Parental refusal of life-saving treatments for adolescents: Chinese familism in medical decision-making re-visited

This paper reports two cases in Hong Kong involving two native Chinese adolescent cancer patients (APs) who were denied their rights to consent to necessary treatments refused by their parents, resulting in serious harm. We argue that the dynamics of the 'AP-physician-family-relationship' and the dominant role Chinese families play in medical decision-making (MDM) are best understood in terms of the tendency to hierarchy and parental authoritarianism in traditional Confucianism. This ethic has been confirmed and endorsed by various Chinese writers from Mainland China and Hong Kong. Rather than giving an unqualified endorsement to this ethic, based more on cultural sentimentalism than rational moral reasoning, we warn that a strong familism in MDM, which deprives 'weak' family members of rights, represents the less desirable elements of this tradition, against which healthcare professionals working in this cultural milieu need to safeguard. Specifically for APs, we suggest that parental authority and family integrity should be re-interpreted in terms of parental responsibility and the enhancement of children's interests respectively, as done in the West. This implies that when parents refuse to consent to necessary treatment and deny their adolescent children's right to consent, doctors, as the only remaining advocates of the APs' interest, have the duty to inform the state, which can override parental refusal to enable the doctors to fulfill their professional and moral obligations. In so doing the state exercises its 'parens patriae' power to defend the defenseless in society and the integrity of the medical profession.     

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.     

Addiction,Heroin‐Assisted Treatment and the Idea of Abstinence: A reply to Henden

In our previous article on the question whether heroin addicts are able to give informed consent voluntarily to research on heroin‐assisted treatment, we criticized the ongoing bioethical discussion of a flawed conceptualization of heroin addicts' options. As a participant in this discussion, Edmund Henden defends the conceptualization as sufficient for determining whether heroin addicts are able to give informed consent to the research on heroin‐assisted treatment voluntarily. This discussion on research on heroin‐assisted treatment seems to go astray in several respects. In his reply to our article Henden maintains some of the biases, such as the necessity of abstinence in recovery, that seem to prevail in addiction research on a more general level as well. These biases run the danger of having implausible ethical implications on stakeholders in addiction research and treatment. In our reply to him, we will further clarify and discuss the importance of describing the relevant issues in plausible terms that do justice to the realities of the cases of informed consent in research on heroin‐assisted treatment and also raise a wider issue of the ethics of wording as well as of the narrow scope, or ‘tunnel vision’, in addiction research as currently conducted.     

A direct advance on advance directives

Advance directives (ADs), which are also sometimes referred to as 'living wills', are statements made by a person that indicate what treatment she should not be given in the event that she is not competent to consent or refuse at the future moment in question. As such, ADs provide a way for patients to make decisions in advance about what treatments they do not want to receive, without doctors having to find proxy decision-makers or having recourse to the doctrine of necessity. While patients can request particular treatments in an AD, only refusals are binding. This paper will examine whether ADs safeguard the autonomy and best interests of the incompetent patient, and whether legislating for the use of ADs is justified, using the specific context of the legal situation in the United Kingdom to illustrate the debate. The issue of whether the law should permit ADs is itself dependent on the issue of whether ADs are ethically justified; thus we must answer a normative question in order to answer the legislative one. It emerges that ADs suffer from two major problems, one related to autonomy and one to consent. First, ADs' emphasis on precedent autonomy effectively sentences some people who want to live to death. Second, many ADs might not meet the standard criteria for informed refusal of treatment, because they fail on the crucial criterion of sufficient information. Ultimately, it transpires that ADs are typically only appropriate for patients who temporarily lose physical or mental capacity.     

Managing familial risk in genetic testing

Increasing numbers of people are seeking genetic testing and uncovering information that directly concerns their biological relatives as well as themselves. This familial quality of genetic information raises ethical quandaries for physicians, particularly related to their duty of confidentiality. In this article, the American Medical Association's Council on Ethical and Judicial Affairs examines the informed consent process in the specific context of genetic testing, giving particular consideration to the handling of information that has consequences for biological relatives. Furthermore, it addresses the question of whether physicians' obligation to warn biological relatives ever should override the obligation to protect patient confidentiality.     

