Online research in philosophy

The emergence of ethical controversy -- First embryo research regimes -- The ethics of embryonic stem cell research -- Stem cell and cloning politics.

What appeared to be the most momentous scientific advance of 2005 is currently under siege. In June, the prestigious journal Science published an article by the South Korean scientist Woo-Suk Hwang and an international team of co-authors describing how they had developed what were, in effect, “made to order†lines of human stem cells cloned from an adult. Although the scientific validity of their research is now the subject of several separate investigations, it is no less important to examine (...) its ethical implications. (shrink)

The author, a member of the U.S.President's Council on Bioethics, discussesethical issues raised by human cloning, whetherfor purposes of bringing babies to birth or forresearch purposes. He first argues that everycloned human embryo is a new, distinct, andenduring organism, belonging to the speciesHomo sapiens, and directing its owndevelopment toward maturity. He then distinguishesbetween two types of capacities belonging toindividual organisms belonging to this species,an immediately exerciseable capacity and abasic natural capacity that develops over time. He argues that it is (...) the second type ofcapacity that is the ground for full moralrespect, and that this capacity (and itsconcomitant degree of respect) belongs tocloned human embryos no less than to adulthuman beings. He then considers and rejectscounter-arguments to his position, includingthe suggestion that the capacity of embryos isequivalent to the capacity of somatic cells,that full human rights are afforded only tohuman organisms with functioning brains, thatthe possibility of twinning diminishes themoral status of embryos, that the fact thatpeople do not typically mourn the loss of earlyembryos implies that they have a diminishedmoral status, that the fact that earlyspontaneous abortions occur frequentlydiminishes the moral status of embryos, andthat his arguments depend upon a concept ofensoulment. He concludes that if the moralstatus of cloned human embryos is equivalent tothat of adults, then public policy should bebased upon this assumption. (shrink)

Background: The formulation and implementation of national ethical regulations to protect research participants is fundamental to ethical conduct of research. Ethics education and capacity are inadequate in developing African countries. This study was designed to develop a module for online training in research ethics based on the Nigerian National Code of Health Research Ethics and assess its ease of use and reliability among biomedical researchers in Nigeria.MethodologyThis was a three-phased evaluation study. Phase one (...) involved development of an online training module based on the Nigerian Code of Health Research Ethics (NCHRE) and uploading it to the Collaborative Institutional Training Initiative (CITI) website while the second phase entailed the evaluation of the module for comprehensibility, readability and ease of use by 45 Nigerian biomedical researchers. The third phase involved modification and re-evaluation of the module by 30 Nigerian biomedical researchers and determination of test-retest reliability of the module using Cronbach’s alpha. Results: The online module was easily accessible and comprehensible to 95% of study participants. There were significant differences in the pretest and posttest scores of study participants during the evaluation of the online module (p = 0.001) with correlation coefficients of 0.9 and 0.8 for the pretest and posttest scores respectively. The module also demonstrated excellent test-retest reliability and internal consistency as shown by Cronbach’s alpha coefficients of 0.92 and 0.84 for the pretest and posttest respectively. Conclusion: The module based on the Nigerian Code was developed, tested and made available online as a valuable tool for training in cultural and societal relevant ethical principles to orient national and international biomedical researchers working in Nigeria. It would complement other general research ethics and Good Clinical Practice modules. Participants suggested that awareness of the online module should be increased through seminars, advertisement on government websites and portals used by Nigerian biomedical researchers, and incorporation of the Code into the undergraduate medical training curriculum. (shrink)

Research ethics is predominantly taught and practiced in Anglophone countries, particularly those in North America and Western Europe. Initiatives to build research ethics capacity in developing countries must attempt to avoid imposing foreign frameworks and engage with ethical issues in research that are locally relevant. This article describes the process and outcomes of a capacity-building workshop that took place in Kinshasa, Democratic Republic of Congo in the summer of 2011. Although the workshop focused on a (...) specific ethical theme – the responsibilities of researchers to provide health-related care to their research participants – we argue that the structure of the workshop offers a useful method for engaging with research ethics in general, and the theme of ancillary care encourages a broad perspective on research ethics that is highly pertinent in low-income countries. The workshop follows an interactive, locally driven model that could be fruitfully replicated in similar settings. (shrink)

The role of the Research Ethics Committee (REC) in the design, conduct and dissemination of scientific research is still evolving and many important questions remain unanswered. Hence, the aim of this paper is to address some of the uncertainty that exists around the role and responsibilities of RECs and to discuss some of the controversy that exists over the criteria that RECs should follow when evaluating a research proposal. The discussion is organised around five of the (...) major roles currently performed by RECs when assessing proposals in the biomedical sciences. It will be shown that these five roles need to be critically evaluated and reassessed. The five roles addressed are: assessing the legitimacy and validity of the informed consent process, second, conducting a comprehensive risk/benefit analysis, third, assessing the validity of a research proposal, fourth, ensuring that researchers observe the social norms, values, customs, traditions and laws that prevail in the community or jurisdiction in which the research will be conducted and finally, monitoring the research project as it unfolds and providing an ongoing advisory and consultancy service to both new and experienced researchers. In reassessing the role of the REC, this paper concludes with a set of general recommendations for RECs. These provide some guidance on the minimum criteria that should be followed when RECs evaluate proposals. These guidelines will be beneficial for new and experienced members of REC, and will help to make the process a more objective, efficient and standardised process. The guidelines will also be beneficial for researchers in the biomedical sciences who are preparing proposals for ethical review. (shrink)

The CQUniversity Australia Human Research Ethics Committee (HREC) is a human ethics research committee registered under the auspices of the National Health and Medical Research Council. In 2009 an external review of CQUniversity Australia’s HREC policies and procedures recommended that a low risk research process be available to the institution’s researchers. Subsequently, in 2010 the Human Research Ethics Committee Low Risk Application Procedure came into operation. This paper examines the applications made under (...) the Human Research Ethics Committee Low Risk Application Procedure during the course of 2010 and 2011. The paper contributes to the literature analyzing the decision-making processes of research review committees through an analysis of the quantitative data relating to the low risk research applications made and through discourse analysis of the qualitative data represented by the assessment comments of the members of the Committee. (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)

The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC’s compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009–February 2011) divided into quarters to better value the influence of the new insurance (...) coverage regulation that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC’s opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place. (shrink)

This paper describes a three-year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross-section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement (...) in the research. Following the training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants’ knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically. (shrink)

The significance of animals in research cannot be over-emphasized. The use of animals for research and training in research centres, hospitals and schools is progressively increasing. Advances in biotechnology to improve animal productivity require animal research. Drugs being developed and new interventions or therapies being invented for cure and palliation of all sorts of animal diseases and conditions need to be tested in animals for their safety and efficacy at some stages of their development. Drugs and (...) interventions for human use pass through a similar development process and must be tested pre-clinically in laboratory animals before clinical trials in humans can be conducted. Therefore, animals are important players in research processes which directly and indirectly benefit animals and humans. However, questions remain as to whether these uses of animals consider the best interests of animals themselves. Various research and training institutions in Tanzania have established some guidelines on animal use, including establishing animal ethics committees. However, most institutions have not established oversight committees. In institutions where there may be guidelines and policies, there are no responsible committees or units to directly oversee if and how these guidelines and policies are enforced; thus, implementation becomes difficult or impossible. This paper endeavours to raise some issues associated with the responsible use of animals in research and training in Tanzania and highlights suggestions for improvement of deficiencies that exist in order to bridge the gap between what ought to be practised and what is practised. (shrink)

