Cross-border academic collaborations in conflict zones are vulnerable to escalated turbulence, liability concerns and flagging support. Multi-level stakeholder engagement at home and abroad is essential for securing the political and financial sustainability of such collaborations. This study examines the multilayered stakeholder arrangements within an international academic health science network contributing to peace-building in the Middle East. While organizational forms in this collaboration change to reflect the structural, epistemic and political expectations of various support groups operating locally and (...) globally, the legitimacy of the international research and its contribution to the peace-building process last as long as institutional norms of academic enterprise – integrity, impartiality and collegiality – are sustained. This paper analyzes the reconciliatory strategies used by the collaborating health scientists to mitigate organizational turbulence, reduce resource asymmetries and continually build and rebuild bridges across stakeholder communities. (shrink)

The Global Code of Conduct for Research in Resource-Poor Settings (GCC) aims to stop the export of unethical research practices from higher to lower income settings. Launched in 2018, the GCC was immediately adopted by European Commission funding streams for application in research that is situated in lower and lower-middle income countries. Other institutions soon followed suit. This article reports on the application of the GCC in two of the first UK-funded projects to implement this new code, (...) one situated in India and one in Pakistan. Through systematic ethics evaluation of both projects, the practical application of the GCC in real-world environments was tested. The findings of this ethics evaluation suggest that while there are challenges for implementation, application of the GCC can promote equity in international research collaborations. (shrink)

Human Biological Materials (HBMs) are an invaluable resource in biomedical research.ObjectiveTo determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries.Study DesignEthically approved retrospective cross‐sectional descriptive audit.ResultsOf the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 (...) protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively.ConclusionsResearchers and the REC did not adequately address the inter‐related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

Human Biological Materials are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross-sectional descriptive audit. Results Of the 1305 protocols audited, 151 fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors were from the USA . The principle investigators in all 151 protocols (...) informed the REC of their intent to store HBMs. Only 132 protocols informed research participants . In 148 protocols informed consent was obtained from research participants, 116 protocols solicited broad consent compared to specific consent [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC than the research participants that HBMs would be exported . Export permits and Material Transfer Agreements were not available in 109 and 143 protocols, respectively. Conclusions Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

This article presents a review of the literature, summarizes current initiatives, and provides a heuristic for assessing the effectiveness of a range of institutional review board collaborative strategies that can reduce the regulatory burden of ethics review while ensuring protection of human subjects, with a particular focus on international research. Broad adoption of IRB collaborative strategies will reduce regulatory burdens posed by overlapping oversight mechanisms and has the potential to enhance human subjects protections.

Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these (...) concerns, the Drugs for Neglected Diseases Initiative, an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis. The project involved the implementation of a novel ‘pre-review’ process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process. (shrink)

Research partnerships between institutions in the Global North and institutions in the Global South have many potential benefits, including sharing of knowledge and resources. However, such partnerships are traditionally exploitative to varying degrees. In order to promote equity in South‐North research partnerships, it is necessary to learn from the experiences of researchers collaborating internationally. This study analyzed transcripts from eleven semi‐structured qualitative interviews with researchers working at Clínica de Familia La Romana, an institution in the Dominican Republic with (...) decades of experience with research and research partnerships with institutions from the Global North. The findings of this study suggest that respect for resources invested in research, as well as for the researchers and institutions themselves, are vital components to a successful global health research partnership. These findings have implications for individual research partnerships, as well as the policies of journals and institutions providing funding that affect these partnerships. (shrink)

