Consent in escrow

Disasters such as flash flooding, mass shootings, and train and airplane accidents involving large numbers of victims produce significant opportunity for research in the biosciences. This opportunity exists in the extreme tails of life events, however, during which decisions about life and death, valuing and foregoing, speed and patience, trust and distrust, are tested simultaneously and abundantly. The press and urgency of these scenarios may also challenge the ability of researchers to comprehensively deliver information about the purposes of a study, risks, benefits, and alternatives. Under these circumstances, we argue that acquiring consent for the immediate use of data that are not time sensitive represents a gap in the protection of human study participants. In response, we offer a two-tiered model of consent that allows for data collected in real-time to be held in escrow until the acute post-disaster window has closed. Such a model not only respects the fundamental tenet of consent in research, but also enables such research to take place in an ethically defensible manner.     

The most plausible pro-coercion view: requiring informed agreement while penalizing non-participation in research

In ‘(Why) should we require consent to research?’ Alan Wertheimer probes whether it is legitimate for the government to ‘coerce’ people into participating in biomedical research, including interventional biomedical research. In debating the rules that ought to govern participation in interventional biomedical research, we should distinguish two separate moral claims. First, interventional research should proceed only when the subject has given her informed agreement. Second, it is legitimate for the state to set a requirement that people participate in interventional biomedical research, and to penalize or punish those who refuse to participate. The most plausible ‘pro-coercion’ view accepts both of these claims. Though I stop short of endorsing this view, it captures important ‘pro-coercion’ and ‘anti-coercion’ intuitions.     

人脸识别技术中的个人信息保护——兼论动态同意模式的建构

人脸识别技术在现有应用场景中已经被证明了其便捷性和高效性,但是,围绕该技术自身准确性、安全性、伦理性和合法性等问题的争议也从未停息。2020年我国"人脸识别第一案"引发公众及学界关注与讨论,急需在快速扩散的技术应用中,寻找信息法益保护模式。完善人脸识别技术中个人信息保护模式的可能性如下:第一,坚持"合法、正当、必要"原...     

论知情同意的豁免

本文围绕医疗实务中的知情同意豁免，首先讨论了知情同意豁免规则的法律政策，详细分析了紧急情形豁免、治疗豁免、知情同意权的放弃和强制治疗这四种豁免情形，简述了医务人员在适用知情同意豁免规则时可能的法律责任。     

论法医临床鉴定中被鉴定人的知情同意权

临床医学中的知情同意权是医学实践中由基本伦理上升为受法律保障的患者权利,通过告知同意书的契约形式表达。法医临床鉴定中的被鉴定人与医疗体系中的患者具有类似的法律地位,但尚无相应的法律法规赋予被鉴定人知情同意权。笔者建议法医临床学鉴定中可赋予被鉴定人一定的知情同意权,在与鉴定机构的契约化关系下,参与鉴定过程,知悉必要的鉴定信息,并对鉴定意见有选择性同意权,从而实现司法鉴定程序的公平、正义。     

Assessment of the Capacity to Express Informed Consent for Organ Donation in Patients with Schizophrenia

Abstract: In Italy, the “silent‐consent” principle of donor’s willingness regulates organ donation for postmortem transplantation, but civil incompetence excludes it. We investigated decisional capacity for organ donation for transplantation of 30 controls and 30 nonincompetent patients with schizophrenia as related to clinical symptoms, cognition, and functioning. Assessments were carried out through the Competence for Donation Assessment Scale (CDAS), Brief Psychiatric Rating Scale (BPRS), Scale for the Assessment of Positive Symptoms (SAPS), Scale for the Assessment of Negative Symptoms, Life Skills Profile (LSP), Raven’s Colored Progressive Matrices (RCPM), Wisconsin Card Sorting Test, Rey RI, Rey RD, and Visual Search. Patients and controls differed on the CDAS Understanding and Choice Expression areas. Patients showed significant inverse bivariate correlations between CDAS Understanding and scores on total BPRS, LSP self‐care scale, and RCPM cognitive test. Our results show that decisional capacity for participating in research does not predict decisional capacity for postmortem organ donation in patients with schizophrenic or schizoaffective psychosis; hence, before judging consent for donation, patients must be provided with enhanced information to better understand this delicate issue.     

