This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help (...) ensure that scarce resources such as tissue samples or limited subject popula- tions are employed where they do the most good; can support parallel efforts by providers and insurers to promote cost-effectiveness; and can ensure that research has social value and benefits subjects. I discuss and rebut potential objections to the consideration of cost-effectiveness in research, including the difficulty of predicting effectiveness and cost at the research stage, concerns about limitations in cost-effectiveness analysis, and worries about overly limiting researchers’ freedom. I then consider the advantages and disadvantages of having certain participants in the research enterprise, including IRBs, advisory committees, sponsors, investigators, and subjects, consider cost-effectiveness. The project concludes by qualifiedly endorsing the consideration of cost-effectiveness at the research stage. While incorporating cost-effectiveness considerations into the ethical evaluation of human subjects research will not on its own ensure that the health care system realizes cost-effectiveness goals, doing so nonetheless represents an important part of a broader effort to control rising medical costs. (shrink)

This paper assesses the state of research ethics in low- and middle-income countries and the achievements of the Fogarty International Center's bioethics training program since 2000. The vision of FIC for the next decade of research ethics education is encapsulated in four proposed goals: (1) Ensure sufficient expertise in ethics review by having someone with long-term training on every high-workload REC; (2) Develop LMIC capacity to conduct original research on critical ethical issues by supporting (...) doctoral and postdoctoral training and career paths for research ethicists; (3) Make research training and review at LMIC institutions sustainable by identifying additional funding mechanisms and models; (4) Make institutional research systems more ethical and efficient through context-specific training integrated into all levels of scientific training. (shrink)

The essays selected for this volume focus on issues that arise when attempting to design, review and undertake research involving human participants who are experiencing a private or public emergency. The main themes discussed by the essays are: the distinctive and significant ethical questions as to how research participants can be treated during emergency settings; the ethical challenges raised by emergencies for researchers undertaking research and its effects on the nature of research pursued; and procedural obstacles (...) raised by emergencies which can affect the quality of good research ethics review. The volume is unique in that it is the first collection to exclusively deal with all of the central ethical aspects of conducting human subject research in the context of emergency. (shrink)

Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey (...) of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee. (shrink)

Whether an individual doctoral study or a large-scale multidisciplinary project, researchers working across cultures face particular challenges around power, identity, and voice, as they encounter ethical dilemmas which extend beyond the micro-level of the researcher-researched relationship. In using a cross-cultural perspective on how to conceptualise research problems, collect data, and disseminate findings in an ethical manner, they also engage with the geopolitics of academic writing, language inequalities, and knowledge construction within a globalised economy. It is increasingly recognised that existing (...) ethical codes and paradigms either do not sufficiently address such issues or tend to be rather restrictive and insensitive to multiple and complex cultural and contextual differences. This book extends our understanding of the ethical issues and dilemmas faced by researchers in comparative and international education. It asks what the relevance of postcolonial theory is for understanding research ethics in comparative and international education; whether Western ethical practices in qualitative social research are incompatible with cultures outside the West; how a ‘situated’ approach can be developed for exploring research ethics across cultures and institutions; and how ‘informed consent’ can be negotiated when the process appears to contradict community values and practices. In sharing experiences from a wide range of cultural and institutional contexts, the authors offer both theoretical resources and practical guidance for conducting research ethically across cultures. This book was originally published as a special issue of _Compare: A Journal of Comparative and International Education. _. (shrink)

Education in the responsible conduct of research typically takes the form of online instructions about rules, regulations, and policies. Research Ethics takes a novel approach and emphasizes the art of philosophical decision-making. Part A introduces egoism and explains that it is in the individual's own interest to avoid misconduct, fabrication of data, plagiarism and bias. Part B explains contractualism and covers issues of authorship, peer review and responsible use of statistics. Part C introduces moral rights as the (...) basis of informed consent, the use of humans in research, mentoring, intellectual property and conflicts of interests. Part D uses two-level utilitarianism to explore the possibilities and limits of the experimental use of animals, duties to the environment and future generations, and the social responsibilities of researchers. This book brings a fresh perspective to research ethics and will engage the moral imaginations of graduate students in all disciplines. (shrink)

The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject.