Is it permissible to use a human embryo in stem cell research, or in general as a means for benefit of others? Acknowledging each embryo as an object of moral concern, Louis M.Guenin argues that it is morally permissible to decline intrauterine transfer of an embryo formed outside the body, and that from this permission and the duty of beneficence, there follows a consensus justification for using donated embryos in service of humanitarian ends. He then proceeds (...) to show how this justification commands assent even within moral and religious views commonly thought to oppose embryo use. Beneath his moral reasoning lies a carefully constructed metaphysical foundation incorporating accounts of the ontology of development, embryos, and species. He also incisively discusses nonreprocloning, reprocloning, ectogenesis, and related scientific frontiers. This compelling philosophical study will interest all concerned to understand virtue and obligation in the relief of suffering. (shrink)

With increasing calls for global health research there is growing concern regarding the ethical challenges encountered by researchers from high-income countries (HICs) working in low or middle-income countries (LMICs). There is a dearth of literature on how to address these challenges in practice. In this article, we conduct a critical analysis of three case studies of research conducted in LMICs. We apply emerging ethical guidelines and principles specific to global health research and offer practical strategies that researchers (...) ought to consider. We present case studies in which Canadian health professional students conducted a health promotion project in a community in Honduras; a research capacity-building program in South Africa, in which Canadian students also worked alongside LMIC partners; and a community-university partnered research capacity-building program in which Ecuadorean graduate students, some working alongside Canadian students, conducted community-based health research projects in Ecuadorean communities. We examine each case, identifying ethical issues that emerged and how new ethical paradigms being promoted could be concretely applied. We conclude that research ethics boards should focus not only on protecting individual integrity and human dignity in health studies but also on beneficence and non-maleficence at the community level, explicitly considering social justice issues and local capacity-building imperatives. We conclude that researchers from HICs interested in global health research must work with LMIC partners to implement collaborative processes for assuring ethical research that respects local knowledge, cultural factors, the social determination of health, community participation and partnership, and making social accountability a paramount concern. (shrink)

In their recent paper in this journal, Heinz and colleagues accuse proponents of cognitive enhancement of making two unjustified assumptions. The first of these is the assumption that neuroenhancing drugs will be safe; the second is that research into cognitive enhancement does not pose particular ethical problems. Heinz and colleagues argue that both these assumptions are false. Here, I argue that these assumptions are in fact correct, and that Heinz and colleagues themselves make several assumptions that undermine their argument. (...) Neuroenhancement does raise several ethical concerns, but safety and research in this area pose no unique difficulties. (shrink)

While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration (...) journals over the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research. (shrink)

Biomedical Research and Beyond: Expanding the Ethics of Inquiry investigates the ethics of biomedical and scientific inquiry, including embryonic research, animal research, genetic enhancement, and fairness in research in the developing world. Core concerns of biomedical and scientific research ethics are then shown also to be key in humanistic areas of inquiry. Biomedical Research and Beyond concludes with a discussion of the virtues that all inquirers, scientific, medical, and humanistic, should possess.

This article is a response to McLeod and Baylis (2007) who speculate on the dangers of requesting fresh ‘spare’ embryos from IVF patients for human embryonic stem cell (hESC) research, particularly when those embryos are good enough to be transferred back to the woman. They argue that these embryos should be frozen instead. We explore what is meant by ‘spare’ embryos. We then provide empirical evidence, from a study of embryo donation and of embryo donors' views, to (...) substantiate some of their speculations about the problems associated with requesting fresh embryos. However, we also question whether such problems are resolved by embryo freezing, since further empirical evidence suggests that this raises other social and ethical problems for patients. There is little evidence that the request for embryos for research, in itself, causes patients distress. We suggest, however, that no requests for fresh embryos should be made in the first cycle of IVF treatment. Deferring the request to a later cycle ensures that potential donors are better informed (by experience and reflection) about the possible destinations of their embryos and about the definition of ‘spare embryos’. Both this article, and that by McLeod and Baylis, emphasize the need to consider the views and experiences of embryo donors when evaluating the ethics of embryo donation for hESC research. (shrink)

The context of international health research involving human subjects, and this should appear obvious, is the human community. As such, basic questions of how human beings should be treated by other human beings, particularly in situations of unequal power – e.g., in the form of control, choice, or opportunity – lay at the foundations of related ethical discourse when ethics are discussed at all. I trace a narrative that follows upon a recent revision process of international guidelines for (...) biomedical research involving human subjects. I focus in particular upon the issue of a standard of care. In the second section, I draw upon philosophers John Rawls, Claudia Card, and Allen Buchanan to discuss concerns regarding the 'least advantaged members of society' in the context of global inequality. The paper includes reflections upon pedagogy in courses focused upon international health research involving human subjects. (shrink)

There is wide agreement that community engagement is important for many research types and settings, often including interaction with ‘representatives’ of communities. There is relatively little published experience of community engagement in international research settings, with available information focusing on Community Advisory Boards or Groups (CAB/CAGs), or variants of these, where CAB/G members often advise researchers on behalf of the communities they represent. In this paper we describe a network of community members (‘KEMRI Community Representatives’, or ‘KCRs’) linked (...) to a large multi-disciplinary research programme on the Kenyan Coast. Unlike many CAB/Gs, the intention with the KCR network has evolved to be for members to represent the geographical areas in which a diverse range of health studies are conducted through being typical of those communities. We draw on routine reports, self-administered questionnaires and interviews to: 1) document how typical KCR members are of the local communities in terms of basic characteristics, and 2) explore KCR's perceptions of their roles, and of the benefits and challenges of undertaking these roles. We conclude that this evolving network is a potentially valuable way of strengthening interactions between a research institution and a local geographic community, through contributing to meeting intrinsic ethical values such as showing respect, and instrumental values such as improving consent processes. However, there are numerous challenges involved. Other ways of interacting with members of local communities, including community leaders, and the most vulnerable groups least likely to be vocal in representative groups, have always been, and remain, essential. (shrink)

