A Family-Oriented Decision-Making Model for Human Research in Mainland China.

Journal of Medicine and Philosophy, 40: 400–417, 2015 doi:10.1093/jmp/jhv013 Advance Access publication July 3, 2015

A Family-Oriented Decision-Making Model for Human Research in Mainland China DENG RUI* *Address correspondence to: Deng Rui, PhD, College of Humanities and Social Sciences, Shanxi Medical University, 56 South Xinjian Road, Taiyuan 030001, Shanxi, China. E-mail: [email protected]

This essay argues that individual-oriented informed consent is inadequate to protect human research subjects in mainland China. The practice of family-oriented decision-making is better suited to guide moral research conduct. The family’s role in medical decision-making originates from the mutual benevolence that exists among family members, and is in accordance with family harmony, which is the aim of Confucian society. I argue that the practice of informed consent for medical research on human subjects ought to remain family-oriented in mainland China. This essay explores the main features of this model of informed consent and demonstrates the proper authority of the family. The family’s participation in decision-making as a whole does not negate or deny the importance of the individual who is the subject of the choice, but rather acts more fully to protect research subjects. Keywords: family-oriented decision-making, human subjects research, informed consent, mainland China I. INTRODUCTION In medical research on human subjects, informed consent is particularly important.1 Researchers and subjects often have quite different, if not contradictory, interests. Medical research is not designed to address the particular health problems of its human subjects but, instead, to test or validate therapeutic methods or new pharmaceuticals. Although medicine needs evidence from valid clinical research to guide evidence-based practice, research protocols are designed to gather data, rather than to act in the best interests © The Author 2015. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: [email protected]

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Shanxi Medical University, Taiyuan, China

The Family-Oriented Decision-Making Model for Human Research

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of particular patients. Properly accomplished, informed consent protects the rights and well-being of patients (Karlawish and Hall, 1996) while also ensuring that they are aware of the uncertainties or risk factors of participating in the research protocol. Incentives, such as professional interest in the development of medical science, personal honor or career goals, as well as the profit-oriented interests of industry sponsors, may lead the research team to neglect the interests of research subjects. Patients are motivated to participate in medical research for complicated reasons, but generally they are not moved by an independent interest to promote science, to enrich sponsors, or to help the researchers achieve professional goals. As a result, subjects need to be well informed regarding the research study and its sponsors, including inherent risks and prevention methods, possible adverse events, and so forth, so that they can make decisions that best support their own interests.2 In medical research, even independent, competent adult subjects constitute a potentially vulnerable population. Compared with other classes of vulnerable populations, such as children or the mentally disabled, adult competent subjects are not obviously in need of additional protections. However, even though they are adults, they may not necessarily make wellthought-out decisions. Their reasons may not be fully rational or appropriately informed in all cases. For example, even if they have an education, they may not possess the necessary medical expertise sufficiently to judge the potential benefits and harms of the research protocol. They may possess the general capacity to act autonomously, but this does not necessarily lead to autonomous choices in particular cases. Many adults who choose to be research subjects experience a very complex process of trade-offs to their independence, autonomy, and rationality, which are affected during decision-making. Moreover, at times in mainland China, researchers may attempt to withhold information or provide only filtered, evasive, and vague information. The attitude of many researchers is to try to avoid family participation. Researchers or members of the medical staff may “give patient advice, and promise to give some very attractive lure” to persons who hesitate to sign up for the medical study (Zhang, 2004). Patients are more likely to sign up for medical research if their physician recommends such participation (Li, 2006). More problematically, participants are often unable adequately to understand information or blindly obey researcher directions. Economic rewards and the free provision of expensive pharmaceuticals may influence or lure subjects into joining the study.3 As a result, even reasonably “healthy subjects are more vulnerable compared with the hospital” research team (Liu, 2008). Given such circumstances, adult subjects need intellectual, spiritual, and moral support from their families to help make decisions consistent with their own long-term best interests.

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II. INDIVIDUAL-ORIENTED INFORMED CONSENT IS NOT SUITABLE FOR MAINLAND CHINA

Why Individual-Oriented Informed Consent Is Unsuited to Mainland China First, individual-oriented informed consent has no legal foundation in mainland China. Almost none of the relevant laws specify the individual as the sole or even primary decision maker. Here are three examples: Article 26 of The Law on Practicing Doctors of the People’s Republic of China, June 26, 1998, states that doctors shall truthfully tell patients or their family members the patients’ condition. However, care shall be taken to avoid adverse impact on patients. Doctors shall obtain approval from the hospital and consent from the patient or the patient’s family members before conducting experimental clinical treatment (China Food and Drug Administration, 1998, 26). Article 33 of the Administrative Regulations on Medical Institutions of the People’s Republic of China (1994) stipulates that when an operation, special examination, or special treatment will be implemented by medical institutions, the patient’s consent must be obtained, and doctors must obtain the consent and signature of the patient’s family members or other relations as well (Administrative Regulations on Medical Institutions of the People’s Republic of China, 1994, 33). Article 11 of the Regulation on the Handling of Medical Accidents (2002) requires that in medical institutions, medical staff members shall inform patients and their families truthfully regarding their state of illness, the character of medical treatments and medical risks, and so forth. They are also required to provide timely answers to patient inquiries (The Central People’s Government of the People’s Republic of China, 2002, 11). These laws and regulations establish the legal environment for informed consent in China. Importantly, under normal circumstances, each treats the