In this paper, we report the findings from the data we collected from a survey in order to measure how common research ethics education in economics is. We have found out that (1) research ethics is taught in only a very few economics departments around the globe; (2) topics related to research ethics are not taught in courses on economics and ethics; and (3) the number of papers published in specialised peer-reviewed journals on (...) economics education is only a tiny fraction of the number of papers published in these journals. There has been no evidence in economics showing that economics departments have taken strong initiative on teaching research ethics to undergraduate and graduate students. (shrink)

Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics (...) covered include the unique concerns that arise in specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that occur when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging questions in human subjects research, namely financial conflicts of interest and the interpretation of scientific data. (shrink)

Original chapters complement anthologized readings on topics in research ethics such as informed consent, the use of humans and animals in research, research misconduct, and conflicts of interest.

In order to illuminate the potential harms of MRI research, we present data obtained by examining MRI research proposal files that had been submitted for review to several Canadian Research Ethics Boards. The data reveal that REB review of the studies contained omissions, considerable variability, and sometimes confusion regarding MRI research risks and risk classification. If our findings reflect the general state of REB review of MRI research in Canada and elsewhere, there is a (...) pressing need for REBs to be educated about MRI risks in order to responsibly facilitate the disclosure of these research risks in consent forms and during the consent process. Developing a standard template consent form that discloses MRI research risks might be a way to ensure attention to and disclosure of risks. (shrink)

Psychiatric research often poses special ethical concerns. This chapter first provides historical context, including scandals that stoked public concern about psychiatric research and led to the promulgation of canonical documents and bioethics scholarship, and then explores issues related to the decision-making capacity and safety of participants—including the use of placebos and washout periods, the design of suicide prevention studies, and research in emergency psychiatry. The chapter then describes how shifting models of psychiatric nosology have precipitated conflicts in (...) the determination of research priorities. Finally, the chapter attends to emerging issues related to research in psychedelic psychiatry and the use of artificial intelligence and social media by investigators. (shrink)

Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics (...) covered include the unique concerns that arise in specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that arise when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging issues in human subjects research, namely financial conflicts of interest and the interpretation of scientific data. (shrink)

Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative trials of drugs in developing countries, (...) especially expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research. (shrink)

The role of research ethics committees, and research ethics issues more broadly are often not viewed in the context of the development of scientific methods and the academic community. This topic piece seeks to redress this gap. I begin with a brief outline of the changes we experience within the social sciences before exploring in more detail their impact on research ethics and the practices of research ethics committees. I conclude with recommendations (...) for how the existing research ethics processes may be made more future-proof. (shrink)

Canada’s Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans mandates that all research involving human subjects be reviewed and approved by a research ethics board . We have little evidence on how researchers are dealing with this requirement in multisite studies, which involve more than one REB. We retrospectively examined 22 REB submissions for two minimal-risk, multisite studies in leading Canadian institutions. Most REBs granted expedited review to the studies, while one declared the application to (...) be exempt from review. Time between submission and approval ranged greatly, from four to 546 days. We received a total of 155 REB queries for changes and clarifications, most of which asked for further information, clarification, or additional documents. Less than a third of the REB queries were requests for specific changes, and a vast majority had a very limited impact on the research projects. Institutions also varied broadly in their description of what was required of local principal investigators. We conclude that the organizational and practical challenges these results imply could deter researchers from embarking on multisite research projects, and that recently proposed changes to the TCPS will not solve these problems. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the (...) wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

This book addresses the pressing issues involved with the ethical conduct of research in one developing world region - the Arab Region. Clinical research has soared in the developing world -as pharmaceutical companies continue their search for regions with large, treatment naive populations - including the Arab region, and has profound implications for the health and the economies for the area. The ethical issues involved with the conduct of such research, however, have so far not been adequately (...) addressed. This volume presents the issues regarding research ethics and research governance that have relevance for health authorities, regulators, industry, and academia. As a multi-authored volume it includes both international and local experts on ethical issues in research, representing all stakeholders, thus presenting a balanced view on this timely topic. (shrink)

