Accepted Manuscript

Informed consent—It's more than a signature on a piece of paper

Christine S. Cocanour

PII: S0002-9610(17)30720-1
DOI: 10.1016/j.amjsurg.2017.09.015
Reference: AJS 12536

To appear in: The American Journal of Surgery

Received Date: 19 April 2017

Revised Date: 0002-9610 February 0002-9610
Accepted Date: 18 September 2017

Please cite this article as: Cocanour CS, Informed consent—It's more than a signature on a piece of
paper, The American Journal of Surgery (2017), doi: 10.1016/j.amjsurg.2017.09.015.

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Abstract:

Informed consent is an ethical concept that is codified in the law and is in daily practice at every

health care institution. Three fundamental criteria are needed for clinical informed consent: the

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patient must be competent, adequately informed and not coerced. Physician-patient

interaction is rooted in the ethical concept of beneficence, but over the 19th and 20th centuries,

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case law and societal changes brought respect for autonomy and with it--informed consent.

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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.
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Title:

Informed Consent—It’s More Than a Signature on a Piece of Paper

Southwestern Surgical Congress

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Edgar J. Poth Memorial Lecture

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4 April 2017

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Maui, HI

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Corresponding Author:
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Christine S. Cocanour, MD, FACS, FCCM

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Professor of Clinical Surgery

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University of California Davis School of Medicine

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2315 Stockton Boulevard, Room 4206

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Sacramento, CA 95817
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cscocanour@ucdavis.edu

Telephone: 916 734-7330

FAX: 916 734-7755

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Informed consent is an ethical concept that is codified in the law and is in daily practice

at every health care institution. I plan to review what is an informed consent, when is it

required, how did informed consent evolve into what we have today, and what can we do to

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truly achieve informed consent.

According to Merriam-Webster, informed consent is a “consent to surgery by a patient,

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or to participation in a medical experiment by a subject after achieving an understanding of

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what is involved”. [1] Informed consent is a relatively recent term and concept. The term

informed consent was first used in 1957.[1] A more complete definition is that it is a process by

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which the treating health care provider discloses appropriate information to a competent
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patient so that the patient may make a voluntary choice to accept or refuse treatment.[2]
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The three fundamental criteria that are needed for informed consent is that the patient

must be competent, adequately informed and not coerced. They must have the capacity to be
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able to understand and assess the information given, communicate their choices and
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understand the consequences of their decision. The physician must provide adequate

information, with a minimum being the diagnosis, the procedure with its risks, benefits, and the
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alternatives, along with their benefits and risks—including doing nothing. The decision must be
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voluntary.
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It is the physician’s responsibility to obtain informed consent. This means that the

physician must assess the patient’s ability to understand the relevant medical information and

the implications of treatment alternatives and whether they are able to make an independent,

voluntary decision. There is basic information that must be presented when obtaining an

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informed consent. The AMA and the California Hospital Association have listed the following as

the minimum needed: diagnosis, if it is known, the nature and purpose of the recommended

intervention or procedure, the burdens, risks, and expected benefits of all options including

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forgoing any treatment.[3,4] The conversation with the patient that occurred when going over

this information and the patient’s decision must be documented in the medical record in

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addition to the written consent. In addition, the physician must disclose to the patient whether

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they have any conflicts of interest such as being a consultant for a surgical equipment

manufacturer.[3]

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The federal government has mandated what is needed on the written informed
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consent, as well as what a well-designed form would include and they are listed in Table 1.[5]

At a minimum those elements that are required are the name and signature of the patient
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and/or their legal representative, the name of the hospital, the procedure, the name of the
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responsible practitioner that is performing the procedure, a statement that the procedure,
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including the anticipated benefits, material risks, alternative procedures and their risks and

benefits was explained to the patient or their legal representative, and the date and time of
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obtaining the consent. Additional components that a well-designed form may also include are
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the name of the practitioner who conducted the informed consent discussion, the date, time,
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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 statements, when applicable

that physicians or qualified medical practitioners will be involved in the procedure.

