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Opportunistic testing: the death of informed consent? 机会性测试:知情同意的死亡?
Dena S Davis

This Article focuses on one aspect of prenatal diagnosis: noninvasive prenatal diagnosis, particularly the detection of Trisomy 21 (Down Syndrome) through a simple test of maternal blood. Although I discuss issues salient to this particular test, I place it in the context of "opportunistic" testing generally. It is my view that opportunistic testing presents the most serious challenge to patient autonomy we are facing in the twenty-first century. In this Article, I will explain what I mean by opportunistic testing and consider three different examples of how it threatens informed consent: (1) Prostate-Specific Antigen (PSA) screening, (2) newborn screening, and (3) prenatal diagnosis of maternal blood tests for fetal anomalies.

本文重点介绍了产前诊断的一个方面:无创产前诊断,特别是通过母体血液的简单检测来检测21三体(唐氏综合征)。虽然我讨论了这个特殊测试的突出问题,但我把它放在“机会主义”测试的背景下。在我看来,机会性检测是我们在21世纪面临的对患者自主权的最严重挑战。在本文中,我将解释我所说的机会性检测是什么意思,并考虑三个不同的例子来说明它是如何威胁知情同意的:(1)前列腺特异性抗原(PSA)筛查,(2)新生儿筛查,(3)产前母体血液检测胎儿异常的诊断。
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引用次数: 0
Medicine and law as model professions: the heart of the matter (and how we have missed it). 医学和法律作为模范职业:问题的核心(以及我们是如何忽视它的)。
Rob Atkinson

This article has two coordinate goals: to undergird the functionalist understanding of professionalism with classical normative theory and to advance the classical theory of civic virtue with the insights of modern social science. More specifically, this article seeks to connect classical theories about the care of the body and the soul with modern theories of market and government failure. The first step is to distinguish two kinds of professions, caring professions like medicine and public professions like law, by identifying the distinctive virtue of each. The distinctive virtue of the caring professions is single-minded commitment to those in their care, their principals, to the virtual exclusion of all other concerns; the distinctive virtue of the public professions is commitment to the common good, sometimes even at the expense of their principals' self-defined interest. The next step is to show how these two distinctive professional virtues, the one principal-protecting, the other public-protecting, branch from the same root, the common function of all proper professions: guaranteeing the delivery of socially essential but necessarily esoteric knowledge when the usual protections of both private contracts and government regulation systematically fail. The third and final step is to map out the implications of this neo-classical understanding of professionalism, beginning at its core in the paradigmatic caring and public professions of medicine and law, through putative professions that take these as their models, to the kind of republican society that places care of individuals and concern for the public welfare at the center of its value system. The result of this analysis should be not only a fuller theoretical appreciation of professionalism's proper function, but also a practical guide to professionals themselves for better service to both the individuals in their care and the common good of all humankind.

本文有两个协调的目标:用经典的规范理论来巩固功能主义对专业主义的理解,用现代社会科学的见解来推进经典的公民美德理论。更具体地说,本文试图将关于身体和灵魂护理的经典理论与市场和政府失灵的现代理论联系起来。第一步是区分两种职业,护理类职业,如医学和公共类职业,如法律,通过识别各自的独特美德。护理专业的独特美德是对他们所照顾的人,他们的委托人,全心全意的承诺,几乎排除了所有其他的关注;公共职业的独特美德是致力于共同利益,有时甚至不惜牺牲其负责人自我定义的利益。下一步是展示这两种不同的职业美德,一个是保护委托人,另一个是保护公众,是如何从同一个根源衍生出来的,这是所有适当职业的共同功能:当私人合同和政府监管的通常保护系统失效时,保证提供对社会至关重要但必要的深奥知识。第三步,也是最后一步,是绘制出这种新古典主义对专业主义理解的含义,从其核心的范式关怀和医学和法律等公共职业开始,通过以这些为榜样的假定职业,到那种将个人关怀和对公共福利的关注置于其价值体系中心的共和社会。这种分析的结果不仅应该是对专业精神的适当功能有更充分的理论认识,而且应该是对专业人员本身的实践指导,以便更好地为他们所照顾的个人和全人类的共同利益服务。
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引用次数: 0
Defining intellectual disability and establishing a standard of proof: suggestions for a national model standard. 智力残疾的界定与举证标准的建立:对国家示范标准的建议。
Natalie Cheung
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引用次数: 0
Special topic introduction: Minerva at the departure gate. 专题介绍:密涅瓦在登机口。
Robert N Strassfeld
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引用次数: 0
Protection for psychotherapy notes under the HIPAA Privacy Rule: as private as a hospital gown. 根据HIPAA隐私规则,对心理治疗笔记的保护:就像医院的长袍一样私密。
Stephanie O Corley
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引用次数: 0
Direct and enhanced disclosure of researcher financial conflicts of interest: the role of trust. 研究人员财务利益冲突的直接和强化披露:信任的作用。
Roy G Spece