The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 ± 31.7 (range: 0–131) projects of clinical trials and 71.1 ± 139.8 (range: 0–638) projects of other types of medical research. During one BC meeting an average of 10.3 ± 14.7 (range: (...) 0–71) projects of medical research were assessed (2006). The amendment of Polish laws according with Directive 2001/20/EC caused a percentage increase in BCs which assessed less than 20 projects per year (16% vs. 33% or 42% in 2003 vs. 2005 or 2006 respectively, p < 0,05). The results confirm the usefulness of the current practice of creating BCs by medical universities, medical institutes and regional chambers of physicians and dentists but rationalization of the workload for individual BCs is necessary. (shrink)

This anthology addresses ethical challenges that arise within the field of Internet research. Among the issues discussed in the book are the following:When is voluntary informed consent from research subjects required in using the Internet as a data source?How may researchers secure the privacy of research subjects in a landscape where the traditional public/private distinction is blurred and re-identification is a recurring threat?What are the central ethical and legal aspects of Internet research for individuals, groups, and (...) society? (shrink)

In both law and ethics, precedent shapes the deliberation of novel issues. Despite the interconnection between new and old decisions, few research ethics boards have an explicit mechanism for archiving issue-based research ethics decisions to inform future decisions. With the intent of promoting expediency, consistency, and accountability in REB decision-making, Sunnybrook Health Sciences Centre implemented a “decision bank”: a formal mechanism for systematically capturing institutional REB decisions. We describe the development of the decision bank, its (...) implementation, and the lessons we have learned from both. The decision bank, which is categorized by general issue themes such as consent, study design, and privacy, is still in the early implementation phase, but it provides a much-needed method to address the paucity of formal mechanisms and literature in a biomedical field otherwise inundated with evidence-based information. (shrink)

The Internet has been used as a place for and site of an array of research activities. From online ethnographies to public data sets and online surveys, researchers and research regulators have struggled with an array of ethical issues around the conduct of online research. This paper presents a discussion and findings from Buchanan and Ess's study on US-based institutional review boards and the state of internet research ethics.

Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical approval to begin their research. While such prospective review of research is important, we argue that it is not sufficient to address all aspects of research ethics. (...) We propose retrospective review as an important complement to prospective review. We offer two arguments to support our claim that prospective review is insufficient. First, as currently practiced, research ethics has become for some a ‘tick box’ exercise to get over the ‘hurdle’ of ethics approval. This fails to capture much of what is important in ethics and does not promote careful reflection on the ethical issues involved. Second, the current approach tends to be rules-based and we argue that research ethics should go beyond this to develop people’s capacity to be sensitive to the relevant moral features of their research, their ethical decision-making skills and their integrity. Retrospective review of a project’s ethical issues, and how they were addressed, could help to achieve those aims better. We believe that a broad range of stakeholders should be involved in such retrospective review, including representatives of ethics committees, participating communities and those involved in the research. All stakeholders could then learn from others’ perspectives and experiences. An open and transparent assessment of research could help to promote trust and understanding between stakeholders, as well as identifying areas of agreement and disagreement and how these can be built upon or addressed. Retrospective review also has the potential to promote critical reflection on ethics and help to develop ethical sensitivity and integrity within the research team. Demonstrating this would take empirical evidence and we suggest that any such initiatives should be accompanied by research into their effectiveness. Our article concludes with a discussion of some possible objections to our proposal, and an invitation to further debate and discussion. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in (...) the wrong direction. The aim of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

