Dilemma of informed consent in precision medicine

By PANG CONG and WANG GUOYU / 07-29-2021 / (Chinese Social Sciences Today)

A new model CT machine is on display at the medical devices exhibition sector of China International Import Expo in Shanghai, on Nov.7, 2020. Photo: CFP

Breakthroughs in gene sequencing technology have revolutionized the field of biomedicine and ushered us into a new era of precision medicine. Precision medicine is defined as “an emerging approach to disease treatment and prevention that takes into account individual differences in each person’s genes, environment and lifestyle.” The development of precision medicine, represented by genetic testing, has greatly advanced medical research, benefited patients’ lives and health, and created a huge genetic testing industry.
However, the practice of precision medicine has brought great challenges to the implementation of informed consent—a basic ethical norm in the clinical field. For example, it is impossible to convey the huge amount of information brought by genetic testing, and there is no unified standard on what to inform patients of and what not to. Also, the vast majority of patients have a limited understanding of relevant technical or medical knowledge necessary to provide informed consent.
Informed consent
Informed consent is an individual’s autonomous authorization. American philosophers Tom Beauchamp and James Childress postulated seven structural elements essential in informed consent, including competent understanding and decision-making; voluntary decision-making; disclosure of material information; recommending a plan; understanding information and the recommended plan, making decisions in favor of the plan; and authorization of the chosen plan.
So when does “the action to inform” begin? There is a misconception that “informed” means fully disclosing the contents of an informed consent form (ICF) to the patient. However, informed consent begins before the patient is actually presented with the ICF. In fact, the process of genetic counseling, which involves both doctors and patients, includes the doctor’s diagnosis process as well as the patients’ chance to learn about what and why a certain treatment is suggested. 
In this interaction, the patients’ role is not to passively wait to say yes or no to the final medical plans proposed by doctors, but to ask questions and voice concerns. The interaction will directly affect the final medical plan, in which the patients’ autonomy is largely embodied. 
When the final medical plan is determined, patients need to sign the ICF before specific medical measures are implemented, by which time patients actually practice the last step of informed consent—giving authorization. At this stage, the patient’s autonomy is still manifested in the right to veto.
In short, if we can correctly understand the meaning of “informed,” it is not difficult to conclude it is not a separate or redundant step in clinical practice, but closely related to routine outpatient activities. It represents the patient’s need to obtain medical services autonomously, and is an essential part of medical activities, so it is by no means a formality.
Being fully informed is indispensable to carrying out medical activities and showing respect for patient autonomy, so how do doctors and patients communicate in reality and can the requirements of being fully “informed” be met? 
The core, and most important communication between doctors and patients, is undoubtedly face-to-face communication in outpatient activities. Despite the assistance of other means of communication, barriers to doctor-patient communication are still common in outpatient clinics. A large number of excerpts from doctor-patient conversations reveal that good communication is difficult, and sometimes even impossible.
Doctor-patient communication
According to our research, the main obstacle in doctor-patient communication is not that doctors inadequately inform, or that patients cannot obtain enough information, but that the professional gap is difficult to hurdle. Such a gap is reflected in the following three aspects: the complexity of medical knowledge, limitations of medical technology, and specialization of medical activities.
In many doctor-patient conversations, the patient, as a “layman,” is unable to understand the doctor’s professional analysis of his conditions and reasons for taking appropriate medical procedures. They either admit plainly that they don’t understand and ask the doctor for a conclusion directly, or ask questions that display their lack of knowledge.
At the same time, due to the limitations of medical technology, doctors are often unable to provide patients with a one-size-fits-all cure and sometimes can’t offer a solution. If a solution is offered, there is no guarantee that it will work. The divide between patients’ expectations and the limitations of medical technology add to communication barriers between doctors and patients, with some patients insisting that doctors do things they simply cannot do. This dynamic may make doctors feel powerless, while increasing patient’s distrust in doctors.
Finally, medical activities are highly specialized and professional. Therefore, patients need an understanding of medical activities and the role they should assume in order to facilitate doctor-patient communication.
In conclusion, we found that the professional gap between doctors and patients seriously hindered their daily communication, leaving patients in a helpless passive state through medical activities and unable to truly make independent choices, so that informed consent slipped into a formality. This is far from the ideal image painted by the informed consent theory, where patients make fully informed and autonomous decisions about their medical treatment for the sake of their health.
Steps forward
The professional gap between doctors and patients predates the rise of precision medicine. However, precision medicine’s application is likely to further widen the gap, thus increasing patients’ misunderstanding of information, challenging patients’ ability to make decisions, and correspondingly adding burdens to doctors as they attempt to inform and explain. 
Based on the knowledge gap theory in communication studies, people of high socioeconomic status can acquire more knowledge than those of low socioeconomic status, due to differences in exposure to stored information, relevant social contact, and ability to acquire new knowledge. 
In the application of precision medicine, doctors’ professional advantages enable them to better absorb and utilize knowledge and technology as it is constantly updated, whereas most patients will find it hard to adapt to these changes as quickly as doctors.
In the face of a growing professional gap, protecting the patient’s right to knowledge, autonomy, and right to health, is not only a test for individual patients and doctors, but also a test of the medical system, especially in China where medical resources are relatively underdeveloped and genetic counselling is not yet popularized. 
If the gap cannot be properly addressed, it will not only affect precision medicine’s effectiveness, but also may make the already tense doctor-patient relationship much worse, even causing doctor-patient disputes, resulting in medical, social, and legal problems. In order to better solve the dilemma, we put forward the following suggestions.
In the context of precision medicine, the reasonable use of informed consent norms and procedures based on specific situations is a theoretical issue worthy of further discussion. But one thing is clear, informed consent must consider factors such as patients’ literacy, capacity for understanding, and psychological status. In addition, doctors and hospitals must account for patients’ actual situation, using auxiliary means when necessary to better inform patients, so as to avoid making informed consent a mere formality.
Given the high expectations that patients have for their doctors, mutual trust between doctors and patients should be further enhanced through daily communication. For many patients without sufficient professional knowledge, bioethicist Onora O’Neill argued that we should abandon the assumption of ideal autonomy, and face up to the fact that patients have only limited autonomy. For such patients, the information should be concise, accurate, and understandable, rather than complex and detailed, as O’Neill believes that consent encompasses the patient’s trust in the doctor, and only in this way can trust be reinforced.
Needless to say, efforts could be made to narrow the professional gap between doctors and patients, to reduce objective barriers in informed consent. It requires us to popularize education, to improve the literacy and knowledge of patients. It also means we should continue to enhance the level of medical services, by strengthening doctors’ communication ability and training more professionals in genetic counseling. In recent years, a variety of decision-making aids have been widely used in foreign countries, some of which have achieved good results.
In summary, the dilemma of informed consent is caused by inherent professional gaps between doctors and patients, and the rise of precision medicine is likely to widen such a gap. As precision medicine represents medicine’s future trend to a large extent, we must pay close attention to the issue. 
Meanwhile, we need to clarify a misunderstanding about informed consent through theoretical analysis and empirical study—it is a necessary part of medical activities—rather than a superfluous procedure.
On top of all this, it is hoped that the aforementioned suggestions could help alleviate the dilemma of informed consent in the context of precision medicine, and provide reference for similar problems encountered in the implementation of informed consent in relevant fields.
Pang Cong is from the School of Philosophy at Fudan University and Wang Guoyu is from the Research Center for Life and Medical Ethics at Fudan university.



Edited by YANG XUE