For graduate students and junior researchers alike, organising a science café may seem a simple and relatively harmless academic activity. However, organising such an event, especially when it aims to share complex and sophisticated thinking with the general public, can raise challenges from conception to completion. In this text, we share our reflections on the challenges and other lessons learned by the members of the organising team of a bioethics café funded by the Canadian Institutes of Health Research, (...) in the hope that our experience can be of use to others in organising similar events. (shrink)

Guideline 20 of the updated International Ethics Guidelines for Health‐related Research Involving Humans (2016) by the Council for International Organizations of Medical Sciences (CIOMS) provides guidance on research in disasters and disease outbreaks against the background of the need to generate knowledge quickly, overcome practical impediments to implementing such research, and the need to maintain public trust. The guideline recommends that research ethics committees could pre‐screen study protocols to expedite ethical reviews in a (...) situation of crisis, that pre‐arrangements be made regarding data sharing and biomedical sample sharing, and that sponsors and research ethics committees seek to minimize risk to researchers conducting research during a disaster. This paper critiques these recommendations against the background of the findings of a survey of public health officials and chairs of research ethics committees in the Caribbean during 2016, which sought to determine the best template for the expeditious ethical review of research proposals in emergency and epidemic situations in the Caribbean, and whose findings can serve as a model for other low‐ and middle‐income countries. (shrink)

While open science gains prominence in South Africa with the encouragement of open data sharing for research purposes, there are stricter laws and regulations around privacy – and specifically the use, management and transfer of personal information – to consider. The Protection of Personal Information Act No. 4 of 2013 (POPIA), which came into effect in 2021, established stringent requirements for the processing of personal information and has changed the regulatory landscape for the transfer of personal information across (...) South African borders. At the same time, draft national policies on open science encourage wide accessibility to data and open data sharing in line with international best practice. As a result, the operation of research ethics committees (RECs) in South Africa is affected by the conflicting demands of the shift towards open science on the one hand, and the stricter laws protecting participants’ personal information and the transfer thereof, on the other. This article explores the continuing evolving role of RECs in the era of open data and recommends the development of a data transfer agreement (DTA) for the ethical management of personal health information, considering the challenges that RECs encounter, which centres predominantly on privacy, data sharing and access concerns following advances in genetic and genomic research and biobanking. (shrink)

Background The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022. Methods The GFBR is an annual meeting organized (...) by the World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was “Ethics of AI in Global Health Research”. The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022. Results We describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships. Conclusions The 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research. (shrink)

One interesting aspect of the Hwang-case has been the way in which this affair was assessed by academic journals such as Nature. Initially, Hwang’s success was regarded as evidence for the detrimental effects of research ethics, slowing down the pace of research in Western countries. Eventually, however, Hwang’s debacle was seen as evidence for the importance of ethics in the life sciences. Ironically, it was concluded that the West maintains its prominence in science (as a (...) global endeavour) precisely because it has its ethics in place. Bioethics was now seen as an indispensable part of quality control. In this article, I will claim that the Hwang case rather reveals that there is no reason for complacency and that there are substantial challenges awaiting us. They have to do with major transformations in the way knowledge is produced and research in the life sciences is conducted (such as the increase in pace and scale, globalisation and the growing importance of ICT and bioinformation). These transformations call for a different kind of bioethics. The focus must shift from duties of autonomous researchers concerning visible research subjects (“micro-ethics”) to responsibilities of institutionalised research networks in managing and processing large amounts of bioinformation (“macro-ethics”). Concepts such as transparency, reliability and benefit-sharing will become more important than concepts such as informed consent. Basically, it is a resurgence of the tension between the Kantian and the Hegelian view of ethics. The contours of macro-ethics will be elaborated notably as it is emerging in bioethical debates over biobanking and genetic databanks. (shrink)

Certain critical accounts of conventional research practices in business and the social sciences are explored in this essay. These accounts derive from alternative social paradigms and their underlying assumptions about appropriate social inquiry and knowledge construction. Among these alternative social paradigms, metatheories, mindscapes, or worldviews are social constructionist, critical, feminist, and postmodern or poststructural thinking. Individuals with these assumptions and values for knowledge construction are increasingly challenging conventional scholarship in what has been referred to as paradigm debates (...) or wars. Issues of incommensurability or cross-paradigmatic communication potentials, as well as reflexivity, are raised in terms of moral education and development potentials for applied social science fields. Barriers and suggestions for increased moral development in academic and professional communities are discussed. In particular, moral forums in which participants have enhanced intrapersonal and interpersonal communication skills appear to be needed to surface and share often taken-for-granted assumptions concerning moral knowledge construction. (shrink)