Introduction The Brazilian national curriculum guidelines for undergraduate medicine courses inspired and influenced the groundwork for knowledge acquisition, skills development and the perception of ethical values in the context of professional conduct. Objective The evaluation of ethics education in research involving human beings in undergraduate medicine curriculum in Brazil, both in courses with active learning processes and in those with traditional lecture learning methodologies. Methods Curricula and teaching projects of 175 Brazilian medical schools were analyzed using a retrospective (...) historical and descriptive exploratory cohort study. Thirty one medical schools were excluded from the study because of incomplete information or a refusal to participate. Active research for information from institutional sites and documents was guided by terms based on 69 DeCS/MeSH descriptors. Curriculum information was correlated with educational models of learning such as active learning methodologies, tutorial discussions with integrated curriculum into core modules, and traditional lecture learning methodologies for large classes organized by disciplines and reviewed by occurrence frequency of ethical themes and average hourly load per semester. Results Ninety-five medical schools used traditional learning methodologies. The ten most frequent ethical themes were: 1 – ethics in research (26); 2 – ethical procedures and advanced technology (46); 3 – ethic-professional conduct (413). Over 80% of schools using active learning methodologies had between 50 and 100 hours of scheduled curriculum time devoted to ethical themes whereas more than 60% of traditional learning methodology schools devoted less than 50 hours in curriculum time to ethical themes. Conclusion The data indicates that medical schools that employ more active learning methodologies provide more attention and time to ethical themes than schools with traditional discipline-based methodologies. Given the importance of ethical issues in contemporary medical education, these findings are significant for curriculum change and modification plans in the future of Brazilian medical education. (shrink)

We discuss how academically-based interdisciplinary teams can address the extreme challenges of the world’s poorest by increasing access to the basic necessities of life. The essay’s first part illustrates the evolving commitment of research universities to develop ethical solutions for populations whose survival is at risk and whose quality of life is deeply impaired. The second part proposes a rationale for university responsibility to solve the problems of impoverished populations at a geographical remove. It also presents a framework for (...) integrating science, engineering and ethics in the efforts of multidisciplinary teams dedicated to this task. The essay’s third part illustrates the efforts of Howard University researchers to join forces with African university colleagues in fleshing out a model for sustainable and ethical global development. (shrink)

This is a comprehensive and practical guide to the ethical issues raised by different kinds of medical research, and is the first such book to be written with the needs of the researcher in mind. Clearly structured and written in a plain and accessible style, the book covers every significant ethical issue likely to be faced by researchers and research ethics committees. The author outlines and clarifies official guidelines, gives practical advice on how to adhere to these, (...) and suggests procedures in areas where official recommendations are vague or absent. This invaluable handbook will help researchers identify and address the ethical issues at an early stage in the design of their studies, to avoid unnecessary delay and to safeguard the wellbeing of patients and healthy volunteers. It will also be extremely useful to members of research ethics committees. (shrink)

The review system on research with human participants in the Netherlands is characterised as a decentralised controlled and integrated peer review system. It consists of an independent governmental body, the Central Committee on Research Involving Human Subjects (or Central Committee), which regulates the review of research proposals by accredited Medical Research Ethics Committees (MRECs). The legal basis was founded in 1999 with the Medical Research Involving Human Subjects Act. The review system is a decentralised (...) arrangement since most research proposal are reviewed by the 30 accredited MRECs in the country. It is a controlled system in which the Central Committee is responsible for the accreditation and oversight of the MRECs and can make legally binding directives for these committees. The assessment of research proposals is an integrated peer review process in which all documents of the research file are reviewed by experts in one committee only. A small number of research proposals are assessed by the Central Committee and not by accredited MRECs. These proposals are on specific research categories such as gene therapy, cell therapy and embryo research. The review of research with surplus human embryos is regulated separately in the Embryos Act. The Central Committee provides support to the accredited MRECs and to researchers and sponsors. It is currently developing an internet portal to reduce the bureaucracy and make the review process more efficient and transparent. The Central Committee stimulates confidence on medical research in society by providing a public trial registry with core data on reviewed research proposals. (shrink)

For more than 30 years, beginning with the Reagan administration's refusal to support and provide oversight for embryo research, and continuing to the present in congressionally imposed limits on funding for such research, progress in infertility medicine and the development of stem cell therapies has been seriously delayed by a series of political interventions. In almost all cases, these interventions result from a view of the moral status of human embryo premised largely on religious assumptions. Although (...) some believe that these interventions are valid expressions of religious values in the public sector, it is argued here that they, in fact, contradict Rawls's conception of public reasoning. Both the prohibition of research involving the human embryo as well as bans on federal funding for embryo-related research place the particular religious views of some citizens above the pressing health needs of almost all, and thus violate the ideal of civility implicit in the Rawlsian standard. (shrink)

Globalization, political upheavals, and Western economic struggles have caused a geographical reprioritization in the realm of drug development and human clinical research. Regulatory and cost hurdles as well as a saturation of research sites and subjects in Western countries have forced the pharmaceutical industry to place an unprecedented level of importance on emerging markets, injecting Western corporate initiatives into cultures historically and socially isolated from Western-centric value systems. One of the greatest recipients of this onslaught of Western business (...) and research practices is the Russian Federation. Namely, market forces are dictating a focused research initiative in the traditional emerging markets, but this focus may be at the expense of individual and societal dignity. (shrink)

Comprehensive in scope and research, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students alike.

When is clinical research ethical? The difficulty in answering this question lies in the dual nature of research on human subjects, which yields two somewhat conflicting sets of obligations. On the one hand, there is the traditional view of science that includes the idea of an obligation to learn about the world. On the other hand, there is the obligation of care on the part of researchers towards individual participants in the research ...

In this paper we argue that the consensus around normative standards for the ethics of research in clinical trials, strongly influenced by the Declaration of Helsinki, is perceived from various quarters as too conservative and potentially restrictive of research that is seen as urgent and necessary. We examine this problem from the perspective of various challengers who argue for alternative approaches to what ought or ought not to be permitted. Key themes within this analysis will examine these (...) claims and argue they have implications for the interests of the research subject, research governance and regulation. Using our work with TREAT-NMD, the neuromuscular clinical trials network, we posit that there is a place for advancing the discourse of moral rights and moral duties in the context of research, especially from the perspective of patients and their families, and for including the politics of patient activism and empowerment. At the same time we remain vigilant to the danger that the therapeutic misconception and other serious vulnerabilities for the patient population in clinical trials, are at risk of being overlooked. (shrink)

Biomedical research on humans is an important part of medical progress. But, when lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research -- institutional review boards, or IRBs -- is growing. IRB members face difficult decisions every day. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them (...) better understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the lives of human participants. For three major research areas -- drugs, medical devices, and genetic information -- Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process. (shrink)

This paper reports on recent regulations and guidelines in the Federal Republic of Germany bearing on perinatal medical ethics, embryo research and trophoblast biopsy. Some of the regulations are defensive responses to new moral opportunities. In contrast, this paper calls for a more aggressive moral cost-benefit assessment of high technology medicine, which would include large-scale research on embryos prior to the fiftieth day post-menstruation. Keywords: abortion, embryo research, moral triage, prenatal diagnosis, withholding treatment CiteULike (...) Connotea Del.icio.us What's this? (shrink)

A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.

This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the evolution and ...

Introduction The present volume contains the proceedings of the First International Conference on Medical Ethics which took place in Nicosia, from the 24th ...

