Transcript No Slide Title

Informed Consent
Anthony Cozzolino, M.D.
Chief Psychiatrist – Valley Medical Center
Adjunct Clinical Faculty- Stanford University
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
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
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
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
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
Historical Perspectives (cont.)
Salgo v. Leland Stanford Jr University 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
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
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
“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
Components of Informed Consent
1- Disclosure
2- Lack of coercion- voluntariness
3- Competency
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
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)?
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
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?
Levels of competency:
-Simple choice- least restrictive, lowest level
-Demonstrated understanding
-Reasoning
-Appreciation
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; 134:279284
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
Competency (cont.)
1- A mental disorder should not prevent a patient from understanding what s/he
consents to.
2- A mental disorder should not prevent a patient from choosing decisively
for/against the intervention.
3- A mental disorder should not prevent a patient from communicating his/her
consent (presuming that at least reasonable steps have been taken to
understand the patient's communication if present at all)
4- A mental disorder should not prevent a patient from accepting the need for a
medical intervention.
J Med Ethics 2003;29:41-43
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?
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
Clinical applications
• Hospitalization
• Medications
• ECT
• Psychotherapy
• Human subjects research
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
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
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
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
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
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
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
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
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
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
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
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?
Q & A……………