Emergency Medicine Specialty Reports: Informed Consent for Emergency Procedures
Authors: Catherine A. Marco, MD, FACEP, Clinical Professor, Department of Surgery, Division of Emergency Medicine, Medical College of Ohio, Attending Physician, St. Vincent Mercy Medical Center, Toledo, OH; Arthur R. Derse, MD, JD, Director for Medical and Legal Affairs and Associate Director, Center for the Study of Bioethics, Clinical Professor of Bioethics and Emergency Medicine, Medical College of Wisconsin; and Kurt Kaczander, DO, Department of Emergency Medicine, St. Vincent Mercy Medical Center, Toledo, OH.
Peer Reviewer: Jonathan Lawrence, MD, JD, Emergency Physician, St. Mary Medical Center, Long Beach, CA; Assistant Professor Medicine, Department of Emergency Medicine, Harbor/UCLA medical Center, Torrance, CA
Informed consent for medical treatment is an essential aspect of emergency medical care. The informed consent process is intended to assure the protection of the rights of patients. Numerous barriers to the informed consent process may exist among emergency patients, including impaired decisional capacity, impaired cognition, language barriers, illiteracy, insufficient time and communication, and numerous others. Because of the inherent vulnerability of ED patients, particular attention should be paid to addressing barriers to adequate informed consent, and steps should be taken to ensure adequate delivery of information, understanding of the proposed intervention and its risks and benefits, and voluntariness of the informed consent.—The Editor
What Is Informed Consent?
The principle of informed consent is a fundamental principle of American ethics, recognized in 1914 when the New York State Supreme Court held that adults of sound mind have the right to make medical decisions.1 The term “informed consent” requires both disclosure of information to the patient before the patient agrees to the proposed intervention, and voluntariness on the part of the patient to consent. Similarly, patients with decisional capacity also voluntarily may refuse a proposed treatment or procedure. Although physicians have the training and experience to make diagnoses and recommend treatment, it is accepted that the patient is most capable of deciding whether the proposed interventions are compatible with his/her value system and goals.
Informed consent is a fundamental right of patient autonomy in medical decision making.2-9 Many emergency department (ED) procedures, such as intravenous lines and blood drawing, are considered routine, and are performed after general consent to treatment, agreed orally or in writing. Other more invasive procedures should be performed following a discussion with the patient regarding the procedure, purpose, risks, benefits, and alternatives to the proposed procedure or intervention.10-12 Certain important exceptions exist to obtaining informed consent and will be discussed below.
In reality, compliance with informed consent discussions and documentation of informed consent, varies widely.13 The American Medical Association (AMA) has a general policy that states, “Health care professionals should inform patients or their surrogates of their clinical impression or diagnosis; alternative treatments and consequences of treatments, including the consequence of no treatment; and recommendations for treatment.”14 The American College of Emergency Physicians (ACEP) Code of Ethics States, “Emergency physicians shall communicate truthfully with patients and secure their informed consent for treatment, unless the urgency of the patient’s conditions demands an immediate response.”15
There are three basic types of informed consent. The first is express consent, when a patient specifically agrees to an intervention. The second type is implied consent, which is consent that is implied by the patient’s conduct, for example, when a patient willingly holds his arm out to have blood drawn. Thirdly, consent implied in law refers to emergency treatment given to save life or preserve health, for patients unable to give consent in life-threatening situations.
In most cases, providing medical care to adult patients requires their consent. However, there are several important exceptions to the duty to obtain informed consent. In emergent situations, when the patient in unable to provide informed consent, and a surrogate decisionmaker is not available, if immediate treatment is indicated to prevent death or serious harm, appropriate medical interventions should be performed, under the presumption that a reasonable person would desire such. Other notable exceptions to the duty to obtain informed consent include: patients who waive their right to consent, patients who are unable to consent, certain public health or legal requirements, and the rarely used therapeutic privilege, in circumstances in which it is judged that the information would be so traumatic as to impair the patient’s ability to consent.
The process of informed consent includes three important elements: determination of decisional capacity, delivery of information, and voluntary consent from the patient.
Who Should Obtain Informed Consent?