On both sides of the debate on the use of embryos in stem cell research, and in reproductive technologies more generally, rhetoric and symbolic images have been evoked to influence public opinion. Human embryos themselves are described as either “very small human beings” or “small clusters of cells.” The intentions behind the use of these phrases are clear. One description suggests that embryos are already members of our community and share with us a right to life or at least (...) respectful treatment, whereas the other focuses on the differences between embryos and adult human beings with normal capacities, that is, their lack of sentience and of personal identity. The research on stem cells has been nicknamed “Frankenstein science” or presented as “research that could stop Parkinson disease.” Again, one description reminds us of scary science-fiction scenarios where the scientist is guilty of “playing God,” whereas the other description highlights the worth and potential benefits of the research outcomes. (shrink)

While many European countries are entering unknown legal terrain where the embryo in vitro is concerned, France can already look back on a long tradition of public discussion and legal codification of ways of dealing with in vitro embryos. In its comprehensive law of 1994, France had still rejected embryo research; however, due to the promising perspectives of stem cell research, the new law now pending implies a clear liberalization of the 1994 provisions. Both the French (...) lawmakers and the National Ethics Commission have repeatedly argued that possible utilization of embryos for research purposes may seem legitimate from the moment that there is no more "parental project." De facto, this concept implies that an embryo can be transformed into an object from the moment that the parents cease to desire it and that the value of protection is solely dependent on the will of third persons. At the same time, France is still speaking of guaranteeing respect for the "dignity of the embryo," which would mean that an embryo must not be reduced to a thing and treated for purposes which are not his own. Therefore, the French solution is not a consistent and honest solution, and in its new legal provisions, France has involved herself in manifold contradictions. France has rejected the conception of pre-embryo, but is de facto following Britain's model without making it explicit. (shrink)

Feminists have indicated the inadequacies of bioethical debates about human embryonic stem cell research, which have for the most part revolved around concerns about the moral status of the human embryo. Feminists have argued, for instance, that inquiry concerning the ethics and politics of human embryonic stem cell research should consider the relations of social power in which the research is embedded. My argument is that this feminist work on stem cells is itself inadequate, however, (...) insofar as it has not incorporated an analysis of disability into its considerations of the ethical and political issues that surround the phenomena. Thus, I consider claims that disability theorists and anti-disability activists have made about the research. I conclude by indicating that stem cell research must be situated within a cultural matrix that operates in the service of normalisation. (shrink)

On 25 April 2002, the German Parliament has passed a strict new law referring to stem cell research. This law took effect on July 1, 2002. The so-called embryonic Stem Cell Act ( Stammzellgesetz — StZG ) permits the import of embryonic stem (ES) cells isolated from surplus IvF-embryos for research reasons. The production itself of ES cells from human blastocysts has been prohibited by the German Embryo Protection Act of 1990, with the exception of the use (...) of ES cells which exist already. The debate on the legitimate use of ES cells escalated, after the main German research funding agency, the Deutsche Forschungsgemeinschaft (DFG), unexpectedly published new guidelines recommending are stricted use of human ES cells for research. Meanwhile, the debate has ethically dividedsociety, political parties, government and church members into a group supporting and a group rejecting ES cell research. The arguments in favour of such a research can be summarized as arguments derived from a new ethics ofhealing calling for a therapeutic imperative, whereas the arguments against can be summarized as arguments violating the fundamental principle of human dignity as they imply the destruction of human embryos. This article willtry to present and evaluate various ethical arguments founded on the latest biological and medical data on the potential use of stem cell technologies. It will finally come to the conclusion that ES cell research is opposed to human dignity, since the procedures of isolating ES cells require the destruction and instrumentalization of human embryos. Human embryos are human beings at a very early stage of their development, fully possessing the ability of completing their development. At this very early stage, human embryos are extremely dependent and fragile, and thus vulnerable corporealities. Vulnerability and human dignity demand the protection of the embryo's corporeal integrity. Hence, this essay will try to propagate research with adult stem(AS) cells, a procedure which does not require the destruction of human embryos; with regard to the necessary plasticity, it should be emphasized that AS cells very much resemble ES cells. (shrink)

To determine the knowledge, attitude, and ethical concerns of medical students and graduates with regard to Embryonic Stem Cell (ESC) research. This questionnaire based descriptive study was conducted at the Civil Hospital Karachi (CHK), Pakistan from February to July 2008. A well structured questionnaire was administered to medical students and graduate doctors, which included their demographic profile as well as questions in line with the study objective. Informed consent was taken and full confidentiality was assured to the participants. Data (...) were entered in a Statistical Package for Social Sciences (SPSS version.12) and analyzed. A total of 204 male and 216 female medical students and doctors were administered questionnaires out of which 105 males (51.4%) and 108 females (50%) were aware of the embryonic stem cell research and its ethical implications. Forty percent males and 47% of females were of the opinion that life begins at conception. Forty-six percent males and 39% females were in favor of stem cell research while only 31% males and 28% females supported the ESC research. Less than 1/3 of students supported using frozen embryos for research purposes while more than 2/3 indicated that they were unlikely to support abortion for stem cell research purposes. The majority of the students were in favor of stem cell research with some reservations regarding ESC research. A sizeable number of students withheld their views, reflecting their poor understanding of medical ethics. The result of the study indicates a need for incorporating bioethics into the medical curriculum. (shrink)

The sixth edition of the Manual for Research Ethics Committees is a unique compilation of legal and ethical guidance which will prove invaluable for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy. Presented in a clear and authoritative form, it incorporates the key legal and ethical guidelines and specially written chapters on major topics in bioethics by leading academic (...) authors and practitioners, pharmaceutical industry associations and professional bodies. In the sixth edition there are fifteen new chapters covering key issues from participation in clinical trials to cloning, and for the first time the manual has been produced in one easy-to-search hardback volume. (shrink)

This article deals with the discussion on the status of the human embryo in Italy on a philosophical, socio-ethical and juridical level before, during and after the law (n. 40/2004). Different lines of thought are outlined and critically discussed. The focus is the debate over the so-called embryonic stem cells, pointing out the ethical premises and the juridical implications. The regulations in Italy are analysed in detail, referring to legislation and jurisprudence (showing analogies and differences). In particular the author (...) includes evidence for the debate after the law came in, with specific attention on the question of the use of imported embryonic stem cells and public financing for research and the problem of the use of frozen and non-implantable embryos. (shrink)

Millions of people undergo displacement in the world. Internally displaced people (IDP) are especially vulnerable as they are not protected by special legislation in contrast to other migrants. Research conducted among IDPs must be correspondingly sensitive in dealing with ethical issues that may arise. Muslim IDPs in Puttalam district in the North-Western province of Sri Lanka were initially displaced from Northern Sri Lanka due to the conflict in 1991. In the backdrop of a study exploring the prevalence of common (...) mental disorders among the IDPs, researchers encountered various ethical challenges. These included inter-related issues of autonomy, non-maleficence, beneficence, confidentiality and informed consent, and how these were tailored in a culture-specific way to a population that has increased vulnerability. This paper analyses how these ethical issues were perceived, detected and managed by the researchers, and the role of ethics review committees in mental health research concerning IDPs. The relevance of guidelines and methodologies in the context of an atypical study population and the benefit versus risk potential of research for IDPs are also discussed. The limitations that were encountered while dealing with ethical challenges during the study are discussed. The concept of post-research ethical conduct audit is suggested to be considered as a potential step to minimize the exploitation of vulnerable populations such as IDPs in mental health research. (shrink)