论医疗知情同意理论

知情同意作为一项有利于实现医疗目的的私法原则,具有其独立的利益设计和价值取向。告知说明义务的履行是实现知情同意原则的前提,而知情同意理论的要件是具体落实知情同意原则的关键,其中判断患者是否具备同意能力是知情同意的重要因素。但在适用知情同意原则时应注意识别几种例外情势。为了切实保障知情同意原则的实现,减少和防范医疗纠纷的发生,构建和谐的医患关系,有必要进一步完善我国知情同意理论体系。     

(Why) should we require consent to participation in research?

It is widely accepted that informed consent is a requirement of ethical biomedical research. It is less clear why this is so. As an argumentative strategy the article asks whether it would be legitimate for the state to require people to participate in research. This article argues that the consent requirement cannot be defended by appeal to any simple principle, such as not treating people merely as a means, bodily integrity, and autonomy. As an argumentative strategy the article asks whether it would be legitimate for the state to require people to participate in research. I argue that while it would be legitimate and potentially justifiable to coerce people to participate in research as a matter of first-order moral principles, there are good reasons to adopt a general prohibition on coercive participation as a matter of second-order morality.     

Public preferences and the challenge to genetic research policy

Modern genetic research requires scientists to collect, store, and study DNA samples and health information from thousands of people. Longstanding policy allows researchers to use samples and information without a person''s informed consent as long as the person''s identity is protected. Under existing policy, researchers must neither disclose study results to interested research participants nor compensate people who contribute to genetic research. Research and ethics experts developed these policy approaches without input from the people whose contributions are essential to the genetic research enterprise. A growing body of evidence shows that many research participants and would-be participants disagree with the current policy approaches. For ethical and practical reasons, participants should have a greater role in determining how genetic research is conducted.     

《侵权责任法》中患者近亲属知情同意评析

《侵权责任法》在患者知情同意制度中使用了“近亲属”这一概念,并在第五十五条提出：“不宜向患者说明的,应当向患者的近亲属说明。”此提法不仅与国外“病人自治”原则存有差异,而且“近亲属”这一概念范围也不明确。本文拟对第五十五条立法中所体现的“近亲属知情同意”的合理性以及“近亲属”这一概念使用的恰当性进行探讨。     

论遗传资源获取与惠益分享中的事先知情同意制度

为了应对遗传资源利用中的"生物剽窃"现象,对遗传资源的获取与惠益分享进行有效管制,1992年《生物多样性公约》借鉴其他领域的成功经验,引入了事先知情同意的程序制度,并为各国建立国家与利益相关者的双重事先知情同意制度确立了国际法框架。事先知情同意要求遗传资源获取申请者应在其生物开发活动开展之前的合理期限内寻求相关主体的同意,在这段时间内相关主体可以根据获取申请者以合理方式提供的信息做到全面知情,并以特定格式就获取申请者的获取与惠益分享安排作出明确的、肯定的授权。     

Intoxicated Consent in Rape: Bree and Juror Decision-Making

The article examines the recent Court of Appeal judgment in Bree, in which the court considered the guidance that should be given to a jury when the complainant is intoxicated at the time of an alleged rape. As well as analysing the reasoning of the court in Bree, the judgment is placed in context by examining factors, such as social attitudes, that influence juror decision-making in rape cases. It also examines the suggestion made by the court in Bree that further law reform in this area would represent 'patronising interference' in the lives of women.     

