This paper is a critique of NIH guidelines for the care and protection of laboratory animals. It exposes four serious deficiencies in these guidelines: (1) failure to make it dear that the mere pursuit of knowledge does not justify using animals; (2) failure to give any guidance concerning what constitutes human benefit or well-being; (3) failure to countenance trade-offs between human benefit or well-being and animal well-being; (4) failure to clearly specify what constitutes keeping animals in an ‘environment appropriate to (...) the species and its life history.’ It concludes with the suggestion that the construction and revision of these guidelines is too important to be left to the professionals. Keywords: animals, benefit, NIH, research, trade-offs, well-being CiteULike Connotea Del.icio.us What's this? (shrink)

In the United States, the National Institute of Mental Health is seeking to encourage researchers to move away from diagnostic tools like the Diagnostic and Statistical Manual of Mental Disorders. A key mechanism for this is the “Research Domain Criteria” initiative, closely associated with former NIMH Director Thomas Insel. This article examines how key figures in US psychiatry construct the purpose, nature, and implications of the ambiguous RDoC project; that is, how its novelty is constituted through discourse. In (...) this paper, I explore and analyze these actors’ accounts of what is new, important, or desirable about RDoC, demonstrating how they are constituted through institutional context and personal affects. In my interviews with mental health opinion leaders, RDoC is presented as overly reliant on neurobiological epistemologies, distant from clinical imaginaries and imperatives, and introduced in a top-down manner inconsistent with the professional norms of scientific research. Ultimately, the article aims to add empirical depth to current understandings about the epistemological and ontological politics of contemporary psychiatry and to contribute to science and technology studies debates about “the new” in technoscience. Accordingly, I use discussions about RDoC as a case study in the sociology of novelty. (shrink)

Public funders of health research have been widely criticized on the grounds that their allocations of funding for disease-specific research do not reflect the relative burdens imposed by different diseases. For example, the US National Institutes of Health spends a much greater fraction of its budget on HIV/aids research and a much smaller fraction on migraine research than their relative contribution to the US burden of disease would suggest. Implicit in this criticism is a normative claim: (...) Insofar as the scientific opportunities are equal, each patient merits research into their condition proportional to the burden of disease for which that condition is responsible. This claim—the proportional view—is widely accepted but has never been fully specified or defended. In this paper, I explain what is required to specify the view, attempt to do so in the most charitable way, and then critically evaluate its normative underpinnings. I conclude that a severity-weighted proportional view is defensible. I close by drawing out five key lessons of my analysis for health research priority-setting. (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)

The demand for greater public accountability is changing the nature of ex ante peer review at public science agencies worldwide. Based on a four year research project, this essay examines these changes through an analysis of the process of grant proposal review at two US public science agencies, the National Institutes of Health (NIH) and the National Science Foundation (NSF). Weaving historical and conceptual narratives with analytical accounts, we describe the ways in which these two agencies (...) struggle with the question of incorporating considerations of societal impact into the process of peer review. We use this comparative analysis to draw two main conclusions. First, evaluation of broader societal impacts is not different in kind from evaluation of intellectual merit. Second, the scientific community may actually bolster its autonomy by taking a broader range of considerations into its peer review processes. (shrink)

Introduction Scholars have debated how to define coercion and undue influence, but how institutional review boards (IRBs) view and make decisions about these issues in actual cases has not been explored. Methods I contacted the leadership of 60 US IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health funding), and interviewed 39 IRB leaders or administrators from 34 of these institutions (response rate=55%), and 7 members. Results IRBs wrestled with (...) defining of ‘coercion’ and ‘undue inducement’, most notably in deciding about participant compensation. IRBs often use these terms synonymously and define undue inducement in varying ways, often wrestling with these issues, relying on ‘gut feelings’, and seeking compromises. Ambiguities arose, partly reflecting underlying tensions: whether subjects should ‘get paid’ versus ‘volunteer’ (ie, whether subjects should be motivated by compensation vs altruism), and whether subjects should be paid differently based on income, given possible resultant selection bias. Lack of consistent standards emerged between and even on single IRBs. Questions arose concerning certain aspects and types of studies; for example, how to view and weigh providing free care in research, whether and how recruitment flyers should mention compensation, and how to avoid coercion in paediatric, developing world, or students research. Conclusions These data, the first to probe qualitatively how IRBs view and approach questions about coercion, undue influence and participant compensation, and to examine how IRBs have reviewed actual cases, reveal several critical ambiguities and dilemmas, and have vital implications for future practice, education, policy and research. (shrink)

Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in (...) developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (shrink)

Public funders of health research have been widely criticized on the grounds that their allocations of funding for disease-specific research do not reflect the relative burdens imposed by different diseases. For example, the US National Institutes of Health spends a much greater fraction of its budget on HIV/AIDS research and a much smaller fraction on migraine research than their relative contribution to the US burden of disease would suggest. Implicit in this criticism is a normative claim: (...) Insofar as the scientific opportunities are equal, each patient merits research into their condition proportional to the burden of disease for which that condition is responsible. This claim—the proportional view—is widely accepted but has never been fully specified or defended. In this paper, I explain what is required to specify the view, attempt to do so in the most charitable way, and then critically evaluate its normative underpinnings. I conclude that a severity-weighted proportional view is defensible. I close by drawing out five key lessons of my analysis for health research priority-setting. (shrink)

Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear.METHODS: I conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%).RESULTS: (...) US IRBs face ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and ‘negotiate’ for maximum benefits for participants and fearing ‘worst-case scenarios’.CONCLUSIONS: US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice. (shrink)

The Bermuda Principles for DNA sequence data sharing are an enduring legacy of the Human Genome Project. They were adopted by the HGP at a strategy meeting in Bermuda in February of 1996 and implemented in formal policies by early 1998, mandating daily release of HGP-funded DNA sequences into the public domain. The idea of daily sharing, we argue, emanated directly from strategies for large, goal-directed molecular biology projects first tested within the “community” of C. elegans researchers, and were introduced (...) and defended for the HGP by the nematode biologists John Sulston and Robert Waterston. In the C. elegans community, and subsequently in the HGP, daily sharing served the pragmatic goals of quality control and project coordination. Yet in the HGP human genome, we also argue, the Bermuda Principles addressed concerns about gene patents impeding scientific advancement, and were aspirational and flexible in implementation and justification. They endured as an archetype for how rapid data sharing could be realized and rationalized, and permitted adaptation to the needs of various scientific communities. Yet in addition to the support of Sulston and Waterston, their adoption also depended on the clout of administrators at the US National Institutes of Health and the UK nonprofit charity the Wellcome Trust, which together funded 90% of the HGP human sequencing effort. The other nations wishing to remain in the HGP consortium had to accommodate to the Bermuda Principles, requiring exceptions from incompatible existing or pending data access policies for publicly funded research in Germany, Japan, and France. We begin this story in 1963, with the biologist Sydney Brenner’s proposal for a nematode research program at the Laboratory of Molecular Biology at the University of Cambridge. We continue through 2003, with the completion of the HGP human reference genome, and conclude with observations about policy and the historiography of molecular biology. (shrink)

In this essay, we suggest practical ways to shift the framing of crisis standards of care toward disability justice. We elaborate on the vision statement provided in the 2010 Institute of Medicine (National Academy of Medicine) “Summary of Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations,” which emphasizes fairness; equitable processes; community and provider engagement, education, and communication; and the rule of law. We argue that interpreting these elements through disability justice entails a commitment to (...) both distributive and recognitive justice. The disability rights movement's demand “Nothing about us, without us” requires substantive inclusion of disabled people in decision‐making related to their interests, including in crisis planning before, during, and after a pandemic like Covid‐19. (shrink)

Successfully navigating the norms of a society is a complex task that involves recognizing diverse kinds of rules as well as the relative weight attached to them. In the United States, different kinds of rules—federal statutes and regulations, scientific norms, and professional ideals—guide the work of researchers. Penalties for violating these different kinds of rules and norms can range from the displeasure of peers to criminal sanctions. We proposed that it would be more difficult for researchers working in the U.S. (...) who were born in other nations to distinguish the seriousness of violating rules across diverse domains. We administered a new measure, the evaluating rules in science task, to National Institutes of Health-funded investigators. The ERST assessed perceptions of the seriousness of violating research regulations, norms, and ideals, and allowed us to calculate the degree to which researchers distinguished between the seriousness of each rule category. The ERST also assessed researchers’ predictions of the seriousness that research integrity officers would assign to the rules. We compared researchers’ predictions to the seriousness ratings of 112 RIOs working at U.S. research-intensive universities. U.S.-born researchers were significantly better at distinguishing between the seriousness of violating federal research regulations and violating ideals of science, and they were more accurate in their predictions of the views of RIOs. Acculturation to the U.S. moderated the effects of nationality on accuracy. We discuss the implications of these findings in terms of future research and education. (shrink)

