Review Article

Consent to Care

Felicia F. Lo1, Molly Sanborn2,*
1Milken Institute School of Public Health, The George Washington University, 950 New Hampshire Ave, NW, 6th Floor Washington, USA
2Global Health Epidemiology and Disease Control, George Washington University, Washington, USA

*Corresponding author:

Ms. Molly Sanborn, Global Health supEpidemiology and Disease Control, George Washington University, Washington, USA, Email: msanborn@gwmail.gwu.edu

Keywords:

Consent to care, Health care providers, Informed consent, Reasonable patient standard, Reasonable physician standard, Subjective standard

Created as a brief literature review, this chapter focuses on “Consent to Care”, also known as informed consent, which has risen as an essential topic for patient health care and the medical process. As an interactive dialogue between a physician and his/her patient, consent to care is rooted in four major court cases between 1905 and 1914: (1), Mohr v. Williams, (2) Pratt v. Davis, (3) Rolater v. Strain, and (4) Schloendorff v. Society of New York Hospitals [1]. In order to make a fully informed decision, there are three standards: the reasonable physician standard, the reasonable patient standard, and the subjective standard. This study reviews the current problems with this process including vulnerable patients, accessibility, and comprehension. The study also discusses why Consent to Care is important to society and, a key hallmark of American culture, individual autonomy. Overall, to ensure trust, patients must be presented with complete and thorough information regarding their impending medical treatment. A systemic lack of trust could derail the health care system as it did in the U.S. Department of Veterans Affairs (VA). Dr. David Shulkin, the new Secretary of the VA was quoted in an interview stating “We’re in critical condition, but moving toward stable…The V.A. has experienced a very, very tough time. It lost the most important thing any organization could have: its trust” [2].

Informed consent is the process by which doctors obtain permission from a patient to perform a medical procedure or operation. However, contrary to what many patients may think, consent is not merely a process of signing the documentation [3]. Rather, it is an interactive dialogue between physician and patient. The complete process of consent involves seven key elements: discussing the 1) patient’s role in the decision-making process, 2) the clinical issue and suggested treatment, 3) alternatives to the suggested treatment, 4) the risks and benefits of the suggested treatment, 5) the related uncertainties, 6) the patient’s understanding of the information provided, and 7) obtaining the patient’s preference and consent [3]. Clearly, this process is far more involved than merely providing a patient with a form to sign; rather it is an in-depth discourse aimed at involving the patient in his or her own health care.
Informed consent must contain three key characteristics to be valid:

Voluntary

The person giving the consent must have the capacity to do so [4].

Informed

The patient must make the decision on his/her own with all of the information needed to do so.

Comprehended

Additionally, the patient must be capable of giving consent, by fully understanding the information and the implications [4]. Not only should the information be conveyed, but also should be understood, if not digested [5]. In order to make an informed decision, patients must be presented with complete and thorough information regarding their impending medical treatment.

There are several approaches that a physician can use to decide if sufficient information is passed to the patient. According to DeBord [6] there are three standards: the reasonable physician standard, the reasonable patient standard, and the subjective standard. The reasonable physician standard asks what a typical physician would say about the medical intervention; this allows doctors to determine what information is appropriate to disclose to the patient [7]. However, this standard is often inadequate, as many physicians do not explain the health care situation fully (or completely) to the patient. Another issue with this standard is its focus on the physician, rather than the patient, and therefore it violates the purpose of informed consent [6]. The reasonable patient standard asks what the average patient would need to know in order to make an informed decision [8]. This standard is more patient focused, and therefore more aligned with the purpose of informed consent. However, it does lack a personalized approach to the particular patient’s situation. The final approach is the subjective standard, which asks what this particular patient would need to know and understand in order to make an informed decision [9]. This approach takes into account the patient at hand and is, therefore, the most individualized. Most states have some sort of legislation that determines the required standard for informed consent [6].

Informed consent has its basis in several arenas, including ethical, legal, and administrative contexts. According to Hall, Prochazka, and Fink [10], the ethical purpose of informed consent is to “respect patient autonomy by ensuring that treatment is directed toward the ends desired and chosen by the patient”. Informed consent supports patient-defined goals and protects autonomous decision-making [10].