知情同意诉讼中的证据学:英美法的观察

在传统的医疗过失侵权诉讼中,为了体现行外人士对医疗这一专家型行业的尊重,医疗专家证言在诉讼中发挥着重要的甚至决定性的作用。知情同意诉讼,虽被归入医疗过失侵权诉讼,却提供了一个不同于传统的医疗领域——诊断治疗——的情景。知情同意的独特性改变了专家证言在诉讼中的格局。在知情同意诉讼中,医疗专家证言的参与度和重要性遭到削弱。以患者为取向的信息披露标准的建立意味着法律的关注点已从"专家"整体转移到"患者";对"医学判断"所管辖领域的精细分割也说明,医疗专家证言只应在证明医疗信息的感知和启用"医疗特权"上有应用价值,医疗信息的实质性判断已让位于一般人知识,而且对"医疗特权"的严格控制会缩减医疗专家证言的适用空间;因果关系的认定和选择影响到医疗专家证言和患者证言的地位变化,尽管存在"事后诸葛"效应,为了与知情同意法则之主旨相匹配,主观化的因果关系应是前进方向。     

论有限责任公司股东的同意权与优先购买权

《公司法》第35条对有限责任公司股权的向外转让规定其他股东的同意权和优先购买权,以期作为限制。但实践中关于如何理解该条的限制颇有歧义。要正确地理解该条,必须在澄清法条含义的基础上,理顺有限责任公司对外转让股权的规范。由于同意权纯粹只起到摆设的作用,故应该废除同意权,同时完善优先购买权,更好地协调有限责任公司的人合性与资合性。     

论认罪认罚程序中的被追诉人同意

在我国,认罪认罚并非控辩协商的结果,而是被追诉人对指控事实、量刑建议及程序适用的同意。将认罪认罚界定为同意的价值有三:凸显被追诉人的诉讼主体地位;维护被追诉人的合法利益;增强被追诉人应对多元复杂程序的能力。被追诉人有效同意需要同时具备四个要件:一为同意能力,被追诉人应当具有理解、评判、决策与沟通能力;二为知情同意,被追诉人的同意应当建立在对案件信息的全面了解与掌握之上;三为自愿同意,被追诉人认罪认罚的意思表示应当是自由作出的;四为同意意向性,被追诉人认罪认罚的意向在于获得从宽处理。以此标准审视,为保障被追诉人同意有效性,尚需要从三个方面进行调整与完善:进一步规范检察机关的权利告知程序;在审查起诉环节建构证据开示程序;为值班律师提供更为宽松、便利的履职环境。     

论医疗告知义务——以经济学和法学为视角

医疗告知是医疗单位在医疗过程中的一项法定义务,是以患者知情同意权为其理论基础,是判定医疗行为是否存在过失的一项重要标准。我国目前医疗实践中医疗纠纷频发的主要原因在于我国医疗告知义务立法不完善以及学界对医疗告知义务研究甚少。文章以经济学和法学为视角,从医疗告知义务之经济学基础、医疗告知义务之法学基础、医疗告知义务之履行及其评判标准等方面,结合我国立法现状,就医疗告知义务进行了深入研究,以期为我国医疗实践和司法实践提供理论根据。     

病人家属参与医疗决定之法律研究

在我国目前的收入结构与医疗体制之下,对于大多数人而言,一旦面对大的病患风险,家属往往是其医疗成本以及医疗后果的直接承担者。当医疗决定牵涉到家庭成员的重大利益时,患者自主权应该受到家属决定权的制约。病人并非如病患自主理论所预设的前提一样是一个自由且理性的选择者,而是一个组织社群所有关系的总和,因此个人自决并不应该豁免其社群义务,尤其是对于家庭之义务。即使是成年具有意思能力病人其家属亦应具有相应的权利。     

Justifications for Non-Consensual Medical Intervention: From Infectious Disease Control to Criminal Rehabilitation

A central tenet of medical ethics holds that it is permissible to perform a medical intervention on a competent individual only if that individual has given informed consent to the intervention. Yet it occasionally seems morally permissible to carry out non-consensual medical interventions on competent individuals for the purpose of infectious disease control (IDC). We describe two different moral frameworks that have been invoked in support of non-consensual IDC interventions and identify five desiderata that might be used to guide assessments of the moral permissibility of such interventions on either kind of fundamental justification. We then consider what these desiderata imply for the justifiability of carrying out non-consensual medical interventions that are designed to facilitate rehabilitation amongst serious criminal offenders. We argue that these desiderata suggest that a plausible case can be made in favor of such interventions.