In the world of research, compliance with research regulations is not the same as ethics, but it is closely related. One could say that compliance is how most societies with advanced research programs operationalize many ethical obligations. This paper reports on the development of the How I Think about Research questionnaire, which is an adaptation of the How I Think questionnaire that examines the use of cognitive distortions to justify antisocial behaviors. Such an adaptation was justified based on a review (...) of the literature on mechanisms of moral disengagement and self-serving biases, which are used by individuals with normal personalities in a variety of contexts, including research. The HIT-Res adapts all items to refer to matters of research compliance and integrity rather than antisocial behaviors. The HIT-Res was administered as part of a battery of tests to 300 researchers and trainees funded by the US National Institutes of Health. The HIT-Res demonstrated excellent reliability. Construct validity was established by the correlation of the HIT-Res with measures of moral disengagement, cynicism, and professional decision-making in research. The HIT-Res will enrich the set of assessment tools available to instructors in the responsible conduct of research and to researchers who seek to understand the factors that influence research integrity. (shrink)

Gain-of-function research involves experimentation that aims or is expected to increase the transmissibility and/or virulence of pathogens. Such research, when conducted by responsible scientists, usually aims to improve understanding of disease causing agents, their interaction with human hosts, and/or their potential to cause pandemics. The ultimate objective of such research is to better inform public health and preparedness efforts and/or development of medical countermeasures. Despite these important potential benefits, GOF research can pose risks regarding biosecurity and biosafety. In 2014 (...) the administration of US President Barack Obama called for a “pause” on funding of GOF experiments involving influenza, SARS, and MERS viruses in particular. With announcement of this pause, the US Government launched a “deliberative process” regarding risks and benefits of GOFR to inform future funding decisions—and the US National Science Advisory Board for Biosecurity was tasked with making recommendations to the US Government on this matter. As part of this deliberative process the National Institutes of Health commissioned this Ethical Analysis White Paper, requesting that it provide review and summary of ethical literature on GOFR, identification and analysis of existing ethical and decision-making frameworks relevant to the evaluation of risks and benefits of GOFR, decision-making about the conduct of GOF studies, and the development of US policy regarding GOFR, and development of an ethical and decision-making framework that may be considered by NSABB when analyzing information provided by GOFR risk-benefit assessment, and when crafting its final recommendations. The ethical and decision-making framework ultimately developed is based on the idea that there are numerous ethically relevant dimensions upon which any given case of GOFR can fare better or worse : research imperative, proportionality, minimization of risks, manageability of risks, justice, good governance, evidence, and international outlook and engagement. Rather than drawing a sharp bright line between GOFR studies that are ethically acceptable and those that are ethically unacceptable, this framework is designed to indicate where any given study would fall on an ethical spectrum—where imaginable cases of GOFR might range from those that are most ethically acceptable, at one end of the spectrum, to those that are most ethically problematic or unacceptable, at the other. The aim should be that any GOFR pursued should be as far as possible towards the former end of the spectrum. (shrink)

The number of women living with HIV/AIDS is increasing worldwide, and there is an urgent public health need to develop new user-initiated HIV prevention methods, including microbicides. Although funding for microbicide development has increased since 2000, financial support is provided predominantly by governmental agencies and private foundations. Many donors, including the US Agency for International Development (USAID) and the US National Institutes of Health (NIH), have policies that restrict how research funds may be used. Among these (...) are the now-rescinded Mexico City Policy, elements of the US Foreign Assistance Act, and restrictions on non-study-related care. The effect of these restrictions on the design and conduct of clinical research is poorly understood. As part of a recent mapping exercise conducted by the Global Campaign for Microbicides, we reviewed the impact of donor restrictions on seven HIV prevention trials. We found considerable confusion within the HIV prevention field as to whether and how Mexico City and other policies affect the use of research funds. We also found that these donor-imposed policies limited the level of care provided to trial participants and the types of capacity building projects undertaken. (shrink)