In a 2000 paper, Bettrell and colleagues found that of 157 hospitals, only 26% of consent

forms included even the “basic elements” of procedure, risks, benefits and alternatives. [6]

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A written informed consent is not necessary for every single thing that happens to a

patient. A simple consent can be oral and is used for procedures such as phlebotomy or chest x-

ray, which are considered simple and common. It is often included in the consent for

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hospitalization which hospitals obtain to avoid the risk of being held liable for kidnapping! [3] A

written informed consent is required when a procedure is considered complicated. But, what is

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considered complicated varies from state to state and hospital to hospital. It is influenced by

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clinicians, and interpreted by hospitals with recommendations from professional and specialty

groups. Joint Commission has set a standard that hospitals must establish and follow policies

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that describe which procedures or care, treatment, or services require informed consent.
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The Veterans Health Administration has a well-developed consent policy. [7] Oral

consent still requires meaningful discussion but is acceptable for those treatments and
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procedures that are considered low risk such as administration of drugs or vaccines, bloodwork
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or routine x-rays. Complicated procedures for which written consent is needed are procedures
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that are expected to produce significant pain or discomfort or require sedation, anesthesia or

narcotic analgesia, procedures that are considered to have a significant risk of complication or
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morbidity or any procedure that requires injections into a joint space or body cavity. In
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addition to these conditions, the policy includes a list of specific procedures.

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In obtaining informed consent, how much information is necessary to be given to the

patient. How many potential risks must be described? How many alternatives?

There have been three standards proposed for what information must be given to the patient

regarding a procedure: the professional practice standard or what a reasonable physician

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would provide, the reasonable person standard which is what a reasonable person would

expect to hear and the “subjective standard” which is what a particular patient would need to

know and understand to make an informed decision. The reasonable physician standard is

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often inadequate as the typical physician tells very little. The subjective standard is the most

challenging to incorporate into practice as it requires tailoring information to each patient.

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The scope of the physician’s communications to the patient, must be measured by the

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patient’s need, and that need is whatever information is material to the decision. These

standards have evolved as we will see later, through the influence of the legal system. CMS has

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defined material risk as having a high degree of likelihood but a low degree of severity, as well
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as those complications with a very low degree of likelihood but high degree of severity. [3]

Hospitals are free to delegate to the physician, who uses the available clinical evidence as
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informed by their professional judgement, the determination of which material risks, benefits
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and alternatives will be discussed with the patient.

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A number of risk calculators have been developed with one of the most widely used

being the surgical risk calculator from the American College of Surgeons.[8-10] These can help
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determine the risk of operation for your patient and aid the discussion of risks and benefits.
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There are five recognized exceptions when informed consent of the patient is not
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necessary: a public health emergency, a medical emergency, patient waiver, ‘therapeutic

privilege” and when the patient is incompetent. A public health emergency occurs when the

health of a population may depend upon adopting certain measures—in this context, consent

would not be required. An example is the use of quarantine of potential ebola victims to

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contain ebola. A medical emergency is when the provider believes that a medical procedure is

needed immediately, and there is insufficient time to obtain the consent of the patient or their

surrogate or the patient is unable to give consent. The law implies that if the patient were able

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to give consent, then consent would be given, that is, implied consent. For definition purposes,

a medical emergency exists when immediate services are required to alleviate severe pain or

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the immediate diagnosis and treatment of an unforeseeable medical condition that would lead

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to either serious disability or death if not immediately diagnosed and treated. [3] Legally, only

the emergency condition may be treated. If the patient or their surrogate had refused

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treatment in the past and the emergency condition arises because treatment had been refused,
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then the emergency treatment exception does not apply.

There is a common misconception that a “two person consent” is required when a

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patient would benefit from a procedure and the patient cannot give consent. No federal law
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permits two doctors to consent on behalf of the patient, no matter whether the patient has
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capacity to make health care decisions or not.[3] There is also no legal requirement for a

physician to consult a second physician to confirm the existence of an emergency. However,

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because hospital requirements may vary, this may be required by your hospital or medical staff
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policy.
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If an emergency requires surgery and written informed consent is not possible,

document the emergency and the need for operation in the medical record, e.g. “ the

immediate treatment of the patient is necessary because….”

