Informed consent serves three intersecting objectives:

1. protecting the legal rights of the individual

2. promoting the ethical practice in medicine

3. fulfilling the administrative demand on hospitals to ensure adequate informed consent (4)

Legally, informed consent provides patients protection from assault and battery. The 1914 case of Schloendorff v. Society of New York Hospital inaugurated the modern legal precept in America of consent, determining that a patient has a “right to determine what shall be done with his body” (5). In the 1950s, courts determined that physicians must disclose all pertinent facts needed for a patient to make an informed decision—the so-called “reasonable physician” standard. In the 1970s, the concept of the “reasonable person” standard arose, stating that the information disclosed should be that which a reasonable person would want to know (5). According to this standard, patients or their surrogates should have all of the information they need to compare treatment options and make decisions based on their personal values, goals, and preferences (6).

Ethical principles of informed consent center on respect for patient autonomy, ensuring that individuals have “the capacity to live life according to [their] own reasons and motives” (2). By this precept, patients or their representatives will use the information that they receive to make informed, rational, autonomous decisions. While the nature of the risks, benefits, and alternative therapies discussed is at the discretion of, and based on the judgment of, the clinician obtaining the consent, enough detail should be provided to allow for the patient or the patient’s representative to make an informed decision (5). The American Academy of Pediatrics (AAP) notes that, in certain instances, the discussion of provider-specific data or clinician experience is also warranted (2). With an ethical focus, experts have proposed that a more appropriate ideal for the informed consent process is a “shared decision-making” model in which providers make recommendations based on collaborative communication and an understanding of the family’s goals and values (2). The administrative aspects of informed consent center on compliance, including the development of policies surrounding patient consent for treatment or procedures as well as the documentation of an adequate informed consent process.

In addition to a signed consent form, there are four required components to an acceptable informed consent process:

1. Communication of adequate information allowing for an informed decision including details of the proposed procedure or treatment and the probability of success.

2. Assessment of the decision maker’s understanding of the information conveyed.

3. Appraisal of the patient’s or patient representative’s capacity for appropriate decision making.

4. Assurance that the consent that is provided is voluntary (2).

Little is written about who should be responsible for obtaining informed consent from a patient or a surrogate decision maker. Some institutions require that only the individual performing the procedure may obtain the consent (7). Others have suggested that individuals who are capable of performing a procedure should be able to obtain consent for that procedure, as they would be most likely to understand the potential risks and their frequency, as well as the anticipated benefits of a procedure. Additionally, those responsible for acquiring consents should have training to familiarize them with the specific requirements of the informed consent process (8). In practice, however, it is often trainees with relatively little hands-on experience who are tasked with obtaining consents for specific procedures from patients or their representatives (9).

There are a variety of approaches to obtaining informed consent for procedures for patients being cared for in the intensive care unit (ICU).

Informed consent can be:

Weiss et al. surveyed many different types of adult ICUs about their consent practices for 16 procedures commonly performed in the ICU setting. They found that in the majority of ICUs, practitioners obtained procedure-specific consents. Only about 20% of ICUs had bundled procedure consents. About 25% acquired an overall consent for ICU admission, though some of these also asked for procedure-specific consents (10). Davis et al. explored the use of bundled consents covering 8 procedures frequently required in adult ICUs. They demonstrated a 70% increase in the frequency with which consent was documented prior to the procedure being performed. In both groups, the majority of consents were provided by patient surrogates rather than by the patients themselves. No decline was seen in comprehension of the procedure indications or risks with the bundled consent form (11). Other studies have shown increased family satisfaction following the introduction of a bundled consent form that was presented and signed at a family meeting within the first 2 days of an ICU admission (12).

In a recent survey of informed consent practices in neonatal ICUs and pediatric ICUs, 70% of respondents reported using procedure-specific written consents. This was also the method respondents deemed most likely to satisfy all of the criteria for adequate informed consent (13). To date, however, studies of interventions to improve informed consent practices in NICUs are lacking.

According to the CMS, a consent form must be completed prior to a procedure or treatment and in accordance with hospital guidelines as well as state and national laws (14). At a minimum, informed consent forms must include:

CMS suggests that a well-designed informed consent form could also include: