BACKGROUND AND HISTORY OF THE PATIENT-PROVIDER RELATIONSHIP

Over the last four decades, there has been a dramatic shift in the character
of the physician-patient relationship, from one traditionally paternalistic or
physician-focused in nature, to one that recognizes patient autonomy and
is predominantly patient-centered. This struggle between paternalism and
autonomy has been central to the discussions of ethically acceptable medical
practice and has formed the basis for the doctrine of informed consent.
Paternalism is based on the principle of beneficence, the desire to do good
for the patient. The concept of informed consent asserts that the desire to do
good is not a justification for overriding a competent patient’s right to
personal autonomy and self-determination. Although there is some question
about whether consent to medical procedures can ever be truly informed,
the process of obtaining informed consent from a patient has been incorporated
into American society’s expectation of good medical practice.

PURPOSE OF INFORMED CONSENT
In May 2000 (amended May 2004), the House of Delegates of the American
Academy of Physician Assistants adopted a policy of comprehensive “Guidelines
for Ethical Conduct for the Physician Assistant Profession.” The guidelines
address the profession’s responsibility in protecting a patient’s autonomy.

Physician assistants have a duty to protect and foster an individual
patient’s free and informed choices. The doctrine of informed consent
means that a PA provides adequate information that is comprehendible to
a competent patient or patient surrogate. At a minimum, this should
include the nature of the medical condition, the objectives of the proposed
treatment, treatment options, possible outcomes, and the risks involved.
PAs should be committed to the concept of shared decision making, which
involves assisting patients in making decisions that account for medical,
situational, and personal factors.
(American Academy of Physician Assistants, 2004)

Informed consent should be obtained from a patient before all medical
interventions that have the potential for harm, including diagnostic and
therapeutic procedures. A patient, through the exercise of personal autonomy,
may either agree to or refuse a proposed procedure or treatment, but it is the
responsibility of the practitioner to make sure that the decision is based on
complete and appropriate information.
At the present time, the United States has no federal statute that comprehensively
sets national standards of practice regarding patient consent for
medical procedures. There is an implied moral obligation on professionals to
disclose the necessary information to the patient, but the nature and extent of the legal obligation varies from one jurisdiction to another (Beauchamp,
2001). In most states, health care providers have an “affirmative duty” to
disclose information regarding medical treatments, which means that information
must be volunteered and not just provided in response to questions
posed by the patient. Once the information has been disclosed, the provider’s
obligation has been met. Weighing the risks and deciding on a course of action
then becomes the responsibility of the patient or the patient’s surrogate.
Legal actions against health care professionals for failure to obtain informed
consent to treatment have been pursued under two separate theories of
liability—one based on the concept of battery and the other on the concept
of negligence (Applebaum, 1987).
Most early litigation involving informed consent argued that the provision
of treatment without consent constituted battery—an intentional, nonconsensual
touching of the patient. The concept of battery protects a person’s
physical integrity against unwanted invasion.
After 1957, most suits alleging lack of informed consent were brought
under the legal theory of negligence. Under this theory, an injured patient
argues that he or she was harmed by the provider’s unintentional failure to
satisfy a professional standard of care. When applied in an informed consent
case, the alleged negligence results from a failure to disclose sufficient
information about the risks or complications of a treatment.

ESSENTIAL COMPONENTS OF
INFORMED CONSENT
There are three essential conditions that must be met to ensure effective
informed consent. First, the patient must have the capacity, or competence,
to make an informed decision. A distinction is sometimes made between the
medical judgment of a patient’s capacity to consent and the legal judgment
of his competence; however, in clinical practice the two are closely linked
(Beauchamp, 2001). Second, the patient must be given sufficient information
about the procedure or treatment and the alternatives available, to allow him
or her to make an informed choice. Third, the patient must give consent to
treatment voluntarily, without coercion, manipulation, or duress.

PATIENT CAPACITY
There is no universally accepted test of a patient’s capacity to consent to
treatment. In general, an adult is presumed to be legally competent unless he
or she has been formally and legally declared incompetent. Conversely, a
minor is generally presumed to be legally incompetent to make medical
decisions, although a number of exceptions to this rule exist and are often
state-specific (e.g., emancipation). Additionally, specific legislation sometimes
grants minors legal status to make some medical decisions for themselves
(e.g., testing for sexually transmitted diseases, reproductive decisions).

Competency is usually established by assessing whether the patient has
the capacity to understand the nature of his or her condition and the various
options available and whether he or she is capable of making a rational
decision. To make a rational choice, patients must be able to understand the
treatments available and the likely outcomes in each case. They must also be
able to deliberate and consider their options and weigh them against one
another to choose the best alternative. To do so effectively, they must assess
the options available in relation to a set of values and goals, without which
they would have no basis for preferring one outcome to any other (Moskop,
1999). They must also be able to communicate their understanding and their
decision in some intelligible way.