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A third potential exception to informed consent is when the patient has requested not

to be informed. They may delegate the decision making to the physician. However, this has

potential for abuse as there is a fine line between a voluntary waiver after a suggestion versus a

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non voluntary waiver after intimidation.[3]

“Therapeutic privilege” is a fourth potential exception to informed consent. A physician

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is not required to disclose information to the competent patient if the physician feels that such

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a disclosure would seriously harm, rather than benefit the patient. Rarely would a patient

become so distraught or emotionally ill when given information about their condition that they

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require the physician to withhold information. This also has a great deal of potential abuse as it
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conflicts with the patient’s right to know and decline treatment. If the use of “therapeutic

privilege becomes necessary, it is important to document the facts and circumstances that led
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to the decision to not give all of the information to the patient and what information was
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actually given to the patient. It is also important to document any discussion with the patient’s
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designated surrogate.

The fifth exception to informed consent is that of an incompetent patient. In this case,
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there is a need for determination of a surrogate. As our patient population ages, this has
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become increasingly common. Any condition or treatment that affects cognition may impair
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decision-making capacity. Neurodegenerative diseases such as Alzheimers or Parkinsons,

traumatic brain injury, psychiatric illnesses, cognitive aging, or delirium may leave the patient

unable to give informed consent.

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There is also much confusion between the terms competence and capacity, although

some authors deliberately use then interchangeably. Competence is a legal term. All adults are

presumed to be competent unless they are determined by a court to be incompetent. Capacity

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is task specific and decision-making capacity is determined by a clinician. Because capacity is

task specific it can be divided into 8 different areas, with the scope of abilities and skills that are

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required different for each capacity.[11] For instance, a person who is unable to live

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independently is still able to give consent for a procedure. Living independently, the scope of

abilities is broad and requires both cognition and procedural skills, but giving consent to a

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treatment requires a narrow scope, primarily that of cognitive ability.
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In determining whether a patient has decision-making capacity, the physician must

determine whether they are capable of these four abilities: understanding, expressing a choice,
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appreciation and reasoning. Understanding or the ability to know the meaning of the
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information is a key decisional ability. If the patient has a hernia, do they understand what is a
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hernia? The second ability is whether the person can express a choice, ie can they choose to

have the hernia repaired. If they frequently reverse their choice this may actually indicate a
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lack of capacity. The third ability required is that of appreciation. Appreciation is more than just
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knowing the facts essential to making a decision. It is about applying those facts to the person’s
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own life. In this case, the person would recognize that they have a hernia. The last ability

required is that of reasoning or the ability to compare options and to infer the consequences of

their choice. Like reasoning, appreciation will draw on the patient’s core values and beliefs. In

our patient with the hernia, they would need to compare the consequences of having or not

having the hernia repaired.

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Consent has evolved through the ages. Three ethical principles come into play in

informed consent as we know it in 2017: beneficence, respect for autonomy and justice.

Beneficence has played the biggest role over the centuries. Beneficence requires that the

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physician must promote the welfare of their patient and to do or promote good. Respect for

autonomy, as we will see, has only relatively recently been brought into the discussion of

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consent. Persons should be free to choose and act without controlling constraints imposed by

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others. The third ethical principal is justice and is more applicable to research consent of which

I am not going to discuss today. In the principle of justice, there must be a just distribution of

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the burden of risks of research participation within society.
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The Corpus Hippocraticum is a collection of around 60 medical texts from ancient

Greece associated with the Hippocratic school. Nothing in this collection suggests obtaining
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consent from patients was attempted. In fact, the Corpus bluntly advises of the wisdom of
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“concealing most things from the patient, while you are attending to him, or “turning his
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attention away from what is being done to him… or revealing nothing of the patient’s future or

present condition.”[12] As we know from the Hippocratic Oath, a public pledge to uphold
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professional responsibility and to do no harm, Hippocratic medicine is firmly rooted in

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beneficence.
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In the medieval age, physicians traditionally held to the Hippocratic traditions where the

authoritarianism and obedience of patients was further strengthened by Christian theology.

Henri de Mondeville was a French surgeon who carried on the Hippocratic tradition of

beneficence. He recommended to his colleagues to “promise a cure to every patient but …to

tell the parents or friends if there is any danger.” He considered that maintaining hope justified

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any deception necessary, such as saying that “if a canon is sick, tell him that his bishop just died

and the hope of succeeding him will quicken his recovery.” He also recommended not to

accept a case where the patient violently refused a medical intervention, that is, did not give

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consent, “as a patient who is screaming or fighting is unlikely to enhance the physician’s good

reputation”.[13]

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During the 1700’s, western medicine was still deeply rooted in the Hippocratic tradition

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with its core of beneficence, but there were now early stirrings of a less authoritarian flavor.