The physician who will be performing the procedure should obtain informed consent from the patient.16,17 Similarly, the physician involved has the ultimate responsibility for the discussion of the risks, benefits, and alternatives. The process of informed consent should not be delegated to others who will not be in attendance, or who may be unfamiliar with the intervention and its risks, benefits, and alternatives (e.g., residents, secretaries,)
How Should Decisional Capacity Be Assessed?
Decisional capacity refers to a patient’s ability to make an authentic choice. Capacity includes cognitive and affective functions, including attention, intellect, memory, judgment, insight, language, emotion, and calculation. Decisional capacity includes the following four abilities on the part of the patient:
- Receive information;
- Process and understand information;
- Deliberate; and
- Make and articulate a choice.
Decisional capacity should be assessed on some level in all patients. Capacity is essential to the processes of informed consent and informed refusal of treatment.18-20
The assessment of medical decision-making capacity is an important skill for emergency physicians. In many cases, this can be accomplished by routine interactions with the patient who is alert, conversational, and appropriate. In such cases, physicians are able to determine a patient’s capacity to participate in the informed consent process. In some cases, however, the determination of adequate decisional capacity can be challenging.
Decisional capacity may vary over time, as a function of host and environmental factors over time. Capacity is a dynamic, task-specific, and changing attribute, and may be viewed as a spectrum, pertaining to the particular healthcare decision at hand. Some impairments of capacity may be temporary, such as acute alcohol intoxication.
A stepwise approach may be used in the determination of decision-making capacity.21 Essential elements of a suggested stepwise approach are summarized in Table 1.
Stepwise Approach to Determination of Capacity
Standardized tests may be valuable in the determination of capacity.22-29 One standardized test easily administered in the ED is the Mini-Mental Status Examination. (See Table 2.)30 Typically, a score of 25-30 is acceptable for establishing appropriate mental status, 20-25 is borderline, and below 20 indicates serious impairment of mental status.
Mini-Mental Status Examination
The formulation by the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research is another standardized test that is well recognized and useful.31
Impaired decision making capacity may result from impairment in any of the four essential elements: impaired ability to receive, process, and understand information, deliberate, or to communicate a decision.
Numerous threats and barriers to capacity exist, many of which are reversible, or may change over time.32,33 Although a detailed review of causes of altered mental status is beyond the scope of this document, some examples of clinical settings of impaired capacity may include patients with dementia,34,35 intoxicated patients, psychiatric patients, patients of other cultures or languages, patients with physical communication impairments, severe pain, organic disease states,36,37 and numerous other clinical settings. Every effort should be made to correct reversible etiologies of diminished capacity. Emergency physicians must be aware of potential barriers to capacity and must make an individual assessment of capacity in each case.38-40 Even individuals who have some impairment of capacity may demonstrate sufficient understanding of the decision at hand to make an appropriate informed choice.
What Procedures Require Informed Consent?
There is tremendous variability among emergency physicians regarding the type of consent (verbal, written, or none) for many emergency procedures, including lumbar puncture, endotracheal intubation, arthrocentesis, venipuncture, and others.41 In general, risks and benefits of all medical interventions should be discussed with patients. There is no national standard that dictates which procedures require written consent. Interventions with high risk, uncertain necessity, or other such factors may dictate written documentation of the discussion of the procedure, risks, benefits, and alternatives. Previous authors have suggested that specific written consent be obtained for a variety of procedures and interventions, including invasive procedures, HIV testing, radiographic procedures, treatment with controlled substances, and others.42,43
What Information Should Be Disclosed?
How much information should be presented to patients? Should every possible complication be detailed? Or might this frighten a patient, perhaps unnecessarily? The balance of the right amount of information to be delivered can be challenging to discern. Certainly sufficient information to weigh the risks and benefits should be presented. However, an overwhelming amount of information may be confusing or even intimidating to patients.
The “reasonable person” standard of disclosure counsels that sufficient information should be disclosed that would be “material” to a reasonable person to make a decision in that particular case. Needless to say, a judgment about what information is considered “material” can be very subjective. “Material” risks are those considered significant for decision making by a reasonable person. Although most states favor the “reasonable person” disclosure standard, some states utilize the “professional standard,” which indicates that the physician should disclose what other physicians in the community would disclose in similar circumstances. Risks that are considered very remote or those that are commonly known, need not be disclosed in every case.
Should Status as a Resident or Medical Student Be Disclosed?