Background: Despite an increase in health research conducted in Africa, there are still inadequate human resources with research ethics training and lack of local long-term training opportunities in research ethics. A research ethics training program named United States-Mali Research Ethics Training Program (US-Mali RETP) was established through a partnership between the George Washington University Milken Institute School of Public Health (GWSPH), USA and University of Sciences, Techniques & Technologies of Bamako (USTTB), to address the critical (...) need for improved bioethics training, leadership, and policy in Mali. Methods: The aims of the capacity building programme are achieved by leveraging US and Africa-based expertise to strengthen research ethics education and capacity through: (1) intensive faculty development to design ethics training curricula; (2) development of a research ethics specialization within the existing Masters of Public Health program (MPH); and (3) establishing professional development courses through short-term training workshops and webinars to address research and professional needs in ethics. Results: The program will strengthen USTTB’s capacity of research ethics by training at least 15 MPH students over 5 years to prepare the next generation of ethics researchers. During the first two years of the program, a new ethics training curricula was developed, two cohorts of Master’s students were enrolled, and a series of webinars and workshops were conducted with participation of Malian and international researchers. Conclusions: US-Mali RETP will promote a sustainable bioethics enterprise at USTTB, and enable dissemination of research ethics training to increase health research capacity in Mali. (shrink)

Achieving equity in international research is one of the pressing concerns of the twenty-first century. In this era of progressive globalization, there are many opportunities for the deliberate or accidental export of unethical research practices from high-income regions to low- and middle-income countries and emerging economies. The export of unethical practices, termed “ethics dumping,” may occur through all forms of research and can affect individuals, communities, countries, animals, and the environment. Ethics dumping may be the result (...) of purposeful exploitation but often arises from lack of awareness of good ethical and governance practice. This chapter describes the work of the TRUST project toward counteracting the practice of ethics dumping through the development of tools for the improvement of research governance structures. Multi-stakeholder consultation informs all of TRUST’s developments. Most importantly, this gives voice to marginalized vulnerable groups and indigenous people, who have been equal and active partners throughout the project. At the heart of the TRUST project is an ambitious aim to develop a Global Code of Conduct for Research in Resource-Poor Settings. Uniquely, the Code provides guidance across all research disciplines in clear, short statements, focusing on research collaborations that entail considerable imbalances of power, resources and knowledge and using a new framework based on the values of fairness, respect, care, and honesty. The code was recently adopted by the European Commission as a reference document for Horizon 2020 and Horizon Europe. (shrink)

Interest in the ethics of research on human subjects, stimulated by atrocious human experimentation during WWII and the resultant Nuremberg Code, has been sustained by examples of unethical research in many countries and by proliferation of codes and guidelines. Such interest has intensified in recent years in association with expanding international collaborative research endeavors. The ongoing controversy in international research ethics takes place at two levels. At the practical level it is about the competing (...) concerns of those predominantly interested in doing research to advance knowledge and those who, while supporting the need for research, are more acutely aware of the potential to exploit vulnerable participants, especially in developing countries. At the level of theory the controversy pits ethical universalism against moral relativism.In her recent review of agreements and controversies in international research ethics, Ruth Macklin has concluded that, despite seeming agreement on several issues, many different viewpoints persist. In her view it is unlikely that these will be resolved easily. (shrink)

Interest in the ethics of research on human subjects, stimulated by atrocious human experimentation during WWII and the resultant Nuremberg Code, has been sustained by examples of unethical research in many countries and by proliferation of codes and guidelines. Such interest has intensified in recent years in association with expanding international collaborative research endeavors. The ongoing controversy in international research ethics takes place at two levels. At the practical level it is about the competing (...) concerns of those predominantly interested in doing research to advance knowledge and those who, while supporting the need for research, are more acutely aware of the potential to exploit vulnerable participants, especially in developing countries. At the level of theory the controversy pits ethical universalism against moral relativism.In her recent review of agreements and controversies in international research ethics, Ruth Macklin has concluded that, despite seeming agreement on several issues, many different viewpoints persist. In her view it is unlikely that these will be resolved easily. (shrink)

The “fair benefits” approach to international research is designed to produce results that all can agree are fair without taking a stand on divisive questions of justice. But its appealing veneer of collaboration masks ambiguities at both a conceptual and an operational level. An attempt to put it into practice would look a lot like an auction, leaving little reason to think the outcomes will satisfy even minimal conditions of fairness.

