Barriers to Informed Consent in Japan

- Atsushi Asai, M.D.

Department of General Medicine and Clinical Epidemiology
Kyoto University School of Medicine, Kyoto 606, JAPAN

Eubios Journal of Asian and International Bioethics 6 (1996), 91-93.

In the Japanese clinical setting, informed consent has not been well adopted although the idea is no longer novel and the bioethics movement is well known. There are several barriers to informed consent in Japan.

It is possible that both patients and physicians do not know the idea or misunderstand it. Some may think that informed consent can be obtained from a patient who does not know his or her diagnosis or from family members of a competent patient. Because of no history to develop informed consent, the ethical principle of patient self-determination can be lost in Japan. Paternalistic physicians and protective family members would counteract informed consent and try to make medical decisions to promote their patients' well being independent of their wishes and values. Dependent attitudes of some patients who never ask medical information and expect their physicians to consider all they need would make the idea of self-determination irrelevant in Japan.

Does informed consent work in Japan and who wants it? Before answering this question, we have to know patients' preferences and understanding regarding informed consent. Informed consent has failed to describe the role of family members in decision making and may not work with Japanese patient-family-physicians. Imposing informed consent on people who do not want medical information and decision-making is ethically wrong and paradoxically paternalistic. When they want it, however, barriers to informed consent in Japan should be removed.

Informed consent requires physicians to share decision-making power with their patients (1). Informed consent is originally a legal doctrine and was introduced into clinical medicine in the United States in the mid 1950s. Social movements regarding the right of minorities, women, consumers and prisoners at that time stimulated patient's awareness to their right for information and self-determination in clinical setting (2). In Salgo v. Leland Stanford Jr. University Broad of Trustees in 1957, the court coined the term informed consent and provided the notion of a duty to disclose when patient's consent is obtained (3). In the case of Canterbury v. Spence in 1972, the court used a new patient-oriented standard rather than a professional standard, requiring that physicians disclose as much information as a reasonable patient would want to know to decide whether to consent to the physician's recommendation (4). In Truman v. Thomas in 1980, a case about the refusal of a patient to have a certain diagnostic procedure, the court decided that information about the risk generated by not having a test or treatment had to be disclosed even if the patient refused treatment (5). In Arato v. Avedon in 1992, a case about a physician's duty to disclose a prognosis to cancer patient, stated that physicians were under an obligation to disclose statistics concerning life expectancy to patients so that they might take timely action to plan for their deaths (6). Thus, this idea has been established through several court series in a 40-year history. Its history has repeatedly declared the right of a competent patient to make the final medical decision. Every effort has been made to clarify the patients' preferences with regard to their medical treatment and to facilitate their choices.

During a 2-year stay in the United States as a research fellow in medical ethics, I observed many patients enjoying their right to and responsibility for autonomous medical choices. They wanted to know, they wanted to decide, and they were usually willing to take responsibility for the outcomes of their decisions. This is not the case in Japan, although the idea of informed consent is no longer novel and the bioethics movement is well known. Articles regarding informed consent and other ethical problems in clinical settings often appear in newspapers. Many books discussing informed consent are now available. The HIV and AIDS endemics require physicians to be aware of their patients' right for self-determination and privacy (7). In 1990, the Japan Medical Association (JMA) officially declared that physicians should obtain informed consent from their patients for treatment and addressed the significance of patient self-determination. The definition of informed consent is identical to that used in the US (8). The JMA and the Ministry of Health and Welfare (MHW) jointly published a manual for care of cancer patients suggesting that physicians should disclose a diagnosis of cancer to a patient and promote informed consent (9). In 1990, the MHW also published a manual concerning clinical trials for experimental drugs (Good Clinical Practice: GCP) that requires researchers to obtain oral or written informed consent from participating subjects (10). Explicit consent of subjects is essential to ensure that the results of clinical research are valid and acceptable by the government. The GCP manual has improved the attitudes of researchers and physicians toward informed consent, albeit gradually. Investigation done by the MHW revealed that about half the researchers obtained informed consent from participants on written forms while the rest obtained oral consent (11). One survey done on an oncology ward in Japan demonstrated that most physicians thought that informed consent should be obtained when subjects participated in clinical trial; a majority had done so (12).

In contrast, my overriding impression is a majority of physicians and patients have not significantly changed their clinical practice relationships. It is still not uncommon for physicians to make unilateral decisions in the clinical setting. Some physicians would withhold relevant medical information from patients, on which they can judge what they need and what they want to avoid. Disclosing a true diagnosis to a patient with cancer is still controversial. Several recent surveys showed that only a minority of physicians disclosed a diagnosis of cancer to the patient (13). It seems that the recommendations made by the MHW and the JMA have failed to change physicians' attitudes about informed consent in clinical settings. Compared to informed consent on clinical research, informed consent in clinical practice, especially when a patient has a grave disease, is not developed in Japan.