Informed consent is one of the basic principles of ethical human research, but there are some conflicts within Western theories of informed consent. Let us enumerate two sets of conflicts. The first concerns the purpose of informed consent. Is it designed to respect the autonomy of research subjects or to safeguard their interests? The second regards who should be understood as in authority to provide informed consent: the doctor/researcher or the patient/research subject, or should such authority be shared between the researcher and the subject? In each case, the focus is on a model of individual-oriented informed consent. Once Western principles of informed consent began to be applied to research involving human subjects in China, the challenges posed by these two sets of issues became apparent in our very different legal, cultural, and moral contexts.


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Deficiencies of Individual-Oriented Informed Consent in Mainland China: Two Cases The Western concept of autonomy, however, has begun to influence medical staff, research subjects, and family members to support individual autonomybased decision-making. They have been encouraged to believe that any culture that has not yet shifted from the traditional physician-centered medical paternalism model of decision-making to the more contemporary patientcentered self-determination model is behind the times and encumbered by a problematic ethics (Fan, 2002). China, however, more characteristically utilizes a process of shared decision-making based on family consultation. This family-based shared decision-making model is more effective at protecting


patient and the patient’s family members as equally the subject of informed consent. This differs from Western informed consent, which focuses primarily on the patient as an autonomous individual decision maker. Second, individual-oriented informed consent undermines the integrity of the family. Individual-oriented informed consent highlights the autonomy of individuals over against their families. The individual himself is appreciated as in authority to control his own body, lifestyle, and death style. Persons are approached individually to make medical decisions as if they were not members of functioning families. Family members have no particular authority to participate in the decision-making process, unless such participation has been explicitly authorized by the patient through a formal or quasi-formal procedure (Faden and Beauchamp, 1986; Wear, 1993). Part of the challenge in the West is that high rates of divorce and unmarried births have led to the breakdown of the traditional family. China’s background moral culture is largely Confucian. For Confucians, maintaining the integrity and harmony of the family is essential. Third, individual-oriented informed consent fails adequately to support the interests of patients or research subjects. Given complex medical information, it can be difficult for individuals to make reasonable and rational decisions on their own. Research subjects, for example, may find their own decision-making capacity undermined by internal weaknesses or psychological impediments such as irrational preferences, false consciousness, a belief in oppressive norms, or deformed desires. In the face of medical authorities, the research subject’s own ideas may often sound broken, ambiguous, or frustrated. As a result, it may be challenging for the potential research subject to make reasonable decisions in his own best interests. The Confucian culture of China recognizes that the family has a strong moral obligation to protect the interests of its members, especially those who are ill. The family, with its extensive social capital, reaches out in love to care for its members, and the combined talents of the family as a whole can significantly improve rational decision-making.

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research subjects than the model of individual autonomy-based decisionmaking.4 It not only preserves family harmony but also protects research subjects, who would otherwise be in greater danger without the family’s effective oversight of their interests. Case 1: Guo Chaobin, a 56-year-old retired worker, has diabetes. For six years his condition has been stable. In September 2005, however, his blood sugar began to fluctuate due to the cold. He went to a tertiary hospital (a top-level hospital) in Nanjing. Following medical examination, the doctor suggested that he be hospitalized to undergo insulin replacement therapy. When Guo Chaobin checked into the hospital two days later, the doctor recommended that he participate in a drug research protocol organized by a pharmaceutical factory in Xuzhou. The doctor purportedly asserted that the new diabetes drug being tested might be beneficial. Guo Chaobin took the doctor’s advice, in part, because the study offered access to the new treatment free of charge and provided a glucometer as a valuable gift. Guo Chaobin was thereby very effectively recruited to participate in Phase III clinical trials of the new diabetes drug. Physical examination showed that Guo Chaobin’s urine protein was 2+ before he took the experimental new drugs, which indicated that his kidney function was not good. Unfortunately, he did not fully understand the importance of this information. When the doctor asked him to sign an informed consent form agreeing to participate in the study, Guo Chaobin was vaguely aware that the treatment was part of a research trial, rather than conventional therapy. He became one of 480 subjects. The pharmaceutical company required him to pay a 500 Yuan deposit for the gluocometer. If he stayed in the study for the entire course of the trial, only then would the glucometer really belong to him. On the 29th of September, Guo Chaobin started the new drug regimen and, as required by the research trial, stopped taking his regular diabetes drugs. The doctor progressively increased the dosage of trial drugs from 14 units to 40 units. After one week of the trial, Guo Chaobin’s diabetes did not improve, and his blood sugar was out of control. His body began to show signs of edema, weakness in the lower limbs, bilateral waist ache, and so forth. In January 2006, Guo Chaobin was diagnosed with type 2 diabetes and diabetic nephropathy (Li, 2006; Liu, 2008). Guo Chaobin’s situation in this case is very typical of the majority of the patients currently in mainland China, who participate in human research. First, they are in a weak economic situation and often agree to participate in research because the study sponsors will provide remuneration, gifts, or free medicine. This raises the moral concern that financial incentives may create undue pressure to participate in research studies (Dickert and Grady, 1999; Pace, Miller, and Danis, 2003). Informed consent protocols should allow the research subject to withdraw from the trial at any time. Unfortunately, Guo Chaobin had not been provided with, or did not remember, such information. The 500 Yuan deposit for the glucometer before the trial was an additional


