The American Journal of Surgery 214 (2017) 993e997

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The American Journal of Surgery

journal homepage: www.americanjournalofsurgery.com

Informed consentdIt's more than a signature on a piece of paper*

Christine S. Cocanour
University of California Davis School of Medicine, Sacramento, CA, USA

a r t i c l e i n f o a b s t r a c t

Article history: Informed consent is an ethical concept that is codified in the law and is in daily practice at every health
Received 19 April 2017 care institution. Three fundamental criteria are needed for clinical informed consent: the patient must be
Accepted 18 September 2017 competent, adequately informed and not coerced. Physician-patient interaction is rooted in the ethical
concept of beneficence, but over the 19th and 20th centuries, case law and societal changes brought
respect for autonomy and with it–informed consent. This article briefly reviews the basics of informed
consent, when is it required, how did informed consent evolve into what it is today and what can the
surgeon do to truly achieve informed consent.
© 2017 Elsevier Inc. All rights reserved.

Informed consent is an ethical concept that is codified in the law of treatment alternatives and whether they are able to make an
and is in daily practice at every health care institution. I plan to independent, voluntary decision. There is basic information that
review what is an informed consent, when is it required, how did must be presented when obtaining an informed consent. The AMA
informed consent evolve into what we have today, and what can we and the California Hospital Association have listed the following as
do to truly achieve informed consent. the minimum needed: diagnosis, if it is known, the nature and
According to Merriam-Webster, informed consent is a “consent purpose of the recommended intervention or procedure, the bur-
to surgery by a patient, or to participation in a medical experiment dens, risks, and expected benefits of all options including forgoing
by a subject after achieving an understanding of what is involved”.1 any treatment.3,4 The conversation with the patient that occurred
Informed consent is a relatively recent term and concept. The term when going over this information and the patient's decision must
informed consent was first used in 1957.1 A more complete defi- be documented in the medical record in addition to the written
nition is that it is a process by which the treating health care pro- consent. In addition, the physician must disclose to the patient
vider discloses appropriate information to a competent patient so whether they have any conflicts of interest such as being a
that the patient may make a voluntary choice to accept or refuse consultant for a surgical equipment manufacturer.3
treatment.2 The federal government has mandated what is needed on the
The three fundamental criteria that are needed for informed written informed consent, as well as what a well-designed form
consent is that the patient must be competent, adequately would include and they are listed in Table 1.5 At a minimum those
informed and not coerced. They must have the capacity to be able elements that are required are the name and signature of the pa-
to understand and assess the information given, communicate their tient and/or their legal representative, the name of the hospital, the
choices and understand the consequences of their decision. The procedure, the name of the responsible practitioner that is per-
physician must provide adequate information, with a minimum forming the procedure, a statement that the procedure, including
being the diagnosis, the procedure with its risks, benefits, and the the anticipated benefits, material risks, alternative procedures and
alternatives, along with their benefits and risksdincluding doing their risks and benefits was explained to the patient or their legal
nothing. The decision must be voluntary. representative, and the date and time of obtaining the consent.
It is the physician's responsibility to obtain informed consent. Additional components that a well-designed form may also include
This means that the physician must assess the patient's ability to are the name of the practitioner who conducted the informed
understand the relevant medical information and the implications consent discussion, the date, time, and signature of the person
witnessing the signing of the consent form, the indication or listing
of the material risks of the procedure that were discussed and
*
Southwestern Surgical Congress, Edgar J. Poth Memorial Lecture, 4 April 2017, statements, when applicable that physicians or qualified medical
Maui, HI, USA. practitioners will be involved in the procedure.
E-mail address: cscocanour@ucdavis.edu.

https://doi.org/10.1016/j.amjsurg.2017.09.015
0002-9610/© 2017 Elsevier Inc. All rights reserved.
994 C.S. Cocanour / The American Journal of Surgery 214 (2017) 993e997

Table 1
What is needed on the informed consent form.5

Minimum Elements:

Name of the hospital where the procedure is to take place

Name of the specific procedure

Name of the responsible practitioner who is performing the procedure

Statement that the procedure, including the anticipated benefits, material risks and alternative therapies, was explained to the patient or their legal representative

Name and signature of the patient, or when needed, the patient's legal representative

Date and time the informed consent form is signed
Well-designed form may also include:

Name of the practitioner who conducted the informed consent discussion

Date, time, and signature of the person witnessing the patient or the patient's legal representative signing the consent form

Indication or listing of the material risks of the procedure that were discussed

Statement, if applicable, that physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the
surgery, in accordance with the hospital's policies