Benjamin Rush was the physician who signed the Declaration of Independence. He had a

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background in classical learning that included reading philosophers such as Locke, Descartes,
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Hutchinson, and Smith. He firmly believed that physicians should share information with their

patients. However, it was not in terms of respecting autonomy but to allow the patient to
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better understand and be motivated to comply with the physician’s recommendations.

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Rush’s teacher, John Gregory was a Professor of Medicine at the University of Edinburgh.
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Influenced by Francis Bacon, he realized the need to educate the patient and the public. He

viewed the role of the physician in the traditional terms of beneficence but with more openness
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and honesty. Despite believing that patients should be better informed, it was not to obtain
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consent, but compliance with the recommended treatment.

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In 1803, Thomas Percival published his treatise on Medical Ethics which provided a

modern foundation for medical ethics in North America. [14] Medical Ethics was much more

concerned with medical etiquette and recommended gentleman-like behavior than the

autonomy or rights of patients. Influenced by the Reverend Thomas Gisborne who opposed

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lying to patients, Percival struggled with how deception would affect the perception of the

gentleman’s image of the physician. But because Percival felt that the role of the physician was

to be the minister of hope and comfort, beneficence won out when deception was necessary to

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give hope.

The AMA’s first code of Medical Ethics, published in 1847, borrowed heavily from

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Percival’s text. Interestingly, a passage by John Bell in the introduction to the Code

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championed “veracity, so requisite in all the relations of life, is a jewel of inestimable value in

medical description and narrative….”, yet it was in the section regarding the interaction

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between physicians ---not between physician and patient. [15]
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After the publication of the AMA Medical Ethics, a Connecticut physician, Worthington
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Hooker, published a commentary on the code that is considered one of the most influential

contributions to medical ethics by an American author in the 19th century, Physician and
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Patient.[16] He denounced lying and deception in medicine. He criticized physicians for

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deceiving patients, doing unnecessary services and studying “the science of patient getting, to

the neglect, to some extent, at least, of the science of patient curing”.

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In the early 1900’s, physicians were more concerned about interactions between
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physicians. Remember, 1910 is when Abraham Flexner published his infamous report on
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medical education. Beneficence continued to be the main principle underlying the interaction

between physician and patient. However, autonomy, is just beginning to be seen on the

horizon.

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The legal foundation of informed consent really began being laid in the early 1900s.

From a legal perspective, informed consent is interpreted and grounded in the respect for

autonomy. Case law is directed towards the rights and duties to protect that patient’s right to

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self-determination. The two legal theories that informed consent derives from are battery and

negligence.

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Battery is the intentional touching of a person in a harmful or offensive manner without

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their consent. In medicine, it can be a medical procedure without a consent, or when a

provider exceeds the scope of the consent or performs a procedure for which consent was not

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obtained. Battery can occur even if the intention is to aid the patient, the procedure is
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performed competently and with no adverse outcome. [3] Negligence, as it pertains to

informed consent, requires five elements: duty to give information to the patient, the
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physician breeches that duty, an injury to the patient occurs and is financially measurable, the
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injury is due to an undisclosed or possible outcome and had the patient been informed of this
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outcome, a reasonable person would not have consented. [17]

Although there are a few cases that occurred in the 1800’s, there are four cases from
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1905 to 1914 that are considered the legal basis of informed consent. [18-21] In Mohr v.
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Williams, the physician had obtained consent to operate on the right ear, but then decided that
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the ear that really required operation was the left. The opinion from the court was that when

entering into a contract, the physician can operate to the extent of the consent given, but no

further.[18] In Pratt v Davis, there was no consent for a hysterectomy.[19] This decision

limited implied consent to emergencies or when the patient knows the consequences of

allowing the physician to exercise professional judgement. In Rolater v Strain, the patient gave

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consent to drain a foot infection but specifically asked that no bone be removed. [20] The

physician removed a piece of bone. The operation was not performed as the patient and

physician agreed. As a result, this decision strengthened the patient’s control. The most

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important case was Schloendorff v Society of NY Hospital which drew on the opinions of the

previous three for its decision.[21] The patient consented to an abdominal exploration but “no

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operation”; the physician removed the fibroid anyway. Judge Cardozo’s landmark opinion:

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“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

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commits an assault, for which he is liable in damages.”[21] This is the first true description of
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the patient’s right to self-determination.

