Paying for informed consent

The Japanese Ministry of Health and Welfare has implemented a policy of paying physicians to explain the nature of the patient's medical condition and the treatment plan. We describe the precepts of this policy and examine ethical dimensions of this development. We question whether this policy will be sufficient to ensure patients will have the opportunity to become informed participants in medical decision making. The policy also raises a broader philosophical question as to whether informed consent is a fundamental ethical requirement of all doctor-patient encounters or an option that can be exercised by physicians for financial gain. The impact of this policy in Japan merits continued observation from abroad.     

实施知情同意构建医患和谐

实施知情同意旨在有效地保护患者的合法权益不受侵犯,同时也是缓解医患关系,减少医疗纠纷的有效手段.我院在医疗行为中,通过落实医患沟通制度,尊重患者知情同意权,增进了医患信任,促进了医院发展,构建了医患和谐.     

Beyond informed consent: the therapeutic misconception and trust

The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degree, this confusion invalidates the consent of subjects. We argue here that this focus on the understanding component of informed consent, while important, might be too narrow to capture the ethical complexity of the therapeutic misconception. We show that concerns about misplaced trust and exploitation of such trust are also relevant, and ought to be taken into account, when considering why the therapeutic misconception matters ethically.     

Autonomy and negatively informed consent

The requirement of informed consent (IC) to medical treatments is almost invariably justified with appeal to patient autonomy. Indeed, it is common to assume that there is a conceptual link between the principle of respect for autonomy and the requirement of IC, as in the influential work of Beauchamp and Childress. In this paper I will argue that the possible relation between the norm of respecting (or promoting) patient autonomy and IC is much weaker than conventionally conceived. One consequence of this is that it is possible to exercise your autonomy without having the amount of and the kind of information that are assumed in the standard requirement of IC to medical treatments. In particular, I will argue that with a plausible conception of patient autonomy, the respect for and the promotion of patient autonomy are in certain circumstances better protected by giving patients the right to give their negatively informed consent to medical treatments.     

Professional-patient relationships and informed consent

Four theoretical ethical perspectives on professional-patient relationships-autonomy, justice, virtue ethics, and the ethic of care-are surveyed, and some of their implications for the informed consent requirement in health care are sketched out. The practical issues of competence to consent, adequate information, and voluntariness are reviewed, and examples are given of the ways in which the theoretical perspectives outlined earlier might inform practice in areas such as these. Finally, the situation of patients not competent to consent is considered in the light of the same theoretical perspectives.     

Acupuncture trials and informed consent

Participants are often not informed by investigators who conduct randomised, placebo-controlled acupuncture trials that they may receive a sham acupuncture intervention. Instead, they are told that one or more forms of acupuncture are being compared in the study. This deceptive disclosure practice lacks a compelling methodological rationale and violates the ethical requirement to obtain informed consent. Participants in placebo-controlled acupuncture trials should be provided an accurate disclosure regarding the use of sham acupuncture, consistent with the practice of placebo-controlled drug trials.     

On the Ottoman consent documents for medical interventions and the modern concept of informed consent

Information for patients prior to medical intervention is one of the principles of modern medical practice. In this study, we looked at an earlier practice of this principle. Ottoman judges had record books called sicil. One of the categories in sicils was the consent documents called riza senedi, which was a patient-physician contract approved by the courts. These contracts were especially for the protection of physicians from punishment if the patient dies. It is not clear whether patients were informed properly or not. Consent for minors was obtained from parents. However, a situation where an adult does not have the capacity to consent, was not clear in these documents. Any sign of free withdrawal of consent was not found in these records. Due to the legal system of Ottoman State, these contracts were related to Islamic law rather than modern civil law. We aim, in this paper, to present a legal practice, which is possible to consider as an early example of the informed consent practice.     

Clinicians' knowledge of informed consent

OBJECTIVE: To audit doctors' knowledge of informed consent. DESIGN: 10 consent scenarios with "true", "false", or "don't know" answers were completed by doctors who care for children at a large district general hospital. These questions tested clinicians' knowledge of who could give consent in different clinical situations. SETTING: Royal United Hospital, Bath, UK. RESULTS: 51 doctors participated (25 paediatricians and 26 other clinicians). Paediatricians scored higher than other clinicians (average correct response 69% v 49%). Only 36% (9/25) of paediatricians and 8% (2/26) of other clinicians realised that the biological father of a child born before 1 December 2003 needed a court order or a parental responsibility agreement to acquire parental responsibility, and thus be able to consent on behalf of his child, if he was not married to the child's mother. Non-paediatric clinicians were unsure or incorrect when tested on situations where people with parental responsibility do not agree, or where young people (<16 years), who are Fraser competent do not want to consult their parents. Most clinicians did not know that the parents of a 20-year-old man with severe learning difficulties are unable to consent to surgery on his behalf, and many non-paediatricians were unclear on who could give consent when a child lived with foster parents. CONCLUSION: Clinicians who obtain consent for the treatment of children need to increase their knowledge on who is able to give informed consent to ensure best (legal and safe) practice.     

The battering of informed consent

Autonomy has been hailed as the foremost principle of bioethics, and yet patients' decisions and research subjects' voluntary participation are being subjected to frequent restrictions. It has been argued that patient care is best served by a limited form of paternalism because the doctor is better qualified to take critical decisions than the patient, who is distracted by illness. The revival of paternalism is unwarranted on two grounds: firstly, because prejudging that the sick are not fully autonomous is a biased and unsubstantial view; secondly, because the technical knowledge of healthcare professionals does not include the ethical qualifications and prerogative to decide for others.Clinical research settings are even more prone to erode subjects' autonomy than clinical settings because of the tendency and temptation to resort to such practices as shading the truth when consent to participation is sought, or waiving consent altogether when research is done in emergency settings.Instead of supporting such dubious practices with unconvincing arguments, it would seem to be the task of bioethics to insist on reinforcing autonomy.     

Some limits of informed consent

Many accounts of informed consent in medical ethics claim that it is valuable because it supports individual autonomy. Unfortunately there are many distinct conceptions of individual autonomy, and their ethical importance varies. A better reason for taking informed consent seriously is that it provides assurance that patients and others are neither deceived nor coerced. Present debates about the relative importance of generic and specific consent (particularly in the use of human tissues for research and in secondary studies) do not address this issue squarely. Consent is a propositional attitude, so intransitive: complete, wholly specific consent is an illusion. Since the point of consent procedures is to limit deception and coercion, they should be designed to give patients and others control over the amount of information they receive and opportunity to rescind consent already given.