Scientific collaboration between Northern and Southern researchers and development programs for research capacity-building have received new attention of practitioners and scholars during the last decades. This essay review takes four recent publications on North-South research cooperation and development politics as a starting point to ask for possible links between macro-, meso-, and micro-levels of social analysis that has found renewed interest in the sociology of science literature. The approach has the advantage to heuristically systematize the anthropological, sociological and (...) policy-driven approaches chosen by the editors and authors of the books under review. Moreover, the focus on links between the three levels adds to the conceptual interaction of sociology of science and the science policy fields to estimate the effects of science governance in international and especially in asymmetrical relations with different access to resources. (shrink)

Interdisciplinarity is widely considered necessary to solving many contemporary problems, and new funding structures and instruments have been created to encourage interdisciplinary research at universities. In this article, we study a small technical university specializing in green technology which implemented a strategy aimed at promoting and developing interdisciplinary collaboration. It did so by reallocating its internal research funds for at least five years to “research platforms” that required researchers from at least two of the three schools within (...) the university to participate. Using data from semi-structured interviews from researchers in three of these platforms, we identify specific tensions that the strategy has generated in this case: in the allocation of platform resources, in the division of labor and disciplinary relations, in choices over scientific output and academic careers. We further show how the particular platform format exacerbates the identified tensions in our case. We suggest that certain features of the current platform policy incentivize shallow interdisciplinary interactions, highlighting potential limits on the value of attempting to push for interdisciplinarity through internal funding. (shrink)

This article reviews some of the ethical aspects of collaborative research. Scientific collaboration has known potential benefits but it’s a challenging task to successfully accomplish a collaborative venture on ethically sound grounds. Current trends in international healthcare research collaboration reflect limited benefits for the majority of world population. Research collaboration between scientists of academia and industry usually has financial considerations. Successful cross-cultural and international collaborations have to overcome many regional and global barriers. Despite these (...) difficulties, many scientific collaborations usually begin with an informal meeting or contact. With advancement in global communications, scientists have greater responsibility towards the world community while considering the impact of their collaborative partnerships. I review the basic factors that are required for forging a collaborative partnership and responsible attitudes to sustain the relationship. Finally I conclude that scientists in healthcare research can play important roles beyond collaborations and contribute to bringing harmony, resolving differences across the nations and countries in today’s troubled world. (shrink)

This article analyzes international scientific collaboration in the context of the globalization of science and technology as a crossing point not only between local and global identities but also between scientific and sociocultural identities. It also elucidates how international collaboration—where middle scientific actors in the hierarchical multilayered center-periphery in the globalization of science and technology obtain advanced knowledge from core science and technology—takes place and structures the global division of research labor. This article emphasizes that we should (...) develop the context of the globalization of science and technology with dynamic and interdependent interactions between multistructured, core-periphery scientific actors. Dichotomous colonialist discourse is not a useful analytical tool in this context. The author found that sociocultural factors, including economic, cultural, organizational, and political ones, as well as the multilayered center-periphery in the globalization of science and technology, operate as forces that encourage international collaboration. (shrink)

Numerous evaluations of the Bean/Cowpea Collaborative Research Support Program (CRSP) have documented CRSP contributions to food production and availability with impacts valued in the millions of dollars in developing countries as well as in the US. These reports emphasized collaboration as a critical factor in the success that emanated from CRSP research and training. Real collaboration among males and females across disciplinary, national, ethnic, cultural, and language differences is not easy. This review of CRSP experiences in building productive (...) collaborations gives actual case studies, including some failures, and discusses lessons learned in the process. The importance of wide participation, shared resources, and facilitated interpersonal relations to back up the dedication and commitment of the participants in emphasized. The program represents an investment of the US Agency for International Development with contributions in excess of 25 percent from participating US and Host Country institutions. (shrink)

BackgroundInternational partnerships in research are receiving ever greater attention, given that technology has diminished the restriction of geographical barriers with the effects of globalisation becoming more evident, and populations increasingly more mobile.DiscussionIn this article, we examine the merits and risks of such collaboration even when strict universal ethical guidelines are maintained. There has been widespread examples of outcomes beneficial and detrimental for both high and low –income countries which are often initially unintended.SummaryThe authors feel that extreme care and forethought (...) should be exercised by all involved parties, despite the fact that many implications from such international work can be extremely hard to predict. However ultimately the benefits gained by enhancing medical research and philanthropy are too extensive to be ignored. (shrink)

This article is a response to a Main Article published in this journal: Thurner, T. W., & Proskuryakova, L. (2013). Collaborative research in energy efficiency and renewable energy: Evidence from 5 years of US-Russian research cooperation. Journal of Research Practice, 9(1), Article M4.

