Informed procedural consent in the intensive care unit

INTRODUCTION — Patients in the intensive care unit (ICU) commonly undergo procedures that require obtaining consent from the patient or their surrogate.

Ethical issues related to informed consent in the ICU are reviewed here. Our emphasis is on informed consent for medical interventions performed by the ICU team, such as arterial catheterization, central venous catheterization, bronchoscopy, endotracheal intubation, paracentesis, and thoracentesis (table 1). Although many principles also apply to informed consent for surgery, endoscopy, interventional radiology procedures, and participation in clinical research, these areas are beyond the scope of this review. Other topics with relevant information are discussed separately.

●(See "Withholding and withdrawing ventilatory support in adults in the intensive care unit".)

●(See "Responding to requests for potentially inappropriate or futile therapies in adult intensive care unit".)

●(See "Communication in the ICU: Holding a meeting with families and caregivers".)

●(See "Informed procedural consent" and "Assessment of decision-making capacity in adults".)

●(See "Informed consent in obstetrics".)

●(See "Informed procedural consent" and "Assessment of decision-making capacity in adults".)

DEFINITION, JUSTIFICATION, EXCEPTIONS

Definition — Informed procedural consent is a process of communication between a clinician and a patient or surrogate decision-maker that results in the patient/surrogate agreeing (or refusing) to undergo a specific medical intervention. The process is fluid such that although consent has been obtained, it should be recognized that consent may change with new information. Further details regarding informed procedural consent are provided separately. (See "Informed procedural consent".)

Ethical justification — The primary ethical justification for obtaining informed consent is to respect the patient's right to determine what happens to their body (ie, respect for autonomy). This entails a right to approve or refuse treatments that clinicians judge to be medically reasonable.

One of the requirements of autonomous choice is that the patient is able to make a choice. Since many patients in the ICU are incapacitated, autonomous choice is often not feasible, unless an oral or written advanced directive with specific instructions is in place. In such situations, clinicians and surrogates analyze the patient's prior statements, values, and beliefs to make a decision that broadly respects the patient as a person. This is termed "substituted judgment," which does not constitute an autonomous choice by the patient but rather attempts to make decisions that are "authentic" to the patient [1]. Importantly, evidence suggests that >90 percent of patients prefer family members to work with the clinician to make medical decisions for them if they are incapacitated [2].

Emergency exception for consent — An exception to the requirement for informed consent is recognized when an emergent, lifesaving procedure is required and delaying the procedure to obtain informed consent would pose a risk of serious, imminent harm (eg, death or severe disability). Such situations are not uncommon in the ICU. However, it is sometimes possible in emergency settings to have an abbreviated discussion about the treatment in question; whether this constitutes informed consent is unclear. Documentation of the precise circumstances for the exception is important. (See 'Documentation' below.)

In such emergencies, the courts have recognized the permissibility of an exemption from the requirement for informed consent. Examples include endotracheal intubation in the setting of an incapacitated patient with acute respiratory failure, administering cardiopulmonary resuscitation to someone who collapses on the street with cardiac arrest, or establishing central vascular access in the setting of an acute, massive upper gastrointestinal hemorrhage.

The emergency exception should not be used when it is possible to obtain informed consent. Moreover, it should not be used to override a patient's clearly articulated or written treatment preferences (eg, a patient who refuses blood transfusions on religious grounds).

PROCESS OF INFORMED CONSENT — Informed consent is a communication process rather than merely obtaining a signed consent document. The process of obtaining informed consent in the ICU follows the same principles as those outside the ICU and involves the following five steps with the patient and/or surrogate:

●Ensuring the patient or surrogate has decision-making capacity (see 'Assess decision-making capacity' below)

●Discussing pertinent medical information (see 'Discuss pertinent information' below)

●Ensuring adequate understanding of the information (see 'Assess comprehension' below)

●Ensuring voluntariness of patient's or surrogate's decision (see 'Ensure voluntariness' below)

●Jointly deliberating and obtaining the patient's or surrogate's agreement to a plan of care (see 'Joint deliberation' below)

Assess decision-making capacity — Valid consent requires that the patient or surrogate have decision-making capacity. Further details on assessing decision-making capacity are provided separately (see "Assessment of decision-making capacity in adults"). Pertinent to ICU patients are the following:

