论知情同意的中国本土化--中国文化视野中的知情同意走向

知情同意原产于西方,移植到中国后被"家文化"、"功利论"、"简单化"等中华传统文化彻底改造过以后,浓缩成了手术前一味要求病人家属或单位领导签字的行为模式,远离了知情同意的主旨,但曾一度非理性地普遍流行.现在,又出现了一种照搬欧美知情同意的倾向,在一线医务人员中引发了诸多困惑和不满.在实施知情同意时,离开中华文化语境,或者在本土化中化掉其本质的做法,都是不可行的.正确的取向只能是立足于中国当代医学实践,以正在形成中的中国现代文化去整合西方知情同意的本质、理念和规范,构建成一套适合中国国情的知情同意机制.     

纸质与视频补充材料对手术知情同意体验的影响：以腹腔镜胆囊切除手术为例

知情同意书在医患沟通中起着间接传递信息的重要作用。以159名大学生为被试,通过操纵不同的知情同意方式,考察了纸质或视频补充信息对患者知情同意满意度、理解程度以及患者信息需求的满足程度影响。结果发现,接受纸质补充知情同意或视频补充知情同意的被试对知情同意过程的满意度、对手术信息的理解程度与知情同意信息需求的满足程度显著高于接受普通知情同意的被试。同时,纸质补充知情同意使得“治疗信息需求的满足程度”最高。这表明,纸质补充知情同意更能满足患者对治疗信息的需求。     

Informed Consent: An Ethical Issue in Conducting Research with Male Partner Violent Offenders

Ethical codes help guide the methods of research that involves samples gathered from “at-risk” populations. The current article reviews general as well as specific ethical principles related to gathering informed consent from partner violent offenders mandated to outpatient treatment, a group that may be at increased risk of unintentional coercion in behavioral sciences research due to court mandates that require outpatient treatment without the ethical protections imbued upon prison populations. Recommendations are advanced to improve the process of informed consent within this special population and data supporting the utility of the recommendations in a sample 70 partner violent offenders are provided. Data demonstrate that participants were capable of comprehending all essential elements of consent.     

On the Prospects of Collective Informed Consent

abstract    It has been suggested that collective informed consent procedures could be used in solving moral problems arising in connection with such collective arrangements as land use planning, business administration, and developing new technology. Critics have however argued that informed consent is not an appropriate method for collective moral decision-making for three reasons. Firstly, informed consent procedures only allow the affected parties to choose between rejecting and accepting certain predetermined options, while those parties should be allowed to take part in the decision-making process as a whole. Secondly, identifying the parties whose informed consent should be sought would in many cases be problematic. Thirdly, informed consent is a veto power concept, and granting all parties affected by a collective arrangement veto power as to its completion would make taking such collective action extremely difficult. In this article, it is argued that these criticisms do not undermine collective informed consent.     

Audit of the Informed Consent Process as a Part of a Clinical Research Quality Assurance Program

Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.     

从辅助生殖技术的个案析要论知情同意的完善

结合在人类辅助生殖技术服务过程中发生的案例进行分析,就如何完善知情同意提出了一些见解。认为,医疗技术服务中,知情同意的完善必须注重两个环节,知情同意过程和签署知情同意书。这两个环节必须根据具体情况来进行实施,绝不能敷衍走过场。因此,相关医生对知情同意的认识和伦理监督就显得尤为重要。     

Stakeholders’ Opinions on the Implementation of Pediatric Whole Exome Sequencing: Implications for Informed Consent

Advances in whole genome and whole exome sequencing (WGS/WES) technologies have led to increased availability in clinical settings. Currently, there are few guidelines relating to the process and content of informed consent for WGS/WES, nor to which results should be returned to families. To address this gap, we conducted focus groups to assess the views of professionals, parents, and adolescents for the future implementation of WES. The discussions assessed understanding of the risks and benefits of WES, preferences for the informed consent discussion, process for return of results, and the decision-making role of the pediatric patient. Professional focus group participants included bioethicists, physicians, laboratory directors, and genetic counselors. Parent focus groups included individuals with children who could be offered sequencing due to a potential genetic cause of the child’s condition. On-line discussion groups were conducted with adolescents aged 13–17 who had a possible genetic disorder. We identified discrepancies between professionals and patient groups regarding the process and content of informed consent, preference for return of results, and the role of the child in decision-making. Professional groups were concerned with the uncertainty regarding professional obligations, changing interpretation in genomic medicine, and practical concerns of returning results over time. Parent and adolescent groups focused on patient choice and personal utility of sequencing results. Each group expressed different views on the role of the child in decision-making and return of results. These discrepancies represent potential barriers to informed consent and a challenge for genetic counselors regarding the involvement of pediatric patients in decision-making and return of results discussions.     