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costly influence on his decision to stay in the study.5 Second, research subjects in China are often poorly educated and, as a result, are routinely unable adequately to appreciate their own state of health, the potential risks of participating in the trial, or the content of the informed consent forms. These are not circumstances that they can easily change. Third, many research subjects lack adequate external support. When Guo Chaobin had questions or puzzles, the doctor may not have fulfilled his obligations to provide proper explanations. The physician-in-charge may even be in the habit of inducing patients to participate in research trials and, once having begun, to stay in that study until it is complete. Within China, only the family is likely to provide advice designed to support the best interests of the patient/research subject. In this case, however, the individual-oriented practice of informed consent failed to leave time and space for the family to participate in the decision-making process. In such cases, individuals are often at their most frail and, as noted, external factors may be influencing their decision to participate in medical research. Since they tend to live together, for the vast majority of cases it is the family that knows its members best, including their health, preferences, and character flaws. The family knows how to discuss and analyze the harms and benefits of a research study for its member. The family also has a more objective stance than the patient and can obtain critical information regarding the study. When compared with the research team, the family is much more likely to act in the best interests of the family member. Therefore, family participation in the informed consent process is a highly valuable component of the decision-making process for potential research subjects. Case 2: Zhang Zuning, a 77-year-old female, was hospitalized in Peking University People’s Hospital on October 17, 2006. Her intention was to have an operation to replace her artificial left knee joint. However, she was recruited by her physician to participate in the research study of a new pharmaceutical designed to prevent postoperative thrombosis. The research was performed by Peking University People’s Hospital. She signed the informed consent form after reading it through. At that time, her son, Liao Zhijie, was on a business trip. Zhang Zuning suffered anaphylactic shock at the end of both lower extremities on the 7th of November, 2006. She survived emergency treatment. The hospital identified her reaction as a serious adverse event, because it endangered her life, led to re-hospitalization, and delayed the rehabilitation of her left knee. Liao Zhijie did not know about the event until after he returned from his business trip. He said that he certainly would not have agreed with his mother’s decision to participate in the new drug trial, if he had been beside her (Wang, 2013; Wang and Tu, 2013). In this case, the patient was too old sufficiently to understand the information on her own to agree to participate in the trial. Her judgment was questionable, and she agreed to participate because she did not want to refuse the doctor’s request. Perhaps she was reluctant to believe that the physician

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III. THE CULTURAL BASIS OF FAMILY PARTICIPATION IN MEDICAL DECISION-MAKING Informed consent is a very important duty for both healthcare institutions and medical researchers to perform. However, at times, neither adequately fulfills this duty (see, e.g., Sun and Liu, 2005; Shen, 2007; Li, 2010). As a result, the protection of the research subject’s rights and interests requires proactive measures, such as family-based shared decision-making. Ruiping Fan argues, for example, that “the pattern of surrogate decision-making in any society is determined first and foremost by the dominant perspective on human life and relations that is accepted by that society” (Fan, 2002, 346). “Chinese bioethics is a family-oriented and harmony-oriented bioethics embedded in the Confucian way of life” (Chen and Fan, 2010, 573). Family participation in the decision-making process is a feasible and proactive way to protect research subjects in accordance with the requirement of traditional Chinese ethics. Benevolence (ren) and Family-Directed Decision-Making Family members are allowed to participate in the informed consent process in the West, as well as in China. A key difference, however, is that in the West, primary consent is provided by the adult research subject himself, rather than the family. In China, the family, motivated by the Confucian virtue of benevolence (ren), reaches out in love to protect the best interests of family members. In the West, family members are permitted to act as surrogate decision makers if the adult patient’s autonomy has been compromised and the


was motivated by other than good intentions. Maybe she was worried that refusal to participate in the study would result in poor medical treatment in the future. Regardless, she did not know that it was the right time to say “no.” She read and signed the consent form, without the assistance of close family members. Moreover, the degree to which she could understand the content of the informed consent material is doubtful, so treating her decision as truly informed is problematic. Indeed, the decision caused serious harm. Again, there was no time and space for the family to participate in the decision-making process. With the focus on individual-oriented consent, her son had no chance to advise her, even though he knew his mother’s weaknesses. If he had been at the hospital at the time the decision was made, he could have helped his mother to remember that the purpose of being in the hospital was to replace the artificial left knee joint, not to participate in a pharmaceutical trial. He could have decisively rejected participation. After all, sons are obliged to protect and advocate on behalf of their mothers. Family participation in the decision would have been of significant benefit.