In most teaching institutions, general consent to treatment includes basic information about being treated by residents, interns, and students under appropriate supervision. However, many patients are unaware of the training status of many health care professionals.44,45 General ethical principles dictate that patients should be informed about the identity and training level of health care providers participating in their care. However, disclosing details about previous training and experience is less clear. The issues of patient autonomy regarding health care and necessity to train health care professionals must be balanced.
Many patients are willing to be treated by students and residents, if this information is disclosed.46 Many patients are reluctant to have students perform a procedure for the first time on them, and many believe that they should be informed if the resident or student is performing a procedure for the first time.47,48
What About Patients Who Refuse to Consent?
Just as all competent patients have the right to participate in the informed consent processs prior to medical interventions, patients also have the right to refuse medical care. Refusal of care may occur at several levels, including general treatment, hospital admission, or specific tests or therapies. As with informed consent, informed refusal is a process, not merely a signature on a form documenting that the patient is leaving against medical advice, or an AMA form. The process should similarly consist of determination of decisional capacity, delivery of information, including risks of refusing treatment, and documentation of the process. When a patient refused medical treatment, great care should be taken that the patient understands the consequences, and that the physician remains willing to treat the patient.
In some circumstances, patients should be treated appropriately even without informed consent, or even if they specifically refuse care. Examples of treatment without consent include patients who lack decisional capacity, patients with public health risks, and patients who pose an immediate threat to the health or well-being of themselves or others. Medical treatments necessary to prevent potential loss of life, limb, or impaired quality of life should be undertaken in such circumstances.
When caring for patients, the safety of staff and patients is a primary objective.49,50 As a result, some patients may need to be physically restrained without their consent to assure safety of the environment. The use of physical restraints should be limited to cases in which the safety of the patient, other patients, or staff is threatened, such as for patients who are violent or suicidal patients who pose an immediate elopement risk. Restraints should be used in the least restrictive manner possible, and for the least amount of time necessary to achieve the desired goals. According to policy set by the American College of Emergency Physicians (ACEP), “restraints should be individualized and afford as much dignity to the patient as the situation allows” and “any restraints should be humanely and professionally administered.” Additionally, this policy states that protocols should ensure appropriate observation, treatment, assessments, and documentation.51 Restraints should never be used for competent patients who refuse medical therapy.52
Though every recommendation a patient chooses to refuse should be accompanied by an informed refusal discussion, every refusal need not be accompanied by an AMA form. When the dangers to the health of the patient from refusal are great, and a reasonable patient would follow the course of action the physician recommends (e.g., treatment and hospitalization for a probable myocardial infarction), but this particular patient who is decisional is not following the physician’s recommendation, an AMA form can act as an important documentation of the refusal to the physician and the information that the patient understood before refusing treatment.
What About Minors?
Unlike adults, who generally are deemed capable of making their own health care decisions, minors generally do not have this right legally recognized. Under most circumstances, parents have the right to consent or refuse medical care for their minor children. Many states allow adolescent minors some limited autonomy, often specifically in the areas of contraception, treatment for sexually transmitted disease or substance abuse without parental permission. State laws vary widely, and emergency physicians should be aware of the state laws where they practice. In many states, “emancipated minors” are considered competent to make their own healthcare decisions. Emancipated minors often are defined as minors who are married or living independently and supporting themselves, in the military, or who are pregnant or have children. In addition, case law in some states on the “mature minor” now recognizes that as the adolescent’s age increases toward maturity, he or she can have a progressively greater part in the decision-making process for important medical decisions.
Many pediatric and adolescent patients present to the ED without parent or guardian to consent for treatment (approximately 2-3% of pediatric ED patients).53 In such circumstances, “Appropriate medical care for the pediatric patient with an urgent or emergent conditions should never be withheld or delayed because of problems with obtaining consent.”(This statement is endorsed by The American College of Emergency Physicians, American College of Surgeons, Emergency Nurses Association, and National Association of EMS Physicians).54 In addition, the Emergency Medical Treatment and Active Labor Act (EMTALA), federal law, requires that a screening examination for an emergency medical condition be performed for all patients presenting to emergency departments, including minors, with or without parental consent.
