Describing our “humanness”: Can genetic science alter what it means to be “human”?

Over the past several decades, geneticists have succeeded in identifying the genetic mutations associated with disease. New strategies for treatment, including gene transfer and gene therapy, are under development. Although genetic science has been welcomed for its potential to predict and treat disease, interventions may become ethically objectionable if they threaten to alter characteristics that are distinctively human. Before we can determine whether or not a genetic technique carries this risk, we must clarify what it means to be “human”. This paper inquires how “humanness” has been defined within various academic fields. The views of several legal theoreists, scientists, bioethicists, psychologists, philosophers and anthropologists whose works seem to best reflect how “humanness” is understood in their respective fields of study are considered. Our survey attempts to chart a path for a more detailed study on the meaning of “humanness” in the future. We assess four traits commonly identified in the literature as defining what it means to be human: cognition, biological or physiological composition, social interaction with other “human” beings, and spirituality. The nature of the relationship between these characteristics, in our view, is symbiotic: genetic intervention which alters one of them could have repercussions on one or more of the others. In conclusion, we offer guidance to those participating in genetic research and treatment regarding the parameters within which they may proceed without threatening the preservation of what is distinctively human.     

Detecting Duplication in Students’ Research Data: A Method and Illustration

Research integrity is core to the mission of higher education. In undergraduate student samples, self-reported rates of data fabrication have been troublingly high. Despite this, no research has investigated undergraduate data fabrication in a more systematic manner. We applied duplication screening techniques to 18 data sets submitted by psychology honors students for assessment. Although we did not identify any completely duplicated cases, there were numerous partial duplicates. Rather than indicating fabrication, however, these partial duplicates are likely a consequence of poor measure selection, insufficient data screening, and/or participant characteristics. Implications for the teaching and supervision of honors students are discussed.     

健康医疗数据的科研共享应用思考

针对工作调研中了解到的科研机构、科技企业、医疗机构和相关监管部门在数据共享中面临的现实问题,探讨在实践层面的应对策略,包括:建立可操作性强的共享制度与机制保障,厘清健康医疗数据监管者、提供者、使用者等相关各方的职责与权益;提供数据共享基础设施与先进技术保障,建立以应用为出发点的数据平台,确保数据全生命周期能够安全、可靠且可及的共享;提高涉及各相关方数据共享的伦理责任意识,并针对各种难点开展相关研究。     

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.     

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.     

Scientific societies and research integrity: What are they doing and how well are they doing it?

Scientific societies can play an important role in promoting ethical research practices among their members, and over the past two decades several studies have addressed how societies perform this role. This survey continues this research by examining current efforts by scientific societies to promote research integrity among their members. The data indicate that although many of the societies are working to promote research integrity through ethics codes and activities, they lack rigorous assessment methods to determine the effectiveness of their efforts. 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.     

“Sherry’s Secret”

The case and commentaries below were developed as part of a project, Graduate Research Ethics Education, undertaken by the Association for Practical and Professional Ethics with funding from the National Science Foundation (NSF Grant No. SBR 9421897 and NSF Grant No. 9817880). The project aims at training graduate students in research ethics and building a community of scientists and engineers who are interested in and capable of teaching research ethics. As part of the project, each graduate student participant develops a case for use in teaching and writes a commentary to go with the case, and then a staff member is asked to write additional commentary on the case. The case below was written in the second year of the project and was published in Research Ethics: Cases and Commentaries edited by B. Schrag, Association for Practical and Professional Ethics, Bloomington, Indiana, Vol. II (1998). Publication of these cases and commentaries will be a recurring feature of Science and Engineering Ethics.     

“学界热”与“行业冷”：医学伦理学落地医疗实践之思

医学伦理学是医学人文教育的基础阵地,中国过去40年医学伦理学科建设有成绩也有不足。当前医学伦理学落地医疗实践成为问题的焦点。从伦理学界的热点问题出发,描述热中有冷、冷热交加的伦理现象：应用伦理热、科研伦理热、医学伦理热,分析现象背后的原因可能是伦理观念与意识不足,理论与实践脱节及实践深度与广度不够。以此为基点寻生根之径,知的层面要自上而下多层保障;行的层面要理论联系实践,要深化内化转化;最终达到知行合一,入脑入心入行,加速医学伦理学落地生根。     

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。     

Statistics and ethics in medical research

Ethical conduct is an essential component in research, especially in medical research. Statistical methods for design and analysis are powerful research tools if used properly. Abuse of these principles and methods are just as unethical as other laboratory or clinical misconduct. Inadequate research design can produce worthless results and thus wastes effort and valuable resources. For clinical research, patient resources are wasted. Inappropriate analysis of data can also produce misleading results and conclusions. For clinical research, inferior therapy might be given to patients as a consequence. These ethical concerns can have implications for and affect the individuals responsible for the statistical design and analysis. Examples are provided which illustrate some possible abuses and inappropriate pressures.     

