A Troubled Dance: Doing the Work of Research Ethics Review

The fast growing interest in the work of university ethics review boards is evident in the proliferation of research and literature in the area. This article focuses on a Research Ethics Board (REB) in the Canadian context. In-depth, open-ended interviews with REB members and findings from a qualitative study designed to examine the ethics review of school-based research are used to illustrate points raised in the paper. The author’s experiences as academic researcher, advisor to student researchers and a 3-year term as an REB member inform the discussion. Macro issues related to the general workings of the board (e.g., maintaining appropriate membership) and micro issues connected to individual REB members’ experiences of reviewing research applications are examined. The author’s goal is to contribute to a fastgrowing conversation related to the issues that influence university ethics review while drawing attention to the contribution that faculty members’ understandings of their work as REB members can make to that conversation.     

某三甲医院五年科研项目伦理审查情况分析

通过对国内某三甲医院五年科研伦理审查情况进行分析,探讨科研项目伦理审查工作的重点、难点及对策。汇总2013年~2017年经医学伦理委员会会议审查的科研项目,分析研究者的学历、职称、学科与通过率关系。近5年医学伦理委员会共审查科研项目285项,通过238项,未通过47项,其中内科通过率高于外科(P<0.05),副高以上职称通过率高于中级(P<0.05),研究生以上学历通过率高于本科及以下学历(P<0.05)。只有强化伦理意识,规范审查形式,健全监管机制,才能保证科研伦理工作健康规范发展。     

National Human Research Ethics: A Preliminary Comparative Case Study of Germany,Great Britain,Romania, and Sweden

Although international research is increasing in volume and importance, there remains a dearth of knowledge on similarities and differences in “national human research ethics” (NHREs), that is, national ethical guidelines (NEGs), Institutional Review Boards (IRBs), and research stakeholder’ ethical attitudes and behaviors (EABs). We begin to address this situation by reporting upon our experiences in conducting a multinational study into the mental health of children who had a parent/carer in prison. The study was conducted in 4 countries: Germany, Great Britain, Romania, and Sweden. Data on NHREs were gathered via a questionnaire survey, two ethics-related seminars, and ongoing contact between members of the research consortium. There was correspondence but even more so divergence between countries in the availability of NEGs and IRBs and in researcher’ EABs. Differences in NHREs have implications particularly in terms of harmonization but also for ethical philosophy and practice and for research integrity.     

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。     

激励发展中国家的卫生研究——再思考与研讨新策略时代正在兴起

发展中国家需要更清晰地明确其卫生研究面临的优先项目,即国家应共同分担全球性研究项目,增强激励和纳入研究轨道的国家能力,把循证决策人微言轻政策决策的基础,加强国家与国际合作问题是卫生研究中的中心议题。     

Introducing ethics and engineering: the case of Delft University of Technology

This article focuses mainly on (1) the policy of Delft University of Technology since 1992 as regards the university-wide introduction of a compulsory course on ethics and engineering, and (2) the ideal structure of such a course, including the educational goals of the course. Dr. G. J. Scheurwater is Senior policy-advisor to the Board of Delft University of Technology. Prof. S. J. Doorman is Chairman of the Advisory Committee on Ethics of Delft University of Technology.     

加拿大三大研究理事会政策宣言及对我国多中心伦理审查的启示

1998年, 三大研究理事会政策宣言 (Tri-Council Policy Statement, TCPS) 正式通过, 2011年通过了第二版, 是加拿大多中心伦理审查领域的重要准则。TCPS通过构建适宜的多中心伦理审查决策框架、注意多中心伦理审查的沟通及透明度、确保充足的资源以支持多中心伦理审查进程以及妥善处理操作层面问题等途径, 提高多中心伦理审查的效率与成功率。可以在强化多中心伦理审查立法、注意协调多方关系、确保研究项目的科学性以及对审查人员进行教育培训等方面为我国多中心伦理审查提供借鉴。     

医学研究中的机构伦理问题探究

机构作为医学研究活动的主体,在构建国家科研伦理治理体系和倡导负责任的医学研究方面发挥着个体科研人员不可替代的作用,也引发了一系列独特而又时常被忽视的伦理问题和挑战。为此,引入一个全新的观点“机构伦理”,并辨析其与管理伦理、制度伦理、组织伦理之间的区别和联系,进而厘清机构伦理的概念和主要内容。重点剖析了医学科研机构中的两大伦理议题:机构伦理责任和机构利益冲突。医学科研机构的责任担当和有效规避利益冲突,在促进公众对医学研究的信任及营造良好的科研伦理环境方面具有重要意义。     

The study of behavioral ethics within organizations: A special issue introduction

Ethics has emerged as one of the most critical issues facing organizations. Given its importance, an extensive literature has evolved to understand the causes and consequences of (un)ethical decision making and behaviors in organizations. To date, much of this research has relied on research methods (e.g., experiments) that emphasize internal validity and control over external validity and generalizability. Although very informative, such studies frequently utilize samples that are not representative of working adults and their designs often fail to capture the contextual complexity that defines the day-to-day realities of organizational life. In this light, this special issue of Personnel Psychology encouraged scholars to investigate ethics within organizations and to offer rich theoretical explanations for why ethical failures and successes occur. The articles in this special issue address this important research agenda and make significant contributions to our understanding of ethics in organizations. Our introduction synthesizes these works, provides an overview of issues facing the broader behavioral ethics literature, and discusses areas for future research.     