This article explores two key facets of institutionalized ethical review processes in Germany: (1) their importance in shaping ethical research and (2) their associated challenges, with a specific focus on their implications within the social sciences. Ethical considerations play a pivotal role in (social science) research, safeguarding, amongst others, the rights and well-being of participants and ensuring research integrity. Despite notable progress in promoting research ethics, German research institutions still need to significantly improve (...) their ethics review processes. To address these challenges, this article emphasizes the need for expanding the current management of research ethics and implementing what we call “Institutionalized Research Ethics Practices’’ (IREPs), which include but go beyond the scope of common Institutional Review Boards (IRBs). Drawing on two workshops with researchers and IRB members, and a systematic review of existing IRBs in the German social sciences, we propose concrete recommendations for developing and enhancing IREPs, including a conducive environment, accessibility, fairness, and fostering expertise (CAFE). These enhancements aim to strengthen Germany’s research ethics infrastructure and promote responsible and ethical research practices in the social sciences. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Research Ethics after World War II: The Insular Culture of BiomedicineAllan M. Brandt (bio) and Lara Freidenfelds (bio)Human subjects research in the United States has only recently emerged as an important area of historical investigation. Over the last quarter century, scholars have begun the process of grounding within an historical context both the complex relationship between researchers and subjects and the processes by which biomedical (...) class='Hi'>knowledge is produced. Their studies examine topics ranging from the impact of the anti-vivisectionist movement on human experimentation in the early twentieth century (Lederer 1995) to the development of the discipline of bioethics in the 1960s and 1970s (Rothman 1991) and the emergence of the legal concept of informed consent for human research (Katz, Glass, and Capron 1972). Many of the discussions focus on isolated incidents of scandal, such as the Tuskegee Syphilis Study (Jones 1993; Brandt 1978) and the Willowbrook School hepatitis study (Rothman and Rothman 1984). In doing so, they attempt to explain how such clearly unethical research could have been initiated and what consequences have resulted from public knowledge of such research.Nonetheless, the broader historical contexts and implications of human subjects research have yet to be fully delineated. This project will be of crucial importance, not only for historians, but also for those concerned with research policy and medical ethics. The historical examination of human subjects research will provide further insight into the details of research methods, the construction of protocols, and the historically specific interest in certain diseases. In addition, scholars will better understand the relationships of power and authority between researcher and subject, as well as the social and scientific mechanisms for the production of new biomedical knowledge. The process of enlisting research subjects illuminates the significance of class, gender, ethnicity, and race in science, in biomedicine, and in society. The fact that, historically, much research has employed research subjects from vulnerable populations, who participated in coercive contexts, has exposed powerful social assumptions embedded in the research enterprise. [End Page 239]The revelation of new documents indicating past abuses has sparked much of the investigation into human subjects research and the recent investigation of human radiation experiments during the Cold War era. One of the most important achievements of the Advisory Committee on Human Radiation Experiments was the uncovering of thousands of documents, a remarkable mine of archival data, that had been previously inaccessible to researchers. Jonathan Moreno and Susan Lederer’s article on the history of Cold War research ethics in this issue of the Kennedy Institute ofEthics Journal represents the first attempt since the publication of the Committee’s Final Report to analyze the Committee’s findings in a serious historical context.Historical accounts of the emergence of bioethics traditionally have left a great void in their discussions of human experimentation, generally ignoring the period between the writing of the Nuremberg Code in 1947 and the publication of Henry Beecher’s 1966 New England Journal ofMedicine article condemning systematic, unethical practices in human experimentation (Rothman 1991). The period from 1946 to 1966, however, was a time of vigorous research characterized by a fragmented community of medical researchers who applied inconsistent ethical standards and employed highly variable research practices. Both military and civilian medical researchers were intensely interested in radiation and thus conducted human subjects research along those lines, including examinations of the effects of plutonium injections and of total body irradiation, the use of trace radioisotopes to study various body processes, and observations of the effects of radiation intentionally released into the environment. The U.S. Government sponsored several thousand such studies (ACHRE 1995 [GPO, pp. 227–31; Oxford, pp. 135–38]), some of which were conducted on hospital patients, institutionalized children, military personnel, and prisoners. The Cold War scientific culture that produced this research must be examined from an historical ethical perspective.A central aspect of the culture of biomedical science after World War II was its insularity. Increasingly high standards of admission and challenging training had come to ensure that only a select group of individuals was admitted to the professions of medicine and research science. In this culture of experts, trustworthiness and ethical judgment were considered to be dependent upon expertise... (shrink)

In 1997 President Clinton apologized to the survivors of the U.S. Public Health Service Syphilis Study. Since then, two of his recommendations have received little attention. First, he emphasized the need to remember the shameful past so we can build a better future for racial'ethnic minority populations. Second, he directed the creation in partnership with higher education to prepare training materials that would instruct biomedical researchers on the application of ethical principles to research with racial/ethnic minority populations. This article (...) proposes the inclusion of these issues in the implementation of the Affordable Care Act. It asks, What is the right or good thing to do? What are our obligations to one another? Two challenges are examined: (a) Conducting research with African Americans without knowledge of bioethics specific to this population, and (b) the ethical dilemma of conducting research that does not adequately take into account the diversity within the Black population that is a contributing factor in health disparities. Training and policy recommendations responsive to President Clinton's Apology are presented. (shrink)

Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases (...) to each other and engage in substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features- Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise. Supplemented by short introductions to each section. Focus on ethical rather than regulatory issues. Essential Reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies. (shrink)

A multitude of legislation impacts the use of samples and data for research in South Africa. With the coming into effect of the Protection of Personal Information Act No. 4 of 2013 in July 2021, recent attention has been given to safeguarding research participants’ personal information. The protection of participants’ privacy in research is essential, but it is not the only risk at stake in the use and sharing of personal information. Other rights and interests that must (...) also be considered and safeguarded include the right to non-discrimination, the right to dignity, and the right to enjoy the benefits of scientific progress. This can be achieved by ensuring that the ethical values and universal principles that underpin the research landscape, namely equity, reciprocity, justice and solidarity, are embedded in the regulatory framework for the management and use of personal information. This paper advocates an integrated bioethics approach to the use of personal information for research in SA. A key feature in embedding such an approach is a Data Transfer Agreement that appropriately integrates the safeguards and protections set out by our regulatory framework with bioethical rules and procedures when personal information is used and shared for research purposes. This paper thus calls for the development of a national DTA that is guided by key ethical principles when data are shared for research purposes. This paper will be followed by a webinar on 23 June 2022 hosted by the Department of Science and Innovation and the SA Medical Research Council, where the recommendations and suggestions set out herein will be unpacked, discussed and debated by relevant stakeholders. (shrink)

Many Christian scholars, if not all of them, consider Genesis to be foundational texts of the Bible and the spring for all the other doctrines of the Scripture. Therefore, I'm considering the attempt to search and find arguments for cell therapy ethical issues in the fundamental text of Genesis as a challenging and educative task. Moreover, this could be the first step in analyzing the relationships between Christian religions and bioethics, in terms of finding reasonable decisions for ethical challenges, raised (...) by the current biomedical research. As for many other dilemmas of humanity, we have to recall the text of Genesis for analyzing the goodness or evilness of our actions in translational medicine, even though that is not the only way to get a reasonable ethical decision. My contribution is an essay that is trying to correlate the Genesis lessons with the needed arguments in deciding what could be good and what could be evil in the stem cell research, according to the religious convictions. The biggest challenges of biomedical research for Christian religions were due to the human cloning issue, made possible by the somatic cell nuclear transfer, but those challenges update the older debates on birth control pill, technologically assisted reproduction, or gene therapy. Issues related to in vitro fertilization, gene enhancement and gene therapy, human cell cloning, embryonic stem cell using, and chimera cell obtaining for research are being considered and related to the putative arguments extracted from the book of Genesis, describing the origins. As a matter of fact, I may conclude that the single way to reach a reasonable ethical decision in our society is to intersect ethics, science and theology and to engage large debates involving scientists, theologians, civil society representatives, ethicists (experts in applied ethics) and moral philosophers, having the two latest professionals as referees. (shrink)