The U.S. National Institute of Allergies and Infectious Diseases and the National Institute of Mental Health have a new research priority: inclusion of terminally ill persons living with HIV in HIV cure-related research. For example, the Last Gift is a clinical research study at the University of California San Diego for PLWHIV who have a terminal illness, with a prognosis of less than 6 months. As end-of-life HIV cure research is relatively new, the scientific community has a (...) timely opportunity to examine the related ethical challenges. Following an extensive review of the EOL and HIV cure research ethics literature, combined with deliberation from various stakeholders and our experience with the Last Gift study to date, we outline considerations to ensure that such research with terminally ill PLWHIV remains ethical, focusing on five topics: 1) protecting autonomy through informed consent, 2) avoiding exploitation and fostering altruism, 3) maintaining a favorable benefits/risks balance, 4) safeguarding against vulnerability through patient-participant centeredness, and 5) ensuring the acceptance of next-of-kin/loved ones and community stakeholders. EOL HIV cure-related research can be performed ethically and effectively by anticipating key issues that may arise. While not unique to the fields of EOL or HIV cure-related research, the considerations highlighted can help us support a new research approach. We must honor the lives of PLWHIV whose involvement in research can provide the knowledge needed to achieve the dream of making HIV infection curable. (shrink)

This paper examines the implications of the General Agreement on Trade in Services (GATS), the World Trade Organization’s agreement governing trade in health-related services, for health policy and healthcare reform in the United States. The paper describes the nature and scope of US obligations under the GATS, the ways in which the trade agreement intersects with domestic health policy, and the institutional factors that mediate trade-offs between health and trade policy. The analysis suggests that the GATS (...) provisions on market access, national treatment and domestic regulation, which are designed to eliminate ‘regulatory barriers’ to global trade in health services, limit the range of options that state and federal regulators and legislative bodies can employ to regulate the health sector and implement healthcare reforms. As such, the paper identifies the broader social and ethical implications of free trade policy. (shrink)

The number of women living with HIV/AIDS is increasing worldwide, and there is an urgent public health need to develop new user-initiated HIV prevention methods, including microbicides. Although funding for microbicide development has increased since 2000, financial support is provided predominantly by governmental agencies and private foundations. Many donors, including the US Agency for International Development and the US National Institutes of Health, have policies that restrict how research funds may be used. Among these are the (...) now-rescinded Mexico City Policy, elements of the US Foreign Assistance Act, and restrictions on non-study-related care. The effect of these restrictions on the design and conduct of clinical research is poorly understood. As part of a recent mapping exercise conducted by the Global Campaign for Microbicides, we reviewed the impact of donor restrictions on seven HIV prevention trials. We found considerable confusion within the HIV prevention field as to whether and how Mexico City and other policies affect the use of research funds. We also found that these donor-imposed policies limited the level of care provided to trial participants and the types of capacity building projects undertaken. (shrink)

In 1960, American parasitologist Don Eyles was unexpectedly infected with a malariaparasite isolated from a macaque. He and his supervisor, G. Robert Coatney of the National Institutes of Health, had started this series of experiments with the assumption that humans were not susceptible to “monkey malaria.” The revelation that a mosquito carrying a macaque parasite could infect a human raised a whole range of public health and biological questions. This paper follows Coatney’s team of parasitologists and (...) their subjects: from the human to the nonhuman; from the American laboratory to the forests of Malaysia; and between the domains of medical research and natural history. In the course of this research, Coatney and his colleagues inverted Koch’s postulate, by which animal subjects are used to identify and understand human parasites. In contrast, Coatney’s experimental protocol used human subjects to identify and understand monkey parasites. In so doing, the team repeatedly followed malaria parasites across the purported boundary separating monkeys and humans, a practical experience that created a sense of biological symmetry between these separate species. Ultimately, this led Coatney and his colleagues make evolutionary inferences, concluding “that monkeys and man are more closely related than some of us wish to admit.” In following monkeys, men, and malaria across biological, geographical, and disciplinary boundaries, this paper offers a new historical narrative, demonstrating that the pursuit of public health agendas can fuel the expansion of evolutionary knowledge. (shrink)