Parents may in some cases refuse care for their minor children. In some circumstances, the state allows medical personnel to deliver emergency medical care to children, even if parents refuse care, because of the state’s interest in the well-being of the child. In such circumstances, physicians can and should treat emergency medical conditions of minors, even if the parents object.55,56 In general, a court order should be obtained, if it would not inappropriately delay treatment.
Should Religious and Moral Issues Be Considered?
Some patients may refuse medical interventions because of religious or moral reasons. One example is the Jehovah’s Witness patient who refuses blood transfusions. If considered to have appropriate decisional capacity, adult patients can agree to or refuse treatment based on religious or moral considerations or other personal reasons, even if it results in adverse outcomes, including death.
What About Mandatory Reporting?
Certain clinical situations warrant the disclosure of protected health information (PHI) without specific consent from patients. Situations in which the disclosure of PHI is permissible include when required by law (court order, statute, or regulation), FDA reporting, certain communicable diseases, and certain work-related illnesses or injuries. Additionally, release of PHI may be required or permitted by law in cases of suspected neglect, abuse, or domestic violence.
According to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), disclosure to law enforcement officials without consent may be permissible in some circumstances, including in response to court orders, warrants, or subpoenas, to assist in the identification or location of a suspect, fugitive, witness, or missing person, or when responding to a law enforcement official’s request for information about a crime victim. Disclosure also is permissible when a person’s death may be the result of criminal activity, when PHI may be evidence of a crime that occurred on hospital property, or when necessary to inform officials about the nature of a crime, the location of victims, or the perpetrator.57
Physicians have a duty to warn individuals or groups when information is available that indicates that there is a significant risk posed by a patient or by information divulged by a patient, without specific consent from the patient. This duty to warn has been upheld in multiple legal cases by the U.S. courts. National policies including those written by the AMA, ACEP, and language in HIPAA also recognize that disclosure of PHI may be appropriate in cases in which there is a potential threat to the public or to an individual.58-62
Individual states regulate the reporting of certain conditions as reportable to public health officials. Although there is some variation in conditions that mandate reporting, certain conditions commonly are recognized as reportable conditions. Examples of statewide reportable conditions include traffic crashes, penetrating trauma, residential fires, occupational injuries, suicide prevention, falls, poisoning, violence, and drowning. The Centers for Disease Control and Prevention (CDC) maintains a Public Health Information Network, which contains data regarding national reportable conditions.
What About Informed Consent for Research?
Informed consent should be obtained from potential research subjects prior to participation in medical research. In some cases, verbal consent is sufficient, but in most cases, written informed consent is appropriate. Informed consent documents for research should be worded appropriately, understandable, and should include an explanation of the purposes of research, duration of participation, description of the study, risks, benefits, alternates, confidentiality, compensation, and information about voluntary participation.63-68 Informed consent documents and discussions should be written and delivered at a reading level appropriate to the potential subject. This may require some individual adaptation.
There exist many unanswered questions about the ideal informed consent process. Several recent studies demonstrate that research subjects’ understanding of detailed informed consent is poor.69-71 Several recent reports indicate that a majority of patients prefer detailed information compared with abbreviated information.72-74 Another study demonstrated improved information retention with a short form compared with a more detailed form.75 Although many informed consent documents are written at an inappropriately high reading level,76-78 careful attention to the written informed consent document and its linguistics can improve its readability.79
The same process of informed consent should be utilized in research settings that is used in clinical settings. Decisional capacity should be assessed, information should be delivered, and the patient should voluntarily agree to participate. A detailed discussion with the potential subject, including feedback from the subject regarding his or her understanding of risks and benefits, may elucidate the level of understanding and provide opportunity for additional education.
Coercion of potential research subjects, either overt or masked, is unethical. Although most researchers agree with this in principle, many continue to coerce subjects in subtle ways. Examples of inappropriate coercion include excessive monetary incentives, failure to inform the subject of voluntariness of participation, repeated questioning, inappropriate representation of the study benefits, withholding of care prior to consent, and numerous others. Any form of coercion must be avoided.
How Should Informed Consent Be Documented?
