BiomedicalResearch 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 researchethics are then shown also to be key in humanistic areas of inquiry. BiomedicalResearch and Beyond concludes with a discussion of the virtues that all inquirers, scientific, medical, (...) and humanistic, should possess. (shrink)
The role of the ResearchEthics 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)
We argue that the recommendations made by the Institute of Medicine’s 2011 report, Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity, are methodologically and ethically confused. We argue that a proper understanding of evolution and complexity theory in terms of the science and ethics of using chimpanzees in biomedicalresearch would have had led the committee to recommend not merely limiting but eliminating the use of chimpanzees in biomedicalresearch. Specifically, we argue (...) that a proper understanding of the difference between the gross level of examination of species and examinations on finer levels can shed light on important methodological and ethical inconsistencies leading to ignorance of potentially unethical practices and policies regarding the use of animals in scientific research. (shrink)
The European project European and Latin American Systems of Ethics Regulation of BiomedicalResearch Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedicalresearch in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedicalresearch’ as a set of actors, institutions, codes and laws involved in (...) overseeing the ethics of biomedicalresearch on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and researchethics committees, but the Brazilian system has strong and noteworthy specificities. (shrink)
Ontologies describe reality in specific domains in ways that can bridge various disciplines and languages. They allow easier access and integration of information that is collected by different groups. Ontologies are currently used in the biomedical sciences, geography, and law. A BiomedicalEthics Ontology would benefit members of ethics committees who deal with protocols and consent forms spanning numerous fields of inquiry. There already exists the Ontology for Biomedical Investigations (OBI); the proposed BMEO would interoperate (...) with OBI, creating a powerful information tool. We define a domain ontology and begin to construct a BMEO, focused on the process of evaluating human research protocols. Finally, we show how our BMEO can have practical applications for ethics committees. This paper describes ongoing research and a strategy for its broader continuation and cooperation. (shrink)
Conflict of interest is an issue that has been put in the spotlight by the commercial application of the new biomedical technologies. This paper presents the approach of the Council of Europe and the binding legal instruments to deal with this problem. The main focus is on the Convention on Human Rights and Biomedicine, and its draft additional Protocol on BiomedicalResearch.
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 researchethics, and the relationship between ethics and compliance. ResearchEthics 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 Human Genome Project (HGP) is regarded by many as one of the major scientific achievements in recent science history, a large-scale endeavour that is changing the way in which biomedicalresearch is done and expected, moreover, to yield considerable benefit for society. Thus, since the completion of the human genome sequencing effort, a debate has emerged over the question whether this effort merits to be awarded a Nobel Prize and if so, who should be the one(s) to (...) receive it, as (according to current procedures) no more than three individuals can be selected. In this article, the HGP is taken as a case study to consider the ethical question to what extent it is still possible, in an era of big science, of large-scale consortia and global team work, to acknowledge and reward individual contributions to important breakthroughs in biomedical fields. Is it still viable to single out individuals for their decisive contributions in order to reward them in a fair and convincing way? Whereas the concept of the Nobel prize as such seems to reflect an archetypical view of scientists as solitary researchers who, at a certain point in their careers, make their one decisive discovery, this vision has proven to be problematic from the very outset. Already during the first decade of the Nobel era, Ivan Pavlov was denied the Prize several times before finally receiving it, on the basis of the argument that he had been active as a research manager (a designer and supervisor of research projects) rather than as a researcher himself. The question then is whether, in the case of the HGP, a research effort that involved the contributions of hundreds or even thousands of researchers worldwide, it is still possible to individualise the Prize? The HGP Nobel Prize problem is regarded as an exemplary issue in current researchethics, highlighting a number of quandaries and trends involved in contemporary life science research practices more broadly. (shrink)
This book is the result of a three-year study undertaken by a multidisciplinary working party of the Institute of Medical Ethic (UK). The group was chaired by a moral theologian, and its members included biological and ethological scientists, toxicologists, physicians, veterinary surgeons, an expert in alternatives to animal use, officers of animal welfare organizations, a Home Office Inspector, philosophers, and a lawyer. Coming from these different backgrounds, and holding a diversity of moral views, the members produced the agreed report as (...) a result of detailed and rigorous discussions. The book sets out facts about animal experiments and about animal abilities to experience pain, distress and anxiety. There is a detailed examination of the moral claims related to the benefits likely to accrue from animal research, and of strategies for weighing these benefits against the harm caused to animals, in order to decide whether particular research projects ought or ought not to proceed. This leads to consideration of the statutory and non-statutory controls which safeguard standards in such research. The final section explores a variety of philosophical arguments about the use of animals in research, and offers a philosophical justification for the Working Party's more practical conclusions. Written in clear, nontechnical language, this book is accessible to lay people as well as to scientists. It is the first such document to emerge from a meeting of people with such widely differing views on this highly controversial subject, and represents a major contribution towards informing and raising the quality of contemporary debate. The book is unique in drawing together material and ideas never before found in one volume. It will interest a broad spectrum of readers, from ethicists and animal rights advocates to scientific researchers and laboratory administrators, along with general readers concerned about this compelling issue. (shrink)