Many people have moral qualms about embryo research, feeling that embryos must deserve some kind of protection, if not so much as is afforded to persons. This paper will show that these qualms serve to camouflage motives that are really prudential, at the cost of also obscuring the real ethical issues at play in the debate concerning embryo research and therapeutic cloning. This in turn leads to fallacious use of the Actions/Omissions Distinction and ultimately neglects the (...) duties that we have towards future persons. (shrink)

Climate engineering (CE), the intentional modification of the climate in order to reduce the effects of increasing greenhouse gas concentrations, is sometimes touted as a potential response to climate change. Increasing interest in the topic has led to proposals for empirical tests of hypothesized CE techniques, which raise serious ethical concerns. We propose three ethical guidelines for CE researchers, derived from the ethics literature on research with human and animal subjects, applicable in the event that CE research (...) progresses beyond computer modeling. The Principle of Respect requires that the scientific community secure the global public's consent, voiced through their governmental representatives, before beginning any empirical research. The Principle of Beneficence and Justice requires that researchers strive for a favorable risk–benefit ratio and a fair distribution of risks and anticipated benefits, all while protecting the basic rights of affected individuals. Finally, the Minimization Principle requires that researchers minimize the extent and intensity of each experiment by ensuring that no experiments last longer, cover a greater geographical extent, or have a greater impact on the climate, ecosystem, or human welfare than is necessary to test the specific hypotheses in question. Field experiments that might affect humans or ecosystems in significant ways should not proceed until a full discussion of the ethics of CE research occurs and appropriate institutions for regulating such experiments are established. (shrink)

This article is the first in a two-part review of policy design for human embryo research in Canada. In this article we explain how this area of research is circumscribed by law promulgated by the federal Parliament (the Assisted Human Reproduction Act ) and by guidelines issued by the Tri-Agencies (the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans and Updated Guidelines for Human Pluripotent Stem Cell Research ). In so doing, we provide the (...) first comprehensive account of the rules currently governing human embryo research in Canada. In this article we also provide a chronological description of relevant policy initiatives and outcomes related to these policy instruments over the past 20 years, with particular attention to public involvement in policy design. This sets the stage for the second article (scheduled to appear in vol. 6 issue 3) in which we critically analyse the history of policy design for human embryo research in Canada, applying a typology of modes of public consultation developed by Eric Montpetit. Our goal is to carefully explain the various episodes of policy development and their corresponding outcomes, in order to more effectively address emerging questions about the legitimacy of future policy initiatives for human embryo research in Canada. (shrink)

Introduction TEMPE (Teaching Ethics: Material for Practitioner Education) is a two-year research project (2000-2002) funded by the European Commission ...

Ethics and Educational Research: An Introduction Robert G. Burgess Ethical questions are the subject of interdisciplinary discussions and debates. ...

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 ...

This paper addresses the growing concern over violation of research ethics in marketing, in particular rights of human subjects in fieldwork, notably the right to informed consent; right to privacy and confidentiality; and right not to be deceived or harmed as a result of participation in a research. The paper highlights the interaction of the three main parties involved in most marketing research: the sponsoring organization (client or user), researcher, and participant in the survey, focusing on (...) researcher’s ethical responsibilities in interacting with human subjects in surveys. The paper stresses the importance of ethical integrity in marketing research and emphasizes the need to establish a universal model for regulatory requirements and well institutionalized practice of ethical research. (shrink)

All agree that if the Milgram experiments were proposed today they would never receive approval from a research ethics board. However, the results of the Milgram experiments are widely cited across a broad range of academic literature from psychology to moral philosophy. While interpretations of the experiments vary, few commentators, especially philosophers, have expressed doubts about the basic soundness of the results. What I argue in this paper is that this general approach to the experiments might be in (...) error. I will show that the ethical problems that would prevent the experiments from being approved today actually have an effect on the results such that the experiments might show less than many currently suppose. Making this case demonstrates two conclusions. The first is that there are good reasons to think that the conclusions of many of Milgram’s commentators might be too strong. The second conclusion is a more general one. The ethics procedures commonly used by North American research ethics boards serve not only to protect human participants in research but also can sometimes help secure, to an extent, the integrity of results. In other words, good ethics can sometimes mean better science. (shrink)

This book will attempt to show that these and other problems are ultimately resolvable, given careful and unbiased application of established ethical principles ...

s With the unprecedented increase in the number of females holding executive positions in business, there has arisen interest in issues pertaining to the role of women in business organizations, including that of malefemale differences in ethical attitudes/behavior. To add to the research evidence on the issue, this paper examines differences in research ethics judgments between male and female marketing professionals. The results indicate that female marketing professionals evince higher research ethics judgments than their male (...) counterparts. (shrink)

Ethics is normative; ethics indicates, in broad terms, what researchers should do. For example, researchers should respect human participants. Empirical study tells us what actually happens. Empirical research is often needed to fine-tune the best ways to achieve normative objectives, for example, to discover how best to achieve the dual aims of gaining important knowledge and respecting participants. Ethical decision making by scientists and institutional review boards should not be based on hunches and anecdotes (e.g., about such (...) matters as what information potential research participants would want to know and what they understand, or what they consider to be acceptable risks). These questions should be answered through empirical research. Some of the preceding articles in this special issue illustrate uses of empirical research on research ethics. This article places empirical research on research ethics into broader perspective and challenges investigators to use the tools of their disciplines to proactively solve ethical problems for which there currently exist no empirically proven solutions. (shrink)

The Human Tissue Act 2004 in the United Kingdom clearly represents not a principled approach but instead a compromise, a pragmatic approach which balances several different ethical considerations against each other. In regards to the use of tissue in research it has left much of the more difficult decisions to be made by research ethics committees on a case by case basis. In particular it is now the role of research ethics committees to decide whether (...) research can be carried out using human tissue where no consent was given for the use of this tissue in research. Likewise research ethics committees are now charged with approving of human tissue banks which then need no further ethical approval to carry out research solely using tissue from that bank. There has however been little guidance in regards to the decisions these committees must make. This paper aims to delineate these decisions and offer some philosophical guidance to research ethics committees in making these decisions. (shrink)

It has become almost a truism to describe the interaction between research ethics committees and researchers as being marred by distrust and conflict. The ethical conduct of researchers is increasingly a matter of institutional concern because of the degree to which non-compliance with national standards can expose the entire institution to risk. This has transformed research ethics into what some have described as a research ethics industry. In an operational sense, there is considerable focus (...) on modifying research behaviour through a combination of education and sanctions. The assessment of whether a researcher is ethical is too often based on whether they submit their work for review by an ethics committee. However, is such an approach making a useful contribution to the actual ethical conduct of research and the protection of the interests of participants? Does a focus on ethical review minimise institutional risk? Instead it has been suggested that ethics committees may be distorting or frustrating useful research and are promoting a culture of either mindless rule following or frustrated resistance. An alternative governance approach is required. There is a need for a strong institutional focus on promoting and supporting the reflective practice of researchers through every stage of their work. By situating research ethics within the broader framework of institutional governance, this paper suggests it is possible to establish arrangements that actually facilitate excellent and ethical research. (shrink)

The purpose of this paper is to provide a simple yet comprehensive organizing scheme for the responsible conduct of research (RCR). The heuristic offered here should prove helpful in research ethics education, where the many and heterogeneous elements of RCR can be bewildering, as well as research into research integrity and efforts to form RCR policy and regulations. The six domains are scientific integrity, collegiality, protection of human subjects, animal welfare, institutional integrity, and social responsibility.