医患不同角色群体对患者知情同意权的态度研究进展

概述目前国内外关于医患不同角色群体对患者知情同意权的态度的研究状况。现有的研究重点是关于癌症患者和精神分裂症患者的知情同意权问题,研究结果表明,患者、家属、医务人员三个不同角色群体的认知和态度存在明显差异;对普通疾病患者的知情同意权的认知和态度问题,目前国内尚缺乏比较全面系统的研究。     

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。     

Hide-and-seek or show-and-tell? Emerging issues of informed consent

This article reviews key philosophical and legal underpinnings of mental health professionals' obligation to obtain informed consent from consumers of their services. The basic components of informed consent are described, and strategies for clinically and ethically appropriate methods of obtaining informed consent are discussed. Emerging issues in informed consent involving duty to assess and protect against client dangerousness, obligations to third parties, and issues of deception are considered as well. The article proposes that part of the process of obtaining informed consent is the cultivation of a treatment environment that emphasizes beneficence and client autonomy.     

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.     

Rethinking research ethics

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research.     

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.     

Rethinking research ethics

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research.     

Black Boxing Restraints: The Need for Full Disclosure and Consent

In this article we discuss the necessity of fully informing patients and their families of what constitutes physical interventions and their attendant risks under the established principles and obligations of informed consent. After a brief review of the elements of informed consent and the nature of the duty to advise patients and their families of treatment risks, we argue that physical interventions are an unvalidated treatment for aggressive and violent behavior and should be used only as a safety intervention. We focus our discussion on the informed consent issues for school aged children, adolescents, and emancipated minors and contend that if restraints are used they must pose less risk than the behavior they are trying to alleviate. We also opine that if restraints are misused by mental health or child welfare treatment settings, then their misuse may be considered a subject of a patient maltreatment, abuse, criminal or civil action. A central thesis of the article is that informed consent must be seen as an integral and dynamic process of treatment. We recommend strategies that gain parental permission and child assent, that view informed consent as a dynamic and individualized process that aids and supports the therapeutic relationship, and that stress the importance of simplicity and clarity.     

Malpractice Arising From Negligent Psychotherapy: Ethical,Legal, and Clinical Implications of Osheroff v. Chestnut Lodge

This article reviews key philosophical and legal underpinnings of mental health professionals' obligation to obtain informed consent from consumers of their services. The basic components of informed consent are described, and strategies for clinically and ethically appropriate methods of obtaining informed consent are discussed. Emerging issues in informed consent involving duty to assess and protect against client dangerousness, obligations to third parties, and issues of deception are considered as well. The article proposes that part of the process of obtaining informed consent is the cultivation of a treatment environment that emphasizes beneficence and client autonomy.     

Informed consent and the use of placebo in poland: Ethical and legal aspects

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.     

Defining and Delineating a Duty to Prognosticate

Prognostication, the process offormulating and communicating a prognosis, isno longer considered by most physicians to bean essential task in caring for patients withserious illness. Because of this fact, it isnot surprising to find that when physiciansattempt to engage in prognostication, they doit poorly. What may be surprising to thoseoutside the medical community is the extent towhich professional norms have developed whichactively discourage physicians from engaging inprognostication. This article explores thecauses of this state of affairs and thejustifications offered for it. The conclusionis reached that physicians have a professionalresponsibility to competently engage inprognostication based upon the doctrine ofinformed consent, and that a failure or refusalto do so has not only potential legalramifications, but serious negativeimplications for many of the core issues inbioethics, such as the use of advancedirectives, palliative medicine, and medicalfutility.     

Informed Consent

Summary

This article focuses on informed consent and the components to be reviewed with clients in the first session or as early as possible thereafter. Recent changes that give patients greater autonomy in the treatment process are also presented. The process of obtaining informed consent or informed refusal places a new responsibility on the practitioner. Informed consent as it pertains to clinical practice, supervision and training, and psychological research is also discussed.     

The emerging debate over the shape of informed consent: can the doctrine bear the weight?

Informed consent has traditionally focused on treatment-related issues. However, since the mid-1990s, courts have debated whether informed consent should be stretched to accommodate other concerns. For example, some courts have considered whether economic limitations on treatment availability must be made known to a patient as part of the informed consent process. Other courts have considered whether characteristics of the treatment provider (e.g., experience with a particular procedure) should be disclosed as part of informed consent. Consideration of these issues turns in large part on whether the information in question would be considered "material" to a decision to accept or reject treatment. This article discusses these developments, and suggests that expanding informed consent beyond treatment-related issues in some circumstances may erode trust in the clinical relationship, thus undermining one of the central values of the informed consent doctrine. It concludes with some suggestions on how research could inform this debate.