: Controversy has surrounded the institutions that facilitate discussion and regulation of American biomedicalresearch for years. Recent challenges to the legitimacy of the President's Council on Bioethics have been focused on stem cell research. These arguments represent an opportunity to reconsider the legislation under which stem cell research is regulated, as well as to consider preexisting bodies like the Recombinant DNA Advisory Committee and National Bioethics Advisory Commission. This paper proposes a Federal Life Sciences Policy (...) Commission, a novel commission with advisory and regulatory powers that would benefit from the positive and negative lessons learned under the legislation that currently shapes the formation and institutional characteristics of advisory bodies in the United States. The Federal Life Sciences Policy Commission would have institutional independence not present in previous advisory bodies, while maintaining the tradition of broad societal representation and thoughtful discourse that has developed in the United States. (shrink)
Background Clinical trials throughout the world must be evaluated by researchethics 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 ResearchEthics 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 ResearchEthics 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 ResearchEthics Committees. (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 researchethics based on the Nigerian National Code of Health ResearchEthics 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 ResearchEthics (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 researchethics 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)
Context The conduct of medical research led by Northern countries in developing countries raises ethical questions. The assessment of research protocols has to be twofold, with a first reading in the country of origin and a second one in the country where the research takes place. This reading should benefit from an independent local ethical review of protocols. Consequently, ethics committees for medical research are evolving in Africa. Objective To investigate the process of establishing (...) class='Hi'>ethics committees and their independence. Method Descriptive study of 25 African countries and two North American countries. Data were recorded by questionnaire and interviews. Two visits of ethics committee meetings were conducted on the ground: over a period of 3 months in Kigali (Rwanda) and 2 months in Washington DC (USA). Results 22 countries participated in this study, 20 from Africa and two from North America. The response rate was 80%. 75% of local African committees developed into national ethics committees. During the last 5 years, these national committees have grown on a structural level. The circumstances of creation and the general context of underdevelopment remain the major challenges in Africa. Their independence could not be ensured without continuous training and efficient funding mechanisms. Institutional ethics committees are well established in USA and in Canada, whereas ethics committees in North America are weakened by the institutional affiliation of their members. Conclusion The process of establishing ethics committees could affect their functioning and compromise their independence in some African countries and in North America. (shrink)
In researchethics there is a canon regarding what ethical rules ought to be followed by investigators vis-à-vis their treatment of subjects and a canon regarding what fundamental ethical principles apply to the endeavor. What I aim to demonstrate here is that several of the rules find no support in the principles. This leaves anyone who would insist that we not abandon those rules in the difficult position of needing to establish that we are nevertheless justified in believing (...) in the validity of the rules. I conclude by arguing that this is not likely to be accomplished.The rules I call into question are the rules requiring:– that studies be designed in a scientifically valid way– that risks to subjects be minimized– that subjects be afforded post-trial access to experimental interventions– that inducements paid to subjects not be counted as a benefit to them– that inducements paid to subjects not be ‘undue’– that subjects must remain free to withdraw from the study at any time for any reason without penaltyBoth canons, the canon on principles and the canon on rules, are found in the overlap among ethical pronouncements that are themselves canonical: the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, CIOMS's International Ethical Guidelines for BiomedicalResearch Involving Human Subjects, and NBAC's 2001 report, Ethical Issues in International Research: Clinical Trials in Developing Countries. (shrink)
Pharmaceutical companies are major sponsors of biomedicalresearch. Most scholars and policymakers focus their attention on government and academic oversight activities, however. In this article, I consider the role of pharmaceutical companies’ internal ethics statements in guiding decisions about corporate research and development (R&D). I review materials from drug company websites and contributions from the business and medical ethics literature that address ethical responsibilities of businesses in general and pharmaceutical companies in particular. I discuss positive (...) and negative uses of pharmaceutical companies’ ethics materials and describe shortcomings in the companies’ existing ethics programs. To guide employees and reassure outsiders, companies must add rigor, independence, and transparency to their R&D ethics programs. (shrink)
Assessment of risk is one of the key issues in the field of responsible conduct of research which covers discourses of researchethics and research integrity. The principle of minimizing risks and balancing of risks and benefits is one of the main requirements of researchethics. In addition, the content of informed consent that is another fundamental principle of researchethics derives from the assessment of risks and benefits related to a particular (...)research project. Risk assessment also plays a crucial role in methodological design of the research project. This is an important point where researchethics and research integrity discourses overlap. Firstly, because the choice of a control group (e.g., placebo control) is a key ethical issue related to the protection of the research subjects’ interests. Secondly, because the quality of the research data, that is one of the key elements of research integrity, is closely connected to the choice of research methodology as well. The problem of biased interpretation or manipulation of risk related features of biomedicalresearch should also be taken into account. Despite the importance of the concept of risk to the field of biomedicalresearch, its relevance has not yet attracted a sufficient attention in the responsible conduct of research debate. (shrink)
This paper describes a three-year project designed to build the capacity of members of researchethics 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 ResearchEthics 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 biomedicalresearch 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 International Committee of Medical Journal Editors (ICMJE) is a working group of editors of selected medical journals that meets annually. Founded in Vancouver, Canada, in 1978, it currently consists of 11 member journals and a representative of the US National Library of Medicine. The major purpose of the Committee is to address and provide guidance for the conduct and publishing of biomedicalresearch and the ethical tenets underpinning these activities. This advice is detailed in the Committee's _ (...) Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication (URM)._ Recently, the ICMJE has adopted an interventionist role to ensure transparency of conflict of interest revelations in the conduct and publication of industry supported research. It also pursues a policy for the lodgement with trial registries of specified details of Phase III clinical trials. Failure to comply would jeopardise publication of trial outcomes in ICMJE member journals. This policy has resulted in the coming on stream of trial registries, international agreement on trial minimal datasets and compliance with trial registration requirements._. (shrink)