This paper was delivered at the 2009 annual conference of the National Council on Ethics in Human Research. It is a reflective piece based on many years of experience with human research ethics and the role of Research Ethics Boards in human participant research.

This paper shares my reflections on the research ethics review process, from the point of view of both a qualitative researcher and a member of an institutional research ethics review board. By considering research ethics review, first as practice, then as policy, as a relationship and, finally, as a performance, I attempt to outline a new vision of research ethics, one that engages seriously with the relationship between receiving ethics approval, and (...) conducting ethical research. (shrink)

There is a growing body of literature on the research ethics review process, a process that can have important effects on the nature of research in contemporary times. Yet, many people know little about what the actual process entails once an application has been submitted for review. This lack of knowledge can affect researchers and committee members' responses to the review process. Based on ethnographic research on the ethics review process in 5 countries (Australia, Canada, (...) New Zealand, the United States, and the United Kingdom) this article takes the reader through common aspects of the research ethics review process, including some of the kinds of narratives that influence decision making. Greater understanding of the nature of the review process and the narratives that often form the core of the process can help contextualize responses that researchers get from committees so they can better address them. It may also help committee members reflect on how these narratives influence their decision making and the responses they make to researchers. (shrink)

Research Ethics Boards (REBs) provide oversight for Canadians that research projects will comply with standards of ethics if the studies are carried out as described in the documents that have been approved. While REBs have traditionally been affiliated with institutions such as universities and hospitals, a number of factors - including the increased volume of research being conducted outside academic centres - have resulted in the establishment of some private or independent REBs. This, in turn, (...) has raised concerns about the credibility of REBs in the private sector and their capacity to handle issues around conflict of interest. This Breakout Session was an opportunity to hear the perspectives of people associated with institutional and private REBs and examine perceived problems with boards in the private sector, scrutinize theoretical and structural differences between types of REBs, and look at whether or not there is room for both institutional and private boards in the Canadian research review landscape. (shrink)

The growing emphasis on the importance of publishing scientific findings in the academic world has led to increasing prevalence of potentially significant publications in which scientific and ethical rigour may be questioned. This has not only hindered research progress, but also eroded public trust in all scientific advances. In view of the increasing concern and the complexity of research misconduct, the Committee on Publication Ethics (COPE) was established in 1997 to manage cases with ethical implications. In order (...) to review the outcomes of cases investigated by COPE, a total of 408 cases that had been managed by COPE were successfully extracted and analysed with respect to 7 distinct criteria. The results obtained indicate that the number of ethical implications per case has not changed significantly (p > 0.01) since the year COPE was instigated. Interestingly, the number of ethical cases, and to some extent, research misconduct, is not diminishing. Therefore, journal editors and publishers need to work closely together with COPE to inculcate adoption of appropriate research ethics and values in younger researchers while discouraging others from lowering standards. It is hoped that with a more concerted effort from the academic community and better public awareness, there will be fewer incidences of ethically and scientifically challenged publications. The ultimate aim being to enhance the quality of published works with concomittant public trust in the results. (shrink)

Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other hand, a sizeable body of literature has emerged criticising the work of RECs, as, among other things, overly bureaucratic and unresponsive to the needs (...) of disciplines outside the biomedical sciences. This article adopts the format of a debate between a Chair of a university REC and a social science researcher as a vehicle for contrasting different perspectives on research ethics. The fictional debate allows for a productive discussion between the two sides, incorporating key insights from the recent literature and concludes with a synthesis that sketches out some ideas about how university RECs can be made more responsive and accountable. (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)

Institutions create their own internal cultures, including the culture of ethics that pervades scientific research, academic policy, and administrative philosophy. This paper addresses some of the issues involved in institutional enhancement of its culture of research ethics, focused on individual empowerment and strategies that individuals can use to initiate institutional change.

Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) are rapidly becoming indispensable mechanisms in the overall workings of university institutions. In fact, the ethical dimension is an important aspect of research governance processes present in institutions of higher learning. However, it is often deemed that research in the social sciences do not require ethical appraisal or clearance, because of the alleged absence of harm in conducting such research. This is an erroneous and dangerous assumption (...) given that research in social sciences poses various and complex dilemmas related to ethics. The article aims to gauge the importance of ethical appraisal at a particular institution of higher learning’s Faculty of Humanities. This is done by scrutinising its defunct REC, and the views that Heads of Departments of the Faculty have of ethics in research and the need for ethical appraisal by this REC. Finally, some suggestions are made to proceed to review and restructure the current REC with the ultimate objective to make it functional again. It was found that the development and discussion around ethics in research and ethical appraisal are part of a much needed thrust to sensitise the entire Faculty and the institution on the widespread beneficial repercussions of ethical awareness in research and beyond. (shrink)

A model is described for implementing a program in research ethics education in the face of federal and institutional mandates and current resource, disciplinary, and infrastructure limitations. Also discussed are the historical background, content and evaluation process of the workshop at the heart of the program, which reaches a diverse group of over 250 students per year—from first-year graduate students in basic research labs to clinical fellows. The workshop addresses central issues in both everyday laboratory ethics (...) and in larger societal questions. Goals include improving overall awareness of ethics guidelines and philosophy and enhancing skills in identifying and then analyzing the ethical components of situations. Pedagogies used and their effectiveness and that of the overall workshop and extended program are addressed. Programs like these have initiated a shift in the culture of basic research, which is a critical need given the current atmosphere. (shrink)

Background: Concerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs) in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges. Methods: We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of (...) the REC, membership composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. We used basic descriptive statistics to evaluate the quantitative data. Results: We obtained responses from 67% (12/18) of the identified RECs. Most RECs (10/12) have standard operating procedures and many (7/12) have established policies to manage conflicts of interests. The average membership was 10.3 with a range from 7-19. The predominant member type was physicians (69.5% of all of the REC members) with little lay representation (13.7%). Most RECs met at least once/month and the average number of protocols reviewed per meeting was 3.8 with a range from 1-10. Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. Regarding resources, roughly half of the RECs have dedicated capital equipment (e.g., meeting room, computers, office furniture, etc); none of the RECs have a formal operating budget. Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics. Conclusion: Our study documents several areas of strengths and areas for improvements in the operations of Egyptian RECs. Regarding strengths, many of the existing RECs meet frequently, have a majority of members with prior training in research ethics, and have written policies. Regarding areas for improvements, many RECs should strive for a more diverse membership and should receive more financial resources and administrative support personnel. We recommend that RECs include more individuals from the community and develop a continuing educational program for its members. Institutional officials should be aware of the resource capacity needs of their RECs. (shrink)