The Joint Research Centre (JRC) is the European Commission’s in-house science and knowledge service, employing a substantial staff of scientists devoted to conducting research to provide independent scientific advice for EU policy. Focussed on various research areas aligned with EU priorities, the JRC excels in delivering scientific evidence for policymaking and has published numerous science-for-policy reports and scientific articles. Drawing on a scientific integrity statement, surveys among JRC’s research staff, and thematic discussions with (...) JRC’s research leaders, the JRC has developed a comprehensive Scientific Integrity and Research Ethics (SIRE) framework, including instruments, procedures, and guidelines to ensure high standards and independence in its research. Key components of the SIRE framework include a Scientific Integrity Officer, an Editorial Review Board, a Research Ethics Board, and guidelines for responsible conduct of research. This article provides an overview of the JRC’s SIRE framework and how it was developed, emphasising the importance of maintaining independence, integrity, and ethics in scientific research that supports EU policy. The article also discusses potential gaps in the framework and where additional efforts may be needed, comparing with the recent U.S. National Science and Technology Council report on Protecting the Integrity of Government Science. (shrink)

Ethical conduct is a maxim in scholarly research as well as scholarly endeavour generally. In the case of research involving humans, few if any question the necessity for ethics approval of procedures by ethics boards or committees. However, concerns have been raised about the appropriateness of ethics approval processes for social science research arguing that the orientation of ethics boards and committees to biomedical and experimental scientific research, institutional risk aversion, and (...) other factors lead to over-protection of research participants and overly restrictive processes that delay and sometimes prevent important social science research. This is particularly significant when social science research is required to respond to social, environmental, or health emergencies and in contract research projects for the reasons explained. This analysis of an ethics approval case study adds to increasing concerns that ethics approval processes can have perverse effects in the social sciences. While a single case study does not provide generalizable findings, in-depth analysis of a significant case can identify issues that need to be further explored. Recommendations offer pathways for facilitating social science research including in emergency situations in which timeliness is important and in collaborative approaches such as participatory action research, while maintaining high ethical standards. (shrink)

Visual research methods like photography and digital storytelling are increasingly used in health and social sciences research as participatory approaches that benefit participants, researchers, and audiences. Visual methods involve a number of additional ethical considerations such as using identifiable content and ownership of creative outputs. As such, ethics committees should use different assessment frameworks to consider research protocols with visual methods. Here, we outline the limitations of ethics committees in assessing projects with a visual focus (...) and highlight the sparse knowledge on how researchers respond when they encounter ethical challenges in the practice of visual research. We propose a situated approach in relation to visual methodologies that encompasses a negotiated, flexible approach, given that ethical issues usually emerge in relation to the specific contexts of individual research projects. Drawing on available literature and two case studies, we identify and reflect on nuanced ethical implications in visual research, like tensions between aesthetics and research validity. The case studies highlight strategies developed in-situ to address the challenges two researchers encountered when using visual research methods, illustrating that some practice implications are not necessarily addressed using established ethical clearance procedures. A situated approach can ensure that visual research remains ethical, engaging, and rigorous. (shrink)

Bioscience ethics facilitates free and accurate information transfer from applied science to applied bioethics. Its major elements are: increased understanding of biological systems, responsible use of technology, and attuning ethnocentric debates to new scientific insights. Pioneered by Irina Pollard in 1994, bioscience ethics has become an internationally recognized discipline, interfacing science and bioethics within professional perspectives such as medical, legal, bio-engineering, and economics. Written for students and professionals alike, the fundamental feature of this book is its (...) breadth, important because bioscience ethics interweaves many diverse subjects in the process of gathering specialist scientific knowledge for bioethical review. It contains chapters which embrace topics affecting human reproduction, end-of-life care and euthanasia, challenge human-dominated ecosystems, and review population growth, economic activity and warfare. A background section describes the evolution of ethical consciousness, explores the future, and proposes that the reworking of ethical boundaries can enhance mature decision-making in harmony with changing technology. (shrink)

It has become evident that neuroimaging raises new normative questions that cannot be addressed adequately within the (in this regard unspecific) frameworks of existing research ethics. Questions that are especially troubling are, among others, provoked by incidental findings. Two questions are particularly intricate in view of incidental findings: (1) How can the research subject’s right not to know be guaranteed? And (2) should a diagnostic check of scans by a neuroradiologist become an obligatory part of neuroscientific (...) class='Hi'>research protocols? The present paper examines these question against the background of two recent recommendations. The differentiation between difference position and similarity position serves as an analytic tool to further investigate the issue and to develop a distinct proposal for answering the questions. (shrink)

How to engage the public in a reflection on the most pressing ethical issues of our time? What if part of the solution lies in adopting an interdisciplinary and collaborative strategy to shed light on critical issues in bioethics? An example is Art + Bioéthique, an innovative project that brought together bioethicists, art historians and artists with the aim of expressing bioethics through arts in order to convey the “sensitive” aspect of many health ethics issues. The aim of this (...) project was threefold: 1) to identify and characterize mechanisms for the meeting of arts and bioethics; 2) to experiment with and co-construct a dialogue between arts and bioethics; and 3) to initiate a public discussion on bioethical issues through the blending of arts and bioethics. In connection with an exhibition held in March 2016 at the Espace Projet, a non-profit art space in Montréal, the project developed a platform that combined artworks, essays and cultural & scientific mediation activities related to the work of six duos of young bioethics researchers and emerging artists. Each duo worked on a variety of issues, such as the social inclusion of disabled people, the challenges of practical applications of nanomedicine and regenerative medicine, and a holistic approach to contemporary diseases. This project, which succeeded in stimulating an interdisciplinary dialogue and collaboration between bioethics and arts, is an example of an innovative approach to knowledge transfer that can move bioethics reflection into the public space. (shrink)