Background Despite the growth of biomedicalresearch in South Africa, there are few insights into the operation of ResearchEthics 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 researchethics 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 researchethics 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)
Background: As actors with the key responsibility for the protection of human research participants, ResearchEthics Committees (RECs) need to be competent and well-resourced in order to fulfil their roles. Despite recent programs designed to strengthen RECs in Africa, much more needs to be accomplished before these committees can function optimally.Objective: To assess training needs for biomedicalresearchethics evaluation among targeted countries.Methods: Members of RECs operating in three targeted African countries were surveyed between (...) August and November 2007. Before implementing the survey, ethical approvals were obtained from RECs in Switzerland, Cameroon, Mali and Tanzania. Data were collected using a semi-structured questionnaire in English and in French.Results: A total of 74 respondents participated in the study. The participation rate was 68%. Seventy one percent of respondents reported having received some training in researchethics evaluation. This training was given by national institutions (31%) and international institutions (69%). Researchers and REC members were ranked as the top target audiences to be trained. Of 32 topics, the top five training priorities were: basic ethical principles, coverage of applicable laws and regulations, how to conduct ethics review, evaluating informed consent processes and the role of the REC.Conclusion: Although the majority of REC members in the targeted African countries had received training in ethics, they expressed a need for additional training. The results of this survey have been used to design a training program in researchethics evaluation that meets this need. (shrink)
Traffic research shares a fundamental dilemma with other areas of empirical research in which humans are potentially put at risk. Research is justified because it can improve safety in the long run. Nevertheless, people can be harmed in the research situation. Hence, we need to balance short-term risks against long-term safety improvements, much as in other areas of research with human subjects. In this paper we focus on ethical issues that arise when human beings are (...) directly affected in the performance of research by examining how the ethical requirements in biomedicalresearch can inform traffic research. After introducing the basic ethical requirements on biomedicalresearch, each of the major requirements is discussed in relation to traffic research. We identify the main areas where biomedicalresearch and traffic research differ, and where the ethical requirements from the former cannot easily be transferred to the latter. Finally, we argue that there is a need for systematic studies of the ethics of traffic research and point to some of the issues that need to be addressed. (shrink)
In clinical research there is a tension between the role of a doctor, who must serve the best interests of the patient, and the role of the researcher, who must produce knowledge that may not have any immediate benefits for the research participant. This tension is exacerbated in HIV research in low and middle income countries, which frequently uncovers comorbidities other than the condition under study. Some bioethicists argue that as the goals of medicine and those of (...)research are distinct, it is a mistake for researchers to assume therapeutic responsibilities while engaging in research. Others propose that there is a duty of care, but disagree as to how this is limited and specified. In this qualitative study, principal investigators from HIV prevention trials discuss their experience of providing medical benefits to participants within the context of conducting research into HIV biomedical prevention technologies. They describe the limitations imposed at times by funders and at times by infrastructure constraints, and canvass the importance of ancillary care provision and capacity building in trial communities. The views of the principal investigators are compatible with the perspective that there is a duty of care, limited by the nature of the research, the depth of the relationship between research and participant, and the capacity of the research site. The therapeutic orientation in HIV prevention trial appears to be indivisible from competent research practise by making concrete and appropriate benefits available to trial participants and their communities that support rather than compete with local infrastructure. (shrink)
The ethical case for Open Access (OA) (free online access) to research findings is especially salient when it is public health that is being compromised by needless access restrictions. But the ethical imperative for OA is far more general: It applies to all scientific and scholarly research findings published in peer-reviewed journals. And peer-to-peer access is far more important than direct public access. Most research is funded so as to be conducted and published, by researchers, in order (...) to be taken up, used, and built upon in further research and applications, again by researchers (pure and applied, including practitioners), for the benefit of the public that funded it – not in order to generate revenue for the peer-reviewed journal publishing industry (nor even because there is a burning public desire to read much of it). Hence OA needs to be mandated, by researchers' institutions and funders, for all research. (shrink)
Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union (Eastern EU) and South-East European countries (South-East Europe) that are not (...) members of the European Union.The most common ethical issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors’ conflicts of interest and registration of clinical trialswere the least common ethical policies. Three aspects were significantly morecommon in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation.On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences amongbiomedical journals’ ethical policies calls for further research and active measuresto harmonize policies across journals. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals’ ethical policies calls for further research and active measures to harmonize policies across journals. (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 (...)biomedicalresearch 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)
Recently adopted international texts have given a new focus on conflicts of interests and access to information resulting from biomedicalresearch. They confirmed ethical review committees as a central point to guarantee individual rights and the effective application of ethical principles. Therefore specific attention should be paid in giving such committees all the facilities necessary to keep them independent and qualified.
