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Informed consent
In California, the current law on informed consent is derived largely from the case of
Cobbs vs. Grant (1972) 8 Cal.3d 229. The judge in an informed consent case may
instruct the jury that “. . . it is the duty of the physician or surgeon to disclose
to the patient all material information to enable the patient to make an informed
decision regarding the proposed operation or treatment.
“Material information is information which the physician knows or should have known
would be regarded as significant by a reasonable person in the patient’s position when
deciding to accept or reject a recommended medical procedure. To be material a fact
must also be one which is not commonly appreciated.
“There is no duty to make disclosure of risks when the patient requests that he or she
not be so informed or where the procedure is simple and the danger remote and commonly
understood to be remote.
“Likewise, there is no duty to discuss minor risks inherent in common procedures, when
such procedures very seldom result in serious ill effects.
“However, when a procedure inherently involves a known risk of death or serious bodily
harm it is the physician’s duty to disclose to the patient the possibility of such
outcome and to explain in lay terms the complications that might possibly occur. The
physician or surgeon must also disclose such additional information as a skilled
practitioner of good standing would provide under the same or similar circumstances.”
[Book of Approved Jury Instructions (BAJI) 6.11]
MIEC’s defense attorneys recommend that doctors tell patients in lay terms the nature
and purpose of the proposed surgery or treatment. (The Cobbs Court stated that “. . .
the patient’s interest in information does not extend to a lengthy polysyllabic
disclosure on all possible complications. A mini-course in medical science is not
required; the patient is concerned with the risk of death or bodily harm, and the
problems of recuperation.”)
The risks, complications, expected benefits of the recommended treatment, as well as
alternatives, including the absence of treatment, and the consequent risks and
benefits should be explained. The physician should advise the patient why one mode of
treatment is more desirable than others, but should not accede to a patient’s demand
for treatment the physician knows would be inappropriate, ineffective, or harmful.
Court rulings address physicians’ concerns that informing patients of the risks of
medical treatment will frighten them and thus make them greater risks: “A physician
has no duty of disclosure beyond that required of physicians of good standing in the
same or similar locality when he or she relied upon facts which would demonstrate to a
reasonable person that the disclosure would so seriously upset the patient that the
patient would not have been able to rationally weigh the risks of refusing to undergo
the recommended [treatment] [operation].” (BAJI 6.11)
This decision to forego the consent discussion so as to not seriously upset the
patient should be very carefully considered and used only in rare
situations. In such cases, defense attorneys advise physicians to have a consent discussion with the
patient’s closest relative. The physician’s reasons for foregoing the discussion
should be documented.
Physicians may be excused from disclosing risks if the patient requests not to be
informed: “There is no duty to make disclosure of risks when the patient requests that
he or she not be so informed or where the procedure is simple and the danger remote
and commonly understood to be remote.” (BAJI 6.11) The patient’s refusal should be
documented.
When a patient is incompetent
Adults who have been legally adjudged to be incompetent usually cannot consent to
medical treatment. Consent must be obtained from the patient’s guardian. There is
little direct authority on the right to consent where an adult has not formally been
adjudged incompetent, but his or her reasoning is impaired due to mental illness,
intoxication, pain or other causes. In the absence of a legal guardian, defense
attorneys advise that the right to consent passes to the patient’s closest available
relative. If there is no relative, emergency consent may be implied if a genuine
emergency exists. If the patient’s mental disability is temporary (for example, if
the patient is delirious with pain), the patient’s own consent for further treatment
must be obtained as soon as he or she is able to reason for him or herself. If the
patient does not possess decision-making capacity, the decision-making authority
passes to: the Attorney-in-Fact under a Durable Power of Attorney for Health Care, if
any; the conservator, if any; the closest available relative; or court order, if
circumstances warrant.
Physicians should be familiar with each hospital’s policy concerning obtaining consent
from legally or mentally incompetent patients.
Consent for treating minors
The age of majority in California is 18 years. A person under the age of 18 lacks the
legal capacity to give consent for medical treatment except under the circumstances
cited below.
Married Minor: Any minor who is or was married (whether or not the marriage has
terminated by divorce) may consent to medical, surgical, psychiatric, or hospital care
without parental consent or knowledge. Health professionals may require the minor to
produce a marriage certificate [Family Code §7002 and §7050 (e)(1)].
Minor Emancipated By a Court
Order: A minor may petition the superior court of the county in which the individual resides, or is temporarily living, for a declaration of
emancipation. The minor must be at least 14 years of age, willingly lives separate and
apart from his or her parents or guardian (who have consented to this arrangement),
and manages his or her own financial affairs [Family Code §7120].