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patient is currently incompetent or otherwise unable to make a decision (e.g., in cases of coma, psychosis, Alzheimer’s dementia). Patients often designate other persons as their surrogate decision makers in the event that they become incompetent (Fan, 2002). In China, however, the family participates in medical decision-making regardless of whether the adult family member is incompetent. Even when the adult family member is competent to decide on his own, family members participate in the decision-making process. Families function in this way as a part of the Confucian emphasis on individual moral cultivation (Zhang, 2010). According to Confucianism, it is an unquestionable moral truth that family members care for each other. This originates from the voluntary actions of each family member. Derived from the works of Mencius, Confucianism describes “the five cardinal relationships” (wu-lun) of humanity. These are as follows: “between father and son, there should be affection; between sovereign and minister, righteousness; between husband and wife, attention to their separate functions; between old and young, a proper order; and between friends, fidelity” (The Works of Mencius, Kung, part I. 8; see also Legge, 2011, 2:251–252). Of these five cardinal relationships, three are core intrafamilial relations; the other two are similar to family relations. Confucian society is familyoriented. As a result, within China it is very typical for the entire family actively to discuss important decisions, such as whether a family member should participate in a research trial. This demonstrates benevolence and love within the family. Second, in China, the family is appreciated as in authority to make medical decisions. Here, the family includes the patient’s parents, children, spouse, and other relatives with authority in the family. Confucianism holds that “a youth, when at home, should be filial and, abroad, respectful to his elders” (Confucian Analects, Book I. HSIO R. Chap. VI; see Legge, 2011, 1:140). Benevolence and charity begin at home: “Benevolence is the characteristic element of humanity, and the great exercise of it is in loving relatives” (The Doctrine of the Mean, Chap. XX. 5; see Legge, 2011, 1:405). The principle of benevolence requires loving others. However, the proper order of love is from close to distant, such as from parents, children, siblings, spouse to more distant relatives, neighbors, friends and colleagues, etc. Benevolence to one’s family takes priority over helping others. To put benevolence properly into practice is to do good things for or to be kind to one’s parents. As Mencius said, “the richest fruit of benevolence is this—the service of one’s parents. The richest fruit of righteousness is this—the obeying of one’s elder brothers” (The Works of Mencius, Li Lau, Part I. CHXXVII; see Legge, 2011, 2: 313). Confucianism regards the family as a whole. Each family member has a right to receive help from the whole family, but each also has an obligation to provide assistance to other family members. When a person is ill or in the hospital, or perhaps being recruited to be the subject of a research trial, he is facing an unfamiliar and complicated decision. Undoubtedly, the first

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The Moral Order of the Family: Benevolence (ren) and Harmony (he) The family-oriented character of Confucian culture supports a family-directed process of informed consent, which assists potential research subjects. The family protects one’s material life; it is also the main focus of one’s social activities. This central social unit provides much needed emotional, spiritual, and material support. When faced with a decision to join a research study, potential research subjects need more than the kindness of their doctors or members of the research team. As already noted, there are often significant conflicts between the goals of medical science and the research subject’s interest in good quality health care. Different values and educational backgrounds further separate doctors and patients, and researchers and subjects. Mainland China does not utilize a system of family doctors who might know their patients well. Patient notification and medical decision-making often takes places in unfamiliar institutional surroundings. Frequently, no one particular doctor is responsible for each patient. Consequently, when patients are recruited to participate in medical studies, they may be approached by several different members of the medical staff, including the attending physician, the doctor currently on duty, a nurse, or even the principal investigator


persons from whom he can seek help are in his family, and the family will undertake this obligation without hesitation. Third, while surrogate decision makers in the West are supposed to reflect what the adult patient would have said, had he been able to consent for himself, the Chinese family participates in the decision-making process actively to decide if a family member should participate in the study. The final decision will be made by the whole family. Decision makers come together in a big group because of the ancient understanding of the large family in China, including the “nine classes,” proposed in the Shoo King (Shang Shu): “he was able to make the able and virtuous distinguished, and thence proceeded to the love of the nine classes of his kindred, who all became harmonious” (The Shoo King. The Canon of Yaou; see Legge, 2011, 3:17). This is an accurate description of family ethics. In contemporary China, the number of large multigenerational families, all of whose members live together, has declined. However, the Chinese family still exists with a stable social structure, lower divorce rate, fewer single-parent families, and so forth, than are frequently experienced in the West. Increased personal mobility in modern society, together with state-based social welfare systems, have encouraged changes in the relationship between the individual and the family. Individuals today must accept more risks than ever before in finding employment and health care, or for handling the challenges of disability, accidents, and retirement. Yet, the mutual support of family members provides a significant benefit when dealing with challenges of the outside world. Family cohesion makes the family into a safe and warm haven (Yang, 2011).