The meaningful consideration of cultural practices, values and beliefs is a necessary component in the effective translation of advancements in neuroscience to clinical practice and public discourse. Society’s immense investment in biomedical science and technology, in conjunction with an increasingly diverse socio-cultural landscape, necessitates the study of how potential discoveries in neurodegenerative diseases such as Alzheimer disease are perceived and utilized across cultures. Building on the work of neuroscientists, ethicists and philosophers, we argue that the growing field of neuroethics (...) provides a pragmatic and constructive pathway to guide advancements in neuroscience in a manner that is culturally nuanced and relevant. Here we review a case study of one issue in culturally oriented neuroscience research where it is evident that traditional researchethics must be broadened and the values and needs of diverse populations considered for meaningful and relevant research practices. A global approach to neuroethics has the potential to furnish critical engagement with cultural considerations of advancements in neuroscience. (shrink)
We surveyed 1005 postdoctoral fellows by questionnaire about ethical matters related to biomedicalresearch and publishing; 33% responded. About 18% of respondents said they had taken a course in researchethics, and about 31% said they had had a course that devoted some time to researchethics. A substantial majority stated willingness to grant other investigators, except competitors, access to their data before publication and to share research materials. Respondents’ opinions about contributions justifying (...) authorship of research papers were mainly consistent but at variance with those of many biomedical journal editors. More than half said they had observed what they considered unethical research practices. To increase the chances of getting a grant funded, 27% said they were willing to select or omit data to improve their results; to make publication of their work more likely or to benefit their career, 15% would select or omit data and 32% would list an undeserving author. Of respondents who thought they had been unfairly denied authorship on a paper, or been listed with or asked to list an undeserving author, 75% said they would be willing to list an undeserving author (P<0.001). Having taken a course dealing with researchethics had no effect on stated willingness to select or omit data or to fabricate data in the future, but was positively associated with willingness to grant undeserved authorship (P<0.04). Although these results do not controvert research demonstrating the effectiveness of ethics courses during professional education, they indicate that the research environment is a powerful component of a trainee’s experience and ethical development. (shrink)
Biomedicalresearch 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)
It has become almost a truism to describe the interaction between researchethics 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 researchethics into what some have described as a researchethics 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 researchethics within the broader framework of institutional governance, this paper suggests it is possible to establish arrangements that actually facilitate excellent and ethical research. (shrink)
Biomedicalresearch has increased in magnitude over the last two decades. Increasing number of researchers has led to increase in competition for scarce resources. Researchers have often tried to take the shortest route to success which may involve performing fraudulent research. Science suffers from unethical research as much time, effort and cost is involved in exposing fraud and setting the standards right. It is better for all students of science to be aware of the methods used (...) in fraudulent research so that such research can be detected early. Biomedicalresearch is one area that seems to have attracted maximum numbers of fraudulent researchers; hence this article devotes itself to biomedicalresearch scenario. (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 researchethics 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 researchethics and the role of ResearchEthics Boards in human participant research.
This paper shares my reflections on the researchethics review process, from the point of view of both a qualitative researcher and a member of an institutional researchethics review board. By considering researchethics review, first as practice, then as policy, as a relationship and, finally, as a performance, I attempt to outline a new vision of researchethics, one that engages seriously with the relationship between receiving ethics approval, and (...) conducting ethical research. (shrink)
Principles of researchethics, 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 researchethics 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 researchethics 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 researchethics, focused on individual empowerment and strategies that individuals can use to initiate institutional change.
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 researchethics 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 researchethics 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 researchethics 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)
ResearchEthics 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)
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 ResearchEthics 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)