International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs (...) involving exchange of biospecimens and data and in monitoring compliance. (shrink)

Smart farming has largely been driven by productivity and efficiency aims, but there is an increasing awareness of potential socio-ethical challenges. The responsible research and innovation approach aims to address such challenges but has had limited application in smart farming contexts. Using smart dairying research and development in New Zealand as a case study, we examine the extent to which principles of RRI have been applied in NZ smart dairying development and assess the broader lessons for RRI application (...) in smart farming. We draw on insights from: a review of research on dairy technology use in NZ; interviews with smart dairying stakeholders; and the application of an analytical framework based on RRI dimensions. We conclude that smart dairying R&D and innovation activities have focused on technology development and on-farm use without considering socio-ethical implications and have excluded certain actors such as citizens and consumers. This indicates that readiness to enact RRI in this context is not yet optimal, and future RRI efforts require leadership by government or dairy sector organisations to fully embed RRI principles in the guidelines for large R&D project design. More broadly, enacting RRI in smart farming requires initial identification of RRI readiness in a given sector or country and devising a roadmap and coherent project portfolio to support capacity building for enacting RRI. Additionally, methods for operationalising RRI must be adapted to the context of the national or sectoral innovation system in which smart farming is being developed. (shrink)

The COVID-19 pandemic posed many ethical and practical challenges for academic research. Some of these have been documented, particularly in relation to health research, but less attention has been paid to the dilemmas encountered by educational and social science research. Given that pandemics are predicted to be more frequent, it is vital to understand how to continue crucial research in schools and other learning communities. This article therefore focuses specifically on research ethics in (...) educational and social science during the pandemic of 2020–2022. The research involved interviews and workshops with University College London (UCL) academics, professional staff and graduate students and encompassed those involved in reviewing ethics applications, researchers dealing with ethics in projects that continued despite disruptions caused by COVID-19, and successful research projects specifically designed to study the effects of COVID-19 in various contexts. The article discusses some of the crucial knowledge and practical experiences that were accumulated. The operational and epistemological lessons learned from this particular institution may have wider relevance to research ethics processes in higher education environments where academics and students are grappling with post-COVID-19 ethical dilemmas and inform broader debates about how research institutions can build institutional knowledge to improve practices of ethics review at the times of health emergencies in future. Our evidence points to the significance of inter- and multidisciplinary, collaborative approaches that flatten institutional hierarchies and to the crucial role played by professional staff. In addition, we argue that ethics review processes must be underpinned by critical debates about wider issues of unequal power relationships between research partners, the nature of knowledge production, ownership and utilisation. To enhance equity and epistemic justice in research practices, ethics education should be an ongoing integral part of research ethics within research institutions. (shrink)

Research Ethics in Applied Economics Emphasizing the new challenges posed by the data science revolution, digital media, and changing standards, Research Ethics in Applied Economics examines the ethical issues faced by the applied economics researcher at each stage of the research process. The first section of the book considers project development, including issues of project management, selection bias in asking research questions, and political incentives in the development and funding of research ideas. (...) The second section addresses data collection and analysis, discussing concerns about participant rights, data falsification, data management, specification search, p-hacking, and replicability. The final section focuses on sharing results with academic audiences and beyond, with an emphasis on self-plagiarism, self-promotion, and the importance of achieving policy impact. The discussion and related recommendations highlight emergent issues in research ethics. Featuring case studies from experienced researchers on how they address ethical issues, this book provides practical guidance to both students and experienced practitioners seeking to navigate ethical issues in their applied economics research. (shrink)

BackgroundThe ethical concerns associated with HIV prevention and treatment research have been widely explored in South Africa over the past 3 decades. However, HIV cure research is relatively new to the region and significant ethical and social challenges are anticipated. There has been no published empirical enquiry in Africa into key informant perspectives on HIV cure research. Consequently, this study was conducted to gain preliminary data from South African HIV clinicians, researchers and activists.MethodsIn-depth interviews were conducted on (...) a purposive sample of fourteen key informants in South Africa. Audiotaped interviews were transcribed verbatim with concurrent thematic analysis. The perspectives of HIV clinicians, researchers and activists were captured. Analyst triangulation occurred as the data were analysed by three authors independently.ResultsThe rapid evolution of HIV cure research agendas was prominent with participants expressing some concern that the global North was driving the cure agenda. Participants described a symbiotic relationship between cure, treatment and prevention research necessitating collaboration. Assessing and managing knowledge and expectations around HIV cure research emerged as a central theme related to challenges to constructing ‘cure’ - how patients understand the idea of cure is important in explaining the complexity of cure research especially in the South African context where understanding of science is often challenging. Managing expectations and avoiding curative misconception will have implications for consent processes. Unique strategies in cure research could include treatment interruption, which has the potential to create therapeutic and ethical conflict and will be perceived as a significant risk. Ethical challenges in cure research will impact on informed consent and community engagement.ConclusionsIt was encouraging to note the desire for synergy amongst researchers and clinicians working in the fields of prevention, treatment and cure. Translation of complex HIV cure science into lay language is critical. Moving forward, RECs must be adequately constituted with scientific expertise and community representation when reviewing cure protocols. It is hoped that knowledge and resource sharing in the context of collaboration between research scientists working in cure and those working in treatment and prevention will accelerate progress towards cure. (shrink)

Successful innovative ‘leaps’ in surgical technique have the potential to contribute exponentially to surgical advancement, and thereby to improved health outcomes for patients. Such innovative leaps often occur relatively spontaneously, without substantial forethought, planning, or preparation. This feature of surgical innovation raises special challenges for ensuring sufficient evaluation and regulatory oversight of new interventions that have not been the subject of controlled investigatory exploration and review. It is this feature in particular that makes early-stage surgical innovation especially resistant to classification (...) as ‘research’, with all of the attendant methodological and ethical obligations—of planning, regulation, monitoring, reporting, and publication—associated with such a classification. This paper proposes conceptual and ethical grounds for a restricted definition according to which innovation in surgical technique is classified as a form of sui generis surgical ‘research’, where the explicit goal of adopting such a definition is to bring about needed improvements in knowledge transfer and thereby benefit current and future patients. (shrink)

