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)

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)

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)

Hofmann and Holm’s recent survey on issues of research misconduct with PhD graduates culminated with a notable conclusion by the authors: ‘ Scientific misconduct seems to be an environmental issue as much as a matter of personal integrity’. Here, we re-emphasise the usefulness of an education-based countermeasure against toxic research environments or cultures that promote unethical practices amongst the younger researchers. We posit that an adequately conducted course in research ethics and integrity, with a good dose (...) of case studies and analyses, can function in a manner that is metaphorically akin to vaccination. The training would cultivate the ability to analyse and build confidence in young researchers in making decisions with sound moral reasoning as well as in speaking up or arguing against pressure and coercions into unacceptable behaviour. A sufficiently large number of young researchers exposed to research ethics trainings would essentially provide a research community some degree of lasting herd immunity at its broadest base. Beyond passive immunity, a crop of research ethics-savvy young researchers could also play active and influential roles as role models for others at their level and perhaps even help correct the wayward attitudes of some senior researchers and initiate prompt action from institutional policy makers in a bottom-up manner. (shrink)

In this paper we argue the need to reimagine research ethics frameworks to include notions of environmental sustainability. While there have long been calls for healthcareethics frameworks and decision-making to include aspects of sustainability, less attention has focused on howresearchethics frameworks could address this. To do this, we first describe the traditional approach to research ethics, which often relies on individualised notions of risk. We argue that we need to broaden this notion of individual risk to (...) consider issues associated with environmental sustainability. This is because research is associated with carbon emissions and other environmental impacts, both of which cause climate change health hazards. We introduce how bioethics frameworks have considered notions of environmental sustainability and draw on these to help develop a framework suitable for researchers. We provide a case study of data-driven health research to apply our framework. (shrink)

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)

This article provides a critical overview of the most important issues pertaining to the ongoing debate on international research ethics. It critically describes three problems of continuing concern: 1) the question of whether the distinction between therapeutic and non‐therapeutic research should be upheld; 2) the questions of whether the currently demanded best proven diagnostic and therapeutic method of treatment for all research subjects is feasible both in developed and in developing countries, and whether it should be (...) upheld; 3) the questions of who owns international research ethics guidelines and regulatory frameworks and, how decisions about changes to such international guidelines can possibly be achieved, given that it seems to be the case that genuine disagreement about issues of content is possible and likely. (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)

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)

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)

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)

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 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)

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees. The urgent need for continued capacity development in Africa has necessitated research initiatives to identify existing capacity. This discussion paper describes the mapping of RECs in (...) Africa through MARC project, second phase and discusses the findings. MARC provides a platform and tool on COHRED's Health Research HRWeb, which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. (shrink)

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)

Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. (...) Results Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity. (shrink)

The application of artificial intelligence and machine learning technologies in healthcare have immense potential to improve the care of patients. While there are some emerging practices surro...

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)

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)

Research ethics training during post-graduate education is necessary to improve ethical standards in the design and conduct of biomedical research. We studied quality and quantity of research ethics training in the curricula of post-graduate programs in the medical science in I.R. Iran. We evaluated curricula of 125 post-graduate programs in medical sciences in I.R. Iran. We qualitatively studied the curricula by education level, including the Master and PhD degrees and analyzed the contents and the amount (...) of teaching allocated for ethics training in each curriculum. We found no research ethics training in 72 of the programs. Among the 53 programs that considered research ethics training, only 17 programs had specific courses for research ethics and eight of them had detailed topics on their courses. The research ethics training was optional in 25% and mandatory in 76% of the programs. Post-graduate studies that were approved in the more recent years had more attention to the research ethics training. Research ethics training was neglected in most of the medical post-graduate programs. We suggest including sufficient amount of mandatory research ethics training in Master and PhD programs in I.R. Iran. Further research about quality of research ethics training and implementation of curricula in the biomedical institutions is warranted. (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)

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)

Animal research remains a deeply controversial topic in biomedical science. While a vast amount has been written about the ethical status of laboratory animals, far less academic attention has been devoted to the public and, more specifically, to public opinion. Rather than what the public think, this article considers the role of ‘public opinion’. It draws on a recent empirical study which involved interviews with laboratory scientists who use animals in their research, and with other UK stakeholders. The (...) first section of the paper demonstrates that public opinion has become a kind of resource in the animal research debate. Public opinion polls, in particular, are frequently cited. The second section explores this further and argues that, for all sides, appealing to public opinion is a key way to show legitimacy. Finally, the paper shifts gear to consider whether public opinion should matter, both for ethical reasoning and for science policy. (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)

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)

The increasing use of information and communication technologies (ICT) to help facilitate neuroscience adds a new level of complexity to the question of how ethical issues of such research can be identified and addressed. Current research ethics practice, based on ethics reviews by institutional review boards (IRB) and underpinned by ethical principalism, has been widely criticised and even called ‘imperialist’. In this paper, we develop an alternative way of approaching ethics in neuro-ICT research, based (...) on discourse ethics, which implements responsible research and innovation through dialogues. We draw on our work in Ethics Support, using the Human Brain Project as empirical evidence of the viability of this approach. (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.