Self-Sufficient
Minor: A person 15 years of age or older living separate and apart from his or her parent(s) or legal guardian, with or without the parents’ consent, and
managing his or her own financial affairs, regardless of the source of income, is
capable of giving consent for medical, surgical, dental, hospital, or psychiatric care
without parental consent, knowledge, or financial liability [Family Code §6922].
Physicians may wish to ask such minors to complete a form which provides information
demonstrating that the minor falls within the statute.
Minor on Active
Duty: Regardless of age, any minor serving on active duty with any branch of United States armed services may consent to treatment without parental
approval [Family Code §7002 and §7050 (e)(1)].
Pregnant Minor: Any minor, without respect to age or marital status can consent to
care for the prevention or treatment of pregnancy, except that a minor cannot consent
to sterilization. A pregnant minor also may consent to an abortion, provided she
demonstrates the requisite understanding and maturity to give her informed consent to
the procedure. The physician is charged with making this determination [Family Code
§6925].
Minor with an Infectious
Disease: A minor who is 12 years or older and may have come into contact with a contagious, infectious, or communicable disease, including
sexually-transmitted disease of the type which must be reported to the local health
officer and a variety of non?reportable sexually?transmitted diseases, may consent to
care related to the diagnosis or treatment of the disease [Family Code §6926].
Rape Victims and Victims of Sexual Assault: A minor age 12 or older who alleges to
have been raped may consent to care related to the diagnosis and treatment of the
condition. A minor under the age of 18 who is alleged to have been sexually assaulted
may consent to treatment for the condition. The health professional providing
treatment to a minor victim of sexual assault must attempt to notify the minor’s
parent(s), and document the contact or unsuccessful effort to reach the parent(s).
Note: The professional person may defer such contact with the parent if he or she
reasonably believes the parent(s) or legal guardian of the minor committed the sexual
assault, in which case the professional should document that contact was not attempted
and why it was not. The professional should also document compliance with sexual abuse
reporting laws when appropriate [Family Code §6927 and §6928].
Minor with Drug or
Alcohol- Related Problems: A minor age 12 years or older may consent to medical care and counseling for drug- or alcohol?related problems.
Counseling services must be rendered by a provider under a contract with the state or
county to provide alcohol or drug abuse services [Family Code §6929(a)
(1)]. [Treatment with methadone and/or levoalphacetylmethadol (LAAM) is excluded.] While the
consent of the parent or guardian is not required, the parent or guardian must be
afforded an opportunity to participate in the treatment or counseling, unless the
treating professional, or treating facility, considers this inappropriate. The refusal
or objection to the minor’s treatment by the parent or guardian so notified does not
require the professional to discontinue the treatment. The treating health
professional must document efforts to contact the parent or guardian or the reasons
why it was inappropriate to make such contact.
Effective January 1, 1997, a parent or legal guardian can seek medical care and
counseling for a drug- or alcohol-related problem of a minor child without the minor’s
consent. In such cases where a parent or guardian sought treatment for a minor, the
physician will disclose medical information concerning the care to the minor’s parents
or legal guardian upon their request, even if the child does not consent to disclosure
[Family Code §6929].
Mental Health Treatment of
Minor: A minor age 12 or older may consent to mental health treatment or counseling on an outpatient basis, or specifically defined residential
shelter services, if the minor is considered: mature enough to intelligently
participate in the program; there is a present danger of serious physical or mental
harm to the minor or others if he or she is not permitted to participate in the
program; or the minor is an alleged victim of child abuse or incest. The minor
described in this section may not receive convulsive therapy, psychosurgery, or
psychotropic drugs without parental or guardian consent. The parent or guardian must
be afforded an opportunity to participate in the treatment or counseling, unless the
treating professional considers this inappropriate. The treating health professional
must document efforts to contact the parent or guardian or the reasons why it was
inappropriate to make such contact [Family Code §6924]. The refusal or objection to
the minor’s treatment by the parent or guardian so notified does not require the
professional to discontinue the treatment.
Other: Minors over the age of 12 may consent to performance of a blood test to detect
HIV antibodies [Health and Safety Code §121020].
Minors 17 and older may consent to donate blood. Minors 15 years and older may consent
to give blood if the minor’s parents or legal guardian and a physician authorize the
donation in writing [Health & Safety Code §1607.5].
A minor’s parent(s) or guardian may sign a statement authorizing a third party to
consent to a minor’s medical care in the parents’ absence. If a physician treats a
minor with the third party’s informed consent, the physician should keep a copy of the
parental authorization in the medical record [Family Code §6910].