●High prevalence of incapacity – Many patients in the ICU are incapable of making decisions for themselves for reasons such as pharmacologic sedation, delirium, and encephalopathy [3]. This is termed "incapacity." Incapacity is a clinical determination typically made by the treating clinician and is different from incompetence, which is a legal determination that can only be made by the legal system (see "Assessment of decision-making capacity in adults", section on 'Capacity and competency'). Consequently, the clinician is frequently reliant upon a surrogate with capacity to obtain consent. Additionally, sometimes the appointed surrogate decision maker may also lack capacity, due to substance abuse, severe mental illness, or dementia. If concerns are suspected about a surrogate's decision-making capacity, we conduct a formal capacity assessment and, if the individual lacks capacity, another surrogate should be sought. Further details regarding assessing capacity and types of surrogate decision-makers are provided separately. (See "Assessment of decision-making capacity in adults", section on 'When to assess capacity' and "Assessment of decision-making capacity in adults", section on 'How to assess capacity' and "Informed procedural consent", section on 'Comatose or incompetent patients'.)

●Reassessment is necessary over time – Reassessment of decision-making capacity is important since patients may regain capacity as their illness improves and/or the effects of medications wear off. Once capacity is re-established, the patient's stated preferences supersede the wishes of any surrogate or family members.

Discuss pertinent information — The clinician who is performing the intervention should communicate this information concisely using terminology that the patient or surrogate can understand. Principles of effective communication such as comprehensible language, educational materials, and interpreters are discussed separately. (See "Informed procedural consent", section on 'Effective communication'.)

Components of the discussion — It is generally accepted that the informed consent conversation should include a description of the following:

●The intervention (including the personnel who will be participating)

●The potential benefits and risks of the intervention

●Reasonable alternatives (including no intervention)

●The potential benefits and risks of the alternatives

Provision of pertinent detail — There is no single widely accepted standard for how much detail should be provided in the informed consent process. The goal is to be informative, but communicating every detail is neither possible nor practical. Generally speaking, all adverse events that are either frequent or severe should be described. However, this process is challenging [4-6] and is sometimes impractical in the ICU where performing procedures may have time constraints.

Legal aspects — Descriptions of the professional, reasonable person, and subjective legal standards are provided separately. (See "Informed procedural consent", section on 'The duty to inform'.)

Assess comprehension — We ensure that the information that was provided is understood by the patient or surrogate. A useful technique to assess understanding is to ask the patient or surrogate to summarize the information that has been conveyed and to clarify any misunderstandings. If feasible, the patient or surrogate should be allowed time to process the information and discuss it with other individuals before making a decision. However, the latter may be impractical in the ICU if there are time constraints associated with performing the procedure (eg, intubation, bronchoscopy for hemoptysis).

Ensure voluntariness — A condition for valid informed consent is that the patient/surrogate is able to make decisions voluntarily, free from coercion or manipulation [7]. Coercion or manipulation could arise from either the clinician's behavior or the behavior of the patient's family/surrogate. In the latter circumstance, we have conversations with the patient without the family/surrogate in the room or seek an ethics consultation to assist in managing suspected coercion or manipulation.

●Coercion occurs when intentional threats or other actions substantially constrain patients' or surrogates' ability to choose freely. For example, an ICU clinician might attempt to coerce a patient by stating that they will not treat them in the ICU unless the patient undergoes endotracheal intubation.

●Manipulation involves attempts to influence patients' or surrogates' choices through behaviors such as withholding information or lying. An example of manipulation in the ICU context is a clinician who intentionally withholds information about the risks of placing a central venous catheter when discussing the procedure with a surrogate of a patient.

Joint deliberation — A robust consent process is best achieved by a shared deliberation/dialogue between those who have in-depth knowledge of the patient's values and wishes and those who understand the pertinent medical considerations [8]. This involves collaboration between the clinician and the patient (if possible) or one or more surrogates. Joint deliberation between the patient/surrogate and the clinician is particularly important in the ICU since more than one procedure is commonly performed, some of which may be lifesaving or particularly risky (eg, intubation in a patient with a difficult airway, bronchoscopy in a patient with significant hypoxemia).

In the ICU, patients or surrogates often ask for the clinician's opinion before giving final consent, in which case the clinician should render their opinion regarding the proper course of action considering the patient's values and goals. Occasionally, the opinion of other surrogates or family members and friends are requested, which can enrich the deliberative process. In addition, patients or their surrogate may ask the clinician how many similar interventions they have performed and their success rate. Such questions should be answered truthfully.