In this paper, we explain how our individual PhD enquiries have informed the philosophical underpinnings of our postgraduate programmes. The approach used to ensure validity and rigour in the research process is presented. We report on the development of the International Research Centre for e-Innovation and Workplace Learning and its collaboration in European projects such as Pathway to Inquiry Based Learning, Inspiring Science Education and the African based Global e-Schools and Communities Initiative project Leadership Development in ICT (...) and the Knowledge Society. Our claim is that researching our own practice can be a transformative experience for the practitioner-researcher who is committed to generating knowledge that has personal, professional and social value. (shrink)

The importance of communities in strengthening the ethics of international collaborative research is increasingly highlighted, but there has been much debate about the meaning of the term ‘community’ and its specific normative contribution. We argue that ‘community’ is a contingent concept that plays an important normative role in research through the existence of morally significant interplay between notions of community and individuality. We draw on experience of community engagement in rural Kenya to illustrate two aspects of this (...) interplay: (i) that taking individual informed consent seriously involves understanding and addressing the influence of communities in which individuals’ lives are embedded; (ii) that individual participation can generate risks and benefits for communities as part of the wider implications of research. We further argue that the contingent nature of a community means that defining boundaries is generally a normative process itself, with ethical implications. Community engagement supports the enactment of normative roles; building mutual understanding and trust between researchers and community members have been important goals in Kilifi, requiring a broad range of approaches. Ethical dilemmas are continuously generated as part of these engagement activities, including the risks of perverse outcomes related to existing social relations in communities and conditions of ‘half knowing’ intrinsic to processes of developing new understandings. (shrink)

The increasing concern about ethics and integrity in research communities has brought attention to how students and junior academics can be trained on this regard. Moreover, it is known that ethical behaviour and integrity not only involve individual but also group norms and considerations. Thus, through action research and participant observation, this research investigates the learning processes through which 64 students collaboratively develop research ethics and integrity competencies. The aim was to understand how bachelor, master and (...) PhD students approach ethical dilemma cases through a collaborative process. The data consisted of recorded group work on ethics cases, student group reports, and post-training questionnaires. Later, the analyses considered groups as the unit of analysis. These data were analysed through content analysis utilizing the SOLO taxonomy to identify levels of understanding and assess evolvement of ethical sensitivity during a case-based training session. The results show that all groups reached the level of understanding where the groups demonstrated that concepts had been understood appropriately, but occasionally struggled to make connections between them. Students perceived working collaboratively as beneficial. The results help teachers of research ethics and integrity to make pedagogically justified choices in their teaching. Drawing on the results of this study, we propose a tool for the formative assessment of student learning of research ethics and integrity. (shrink)

Shows how international biomedical researchers in Sri Lanka work across cultural, epistemic, economic, and power differences to accomplish clinical trials.

The International Panel on Social Progress is an independent association of top research scholars with the goal of assessing methods for improving the main institutions of modern societies. The IPSP has produced a report consisting of twenty-two chapters in three volumes that distills the research of these scholars and outlines what the best social science has to say about positive social change. Written in accessible language by scholars across the social sciences and humanities, these volumes assess the (...) achievements of world societies in past centuries, the current trends, the dangers that we are now facing, and the possible futures in the twenty-first century. It covers the main socio-economic, political, and cultural dimensions of social progress, global as well as regional issues, and the diversity of challenges and their interplay around the world. The authors offer a cautious optimistic conclusion: multiple ideas for social progress and better policies are already available and deserve to be tested and implemented. (shrink)