In earlier writing, I recommended direct disclosure of major researcher financial conflicts of interest in per capita funding arrangements--the practice of providing researchers with a fixed sum for each subject recruited and enrolled in a study. This Article adds a recommendation for enhanced direct disclosure. The enhancement in the disclosure is a summary of why per capita and excess payments are being discussed and further includes whether the sponsors of the research and the researchers have claimed that there are no excess payments. The reason per capita payments are being discussed is because of the risk--with special caution when sponsors and researchers are not willing to claim that there are no excess payments--of introducing bias into researchers' decisions regarding study design, implementation, and interpretation, as well as concerning whom to enroll or keep in studies. Researchers' claims that there are no excess payments do not vitiate the risk of such payments. Nevertheless, a special admonition when sponsors and researchers do not claim the absence of excess payments would hopefully encourage them to eschew excess payments. My recommendations are required by the rights to bodily integrity and autonomy embedded in informed consent. Several arguments have been made against my recommendations, many of which relate to supposed effects on trust. My rights-based recommendations should not be rejected because of objections based on propositions that (1) are conceptually unclear because of a failure to unbundle different kinds and degrees of trust and (2) have not been empirically proven even where concepts are clarified. In some instances, the required strong empirical confirmation cannot be made because of practical or ethical restraints, including the fact that some of the necessary studies would require invasion of the right to informed consent. Finally, I suggest and partially apply an organizational method to generate empirical questions and guidance for future research in this area. Even the few hypothetical scenarios addressed demonstrate how complex--and sometimes practically or ethically impossible--the empirical studies must be to adduce proofs sufficient to overcome the imperative of informed consent.

在早期的写作中,我建议在人均资助安排中直接披露主要研究人员的经济利益冲突——为研究人员招募和登记的每个受试者提供固定金额的做法。本文增加了加强直接披露的建议。信息披露方面的改进总结了为什么要讨论人均薪酬和超额薪酬,并进一步包括研究发起人和研究人员是否声称没有超额薪酬。讨论人均报酬的原因是,当赞助者和研究人员不愿意声称没有额外报酬时,特别要注意的是,在研究人员关于研究设计、实施和解释的决策中,以及在研究中招募或保留谁的问题上,存在引入偏见的风险。研究人员声称不存在超额支付,但这并不能消除此类支付的风险。然而,当赞助者和研究人员不声称没有超额报酬时,一个特别的警告有望鼓励他们避免超额报酬。我的建议是根据知情同意中所包含的身体完整性和自主权的要求提出的。有人提出了一些反对我的建议的论点,其中许多都与所谓的信任影响有关。我的基于权利的建议不应该被拒绝,因为反对意见基于以下命题:(1)由于未能将不同种类和程度的信任分开而在概念上不明确;(2)即使在概念明确的情况下也没有得到经验证明。在某些情况下,由于实际或道德上的限制,包括一些必要的研究需要侵犯知情同意权这一事实,所要求的强有力的经验证实无法得到。最后,我建议并部分应用一种组织方法来产生实证问题,并为该领域的未来研究提供指导。即使是少数几个假设的场景也表明,要找到足够的证据来克服知情同意的必要性,实证研究必须是多么复杂——有时在实践或道德上是不可能的。
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引用次数: 0
Setting gender identity free: expanding treatment for transsexual inmates. 消除性别认同:扩大对变性囚犯的治疗。
Travis Wright Colopy
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引用次数: 0
Medical marijuana and the ADA: removing barriers to employment for disabled individuals. 医用大麻与《美国残疾人法》:消除残疾人就业障碍。
Russell Rendall
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引用次数: 0
Waiver of the psychotherapist-patient privilege: implications for child custody litigation. 放弃心理治疗师-患者特权:对儿童监护诉讼的影响。
Marcia M Boumil, Debbie F Freitas, Cristina F Freitas

The psychotherapist-patient privilege, rooted in both common and statutory law, is predicated upon the public policy goal of protecting the reasonable expectation of privacy of individuals seeking psychotherapy. The privilege is not absolute, however. State and federal courts are far from uniform in determining how and when the privilege should be waived, in whole or in part, through implication, inadvertence or the affirmative action of the parties. In the family law context, the law that has evolved around the exercise of this privilege is even more complex as the needs of children add another wrinkle to the goal of balancing the imperative of confidentiality with the need for useful information that may be provided.

心理治疗师-患者特权,根植于普通法和成文法,是建立在公共政策目标的基础上的,即保护寻求心理治疗的个人对隐私的合理期望。然而,这种特权并不是绝对的。州法院和联邦法院在决定如何以及何时应通过暗示、疏忽或当事人的积极行动全部或部分放弃特权方面存在很大分歧。在家庭法方面,围绕行使这一特权而发展起来的法律甚至更为复杂,因为儿童的需要给平衡保密的必要性与可能提供的有用信息的需要这一目标增添了另一个问题。
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引用次数: 0
PGTandMe: social networking-based genetic testing and the evolving research model. PGTandMe:基于社会网络的基因检测和不断发展的研究模式。
Valerie Gutmann Koch

The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and--highlighting the challenges associated with a new paradigm of "patient-driven" genomic research--focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article also explores potential ethical, legal, and regulatory issues that arise from the hybrid between personal genomic research and online social networking, particularly regarding informed consent, institutional review board (IRB) oversight, and ownership/intellectual property (IP) considerations.

利用广泛的基因数据、个人信息和家族病史进行研究的机会自然会吸引个人基因检测(PGT)行业,该行业已经将直接面向消费者(DTC)的产品与社交网络技术结合起来,同时也吸引了潜在的行业或机构合作伙伴。本文评估了PGT和社交网络的混合将带来的研究转变,并强调了与“患者驱动”基因组研究新范式相关的挑战,重点关注了通过基因众包改变研究结构、位点、时间和范围的后果。本文还探讨了个人基因组研究与在线社交网络相结合所产生的潜在伦理、法律和监管问题,特别是在知情同意、机构审查委员会(IRB)监督和所有权/知识产权(IP)考虑方面。
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引用次数: 0
期刊
Health matrix (Cleveland, Ohio : 1991)
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