In Canada, all research conducted by individuals associated with universities must be subjected to review by research ethics boards (REB). Unfortunately, decisions reached by REBs may seriously compromise the integrity of university-based research. In this paper attention will focus on how requirements of REBs and a legal department in four Canadian universities affected response rates to a survey of domestic and international students. It will be shown that in universities in which students were sent a legalistic (...) cover letter to a mail survey, or were required to sign a consent form, lower response rates were achieved than in universities in which students were sent a relatively friendly letter. In turn, lower response rates resulted in: sample characteristics that deviated from population characteristics; a reduction in the possibility of testing research hypotheses; and increased survey costs. As a consequence, it is argued that the unreasonable demands of REBs are seriously compromising the quality of research that can be carried out on Canadian university students. (shrink)

Key messages The research environment has changed since clinical equipoise was first proposed 30 years ago New trial designs—such as umbrella and basket trials, adaptive platform trials, and cluster randomised trials—raise new ethical challenges for evaluating the state of scientific uncertainty and communicating about risks with patients and participants Clinical equipoise needs to evolve We propose the design of specific guidelines to provide ethics committees and trialists with instructions for how to evaluate equipoise in the context of new (...) designs and biomarkers and how to optimise communication with participants. (shrink)

This volume presents a framework of general principles for animal research ethics together with an analysis of the principles' meaning and moral requirements. Tom L. Beauchamp and David DeGrazia's comprehensive framework addresses ethical requirements pertaining to societal benefit and features a thorough, ethically defensible program of animal welfare. The book also features commentaries on the framework of principles by eminent figures in animal research ethics from an array of relevant disciplines: veterinary medicine, biomedical research, biology, (...) zoology, comparative psychology, primatology, law, and bioethics. (shrink)

Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed ‘too great an emphasis on guidelines and research ethics review’, which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to (...) ethical practices that are reinforced by upstream enabling conditions, which are in turn influenced by developmental conditions. Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities. (shrink)

In response to the increasing need for research ethics expertise in low and middle income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the (...) lessons learned over 12 years of international research ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection. (shrink)

This paper presents challenges facing researchers in applying basic ethical principles while conducting research with youth in a developing country context. A discussion of the cultural and social challenges to adherence to the elements of informed consent: disclosure, comprehension, capacity, voluntariness and consent is presented. The authors argue that the current institutional review board requirements that guide research reflect values and stem from western contexts that may not be fully applicable to non-western contexts. More dialogue is needed among (...) researchers in developing world contexts on challenges of and possible revisions to requirements that maintain respect for persons, beneficence, autonomy and justice, particularly when working with youth. (shrink)

The Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has offered a fully-funded, one-year, non-degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub-Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of (...) its trainees.Our data show that since 2001, the 28 former FABTP trainees have authored or co-authored 105 new bioethics-related publications; were awarded 33 bioethics-related grants; played key roles on 78 bioethics-related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post-training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

The Johns Hopkins‐Fogarty African Bioethics Training Program (FABTP) has offered a fully‐funded, one‐year, non‐degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub‐Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of (...) its trainees.Our data show that since 2001, the 28 former FABTP trainees have authored or co‐authored 105 new bioethics‐related publications; were awarded 33 bioethics‐related grants; played key roles on 78 bioethics‐related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post‐training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

Research ethics committees are charged with providing an opinion on whether research proposals are ethical. These committees are overseen by a central office that acts for the Department of Health and hence the State. An advisory group has recently reported back to the Department of Health, recommending that it should deal with inconsistency in the decisions made by different RECs. This article questions the desirability and feasibility of questing for consistent ethical decisions.

ABSTRACT Many people argue that disagreements and inconsistencies between Research Ethics Committees are morally problematic and there has been much effort to ‘harmonise’ their judgements. Some inconsistencies are bad because they are due to irrationality, or carelessness, or the operation of conflicting interests, and so should be reduced or removed. Other inconsistencies, we argue, are not bad and should be left or even encouraged. In this paper we examine three arguments to reject the view that we should strive (...) for complete consistency between committees. The first argument is that differences in judgement are not necessarily incompatible with ideas of justice for patients who are potential participants of research reviewed by different committees. We call this ‘the justice argument.’ The second argument is that such committees do not have access to a single moral truth, to which their judgement is supposed to correspond. We call this the ‘moral pluralism argument.’ The third argument is that the process of ethics committee review is also morally relevant and not solely the outcome. We call this the ‘due process argument.’ While we fall short of establishing exactly how much variation and on what substantive issues would be ethically permissible, we show that it is largely inevitable and that a certain amount of variation could be seen as a desirable part of the institution of medical research. (shrink)