The current ethical structure for collaborative international health research stems largely from developed countries' standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and (...) components necessary for the conduct of human behavior research and research capacity building in the host country. (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or (...) are not expressed in local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

National and international research cultures for the innovation of new medicines involve various value claims about the ethics of the placebo entity as differentiating comparator. Yet, in turn, the instantiation of the placebo comparator as cultural artefact for the creation and identification of the ‘control group’ depends also upon prior social understandings of ‘comparability’. Reading back the ethics controversies surrounding the Risperidone psychiatry trials in India, the paper illustrates why drug efficacies need to be studied not only through (...) comparative techniques such as randomised controlled trials, but also through analytical modes of inquiry that can begin to place the problem of efficacy within particular social and cultural contexts, as well as across disciplines. It is suggested that future bioethics debates could benefit from a revised conception of the interdisciplinary placebo — one that is rooted in ‘placebo politics’ and that listens responsively to the voices of the global South. (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or (...) are not expressed in local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

There are complex unresolved ethical, legal and social issues related to the use of human tissues obtained in the course of research or diagnostic procedures and retained for further use in research. The question of intellectual property rights over commercially viable products or procedures that are derived from these samples and the suitability or otherwise of participants relinquishing their rights to the samples needs urgent attention. The complexity of these matters lies in the fact that the relationship between (...) intellectual property rights and ownership or rights pertaining to the samples on which the intellectual property right is based may either be overlooked or taken for granted. What equally makes the matter complex is that samples may be obtained from participants in developing countries and exported to developed countries for analysis and research. It is important for research ethics committees to tread carefully when reviewing research protocols that raise such issues for purposes of ensuring that appropriate benefit sharing agreements, particularly with developing countries, are in place.This paper attempts to analyse the key questions related to ownership and intellectual property rights in commercially viable products derived from human tissue samples. Patent law is used as a point of reference as opposed to other forms of intellectual property rights such as industrial designs because it is the right that most inventors apply for in respect of human tissue-related inventions. The key questions are formulated following a systematic analysis of peer reviewed journal articles that have reported original investigations into relevant issues in this field. Most of the cases and reported studies that are referred to in this paper do not directly deal with HIV/AIDS research but the underlying principles are helpful in HIV/AIDS research as well. Pertinent questions, which members of ethics review committees should focus on in this regard are discussed and suggestions on appropriate approaches to the issues are proposed in the form of specific questions that an ethics review committee should consider. Specific recommendations regarding areas for further research and action are equally proposed. (shrink)

In this paper we discuss two research programs – MELARETE and Philosophical Ethics in Early Childhood – and an emerging international research collaboration based on the benefits of practicing philosophy for meaning in early and middle childhood education. We argue for the good of philosophical thinking and its benefits to young students, with a particular focus on ethical development and meaning. We contend that through philosophical pedagogy we can make learning, meaning, vital to students. This is particularly (...) relevant when dealing with questions of ethics and virtue, questions that are close to the lives of children from their earliest years. By discussing these questions and advancing philosophical ethics and virtue programs philosophers can play a central role in the development of responsible and ethical persons in the world. In order to do this, we contend, it is important that philosophy be introduced to children from a young age, in the early stages of schooling. Following a discussion of our respective research and education programs in Italy and USA, we discuss our current and ongoing plans for an international research collaboration on ethics and philosophy with children. (shrink)

While research ethics and developing respective competencies is gaining prominence in higher education institutions, there is limited knowledge about the learning process and scaffolding during such training. The global health crisis has made the need for facilitator-independent training materials with sufficient support even more pronounced. To understand how knowledge building takes place and how computer-supported collaborative learning supports research ethics learning, we analysed: 1) how the participants’ understanding was displayed during the collaborative learning process utilising the developed ethics (...) resource; and 2) whether the scaffolding provided by the resource supported the learning process. Epistemic evidence was collected during design-based research involving 36 PhD students and researchers with supervisory experience divided into 11 groups. Data was analysed qualitatively utilising the SOLO taxonomy. The results revealed that: 1) participants displayed high levels of understanding and the need for the facilitator support decreased with the use of the online ethics resource; 2) the learners were able to evaluate their learning outcomes with satisfactory accuracy; 3) when used linearly, the online ethics resource helped learners to achieve high levels of understanding even when the scaffolding gradually faded. Based on the lessons learnt, design principles were extracted to develop research ethics competencies in higher education, and also recommendations for research ethics training were outlined. (shrink)