The legal basis for informed consent has its beginnings in the early 20th century when the US courts established the legal precedent for a patient’s “right to determine what shall be done with his body” [10]. According to Wandler [1], this precedent is rooted in four major court cases between 1905 and 1914: (1) Mohr v. Williams, (2) Pratt v. Davis, (3) Rolater v. Strain, and (4) Schloendorff v. Society of New York Hospitals. Though these cases established the patient’s right to determine what happens to his or her own body, the legal obligation for physicians to disclose details about treatment did not emerge until the 1950s [1]. Finally, in 1972, the reasonable person standard was established, creating the requirement that physicians disclose the information a reasonable person would want in order to make an informed decision [1]. In this short legal timeframe, simple informed consent protected patients against assault and battery – in the form of unwanted medical interventions – while full informed consent protects a patient’s right to autonomy, self-determination, and inviolability [10]. 

The process of informed consent has a basis in administrative procedure. The full process of gaining a patient’s consent to care culminates in the signing of documentation, formally giving consent for medical treatment. This documentation is an important part of informed consent since it serves as a systems-level check to ensure that the process has occurred correctly [10].

As outlined by DeBord [6] all medical interventions require some kind of consent. Blanket consent for a scenario – i.e. giving consent to carry out any test, procedure, or surgery in the course of treatment – is not sufficient [11]. Rather, consent should be specific for the treatment at hand. However, for many decisions, explicit written consent is not necessarily needed [12]. Even when this is the case, meaningful discussion between the physician and the patient is always necessary.

Despite this standard of always requiring consent, there are certain scenarios when it is acceptable not to have full informed consent. These include situations in which the patient lacks decision-making capacity, has waived consent, or has designated a loved one to make their medical decisions for them [13]. In these scenarios, informed consent is still required, but it is given from another individual. Consent should only be implied or presumed in emergency situations, in which the patient’s life is in danger and they have not designated any advanced directives regarding their care [14].

As patients have complete autonomy over body and care, they also have the right to refuse medical treatment. If a procedure or test conflicts with religious or personal beliefs, a patient may choose to forgo this treatment in favor of inaction [11]. In this case, it is the doctor’s duty to fully explain the consequences of non-treatment and benefits of treatment [11]. Patients must be presented with all the information necessary to make an informed decision about refusing medical treatment for their condition.

Prisoners

One of the key elements of a fully informed consent is that of voluntarism; this refers to the idea that the individual is free from coercion in making his or her decision [13] Working with prisoners, especially in clinical research settings, challenges this tenet, as they may lack the ability to make decisions free from coercion [13]. Rather than operating free from persuasion, they may feel compelled to agree to do things that those outside this vulnerable group would not [13] Institutional Review Boards have delineated several requirements in working with prison populations in order to ensure their protection. These include risks acceptable to non-prisoners, fair subject selection, the use of understandable language in the disclosure of information, parole board decisions that are not based on research participation, and the consideration of the prisoner’s length of incarceration in research follow up plans [13].

Children

As children are not capable of giving full consent, parents are generally responsible for giving consent for their participation in clinical research [14]. Therefore, the parents must understand the risks, benefits, and consequences of their child’s participation [14]. Though this is legally required, it is also necessary for the child to assent to participation when he or she is capable of doing so. This affirmative agreement conveys a respect for the child’s own autonomy and right to self-determination [13]. However, requiring the permission of the parents affords this vulnerable group special protection so as to avoid exploitation [13].

Cognitively Impaired

Individuals who are cognitively impaired, such as those with mental illness or other conditions that impair decision making, may lack the capacity to make a fully informed decision regarding their health care. There are no current federal regulations regarding consent from this particular population [13]. Generally, physicians and researchers obtain consent from the individual’s legally authorized representative [13]. This consent helps to protect this vulnerable population by designating the decision to an individual who has the capacity to make an informed decision that is in the best interest of the individual.

Educationally and Socioeconomically Disadvantaged Persons

Due to several factors, individuals with minority status and low literacy are at risk for lower comprehension in the informed consent process [15,16]. Information necessary for informed consent may be presented in language that is not understandable for those with lower educational attainment [13] Additionally, those of low socioeconomic status are vulnerable, as they may lack access to financial resources and health care, and thus may be coerced into participation in clinical research [13]. In order to protect these populations, information should be presented in a way that is understandable and compensation for study participation should not be coercive.

Informed-decision care

Informed consent to care is a very important component of health care. Without this discussion-based process, patients would lack the information needed to make decisions about their own care. Informed care is important for society, as it guarantees personal autonomy and the right of self-determination. The cultural values of the United States are highly centered on respect for individual autonomy [17]. This individual autonomy is reflected in our major historical documents, laws, and court decisions as one of the hallmarks of American culture as noted in the four precedent cases that laid the foundation for consent to care [1]. Therefore, it is essential that this value for consent to care is represented in the field of medicine. The process of informed consent is one way in which personal autonomy is honored in health care.

