LOCAL ATTITUDES, MORAL OBLIGATION, CUSTOMARY OBEDIENCE AND OTHER CULTURAL PRACTICES: THEIR INFLUENCE ON THE PROCESS OF GAINING INFORMED CONSENT FOR SURGERY IN A TERTIARY INSTITUTION IN A DEVELOPING COUNTRY

The process of obtaining informed consent in a teaching hospital in a developing country (e.g. Nigeria) is shaped by factors which, to the Western world, may be seen to be anti-autonomomous: autonomy being one of the pillars of an ideal informed consent. However, the mix of cultural bioethics and local moral obligation in the face of communal tradition ensures a mutually acceptable informed consent process. Paternalism is indeed encouraged by the patients who prefer to see the doctor as all-powerful and all-knowing, and this is buttressed by the cultural practice of customary obedience to those 'above you': either in age or social rank. The local moral obligation reassures the patients that those in authority will always look after others placed in their care without recourse to lengthy discussions or signed documentation, while the communal traditions ensure that the designated head of a family unit has the honor and sole responsibility of assenting and consenting to an operation to be carried out on a younger, or female, member of the family. Indeed it is to only a few educated patients that the informed consent process is deemed a shield against litigation by the doctors. This paper later addresses the need for physicians to update their knowledge on the process of informed consent through the attendance of biomedical ethics courses, which should highlight socio-cultural practices that may make this process different from the Western concept, but perfectly acceptable in this setting.     

A Confucian View of Personhood and Bioethics

This paper focuses on Confucian formulations of personhood and the implications they may have for bioethics and medical practice. We discuss how an appreciation of the Confucian concept of personhood can provide insights into the practice of informed consent and, in particular, the role of family members and physicians in medical decision-making in societies influenced by Confucian culture. We suggest that Western notions of informed consent appear ethically misguided when viewed from a Confucian perspective.     

Ethical obligation and legal requirements: On informed consent practices in Bangladesh

Informed consent to medical intervention is fundamental in both ethics and law. But in practice it is often not taken seriously in developing countries. This paper provides an appraisal of informed consent practices in Bangladesh. Following a review of the ethical and legal principles of informed consent, it assesses the degree to which doctors adhere to it in Bangladesh. Based on findings of non-compliance, it then investigates the reasons for such non-compliance through an appraisal of informed consent practices in Bangladesh and provides recommendations aimed at improving such practices. The significance of this paper lies in unveiling the interdependence between the ethical and legal traits of informed consent and their ramifications on strengthening the patient-oriented approach of duty to care.     

On Taylor's justification of medical informed consent

In contemporary Western biomedical ethics, informed consent practices are commonly justified in terms of the intrinsic value of patient autonomy. James Stacey Taylor maintains that this conception of the moral grounding of medical informed consent is mistaken. On the basis of his reasoning to that effect, Taylor argues that medical informed consent is justified by the instrumental value of personal autonomy. In this article, I examine whether Taylor's justification of medical informed consent is plausible.     

Physicians and the minefield surrounding informed consent.

Most of the legal cases that follow the informed-consent standard set in recent court cases have involved surgical procedures. However, issues concerning a pregnant British Columbia mother who contracted chicken pox and whose child was subsequently born with severe medical complications demonstrate the complexity of medical decision making and the inadequacy of established legal requirements, especially when consent has dimensions beyond technical considerations usually associated with medical procedures. The problem physicians face, says lawyer Karen Capen, is to find a way to balance a range of professional responsibilities and the overriding fiduciary obligation to patients in matters associated with informed decision making and consent.     

Family refusal of emergency medical treatment in China: An investigation from legal,empirical and ethical perspectives

This paper is an analysis of the limits of family authority to refuse life saving treatment for a family member (in the Chinese medical context). Family consent has long been praised and practiced in many non-Western cultural settings such as China and Japan. In contrast, the controversy of family refusal remains less examined despite its prevalence in low-income and middle-income countries. In this paper, we investigate family refusal in medical emergencies through a combination of legal, empirical and ethical approaches, which is highly relevant to the ongoing discussion about the place of informed consent in non-Western cultures. We first provide an overview of the Chinese legislation concerning informed consent to show the significance of family values in the context of medical decision-making and demonstrate the lack of legal support to override family refusal. Next, we present the findings of a vignette question that investigated how 11,771 medical professionals and 2,944 patients in China responded to the family refusal of emergency treatment for an unconscious patient. In our analysis of these results, we employ ethical reasoning to question the legitimacy of family refusal of life-sustaining emergency treatment for temporarily incompetent patients. Last, we examine some practical obstacles encountered by medical professionals wishing to override family refusal to give context to the discussion.     

