Transcript Elements of Informed Consent

Walter Davis, M.D.
Center for Biomedical Ethics
Truth Telling:
From Physician Ethics to
Bioethics
A Case of Disclosure
Miss A has chondrosarcoma. “Tell
me,” she pleads with Dr. B, “do I
really have a cancer?”
Henri de Mondeville,
14th C Physician
• “He (the surgeon) may exaggerate…if the
patient has a bold and hardy spirit, or he
may temper and soften the warnings, or
keep silent altogether if the patient is
faint hearted or good natured.”
• “If the patient is defiant, seldom will the
result be successful.”
Benjamin Rush, 18th C
American physician
• “The people rule here in medicine as well as
government.”
• “…truth is simple upon all subjects….strip our
profession of everything that looks like mystery
and imposture, and clothe medical knowledge
in a dress so simple and intelligible, that it may
become…obvious to the meanest capacities.”
Thouvenal,
19thC French physician
• “It is important for the happiness of all that
man be placed under the sacred power of the
physician. That he be brought up, nourished,
clothed after his counsel and that the systems
according to which he should be governed,
educated, punished, etc., be designed by
him....Who is better qualified to play this role
than the physician who has made a profound
study of his physical and moral nature?”
Physician’s note in 1855 record of New
York Hospital case of 6 year old boy
after a train had crushed his arm
• “Patients friends strongly refuse
to give their consent, and would
rather the child should die than
loose (sic) its arm.”
Legal Theories, Ethical Standardby 1900
Legal Standards
–Battery
–Negligence
Ethical Standard
–Beneficence
“Therapeutic privilege” provided
grounds for physician discretion
Scholendorff v. Society of New
York Hospital, 1914
• Every person of sound mind has the right to
determine what shall be done with his own
body….the surgeon who fails to honor this
right “commits an assault.”
– Justice Benjamin Cardozo
Minimal Legal Requirements
• Disclosure
• Authorization
“What to Tell Cancer Patients”
1956
• Case 10: Concealing the Nature of
His (sic) Disease from a Patient
• Miss A has chondrosarcoma. “Tell me,” she
pleads with Dr. B, “do I really have a
cancer?” Dr. B., knowing that Miss A has
ample time to prepare for death and wishing
to spare her needless mental suffering,
answers, “Your pains are due arthritis.”
• Solution. If Miss A actually has arthritis, or
if Dr. B is convinced that everyone at her
age does have at least a mild case of
arthritis, his answer is not morally wrong.
Explanation: Dr. B does not affirm that Miss A’s
pains are due solely to arthritis. If she does have
arthritis, even in a mild form, Dr. B is justified in
thinking that her pain is due in part to the
arthritis, and hence is answer is not a lie. If Miss
A really wanted the entire truth, she would ask,
“Are all my pains due to arthritis?” In such cases
patients often do not wish to pursue the matter,
preferring to accept an answer which leaves them
with some ray of hope, even though in their
hearts they know what the facts are.
»Healy, 1956
“What to Tell Cancer Patients,”
1961
• “…whether or not physicians tell their
patients they have cancer….[there is] a
strong and general tendency to withold this
information. Almost 90 percent of the
group is within this half of the scale.
Indeed, a majority tell only very rarely, if
ever.
• “Euphemisms are the general rule.”
• “The modal policy is to tell as little as
possible in the most general terms
consistent with maintaining cooperation in
treatment.”
• “The vast majority of these doctors feel that
almost all patients really do not want to
know regardless of what people say.”
• “But the total number of those [physicans]
who said they wished to be told (73 out of
122) is far greater than those who tend to
tell their patients.”
» Oken, JAMA 175, 1961
“Changes in Physicians’ Attitudes
Toward Telling the Cancer
Patient,” 1979
• 98% of those surveyed reported a policy of
disclosure to cancer patients.
» Novack et al., JAMA 241, 1979
• Reasons for these changes
– more treatment options for cancer
– improved survival rates for some forms of
cancer
– fear of malpractice suits
– involvement of team members in hospitals
– altered societal attitudes about cancer
– greater attention to patients’ rights
– physicians’ increased recognition of
communication as an effective means of
enhancing patient understanding and
compliance
» Beauchamp and Childress, 2001
Modern Elements of
Informed Consent
• Threshold Elements (Preconditions)
– Competence (to understand and decide)
– Voluntariness (in deciding)
• Information Elements
– Disclosure (of material information)
– Recommendation (of a plan)
– Understanding (of disclosure and recommendation)
• Consent Elements
– Decision (in favor of a plan)
– Authorization (of the chosen plan)
» Beauchamp and Childress, 2001
What counts as disclosure?
• Professional practice
• Reasonable person
• Particular patient
Possible exceptions to disclosure
requirement
• “Therapeutic exception/privilege”
• Emergency
• Placebo
• Waiver
Clinical research scandals and
lack of disclosure
• (A modest selection in order of discovery)
– Brooklyn Jewish Chronic Disease Hospital,
1963
– Willowbrook State Hospital, 1966
– U.S. Public Health (Tuskegee) Syphilis Study,
1932-72
– Fernald School, early 1950s
– Plutonium injections, 1944-45
Truth-telling and Third Party
Payers
• 70% of physicians in a study indicated that
they would use the words “rule out cancer”
rather “screening mammography” so that a
patient’s insurance would cover costs
• “Rule out cancer” was to be used only if
there was evidence of a breast mass or
objective clinical evidence of breast cancer.
• 85% of respondents did not think that “rule
out cancer” was deceiving the company.
» Novak et al., JAMA 261, 1989
• In 1999, nearly 50% of physicians admitted
to exaggerating severity of their patients
medical condition for insurance coverage.
• Late 1990s, 39% of physicians reported
exaggerating severity, altered diagnoses,
and/or reported symptoms patients did not
have to help them obtain coverage.
Truth-telling in Clinical Research
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Single and double-blinded designs
Placebo controls
“Sham” interventions
Adverse events
Financial conflicts of interest