Statement, if applicable, that qualified medical practitioners who are not physicians who will perform important parts of the surgery or administration of anesthesia will
be performing only tasks that are within their scope of practice

In a 2000 paper, Bettrell and colleagues found that of 157 hos- severity.3 Hospitals are free to delegate to the physician, who uses
pitals, only 26% of consent forms included even the “basic ele- the available clinical evidence as informed by their professional
ments” of procedure, risks, benefits and alternatives.6 judgement, the determination of which material risks, benefits and
A written informed consent is not necessary for every single alternatives will be discussed with the patient.
thing that happens to a patient. A simple consent can be oral and is A number of risk calculators have been developed with one of
used for procedures such as phlebotomy or chest x-ray, which are the most widely used being the surgical risk calculator from the
considered simple and common. It is often included in the consent American College of Surgeons.8e10 These can help determine the
for hospitalization which hospitals obtain to avoid the risk of being risk of operation for your patient and aid the discussion of risks and
held liable for kidnapping!3 A written informed consent is required benefits.
when a procedure is considered complicated. But, what is consid- There are five recognized exceptions when informed consent of
ered complicated varies from state to state and hospital to hospital. the patient is not necessary: a public health emergency, a medical
It is influenced by clinicians, and interpreted by hospitals with emergency, patient waiver, “therapeutic privilege” and when the
recommendations from professional and specialty groups. Joint patient is incompetent. A public health emergency occurs when the
Commission has set a standard that hospitals must establish and health of a population may depend upon adopting certain meas-
follow policies that describe which procedures or care, treatment, uresdin this context, consent would not be required. An example is
or services require informed consent. the use of quarantine of potential ebola victims to contain ebola. A
The Veterans Health Administration has a well-developed con- medical emergency is when the provider believes that a medical
sent policy.7 Oral consent still requires meaningful discussion but is procedure is needed immediately, and there is insufficient time to
acceptable for those treatments and procedures that are considered obtain the consent of the patient or their surrogate or the patient is
low risk such as administration of drugs or vaccines, bloodwork or unable to give consent. The law implies that if the patient were able
routine x-rays. Complicated procedures for which written consent to give consent, then consent would be given, that is, implied
is needed are procedures that are expected to produce significant consent. For definition purposes, a medical emergency exists when
pain or discomfort or require sedation, anesthesia or narcotic immediate services are required to alleviate severe pain or the
analgesia, procedures that are considered to have a significant risk immediate diagnosis and treatment of an unforeseeable medical
of complication or morbidity or any procedure that requires in- condition that would lead to either serious disability or death if not
jections into a joint space or body cavity. In addition to these con- immediately diagnosed and treated.3 Legally, only the emergency
ditions, the policy includes a list of specific procedures. condition may be treated. If the patient or their surrogate had
In obtaining informed consent, how much information is refused treatment in the past and the emergency condition arises
necessary to be given to the patient. How many potential risks must because treatment had been refused, then the emergency treat-
be described? How many alternatives? ment exception does not apply.
There have been three standards proposed for what information There is a common misconception that a “two person consent”
must be given to the patient regarding a procedure: the profes- is required when a patient would benefit from a procedure and the
sional practice standard or what a reasonable physician would patient cannot give consent. No federal law permits two doctors to
provide, the reasonable person standard which is what a reason- consent on behalf of the patient, no matter whether the patient has
able person would expect to hear and the “subjective standard” capacity to make health care decisions or not.3 There is also no legal
which is what a particular patient would need to know and un- requirement for a physician to consult a second physician to
derstand to make an informed decision. The reasonable physician confirm the existence of an emergency. However, because hospital
standard is often inadequate as the typical physician tells very little. requirements may vary, this may be required by your hospital or
The subjective standard is the most challenging to incorporate into medical staff policy.
practice as it requires tailoring information to each patient. If an emergency requires surgery and written informed consent
The scope of the physician's communications to the patient, is not possible, document the emergency and the need for opera-
must be measured by the patient's need, and that need is whatever tion in the medical record, e.g. “ the immediate treatment of the
information is material to the decision. These standards have patient is necessary because …”.
evolved as we will see later, through the influence of the legal A third potential exception to informed consent is when the
system. CMS has defined material risk as having a high degree of patient has requested not to be informed. They may delegate the
likelihood but a low degree of severity, as well as those complica- decision making to the physician. However, this has potential for
tions with a very low degree of likelihood but high degree of abuse as there is a fine line between a voluntary waiver after a
 C.S. Cocanour / The American Journal of Surgery 214 (2017) 993e997 995

