Respect for autonomy is among the primary moral principles governing medical research and decision-making in healthcare. Autonomy is defined as the freedom to work following a self-established plan. This paper seeks to comprehensively summarize the concept of autonomy in healthcare and research and identify the factors affecting it.
The Concept of Autonomy and the Principle of Respect for Autonomy
Autonomy is founded on two theories: the split-level theories and the three condition theory (Beauchamp and Childress 102). The split-level ideas of autonomy require an individual to have the capability to control and identify their first-order desires by inferring to their second-order desires. However, in the three-condition theory, the conditions governing autonomous actions include intentionality, understanding, and non-control. All the before-mentioned theories take liberty and agency into consideration. Nevertheless, in some instances, autonomy is compromised by authority, community, and the risk of oppressive socialization.
Due to people’s vulnerability to external factors, the medical and research fields have established a set standard of respect for autonomy. Respect for freedom requires that physicians and researchers acknowledge the right of patients and research subjects to hold their views, make choices, and take actions based on their values and beliefs. The duty of respect for autonomy suggests that a patient has a correlative right to choose instead of a correlative duty to decide. Autonomy occasionally disrespects patients by compelling them to make decisions, even though they might be unwilling to make decisions or receive information about their condition.
To ensure that respect for autonomy is upheld, physicians and researchers have to understand the various complexities with regard to consent that can arise. These complexities vary with the nature of consent. Consent can be implicit, tacit, or presumed. Implied or implicit consent is consent relative to actions. Tacit consent takes place passively or silently through omissions. Lastly, presumed consent is inferior to the choices an individual would or should make.
Consent is usually dependent on preferences and beliefs, thus considered dynamic. Its dynamic nature can lead to the emergence of ethical issues, particularly in cases where an individual’s recent decisions contradict his or her previous choices. Determining whether current options are autonomous partially depends on if they are in character or out of character. If in nature, the decisions are considered independent.
The Capacity for Autonomous Choice
Some patients and research subjects are cognitively, psychologically, or legally incompetent to make a competent decision. Therefore, in healthcare, competence judgments are used to distinguish between individuals whose decisions should be solicited or accepted to those whose decisions are otherwise. Physicians are allowed to judge a person’s incompetence periodically; hence, they have the power to override the patient’s decisions (Beauchamp and Childress 115). Moreover, the competence to make a decision is based on the decision to be made. Therefore, it varies over time. Individuals may sometimes be incompetent to perform a task at one particular point in time but competent to do the same thing at a different point in time.
Seven standards have been established to assist in the determination of incompetence. Standard 1 is grounded on the ability to formulate a preference. Standards 2 and 3 are based on the ability to comprehend information and appreciate an individual’s situation. Standards 4 to 7 are centered on the capability to reason through the lens of a significant life decision. After comparing a patient’s decision to the set standards, physicians can further use medical tests to evaluate incompetence. These medical tests are usually governed by the following elements of normative judgments (Beauchamp and Childress 118):
- Selecting the essential abilities for incompetence;
- Setting a threshold level of the skills in item;
- Choosing an appropriate test for the thing.
To guide decision-making, physicians sometimes use the sliding strategy. This strategy insinuates that an individual’s competence to decide is contingent on the consequences that might follow. It is used in realizing ways in which the standards of competence are linked to levels of maturity, experience, responsibility, and welfare. It acts as a valuable protective device that recognizes that our interest in making good choices is dependent on how we create our standards.
The Meaning and Justification of Informed Consent
There are two meanings of informed consent. In the first definition, an individual should not only agree to a proposal but also authorize action through an act of informed and voluntary consent. On the other hand, in the second definition, consent is governed by the social rules that compel professionals to obtain an institutionally or legally valid authorization. In some cases, informed consent can be defined based on the elements and components of consent.
These elements include competence, disclosure, understanding, voluntariness, consent, recommendation, and decision. Informed consent is justified in the medical and research fields as it preserves personal autonomy and protects the rights of research participants and patients. Therefore, various institutional rules of ethics and medical and research codes advocate that informed consent has to be obtained.
There are three standards of disclosure. The first is the professional practice standard, which states that a professional community’s established practices influence the type and amount of information to be disclosed. The second is the reasonable person standard, which states that information to be disclosed is measured in reference to the significance a rational individual would attach to it when making a decision, that is, a hypothetical reasonable person. The third is the subjective standard, which measures the adequacy of information based on the particular informational needs of an individual.
Although disclosure is warranted in the medical and research fields, there are instances in which physicians and researchers exercise intentional nondisclosure. Embracing intentional nondisclosure is influenced by the type of research and clinical situations. For example, in clinical scenarios, therapeutic privilege allows a physician to intentionally withhold pertinent information if it has the potential to harm an emotionally unstable patient.
However, in research, data can be withheld if the research involves the therapeutic use of placebos. Placebos are drugs that are pharmacologically inert for a condition that is being treated. In study that is not placebo-related, information can still be withheld from the subjects. In such kind of research, nondisclosure is only supported in cases where it is necessary to obtain important information, no substantial risk is involved, researchers inform subjects that incomplete disclosure or deception is part of the study, and the issues agree to participate under such conditions (Beauchamp and Childress 130).
There lacks a unanimous agreement regarding the nature and level of understanding required for informed consent. Most physicians and researchers operate based on the fact that an individual’s knowledge regarding the consequence of their actions need not be complete. They solely need sufficient pertinent information central facts.
Research has identified understanding to be vulnerable to several external factors: the problem of information processing, the issue of nonacceptance and false belief, and the problem of waivers. In information processing, information overload and the use of unfamiliar medical terms affect the processing of information among patients and subjects, impeding the making of an autonomous decision. This is because they lead to the distortion of information, promotion of inferential errors, and the creation of disproportionate fears for some risks.
To mitigate this, the healthcare field has embraced the use of decision aids to assist patients in making decisions. However, in nonacceptance and false belief, the ability of an individual to accept information as unbiased even when they adequately comprehend the information can interfere with decision-making. A single false impression can undermine a subject’s or patient’s consent, even when they have been well-informed.
It is justifiable for researchers and doctors to withhold pertinent information occasionally intentionally. Lastly, while exercising a waiver, a patient usually renounces their right to informed consent and delegate the obligation to obtain informed consent to a physician or a third party. However, the practice of allowing waivers is risky because patients make themselves to physicians who may omit consent procedures for convenience.
Voluntariness is the ability of an individual to freely decide in the absence of external influence, for instance, coercion. Voluntariness is susceptible to various forms of power, which include persuasion, manipulation, and pressure. Coercion ensues when an individual purposefully uses a credible and severe threat of force or harm to control another, impeding intentional and well-informed behavior. On the other hand, persuasion occurs when a person is brought to believe something based on the merit of reasons given by another individual. Lastly, manipulation is referred to as the change in the reasoning of others using either coercion or persuasion.
Coercion and manipulation hinder an individual from making a meaningful choice. However, the validation of these forms of influence remains controversial since their justification is dependent on the type of reinforcement used, positive or negative.
Although the literature indicates that we are autonomous, practically, we are not because we are vulnerable to external factors such as love, which prevent us from making independent decisions. When we make decisions, we usually have to think about how our choices will affect those around us. Therefore, our decision is not usually autonomous.
Beauchamp, Tom, and James Childress. “Respect for Autonomy.” Principles of Biomedical Ethics. 7th ed., Oxford University Press, 2012, pp. 101-140.