BackgroundAlthough a large number of clinical trials on interventions demonstrating efficacy (or lack thereof) are conducted annually, much of this evidence is not accessible to scientists and clinicians.ObjectivesWe aimed to determine the publication rate of posttraumatic stress disorder (PTSD) trials that have been registered in clinical trial registries, and the factors associated with publication.MethodsTrials, completed on January 15, 2015, were identified via the US National Institutes of Health clinical trials registry, the European Union Clinical Trials Register and (...) the WHO International Clinical Trials Registry Platform. A systematic search for publications (published by the end of March 2018) related to each of the registered trials were then performed.ResultsFour hundred and thirty-eight of 1982 potentially eligible trials were included. Only 34% of interventional trials were registered prior to initiation, 9% were registered within 2 months of starting and 20% after trial completion. Of the 438 included trials, 72% had generated peer-reviewed publications, while an additional 7% had disseminated results in some other form (such as on the trial database), 26 months after trial completion. Randomisation of a trial was the only factor individually associated with publication, in logistic regression analysis (p < 0.001). Intervention type, university as sponsor and study registration prior to completion were factors that influenced the time to publication, using Cox regression (p < 0.001).ConclusionsThis study underscores the importance of timely and accurate publication and dissemination of trial results, in order to avoid the potential waste of resources and to ensure research integrity and patient safety. We suggest that authors and journal editors adhere to conditions set out by the International Committee of Medical Journal Editors and that more diligent data sharing is encouraged through prospective trial registration and trial reporting websites. (shrink)

The US government supports drug innovation. It is therefore crucial that it distinguish between high-value and low-value innovation in purchasing expensive prescription drugs and medical devices and ensure the continued discovery of transformative drugs and that patient and taxpayer funds are not wasted.

The advanced sensory, psychological and social abilities of chimpanzees confer upon them a profound ability to suffer when born into unnatural captive environments, or captured from the wild – as many older research chimpanzees once were – and when subsequently subjected to confinement, social disruption, and involuntary participation in potentially harmful biomedical research. Justifications for such research depend primarily on the important contributions advocates claim it has made toward medical advancements. However, a recent large-scale systematic review indicates that invasive chimpanzee (...) experiments rarely provide benefits in excess of their profound animal welfare, bioethical and financial costs. The approval of large numbers of these experiments – particularly within the US – therefore indicates a failure of the ethics committee system. By 2008, legislative or policy bans or restrictions on invasive great ape experimentation existed in seven European countries, Japan, Australia and New Zealand. In continuing to conduct such experiments on chimpanzees and other great apes, the US was almost completely isolated internationally. In 2007, however, the US National Institutes of Health National Center for Research Resources implemented a permanent funding moratorium on chimpanzee breeding, which is expected to result in a major decline in laboratory chimpanzee numbers over the next 30 years, as most are retired or die. Additionally, in 2008, The Great Ape Protection Act was introduced to Congress. The bill proposed to end invasive research and testing on an estimated 1,200 chimpanzees confined within US laboratories, and, for approximately 600 federally-owned, to ensure their permanent retirement to sanctuaries. These events have created an unprecedented opportunity for US legislators, researchers, and others, to consider a global ban on invasive chimpanzee research. Such a ban would not only uphold the best interests of chimpanzees, and other research fields presently deprived of funding, but would also increase the compliance of US animal researchers with internationally-accepted animal welfare and bioethical standards. It could even result in the first global moratorium on invasive research, for any non-human species, unless conducted in the best interests of the individual or species. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:At the Vortex of Controversy:Developing Guidelines for Human Embryo ResearchRonald M. Green (bio)Because of the unavoidable time delay between the submission and publication of this article, its readers will have a significant advantage over its writer: You will know whether the recommendations of the Report of the Human Embryo Research Panel, on which I have served as a member since its inception in January of this year, are progressing (...) smoothly as the basis for evaluating future, federally-funded embryo research—or whether any of the recommendations has become stalled in controversy and political dispute. Staid journals like Science already are predicting that the Panel's Report is likely to create a stormy autumn for the National Institutes of Health.The Panel formally presented its Report to NIH Director Harold Varmus on September 27. The Panel's recommendations will be reviewed by the Advisory Committee to the Director (ACD) until the ACD's next meeting in early December. At that time, the ACD will make formal recommendations to Dr. Varmus, who then will initiate the process of drafting federal regulations that could go into effect by Spring 1995.Historical BackgroundControversy is not new to the area of human embryo research. In the United States, federal regulations enacted in the mid-1970s required any research on the human embryo to be approved by a federally mandated Ethics Advisory Board (EAB). The EAB drafted a significant report that provided ethical guidelines for research on the early, ex utero, human embryo. However, before the report could be acted upon, a new administration, which was opposed to abortion and anything remotely viewed as threatening to prenatal life, came to office, and when the EAB's charter expired in 1980, it was not renewed. In this manner, the Reagan and Bush administrations forestalled any federal support for embryo research in the United States. The next 13 years saw a significant expansion of infertility services in this country, but in the absence of federal funding and [End Page 345] review, there was very little systematic research on either infertility procedures or the human embryo.In January 1993, the U.S. political environment changed again when the Clinton administration fulfilled a campaign promise to remove a nearly five-year-old ban on fetal tissue transplantation research. Although fetal tissue research, which uses the remains of an aborted fetus, significantly differs from embryo research, which involves the developing conceptus ex utero before its transfer to and implantation in a womb, the changed political environment stimulated public discussion of embryo research as well. As a result, in June 1993, Congress nullified the federal regulations requiring EAB review for embryo research. Although this presumably left NIH free to fund embryo research without restrictions, NIH officials felt that guidelines were needed to ensure that such research was conducted in an ethically and socially responsible manner. Accordingly, in January 1994, NIH formed the Human Embryo Research Panel to propose such guidelines.The Panel Begins its WorkChaired by Steven Muller, President emeritus of the Johns Hopkins University, the Panel's 19 members included 7 basic and clinical scientists, 4 ethicists, 2 lawyers, and 6 individuals representing various backgrounds relevant to the making of public policy. Patricia King of the Georgetown University Law Center and Brigid Hogan, a cell biologist at Vanderbilt University, were appointed policy and science co-chairs respectively. Meeting for the first time in early February, the Panel was told by its chair and co-chairs that NIH's need for guidance in the face of pending proposals meant that it had approximately six months—including five one- to two-day meetings each month in Washington—in which to complete its work.In his charge, Dr. Varmus asked the Panel to place the possible areas of research into three categories: (1) acceptable for federal funding; (2) warranting additional review; and (3) unacceptable for federal support. In addition, he asked the Panel to draft guidelines for the review and conduct of the research deemed acceptable.Looking back after months of work, I vividly recall a sense of the enormity of the task facing us. We were being asked, in a short period of time, not only to master... (shrink)