This article parallels a debate similar to the one in Canada and elsewhere where researchers whose work involves humans now operate under a single ethics policy, with a strong biomedical emphasis. The institution of research ethics committees for humanities and social sciences in South Africa are relatively recent, posing unique challenges to researchers and academicians. These factors contribute to the complexity of conducting ethically sound research in the humanities and social sciences. The article explores this specific (...) context and how a research ethics committee in the humanities and social sciences can meet the challenge of the unique South African context. (shrink)

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

This paper explores the perceptions and experiences of four doctoral researchers to examine how research ethics committee (REC) processes have shaped and influenced specific health-based ethnographic studies. This paper considers how a universal tightening of ethical REC scrutiny at university level, as well as those governing the health and social care sector in the United Kingdom, impacts upon social research involving the inclusion of participants from certain groups. Increased restrictions in ethics scrutiny is justified as protecting (...) vulnerable people from intrusive research and is embedded in legislation, specifically the UK Mental Capacity Act 2005. The general international trend towards greater ethical scrutiny is heralded as an uncontested social good, yet this unquestioned assumption is tested in relation to qualitative social research methodologies that seek to explore the experiences of ?vulnerable? individuals. It is consequently argued that ethics review restrictions are in danger of disenfranchising sectors of the community, excluding them from engaging in social research activities that would serve to highlight their experiential and lived conditions. The enhanced bureaucratic control of the doctoral process in conjunction with the REC is also discussed as inhibiting proposed studies. (shrink)

: President Clinton's charge to the Advisory Committee on Human Radiation Experiments included the identification of ethical and legal standards for evaluating government-sponsored radiation experiments conducted during the Cold War. In this paper, we review the traditional account of the history of American research ethics, and then highlight and explain the significance of a number of the Committee's historical findings as they relate to this account. These findings include both the national defense establishment's struggles with legal and insurance (...) issues concerning human experiments, and the medical profession's perspective on human experimentation in the years following the Nuremberg Medical Trials. We conclude that the Committee's work both enriches the traditional view of the history of research ethics and opens important new areas for study. (shrink)

This paper describes the establishment of and the issues experienced by the Research Ethics Committee (REC) of a Business School within a University in Ireland. It identifies the issue of voluntarily given informed consent as a key challenge for RECs operating in a Business School context. The paper argues that whilst the typology of ethical issues in business research are similar to the wider social sciences, the fact that much research is carried out in the workplace (...) adds to the complexity of the REC deliberations. The use of deception in the design of research studies, pestering the local community and the potential for harm to the researcher are also discussed briefly in the context of business research. The experiences of the authors’, two of whom have served as respective chairpersons of the business school REC since its inception in addition to being members of the university level REC, inform the discussion. (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)

Little is known about the mechanisms by which psychology graduate programs transmit responsible conduct of research (RCR) values. A national sample of 968 current students and recent graduates of mission-diverse doctoral psychology programs completed a Web-based survey on their research ethics challenges, perceptions of RCR mentoring and department climate, whether they were prepared to conduct research responsibly, and whether they believed psychology as a discipline promotes scientific integrity. Research experience, mentor RCR instruction and modeling, and (...) department RCR policies predicted student RCR preparedness. Mentor RCR instruction, department RCR policies, and faculty modeling of RCR behaviors predicted confidence in the RCR integrity of the discipline. Implications for training are discussed. (shrink)

The Hwang affair, a dramatic and far reaching instance of scientific fraud, shocked the world. This collective national failure prompted various organizations in Korea, including universities, regulatory agencies, and research associations, to engage in self-criticism and research ethics reforms. This paper aims, first, to document and review research misconduct perpetrated by Hwang and members of his research team, with particular attention to the agencies that failed to regulate and then supervise Hwang’s research. The paper (...) then examines the research ethics reforms introduced in the wake of this international scandal. After reviewing American and European research governance structures and policies, policy makers developed a mixed model mindful of its Korean context. The third part of the paper examines how research ethics reform is proactive (a response to shocking scientific misconduct and ensuing external criticism from the press and society) as well as reactive (identification of and adherence to national or international ethics standards). The last part deals with Korean society’s response to the Hwang affair, which had the effect of a moral atomic bomb and has led to broad ethical reform in Korean society. We conceptualize this change as ethical modernization, through which the Korean public corrects the failures of a growth-oriented economic model for social progress, and attempts to create a more trustworthy and ethical society. (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)

This paper explores issues of professional ethics that are relevant to those who engage in the ethical review of research with human subjects. Codes of ethics of a number of professional groups are examined for guidance offered to research ethics board members. The thought of the philosopher, Mike Martin, is introduced as a way to highlight some of the ethical issues that reviewers encounter in their work. Martin believes that ideals contribute to the coherence of (...) an individual’s life by shaping character. His discussion of caring, justice, trust, and professional distance offer a resource for reviewers to refl ect on the ethicaldimensions of their work. (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)

University based academic Research Ethics Boards (REB) face the particularly difficult challenge of trying to achieve representation from a variety of disciplines, methodologies and research interests. Additionally, many are currently facing another decision – whether to have students as REB members or not. At Ryerson University, we are uniquely situated. Without a medical school in which an awareness of the research ethics review process might be grounded, our mainly social science and humanities REB must also (...) educate and foster awareness of the ethics review process throughout the academic community. Our Board has had and continues to have students as active members. While there are challenges to having students as Board members, these are clearly outweighed by the advantages, for both the academic community and the future of ethically sound research in the social sciences and humanities. Moreover, the challenges are often based on misconceptions and can be easily overcome through increased education and understanding of the research ethics review process by the academic community at large. The purpose of this paper is to describe and discuss the experiences, advantages and challenges of having students as REB members. The advantages of having students as REB members include the following: (1) Students are the proposed participants in many of our reviewed protocols and student members may illuminate unique issues of participation. (2) Students are active and highly engaged members of the REB. (3) Having students on the REB enhances awareness of research ethics within the University. (4) Student REB members have an opportunity to mentor other students and provide leadership for both undergraduate and graduate students. (5) Students are more vigorously recruited than faculty members and often apply for student positions with enthusiasm and preparation. (6) In creating an atmosphere of excellence in research, engaging students at the beginning of their research career will help in creating tomorrow’s leaders in research and research ethics. The challenges of having students as REB members include the following: (1) Faculty members may be uneasy regarding the prospect of students reviewing protocols. (2) Faculty members may be concerned about confidentiality and respect with students reviewing faculty research protocols. (3) There may be an increased burden for students who serve as members on an REB. (4) There is concern that students will offer less continuous service to the REB. (5) There is a common misconception that students do not have the experience to carry out ethical reviews. While there are challenges from faculty members and others regarding having students as REB members, these challenges are often based on misconceptions about the nature of the REB work and the ethics review process in general. These challenges are also often based on the misconception of the ethics review process as one of peer review and evaluation, instead of a community-based and inclusive process. Having student members is a long-term strategy for both overcoming the misconceptions of the REB as a “necessary evil” and for fostering an awareness of the imperative for ethically sound research in the social sciences and humanities. (shrink)

The study examines, in the context of Crawford's (1970) study items, the influence of non-anonymity deriving from feedback of research results on marketing professionals' research ethics judgements, particularly that of response patterns (social desirability of responses) and item omissions. The results indicate that such non-anonymity does not significantly influence the social desirability of responses or item omissions — thus suggesting the appropriateness of its use to stimulate research ethics responses.

