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40 Eubios Journal of Asian and International Bioethics 22 (January 2012) informed consent. The four principles approach to biomedical ethics collectively known as the "principles oriented framework," or "principlism," was developed by Beauchamp and Childress in America in the 1970s, and has been promoted by Raanan Gillon as the "four principles plus scope" approach in Europe. (3) It has been widely accepted, especially in medical circles, as a set of universal guidelines for bioethics, despite much intense criticism. However, as this theory is developed from American common morality, which mirrors certain aspects of American society, may for this reason alone be unacceptable in the context of other societies. (4) Moreover, an inherent tension does exist among these principles not only for their importance over one another, but also for their feasibility in high context Asian culture, which emphasizes interdependence, interconnections with others, and a present time orientation. This contrasts the low context western societies which emphasize independence, the individual and future time orientation. (4) Asian countries: Challenges in medical research One of the great challenges in medical research is the position of individuals. In the Asian countries, the individuals are entangled in a web of intricate complex relationships. Fu-Chang Tsai (5) states that "... in Chinese thinking, individuals are never recognized as separate entities; they are always regarded as part of a network, each with a specific role in relation to others". (5) The physician assumes the role of a family member and makes decisions for the patient for their benefit. This may make the individuals vulnerable and deprive them of choosing their own conception of what is considered good. Further, in the society where individuals live in an extended patriarchal family structure, where families have strong religious and cultural beliefs and values, major decisions are taken collectively by members of the family and, therefore, the western paradigm of individual autonomy may not be practical. (6) In the context of research and delivery of the health care system, the good and benefit are used for the restoration of the health of patient and a commitment toward human welfare. (7) While accomplishing this fiduciary duty of beneficence, the physician and researcher sometimes intentionally override these important preferences and actions that will benefit the research participant in particular and society in general, such as in the case of Tuskegee experiment, in which low income African Americans were kept untreated for syphilis; and the researcher did not disclose the availability of the treatment. (7) The ethical concerns become prominent when the involved parties have different interests or values. In this situation a potential conflict exists between the burden and risk imposed on patients and society. Ethical concerns may also arise when there is a large imbalance in power between doctor and patient, and this may result in the exploitation of the patient as well as research participant. (7) Decision making in Asian culture Medical ethics in the Asian countries has been imported from the West by the Western trained physicians. Practicability of this paradigm in the Asian countries poses ethical difficulties for researchers and health care professionals. The centrality of the family in major human life events such as birth, illness and death is a universal phenomenon; however the level of family involvement may vary from one society to another. (8) In most Asian societies, major decisions are taken collectively by members of the family. Regarding the disclosure of diagnosis and prognosis, patients and family both expect that the physician should inform the family first; especially in the case of an elderly patient with a serious disease. Families usually discuss with the physician how best to inform the patient and to guide the patient for a particular treatment plan. The concept of individual autonomy is bound with the advice of elders in the family such as father or husband in case of married women. Ren-Zong Qiu(9) states that in the postrevolutionary era, China has developed a decision making mechanism that stresses consultation between physicians and family members involving the competent patient, sometimes including close friends or coworkers and the chief of the unit in which the patient works. (9) Therefore, a distinction exists between the roles of Asian (collective) autonomy vs. Western (individual) autonomy in the decision-making process. It has been presumed that the western individualistic notion of patient autonomy is inappropriate in Asian societies. Informed consent from an Asian perspective Informed consent is not only an authorization of medical/research intervention by patients, but it is an ethical right of every human being which signifies respect for the person. (10) The concept of informed consent in most Asian countries, is only a formality and a routine clinical practice or only for the legal protection in case of an adverse outcome; without considering its moral values. The actual perception of consent such as the acceptance of treatment or keenness to participate in research, choice for alternate treatment or refusal of the treatment is uncommon in the urban areas and rare in the rural areas of the country. Further, informed consent should be a continuous process of voluntary informed decision making in which individuals voluntarily agree to participate in research after the purpose, risks, benefits and alternatives have been thoroughly described and understood. However, in resource poor countries in general, it is only considered as a onetime process and there are many instances of informed consent forms being signed by the head of the family (father/husband) instead of the patient or potential research subject. (11) Similarly the clinicians who conduct clinical trials also form an opinion on the amount of information that they are required to provide to patients as part of the process for obtaining informed consent, being the better judges to assess patients’ comprehension of that information as they are in close contact with them all the time. However this is nothing but ignorance as, it is possible that they may overestimate what their research participants understand. (12) A recent study in several hospitals in Mexico City showed that physicians/researcher exercise power and authority over patients/research subject in an effort that