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himself. These members of the medical staff may be completely unfamiliar with the patient’s family, culture, or values. They cannot adequately appreciate the patient’s interests or goals. Communication from members of the research team is routinely one-dimensional: they are most interested in securing consent to participate. They may not possess sufficient interest in the patient’s well-being to ensure that consent is truly informed. In contrast, the family is much more likely to be intimately familiar with the patient’s interests and to advocate for those interests. The family is in a much better position to understand the demands such medical decisions place on a person. In mainland China, if a person engages in making serious decisions without telling his family, the virtue of the individual is questioned. Similarly, if the family knows of the difficult decision but does not provide active advice, the virtue of the whole family is questioned. Because Confucianism teaches that a person must first sort out relationships within the family, each family member has a serious obligation to keep and promote the harmony of the family. Confucianism argues that people should live in harmony with each other. The Confucian Analects says: “in practicing the rules of propriety, a natural ease is to be prized. In the ways prescribed by the ancient kings, this is the excellent quality, and in things small and great we follow them” (Confucian Analects, Book I, HSIO R. CH XII; see Legge, 2011, 1:143). The most important relationship is family harmony. In traditional Chinese culture, the family is the basic unit of social, political, economic, and cultural life. Family harmony should not be violated for personal development or national prosperity. The Great Learning (Da Xue) proposed this way of life to “rectify their hearts, cultivate their persons, regulate their families, order well their states, illustrate illustrious virtue throughout the kingdom.”6 Preserving family harmony means fulfilling the mutual obligations and responsibilities of family members. The relationship among the generations is bidirectional and reciprocal. First, there are mutual obligations and responsibilities between parents and children. The Maoshi Zhengyi states, “if we can be friendly to our family members, not abandon our friends, and not leave behind old friends, people will naturally be led to become more honest” (Ruan, 1980, 410; my translation).7 This means that we should maintain good relations with all of our relatives and friends. A similar view is reflected in the saying “filial piety is the most important of all virtues” (Wang, 2000, 128). Filial piety is love from the heart. Filial piety requires that one make one’s parents happy and comfortable; sons and daughters must not act contrary to the wishes of their parents. Filial piety also means that sons and daughters must strive to minimize their parents’ concerns. Such kindness and care, however, is mutual. Second, there are mutual obligations and responsibilities between husband and wife. A harmonious marital relationship is the primary factor in family harmony. Spouses who discuss medical decisions, including whether to participate in research studies, embody charity. Third, there are mutual obligations and responsibilities among siblings. Wang Jie, a Confucian of

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IV. A MODEL FOR FAMILY-ORIENTED DECISION-MAKING As illustrated, China’s approach to informed consent is family-oriented and family-directed. Within the research environment, healthy volunteers and


the Yuan Dynasty, argued that “elder brother loves his younger brother, younger brother respects his elder brother, never clash because of money, discuss many things (mainly some events about themselves or the family, such as marriage, funeral, health care, etc.), exchange many things (mutual help to make up what the brother lacks, such as food, supplies, information, etc.), care about the joys and sorrows of each other. The family will be in harmony if they can love and respect each other” (Wang, 1934–1935, 12). Siblings are to establish close relationships on the basis of friendship and family love. Even if they are separated by mountains and rivers, such barriers cannot block their mutual humility and conversation, their sharing of joys and sorrows. Brothers and sisters who live in harmony show respect to their parents and elders. Applying this moral viewpoint to human subjects research, Confucians understand that whether a family member participates in research is not merely a personal decision, but a family decision. Family participation in such decisions demonstrates that the health of each individual member is the responsibility of the entire family. “Chinese patients take it for granted that it is the whole family, rather than the patient alone, that should make medical decisions” (Fan, 2002). Family relationships, such as parents and siblings, grandparents, aunts and uncles, provide emotional support and social assistance to every family member. This large and cohesive network of relatives provides people with significant social capital (Li, 2002). Such shared decision-making requires embracing a process in which researcher, subject, and family communicate, discuss, and cooperate equally. In such a partnership, researchers do not stand idly by. They must inform the family regarding the risks and benefits of research, provide advice, and leave time for patients to discuss the possibility of participating in the research protocol with their family. Followed properly, the final decision will represent the view of the whole family. This shared decision-making process emphasizes adequate communication and exchange, and requires the family as a whole to accept responsibility. Only when this process is accomplished will informed consent establish harmony between researcher and subject. It will then accord with the moral goals that “benevolence is the first” and “harmony is the most precious” that Confucians always pursue. Even though family structures have changed somewhat and family sizes have decreased, the Chinese family remains strong. For example, the East Asian Social Survey conducted in 2006 demonstrated that Chinese family cohesion has not been badly damaged (Yang and Li, 2009). The phenomenon provides realistic possibilities for family participation in decision-making.


