When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?

Classic statements of research ethics advise against permitting physician-investigators to obtain consent for research participation from patients with whom they have preexisting treatment relationships. Reluctance about “dual-role” consent reflects the view that distinct normative commitments govern physician–patient and investigator–participant relationships, and that blurring the research–care boundary could lead to ethical transgressions. However, several features of contemporary research demand reconsideration of the ethics of dual-role consent. Here, we examine three arguments advanced against dual-role consent: that it creates role conflict for the physician-investigator; that it can compromise the voluntariness of the patient-participant’s consent; and that it promotes therapeutic misconceptions. Although these concerns have merit in some circumstances, they are not dispositive in all cases. Rather, their force—and the ethical acceptability of dual-role consent—varies with features of the particular study. As research participation more closely approximates usual care, it becomes increasingly acceptable, or even preferable, for physicians to seek consent for research from their own patients. It is time for a more nuanced approach to dual-role consent.     

Ethical and Regulatory Considerations for Using Social Media Platforms to Locate and Track Research Participants

As social media becomes increasingly popular, human subjects researchers are able to use these platforms to locate, track, and communicate with study participants, thereby increasing participant retention and the generalizability and validity of research. The use of social media; however, raises novel ethical and regulatory issues that have received limited attention in the literature and federal regulations. We review research ethics and regulations and outline the implications for maintaining participant privacy, respecting participant autonomy, and promoting researcher transparency when using social media to locate and track participants. We offer a rubric that can be used in future studies to determine ethical and regulation-consistent use of social media platforms and illustrate the rubric using our study team’s experience with Facebook. We also offer recommendations for both researchers and institutional review boards that emphasize the importance of well-described procedures for social media use as part of informed consent.     

The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards (IRBs), to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation (REC) services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research.     

Reassessing the Ethics of Molecular HIV Surveillance in the Era of Cluster Detection and Response: Toward HIV Data Justice

Abstract

In the United States, clinical HIV data reported to surveillance systems operated by jurisdictional departments of public health are re-used for epidemiology and prevention. In 2018, all jurisdictions began using HIV genetic sequence data from clinical drug resistance tests to identify people living with HIV in “clusters” of others with genetically similar strains. This is called “molecular HIV surveillance” (MHS). In 2019, “cluster detection and response” (CDR) programs that re-use MHS data became the “fourth pillar” of the national HIV strategy. Public health re-uses of HIV data are done without consent and are a source of concern among stakeholders. This article presents three cases that illuminate bioethical challenges associated with re-uses of clinical HIV data for public health. We focus on evidence-base, risk-benefit ratio, determining directionality of HIV transmission, consent, and ethical re-use. The conclusion offers strategies for “HIV data justice.” The essay contributes to a “bioethics of the oppressed.”     

护理核心期刊文献的研究伦理审查情况分析

为了解护理核心期刊发文中科研伦理审查现状,以期发挥核心期刊在研究伦理监督原则上的导向作用。检索中国知网数据库,共收集符合纳入标准的科研论文2 474篇,而获得伦理审批号的论文仅20篇(0.81%)。使用SPSS 22.0软件进行统计学处理,不同时期伦理审查情况之间对比,差异具有统计学意义(P<0.05)。在“基因编辑婴儿”事件之后,我国护理核心期刊伦理审查情况有所好转,但整体上护理科研人员伦理意识仍较为淡薄,伦理审查的执行效果不甚理想。建议期刊社规范伦理监督过程,加大伦理监管力度,完善护理研究伦理审查制度及监管体系,以提高护理研究伦理审查效果。     

癌症筛查中的医学伦理问题探究

癌症筛查是实现癌症早诊早治的有效手段。与临床医疗行为类似,癌症筛查存在医学伦理问题。根据当代医学伦理学自主、不伤害、有利和公正的四大基本原则,构建癌症筛查的医学伦理问题分析框架,对由癌症筛查技术本身直接引发的筛查受益与风险等实质伦理问题以及应用过程引发的知情同意、自主性、隐私性、分配公平性、社会包容与歧视等程序伦理问题进行探究。重视伦理问题,规避伦理风险,将提高癌症筛查受益,促进人群健康,需要多方利益相关者共同努力。

     

注重全人群、全方位、全过程——论受试者知情同意伦理审查的强化

通过对医药学研究人体试验受试者知情同意的伦理审查发展现状的说明,分析现阶段知情同意伦理审查工作中存在流于形式,审查结果不够科学、客观和公正等问题。再结合医药学研究的发展需要,说明知情同意伦理审查的工作情况和不断发展的要求。提出对知情同意做到全人群、全方位、全过程的伦理审查的覆盖。并通过实施全人群、全方位、全过程的伦理审查的过程,提高人体试验受试者知情同意伦理审查水平,促进医药学研究和社会医学的发展。     