suggestion versus a non voluntary waiver after intimidation.3 distribution of the burden of risks of research participation within
“Therapeutic privilege” is a fourth potential exception to society.
informed consent. A physician is not required to disclose infor- The Corpus Hippocraticum is a collection of around 60 medical
mation to the competent patient if the physician feels that such a texts from ancient Greece associated with the Hippocratic school.
disclosure would seriously harm, rather than benefit the patient. Nothing in this collection suggests obtaining consent from patients
Rarely would a patient become so distraught or emotionally ill was attempted. In fact, the Corpus bluntly advises of the wisdom of
when given information about their condition that they require the “concealing most things from the patient, while you are attending
physician to withhold information. This also has a great deal of to him, or “turning his attention away from what is being done to
potential abuse as it conflicts with the patient's right to know and him … or revealing nothing of the patient's future or present
decline treatment. If the use of “therapeutic privilege” becomes condition.”12 As we know from the Hippocratic Oath, a public
necessary, it is important to document the facts and circumstances pledge to uphold professional responsibility and to do no harm,
that led to the decision to not give all of the information to the Hippocratic medicine is firmly rooted in beneficence.
patient and what information was actually given to the patient. It is In the medieval age, physicians traditionally held to the Hip-
also important to document any discussion with the patient's pocratic traditions where the authoritarianism and obedience of
designated surrogate. patients was further strengthened by Christian theology. Henri de
The fifth exception to informed consent is that of an incompe- Mondeville was a French surgeon who carried on the Hippocratic
tent patient. In this case, there is a need for determination of a tradition of beneficence. He recommended to his colleagues to
surrogate. As our patient population ages, this has become “promise a cure to every patient but … to tell the parents or friends
increasingly common. Any condition or treatment that affects if there is any danger.” He considered that maintaining hope
cognition may impair decision-making capacity. Neurodegenera- justified any deception necessary, such as saying that “if a canon is
tive diseases such as Alzheimers or Parkinsons, traumatic brain sick, tell him that his bishop just died and the hope of succeeding
injury, psychiatric illnesses, cognitive aging, or delirium may leave him will quicken his recovery.” He also recommended not to accept
the patient unable to give informed consent. a case where the patient violently refused a medical intervention,
There is also much confusion between the terms competence that is, did not give consent, “as a patient who is screaming or
and capacity, although some authors deliberately use then inter- fighting is unlikely to enhance the physician's good reputation”.13
changeably. Competence is a legal term. All adults are presumed to During the 1700's, western medicine was still deeply rooted in
be competent unless they are determined by a court to be incom- the Hippocratic tradition with its core of beneficence, but there
petent. Capacity is task specific and decision-making capacity is were now early stirrings of a less authoritarian flavor. Benjamin
determined by a clinician. Because capacity is task specific it can be Rush was the physician who signed the Declaration of Indepen-
divided into 8 different areas, with the scope of abilities and skills dence. He had a background in classical learning that included
that are required different for each capacity.11 For instance, a person reading philosophers such as Locke, Descartes, Hutchinson, and
who is unable to live independently is still able to give consent for a Smith. He firmly believed that physicians should share information
procedure. Living independently, the scope of abilities is broad and with their patients. However, it was not in terms of respecting
requires both cognition and procedural skills, but giving consent to autonomy but to allow the patient to better understand and be
a treatment requires a narrow scope, primarily that of cognitive motivated to comply with the physician's recommendations.
ability. Rush's teacher, John Gregory was a Professor of Medicine at the
In determining whether a patient has decision-making capacity, University of Edinburgh. Influenced by Francis Bacon, he realized
the physician must determine whether they are capable of these the need to educate the patient and the public. He viewed the role
four abilities: understanding, expressing a choice, appreciation and of the physician in the traditional terms of beneficence but with
reasoning. Understanding or the ability to know the meaning of the more openness and honesty. Despite believing that patients should
information is a key decisional ability. If the patient has a hernia, do be better informed, it was not to obtain consent, but compliance
they understand what is a hernia? The second ability is whether the with the recommended treatment.
person can express a choice, ie can they choose to have the hernia In 1803, Thomas Percival published his treatise on Medical
repaired. If they frequently reverse their choice this may actually Ethics which provided a modern foundation for medical ethics in
indicate a lack of capacity. The third ability required is that of North America.14 Medical Ethics was much more concerned with
appreciation. Appreciation is more than just knowing the facts medical etiquette and recommended gentleman-like behavior than
essential to making a decision. It is about applying those facts to the the autonomy or rights of patients. Influenced by the Reverend
person's own life. In this case, the person would recognize that they Thomas Gisborne who opposed lying to patients, Percival struggled
have a hernia. The last ability required is that of reasoning or the with how deception would affect the perception of the gentleman's
ability to compare options and to infer the consequences of their image of the physician. But because Percival felt that the role of the
choice. Like reasoning, appreciation will draw on the patient's core physician was to be the minister of hope and comfort, beneficence
values and beliefs. In our patient with the hernia, they would need won out when deception was necessary to give hope.
to compare the consequences of having or not having the hernia The AMA's first code of Medical Ethics, published in 1847, bor-
repaired. rowed heavily from Percival's text. Interestingly, a passage by John
Consent has evolved through the ages. Three ethical principles Bell in the introduction to the Code championed “veracity, so
come into play in informed consent as we know it in 2017: benef- requisite in all the relations of life, is a jewel of inestimable value in
icence, respect for autonomy and justice. Beneficence has played medical description and narrative …”, yet it was in the section
the biggest role over the centuries. Beneficence requires that the regarding the interaction between physicians —not between
physician must promote the welfare of their patient and to do or physician and patient.15
promote good. Respect for autonomy, as we will see, has only After the publication of the AMA Medical Ethics, a Connecticut
relatively recently been brought into the discussion of consent. physician, Worthington Hooker, published a commentary on the
Persons should be free to choose and act without controlling con- code that is considered one of the most influential contributions to
straints imposed by others. The third ethical principal is justice and medical ethics by an American author in the 19th century, Physician
is more applicable to research consent of which I am not going to and Patient.16 He denounced lying and deception in medicine. He
discuss today. In the principle of justice, there must be a just criticized physicians for deceiving patients, doing unnecessary
996 C.S. Cocanour / The American Journal of Surgery 214 (2017) 993e997