It characterizes studies in Brazilian Information Science that connect gender and/or women and the Knowledge Organization (KO). The study is characterized as exploratory, descriptive, presenting bibliographical research as a data collection procedure. The bibliographic research was carried out in the Information Science Database (BRAPCI) and in the Brazilian Digital Library of Theses and Dissertations (BDTD). 42 scientific works were analyzed, including articles, dissertations, and theses. The first publication on the subject in the literature analyzed is (...) from 2010, highlighting its incipience, considering that 58% of publications are from 2017 to the present. Considering their objectives, the research was categorized into the three dimensions of ISKO-Brazil: epistemological, applied, political, and social. 22% of the research was categorized into the epistemological dimension, 39% into the applied dimension, and 39% into the political and social dimension. The epistemological dimension of KO concerning gender presents significant challenges, but also opportunities for theoretical and methodological advances that can contribute to a fairer and more inclusive representation of knowledge. Critical analysis of the work shows that, although there is progress, it is still incipient to ensure that KO is truly inclusive and representative of diverse gender identities. (shrink)

Deception in research is contentious, as ethical codes stress informed consent, yet complete disclosure may jeopardise validity. Indian Council for Medical Research (ICMR) guidelines classify deception into active, incomplete, and authorised forms. This study explores the ethical justification for incomplete (partial disclosure), permissible instances, and the dilemma faced by ethics committees in balancing scientific rigour and participant protection. The qualitative, non-experimental cross-sectional research, using in-depth interviews, identifies themes through thematic analysis. Findings reveal challenges for ethics (...) committees, as incomplete information hampers understanding, amongst others. The paper proposes an ethics committee framework, urging researchers to minimise or avoid partial deception and recommending institutional awareness campaigns and standard operating procedures for minimal-harm studies using partial disclosure. Therefore, it proposes that partial disclosure should be justified by the 3Vs—value, validity, and veracity to preserve research integrity. (shrink)

Existing ethics guidelines, influential literature and policies on ethical research generally focus on real-time data collection from humans. They enforce individual rights and liberties, thereby lowering need for aggregate protections. Although dependable, emerging public health research paradigms like research using public health data raise new challenges to their application. Unlike traditional research, RUPD is population-based, aligned to public health activities, and often reliant on pre-collected longitudinal data. These characteristics, when considered in relation to the generally (...) lower protective ethico-legal frameworks of the Global South, including Africa, highlight ethical gaps. Health and demographic surveillance systems are examples of public health programs that accommodate RUPD in these contexts. We set out to explore the perspectives of professionals with a working knowledge of these systems to determine practical ways of appropriating the foundational principles of health research to advance the ever growing opportunities in RUPD. We present their perspectives and in relation to the literature and our ethical analysis, make context relevant recommendations. We further argue for the development of a framework founded on the discussions and recommendations as a minimum base for achieving optimal ethics for optimal RUPD in the Global South. (shrink)

Neuroethics is an interdisciplinary field that arose in response to novel ethical challenges posed by advances in neuroscience. Historically, neuroethics has provided an opportunity to synergize different disciplines, notably proposing a two-way dialogue between an ‘ethics of neuroscience’ and a ‘neuroscience of ethics’. However, questions surface as to whether a ‘neuroscience of ethics’ is a useful and unified branch of research and whether it can actually inform or lead to theoretical insights and transferable practical knowledge (...) to help resolve ethical questions. In this article, we examine why the neuroscience of ethics is a promising area of research and summarize what we have learned so far regarding its most promising goals and contributions. We then review some of the key methodological challenges which may have hindered the use of results generated thus far by the neuroscience of ethics. Strategies are suggested to address these challenges and improve the quality of research and increase neuroscience's usefulness for applied ethics and society at large. Finally, we reflect on potential outcomes of a neuroscience of ethics and discuss the different strategies that could be used to support knowledge transfer to help different stakeholders integrate knowledge from the neuroscience of ethics. (shrink)

ABSTRACT Objective: To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. Methods: Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration (...) with the National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. Results: Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision‐making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. Conclusions: Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research. (shrink)

BackgroundCurrent policies regulating the use of animals for scientific purposes are based on balancing between potential gain of knowledge and suffering of animals used in experimentation. The balancing process is complicated, on the one hand by plurality of views on our duties towards animals, and on the other hand by more recent discussions on uncertainty in the probability of reaching the final aim of the research and problems of translational failure.MethodsThe study combines ethical analysis based on a literature (...) review with neuropsychiatry-related preclinical research as a case study.ResultsBased on the analysis and the case study we show that neuropsychiatry-related preclinical research is an especially interesting case from an ethical perspective. The 3R principles are used to minimize the negative consequences for the animals used in research. However, neuropsychiatric research is characterized by specific challenges in assessing the probability of success of reaching the final aim, due to our limited mechanistic knowledge of human neuropsychiatric illness. Consequently, the translational value of the currently used animal models may be difficult to prove, which undermines the validity of these models and complicated the ethical assessment.ConclusionsWe conclude that a combined approach that deals with both science and the ethical dimensions is necessary to address the problems of validity and translation in neuropsychiatry-related preclinical research. We suggest this approach to comprise first, improved experimental methods, e.g. by using systematic reviews, second, a more patients-based approach that leads to models that reflect interindividual variation better, and third, more interdisciplinary cooperation. (shrink)

In February 1997, following the announcement that the Roslin Institute in Scotland had successfully cloned a sheep by means of cell-nuclear transfer, US President Clinton requested the National Bioethics Advisory Commission to review legal and ethical issues of cloning and to recommend federal actions to prevent abuse. In the meantime he directed the heads of executive departments and agencies not to allocate federal funds for ‘cloning human beings’. The Commission consulted with members of relevant academic disciplines and other professions, representatives (...) of interest groups and members of the general public, and received written submissions. Unsurprisingly, given the prospect of human cloning and the sensational announcement in January 1998 by the American physicist-cum-embryologist Richard Seed that he would aim to clone himself, public debate in the US has been fairly voluble. (shrink)