关于麻醉后监测治疗室的伦理思考

麻醉后监测治疗室(post-anesthesia care unit,PACU)中医学高新技术设备对确保手术后患者的安全发挥极其重大的作用,然而PACU中也产生许多危机与伦理冲突。为了PACU的良性发展,我们认为如下伦理准则必须遵循:科学认定准则、最佳选择准则、精益求精准则、无伤准则、患者自主准则。     

BIG DATA: NEW SCIENCE,NEW CHALLENGES,NEW DIALOGICAL OPPORTUNITIES

The advent of extremely large data sets, known as “big data,” has been heralded as the instantiation of a new science, requiring a new kind of practitioner: the “data scientist.” This article explores the concept of big data, drawing attention to a number of new issues—not least ethical concerns, and questions surrounding interpretation—which big data sets present. It is observed that the skills required for data scientists are in some respects closer to those traditionally associated with the arts and humanities than to those associated with the natural sciences; and it is urged that big data presents new opportunities for dialogue, especially concerning hermeneutical issues, for theologians and data scientists.     

Community-Based Participatory Research for Improved Mental Health

Community-based participatory research (CBPR) focuses on specific community needs, and produces results that directly address those needs. Although conducting ethical CBPR is critical to its success, few academic programs include this training in their curricula. This article describes the development and evaluation of an online training course designed to increase the use of CBPR in mental health disciplines. Developed using a participatory approach involving a community of experts, this course challenges traditional research by introducing a collaborative process meant to encourage increased participation by special populations and narrow the parity gap in effective mental health treatment and services delivery.     

Clinical Audit and Reform of the UK Research Ethics Review System

There is an international consensus that medical research involving humans should only be undertaken in accordance with ethical principles. Paradoxically though, there is no consensus over the kinds of activities that constitute research and should be subject to review. In the UK and elsewhere, research requiring review is distinguished from clinical audit. Unfortunately the two activities are not always easy to differentiate from one another. Moreover, as the volume of audit increases and becomes more formal in response to the demand for evidence-based practice in medicine, the overlap between research and audit grows more acute. Arguably, similar ethical standards and systems for ensuring that those standards are met should be applied regardless of whether or not a project is classified as research or audit. At a time when the research ethics review system in the UK is undergoing significant reform it is important that the opportunity is not missed to address the longstanding research-audit problem. We discuss suggestions for further reform that addresses this issue.     

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.     

Balancing Ethical Principles in Emergency Medicine Research

This paper attempts to provide a broader view into the ethical issues surrounding the field of emergency medicine (EM) research. It starts from defining bioethically relevant features of EM and presents this field in the context of different models of health care provider–patient relationship. The paper also provides a short overview of the “post-Nuremberg” evolution of the main international research ethics guidelines relevant to EM research which demonstrates a tendency of liberalization of research on incapable persons. This tendency culminates with the exceptions to informed consent for EM research which is supposed to be balanced by other research ethics principles, especially a careful rationing of risks and benefits. This finally brings us towards a critical analysis of the minimal risk standard which is one of the main fundamental safeguards in EM research. An earlier version of this paper was presented at The 7th International Conference on Bioethics on “The Ethics of Research in Emergency Medicine”, held on June 2, 2006, Warsaw, Poland.     

Using empirical data to inform the ethical evaluation of placebo controlled trials

There has been considerable debate about the ethical acceptability of using placebo-controls in clinical research. Although this debate has been rich in rhetoric, considering that much of this research is predicated upon the assumption that data from this research is vital to clinical decision-making, it is ironic that researchers have introduced little data into these discussions. Using some published research concerning the use of placebo-controls in clinical research in hypertension and psychiatric drug trials, I suggest some ways that such data might be incorporated into the ethical analysis concerning placebo use in clinical trials. This approach promises to be important for enhancing conceptual and scientific understanding as well as public policy decision-making. 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.