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A Family-Based “Veto Power” Over Participation in Medical Research Confucianism generally appreciates the family as possessing something akin to a “veto power” over inappropriate individual medical decisions. Individuals may be unduly influenced to make medical decisions, which do not accord with their own best interests. Families are encouraged to participate in the decision-making process so as to protect the patient’s best interests. Consider, for example, the case of Guo Chaobin, whose decision to participate in medical research was motivated by free medicine and the free glucometer. Similarly, Zhang Zuning, in case 2, agreed to participate in medical research under the influence of her physician. In both cases, the patient failed adequately to appreciate the difference between research and treatment, each presumed that the protocol would be beneficial, and neither adequately understood the risks of participation. Family members are more likely to be able to provide advice based on a fuller and more objective consideration of the benefits and risks of research. Moreover, family participation in medical decision-making reflects the proper performance of Confucian family ethics. Chinese culture does not emphasize the independence of individuals. However, this does not mean that persons do not possess basic human rights or that they are oppressively under the control of their families. Liang Shuming argues, for example, that Chinese society is organized by an ethics that starts with the family and develops within the family. Ethical relationships require everyone to fulfill


patients confront a large amount of specialized knowledge, as well as potentially significant social pressure to participate, which may undermine their ability fully to understand and appreciate the information necessary to make an informed decision. The family’s role in this model of shared decisionmaking is to protect the best interests of patients and research subjects. The family-oriented decision-making model, which I defend, has four main features. First, the family should be understood as possessing the primary social authority to grant permission for individuals to participate in human subjects medical research. In China, the family structure in both urban and rural social environments includes both the nuclear family and close relatives (Sheng, Li, and Zhao, 2009). Second, the family does not possess an independent right to make a substitute decision; that is, the family as a whole cannot decide on its own whether a particular member should participate in research. Third, the family does, however, possess moral authority akin to “veto power.” That is, the family has the right to forbid a particular member to participate in medical research. Fourth, as a result, the consent of both patient and family is required for an individual to participate in research. Researchers need to gather consent agreements from both the potential subject and his family. If either party refuses to consent, the individual shall not participate.

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The Collective Wisdom of the Family Here, the phrase “veto power” means that the family as a whole has both the right and obligation to disagree with the patient if they disagree with his choices. The goal is to reinforce careful, thoughtful decision-making. At times, critics argue that family-based decision-making fails adequately to represent, and may even damage, the interests and wishes of patients (Dickert and Grady, 1999). Such criticism, however, seems to imagine the family as some sort of barbaric clan, with a rigid hierarchy and a selfish patriarch, who requires family members to engage in dangerous medical trials so as to obtain free pharmaceuticals and health care, against the patient’s wishes and best interests. Nothing could be further from the truth. First, family-directed decision-making engages all family members. Each adult member plays an important role in guiding family decisions. Even if the head of a family is


his or her mutual obligations (Liang, 2011, 87, 90). Family-based informed consent procedures, such as this “veto power” over the patient’s decision to participate in medical research, affirm the authority of the family as a key social unity. Such authority is based on, and strongly affirms, the obligations each family member has toward the others. The Confucian saying, “father guides son and husband guides wife” (Ruan, 1999, 1310), does not mean that fathers and husbands are simply in authority. Its essence requires fathers and husbands to undertake the primary responsibility of the family, to promote family good, and to develop happiness and harmony. As Zhang Dongsun argues, Confucianism always considers the individual as a dependent being who exists in a web of relationships and who must fulfill his or her proper responsibilities (Zhang, 2010). Confucianism requires that each person regard the interests of others as more important than one’s own. This is why Confucians emphasize the importance of moral relationships such as follows: the father’s kindness and the son’s filial duties; the elder brother’s gentleness and the younger brother’s obedience; the husband’s righteousness and the wife’s submission8; everyone must demonstrate respect for the elderly while also cherishing the young. If the patient is an elder member of the family, the younger generation (sons, daughters, and grandchildren) must accept the responsibility to understand the medical information and sign the informed consent forms, because in so doing they will protect their parents or grandparents from such burdens. Similarly, if the patient is a young member of the family, parents and grandparents will do their best to share responsibility with children and grandchildren during the informed consent process. Taking care of the younger generation is an unalterable moral duty; it remains even when children and grandchildren have become adults. Even among siblings, between husband and wife, or other types of family relationships, decisions are to be made together as a group. These practices accord with Chinese virtue.