With the increased use of Artificial Intelligence (AI) in wildlife conservation, issues around whether AI-based monitoring tools in wildlife conservation comply with standards regarding AI Ethics are on the rise. This review aims to summarise current debates and identify gaps as well as suggest future research by investigating (1) current AI Ethics and AI Ethics issues in wildlife conservation, (2) Initiatives Stakeholders in AI for wildlife conservation should consider integrating AI Ethics in wildlife conservation. We (...) find that the existing literature weakly focuses on AI Ethics and AI Ethics in wildlife conservation while at the same time ignores AI Ethics integration in AI systems for wildlife conservation. This paper formulates an ethically aligned AI system framework and discusses pre-eminent on-demand AI systems in wildlife conservation. The proposed framework uses agile software life cycle methodology to implement guidelines towards the ethical upgrade of any existing AI system or the development of any new ethically aligned AI system. The guidelines enforce, among others, the minimisation of intentional harm and bias, diversity in data collection, design compliance, auditing of all activities in the framework and ease of code inspection. This framework will inform AI developers, users, conservationists, and policymakers on what to consider when integrating AI Ethics into AI-based systems for wildlife conservation. (shrink)

The particular dynamics of public health emergencies urge scientists and Ethics Committee (EC) members to change and adapt their operating procedures to function effectively. Despite having previous pandemic experiences, ethics committees were unprepared to adapt to COVID-19 pandemic challenges. This survey aims to learn and thoroughly discuss the most salient issues for ECs during the COVID-19 pandemic. The results indicate that the main problems faced by ECs were lack of/insufficient regulations, lack of data/experience/knowledge, sloppy review, poor (...) class='Hi'>research design, and poor adaptation to quarantine measures. Coping with factors that threaten the autonomy and independence of ECs, the ethical dilemma regarding maximizing common good versus protecting the rights and well-being of study participants, comprehending the change in the context of vulnerable populations, and redefining the role of ECs to strengthen trust in science and vaccine confidence were outstanding issues. (shrink)

Ethics and integrity should be intertwined within the concept of Responsible Research. Integrity Officers should also be Ethics Officers, enforcing compliance with rules and norms, but also raising awareness on the meaning of ethics in researchers’ daily work. Paul Ricoeur’s definition of Ethics – “the aim of living a good life with and for others in just institutions” (Ricoeur in Oneself as Another. University of Chicago Press, 1994 ) –, points out the relational dimension of (...) Ethics that matters to all the stakeholders in scientific research. The dialogical interaction between Ethics and Integrity can help to prevent researchers from assuming self-regulation as the only possible path to be followed. In this paper, the challenges and the opportunities posed by this approach will be outlined and discussed, mainly, the challenges of building trust bottom up, while setting up restrictions to comply with rules and norms top down. Concerning the opportunities, the focus will be on making better science and building a solid network among the various stakeholders of the research system. (shrink)

This scoping review maps research ethics and integrity challenges and best practices encountered by research actors in the DACH countries (Germany, Austria, and Switzerland), including researchers, funders, publishers, research ethics committees, and policymakers, during the COVID-19 pandemic. The COVID-19 pandemic brought research and, in turn, research ethics and integrity, into public focus. This review identified challenges related to changing research environments, diversity in research, publication and dissemination trends, scientific literacy and (...) trust in science, recruitment, research redundancy and study termination, placebo and human challenge studies, data management, and informed consent. These challenges are linked to two crucial factors: first, actors in the DACH research ecosystem lacked a sound knowledge base to assess the risks and benefits of research during the COVID-19 pandemic. Second, researchers in the DACH region faced pressure from policymakers, funders, and the public to generate relevant, timely, and consistent findings to mitigate the impacts of the COVID-19 pandemic. In addition, this review highlights best practices to mitigate the effects of future crises on research ethics and integrity, including enhanced cooperation among actors, continuous ethics assessments, and support for public scientific literacy. (shrink)

Health research has increased during the last decade, which has enhanced the importance of research ethics. However, little is known regarding the knowledge, awareness, attitudes, and practices of investigators in Myanmar. To assess awareness, knowledge, and attitudes of post-graduates regarding research ethics and research ethics committees (RECs) and their informed consent practices and to determine the association between their responses and certain independent factors. We conducted a cross-sectional study using a questionnaire (...) that was distributed to a convenience sample of post-graduates at the Defence Services Medical Academy in Myanmar. We used descriptive, t test, and chi-square statistics to analyze the data. Significance was set at p < 0.05. We obtained surveys from 204 participants, which included 177 MSc and 27 PhDs of whom 63.6% had performed research and 86.5% had prior ethics training. Regarding awareness, 92.2% were aware of an REC at their academy, but only 47.1% were “fully aware” of the functions of an REC and only 52.9% stated they were familiar with ethical principles that govern human subject research. More than 90% thought that research involving human subjects should be submitted to an REC and that post-graduates should have training on research ethics. However, several of their attitudes were sub-optimal; for example, 20.2% said that informed consent is only necessary from the community leader of a village rather than from the individual, 32.8% agreed it is acceptable to fabricate research data, and 33.0% believed that ethical review of research should be restricted to international collaborative research. Calculated mean total attitude scores were statistically significantly higher in post-graduates with PhDs compared with those with MSc and higher in those with knowledge of research ethics principles compared with those lacking such knowledge. Significant gaps exist among post-graduates regarding their knowledge, awareness, and attitudes regarding research ethics and RECs. We recommend that post-graduates receive further training in research ethics to ensure the ethical conduct of research. Further studies should be performed to determine the generalizability of our findings to other institutions in Myanmar. (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 article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human‐nonhuman chimeric research. Led by bioethics researchers (...) working closely with an interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human‐nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics’ previous focus on human‐centered questions about the ethics of “humanization” and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less‐siloed governance and oversight and more‐comprehensive public communication. (shrink)