Rationale for an integrated approach to genetic epidemiology

Conclusion: Genetic knowledge is now in the public domain and its interpretation by the media and the citizens brings the issues into the public forum of discussion for the necessary ethical, legal and socio-cultural evaluation of its application. Science is being perceived by some as dangerous and as requiring international regulation. Others feel that genetic knowledge will be the breakthrough that will permit medical progress and individual autonomy with regards to personal health and lifestyle choices. The mapping of the human genome has already yielded valuable information on an increasing number of diseases and their variants. Prevailing popular and journalistic archetypes ("imaginaires") used in the media are perceived by the producers as slowing down the possible application of genetic knowledge. The answers to these dilemmas are not readily apparent nor are they prescribed by classical philosophy of medicine. Since genetic knowledge eventually resides with the individual who carries the genes of disease and/or susceptibility, a logical approach to integration of this knowledge at a societal level would seem to reside with individual education and decision-making. The politics of the ensuing social debate could transform the current social contract since an individual's interests need to be balanced against those of his or her immediate family in the sharing of information. The ethical foundations of such a contract requires the genetic education of "Everyone" as a matter of urgent priority. Genetic education should not serve ideological power struggles between the medical establishment and the ethical-legal alliance. Instead, it should ensure the transfer of knowledge to physicians, to patients, to users, to planners, to social science and humanities researchers and to politicians, so that they may make "informed" and free decisions....     

Best Practice Guidelines on Informed Consent for Weight Loss Surgery Patients

Objective: To provide evidence‐based guidelines on informed consent and the education that underlies it for legally competent, severely obese weight loss surgery (WLS) patients. Research Methods and Procedures: We conducted a systematic review of the scientific literature published on MEDLINE between 1984 and 2004. Three articles focused on informed consent for WLS; none was based on empirical studies. We summarized each paper and assigned evidence categories according to a grading system derived from established evidence‐based models. We also relied on informed consent and educational materials from six WLS programs in Massachusetts. All evidence is Category D. Recommendations were based on a review of the available literature, informed consent materials from WLS programs, and expert opinion. Results: This Task Group found that the informed consent process contributes to long‐term outcome in multiple ways but is governed by limited legal requirements. We focused our report on the legal and ethical issues related to informed consent, i.e., disclosure vs. comprehension. Recommendations centered on the importance of assessing patient comprehension of informed consent materials, the content of those materials, and the use of active teaching/learning techniques to promote understanding. Discussion: Although demonstrated comprehension is not a legal requirement for informed consent in Massachusetts or other states, the members of this Task Group found that the best interests of WLS patients, providers, and facilities are served when clinicians engage patients in active learning and collaborative decision making.     

Prevention. How much harm? How much benefit? 4. The ethics of informed consent for preventive screening programs.

Preventive interventions may have few or unproven benefits, or they may even be harmful. Since three of the fundamental precepts of Western biomedical ethics are beneficence, non-maleficence and respect for individual autonomy, failure to obtain truly informed consent for many current preventive interventions may be unethical. However, there are many impediments to obtaining such consent. Physicians need to be aware of an immense amount of up-to-date, complex information. It may be difficult for patients to assimilate this information, and there is rarely time for physicians to become informed and to inform their patients. Clinical practice guidelines may be helpful, but not all are based on evidence, and recommendations are often conflicting. Medical institutions, as well as individual clinicians, can help solve these dilemmas. Authors and journal editors can make a commitment to report and publish well-referenced evidence-based guidelines. Organizations such as the Canadian Task Force on the Periodic Health Examination and the US Preventive Services Task Force can develop balanced, evidence-based patient-information material. Faculty at all levels of medical education can increase their emphasis on the ethics of prevention. Individual clinicians should avoid making clinical decisions on the basis of relative reductions of morbidity or mortality, should use evidence-based clinical practice guidelines rather than those based on authority whenever possible, should make use of patient-information material and, most important, should have a consistent policy of obtaining informed consent from patients before they participate in potentially harmful preventive programs.     