A team of philosophers and scientists at Dartmouth College worked for three years to create, train faculty and pilot test an adequate and exportable class in research methods for graduate students of science and engineering. Developing and testing methods for evaluating students’ progress in learning research ethics were part of the project goals. Failure of methods tried in the first year led to the refinement of methods for the second year. These were used successfully in the pilot (...) course and in one university setting external to Dartmouth. The process of development and justification for the final methods are discussed here. (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)

This commentary on K.D. Pimple’s “Six Domains of Research Ethics”, focuses on the area of institutional integrity and looks at “relationships between researchers, their sponsoring institutions, funding agencies, and the government,” considering the implications of institutional demands and support for research, and, in turn, demands and support on research priorities and public education.

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of (...) Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. (shrink)

Little is known about the mechanisms by which psychology graduate programs transmit responsible conduct of research (RCR) values. A national sample of 968 current students and recent graduates of mission-diverse doctoral psychology programs completed a Web-based survey on their research ethics challenges, perceptions of RCR mentoring and department climate, whether they were prepared to conduct research responsibly, and whether they believed psychology as a discipline promotes scientific integrity. Research experience, mentor RCR instruction and modeling, and (...) department RCR policies predicted student RCR preparedness. Mentor RCR instruction, department RCR policies, and faculty modeling of RCR behaviors predicted confidence in the RCR integrity of the discipline. Implications for training are discussed. (shrink)

McGovern, Kevin This article explores the report of the 2010 independent review committee into Australia's cloning and embryo research laws. Its author, the Director of the Centre, was one of the five members of this committee.

University based academic Research Ethics Boards (REB) face the particularly difficult challenge of trying to achieve representation from a variety of disciplines, methodologies and research interests. Additionally, many are currently facing another decision – whether to have students as REB members or not. At Ryerson University, we are uniquely situated. Without a medical school in which an awareness of the research ethics review process might be grounded, our mainly social science and humanities REB must also (...) educate and foster awareness of the ethics review process throughout the academic community. Our Board has had and continues to have students as active members. While there are challenges to having students as Board members, these are clearly outweighed by the advantages, for both the academic community and the future of ethically sound research in the social sciences and humanities. Moreover, the challenges are often based on misconceptions and can be easily overcome through increased education and understanding of the research ethics review process by the academic community at large. The purpose of this paper is to describe and discuss the experiences, advantages and challenges of having students as REB members. The advantages of having students as REB members include the following: (1) Students are the proposed participants in many of our reviewed protocols and student members may illuminate unique issues of participation. (2) Students are active and highly engaged members of the REB. (3) Having students on the REB enhances awareness of research ethics within the University. (4) Student REB members have an opportunity to mentor other students and provide leadership for both undergraduate and graduate students. (5) Students are more vigorously recruited than faculty members and often apply for student positions with enthusiasm and preparation. (6) In creating an atmosphere of excellence in research, engaging students at the beginning of their research career will help in creating tomorrow’s leaders in research and research ethics. The challenges of having students as REB members include the following: (1) Faculty members may be uneasy regarding the prospect of students reviewing protocols. (2) Faculty members may be concerned about confidentiality and respect with students reviewing faculty research protocols. (3) There may be an increased burden for students who serve as members on an REB. (4) There is concern that students will offer less continuous service to the REB. (5) There is a common misconception that students do not have the experience to carry out ethical reviews. While there are challenges from faculty members and others regarding having students as REB members, these challenges are often based on misconceptions about the nature of the REB work and the ethics review process in general. These challenges are also often based on the misconception of the ethics review process as one of peer review and evaluation, instead of a community-based and inclusive process. Having student members is a long-term strategy for both overcoming the misconceptions of the REB as a “necessary evil” and for fostering an awareness of the imperative for ethically sound research in the social sciences and humanities. (shrink)

This paper considers concerns that social care research may be stifled by health-focused ethical scrutiny under the Mental Capacity Act 2005 and the requirement for an ?appropriate body? to determine ethical approval for research involving people who are deemed to lack capacity under the Act to make decisions concerning their participation and consent in research. The current study comprised an online survey of current practice in university research ethics committees (URECs), and explored through semi-structured interviews (...) the views of social researchers engaged in or exploring work concerning people who may, under the Act, lack the capacity to make decisions to consent to participate in a research programme. The paper concludes that there was a lack of overt knowledge of and reference to the implications of the Act for research and some concerns that a restrictive focus on health-related scrutiny might prevent social care research from taking place. There was also a degree of creativity shown by social care researchers in responding to changing demands and a wish to assist people in making decisions to participate where possible. (shrink)

Here we describe the five steps of evidence-based practice as applied to research ethics review and apply these steps to three exemplar dilemmas: incentive payments in substance abuse research; informed consent for biobanking; and placebo-controlled trials involving pregnant women in order to demonstrate the potential of empirical data to inform and improve IRB decision-making.

When it comes to the matter of human embryo research law plays a crucial role in its development by helping to set the boundaries of what may be done, the sanctions for acting outside those boundaries and the rights and responsibilities of key parties. Nevertheless, the philosophical challenges raised by human embryo research, even with the best will of all concerned, may prove too great for satisfactory resolution through the legal process. Taking as its focus the (...) position of Ireland, this paper explores the distinctive constitutional approach taken on this issue and addresses the difficulty of translating sound philosophy into judicial decrees and the difficulty of establishing expert commissions to make law reform proposals on matters of profound normative controversy. It concludes that the Irish experience does have useful lessons for those in other countries who are concerned with the legal approach to research on human embryos and points to the desirability of a diversity of normative positions in order to enrich the quality of the analysis so as to encourage more informed debate in society. (shrink)

Background Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis. Methods Retrospective cohort of 976 protocols approved (...) by a representative sample of 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives. Results Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14–17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25–53) and 37 (95% CI: 27–46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise. Conclusion The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees. (shrink)

In 2006 the Government issued a White Paper in which it proposed a ban on human-animal embryo research pending greater clarity on its potential. The Commons Select Committee on Science and Technology initiated an Inquiry and concluded that such research was necessary and should be permitted immediately. The Government agreed and this is reflected in revised legislation. The Government has issued guidelines on the gathering and use of scientific advice and evidence, designed to ensure that these are (...) “credible, reliable and objective.” This article tests the Committee’s approach in the light of its remit and these, and other, relevant guidelines and concludes that it failed to meet these standards. Rather, it effectively ceded to an interest group the regulation of its own activities. The article ends by suggesting alterations to the Committee’s remit and composition designed to ensure that the public interest is better protected in future. (shrink)