In this essay, I would like to focus on problems regarding informed consent in clinical practice in Japan, because it seems that the central principle in American medical ethics does not have significant practical meaning in the Japanese clinical setting. What are the barriers to informed consent in clinical practice in Japan? And why do some patients never complain about their physicians, who virtually ignore a basic ethical principle from which all might benefit? There seem several potential barriers to informed consent in Japanese clinical practice.

It is possible that Japanese patients do not know about the concept of informed consent. Some physicians do not know it (8). Articles about informed consent in newspapers and books could easily be ignored by people not interested in this issue. It is doubtful that even half of all Japanese physicians are aware of several recommendations made by the JMA and the MHW, which contain a precise definition and an explanation of the value of informed consent. Busy Japanese physicians may be reluctant to use their limited time to read such recommendations if they are not interested in this issue.

It is likely that some physicians do not understand the concept of informed consent. Informed consent, which was imported from the US a decade ago, has no history in Japan. Many Japanese physicians, as well as patients do not know why and how informed consent developed in the US. I doubt that many Japanese physicians know a series of court judgments that promoted the idea in the US. The phrase is usually translated to "explanation and consent" in Japanese. This translation deprives informed consent of its central notion of the patient's right to medical information and self-determination. Many physicians may never think about how much information they should disclose to the patient to make informed consent possible. A survey conducted by the MHW revealed that 40% of 1600 physicians who responded deemed it appropriate that physicians decide how much medical information should be given to a patient, while only 26% responded that they would give as much medical information as a patient wants. A survey of approx. 650 physicians revealed that 21% of the respondents believed that the decision to give medical information to patients should depend on the physician's individual judgment in assessing whether disclosure is advisable (15). Some physicians may think they have to obtain informed consent from a patient only when they conduct clinical trials for a new drug so they may never consider that blood testing or physically non-invasive procedures requires consent also. A survey on HIV antibody testing showed that 67% of hospitals performed tests only after receiving patient consent, 27% sought consent on a case-by-case basis, and 6% required no consent whatsoever (16).

In contrast, some physicians may provide all the information and just let a patient decide upon a course of treatment without making any professional recommendations (17). These particular Japanese physicians believe that a patient's preferences should be respected even if they are irrational or not medically indicated. My experience suggests that many physicians believe valid informed consent can be obtained from a patient's family even if the patient is competent. It is doubtful that most Japanese physicians understand that informed consent requires both respect for patient autonomy and the physician's professional advice. In the absence of crucial history, informed consent lacks its fundamental meaning. In many cases, informed consent in Japan should not be called informed consent (18).

Several major barriers to informed consent still would exist even if most Japanese physicians and patients rightly understood the concept. In Japan, the traditional relationship among a patient, family, and physician may be the strongest barrier to the application of this ethical principle. The paternalistic attitude of Japanese physicians has been often described and discussed in English literature (12, 13, 15). Paternalistic physicians try to promote the patient's well-being independent of the patient's current preferences (17). Japanese physicians tend to believe that patients should follow their medical advice because physicians know best and do what is right for their patients (8). It is undeniable that physicians in Japan have too much authority over their patients. Physician control over medical information and final decisions may leave no room for self-determination. For some Japanese physicians, the medically "right" choice is exclusively correct and the patient's value system is not taken into account.

Excessive protection of a patient by the patient's family may also counteract informed consent. The physician-patient relationship in Japan is strongly influenced by the opinion of the patient's family. Once patients become sick, their families may treat them as if they are incompetent (19). The family-patient relationship sometimes takes on a stronger and more influential role in making medical decisions than does the physician-patient relationship. The family might function as a formidable barrier between the patient and physician, especially when the patient is seriously ill. Patients' families often ask physicians not to disclose a serious diagnosis such as cancer to their patients (20). Such acts deprive competent patients of essential information that is needed to make sound medical decisions for themselves.