An Ethical Exploration of Barriers to Research on Controlled Drugs

We examine the ethical, social, and regulatory barriers that may hinder research on therapeutic potential of certain controversial controlled substances like marijuana, heroin, or ketamine. Hazards for individuals and society and potential adverse effects on communities may be good reasons for limiting access and justify careful monitoring of these substances. Overly strict regulations, fear of legal consequences, stigma associated with abuse and populations using illicit drugs, and lack of funding may, however, limit research on their considerable therapeutic potential. We review the surprisingly sparse literature and address the particular ethical concerns pertinent to research with illicit and addictive substances, such as undue inducement, informed consent, therapeutic misconception, and risk to participants, researchers, and institutions. We consider the perspectives of key research stakeholders and explore whether they may be infected with bias. We conclude by proposing an empirical research agenda to provide an evidentiary basis for ethical reasoning.     

American college of epidemiology ethics guidelines: Foundations and dissemination

Epidemiology is a core science of public health, focusing on research related to the distribution and determinants of both positive and adverse health states and events and on application of knowledge gained to improve public health. The American College of Epidemiology (ACE) is a professional organization devoted to the professional practice of epidemiology. As part of that commitment, and in response to concerns for more explicit attention to core values and duties of epidemiologists in light of emerging issues and increased scrutiny of epidemiology, the College developed, adopted, and published a set of Ethics Guidelines. The structure of the ACE ethics guidelines is in four parts: (1) a brief statement of core values and duties of epidemiologists, coupled with the virtues important to professional practice; (2) concise statements of key duties and obligations; (3) exposition of the duties and obligations with more applications; and (4) a brief summary and conclusion. The Guidelines have been published on the ACE website and in the official College journal Annals of Epidemiology. The guidelines contain (and maintain) core elements that define the discipline of epidemiology and its fundamental duties, but they are also intended to be dynamic and evolving, responsive to a changing professional and social environment. An earlier version of this paper was presented at the AAAS-Office of Research Integrity (ORI) meeting in Washington DC on the theme: “The Role and Activities of Scientific Societies in Promoting Research Integrity” held on April 10–11, 2000. Affiliations of co-authors: Douglas L. Weed, MD, MPH, PhD is Director of the Cancer Prevention Fellowship Program, Office of Preventive Oncology, National Cancer Institute; Jeffrey P. Kahn, PhD, MPH, is Professor of Medicine and Director of the Center for Bioethics, UMN Twin Cities, Minneapolis; Michael A. Stoto, PhD, is Associate Director for Public Health, RAND Center for Domestic and International Health Security, Arlington, VA.     

The professional approach to engineering ethics: five research questions

This paper argues that research for engineering ethics should routinely involve philosophers, social scientists, and engineers, and should focus for now on certain basic questions such as: Who is an engineer? What is engineering? What do engineers do? How do they make decisions? And how much control do they actually have over what they do?     

Neuromarketing Research Practices: Attitudes,Ethics, and Behavioral Intentions

As a new addition to the marketing research toolbox, neuromarketing science has given rise to a variety of questions relevant to consumer perceptions of this nascent area of investigation. Neuromarketing researchers are dependent on consumer involvement as research participants, and finding means to educate the public about neuromarketing is a priority for professionals working in the field. This article describes the results of two online questionnaire studies focused on the role of personal constructs presumed to underlie perceptions of neuromarketing research. The findings point to neuromarketing research knowledge, attitudes toward science, attitudes toward technology, and ethical ideology as important factors linked to neuromarketing research attitudes, perceptions of the ethicality of neuromarketing research, and willingness to participate in neuromarketing studies. We discuss the implications of our findings for educating the public about neuromarketing research and encouraging research participation, and we conclude by suggesting directions for future research.     

The Regulation of Animal Research and the Emergence of Animal Ethics: A Conceptual History

The history of the regulation of animal research is essentially the history of the emergence of meaningful social ethics for animals in society. Initially, animal ethics concerned itself solely with cruelty, but this was seen as inadequate to late 20^th-century concerns about animal use. The new social ethic for animals was quite different, and its conceptual bases are explored in this paper. The Animal Welfare Act of 1966 represented a very minimal and in many ways incoherent attempt to regulate animal research, and is far from morally adequate. The 1985 amendments did much to render coherent the ethic for laboratory animals, but these standards were still inadequate in many ways, as enumerated here. The philosophy underlying these laws is explained, their main provisions are explored, and future directions that could move the ethic forward and further rationalize the laws are sketched.     

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.     

The ethics of secret diplomacy: a contextual approach

Under what conditions is secret diplomacy normatively appropriate? Drawing on pragmatic theories of political and ethical judgement, this paper argues that a three-dimensional contextual approach centred on actors' reasoning process offers an innovative and reliable analytical tool for bridging the ethical gap of secret diplomacy. Using the case of the US extraordinary rendition programme, the paper concludes that secret diplomacy is ethically unjustifiable when actors fail to invoke normatively relevant principles of justification, inappropriately apply them to the context of the case and when the actors' moral reasoning process suffers from deficient levels of critical reflection concerning the broader implications of secret engagements for diplomatic conduct.     

“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.     

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。