The epistemology and ontology of experimentation are discussed in depth with special reference to biology and medicine. Two types of experiments are distinguished: exploratory (or "blazing") and consolidating. They Have objectives and canons that are strikingly different. A contrast is drawn between the literalism of the most pragmatic scientists and the formalism of most statisticians. The terms and notions of the one may have imperfect correspondence with those of the other, or perhaps none at all. The dangers are pointed out (...) of both the conclusion that the gap between the two is unbridgeable and the contrary view that the gap is trivial and merits no serious attention. Substantive discussions address the choice and meaning of a metric, the idea of interaction and time series analysis, the ontology of variation, and the epistemology of randomization, hypothesis-seeking, and multiple comparisons. * From the Division of Medical Genetics, Johns Hopkins University School of Medicine, Baltimore Md. 21205. The research in this paper was supported by grants number GM24736 and RR007722 of the National Institutes of Health. Text of a lecture given to the Maryland Institute for Clinical Research and the Department of Social and Preventive Medicine, University of Maryland, October 6, 1980. CiteULike Connotea Del.icio.us What's this? (shrink)

The US National Institute of Health’s Human Microbiome Project aims to use genomic techniques to understand the microbial communities that live on the human body. The emergent field of microbiome science brought together diverse disciplinary perspectives and technologies, thus facilitating the negotiation of differing values. Here, we describe how values are conceptualized and negotiated within microbiome research. Analyzing discussions from a series of interdisciplinary workshops conducted with microbiome researchers, we argue that negotiations of epistemic, social, and institutional values (...) were inextricable from the reflective and strategic category work that defined and organized the microbiome as an object of study and a potential future site of biomedical intervention. Negotiating the divergence or tension between emerging scientific and regulatory classifications also activated “values levers” and opened up reflective discussions of how classifications embody values and how these values might differ across domains. These data suggest that scholars at the intersections of science and technology studies, ethics, and policy could leverage such openings to identify and intervene in the ways that ethical/regulatory and scientific/technical practices are coproduced within unfolding research. (shrink)