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V. CONCLUSION The traditional Chinese family is strong, resilient, and adaptable. Modernization has not led to the decline of the Chinese family. Individuals rely on and remain loyal to their families. Indeed, there is very good evidence of


arbitrary, he or she can be countered by other family members. Informed consent documents do not require the signature of the “head of the family” but rather seek to record the approval of the family itself. Second, if the patient agrees to participate in medical research solely to maintain family harmony, he should still be able to withdraw consent and remove himself from the protocol. Third, it is unlikely that researchers will recruit a patient when conflict exists within the family or between the family and the patient. Such subjects are very likely to withdraw from the study, or fail fully to participate. What I have described as the family’s “veto power” is a practice designed to ensure that individuals seek advice and consultation with their families. If an individual initially agrees to participate in risky human subject research, but other family members strongly disagree with this decision, this process ensures that researchers will be required to engage in a detailed discussion with the patient’s family. Since other family members are not sick, injured, or otherwise medically compromised, they are in a better position to seek information regarding risks and benefits, so as to help the patient make an informed decision. The family’s “veto power” is a fairly straightforward way to protect the interests of individual family members. Moreover, as a practice, it is consistent with Confucian ethics. Families are obliged comprehensively to assess the risks and benefits of any research studies in which their members wish to participate. Such an obligation originates from the care and love the family owes to its members; it obeys the Confucian golden rule: “what you do not want done to yourself, do not do to others.”9 Confucians believe that we must respect other opinions when we make a decision. Confucianism recommends following the advice of knowledgeable and virtuous people (referred to as “Junzi”). Insofar as there are multiple intelligent viewpoints within the family and consensus cannot be reached, as a practical matter one might simply follow the wishes of the majority (see Ch’un Ts’ew and TSO Chuen, Chunqiu Zuozhuan).10 For example, a patient who had been volunteering as a research subject in drug trials finally told his parents about his participation. His parents strongly objected to his decision to participate. They judged the risks as significantly outweighing any benefits. The patient took his parents’ advice and withdrew from further medical research trials (Ni, 2007). The function of this “veto power” is not simply to thwart the will of the individual but to encourage individuals to participate in the collective wisdom of the family.

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continuing family-based, multigenerational living arrangements, social support, and financial assistance (Yang and Li, 2009). Family-directed informed consent for human subjects research serves the patient’s very practical need for advice and support. Moreover, it recognizes the moral and social reality of the Chinese family. As argued, when compared with individually directed consent, family-directed decision-making is better situated to protect human research subjects. The family’s supportive role effectively protects the interests of patients and research subjects while also maintaining family integrity and mutual harmony.

1. Informed consent for human subjects research is a special theme that should be considered separately from consent to medical treatment. This essay focuses in particular on research involving adults; that is, subjects older than 18 years of age. Research on vulnerable populations, such as infants, children, pregnant women, psychotic patients, those with intellectual disabilities, Alzheimer’s patients, and so forth, raises additional and complex moral questions, which will not be considered herein. 2. In my own experience of human subjects research in mainland China from 2012 to 2013, most informed consent forms were no more than three pages. Important areas of information relevant to the decision to participate could not be found in such forms, including information about the research sponsors, the qualifications of the researchers, adverse events during earlier research, and so forth. Moreover, researchers do not usually provide such information to subjects during the course of research. As a result, subjects are not making an informed decision to participate in such research. In mainland China, the family as a whole is best placed to understand the subjects’ values, his views regarding health, and quality of life. Consequently, it is most appropriate to permit the family to participate in such decision-making. 3. An adult’s ability to make an independent, autonomous and rational decision can be affected by many factors during decision-making. To illustrate, consider a 2005 case from Maqiao town Haining City Zhejiang Province, China. This study involved cooperation between China and South Korea to study the taking of ginseng pills to prevent colorectal cancer. In this case, most of the subjects were more than 50 years old. Researchers allegedly concealed the true nature of the project, telling subjects to take the pills to treat their colorectal polyps. It was reported that the researchers did not inform patients about the risks of taking the drugs or provide time for potential subjects to consult with their families. Expensive ginseng pills were provided free to encourage the elderly to participate in the research. See Liu (2005) and Yang (2005). 4. Human subjects research scandals are not limited to the developing world. Consider, for example, the Tuskegee syphilis study (Jones, 1981); The Jewish Chronic Disease Hospital case (Katz, 1972, 9–43); and the so-called Willowbrook case (Rothman, 1991, 77–81). Similar problems have beset British, Canadian, and New Zealand research. See, for example, Pappworth (1967). For an account of the “Halushka case” from the 1960s in Canada, see Medical Research Council of Canada (1987, 5). See also McNeill (1993, 76–81) for an account of a New Zealand case in which women with cervical cancer were left untreated so as to study the natural history of the disease. 5. It is illegal for the researcher to collect such a deposit. At times, however, in order to keep the sample size stable, researchers make subjects pay 500 Yuan deposit and require them to finish the entire research course to obtain the free glucometer. If subjects withdraw from the trial, they will receive nothing. Such deposits and expensive gifts have a significant effect on the subject’s decision to participate, especially when the research subjects are poor. Such practices are not uncommon in mainland China. For example, the Research of Ginseng Prevention of Colorectal Cancer, a cooperative project between China and South Korea, performed in the rural area of Haining City, Zhejiang Province, China, in 2005, ran into similar moral difficulties. During research, some of the subjects who suffered frequent dizziness and unstable blood pressure sought to stop taking the Ginseng pills. However, the official in the rural health center (乡镇卫生院) told them that if they withdrew from the study, they would be required to pay for the Ginseng pills that they had already taken. The price of free Ginseng pills was said to be 3,900