services and studying “the science of patient getting, to the neglect, If injury results from a known risk that is not disclosed to the pa-
to some extent, at least, of the science of patient curing”. tient, the physician may be liable.
In the early 1900's, physicians were more concerned about in- Three landmark cases in 1972 further determined the scope of
teractions between physicians. Remember, 1910 is when Abraham the physician's communications to the patient.24e26 In Canterbury,
Flexner published his infamous report on medical education. the patient underwent a laminectomy and post operatively fell
Beneficence continued to be the main principle underlying the from his bed and was paralyzed. The court felt that the risk of
interaction between physician and patient. However, autonomy, is possible paralysis should have been disclosed. Disclosure was based
just beginning to be seen on the horizon. on a person's reasonable standard rather than a professional
The legal foundation of informed consent really began being laid standard; therefore, the amount of information must be measured
in the early 1900s. From a legal perspective, informed consent is by the patient's need, and that need by whatever information is
interpreted and grounded in the respect for autonomy. Case law is material to the decision. In Cobbs v. Grant and Wilkinson v. Vesey,
directed towards the rights and duties to protect that patient's right the decisions were more in line with a subjective standard.
to self-determination. The two legal theories that informed consent Whether a patient should proceed with a therapy requires refer-
derives from are battery and negligence. ence to the values of that patient and thus are not exclusively
Battery is the intentional touching of a person in a harmful or medical determinations. From Cobbs, the scope of the physician's
offensive manner without their consent. In medicine, it can be a communications to the patient, must be measured by the patient's
medical procedure without a consent, or when a provider exceeds need and that need is whatever information is material to the
the scope of the consent or performs a procedure for which consent decision.
was not obtained. Battery can occur even if the intention is to aid What is considered “material information” was further clarified
the patient, the procedure is performed competently and with no by Truman v. Thomas (1980).27 The patient had repeatedly refused
adverse outcome.3 Negligence, as it pertains to informed consent, a Pap smear, then died of cervical cancer. Her family sued, saying
requires five elements: duty to give information to the patient, the that she had never been told of the risks of NOT having a Pap smear.
physician breeches that duty, an injury to the patient occurs and is This decision found that the physician must apprise the patient of
financially measurable, the injury is due to an undisclosed or risks of NOT undergoing treatment. If the physician knows or
possible outcome and had the patient been informed of this should know of a patient's unique concern or lack of familiarity
outcome, a reasonable person would not have consented.17 with medical procedures, this may expand the scope of required
Although there are a few cases that occurred in the 1800's, there disclosure.
are four cases from 1905 to 1914 that are considered the legal basis 1973 was a tumultuous year, as Watergate was leading to the
of informed consent.18e21 In Mohr v. Williams, the physician had impeachment of President Nixon, the American Hospital Associa-
obtained consent to operate on the right ear, but then decided that tion adopted the first Patient's Bill of Rights which further led to the
the ear that really required operation was the left. The opinion from use of informed consent.28 The 1970's also saw a marked increase in
the court was that when entering into a contract, the physician can numbers of malpractice cases and increasing size of awards leading
operate to the extent of the consent given, but no further.18 In Pratt to skyrocketing insurance premiums. Between 1975 and 1977, 25
v Davis, there was no consent for a hysterectomy.19 This decision states enacted informed consent laws in an attempt to decrease
limited implied consent to emergencies or when the patient knows malpractice liability. Statutory laws regarding informed consent
the consequences of allowing the physician to exercise professional now exist in all 50 states.
judgement. In Rolater v Strain, the patient gave consent to drain a Today, communication issues are the most frequent root cause