No significant changes occurred with consent over the next 40 years. It wasn’t until
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1957 when the case of Salgo v Stanford gave further direction on what was needed for
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consent.[22] The patient developed permanent paralysis as a result of a translumbar

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aortography. The opinion was that physicians had the duty to disclose any facts which are

necessary to form the basis of an intelligent consent by the patient to the proposed treatment.
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It requires the disclosure of risks and alternatives, although it did give physicians discretion on
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what should be disclosed—reasonable physician standard. It is the first time that the term
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informed consent is used.

In 1960, in the case of Natason v. Kline, the physician did not tell the patient about the

risk of burns from cobalt radiation for breast cancer.[23] This was the first case to firmly

ground the physician’s informed consent liability in negligence theory rather than battery. If

injury results from a known risk that is not disclosed to the patient, the physician may be liable.

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Three landmark cases in 1972 further determined the scope of the physician’s

communications to the patient.[24-26] In Canterbury, the patient underwent a laminectomy

and post operatively fell from his bed and was paralyzed. The court felt that the risk of possible

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paralysis should have been disclosed. Disclosure was based on a person’s reasonable standard

rather than a professional standard; therefore, the amount of information must be measured

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by the patient’s need, and that need by whatever information is material to the decision. In

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Cobbs v. Grant and Wilkinson v. Vesey, the decisions were more in line with a subjective

standard. Whether a patient should proceed with a therapy requires reference to the values of

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that patient and thus are not exclusively medical determinations. From Cobbs, the scope of the
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physician’s communications to the patient, must be measured by the patient’s need and that

need is whatever information is material to the decision.

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What is considered “material information” was further clarified by Truman v. Thomas

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(1980).[27] The patient had repeatedly refused a Pap smear, then died of cervical cancer. Her
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family sued, saying that she had never been told of the risks of NOT having a Pap smear. This

decision found that the physician must apprise the patient of risks of NOT undergoing
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treatment. If the physician knows or should know of a patient’s unique concern or lack of
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familiarity with medical procedures, this may expand the scope of required disclosure.
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1973 was a tumultuous year, as Watergate was leading to the impeachment of

President Nixon, the American Hospital Association adopted the first Patient’s Bill of Rights

which further led to the use of informed consent.[28] The 1970’s also saw a marked increase in

numbers of malpractice cases and increasing size of awards leading to skyrocketing insurance

premiums. Between 1975 and 1977, 25 states enacted informed consent laws in an attempt to

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decrease malpractice liability. Statutory laws regarding informed consent now exist in all 50

states.

Today, communication issues are the most frequent root cause of serious adverse

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events reported to Joint Commission.[29] It’s not surprising since communication is probably

one of the hardest things that we do and especially to do right. There are a multitude of

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barriers to understanding when attempting to obtain a truly informed consent. There may be

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ineffective provider-patient communication because of language differences, or perhaps

because of a lack of health literacy or cultural issues. It may also be due to physician’s

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reluctance to use a shared decision making technique. Zara Cooper has looked at pitfalls in
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communication at the end-of-life and has found numerous potential causes for communication

breakdown which are also applicable to achieving informed consent.[30] It can be on the part
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of the surgeon, patient, surrogate or even systemic factors that contribute to communication
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difficulty.
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Language is one of the most common barriers between patients and physicians. The

Federal Government through Title VI of the Civil Rights Act of 1964 requires interpretation and
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translation services. Culturally and Linguistically Appropriate Services in health care is a national
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standard from Department of Health and Human Services that requires language assistance
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regardless of the number of language speakers in the community and at all points of contact

and at all hours of operation. When a patient has limited English proficiency, you cannot

require a patient to bring an interpreter. The interpreters that you have available must be

qualified. You cannot rely on a minor child except in an emergency situation. You may rely on

an accompanying adult if requested to do so by the patient and that person agrees, but it is

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best to document in the medical record that a qualified interpreter was offered. Be very leery

of relying on friends or family for interpretation. They may not be able to interpret accurately

due to inadequate knowledge of anatomy, physiology or due to the stress of the situation.