Some erroneously believe that a patient signature on an informed consent document is sufficient. Informed consent is a process, with necessary elements, including the discussion between the physician and patient, delivery of important information, including a description of the intervention, risks, benefits, and alternatives, and the patient’s agreement to the proposed intervention. The piece of paper with signatures does not comprise informed consent and is not a substitute for the discussion. However, such signature does provide evidence of the patient’s indication that the informed consent process did take place. Additionally, documentation of the informed discussion, information delivered, patient’s decisional capacity, and the patient’s consent to the intervention all should be documented in the medical record.
Informed consent for procedures in emergency medicine is an essential element of the protection of human subjects’ rights, yet it remains a complex and challenging process. Decisional capacity should be evaluated, and if appropriate, the physician should communicate with the patient regarding the proposed intervention, risks, benefits, and alternatives, and the patient’s goals and values of therapy. If the patient voluntarily agrees, the intervention may be pursued. The patient encounter and important aspects of the communication should be documented in the medical record.
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70. Mader TJ, Playe SJ. Emergency medicine research consent form readability assessment. Ann Emerg Med 1997;29:534-539.
71. David TC, Holcombe RF, Berkel HJ, et al. Informed consent for clinical trials: A comparative study of standard versus simplified forms. J Natl Cancer Inst 1998;90:668-674.
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73. Kruse AY, Kjaergard LL, Krogsgaard K, et al. A randomized trial assessing the impact of written information on outpatients’ knowledge about and attitude toward randomized clinical trials. The INFO trial group. Control Clin Trials 2000;21:223-240.
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79. Bjorn E, Rossel P, Holm S. Can the written information to research subjects be improved? An empirical study. J Med Ethics 1999;25: 263-267.
At the conclusion of this activity, participants should be able to:
- Discuss current laws relating to informed consent
- Explain medical ethical standards relating to providing informed consent
- Share processes involved in providing informed consent.
Physician CME Questions
To participate in this CME program, read the article and then answer the questions below. Review any material related to missed questions. In order to receive credit for this activity, you must complete the evaluation form enclosed with this issue. When your completed form has been received, a certificate will be mailed to you.
1. Which principle of bioethics best relates to the principle of informed consent?
2. Who should obtain informed consent from the patient?
B. Primary care physician
C. Physician performing the procedure
3. Which of the following conditions allows a physician to treat the patient despite his or her refusal?
A. Possibility of bad outcome
C. Life-threatening medical condition
D. Psychiatric diagnosis
4. How much information should be disclosed when obtaining informed consent?
A. All information available in the medical literature
B. Only information requested by the patient
C. Only information requested by the family
D. Information desired by a reasonable person
5. If a patient has decisional capacity and refuses life-saving medical intervention, what is the best course of action?
A. Allow the patient to refuse care
B. Restrain the patient to administer life-saving medical care
C. Obtain consent from the next of kin
D. Obtain consent from two physicians for emergency care
6. What is the most essential element of informed consent?
A. Signature on the informed consent document
B. Discussion with the physician and patient
C. Documentation in the medical record
D. Witness’ signature on the informed consent document
7. What is implied consent?
A. A patient signs the general consent for treatment.
B. A patient signs a specific informed consent document.
C. A patient indicates by actions that he/she agrees with the intervention.
D. A surrogate agrees to the intervention in place of the patient.
8. What is decisional capacity?
A. The patient’s ability to make an authentic choice
B. The patient’s legal competence
C. The surrogate’s ability to consent in place of the patient satisfaction
D. The patient’s mental capacity
9. Which of the following should be included in the written consent for research?
A. Relevant articles from the medical literature
B. Names of other study participants
C. Preliminary results of the research project
D. Purpose of the research project
10. Which of the following statements is true regarding the use of physical restraints?
A. Informed consent from the patient is required prior to use.
B. Restraints may be required for the protection of staff.
C. Restraints should be used for as long a period as possible.
D. Restraints may be used to restrain competent patients who refuse medical care.
CME Answer Key
1. A; 2. C; 3. B; 4. D; 5. A; 6. B; 7. C; 8. A; 9. D; 10. B
Barriers to the informed consent process may exist among emergency patients, including impaired decisional capacity, impaired cognition, language barriers, illiteracy, insufficient time and communication, and numerous others. Because of the inherent vulnerability of ED patients, particular attention should be paid to addressing barriers to adequate informed consent, and steps should be taken to ensure adequate delivery of information, understanding of the proposed intervention and its risks and benefits, and voluntariness of the informed consent.
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