Undisputedly, the United States’ health care system is in the midst of unprecedented complexity and transformation. In 2014 alone there were well over thirty‐five million admissions to hospitals in the nation, indicating that there was an extraordinary number of very sick and frail people requiring highly skilled clinicians to manage and coordinate their complex care across multiple care settings. Medical advances give us the ability to send patients home more efficiently than ever before and simultaneously create ethical questions about (...) the balance of benefits and burdens associated with these advances. Every day on every shift, nurses at the bedside feel an intense array of ethical issues. At the same time, administrators, policy‐makers, and regulators struggle to balance commitments to patients, families, staff members, and governing boards. Ethical responsibilities and the fiduciary, regulatory, and community service goals of health care institutions are not mutually exclusive; they must go hand in hand. If they do not, our health care system will continue to lose valued professionals to moral distress, risk breaking the public's trust, and potentially undermine patient care. At this critical juncture in health care, we must look to new models, tools, and skills to confront contemporary ethical issues that impact clinical practice. The antidote to the current reality is to create a new health care paradigm grounded in compassion and sustained by a culture of ethical practice. (shrink)

Reports of research fraud have raised concerns about research integrity similar to concerns raised about financial accounting fraud. We propose a departure from self-regulation in that researchers adopt the financial accounting approach in establishing trust through an external validation process, in addition to the reporting entities and the regulatory agencies. The general conceptual framework for reviewing financial reports, utilizes external auditors who are certified and objective in using established standards to provide an opinion on the financial reports. These standards have (...) become both broader in scope and increasingly specific as to what information is reported and the methodologies to be employed. We believe that the financial reporting overhaul encompassed in the US Sarbanes–Oxley Act of 2002, which aims at preventing accounting fraud, can be applied to scientific research in 4 ways. First, Sarbanes–Oxley requires corporations to have a complete set of internal accounting controls. Research organizations should use appropriate sampling techniques and audit research projects for conformity with the initial research protocols. Second, corporations are required to have the chief financial officer certify the accuracy of their financial statements. In a similar way, each research organization should have their vice-president of research (or equivalent) certify the research integrity of their research activities. In contrast, the primary responsibility of the existing Research Integrity Officers is to handle allegations of research misconduct, an after-the-fact activity. Third, generally accepted auditing standards specify the appropriate procedures for external review of a corporation’s financial statements. For similar reasons, the research review process would also require corresponding external auditing standards. Finally, these new requirements would be implemented in stages, with the largest 14 research organizations that receive 25% of the total National Institutes of Health funding, adopting these research oversight enhancements first. (shrink)

The relationship between philosophy and the community has become relevant again. It has been the government itself, in the form of public science agencies, which has turned to philosophy and the humanities for help, rather than vice versa. Since 1990, US federal science agencies * agencies such as the National Institutes of Health and the National Science Foundation * have steadily increased their support of social science and humanities research. This support is all the more striking (...) in that it has happened at a time when federal support for direct humanities research, through the National Endowment for the Arts and the National Endowment for the Humanities, has declined. The times demand a corollary to the field of science policy. Just as science policy seeks to offer a systematic evaluation of how science contribute to decision making, humanities policy can methodically investigate how the humanities can better contribute to policy making and how it can help science and technology take better account of societal values. (shrink)

This paper clarifies certain issues raised by Wendell Stephenson ( The Journal of Medicine and Philosophy 18: 375–388, 1993) about research programs and animal care practices at the Oregon Regional Primate Research Center. It also responds to Stephenson's critique of the National Institute of Health's Guide for the Care and Use of Laboratory Animals . It identifies utilitarianism as the ethical theory underlying Stephenson's critique. Arguing that such an ethical theory is unworkable in addressing concerns about biomedical research (...) and the use of animals, the paper defends the Guide's reliance on a wider tradition of ethical theories. Keywords: animal well-being, biomedical research, in-vitro fertilization, NIH, Stephenson, utilitarianism CiteULike Connotea Del.icio.us What's this? (shrink)