Acceptance and Perception of Nigerian Patients to Medical Photography

The aim of the study was to determine the acceptance and perception of Nigerian patients to medical photography. A self‐administered questionnaire was distributed among Nigerian patients attending oral and maxillofacial surgery and plastic surgery clinics of 3 tertiary health institutions. Information requested included patients' opinion about consent process, capturing equipment, distribution and accessibility of medical photographs. The use of non‐identifiable medical photographs was more acceptable than identifiable to respondents for all purposes (P = 0.003). Most respondents were favourably disposed to photographs being taken for inclusion in the case note, but opposed to identifiable photographs being used for other purposes most especially in medical websites and medical journals. Female respondents preferred non‐identifiable medical photographs to identifiable ones (P = 0.001). Most respondents (78%) indicated that their consent be sought for each of the outline needs for medical photography. Half of the respondents indicated that identifiable photographs may have a negative effect on their persons; and the most commonly mentioned effects were social stigmatization, bad publicity and emotional/psychological effects. Most of the respondents preferred the use of hospital‐owned camera to personal camera/personal camera‐phone for their medical photographs. Most respondents (67.8%) indicated that they would like to be informed about the use of their photographs on every occasion, and 74% indicated that they would like to be informed of the specific journal in which their medical photographs are to be published. In conclusion, non‐identifiable rather than identifiable medical photography is acceptable to most patients in the studied Nigerian environment. The use of personal camera/personal camera‐phone should be discouraged as its acceptance by respondents is very low. Judicious use of medical photography is therefore advocated to avoid breach of principle of privacy and confidentiality in medical practice.     

Medical Ghostwriting and Informed Consent

Ghostwriting in its various forms has received critical scrutiny from medical ethicists, journal editors, and science studies scholars trying to explain where ghostwriting goes wrong and ascertain how to counter it. Recent analyses have characterized ghostwriting as plagiarism or fraud, and have urged that it be deterred through stricter compliance with journal submission requirements, conflict of interest disclosures, author‐institutional censure, legal remedies, and journals' refusal to publish commercially sponsored articles. As a supplement to such efforts, this paper offers a critical assessment of medical ghostwriting as contrary to good patient care, on the grounds that it contradicts established general principles guiding clinical ethics. Specifically, I argue that ghostwriting undermines trust relationships between authors and their readers, and between these readers and their trusting patients, and in so doing contradicts the duty of respect for patient autonomy by obstructing informed consent. For this reason, complicity in ghostwriting practices should be understood as a violation of the professional ethical duties of physicians and other healthcare workers.     

论知情同意制度的不足以及术中改变术式的法律责任

知情同意制度贯穿于医疗活动的整个过程，尊重患者的知情同意权是医务人员的法定义务，国内诸多法律法规均对医疗活动中的知情同意做了原则性的规定。但是由于缺乏针对具体医疗行为如何适用知情同意制度的指引或者规范，导致医务人员常常不知如何正确地履行知情同意程序。而且，当前的知情同意制度存在诸多不足，司法实践也对知情同意缺乏深入的研究，这为医务人员的执业活动带来了潜在的法律风险。     

Charitable State-Controlled Foundation Human Tissue and Cell Research: Ethic and Legal Aspects in the Supply of Surgically Removed Human Tissue For Research in the Academic and Commercial Sector in Germany

Tissue engineering using human cells and tissue has one of the greatest scientific and economical potential in the coming years. There are public concerns during the ongoing discussion about future trends in life sciences and if ethic boundaries might be respected sufficiently in the course of striving for industrial profit and scientific knowledge. Until now, the legal situation of using human tissue material for research is not clear. Accordingly, transparency of action and patients' information are a central component when handling patient material inside and outside of the patient-specific treatment. Whereas in the field of therapeutic use of tissue (e.g. transplantation) there is an emergency situation by the shortage of organs with the risk of the premature death of the potential recipient, this cannot be claimed for tissue donation for research. The basis of every surgical operation is the treatment contract, which places the doctor under obligation to the careful exercise of medical treatment containing the patient's informed consent. This contract only covers the treatment that is intended to cure the patient and the medical measures that are necessary therefor. The further scientific use of body-substances, which are discarded after an operation, are not included. Therefore a personal and independent written enlightenment of the patient and a declaration of informed consent is necessary. Examples of guidelines for tissue supply, Patients information and consent were worked out by theologists, lawyers, scientists and physicians reflecting their practical experience in transplant surgery and liver cell research. As a consequence to cover the ethical and legal aspect of tissue donation in Germany a charitable state-controlled foundation Human Tissue and Cell Research (HTCR) was introduced and established.     

Rethinking parenthood within assisted reproductive technology: The need for regulation in Nigeria

In Nigeria, reproduction is highly valued, with many people desiring to produce a child ‘in their own image and likeness’. Previously, aspiring parents often resorted to adoption. Today, the availability of assisted reproductive technologies (ARTs) has provided options other than adoption for those desiring to procreate. Through ARTs, aspirations for a family may be attained through an exchange of reproductive goods and services, and not necessarily through traditional heterosexual relationships. ARTs have altered the perception of parenthood as it exists in Nigeria, and courts face a difficult task in defining parenthood within Nigerian jurisprudence, as they can only adjudicate based on extant law. Although ARTs provide greater individual choices for fulfilling the desire to procreate, they raise a number of ethical and legal issues that evolving legal systems, such as that in Nigeria, are ill-equipped to manage. This paper describes the traditional assignment of parenthood under indigenous laws and other sources of law within the Nigerian jurisprudence. We carried out an in-depth study of the Nigerian legislative framework and found that there are no laws directly regulating parenthood, procreation and ARTs in Nigeria. We also found that the extant laws are only tangentially related and do not answer the relevant questions sufficiently well, especially concerning succession, nationality and assignment of responsibility in collaborative reproduction. We conclude by highlighting the need for and recommending a regulatory framework on ARTs with a particular focus on providing a definition for parenthood achieved through ARTs in Nigeria.     

