Informed Consent: Autonomy and Self-Ownership

abstract    Using the example of an unconsented mouth swab I criticise the view that an action of this kind taken in itself is wrongful in respect of its being a violation of autonomy. This is so much inasmuch as autonomy merits respect only with regard to 'critical life choices'. I consider the view that such an action is nevertheless harmful or risks serious harm. I also respond to two possible suggestions: that the action is of a kind that violates autonomy; and, that the class of such actions violates autonomy. I suggest that the action is wrongful in as much as it is a bodily trespass. I consider, and criticise, two ways of understanding how morally I stand to my own body: as owner and as sovereign. In respect of the latter I consider Arthur Ripstein's recent defence of a sovereignty principle. Finally I criticise an attempt by Joel Feinberg to explain bodily trespass in terms of personal autonomy.     

Obstetric Autonomy and Informed Consent

I argue that public officials and health workers ought to respect and protect women’s rights to make risky choices during childbirth. Women’s rights to make treatment decisions ought to be respected even if their decisions expose their unborn children to unnecessary risks, and even if it is wrong to put unborn children at risk. I first defend a presumption of medical autonomy in the context of childbirth. I then draw on women’s birth stories to show that women’s medical autonomy is often ignored during labor. Medical interventions are performed during childbirth without women’s consent. Childbirth is risky and some coercive medical interventions may be understood as attempts to protect children and to prevent mothers from acting impermissibly. However, even if it is wrong to make risky choices during childbirth, women have rights to do wrong in these cases. Therefore, coercive medical interventions are impermissible during childbirth and institutions should adopt specific protections for obstetric autonomy.     

Informed Consent and the Requirement to Ensure Understanding

It is generally held that doctors and researchers have an obligation to obtain informed consent. Over time there has been a move in relation to this obligation from a requirement to disclose information to a requirement to ensure that that information is understood. Whilst this change has been resisted, in this article I argue that both sides on this matter are mistaken. When investigating what information is needed for consent to be informed we might be trying to determine what information a person would need in order to consent at all, or we might be trying to determine what information a person needs in order to make an informed choice about whether or not to consent. I argue that the obligation to ensure understanding only applies to information generated by the first type of enquiry; but that much of the information generally thought necessary in order for consent to be informed is only required if our concern is with the second type of enquiry. For this reason it is neither the case that doctors and researchers should ensure all the information they provide is understood, nor is it the case that their only obligation is to disclose it.     

正确理解知情同意

知情同意最初由美国于18世纪末19世纪初提出,随着社会不断进步,医学科学的不断发展,人们权力意识的不断增强,知情同意作为患者享有的一项权力,医务人员在医疗过程中应遵循的一条原则已日益到人们的关注。然而在现实的医疗实践中人们对这一的理解和认识还存在一定的偏差。正确理解,践行知情同意既是尊重患者的权利,贯彻“以病人为中心”的原则的保证,也能有效地保护医务人员的合法权益。     

Participants' Understanding of the Process of Psychological Research: Informed Consent

Sixty-five undergraduates participating in a wide range of psychological research experiments were interviewed in depth about their research experiences and their views on the process of informed consent. Overall, 32% of research experiences were characterized positively and 41 % were characterized negatively. One major theme of the negative experiences was that experiments were perceived as too invasive, suggesting incomplete explication of negative aspects of research during the informed consent process. Informed consent experiences were viewed positively 80% of the time. However, most of the participants had a limited view of the purpose of informed consent: Less than 20% viewed the process as a decision point. Results suggest a number of common pitfalls to standard informed consent practices that have not generally been recognized. Results are discussed in terms of both ethical and methodological implications. Suggestions for improving the informed consent process are also provided.     

对知情同意书和知情同意过程的探讨

在《医疗事故处理条例》实施中,存在着一种现象:重视一张由患者签字的知情同意书,轻待知情同意过程。签字的知情同意书不等于知情同意,知情同意书不等于“生死契约”。知情同意的本义:对患者权利、尊严、人格和自由的尊重,只有在知情同意过程中获得。因此知情同意过程应该重要于知情同意书。医生严格履行好法定的告知和说明义务,尊重患者的知情同意权,就是尊重法律,也是医生保护自己的最好方式。     

对知情同意书和知情同意过程的探讨

在<医疗事故处理条例>实施中,存在着一种现象:重视一张由患者签字的知情同意书,轻待知情同意过程.签字的知情同意书不等于知情同意,知情同意书不等于"生死契约".知情同意的本义:对患者权利、尊严、人格和自由的尊重,只有在知情同意过程中获得.因此知情同意过程应该重要于知情同意书.医生严格履行好法定的告知和说明义务,尊重患者的知情同意权,就是尊重法律,也是医生保护自己的最好方式.     

Steven Wear,Informed Consent: Patient Autonomy and Clinician Beneficence Within Health Care

Theoretical Medicine and Bioethics -     

知情同意:从纽伦堡到赫尔辛基

知情同意被视为临床伦理学与研究伦理学的基本原则.大量的文献倡导提高同意的必要条件.据说,同意应当更加明确、具体.经验主义的证据显示,满足任何一方标准是极其困难的,有时是不可能的,因此,这些目标很难行得通.倡导知情同意不实际与不可能的要求,有极小的价值.讨论告知不能作为临床伦理学与研究伦理学的基本标准,知情同意可以最好视为病人与受试者以及其他人所能选择性放弃其他的义务,而不采取侵害性行为的一种方法.它提供了一种调节根本的义务的重要方式,这一义务是由尊重真正执行同意所需要的伦理标准与认识力的双方提供.     

知情同意：从纽伦堡到赫尔辛基

知情同意被视为临床伦理学与研究伦理学的基本原则。大量的文献倡导提高同意的必要条件。据说,同意应当更加明确、具体。经验主义的证据显示,满足任何一方标准是极其困难的,有时是不可能的,因此,这些目标很难行得通。倡导知情同意不实际与不可能的要求,有极小的价值。讨论告知不能作为临床伦理学与研究伦理学的基本标准,知情同意可以最好视为病人与受试者以及其他人所能选择性放弃其他的义务,而不采取侵害性行为的一种方法。它提供了一种调节根本的义务的重要方式,这一义务是由尊重真正执行同意所需要的伦理标准与认识力的双方提供。     

Facilitating Informed Consent: A Multicultural Perspective

Respect for the dignity and autonomy of patients has long been a fundamental principle of ethical decision making. As a practical matter, a primary way of maintaining this ethical standard is by obtaining an individual’s informed consent prior to intervening or collecting data. By giving individuals clear information about alternative treatments and potential risks and benefits, the practitioner tries to ensure that the patient can make an informed choice. However, there are cases in which those seeking informed consent have very different values and belief systems from those whose consent is being sought. In this article we explore such discrepancies using informed consent with Navajo clients as an example, illustrate potential challenges with case examples, and propose ways in which ethical dilemmas may be successfully navigated.     

医疗人工智能对知情同意的挑战与应对

目前在辅助诊断、辅助治疗方面,人工智能技术取得了较大进展,但是医疗人工智能对知情同意带来了诸多新问题：弱人工智能的黑箱属性不突出,患者对医疗人工智能决策过程的知情可以用对临床试验结果等的知情以及其他严格管理措施去间接地实现;强人工智能需要提高可解释性或以其他方式应对黑箱问题。因额外风险的存在,在使用医疗人工智能时,医方应增加患者知情同意的内容,并利用人工智能应对知情同意的形式主义问题。医方还应在必要时特别说明诊疗主体与责任主体。医疗人工智能处理患者个人信息时亦需严守知情同意原则。