Eubios Journal of Asian and International Bioethics 22 (January 2012) 41 they perceive as beneficial or preventing harm. In most cases, due to vague and partial communication, the physicians/researchers do not seem to recognize or respect their patient’s or research subject autonomy. (13) (14) Emanuel reported that that there are seven requirements for the clinical trials to be labelled ethical; these are: 1. Progress of health or knowledge 2. Scientific validity of the research 3. Fairness of subject selection; depending on the scientific objectives 4. Well calculated risk-benefit ratio 5. Independent review of the research 6. Participants should be well informed about the research and provide their voluntary consent; and 7. Respect for subjects (For example, subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored). (14) However, the practicality of these requirements, particularly relating to the voluntary consent, respect for enrolled subjects in terms of protection of subjects’ privacy, opportunity to withdraw, and the wellbeing of research subjects, are less prevalent in Asian countries in general and in Pakistan in particular when compared to the countries like the USA and Canada. Advantages of Western individual autonomy Recent discourse in contemporary bioethics equates autonomy with personhood. This from the perspective of participation in research refers to the obligation of investigators to credit the desires of a competent individual regarding their wish to participate in scientific research. (15) The concept of autonomy remains the intellectual and moral foundation of bioethics and is the direct manifestation of the western concept of individualism, which is a belief of importance, uniqueness, dignity, and sovereignty of each person and the sanctity of each individual life. (15) According to the principle of individual autonomy, every person is entitled to individual rights such as autonomy of self-determination and privacy. This enforces the individual, which renders them resistant to exploitation by the researcher. The individual autonomy concept of western ethics makes a fairly clear distinction between facts and values. The research participant’s values are well defined and known; what they lack are the facts. It is the researcher's obligation to provide all the available facts, and the research participant's values then determine whether to take part in the research or not; whether to be randomized or not. (15) Disadvantages of Western individual autonomy The western individual autonomy is a secular approach in bioethics. By implementing this approach they are isolating the ethical issues from their spiritual and social context to achieve an institutionally sanctioned method of resolving conflicts. Furthermore, the examination of the issues from a non-social perspective makes their approach not only limited but also incomplete and devoid of meaning and is also difficult to understand by the nonwestern observers. (15) Advantages of Asian Shared Decision Making The societal position of physicians and researchers is prime one in Asian culture in general. The Physician/researcher not only holds a good role in a family but also makes decisions for the patient with family assistance. This act of physician and researcher places heavy responsibilities on them regarding the fulfillment of their ethical requirements of beneficence and safety of patients and research participants. This relationship may also prevent patient exploitation by observing a patient’s social and cultural values and shared informed consent. (16) Shared decision making with the involvement of family members in decision making is more pragmatic in the current economic and educational situation of the developing countries of the world. The shared decision making concept in the health care system and research is believed to be the best tool to exercise the autonomy of individuals and to render the researcher and the physician in a position to respect the patient and family values. (17) Disadvantages of Asian Shared Decision Making The paternalistic approach of the health care system is common in the Asian countries. In this approach the physician presents the patient with selected information that will encourage the patient to consent to the intervention the physician considers best. At the extreme, the physician authoritatively informs the patient when the intervention will be initiated. In the tension between the patient's autonomy and well-being, between choice and health, the paternalistic physician's main emphasis is toward the latter. However, Matthews (18) reported that “It is the patient’s life or health which is at stake, not the physician’s...so it must be the patient, not the physician, who must be allowed to decide whether the game is worth the candle.” (18) Similarly, Edmund Pellegrino and David Thomasma (19) argue that the “best interests of the patients are intimately linked with their preferences.” (19) Despite the importance of research participant and patient involvement in decision making and a choice to accept and refuse recommended medical treatment or to take part in the research, medical care practitioners and researchers are expected to do what is best for their patients. In certain situations, they are also expected to consider what is best for society, even if that may not be in the best interests of the patient. Moreover, in the cause of research, the paternalistic act of the researcher often uses different forms of unethical influences such as deception, lying, nondisclosure of information and coercion, so that easy recruitment may be possible. (20,21) Discussion The debate concerning autonomy is a cultural one and in cultures change is a consequence of a creative interaction of ideas, values and activities. In this sense, the extension of family decision making across international boundaries is an exciting and enriching process and one that provides us with opportunities to explore our differences and challenges as well as our successes. (22) In highly individualistic cultures that assume rational choice as the main instrument in patient decision-making, autonomy may be expected as an essential part of the system, although it may have been overemphasized. The degree of normal autonomy may be different between
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