Occasionally, the decision made by a surrogate seems contrary to the patient's known goals and preferences. In such cases, we engage the surrogate to understand the reasons for their decision. As an example, we might say, "Can you tell me a little about why you believe that your father would want to be intubated in the absence of a reversible cause?" or "Can you help me understand why you think your mother would want hemodialysis when she stated that she did not want her life to be prolonged by artificial means?" If it is suspected that the patient's well-being is not the surrogate's primary concern, we involve the hospital ethics committee and, in extreme cases, initiate legal processes to replace the surrogate decision maker with one who will make decisions in accordance with the patient's values and preferences. Details regarding responding to requests that are potentially inappropriate are provided separately. (See "Responding to requests for potentially inappropriate or futile therapies in adult intensive care unit".)

Documentation — Once the appropriate information has been provided, questions have been answered, and comprehension has been confirmed, the clinician should ask the patient or surrogate whether they grant permission for the intervention to be performed and if so, the consent form should be signed.

Clinicians should carefully document any informed consent discussions, regardless of whether consent was ultimately obtained. The components of documentation are discussed separately. (See "Informed procedural consent", section on 'Documentation'.)

SINGLE, BUNDLED, BLANKET CONSENT — There is no agreed upon optimal or ethically correct approach to consent for procedures in the ICU. There is substantial variability in how clinicians approach informed consent for common ICU procedures (table 1) and practice is often dictated by institutional policy. The three most common approaches to obtaining consent in the ICU are the following:

●Informed consent for each procedure. (See 'Informed consent for each procedure' below.)

●Anticipatory bundled consent for common ICU procedures. (See 'Anticipatory bundled consent for common ICU procedures' below.)

●Blanket consent for all "routine ICU interventions." (See 'Blanket consent for all "routine ICU interventions"' below.)

Limited data indicate significant variability among clinician practice. In a national survey of critical care training program directors, 34 percent reported using blanket consent to cover common ICU procedures [9] (see 'Blanket consent for all "routine ICU interventions"' below). The rates of obtaining written informed consent for individual procedures varied widely: 5 percent for placement of indwelling urinary catheters, 51 percent for arterial catheterization, 65 percent for central venous catheterization, 81 percent for thoracentesis, and 85 percent for bronchoscopy.

Informed consent for each procedure — In this approach, the clinician obtains informed consent for each proposed intervention at the time of the procedure, engaging the patient or surrogate in a conversation as described above (See 'Process of informed consent' above.)

The main benefits of this approach are that it adheres closely to the theoretical ideal of informed consent and allows individuals to assess risks and benefits of the procedure in real time.

The main drawbacks are that it is time-intensive and may sometimes result in situations in which no consent can be obtained because circumstances necessitate emergently performing the procedure.

Anticipatory bundled consent for common ICU procedures — Anticipatory bundled consent for common ICU procedures entails obtaining written consent upon ICU admission for specific procedures well before the procedure is needed. There is broad agreement that all nonemergency invasive procedures should at least be discussed with the patient or surrogate as part of the ongoing process of communication that defines true informed consent [10]. However, there is controversy about whether the signature of a patient or surrogate should be obtained on a separate formal consent document for individual common ICU procedures or one signature for them all.

The main advantage of a bundled consent approach is that it is time-saving and rates of obtaining consent for actual procedures may be higher than separate consent forms [11].

The main drawback is that it may discourage communication that is the hallmark of true informed consent. Moreover, it is argued that this approach is not truly informed because it does not allow consideration of the patient's actual condition and how that may affect the risk-benefit ratio.

There are limited data that support this approach. One prospective study compared standard informed consent for individual procedures with an approach in which, upon ICU admission, patients or surrogates were provided a universal consent form for eight common ICU procedures, as well as information about the risks and benefits of each procedure [11]. Procedures included on the bundled consent were arterial catheter, central venous catheter, pulmonary artery catheter, or peripherally inserted central catheter placement; lumbar puncture; thoracentesis; paracentesis; and intubation/mechanical ventilation. Bundled consent resulted in higher rates of obtaining written informed consent for actual procedures performed (90 versus 53 percent) and comparable levels of comprehension among consenters regarding the indications for and risks of procedures.

