’s office presumed to be seeking treatment • - should be applied cautiously and only to certain low risk treatments • 2- Individual lacks decisional capacity • - requires disclosure to third-party decision maker • - should still offer information that patient can process (minors) • - attempt second opinion • 3- Emergencies • - presumption of consent • - time to obtain usual disclosure would present substantial risk American Psychiatric Association resource document 1996

28. Exceptions and variations to informed consent (cont.) 4 - Patient waivers- patient allows physician to make decisions - inform patient that is entitled to receive information including at later date, designate third-party for disclosure - pt may retain right to consent but waive right to disclosure 5 - Involuntary treatment - patient refusal overridden by clinical and judicial review

29. Therapeutic privilege: May information be withheld from a patient? • Physician decides not to inform due to potential harm • Allowed in some jurisdictions when disclosure may be harmful to the patient • - example of unstable cardiac arrythmia, anxiety of disclosure may exacerbate • - harm is not result of patient’s decision not to receive treatment

30. Special populations/controversies • Geriatrics • - nursing home placement, dementia patients • Minors • Developmentally disabled • Terminally ill • Informing family members, partners • Consent to not know (waivers) • Advance directives

31. Case example: Starchild “Abraham Cherrix” – Decisional Capacity of a minor and Parental Rights vs. Government Intervention 15 year-old boy received 4 rounds of chemotherapy for Hodkin’s Lymphoma - experienced significant side effects: weight loss, fatigue, hair loss, severe nausea - therapy significantly reduced tumor mass, did not remit - additional chemotherapy and radiation recommended by oncologists Associated Press- July 22, 2006

32. Starchild (cont.) • Pt response: • “I believe this massive dose of chemo and radiation would finish • me off completely…This is my body, and my parents have the right to help • me take care of it... I would rather die healthy and strong and in my house than die in a hospital bed, bedridden and unable to even open my eyes.” • Patient and parents refused chemotherapy treatment • - preferred alternative treatment- herbal supplements and organic diet from clinic in Mexico: “Hoxsey regimen” • - from Harry Hoxsey- previously accused by FDA of encouraging unfounded • treatments and died from cancer himself • Treating physicians appealed to social services agency

33. Starchild (cont.) • Juvenile Court judge ruling: • - parents negligent • - minor must report to hospital immediately to continue treatment as scheduled • - court to have joint custody of child with parents • Parents appealed • - Virginia appeals court decision concurred with parents, stayed order until trial • - Ultimately allowed continuation of alternative treatment as long as oncologist familiar with alternative treatment supervised

34. Should evidence for “alternative treatment” be relevant? Case of alternative vs. conventional medicine? Would the case be different if an adult chose an unproven treatment?

35. Q & A……………