Final word

Informed consent is also essential in society due to its role in the promotion of trust within the health care field. Trust in medical practice is necessary to ensure that people actively seek and comply with medical advice [18]. Therefore, it is wrong to violate or jeopardize this trust, as it would negatively impact people’s willingness to adhere to medical treatment [18]. Informed consent builds trust because it ensures that there is open communication between physicians and patients, which allows the patient to have the final word on what happens to his or her own body. For this reason, informed consent requirements are justified and necessary.

Trust

Lack of trust in the medical field could have seriously devastating consequences. On an individual level, a lack of trust between a physician and patient could result in the patient formulating a poor decision for his or her treatment, ultimately resulting in negative health consequences. On a larger societal level, a lack of trust in the medical establishment could impact medical research, which is essential for gathering and disseminating vital health data [18]. A systemic lack of trust could derail the health care system as it did in the U.S. Department of Veterans Affairs (VA). Dr. David Shulkin, the new Secretary of the VA was quoted in an interview stating “We’re in critical condition, but moving toward stable…The V.A. has experienced a very, very tough time. It lost the most important thing any organization could have: its trust” [2]. The fact that the VA has such a broken system exemplifies the astounding impact of losing a patient’s trust and faith in that system.

Currently, the Consent to Care process has issues with accessibility. Though patients may sign a consent form indicating their willingness to engage in a clinical trial or receive a particular medical treatment, they may not actually understand the information that was presented to them [19]. Lack of patient comprehension could have serious consequences, including eventual harm to the patient or litigation against physicians or health care institutions. This gap in patient comprehension partially stems from the complex consent forms that are utilized in this process. In a study on the readability of consent forms provided by Institutional Review Boards (IRB), Paasche-Orlow, Taylor, and Brancati [20] found that the included text did not reach the IRB’s readability standards indicating that these forms were not easy for patients to comprehend. Comprehension is an issue partly due to the fact that these forms are written at reading levels above those ideal for basic comprehension. Almost half of American adults read at or below an eighth-grade reading level; therefore consent forms should be written at the fourth-grade level to ensure comprehension [20]. Lack of comprehension creates a barrier to accessibility.

Though simple in theory, the process of obtaining a patient’s informed consent is actually quite difficult. Many patients lack full comprehension of the information that physicians and other health care professionals present to them. This creates issues in the treatment process, as there is a lack of effective communication between physician and patient. However, the consent to care process can be improved in order to achieve increased patient comprehension.

There are two main ways through which this process can be improved: increased person-to-person contact and decreased complexity of consent forms. Flory and Emmanuel [21] found that the most effective method of improving patients’ understanding of the information disclosed in the process of informed consent was to increase person-to-person contact. Holding extended discussions with the patients and utilizing test/feedback interventions resulted in increased comprehension [21]. Kaibara [22] details eight steps to improve the informed consent process, all of which deal with strengthening rapport with patients. These steps include working on your rapport, discussing all treatment options regardless of insurance coverage, using the ABCDEF mnemonic, deciding how much medication information the patient needs, discussing how test results will be communicated, keeping a record of referrals, avoiding making guarantees about procedures, and documenting everything thoroughly [22]. All of these strategies will help improve the process by increasing transparency in conversations with the patient.

Another way to improve the consent to care process is to decrease complexity of consent forms. As previously mentioned, Paasche-Orlow, Taylor, and Brancati [20] found that the readability of IRB-provided consent forms was low. Improving the form templates and sample text via the inclusion of clear, direct language would help elucidate the process. Additionally, writing the consent form on a more comprehensible reading level would ensure that more American adults fully understand the information presented. Combining a less complicated consent form with a teach-to-goal strategy would help patients obtain greater understanding in the process [16].

As health care moves toward the domain of precision medicine, the consent to care process will shift. Precision medicine involves the pairing of clinical-pathological indexes with state of the art molecular profiling techniques to create disease-specific treatment strategies [23]. As a medical treatment becomes more advanced and patient-specific, more information will be available to physicians during the diagnostic and treatment processes. Physicians and other health care professionals will need to find a way to bridge the gap between more advanced and complex technology and patient understanding. Physicians may find decreased patient comprehension in the face of molecular diagnostic testing [23]. As precision medicine becomes more prevalent, the informed consent process will face more challenges.

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Citation: J Precision Med Public Health 1: 004.

Published: 04 September 2017

Reviewed By : Dr. Patricia Rodríguez Fortúnez, Dr. Alexander E. Berezin,

Copyright:

© 2017 Lo et al.. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.