foot infection but specifically asked that no bone be removed.20 The of serious adverse events reported to Joint Commission.29 It's not
physician removed a piece of bone. The operation was not per- surprising since communication is probably one of the hardest
formed as the patient and physician agreed. As a result, this deci- things that we do and especially to do right. There are a multitude
sion strengthened the patient's control. The most important case of barriers to understanding when attempting to obtain a truly
was Schloendorff v Society of NY Hospital which drew on the informed consent. There may be ineffective provider-patient
opinions of the previous three for its decision.21 The patient con- communication because of language differences, or perhaps
sented to an abdominal exploration but “no operation”; the because of a lack of health literacy or cultural issues. It may also be
physician removed the fibroid anyway. Judge Cardozo's landmark due to physician's reluctance to use a shared decision making
opinion: “Every human being of adult years and sound mind has a technique. Zara Cooper has looked at pitfalls in communication at
right to determine what shall be done with his own body; and a the end-of-life and has found numerous potential causes for
surgeon who performs an operation without his patient's consent communication breakdown which are also applicable to achieving
commits an assault, for which he is liable in damages.”21 This is the informed consent.30 It can be on the part of the surgeon, patient,
first true description of the patient's right to self-determination. surrogate or even systemic factors that contribute to communica-
No significant changes occurred with consent over the next 40 tion difficulty.
years. It wasn't until 1957 when the case of Salgo v Stanford gave Language is one of the most common barriers between patients
further direction on what was needed for consent.22 The patient and physicians. The Federal Government through Title VI of the
developed permanent paralysis as a result of a translumbar Civil Rights Act of 1964 requires interpretation and translation
aortography. The opinion was that physicians had the duty to services. Culturally and Linguistically Appropriate Services in
disclose any facts which are necessary to form the basis of an health care is a national standard from Department of Health and
intelligent consent by the patient to the proposed treatment. It Human Services that requires language assistance regardless of the
requires the disclosure of risks and alternatives, although it did give number of language speakers in the community and at all points of
physicians discretion on what should be discloseddreasonable contact and at all hours of operation. When a patient has limited
physician standard. It is the first time that the term informed English proficiency, you cannot require a patient to bring an
consent is used. interpreter. The interpreters that you have available must be
In 1960, in the case of Natason v. Kline, the physician did not tell qualified. You cannot rely on a minor child except in an emergency
the patient about the risk of burns from cobalt radiation for breast situation. You may rely on an accompanying adult if requested to do
cancer.23 This was the first case to firmly ground the physician's so by the patient and that person agrees, but it is best to document
informed consent liability in negligence theory rather than battery. in the medical record that a qualified interpreter was offered. Be
 C.S. Cocanour / The American Journal of Surgery 214 (2017) 993e997 997

very leery of relying on friends or family for interpretation. They Informed consent is more than a signature on a legal document.
may not be able to interpret accurately due to inadequate knowl- It requires a process of communication to truly provide and achieve
edge of anatomy, physiology or due to the stress of the situation. an informed consent. The trust that is inherent in the bond between
Cultural issues may also be a barrier. In some cultures, the de- physician and patient is fragile and must be carefully protected.
cision maker is designated by the group. In others, a signature on a
piece of paper as opposed to a verbal consent may convey a lack of
trust. Illegal immigrants may fear deportation. In some Asian Conflict of interest
communities, the shaman or another person must be consulted
before obtaining a decision. I have no conflicts of interest as it pertains to this subject.
Over the centuries information has been provided to patients in
a variety of models. The paternalistic model or the “doctor knows
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