As the practice of medicine inevitably raises both ethical and legal issues, it had been recommended since 1999 that medical ethics and human rights be taught at every medical school. Most Nigerian medical schools still lack a formal undergraduate medical ethics curriculum. Medical education remains largely focused on traditional medical science components, leaving the medical students to develop medical ethical decision-making skills and moral attitudes passively within institutions noted for relatively strong paternalistic traditions. In conducting a needs (...) assessment for developing a curriculum germane to the Nigerian society, and by extension most of Sub-Saharan Africa, this study determined the views of Nigerian medical students on medical ethics education, ethical issues related to the doctor-patient relationship and the ethical/professional dilemmas they are confronted with. Using self-administered 63-item structured questionnaires, a cross-sectional survey of the final year medical students of the University of Nigeria was conducted in July 2015.Using the Statistical Package for the Social Sciences software (SPSS Version 17), frequency counts and percentages were generated. The sample included 100 males (71.4%) and 40 females (28.6%), with the respective mean (SD) age being 24.6(5.61) and 21.8 (6.38) years. Only 35.7% were satisfied with their medical ethics knowledge, and 97.9% indicated that medical ethics should be taught formally. Only 8.6% had never witnessed a medical teacher act unethically. The dilemmas of poor communication between physicians and patients, and the provision of sub-standard care were reported highest for being encountered ‘often’. A majority (60.7%) indicated that “a doctor should do his best always, irrespective of the patient’s wishes”. No significant difference in responses across gender was noted. There is a strong desire by the contemporary Nigerian medical student for medical ethics education. Their lack of exposure in medical ethics in an ethically challenging environment suggest a dire need for the development of an appropriate medical ethics curriculum for them and the provision of an ethically conducive learning environment. (shrink)

BackgroundBiobanks have recently been established in several low- and middle-income countries in the Arab region of the Middle East. We aimed to explore the views of biobank managers regarding the challenges, ethical issues, and governance arrangements of their biobanks.MethodsIn-depth semi-structured qualitative interviews were conducted with a purposive sample of eight biobank managers from Egypt, Jordan, and Sudan. Interviews were performed either face-to-face, by phone, or via Zoom and lasted approximately 45–75 min. After verbal consent, interviews were recorded and then transcribed. (...) The authors performed a thematic analysis of the transcripts independently and then integrated the themes via a consensus process.ResultsBiobank managers discussed the main challenges in establishing their biobanks. These included the staff’s lack of experience and training, limited funds, deficit awareness of biobanks, obtaining funding from different sources. Only four reported they were active in distributing biospecimens and health data to researchers. Six biobanks used a broad consent model, one used tiered consent, and another allowed participants to opt-out of being recontacted. Five managers avoided partnerships with pharmaceutical companies due to concerns with unfavorable reactions from the community. Five managers did not have clear policies for returning research results to the donors. Five expressed challenges with sample and data sharing with international collaborators; all five used material transfer agreements. The biobank managers revealed variable governance arrangements and activities with community involving awareness and educational efforts rather than active engagement. Several expressed the importance of transparency with the operations of their biobanks and gaining the trust of their stakeholders.ConclusionManagers of biobanks in LMICs in the Arab Middle East encounter financial, operational, and social challenges toward their sustainability efforts. Discussions with key stakeholders are warranted to manage ethical issues involving informed consent, privacy, data sharing, and the return of results. We recommend that biobank managers in the Arab Middle East form collaborative networks within the region and internationally, develop trusting governance relationships with their stakeholders, and pursue engagement activities with their communities to enhance trust. (shrink)

Continuing rapid developments in the life sciences offer the promise of providing tools to meet global challenges in health, agriculture, the environment, and economic development; some of the benefits are already being realized. However, such advances also bring with them new social, ethical, legal, and security challenges. Governance questions form an increasingly important part of the discussions about these advances--whether the particular issue under debate is the development of ethical principles for human genome editing, how to establish regulatory systems for (...) the safe conduct of field trials of gene drive-modified organisms, or many others. However there are continuing concerns that the knowledge, tools, and techniques resulting from life sciences research could also enable the development of bioweapons or facilitate bioterrorism. Between June 10 and 13, 2018, more than 70 participants from 30 different countries and 5 international organizations took part in an international workshop, The Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight, in Zagreb, Croatia. Hosted by the Croatian Academy of Sciences and Arts, the workshop was a collaboration among the InterAcademy Partnership, the Croatian Academy, the Croatian Society for Biosafety and Biosecurity, and the U.S. National Academies of Sciences, Engineering, and Medicine. This publication summarizes the presentations and discussions from the workshop."--Publisher's description. (shrink)

This work presents the case of the Yanomami indigenous people from Brazil that were the object of US ethnography initiated in the 1960s. The research brought harmful repercussions to the life of the Indigenous people of Brazil for several decades, and it took more than 40 years until the beginning of a process of reparation involving the Brazilian government and American universities. Objective: to discuss the meaning of the return of Yanomami blood samples, as well as contributions from the (...) epistemologies of traditional Indigenous knowledge to the debate about research ethics and the structuring of means for the social control of researchers and the protection of participants in scientific studies, having as an example the Yanomami indigenous people from Brazil, subjected to noxious ethnography in the 1960s and the 1970s. This work used data reports recorded in secondary sources. In this article we argue that Bioethics needs to further diversify its epistemological foundations and to consider epistemologies and cosmologies beyond the frontiers of Western science, as the case of the abusive research involving the Yanomami indigenous people in Brazil reveals. We argue that traditional knowledge, such as those of indigenous and quilombolas, with their epistemologies and cosmologies, are fundamental for the election of less colonized and more efficient principles of research ethics, regarding the protection of the participants' rights in scientific studies. Traditional indigenous populations can teach us a great deal about doing research. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women (...) have been inadequately represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

Members of research ethics committees (RECs) face a number of ethical challenges when reviewing genomic research. These include issues regarding the content and type of consent, the return of individual research results, mechanisms of sharing specimens and health data, and appropriate community engagement efforts. This article presents the findings from a survey that sought to investigate the opinions and attitudes of REC members from four Arab countries in the Middle East and North Africa (Egypt, Morocco, Sudan, (...) and Jordan) toward these ethical issues. Our findings suggest that efforts are required to better familiarize REC members with the requirements for ethical biobank research. Additionally, we recommend that further research is undertaken with REC members regarding the main items that should be present in the Material Transfer Agreements /Data Transfer Agreements in their corresponding countries and the type of consent that should be used in genomic research. (shrink)