医学期刊载文的伦理学审查情况分析——以《中国学校卫生》为例

通过查阅《中国学校卫生》近5年纸质期刊,查看文章“对象与方法”中有无“知情同意”或“获得伦理学审查”等信息。结果显示,获得伦理学审查或知情同意的文章884篇,各年份获得伦理学审查、知情同意及总体检出率差异均有统计学意义(χ²=366.29,43.58,219.83,P<0.01)。各年份获得伦理学审查、知情同意的心理学研究及总体检出率(χ²=107.55,16.80,58.66);获得伦理学审查的干预性研究及总体检出率(χ²=44.40,18.46);获得伦理学审查的涉及生物样本的研究检出率(χ²=17.47),差异均有统计学意义(P<0.01)。今后应不断加强引导和教育,加强科研人员及编辑的伦理意识。     

How Payment for Research Participation Can Be Coercive

The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consent-undermining coercion marks out certain actions as impermissible and certain agreements as unenforceable. By contrast, coercion as subjection indicates a way in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. While offers of payment do not normally constitute consent-undermining coercion, they do sometimes constitute coercion as subjection. We offer an analysis of coercion as subjection and propose three possible practical responses to worries about the coerciveness of payment.     

美国人体研究的监督：科学发展中的伦理与规定

美国保护人体受试者的制度建立在伦理学基础之上,并正式通过相关法律。对人体研究的监督是保护受试者个人的健康和权益,确保研究的有效性,整体性,以及科学与社会更大范围的利益,监督审查机构是联邦卫生部下属的两个机构-食品与药品管理局（FDA）和人体研究保护办公室（OHRP）,大部分人体研究受两机构监督。美国人体受试者保护系统的基础部分是伦理审查委员会（IRB）及知情同意,IRBU电在提供一种机制,以进行客观的审查,同意和研究过程听持续监督;知情同意意在保证个人在了解与实验相关的风险,不适,收益后能自由做出参加与否的决定,美国人体研究保护制度正面临着挑战。美国也为促进人体受试者保护在进行新的努力。     

产前超声检查的医学伦理学思考

产前超声检查是指在妊娠期间应用超声检查技术检测母体内胎儿是否存在先天性缺陷和遗传性疾病,随着超声技术的迅速普及和发展,产前超声检查已成为产前诊断的不可缺少的有效手段之一。本文从医学与哲学的角度对产前超声检查的必要性、安全性、局限性以及相关医学伦理问题,如知情同意权、隐私权及人工流产等进行综合分析。     

“Paid to Endure”: Paid Research Participation,Passivity, and the Goods of Work

A growing literature documents the existence of individuals who make a living by participating in phase I clinical trials for money. Several scholars have noted that the concerns about risks, consent, and exploitation raised by this phenomenon apply to many (other) jobs, too, and therefore proposed improving subject protections by regulating phase I trial participation as work. This article contributes to the debate over this proposal by exploring a largely neglected worry. Unlike most (other) workers, subjects are not paid to produce or achieve anything but to have things done to them. I argue that this passivity is problematic for reasons of distributive justice. Specifically, it fails to enable subjects to realize what Gheaus and Herzog call “the goods of work”—a failure not offset by adequate opportunities to realize these goods outside of the research context. I also consider whether granting subjects worker-type protections would accommodate this concern.     

Evidence-Based Ethical Problem Solving: An Idea Whose Time Has Come

This is an account of the evolution of ideas and the confluence of support and vision that has eventuated in the founding of the Journal of Empirical Research on Human Research Ethics (JERHRE). Many factors have contributed to the creation of this rather atypical academic journal, including a scientific and administrative culture that finally saw the need for it, modern electronic technology, individuals across the world who were committed to somehow finding common ground between researchers and those charged with ethical oversight of research, a network of helpful colleagues, and a university whose administration gave moral support to the endeavor in a time of fiscal austerity. Perhaps equally important were the decisions to make JERHRE a nonprofit undertaking, to emphasize the implications of empirical research for specific best practices, to serve the educational needs of those concerned with human research, and to seek to stimulate the interest of students in gaining an evidence-based understanding of the research contexts in which they decide to work. This article explores the ‘chemistry’ that has made it possible to develop a somewhat unorthodox journal and set of related activities.     