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

This is the first of three volumes containing a report from the International Panel on Social Progress. The IPSP is an independent association of top research scholars with the goal of assessing methods for improving the main institutions of modern societies. Written in accessible language by scholars across the social sciences and humanities, these volumes assess the achievements of world societies in past centuries, the current trends, the dangers that we are now facing, and the possible futures in (...) the twenty-first century. It covers the main socio-economic, political, and cultural dimensions of social progress, global as well as regional issues, and the diversity of challenges and their interplay around the world. This particular volume covers topics such as economic inequality and growth, finance and corporations, labor, capitalism, and social justice. (shrink)

BackgroundIn research ethics, the most basic question would always be, “which is an ethical issue, which is not?” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus. In this manuscript, we attempted to do (...) just that.MethodsWe extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative.ResultsWe found that there is no consensus on the majority of the imperatives and that in only 8.2 % of the imperatives were there at least moderate consensus. Of the 12 clusters, Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least.ConclusionThere was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences. (shrink)

203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers.

The tsunami effect of the COVID-19 pandemic is affecting many aspects of scientific activities. Multidisciplinary experimental studies with international collaborators are hindered by the closing of the national borders, logistic issues due to lockdown, quarantine restrictions, and social distancing requirements. The full impact of this crisis on science is not clear yet, but the above-mentioned issues have most certainly restrained academic research activities. Sharing innovative solutions between researchers is in high demand in this situation. The aim of this (...) paper is to share our successful practice of using web-based communication and remote control software for real-time long-distance control of brain stimulation. This solution may guide and encourage researchers to cope with restrictions and has the potential to help expanding international collaborations by lowering travel time and costs. (shrink)

Researchers and others involved in the research enterprise from 12 African countries met with those working in ethics and oversight in the United States as part of an effort to develop research ethics capacity. Drawing on a wealth of experience among participants, discussions at the meeting revealed five categories of issues that warrant careful attention by those engaged in similar efforts as well as international policymakers and those charged with oversight of research. Principal investigators should build (...) ‘true research teams’ where members of the team are meaningfully involved in decisions regarding the protocol and its implementation. There should be explicit discussion about the ‘standard of care’ at the outset of project planning that includes clarification of the terminology that is being used. While internationally collaborative research may involve populations that have inherent vulnerabilities, it is important to recognize the limitations of host country solutions and look for means to negotiate appropriate protections for those willing to participate. In conducting research involving biological materials it would be prudent to develop material transfer agreements at the outset of the study to clarify expectations and to minimize the likelihood of harm. Those engaged in internationally collaborative research need to be alert to the potential conflicts of interests of host country ethics committees during the approval process and to take measures to manage them if they indeed exist. (shrink)

This is the third of three volumes containing a report from the International Panel on Social Progress. The IPSP is an independent association of top research scholars with the goal of assessing methods for improving the main institutions of modern societies. Written in accessible language by scholars across the social sciences and humanities, these volumes assess the achievements of world societies in past centuries, the current trends, the dangers that we are now facing, and the possible futures in (...) the twenty-first century. It covers the main socio-economic, political, and cultural dimensions of social progress, global as well as regional issues, and the diversity of challenges and their interplay around the world. This particular volume covers topics such as world cultures and religions, families, global health, education, and the contributions of social sciences to institutional change. (shrink)