NIH's fogarty international Center has provided grants for the development of training programs in international research ethics for low- and middle-income (LMIC) professionals since 2000. Drawing on 12 years of research ethics training experience, a group of Fogarty grantees, trainees, and other ethics experts sought to map the current capacity and need for research ethics in LMICs, analyze the lessons learned about teaching bioethics, and chart a way forward for research ethics (...) training in a rapidly changing health research landscape. This collection of papers is the result. (shrink)

The researcher : researching and developing ourselves -- The participant : responsibility, care and consideration -- Relational ethics : the relationship between the researcher and the participant -- Establishing trust : the fundamental ingredients -- Research dilemmas, decisions and details -- Research ethics committees : structures and procedures -- The social and political contexts of research and the ethics of dissemination.

Ethical tasks faced by researchers in science and engineering as they engage in research include recognition of moral problems in their practice, finding solutions to those moral problems, judging moral actions and engaging in preventive ethics. Given these issues, appropriate pedagogical objectives for research ethics education include (1) teaching researchers to recognize moral issues in their research, (2) teaching researchers to solve practical moral problems in their research from the perspective of the moral agent, (...) (3) teaching researchers how to make moral judgments about actions, and (4) learning to engage in preventive ethics. If web-based research ethics education is intended to be adequate and sufficient for research ethics education, then it must meet those objectives. However there are reasons to be skeptical that it can. (shrink)

While education in ethics and the responsible conduct of research is widely acknowledged as an essential component of graduate education, particularly in the STEM disciplines, little consensus exists on how best to accomplish this goal. Recent years have witnessed a turn toward the use of games in this context. Drawing from two NSF-funded grants, this paper takes a critical look at the use of games in ethics and RCR education. It does so by: setting the development of (...) research and engineering ethics games in wider historical and theoretical contexts, which highlights their promise to solve important pedagogical problems; reporting on some initial results from our own efforts to develop a game; and reflecting on the challenges that arise in using games for ethics education. In our discussion of the challenges, we draw out lessons to improve this nascent approach to ethics education in the STEM disciplines. (shrink)

Abstract:This paper explores how Finnish research ethics deals with matters of justice on the levels of practical regulation, political morality, and theoretical studies. The bioethical sets of principles introduced by Tom Beauchamp and James Childress in the United States and Jacob Dahl Rendtorff and Peter Kemp in Europe provide the conceptual background, together with a recently introduced conceptual map of theories of justice and their dimensions. The most striking finding is that the internationally recognized requirement of informed consent (...) for research on humans can be ideologically tricky in a Scandinavian welfare state setting. (shrink)

We analysed research ethics committee (REC) letters. We found that RECs frequently identify process errors in applications from researchers that are not deemed “favourable” at first review. Errors include procedural violations (identified in 74% of all applications), missing information (68%), slip-ups (44%) and discrepancies (25%). Important questions arise about why the level of error identified by RECs is so high, and about how errors of different types should be handled.

Principles of research ethics, derived largely from Western philosophical thought, are spreading across the world of higher education. Since 2006 the Japanese Ministry of Education has required universities in Japan to establish codes of ethical conduct and ensure that procedures are in place to punish research misconduct. Drawing on semi-structured interviews with 13 academics in a research-intensive university in Japan, this paper considers how research ethics is interpreted in relation to their own practice. Interviewees (...) articulated a range of ethical issues connected with data gathering and interpretation, applying for and using research funds, relationships with peers and research subjects, and the dissemination of results. The paper also explores the effect of personal values and cultural norms on the Japanese interpretation of research ethics identifying the impact in terms of the treatment of graduate research students and decision-making processes. (shrink)