1. Informed Consent Anthony Cozzolino, M.D. Adjunct Clinical Faculty Stanford University School of Medicine Chief Psychiatrist Santa Clara Valley Medical Center

2. Basic concept Competent individuals have a right to make informed treatment decisions for themselves free from coercion - you have a right to be told the major risks of any treatment and the alternatives to the treatment - in practice more complex and confusing

3. Historical Perspectives Schloendorff v. Society of New York Hospital - 1914 “Every person of adult years and sound mind has a right to determine what shall happen with own body”. - Justice Benjamin Cardozo What is sound mind? How should decision be made?

4. Historical Perspectives (cont.) Salgo v. Leland Stanford (1957) Patient receives spinal cord injury following translumbar aortography - patient claimed not informed of risks prior to procedure Holding: 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

5. Standards of consent “Reasonable Practitioner” standard: Natanson v. Kline (1960) -patient claimed to be inadequately informed of the risks beforehand, was burned by cobalt irradiation following a mastectomy Court held necessary elements of disclosure to include: -nature of illness -nature of proposed treatment and it’s likelihood of success -risks of untoward outcomes -availability of alternative modes of treatment Court established that the physician would be 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

6. “Reasonable Person” standard: Canterbury v. Spence (1972) challenged reasonable practitioner standard shifted focus from what physicians generally do to what patients might want to know did not actually require consideration of particular patient’s need, but what a hypothetical reasonable person would want to know courts may have attempted to balance expansion of patient’s rights with increased malpractice liability that may follow

7. 1- Disclosure 2- Lack of coercion 3- Competency Components of Informed Consent

8. Process of informing one-time disclosure at initiation of treatment or intervention process model - continue to update and inform over time -following remission of psychotic symptoms -encourage patient to ask for additional information following initial consent printed forms for documenting disclosure, or chart documentation -not a substitute for direct discussion

9. Disclosure - adequate information must inform of nature of illness, risks/benefits of recommended treatment include risks/benefits of alternative treatments or no treatment limits on confidentiality What would rational person would want to know significant harms and benefits of a treatment? How much is too much? How likely must harm be to require disclosure (1/10, 1/1,000, 1/10,000)? - different or single standard? Is type of harm relevant (e.g. death vs. tinnitus)?

10. Lack of coercion/Voluntariness clear-cut only in extreme example voluntariness vs. “appropriate persuasion” -telling a suicidal patient that will be hospitalized if non-compliant- coercive? “paternalism” 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

11. Competency adult assumed to be competent- minors assumed to lack competency psychiatrist frequently called to assess in hospital settings for treatment refusal global vs. decisional competency -may lack competency for a specific decision appreciation of information or understanding (e.g. delusional individual believing is superman) -choosing- least restrictive, understanding, reasoning, and appreciating Question: If an individual is actively psychotic is he/she not competent to make a decision?

12. Criteria Summary: 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- appear to apply rational reasoning in the decision 4- has the ability to understand the information disclosed 5- actually understands the information disclosed Competency (cont.) Roth, Meisel and Lidz review

13. 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?

14. Clinical applications hospitalization medications ECT psychotherapy human subjects research

15. Human Subjects Research statement that is research study, explanation of nature and purpose of study expected duration of participation description of procedures description of which interventions are experimental review of reasonably foreseeable risks or discomforts and benefits -if “more than minimal risk” procedure, explain treatment of compensation if injury occurs -more than minimal risk defined as greater than that encountered in daily life explanation of method 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

16. Consent and psychotherapy: A double-edged sword Should inform of cost, negative transference, regression, depression, limitations on confidentiality Argument: Psychotherapy is a valid medical treatment, and as such, therapists have same obligations - allows patients greater autonomy and input into care - decreases dependency and allows a shared liability between therapist and patient Counter argument: Neither the risks nor the benefits of psychotherapy can be known at the outset and is therefore unpredictable. -disclosure may hamper progress of therapeutic process Should discuss mode of psychotherapy, potential risks, benefits, and alternatives to recommended treatment Gutheil- American Journal of Psychiatry 2001

17. Exceptions to informed consent individual lack decisional capacity -state law may require disclosure to third-party decision maker -physician may still offer information that patient can process (minors) -attempt second opinion emergencies -presumption of consent -time to obtain usual disclosure would present substantial risk patient waivers -patient allows physician to make decisions -physician should 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 involuntary treatment -patient refusal overriden by clinical and judicial review American Psychiatric Association resource document 1996

18. Therapeutic privilege: May information be withheld from a patient? 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 to not to receive treatment physician decides not to inform due to potential harm

19. Special populations/controversies geriatrics -nursing home placement, Alzheimer’s patients minors developmentally disabled terminally ill informing family members, partners consent to not know advanced directives