The ethical controversies raised by an industry-sponsored placebo-controlled trial of Risperidone for mania, conducted across eight sites in India, provide opportunities for dialogue, reflection and interdisciplinary consensus building on the processes and validity of the methods of evaluating the efficacy of interventions in health care. This commentary contextualises the debate in considerations of the evolution of morality and double standards. It is suggested that a productive interpretation of this unfolding drama should appreciate the folly of dissociating ethical standards in routine (...) health care from those used in health research, the culturally and economically grounded preferences in research priority setting, and the choice of ethical principles underlying participation in, and conduct of, clinical research. A broader discussion of ethical problems in clinical trials which includes questions about the evidence that informs ethical opinion is required to prevent harm to participants and subsequent recipients of health care and to restore confidence in the methods and the results of research in health care. (shrink)

On October 6, 2015, in Schrems v. Data Protection Commissioner, the European Court of Justice, the European Union's highest court, held that the fifteen-year-old Safe Harbor Framework Agreement with the United States was invalid. Under the agreement, about forty-five hundred American companies each year self-certified to the U.S. Department of Commerce that they were in compliance with the essential privacy protections of the European Union, and therefore it was permissible for entities in the European Union to send personal data to (...) these American companies. According to the court, because some American companies were making the personal data of E.U. citizens available to U.S. government agencies, such as the National Security Agency, the fundamental privacy interests of E.U. citizens were not being protected. As a result of this court decision there has been considerable speculation about what, if any, effect the case has on international collaboration in health research, in particular, the sharing of personal data by E.U. researchers with their U.S. colleagues. (shrink)

Academic education largely concerns knowledge and skills. Where there is attention to ethics, this tends to focus on study-related misconduct such as plagiarising assignments and, more recently, methodological misconduct. The current paper argues that it is also essential to teach students about social misconduct in science, with a focus on questionable collaboration practices. First, this would increase future early career researchers’ ability to succeed and avoid academic snares. Enhancing this ability would appear to be an ethical responsibility going hand-in-hand with (...) our attempts at endowing students with skills that we know could be exploited. Second, such teaching would establish authoritative norms about collaborative practices that are and are not acceptable. This would help to adjust scientific attitudes in next generations of graduates, to the benefit of both themselves and science. Teaching on science-specific social misconduct would also naturally tie in with addressing general forms of antisocial conduct which also occur in academia, such as bullying or sexual harassment. The paper provides a framework for defining and recognizing questionable collaboration practices, and for how to provide students with the attitudes, concepts and skills necessary to protect themselves as they enter the reality of the academic arena. (shrink)

Studies of epistemic communities and collaborative research in the social sciences have deepened the understanding of how science works, and more specifically how the social dimensions of scientific practice both enable and impede social scientists in realizing their epistemic goals. Two types of studies of epistemic communities are distinguished: general theories of epistemic communities aim to construct accounts of theoretical change applicable to all social scientific specialties, whereas historical studies emphasize the contingencies that affect specific social scientific disciplines, subfields, (...) or institutions. Although collaborative research plays a less pronounced role in the social sciences than in the natural sciences, collaboration has enabled social scientists to investigate topics that would otherwise be difficult to investigate. (shrink)

Increasing pragmatic and ethical concerns have been raised about the inadequacies of conventional approaches to agricultural research and extension worldwide and the lack of integrated efforts among researchers, extension educators, and users. This paper examines three models of these relationships: the diffusion or supply model; the induced innovation or demand model; and the synthesis triangular or supply/demand model. The triangular model builds and improves upon the previous models by focusing on the role of clients or users in the broadest (...) sense in creating a demand for science and extension education, as well as on the role of scientists and extension educators in creating a supply. The triangular model views the relationship as an interactive partnership in which research and extension education are conducted in response to client needs and demands expressed through negotiation, persuasion, and coercion involving all partners. To implement this model will require significant organizational and managerial changes as well as reorientation in the values and attitudes of researchers, extension educators, clients, and their organizations. The remainder of the paper presents a brief discussion of suggested strategies at the individual, institutional, regional, national, and international levels for enhancing this partnership in order to more effectively meet the future needs of our food system. (shrink)