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Cultural issues may also be a barrier. In some cultures, the decision maker is designated

by the group. In others, a signature on a piece of paper as opposed to a verbal consent may

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convey a lack of trust. Illegal immigrants may fear deportation. In some Asian communities,

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the shaman or another person must be consulted before obtaining a decision.

Over the centuries information has been provided to patients in a variety of models.

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The paternalistic model or the “doctor knows best” model has been with us since Hippocrates
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and is rooted in beneficence. The informative model developed as physicians were encouraged
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to give their patients all of the information and let them choose. More recently we are

transitioning to an interpretive or shared decision making model.

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Shared decision making informs the patient about the medical condition, clarifies the
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patient’s understanding of diagnosis and expectations for recovery. It identifies the patient’s
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priorities and goals. It determines the health states that the patient would find unacceptable.

It accepts individual self-determination as a desirable goal. The problem that occurs with a
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recitation of risks, benefits and alternatives is that it assumes that the patient has bought into
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aggressive, post-operative care; the alternatives appear as secondary and are not a real choice.

But, it does solve the legal requirement. This leads to unwanted, aggressive treatments,

postoperative stress and conflict between the surgeon and the patient.

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Schwarze, et al has developed a best case/worst case framework as a decision support tool.[31]

Each potential choice is discussed with the patient, taking into account their underlying

comorbidities, and contrasting what happens if the best case scenario occurs with what would

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happen if the worst case occurs. The physician then estimates where on this continuum the

patient would be. This gives the patient and their family a reference point. It appears to help

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provide the physician and the patient with a better understanding of their goals and

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expectations for treatment.

It also allows the disease process and potential procedures that may be required to be

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framed as a story. The scenario should be realistic and accessible to patients; it must help them
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bridge the distance between their known world and the reality of health and illness. This may

be particularly important when considering treatment options in the setting of complex and
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serious health problems. It allows patients to better perceive how their illness might unfold.
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Well-constructed scenarios can help patients comprehend a new, previously unimaginable

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reality that exposes potential challenges, promotes strategic thinking and prepares for major

shifts in a way that simple forecasting cannot.

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In promoting shared decision making, Schwarze has tried to improve on the model
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proposed by Elwyn.[32] The best case/worst case tool – is designed specifically for face-to-face
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clinical interactions to promote dialogue and patient deliberation, and support shared decision

making in the context of life-threatening illness. This helps lead to a truly informed consent.

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Using the best case/worst case tool in shared decision making changes the conversation from

linking a problem to a surgical solution to that of a choice between valid alternatives. It allows

a focus more on outcomes rather than specific risks and benefits.

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Trust is an inherent part of the physician patient relationship. Trust is a pre-requisite of

cooperation and informed consent is important in helping to safeguard trust in the medical

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establishment. It is wrong to jeopardize that trust by not truly providing an informed consent.

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Informed consent is more than a signature on a legal document. It requires a process of

communication to truly provide and achieve an informed consent. The trust that is inherent in

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the bond between physician and patient is fragile and must be carefully protected.
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Table 1. What is needed on the informed consent form. [5]

Minimum Elements:

• Name of the hospital where the procedure is to take place

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• Name of the specific procedure

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Name of the responsible practitioner who is performing the procedure

• Statement that the procedure, including the anticipated benefits, material risks and

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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

•
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Date and time the informed consent form is signed

Well-designed form may also include:

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• Name of the practitioner who conducted the informed consent discussion

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

• Indication or listing of the material risks of the procedure that were discussed
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• 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
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accordance with the hospital’s policies

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• 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

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Highlights:

This is the Edgar J. Poth Memorial Lecture presented at the 2017 Southwestern Surgical Congress. The
topic was clinical informed consent and included basics of informed consent, its history and evolution.

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Conflict of Interest

I have no conflicts of interest as it pertains to this subject

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Christine S. Cocanour, MD, FACS, FCCM

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