This article provides a critical overview of the most important issues pertaining to the ongoing debate on international research ethics. It critically describes three problems of continuing concern: 1) the question of whether the distinction between therapeutic and non‐therapeutic research should be upheld; 2) the questions of whether the currently demanded best proven diagnostic and therapeutic method of treatment for all research subjects is feasible both in developed and in developing countries, and whether it should be (...) upheld; 3) the questions of who owns international research ethics guidelines and regulatory frameworks and, how decisions about changes to such international guidelines can possibly be achieved, given that it seems to be the case that genuine disagreement about issues of content is possible and likely. (shrink)

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)

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.

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)

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs (...) attain different levels of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures. (shrink)

ABSTRACT 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)

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)

Human subjects research has increased in Myanmar since 2010 and, accordingly, the establishment of research ethics committees has increased review of these research studies. However, characteristics that reflect the operations of RECs in Myanmar have not been assessed. To assess the structures and processes of RECs at medical institutions in Myanmar, we used a self-assessment tool for RECs operating in low- and middle-income countries. This tool consists of the following ten domains: organizational aspects, membership and (...) class='Hi'>ethics training, submission arrangements and materials, meeting minutes, policies referring to review procedures, review of specific protocol and informed consent items, communication a decision, continuing review, REC resources and institutional commitment. We distributed this self-administered questionnaire to RECs from 15 medical institutions in Myanmar and one representative from each REC completed this questionnaire and returned it anonymously. We used descriptive, bivariate and multivariate statistics to analyse the data. Out of a maximum 200 points, the total mean score for Myanmar medical institutions was 112.6 ± 12.77, which is lower compared with the aggregate mean score of 137.4 ± 35.8 obtained from RECs in other countries. Domains in which the average percentage score was less than 60% included organizational commitment, membership and ethics training, continuing review and REC resources. Many RECs have a diverse membership and appropriate gender balance but lacked essential policies. The results show that for Myanmar RECs, there is significant room for improvement in their “structures and processes” as well as the extent of institutional commitment. The self-assessment tool proved to be a valuable method to assess the quality of RECs. (shrink)

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans was first developed to establish a standard of practice in research ethics by the three federal agencies responsible for funding institutional research in Canada: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council, and Social Sciences and Humanities Research Council. In 2010, a second edition of the policy, known as the TCPS 2, was released with updated information and expanded coverage of (...) research ethics issues. According to the TCPS 2, the Agencies’ mandate is “to promote research that is conducted according to the highest ethical standards,” and the TCPS 2 serves as a benchmark for this with respect for human dignity as its underlying value. Research institutions receiving Agency funding are to comply with this policy statement by forming Research Ethics Boards to review all research involving human participants. The intention behind this review requirement is to provide a proportionate assessment of the benefit-to-risk ratio of the research, and in that process, to safeguard “respect for persons”, express a “concern for welfare”, and uphold “justice”. Research may not proceed until ethics approval is granted by an institution’s REB. The current study evaluates REB members’ perspectives on their knowledge of research ethics, and juxtaposes these perceptions with those of researchers. Specifically, we are interested in the extent to which REB members with less experience read the TCPS 2, and whether those with less experience have decreased confidence in their ethics knowledge. (shrink)

In this paper the authors argue that research ethics committees should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: competent (...) individuals are epistemologically and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the “normal” constraints on people taking risks with themselves; RECs do not judge individual competence ; individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, the moral and political authority of RECs has not been established in this respect. (shrink)

The term therapeutic misconception was coined by Paul Appelbaum and his colleagues to describe the tendency of patients enrolled in clinical trials to confuse research participation with the personal clinical attention characteristic of medical care. It has not been recognized that an analogous therapeutic misconception pervades ethical thinking about clinical research with patient-subjects. Investigators and bioethicists often judge the ethics of clinical research based on ethical standards appropriate to the physician-patient relationship in therapeutic medicine. This ethical (...) approach to clinical research constitutes a misconception because it fails to appreciate the ethically significant differences between clinical research and clinical care.In this article I argue that the assumption that the ethical principles governing the practice of therapeutic medicine should also apply to clinical research with patient- subjects produces incoherence in research ethics and erroneous guidance concerning certain controversial research designs. (shrink)

