Informed Consent: Variables in Patient Involvement and What It Means Clinically

The Belmont Report of 1974 laid the groundwork for biomedical research ethics and built the foundations for Beauchamp and Childress’s Principles of Biomedical Ethics in 1985, which remains highly influential in the field to this day. The Report outlined informed consent as the application of Respect for Persons, with three main elements: information, comprehension, and voluntariness. The concept of informed consent was created to correct paternalism in the healthcare system (1), but its purpose is shifting as society morphs into a more individualistic, libertarian autonomy-based environment. While the doctrine of informed consent generally points to giving adequate explanation, there is no overarching consensus on how much information is adequate. 

Walker proposed two types of information under informed consent: first, information that a person would need in order to consent at all; and second, what is needed for said person to make an informed choice about whether or not to consent (2). Not in all cases should both be provided in detail, and the decision of where to tip that scale lies on the interactive tension between doctor and patient, and what level of shared decision-making applies in each case. Quoting the theory of the locus of control in health (3), patients with higher internal control may prefer to participate more actively in their decision-making process, whereas those perceiving control externally take the leap of faith and provide consent even under residual doubts and fear, based on their trust of an expert recommendation (4,5). This essay will touch on factors that affect patients’ decisions on where they belong on this spectrum of involvement and the implications on patient management by the care team. 

In the clinical setting, which types of information should be discussed with patients, according to Walker’s model, depends on the patients’ purpose of utilizing the information imparted. A study conducted in Saudi Arabia found demographical correlations of patients to their perceived purpose of the informed consent process: males and older patients tend to see the process as a facilitation to self decision-making, while females and young patients tend to take it as a process of information disclosure (1). Other perceived purposes with considerable responses range from documentation, litigation protection, or meaningless routine. This reveals that the process of giving informed consent is perceived and anticipated very differently among patients.  Conditional to several determinants, patients could be holding an amalgam of expectations from their clinician team, and the best-fit approach may mean different things to everyone. 

The influence of gender on trust in the healthcare system has been a topic well studied. Conforming to gGender stereotypes make women less likely to challenge their physicians’ decisions, and even when they do, it is less likely to be taken in seriousness when compared to the opposite sex (6). A notable example of this is the gender disparity in analgesic treatment in the emergency department (7), where women received less analgesia than men with the same mean pain score. As a result, women may feel a lack of control and agency when interacting with medical staff (8). Another explanation is the remnants of paternalistic approaches in healthcare, which further deteriorates women’s autonomy and creates passive, unengaged women, who ‘without a sense of agency or power, will not convey their tenets, will not make an informed decision about their care options’ (9). The situation of women perceiving informed consent as a disclosure procedure reveals that women may shy away from making independent decisions that are better suited to their needs, due to a fear of medical gaslighting and belittlement. This is not an optimal outcome in bioethics as patients often possess more knowledge about their condition, especially on pain and fatigue levels, than what clinicians can observe; and by bullying female patients into silence, the subsequent passive ‘informed consent’ obtained may be questionable in validity. 

Besides gender constraints, the amount of information patients prefers can vary by personal preference. Some prefer brief information whereas others like to be well-informed (10). It is not uncommon that some patients demonstrate a preference not to receive any information at all (11). Particularly in populations with cognitive decline and frailty, patients themselves feel sufficiently explained to and supported in their informed consent process, even when recollective memory tests later on show that they are not (12,13). Another study also shows that desire to play an active role in healthcare decision-making declines with advanced age (14). In these scenarios, we have to respect patients’ decision on how much information they wish to obtain, since to some people, the burden of processing bad news outweighs the desire for autonomy. In fact, it is argued that some patients intentionally ‘block out’ chunks of information during the consent process due to feelings of overwhelmingness and fear (13), since one in an emotionally charged state can hardly process or retain information (11). The healthcare team should communicate with patients to understand their emotional needs and expectations. 

Emanuel and Emanuel proposed the Four Models of the Physician-Patient Relationship in 1992 – the paternalistic model, informative model, interpretive model and deliberative model. When applied to the conception of patient’s autonomy, they allow the patient to have varying freedom of choice, with paternalistic being the most constrictive and deliberative being the freest (20). While modern ethicists usually prefer the deliberative model, which empowers patients to develop their own morals relevant to their case under guidance, one must remember that dynamics between patient, delivery, and understanding are complex. Patients’ perception of informed consent and their involvement in decision-making depends on involuted factors such as gender, age, ethnicity, socioeconomic power, and other personal preferences that cannot be categorized. In the ideal sense, a narrative approach should be taken by the clinicians to listen to the needs of each individual patient, and offer them the appropriate amount of information and guidance they need to give a level of consent they are comfortable with. This means changes in the timing, setting, and delivery modalities, among other considerations, of the current practice are imminent. 

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