Blanket consent for all "routine ICU interventions" — The third approach is to assert that certain invasive procedures (eg, arterial lines, central lines, bronchoscopy) are common enough to be considered part of routine ICU care and are therefore covered by a "blanket consent" form that patients or surrogates generally sign upon admission consenting to treatment in the hospital. Blanket consent forms broadly cover almost everything a doctor or hospital might do without mentioning anything specific [11].

The argument offered in favor of "blanket consent" being ethically adequate is that it is accepted (and practically necessary) that ICU clinicians routinely do many things without consent that involve at least some risks of harm. These include ventilator mode changes, decisions about pursuing imaging studies, frequent blood pressure monitoring, temperature monitoring via rectal probe, nasogastric tube insertion, extubation, urinary catheterization, and medication changes. It is also argued that there are not adequate differences in risk between these interventions (for which no written consent is required) and some of the invasive procedures commonly performed in the ICU to justify requiring separate written informed consent for the latter.

A criticism of this approach is that informed consent for these procedures is sought when the procedure occurs outside the ICU setting (eg, outpatient placement of central lines). In addition, there are sometimes alternatives to these procedures that reasonable patients might choose. A final criticism is that blanket consent may not actually achieve the ethical goals of informed consent because patients/surrogates are not informed about the specific invasive procedures that will be performed on them.

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Intensive care unit ethics".)

SUMMARY AND RECOMMENDATIONS

●Definition, justification, exceptions – Informed procedural consent is a process of communication between a clinician and a patient or surrogate decision-maker that results in the patient agreeing or refusing to undergo a specific medical intervention. (See 'Definition' above.)

•Justification – Informed consent respects the patient's right to determine what happens to their bodies (ie, respect for autonomy). However, many patients in the intensive care unit (ICU) lack the capacity to make an informed decision (eg, due to the critical illness or medications). Instead, clinicians and surrogates analyze patients' prior statements, values, and beliefs to make a decision that broadly respects the patient as a person. This is referred to as "substituted judgment." (See 'Ethical justification' above.)

•Exceptions – Informed consent is not required when an emergent, lifesaving procedure is indicated and delaying the procedure to obtain informed consent would pose a risk of serious, imminent harm (eg, death or severe disability). Documentation of the precise circumstances for the exception is important. (See 'Emergency exception for consent' above.)

●Process of informed consent – The process of obtaining informed consent involves the following:

•Ensuring the patient or surrogate has decision-making capacity – Most patients in the ICU are incapacitated, necessitating a surrogate. As the illness resolves, reassessment of capacity is important. (See 'Assess decision-making capacity' above and "Assessment of decision-making capacity in adults".)

•Discussing pertinent medical information – Medical information should be communicated concisely using terminology that the patient or surrogate can understand. There is no single widely accepted standard for how much detail should be provided. The goal is to be informative and responsive to patients' preferences for information, but communicating every detail is neither possible nor practical. (See 'Discuss pertinent information' above and "Informed procedural consent", section on 'Effective communication'.)

•Ensuring adequate understanding of the information – The clinician should ensure that the provided information is understood by the patient or surrogate (eg, ask for a summary of the information that has been conveyed and clarify any misunderstandings). (See 'Assess comprehension' above.)

•Ensuring voluntariness of patient's or surrogate's decision – The clinician should ensure that the patient/surrogate is able to make decisions voluntarily, free from coercion or manipulation. (See 'Ensure voluntariness' above.)

•Jointly deliberating and obtaining the patient's or surrogate's agreement to a plan of care – Consent decisions are best made jointly by those who have in-depth knowledge of the patient's values and wishes (ie, patient/surrogate) and those who understand the pertinent medical issues (treating clinician). (See 'Joint deliberation' above.)

•Documentation – Clinicians should document any informed consent discussions, regardless of whether consent was ultimately obtained. The components of this documentation are provided separately. (See 'Process of informed consent' above and "Informed procedural consent", section on 'Documentation'.)

●Single, bundled, or blanket consent – There is substantial variability in how clinicians approach informed consent for common procedures in ICUs (individual consent for each procedure, bundled consent for common procedures, blanket consent for routine ICU interventions). However, there is no agreed-upon optimal or ethically correct approach. As such, clinician adherence to institutional policies is reasonable. (See 'Single, bundled, blanket consent' above.)

ACKNOWLEDGMENT — The UpToDate editorial staff acknowledges John Kellum, MD, who contributed to earlier versions of this topic review.