Reflection on family consent: based on a pregnant death in a beijing hospital

The ‘family consent’ process has been placed at the centre of Chinese clinical practice. Although there has been critical analysis of how the process functions in relation to the autonomy and rights of patients, there has been little examination of the perceptions and attitude of patients and their families and the medical professionals, in relation to moral dilemmas that arise in real cases in the bioethical discourse. When faced with a consent form in an emergency situation, the family member's capacity to act is reduced, as he/she becomes enmeshed in the hospital structure of tacit, socially‐imposed rules. In a questionnaires based on a real death case in 2008, 70.9% of the surveyed medical professionals (n = 3,665) disagreed with performing surgery without the consent of the family even if the patient's life was in danger, while 36.6% of the surveyed patients (n = 1,198) hold the same position. This work demonstrates the weakness of the family consent process as a safeguard of patient's autonomy. Finally, I argue that saving the patient's life should be the overriding obligation rather than the respect for the surrogate's autonomous choice at such a decisive moment.     

The Double Helix: Applying an Ethic of Care to the Duty to Warn Genetic Relatives of Genetic Information

Genetic testing reveals information about a patient's health status and predictions about the patient's future wellness, while also potentially disclosing health information relevant to other family members. With the increasing availability and affordability of genetic testing and the integration of genetics into mainstream medicine, the importance of clarifying the scope of confidentiality and the rules regarding disclosure of genetic findings to genetic relatives is prime. The United Nations International Declaration on Human Genetic Data urges an appreciation for principles of equality, justice, solidarity and responsibility in the context of genetic testing, including a commitment to honoring the privacy and security of the person tested. Considering this global mandate and recent professional statements in the context of a legal amendment to patient privacy policies in Australia, a fresh scrutiny of the legal history of a physician's duty to warn is warranted. This article inquiries whether there may be anything ethically or socially amiss with a potential future recommendation for health professionals or patients to universally disclose particular cancer predisposition genetic diagnosis to genetic family members. While much of the discussion remains applicable to all genetic diagnosis, the article focuses on the practice of disclosure within the context of BRCA1/2 diagnosis. An ‘ethic of care’ interpretation of legal tradition and current practice will serve to reconcile law and medical policy on the issue of physician disclosure of genetic results to family members without patient consent.     

Withholding consent to lifesaving treatment: three cases.

The refusal of children or their parents to consent to treatment that professionals regard as essential always results in a dilemma. Responding to such refusals demands careful and sensitive clinical and thicolegal intervention and close cooperation among professionals, in particular doctors and social workers. Since the introduction of the Children Act 1989 the number of cases in which children have withheld consent to lifesaving treatment has risen, and it is now increasingly recognised that children have a right to have their views legally represented if a local authority or health authority seeks a court''s leave to carry out treatment. Professionals have to consider which legal route, under either the Children Act or the Mental Health Act, is likely to be best for the individual child.     

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research

BackgroundConducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials?MethodsIn a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature.ResultsBetween them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment.ConclusionsIn addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental ‘consent’ to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental ‘consent’ in a perinatal context, parents are authorising infant participation, not giving ‘proxy consent’. Finally, there are reasons for giving weight to both parental ‘consent’ and the infant’s best interests in both research and clinical treatment. However, there are also reasons to treat these factors differently in the two contexts, and this may be partly due to the differing relevance of risk in each case. A significant gap is the lack of any detailed discussion of a process of emergency and/or urgent ‘assent’, in which parents assent or refuse their baby’s participation as best they can during the emergency and later give full consent to continuing participation and follow-up.

Electronic supplementary material

The online version of this article (doi:10.1186/s13063-016-1562-3) contains supplementary material, which is available to authorized users.     

Recruitment to a prospective breast conservation trial: why are so few patients randomised?

OBJECTIVE--To investigate the rate of recruitment to early breast cancer trials and elucidate the reasons for ineligibility and refusal to participate among patients otherwise suitable for these trials. DESIGN--Prospective study of one year''s cohort of patients referred to a breast unit with special reference to the subgroup suitable for conservation management and to the proportion eligible for and (after informed consent) ultimately randomised within the Scottish early breast cancer trials. SETTING--The breast unit, Longmore Hospital, Edinburgh, during 1988. PATIENTS--All 3054 patients referred to the breast unit during the year. 324 Found to have invasive breast cancer and 147 initially thought suitable for conservation management. RESULTS--63 Patients were treated by mastectomy, 19 of whom requested mastectomy rather than conservation management. 84 Patients were excluded from trials, and of the 63 eligible patients, 40 gave informed consent. Most of the 23 patients who refused the trials requested a specific adjuvant treatment after discussion of their management and the trials. CONCLUSIONS--Recruitment to prospective trials in which informed consent is required before randomisation may be slower than predicted because of a high proportion of exclusions and also refusal by patients. Trials may therefore take longer to complete and give distorted results by virtue of the unpredictable nature of the selection of patients.     