ADEQUATE INFORMATION
The second requirement of informed consent is that the patient must be
provided with adequate information with which to make a decision. The right
to informed consent is embedded in the nature of fiduciary relationships,
wherein one party has differential power, and thus that party has the
inherent responsibility to share necessary information with the other.
General categories of information that must be provided are the diagnosis;
the nature of the proposed procedure; the risks, consequences, and benefits
of the procedure; an assessment of the likelihood that the procedure(s) will
accomplish the desired outcomes; and any reasonable and feasible alternatives
to treatment (including the alternative of not having the procedure)
and the risks and benefits of each. In clinical practice, the information
required to be disclosed is frequently summarized by using the abbreviation
PARQ: P (the recommended medical procedure), A (the reasonable alternatives
to the recommended procedure), and R (the risks of the procedure);
Q represents the additional step of asking the patient if he or she has any
questions about the proposed procedure not adequately disclosed in the
discussion.
States are far from uniform in their views of how much information should
be disclosed for meaningful informed consent. Various criteria have been
proposed as both legal and moral standards for adequate disclosure. The
“reasonable physician” standard bases disclosure of information on the
prevailing practice within the profession. What would a typical health
care provider in the same specialty and “community” disclose about this
procedure? This legal standard, the only judicial standard by which courts
judged physicians prior to 1972, allows the practitioner to determine what
information is appropriate to disclose. It is often argued that this more
paternalistic approach, although still dominant in the courts, is inconsistent
with the goals of informed consent and true patient autonomy.
The second standard of disclosure, introduced in 1972, is the “reasonable
person” standard. The reasonable person standard requires a health care
provider to disclose to a patient any material information that the practi-tioner recognizes that a reasonable person in the patient’s position would
consider to be significant to his or her decision making about the recommended
medical intervention. Risks that are not serious, or are unlikely, are
not considered material. Under this standard, the critical requirement shifts
from whether the disclosure met the profession’s standard to whether the
undisclosed information would have been material to a reasonable patient’s
decision making.
The great advantage of the reasonable person standard is the focus on the
preferences of the patient. A requirement for this standard is that the type
and amount of information provided must be at the patient’s level of understanding
if he or she is truly to be an autonomous decision maker. The
disadvantages of this standard include its failure to articulate the nature of
the “hypothetical” reasonable person. In addition, the retrospective
application of this standard presents a significant problem in that any
complication of a procedure is likely to seem material after it has occurred
(Nora, 1998).
Although the reasonable person standard does focus more on the patient,
it does not require that the disclosure be tailored to each patient’s specific
informational needs or desires. Instead, it bases the requirements on what a
hypothetical reasonable person would want to know. The third standard of
disclosure, the “subjective” standard, addresses this limitation by asking the
question, What would this particular patient need to know and understand in
order to make an informed decision? This patient-centered approach allows
greater differentiation based on patient preference, relying on the unique
nature and abilities of the individual patient to determine the degree of
disclosure needed to satisfy the requirements of informed consent. This
standard is the most challenging to implement in practice due to its requirement
to tailor information specifically to each patient.
In addition to providing information, the clinician has the ethical
obligation to make reasonable efforts to ensure comprehension. Communicating
highly technical and specialized knowledge to someone who is not
conversant in the subject presents a formidable challenge. Patient-centered
barriers to informed consent—such as anxiety, language differences, and
physical or emotional impairments—can impede the process. Lack of
familiarity or sensitivity to the patient’s cultural and health care beliefs
on the part of the provider can act as a significant barrier to providing
effective informed consent. Process-centered barriers, including readability
of consent forms, timing of the consent discussion, and amount of time
devoted to the process, also may reflect disrespect for the autonomy of the
patient.
To optimize information sharing, explanations should be given clearly and
simply, and questions should be asked frequently to assess understanding.
Whenever possible, a variety of communication techniques should be used,
including written forms of educational materials, videotapes, CDs, DVDs,
and additional media sources. Computers have taken on a new and everexpanding
role as an effective tool in patient education when integrated into
the clinical setting.

VOLUNTARY CHOICE
In a clinical setting, voluntariness may be influenced by the vulnerability of
the patient and the inherent imbalance in knowledge and power between the
health care professional and the patient. Care needs to be exercised in
advising patients carefully so that what professionals construe in good faith
as rational persuasion does not unintentionally exert undue influence on a
patient’s decision making (Messer, 2004). Consent to treatment obtained using
manipulation or coercion, or both, is the antithesis of informed consent.
Although a health care provider’s recommendation regarding treatment
typically can have a strong influence on a patient’s decision making, a recommendation
offered as part of the clinician’s responsibility to inform and guide
a patient in his or her decision making is not considered coercion.