Special consent requirements
Physicians should be aware that California law mandates special consent requirements,
including the distribution of certain written information and/or the signing of
specific consent forms for some treatments, procedures, and surgeries. These include:
breast cancer treatment, silicone breast implants and collagen implants, dimethyl
sulfoxide (DMSO) treatment, hysterectomies, prostate cancer treatment, sterilization
for both men and women, assisted reproduction treatment, certain vaccinations for
children and adults, experimental procedures, electroconvulsive therapy, HIV testing,
and the administration of antipsychotic drugs.
Informed consent laws as they apply to blood transfusion lack specificity; however, it
is prudent for physicians to discuss the relevant information with patients, obtain
their informed consent to a blood transfusion, and document the discussion in the
patient’s medical record.
The Paul Gann Blood Safety Act
[Health & Safety Code §1645] makes it mandatory for a physician to inform patients of the benefits and risks of receiving various types of
blood transfusions “whenever there is a reasonable possibility that a blood
transfusion may be necessary as a result of a medical or surgical procedure.” This
requirement applies to all non-emergent medical and surgical procedures, not only
those which are “elective.”
Physicians also are required to dispense to patients a standardized summary of those
options in a brochure entitled, If You Need Blood: A Patient’s Guide to Blood
Transfusion, published by the Department of Health Services (DHS). This is the
responsibility of the physician, rather than the hospital. This brochure may be
purchased from the Medical Board of California, Office of Procurement, Publications
Section, P.O. Box 1015, North Highlands, CA 95660. The standardized literature may be
photocopied. The law requires doctors to note in patients’ charts that the brochure
was dispensed.
Consult MIEC’s Loss Prevention Department for further information about special
consent requirements and corresponding consent forms.
Telemedicine
Amended Business & Professions Code §2290.5 established special informed consent
requirements for the practice of “telemedicine.” Telemedicine is defined as: “...the
practice of health care delivery, diagnosis, consultation, treatment, transfer of
medical data, and education using interactive audio, video or data communications.
Neither a telephone conversation nor an electronic mail message between a health care
practitioner and patient constitutes ‘telemedicine’...”
Before a physician, who “has the ultimate authority over the care and primary
diagnosis of a patient” can deliver any health care via telemedicine, the doctor must
obtain the patient’s or legal guardian’s verbal and written informed consent.
The patient or legal guardian must be informed orally and in writing of: (1) the
option to withhold or withdraw consent at any time with affecting the right to future
care or treatment; (2) a description of the potential risks, consequences and benefits
of telemedicine; (3) all existing confidentiality protections that apply; (4) patient
access to medical information and copies of medical records; (5) consent for the
dissemination of any patient identifiable images or information from the telemedicine
interaction to researchers or others entities. The patient or legal guardian must sign
a written statement prior to the delivery of health care via telemedicine to indicate
understanding of the written information given to the patient or legal guardian. The
consent form must become part of the patient’s chart.
This law does not apply to an emergency situation where the patient is unable to give
informed consent and the patient’s representative “is not available in a timely
manner.” The law also does not apply to a patient who is under the jurisdiction of the
Department of Corrections.
‘Informed refusal’
In 1980, the California Supreme Court created a new legal doctrine, “Informed
Refusal,” which holds that a physician may be liable for failing to tell patients the
consequences of refusing to have diagnostic tests or medical treatment [Truman v.
Thomas (1980) 27 Cal.3d 285, 291].
“It is the duty of a physician to disclose to the patient all material information to
enable the patient to make an informed decision regarding the taking or refusal to
take a diagnostic test.
“Material information is information which the physician knows or should know would be
regarded as significant by a reasonable person in the patient’s position when deciding
to accept or reject the diagnostic test or procedure. To be material, a fact must also
be one which is not commonly appreciated.
“Failure of the physician to disclose to his patient all material information,
including the risk to the patient if the test is refused, renders the physician liable
for any injury, a [proximate] [legal] cause of which was the patient’s refusal to take
the test, if a reasonably prudent person in the patient’s position would not have
refused the test if all material information had been given.” [BAJI
6.11.5]
MIEC’s legal counsel advises physicians to tell patients the consequences of their
refusal in broad terms. It is not necessary to discuss every conceivable problem which
might occur. Just as important as telling the patient the risks of refusal is
documenting that you discussed the possible consequences of refusal. A brief, but
meaningful note suffices. Some doctors write: “Patient refuses test (treatment);
explained consequences of not having treatment and degree of urgency, and patient
understands.”
1. California Physician’s Legal Handbook 1998, “Telemedicine,”
6:55.
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