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ACKNOWLEDGMENTS I am grateful to Professor Fan Ruiping for his thoughtful suggestions on each of the six drafts of this essay. I also wish to thank the following friends for their valuable suggestions and timely help on early drafts, as well as for translation assistance: Liu Ting, Li Yanrong, Li Wenyan, Wang Zhanyu, Feng Yi, and Shang Hui. Research support for this article was provided by the Humanities and Social Science Research Fund Plan of the Ministry of Education of the People’s Republic of China (12YJA720003), the Soft Science Project in ShanXi Province (2013041084-01), and the Philosophy and Social Research Project of the Shanxi Higher Education Institution (2014319).


Yuan, a large sum of money for many of the participants. Many subjects simply stayed in the study, with potentially adverse results, to avoid paying the fee. (See Lin, Yang, and Zhaogang, 2005). 6. The way of life that Confucianism advocates is summarized from the Great Learning, which is one of the Confucian classics in Warring States (475 BC-221 BC). The original text is “the ancients who wished to illustrate illustrious virtue throughout the kingdom, first ordered well their own States. Wishing to order well their States, they first regulated their families. Wishing to regulate their families, they first cultivated their persons. Wishing to cultivate their persons, they first rectified their hearts.” See (the Chinese is 正心,修身,齐家,治国,平天下) The Great Learning in Legge (2011, I, 357). 7. Maoshi Zhengyi, also known as Mao Shi Xu, is a book to annotate ShiJing (The Book of Poetry, a famous classic in Western Zhou). The authorship of Mao has not been confirmed; however, Mao Heng in the Han Dynasty (202–220 BC) is generally believed to be the author. The Chinese text is 亲亲以睦友, 友贤不弃,不遗故旧,则民德归厚矣. 8. These Confucian concepts have been discussed in many different classics, such as WuDi BenJi of ShiJi (), Standards for Students (), and Yan’s Family Instruction-Household Management (). The Chinese text is 父慈子孝, 兄友弟悌, 夫义妇听. They all describe the obligations within a family. Everyone plays a different role in the family, and each person must take on the obligations of his or her role. Only in this way can the family be happy and harmonious. The citation here is from Liji-Liyun (also The Classic of Rites: Their Origins, Development, and Intention. In Chinese it is: ). See Donald Sturgeon, Chinese Text Project (http://ctext.org/liji/li-yun/ens). 9. The Confucian version of the golden rule comes from Book XV, Wei Ling Kung, of the Analects: 己所不欲,勿施于人 (see Legge, 2011, I, 301). Its application to human subjects research is useful. For example, if a family member does not want to participate because of uncertain risk factors, he is sure to work to prevent other family members from engaging in such research, because he knows that there is a serious moral obligation to protect other family members from harm. Confucians encourage individuals actively to care for and to take part in important family affairs. If individuals do not care about the family, valuing only personal independence, they are considered to have considerable moral flaws. 10. My analysis of majority-based decision-making within the family draws support from the Ch’un Ts’ew and the Tso Chuen (). The Chinese text is 善钧从众,夫善,众之主也.三卿为主,可谓众矣.从之,不亦可乎? This reads: “It is best to follow the multitude. The best are the lords of the multitude. Such are the three high ministers [who advise against fighting]; they may be called a majority. Am I not doing also what is proper in following them?” (see Book VIII, Duke Ch’ing, Year VI, Legge, 2011, V, 359, 361). Confucians tend to pay more attention to the views of groups than to individuals. In most cases, following the majority requires “giving up one’s own way to follow others” (in Chinese: 舍己从人). That is, one must abandon individualism and respect others. First and foremost, one must respect the family. This conclusion was proposed by the great Shun and the great Yu (two famous kings in ancient China). Consider two key statements from the Chinese Confucian classics. The great Shun took significant delight in what was good. He regarded virtue as the common property of himself and others, giving up his own way to follow others and delighting to learn from others how to practice what was good (The Works of Mencius, Book II, Kung-sun Chau, Part I, Ch. VIII.3, Legge, 2011, II, 205). The Chinese text is 大舜有大焉,善与人同,舍己从人,乐取于人以为善. To ascertain the views of all is to give up one’s own opinion and follow that of others (The Shoo King, Book II. The Counsels of the Great Yu, Ch. 3, see Legge, 2011, III, 53). The Chinese text is 稽于众，舍己从人. Each of these influential Confucians argued that individuals should consult with others whenever an important decision must be made. Such decision-making is designed to keep the country, social group, and family in harmony.

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