TYPES OF INFORMED CONSENT
Consent may take many forms, including implied, general, and special.
Implied consent is often used when immediate action is required. In the
emergency room, consent is presumed when inaction may cause greater
injury or would be contrary to good medical practice. General consent is
often obtained on hospital admission to provide consent for routine services
and routine touching by health care staff. Such “blanket” forms generally do
not list specific procedures, risks, benefits, or alternatives that might be
encountered by a patient during a hospitalization. Additionally, the risk
associated with a procedure may be variable depending upon a patient’s
condition. Therefore, a consent to “general treatment” upon hospital
admission may not be adequate to meet the requirements of informed
consent (Manthous, 2003). Finally, special consent is required for specific
high-risk procedures and medical treatments.
State laws vary as to which interventions require a signed consent form.
Some states require a written consent only for surgical interventions,
anesthesia, or other more invasive procedures. Other states require informed
consent be documented for a broader range of procedures.
In order to ensure that informed consent is properly obtained, the health
care provider should actually discuss with the patient each of the procedures
to be performed, including the nature, risks, and alternatives. Consent
obtained verbally is as binding as written consent because there is no legal
requirement that consent be in written form; however, when disagreements
arise, oral consent becomes difficult to prove. The health care provider
should always document verbal consent explicitly in the medical record.
Written consent is the preferred form of consent. The consent form
provides legal, visible proof of a patient’s intentions. A well-drafted informed
consent document can provide concrete evidence that some exchange of
information was communicated to, and some assent obtained from, the
patient. Such a document, supported by an entry in the patient’s medical
record, is often the key to a successful malpractice defense when the issue
of consent to treatment arises.

Some states have laws that specify certain language on consent forms for
certain procedures. In cases that do not require specific forms, a general
consent form that identifies the patient, the date, and precise time of
signature and documents the procedure, the risks associated with it, the
indications, and the alternatives can be used. Most states require a consent
form to be witnessed. Because of the potential conflict of interest, office
personnel (nursing or other staff) should not act as the sole witness to a
consent document.
A written informed consent document should be prepared with the patient’s
needs in mind and should verify that the patient was given the opportunity
to ask questions and discuss concerns. Consent forms are often written in
great detail and use medical and legal terminology that is far beyond the
capacity of many patients. For true autonomy to exist in informed consent,
consent forms should be understandable and should include the patient’s
primary language or languages whenever possible. When appropriate, an
interpreter should be made available during the informed consent conference.
The issue of comprehension is vital to the process. Health care
providers should not make the mistake of equating the written and signed
document with informed consent. The provider should always take care to
make sure that information-transferring communication did occur.

PATIENT’S RIGHT TO REFUSE
TREATMENT
Patients have the right to refuse treatment. In such circumstances, it is
essential to document carefully such refusals and, most importantly, the
patient’s understanding of the potential consequences of refusing treatment.
The signature of a witness is helpful in these circumstances.