Trouble in the Gap: A Bioethical and Sociological Analysis of Informed Consent for High-Risk Medical Procedures

Concerns are frequently raised about the extent to which formal consent procedures actually lead to “informed” consent. As part of a study of consent to high-risk medical procedures, we analyzed in-depth interviews with 16 health care professionals working in bone-marrow transplantation in Sydney, Australia. We find that these professionals recognize and act on their responsibility to inform and educate patients and that they expect patients to reciprocate these efforts by demonstrably engaging in the education process. This expectation is largely implicit, however, and when it is not met, this can give rise to trouble that can have adverse consequences for patients, physicians, and relationships within the clinic. We revisit the concept of the sick role to formalize this new role expectation, and we argue that “informed” consent is a process that is usually incomplete, despite trappings and assumptions that help to create the illusion of completeness.     

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.     

The challenge of cross-cultural clinical trials research: case report from the Tibetan Autonomous Region, People's Republic of China

Efforts to conduct Western clinical research in non-Western medical settings with little or no familiarity with such methodologies are on the rise, but documented accounts of the ways that biomedical science requires negotiation and translation across cultures are not plentiful. This article adds to this literature through analysis of an NICHD-funded collaborative research effort in women's health carried out in the Tibetan Autonomous Region of the People's Republic of China. The research involved a feasibility study for an eventual clinical trial comparing Tibetan medicine with misoprostol for preventing postpartum hemorrhage in delivering women. It explores strategies of negotiation and translation in and around notions of the scientific method, informed consent procedures, randomization, blinding, placebo, and concepts of medical standardization.     

Paternalism and certitude

When paternalism is deemed morally justified, weak paternalism—which restricts itself to assisting the target of paternalism realize his own preferences—is the preferred (less problematic) alternative. In determining the appropriateness of weak paternalism, the level of certitude of the paternalist regarding the correctness of her assessment of the true preferences of the one-paternalized is obviously a crucial factor. Yet in the ethics of paternalism this parameter has escaped systematic treatment. This paper aims to initiate discussion on this indispensable consideration for weak paternalism. Analysing a real-life dilemma of paternalism in healthcare, the paper focuses on the theoretical question of how the paternalist can optimize her certitude by combining personal knowledge of the individual patient with population data on treatment refusal/consent of patients facing similar decisions. The paper presents an outline of a decision-making scheme that can be valuable in medical ethics and beyond.     

Clinical and personal utility of genomic high-throughput technologies: perspectives of medical professionals and affected persons

In the evaluation of genomic high-throughput technologies, the idea of “utility” plays an important role. The “clinical utility” of genomic data refers to the improvement of healthcare outcomes, its “personal utility” to benefits that go beyond healthcare purposes. Both concepts are contested. Moreover, there are only few empirical insights regarding their interpretation by those professionally involved or personally affected. Our paper presents results from qualitative research (20 semi-structured interviews) regarding professionals’ and personally affected people’s views on the utility of genomic information. We find that the discussion of clinical utility is the domain of professionals who primarily consider aspects of test validity and clinical outcomes. By contrast, personal utility plays a prominent role in affected persons’ discussions. Four different aspects are addressed: (a) life and family planning, (b) relief and justification, (c) self-knowledge and self-determination, and (d) entertainment. These differences have important implications for informed consent and counseling in the context of genomic high-throughput technologies.     

Can children withhold consent to treatment?

A dilemma exists when a doctor is faced with a child or young person who refuses medically indicated treatment. The Gillick case has been interpreted by many to mean that a child of sufficient age and intelligence could validly consent or refuse consent to treatment. Recent decisions of the Court of Appeal on a child''s refusal of medical treatment have clouded the issue and undermined the spirit of the Gillick decision and the Children Act 1989. It is now the case that a child patient whose competence is in doubt will be found rational if he or she accepts the proposal to treat but may be found incompetent if he or she disagrees. Practitioners are alerted to the anomalies now exhibited by the law on the issue of children''s consent and refusal. The impact of the decisions from the perspectives of medicine, ethics, and the law are examined. Practitioners should review each case of child care carefully and in cases of doubt seek legal advice.     

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。     

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.     

A CMA position. Acquired immunodeficiency syndrome.

The following general principles serve as guidelines for various bodies, health care professionals and the general public. Specific aspects of infection with human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) that relate to physicians'' ethical responsibilities as well as society''s moral obligations are discussed. Such matters include the need for education, research and treatment resources; the patient''s right to investigation and treatment and to refusal of either; the need to obtain the patient''s informed consent; the right to privacy and confidentiality; the importance of infection control; and the right to financial compensation in the case of occupational exposure to HIV.