Legal obligation of physicians to disclose information to patients.

Obtaining a patient''s consent is a routine daily process for physicians, although many are unaware of the scope of this legal obligation. In 1980 the Supreme Court of Canada changed the law relating to informed consent; promotion of patient autonomy shifted the focus from a standard of professional disclosure to one of a "reasonable patient." Physicians have a legal obligation to disclose to patients specific information, the scope of which is determined by a court on the basis of a reasonable patient''s expectation and the circumstances of the case. This gives rise to many controversies in the practice of clinical medicine. It is difficult for physicians to know which treatment risks require disclosure, since this is decided by a court in a retrospective analysis of the evidence. Will the court recognize exceptions to the duty of disclosing information? If several health care professionals are involved in a patient''s care who has the duty to disclose information? Can this duty be delegated? This paper provides physicians with guidelines that are consistent with the promotion of patient autonomy and comply with the doctrine of informed consent. In addition, it suggests ways of improving awareness of the doctrine and procedures to ease its application.     

Informed consent and nudging

In order to avoid patient abuse, under normal situations before performing a medical intervention on a patient, a physician must obtain informed consent from that patient, where to give genuine informed consent a patient must be competent, understand her condition, her options and their expected risks and benefits, and must expressly consent to one of those options. However, many patients refrain from the option that their physician believes to be best, and many physicians worry that their patients make irrational healthcare decisions, hindering their ability to provide efficient healthcare for their patients. Some philosophers have proposed a solution to this problem: they advocate that physicians nudge their patients to steer them towards their physician's preferred option. A nudge is any influence designed to predictably alter a person's behavior without limiting their options or giving them reasons to act. Proponents of nudging contend that nudges are consistent with obtaining informed consent. Here I argue that nudging is incompatible with genuine informed consent, as it violates a physician's obligation to tell their patients the truth, the whole truth, and nothing but the truth during adequate disclosure.     

Male fertility attitudes: a neglected dimension in Nigerian fertility research

A sample of 202 male Nigerians enrolled in colleges and graduate schools in the state of Kansas were surveyed to determine their perceptions of population problems in Nigeria; attitudes toward family planning, divorce, and male children; and attitudes toward family size. A major limitation of Nigerian-based fertility research has been the neglect of the role of men in couples' reproductive behavior. The majority of Nigerian students surveyed in this study did not think overpopulation is an impending crisis in Nigeria: 40% thought there are just enough people and 13% indicated there are not enough people. 53% supported the concept of a government population policy, but 67% felt the government should not interfere with family size decisions. Although 84% endorsed the idea that family planning services and information should be available, 69% felt women should not practice family planning without the consent of their husbands. 43% believed a man should divorce his wife if the woman is infertile, unable to produce a male child, or unable to bear the number of children demanded by her husband; in addition, 35% indicated a man should marry a second wife or continue to have children if the couple has 5 daughters and no son. In terms of the value of children, 62% stated that children are wealth or better than wealth, whereas 38% claimed that children use up wealth. Duration of stay in the US was inversely correlated with the number of children considered too many, and the number of male children already born was an important determinant of future family size expectations. In general, it appears that level of education and exposure to US standards do not have a major impact on fertility values among Nigerians, particularly the desire for male children. Educated Nigerian men are an important target for population education, however, because they dominate and control many of the structural, behavioral, and cultural dimensions of fertility behavior.     

Knowledge of possible pregnancy at first coitus: a study of in-school adolescents in Ibadan, Nigeria

This paper discusses the reproductive health knowledge of Nigerian in-school adolescents, with special reference to pregnancy occurrence at first coitus. The data were derived from an Association for Reproductive and Family Health (ARFH) survey carried out in four secondary schools in Ibadan, Nigeria, between August and October 1995. A total of 828 students were interviewed. The results revealed that the majority of sexually active adolescents were not aware of the consequences of their actions. Religious affiliation and number of wives in a male adolescent's family, and religion and marital status of a female adolescent's parents, were found to influence adolescents' knowledge of pregnancy probability at first coitus. This paper confirms earlier findings that the majority of Nigerian adolescents do not know the consequences of sex. Therefore, a clear-cut plan of action is needed to inform sexually active adolescents through an effective sex education programme.