Currently, research ethics committees in the UK meet behind closed doors—their workings and most of the content of their decisions are unavailable to the general public. There is a significant tension between this current practice and a broader societal presumption of openness. As a form of public institution, the REC system exists to oversee research from the perspective of society generally.An important part of this tension turns on the kind of justification that might be offered for the (...) REC system. In this paper I adapt Daniels and Sabin’s accountability for reasonableness model for just resource allocation to the research ethics context to provide some structural legitimacy and to enable progress on the question of openness. After considering the consequences of adopting this model for open REC meetings, I then examine some reasons that might be offered against open meetings. These arguments do not overwhelm the core intuitions behind the presumption of openness but they do, I suggest, give us reason to retreat from fully public meetings. I conclude that there should be important adjustments to the system towards public accountability and that there are grounds for stopping short of fully public meetings. (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.

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.

Research ethics guidelines grew out of several infamous episodes where research subjects were exploited. There is significant international synchronization of guidelines. However, indigenous groups in New Zealand, Canada and Australia have criticized these guidelines as being inadequate for research involving indigenous people and have developed guidelines from their own cultural perspectives. Whilst traditional research ethics guidelines place a lot of emphasis on informed consent, these indigenous guidelines put much greater emphasis on interdependence and trust. (...) This article argues that traditional guidelines are premised on relationships of equal power, and that often the researcher has more power that is not fully equalized by providing information. Where there is a relationship of unequal power, then focusing on interdependence and trust is more likely to achieve ethical safety. We illustrate this thesis by describing the detail of a research project looking at the use of interpreters, where we video-recorded live consultations and then interviewed the patient, interpreter and doctor. We conclude by suggesting that mainstream research ethics guidelines should pay more attention to the development of a trustworthy relationship between subject and researcher, and that, following the lead from clinical medicine, we should develop a culturally competent ethical framework for research on human subjects. (shrink)

The Médecins Sans Frontières ethics review board has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at early development stages. This article examines the MSF ERB’s experience addressing issues related to both the process of review (...) and substantive ethical issues in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees, we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the ‘optimal’ ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process. (shrink)

The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, (...) timing and decision-making. The key finding was that ethics committees received and processed the applications variably, reflecting individual factors and local problems. To improve consensus and facilitate multicentre studies, standard forms and instructions are suggested and the establishment of a national committee or advisory group advocated. (shrink)

Research Ethics, Volume 18, Issue 1, Page 51-63, January 2022. Aboriginal and Torres Strait Islander peoples in Australia, have historically experienced research as another means of colonialization and oppression. Although there are existing frameworks, guidelines and policies in place that respond to this history, the risk of exploitation and oppression arising from research still raises challenging ethical questions. Since the 1990s the National Health and Medical Research Council in Australia has developed specific sets of guidelines (...) that govern research with these populations in an attempt to redress injustices of the past. The current guidelines: Ethical Conduct in Research with Aboriginal and Torres Strait Islander Peoples and Communities: Guidelines for Researchers and Stakeholders, 2018, emphasis six core values which are bound together by “spirit and integrity.” The values are reflected through respect for cultural inheritance, and genuine negotiation of partnerships between researchers, other stakeholders, and communities. We examine whether these guidelines can lead to research and research practices that redress some of the ongoing traumas of colonialization and racism. We draw upon Margaret Urban Walker’s formulation of restorative justice, based upon her “pragmatics of repair” which relies upon “voice, validation and vindication” and at its core, the restoration of relationships. (shrink)

This paper puts forward the case for university research ethics committees to coordinate universities' efforts to foster research ethics in its broadest sense–ethics and integrity–and to foster it proactively and positively.

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)

The purpose of this study is to encourage and highlight discussion on how to improve the teaching of research ethics in institutions of higher education in Malaysia. Drawing on semi-structured interviews with 21 academics in a research-intensive university in Malaysia, interviewees agreed on the importance of emphasizing the subject of research ethics among students, as well as academics or researchers. This study reveals that participants felt that there is an urgent need to improve the current (...) awareness and knowledge of issues related to misconduct in research among students and academics. The results of this study indicate a need for better teaching on the subject of research ethics in order to prevent misconduct in research. Finally, it concludes with suggestions that there should be a clear definition of research misconduct, to include consequences when engaging in misconduct; a separate research ethics syllabus for pure and social sciences should be conducted; research ethics should be implemented as a core subject, and there should be an early intervention and continuous learning of research ethics, with an emphasis on ethics training. (shrink)

This paper is an examination of how research ethics committees have evolved from being advisory committees to more formal regulatory authorities. It is argued that the role of ethics committees should be broader than simple ethical review. Inconsistency in outcome should not be taken to signal failure. Procedural fairness is of the utmost importance. Nor should ethics committees be seen to diminish the ethical responsibilities of researchers themselves.