EXCEPTIONS TO INFORMED
CONSENT REQUIREMENTS
Several types of legitimate exceptions to the right of informed consent have
been described. In rare instances, courts have recognized limited privileges
that potentially can protect health care providers from claims alleging a lack
of informed consent. Such exceptions include emergencies, patients unable
to consent, a patient waiver of consent, public health requirements, and
therapeutic privilege. In all these instances, the provider has the burden of
proving that the claimed exception was invoked appropriately.
According to the emergency exception, if treatment is required to prevent
death or other serious harm to a patient, that treatment may be provided
without informed consent. Courts have upheld that the emergent nature of
the situation and the impracticality of conferring with the patient preclude
the need for informed consent. This exception is based on the presumption
that the patient would consent to treatment to preserve life or health if he orshe were able to do so and if there were sufficient time to obtain consent.
Despite this exception, a competent patient may refuse interventions even if
they are life-saving. For example, courts have repeatedly recognized the
rights of Jehovah’s Witnesses to refuse blood products.
Care of patients who lack decision-making capacity can be provided
without the patient’s informed consent. This exception, however, does not
imply that no consent is necessary; instead, informed consent is required
from a surrogate acting on behalf of the patient. Some surrogate decision
makers are clearly identifiable (e.g., the legal guardians assigned to protect
the best interests of persons judged to be incompetent and the parents of
minor children). In other cases, surrogates are more difficult to determine.
The decision-making authority of surrogates is directed by defined
standards. These standards require surrogates to rely first on any treatment
preferences specifically indicated by the patient, either written or oral,
before he or she lost decision-making capacity. Lacking such direction,
surrogates are then empowered to exercise “substituted judgment,”—that is,
to use their knowledge of the patient’s preferences and values to choose the
alternative they believe the patient would choose if he or she were able to do
so. In some instances, prior knowledge of a patient’s preferences or values is
lacking. In such situations, surrogates are directed to rely on their assessment
of the patient’s best interests and are encouraged to pursue the course
of action they deem most likely to foster the patient’s overall well-being
(Buchanan, 1989).
When a surrogate’s treatment choice appears clearly contrary to a patient’s
previously expressed wishes or best interests, the patient’s provider is dutybound
to question that choice. The health care provider does not have the
authority to unilaterally override the surrogate’s decision but must bring the
issue to the attention of an appropriate legal authority for review and
adjudication.
In the “Guidelines for Ethical Conduct for the Physician Assistant Profession,”
the clinician’s role with regard to surrogates is clearly delineated.
When the person giving consent is a patient’s surrogate, a family member,
or other legally authorized representative, the PA should take reasonable
care to assure that the decisions made are consistent with the patient’s
best interests and personal preferences, if known. If the PA believes the
surrogate’s choices do not reflect the patient’s wishes or best interests, the
PA should work to resolve the conflict. This may require the use of
additional resources, such as an ethics committee.
(American Academy of Physician Assistants, 2004)
Informed consent, although clearly recognized as a patient’s right, is not a
patient’s duty. Patients can choose to waive their right to receive the relevant
information and give informed consent to treatment. The provider may honor
the patient’s right to choose someone else to make treatment decisions on
his or her behalf as long as the request is made competently, voluntarily, and
with some understanding that the patient recognizes that he or she is
relinquishing a right. Health care providers should not feel obligated to accept the responsibility for making treatment decisions for the patient if
they are asked to do so. Instead, they can request that the patient make his
or her own choice or designate another person to serve as surrogate.
Sometimes medical interventions have a potential benefit not only to the
patient but also to others in the community. In such rare instances, public
health statutes may authorize patient detention or treatment without the
patient’s consent. This exception overrides individual patient autonomy in
specific circumstances to protect important public health interests.
The final exception to informed consent is the concept of therapeutic
privilege, which allows the health care provider to let considerations about
the physical, mental, and emotional state of the patient affect what information
is disclosed to the patient. The practitioner should believe that the risk of
giving information would pose a serious detriment to the patient. The anticipated
harm must result from the disclosure itself and not from the potential
influence that the information might have on the patient’s choice. The sole
justification of concern that the patient might refuse needed therapy is not
considered adequate to justify invoking this exception. The therapeutic
privilege is extremely controversial and not universally recognized. Thus,
the value of therapeutic privilege as an independent exception to informed
consent is limited.

CONCLUSIONS
The moral and legal doctrine of informed consent and its counterpart, the
refusal of treatment, are products of the last half of the 20th century. During
this time, judges sought to protect patient autonomy—that is, the patient’s
right to self-determination. Informed consent requires the health care practitioner
to provide the patient with an adequate disclosure and explanation of
the treatment and the various options and consequences.
Informed consent, however, is more than a legal necessity. When conducted
properly, the process of communicating appropriate information to patients
about treatment alternatives can help establish a reciprocal relationship
between health care provider and patient that is based on good and
appropriate communication, considered advice, mutual respect, and rational
choices. The therapeutic objective of informed consent should be to replace
some of the patient’s anxiety and unease with a sense of participation as a
partner in decision making. Such a sense of participation strengthens the
therapeutic alliance between provider and patient. After initial consent to
treatment has occurred, a continuing dialogue between patient and practitioner,
based on the patient’s continuing medical needs, reinforces the original
consent. In the event of an unfavorable outcome, the enhanced relationship
will prove crucial to maintaining the patient’s trust.
In the area of informed consent, as in every other area of risk management,
the best recommendation is to practice good medicine. Informed consent is
an essential part of good medical practice today and is an ethical and moral
responsibility of all health care providers.

REFERENCES
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Clinical Practice. New York, Oxford University Press, 1987.
Beauchamp TL, Childress JF: Principles of Biomedical Ethics, 5th ed.
New York, Oxford University Press, 2001.
Buchanan AE, Brock DW: Deciding for Others: The Ethics of Surrogate
Decision Making. Cambridge, England, Cambridge University Press,
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Manthous CA, DeFirolamo A, Haddad C, Amoateng-Adjepong Y: Informed
consent for medical procedures: local and national practices. Chest
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