While experience often affords important knowledge and insight that is difficult to garner through observation or testimony alone, it also has the potential to generate conflicts of interest and unrepresentative perspectives. We call this tension the paradox of experience. In this paper, we first outline appeals to experience made in debates about access to unproven medical products and disability bioethics, as examples of how experience claims arise in bioethics and some of the challenges raised by these claims. We then (...) motivate the idea that experience can be an asset by appealing to themes in feminist and moral epistemology, distinguishing between epistemic and justice-based appeals. Next, we explain the concern that experience may be a liability by appealing to empirical work on cognitive biases and theoretical work about the problem of partial representation. We conclude with preliminary recommendations for addressing the paradox and offer several questions for future discussion. (shrink)

In clinical research scientific, legal as well as ethical aspects are important. It is well known that clinical investigators at university hospitals have to undertake their PhD-studies alongside their daily work and reconciling work and study can be challenging. The aim of this project was to create a web based course in clinical research bioethics (5 credits) and to examine whether the method is suitable for teaching bioethics. The course comprised of six modules: an initial examination (to assess (...) knowledge in bioethics), information on research legislation, obtaining permissions from authorities, writing an essay on research ethics, preparing one’s own study protocol, and a final exam. All assignments were designed with an idea of supporting students to reflect on their learning with their own research. (shrink)

Cross-cultural research provides invaluable information about the origins of and explanations for cognitive and behavioral diversity. Interest in cross-cultural research is growing, but the field continues to be dominated by WEIRD (Western, Educated, Industrialized, Rich, and Democratic) researchers conducting WEIRD science with WEIRD participants, using WEIRD protocols. To make progress toward improving cognitive and behavioral science, we argue that the field needs (1) data workflows and infrastructures to support long-term high-quality research that is compliant with (...) open-science frameworks; (2) process and participation standards to ensure research is valid, equitable, participatory, and inclusive; (3) training opportunities and resources to ensure the highest standards of proficiency, ethics, and transparency in data collection and processing. Here we discuss infrastructures for cross-cultural research in cognitive and behavioral sciences which we call __Cross-Cultural Data Infrastructures (CCDIs).__ We recommend building global networks of psychologists, anthropologists, demographers, experimental philosophers, educators, and cognitive, learning, and data scientists to distill their procedural and methodological knowledge into a set of community standards. We identify key challenges including protocol validity, researcher diversity, community inclusion, and lack of detail in reporting quality assurance and quality control (QAQC) workflows. Our objective is to help promote dialogue and efforts towards consolidating robust solutions by working with a broad research community to improve the efficiency and quality of cross-cultural research. (shrink)

Pavel Dmitrievich Tishchenko, one of the founders of Russian bioethics, turned 75 on January 10, 2022. Joining the numerous congratulations, journal “Bioethics” publishes the text of the discussion dedicated to this event. The discussion was initiated by the question of the history of Russian bioethics formation in the perspective of its simultaneous emergence in Moscow, Volgograd, St. Petersburg, Kazan. The participants exchanged opinions on the significance of I.T. Frolov's ideas for the formation of the Moscow School of Bioethics. The influence (...) of the concept of "frontier" proposed by Tristram Engelhardt Jr. on the formation of distinctive features of Russian bioethics was revealed during the discussion. It is emphasized that at the early stages of its formation Russian bioethics was more concerned with the problems of clinical trials than with the moral dilemmas arising from medical practice. An important stage for self-understanding of bioethics was the events of the Afghan company, which exposed the imperfection of the healthcare system in the USSR. The discussion touches a critical examination of the traditional principles of bioethics. The conversation of the philosophical foundations of modern bioethics allowed to formulate two theoretical opinions. The firs assertion determines that philosophical theories delay with revolutionary changes in the field of medical and scientific practice. The second one determines the need for the formation of stable teacher-student relations sufficient for enculturation with the tradition of thinking. The participants noted the undoubted humanizing influence of these principles on clinical practice and scientific research. At the same time the risks associated with an attempt to transfer the principles that was established in the Western tradition into the practices of Russian medicine and science were identified. Speakers claimed the idea of harmonization the principles to the traditions of Russian philosophy and ethics. Thus, the medical art should be conceived as an active mercy, and many bioethical problems as social challenges that require solidarity. It was noted, that bioethics is transforming from type of value-based communication of specialists to a formalized procedure. (shrink)

In the early 1970s, a World Health Organization‐initiated and United States‐funded project released lab‐reared mosquitoes outside New Delhi in the first large‐scale field trials of the genetic control of mosquitoes. Despite partnering with the Indian Council of Medical Research and investing significantly in outreach to local communities at the release sites, the project was embroiled in controversy and became an object of vehement debate within the Indian parliament and diplomatic contretemps between the United States and India. This early episode (...) of genetic control research demonstrates how a scientific collaboration was entangled in geopolitics and shaped by the legacy of colonialism. This historical case study has implications for public deliberation in the present, pointing to the challenges of shared decision‐making in the context of structural inequality, the way that a backdrop of military interest in a technology can impede trust, and the long‐term consequences of projects that foster mistrust. (shrink)

The discovery of induced pluripotent stem (iPS) cells in 2006 was heralded as a major breakthrough in stem cell research. Since then, progress in iPS cell technology has paved the way towards clinical application, particularly cell replacement therapy, which has refueled debate on the ethics of stem cell research. However, much of the discourse has focused on questions of moral status and potentiality, overlooking the ethical issues which are introduced by the clinical testing of iPS cell replacement (...) therapy. First-in-human trials, in particular, raise a number of ethical concerns including informed consent, subject recruitment and harm minimisation as well as the inherent uncertainty and risks which are involved in testing medical procedures on humans for the first time. These issues, while a feature of any human research, become more complex in the case of iPS cell therapy, given the seriousness of the potential risks, the unreliability of available animal models, the vulnerability of the target patient group, and the high stakes of such an intensely public area of science. Our paper will present a detailed case study of iPS cell replacement therapy for Parkinson's disease to highlight these broader ethical and epistemological concerns. If we accept that iPS cell technology is fraught with challenges which go far beyond merely refuting the potentiality of the stem cell line, we conclude that iPS cell research should not replace, but proceed alongside embryonic and adult somatic stem cell research to promote cross-fertilisation of knowledge and better clinical outcomes. (shrink)