健康医疗数据相关研究的伦理审查要点重构及其论证

健康医疗数据相关研究极大地拓展了传统生物医学研究的范畴,影响了医学研究的思路、方法和范式,也给伦理审查带来了新的挑战。从梳理国际伦理指南对健康医疗数据相关研究提出的要求出发,探讨此类研究当前的伦理审查现状及挑战,强调伦理审查不仅要关注风险获益比、知情同意程序、隐私保护措施这些核心问题,还需要以更加全面和深入的视角进行关注。同时,针对研究的科学价值和社会价值、研究目的的合理性和合法性、数据治理和数据管理要求、风险获益评估、知情同意模式创新以及研究团队资质等六个伦理审查要点进行重构和探讨。

     

基因组学研究免除具体知情同意的伦理挑战与审查实践

精准医学时代基因组学研究与临床的结合愈加紧密,研究规模和范围大大扩展。然而,机构既往采集保存样本和信息时征询知情同意的方式和质量不尽相同。指引研究者合法合理使用既往留存资源是伦理委员会面临的重要挑战。在适用国际和我国有关规范时,伦理审查应注意基因组信息的身份关联性、终身伴随性和族群相关性,不能仅以研究采样风险不大于最小风险、不免除知情同意增加研究难度为由批准研究者免除具体知情同意的申请,还应结合研究内容,从隐私保护、意外发现对资源提供者健康权益的影响等方面整体权衡个体和群体的风险受益,审慎决定。     

医学伦理审查如何适应转化医学的要求

随着转化医学的兴起,医学伦理审查面临前所未有的机遇与挑战.如何使医学伦理审查工作更好地适应转化医学发展的需要,提高审查质量,成为亟需解决的问题.在分析当前我国医学伦理审查工作现状和主要问题的基础上,进一步探讨了可行的解决方法,如进一步明确和强化管理部门服务功能、保证伦理委员会成员多样性和重视伦理审查多视角、强化伦理委员会后续跟踪审查、规范伦理审查委员的培训与继续教育等,为我国医学伦理审查工作的规范化发展和医学伦理审查质量的进一步提高提供参考.     

基因研究中的知情同意之惑

知情同意作为生命伦理的重要原则,在基因研究中同样占据重要的地位,由于基因研究中知情同意的异质性,在基因研究中面临着诸如如何理解其知情同意的异质性、群体知情同意、基因知情与基因隐私、利益冲突等问题.通过分析基因研究中知情同意的特殊性,综合国内外此领域的已有研究,运用理论联系实际的方法,得出结论认为,只有正确区分基因知情与基因隐私的权利主体,用伦理规范来解决利益冲突,在发展中不断完善知情同意,才能够取得科技与伦理的共赢.     

肤纹学研究的伦理问题

医学伦理学和遗传伦理学的原则同样适合肤纹学的研究.知情同意是肤纹学研究中必须要存在的程序和手续.对于肤纹学研究的检查、分析和保存所涉及的伦理学问题提出了意见.     

Corrected Feedback: A Procedure to Enhance Recall of Informed Consent to Research Among Substance Abusing Offenders

This study examined the efficacy of corrected feedback for improving consent recall throughout the course of an ongoing longitudinal study. Participants (N = 135) were randomly assigned to either a corrected feedback or a no-feedback control condition. Participants completed a consent quiz 2 weeks after consenting to the host study and at months 1, 2, and 3. The corrected feedback group received corrections to erroneous responses and the no-feedback control group did not. The feedback group displayed significantly greater recall overall and in specific content areas (i.e., procedures, protections, risks/benefits). Results support the use of corrected feedback for improving consent recall.     

From posts to protection: Ethical considerations regarding forensic psychiatrists and a duty to warn based on social media

Increasing use of social media in forensic mental health evaluations will lead to new challenges that must be resolved by forensic practitioners and the legal system. One such dilemma is the discovery of information that would typically trigger a legal duty and professional ethics obligation for mental health professionals to breach doctor-patient confidentiality to promote public safety and prevent harm to vulnerable third parties. Although the law and professional organizations offer clear guidance for practitioners in the treatment role, there is currently no clarity from the law or instruction from professional organizations on what mental health professionals should do if they discover such information during a confidential forensic evaluation. For example, a forensic evaluator may find evidence on social media of an evaluee’s threats to seriously harm others, abuse of children and the elderly, or severely impaired driving. There are no clear guidelines for how a forensic psychiatrist should respond in these complicated situations. We review the legal concepts and historical evolution of confidentiality, privilege, and mandated reporter duties that forensic practitioners should consider in these legally ambiguous situations. Finally, we discuss ethics frameworks practitioners can implement to determine their most ethical course of action when faced with such dilemmas.