The attitude of Japanese patients toward medical information and self-determination also contributes to the failure of informed consent in Japan. Some patients do not want to utilize the informed consent model even when their physicians and families try to respect their preferences toward medical information and self-determination. My personal experience in clinical practice clearly suggests that some patients never ask anything about their medical condition, diagnosis and/or treatment despite being given frequent opportunities to express questions or wishes. As for decision-making, some try to avoid making important decisions, knowing that these decisions may significantly affect their course of treatment and even their lives. Japanese patients may be unwilling to decide by themselves, even with a physician's advice. One survey on inpatients in a community hospital showed that about 60% of respondents thought that a physician should make the final decision for the patient (21). A survey on inpatients who had been informed of a diagnosis of lung cancer revealed that about 80% left treatment decisions to their physicians (12). A survey on outpatients demonstrated that half of the respondents would want to make the final decision for treatment if they had serious diseases (22).

Such attitudes of Japanese patients can be explained by their deference and respect for a physician's authority (23). The Japanese tend to flatter authority and the authoritarian master-servant-like model in medical practice (24). The Japanese concept of dependency may best explain why informed consent has not been adopted in Japan (25). The Japanese tend to expect others to consider what they need and unconsciously require others to act in their best interest (26). This form of dependency undoubtedly plays a major role in the Japanese physician-patient relationship. Japanese patients may believe that their physicians should satisfy all of their needs and make the best medical choice. For those who want to leave these important decisions to someone else, and do so without regret, informed consent may be irrelevant. This may be a form of autonomy that Japanese patients choose.

It should be noted, however, that several studies showed that Japanese patients may be dissatisfied with the current situation and may want to make independent decisions for their treatment. In survey of general public, 75% of respondents did not trust Japanese physicians (27). One of the main complaints patients have is insufficient explanation by their physicians (13). A study done in 1995 by the MHW suggested that 71% of 5000 citizens surveyed were interested in informed consent in clinical practice, more than any other problems in current Japanese medicine (11) Another study regarding decisions about life-sustaining treatment also revealed that more than 90% of 300 people surveyed responded that they would want to decide medical treatment at the end of life and few would leave such decisions to their physicians or even to their families (28). All patients in Japan are not the same (19) Their attitudes toward authority and self-determination are gradually changing. In situations where patients want sufficient medical information and self-determination, the traditional attitudes of physicians and families could present major barriers to realization of their wish for informed consent.

Finally, no explicit legal regulation requires a physician to obtain informed consent for treatment or the decision not to treat in Japan. It is legally acceptable to withhold a true diagnosis from a patient with cancer and no distinctive standard of disclosure has yet been established (15). In 1995, after two years of discussion, the council held by the MHW concluded that it is not appropriate to make an informed consent a legal issue as it is in the US. The reason the ministry gave was that legal regulation of informed consent might damage the physician-patient relationship (29).

I have mentioned several potential barriers to the use of informed consent in Japan, all are related to one another. No one reason can exclusively explain why we do not have informed consent in clinical practice in Japan to date. These barriers would be real obstacles to informed consent when Japanese patients really want it. Unlike the US, however, we in Japan lack basic data about patient knowledge and understanding as well as preferences, regarding informed consent. A well-designed nationwide survey should be done to provide us with important information in this regard.

This essay does not intend to say that the idea of informed consent is absolutely right and should be used in Japan. Informed consent has its own problems. Medical decision-making based on it is entirely patient-centered and bioethicists may think about family members only in terms of conflicting interest in the US. It has failed to describe the role of the family in medical care (30). Recent surveys done in the US also showed that people from different ethnicity have different attitudes toward patient self-determination (31). Some wanted family-centered model of medical decision-making and others preferred patient-centered model. It is very unlikely that many Japanese patients would not want to exclude their family members when they have to decide something important. I believe that shared decision-making should be done, not solely between a patient and physician, but among a patient, physician, and family members in Japan. Nevertheless, it should be noted that a patient and his or her family members may have different value system and different wishes about medical care. They may disagree. Therefore, Japanese physicians have to, at least, abandon a traditional bad habit to explain patient's medical situation to his or her family members first and ask them how physicians should deal with them. In many cases, this "family first" method would deprive a patient of even the chance to judge whether informed consent is desirable to him or her. Informed consent about using or waiving it itself should be obtained from a patient. When Japanese patient wants informed consent, barriers I mentioned must be removed.

As a clinical physician, I give my patients as many chances as possible to express their preferences in regard to receiving medical information and self-determination. I try to share decision-making with my patients as far as they want. As a clinical ethicist trained in the US, I emphasize the significance of informed consent to Japanese physicians and promote their understanding of the concept. The history and goal of informed consent should also be taught. As a researcher in medical ethics, I would investigate what Japanese patients think of informed consent and what they want from their physicians.

Informed consent is a complicated notion and can have desirable and undesirable effects on clinical practice. Only a patient can decide whether it is necessary or not in Japan.


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