The ethics of citation has attracted increased attention in recent discussions of research and publication ethics, fraud and plagiarism. Little attempt has been made, however, to situate specific citation misbehaviors in terms of broader ethical practices and principles. To investigate researchers’ perceptions of citation norms, we surveyed active US researchers receiving federal funding from the National Institutes of Health (NIH), the National Science Foundation (NSF), and the National Endowment for the Humanities (NEH). Participants (_n_ = (...) 257) were asked about citation norms they endorse (norm reports), the behaviors they perceive others to engage in (peer reports), and their own citation behaviors (self-reports). Our analyses showed that while considerable discrepancies exist between norm reports, peer reports and self-reports, respondents’ discipline has no significant effect on these. Participants indicated that their own practices and that of their peers falls short of the norms they endorse, but that their own behavior is much less ethically deficient than that of their peers. An exploratory factor analysis revealed that ethically questionable citation behaviors could be grouped usefully into three categories: strategic citations, neglectful citations, and blind citations. Contrary to our hypothesis, the survey showed that greater experience does not always result in better citation practices. A particularly divisive issue pertained to intentionally citing authors from underrepresented demographic groups for reasons of social justice, but broad support for this practice is lacking, although arts and humanities scholars are slightly more supportive. Most researchers view questionable citation practices as negatively affecting their disciplines. Our findings suggest the need for clearer articulations of the citation norms and improved guidance and training about citations. (shrink)

Utilizing social semiotic approaches, this article addresses how genetic researchers’ organizing narratives have involved extensive ontological and epistemological violence in their objectification Karitiana Indigenous people of Western Brazil. The paper analyses how genetic researchers have represented the Karitiana in the US and Canadian courts, post-9/11 forensic identification technology development, and patents. It also considers disputes over the sale of Karitiana cell lines by the US National Institutes of Health-funded Coriell Cell Repositories. These case studies reveal how the (...) prominent population geneticist Kenneth K. Kidd of Yale University and other genetics researchers have constituted the Karitiana as Extreme Other; liminal figures who define the boundaries of humanity. Originally sampled in 1987 by a Yale University epidemiologist, forensic genetic researchers have since utilized Karitiana cell lines to metonymically represent the Karitiana. The practices of objectification have imposed a genetically distinct special status upon the Karitiana that restricts recognition of their self-determination, rights and dignity, and which imposes onerous obligations to serve as research objects for the greater good of Humanity. The Karitiana are included as biological labour, but excluded from decision-making or asserting any other claims. Scientists have organized and maintained biotechnologically-mediated colonial relationships in which they and their institutions extract nearly all immediate and tangible benefits. The fusing of genetic research’s ontological and epistemological violence with the violence of state legal institutions raises important questions about the scope and practices of sovereignty, particularly in determining and enforcing states of exception through violence. (shrink)

In order to increase understanding of the ethical implications of biomedical, behavioral and clinical research, the Fogarty International Center, part of the United States National Institutes of Health, established an International Research Ethics Education and Curriculum Development Award to support programs in low- and middle-income countries. To develop research ethics expertise in Jordan, the University of California San Diego fellowship program in collaboration with Jordan University of Science and Technology provides courses that enable participants to develop skills (...) in varied research ethics topics, including research with human subjects. The program provides a master’s level curriculum, including practicum experiences. In this article we describe a practicum project to modify an existing introduction to human subjects research for a US audience to be linguistically and culturally appropriate to Arabic-speaking-Islamic communities. We also highlight key differences that guided the conversion of an English version to one that is in Arabic. And finally, as Institutional Review Boards follow the ethical principles of the Belmont Report in evaluating and approving biomedical and behavioral human subjects research proposals, we provide observations on the conformity of the three ethical principles of the Belmont Report with Islam. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Adjusting Laboratory Practices to the Challenges of WartimeOksana Sulaieva, Anna Shcherbakova, and Oleksandr DudinFunding. Oksana Sulaieva, MD, PhD is supported by the Loyola University Chicago–Ukrainian Catholic University Bioethics Fellowship Program, funded by the National Institutes of Health Fogarty International Center (D43TW011506).After 500 days of the unjust war initiated by the Russians, we look back to reflect on the challenges our medical laboratory faced during these early (...) days. On the morning of February 24th, we were awakened by the dreadful roar of sirens, the sound of which filled us with adrenaline and anxiety. Although our team had considered the risks of Russian military aggression and thus updated our emergency plan at the beginning of 2022, the first day of the war revealed that nobody was truly ready for the bombing, air alarms, tanks on the streets of towns and cities, violence and murders of civilians. That morning the city’s transportation system collapsed, and the flow of cars cluttered all the roads as people were trying to leave the city and escape the upcoming atrocities and death. Serious and disquieted people hurried along the streets—some people rushed to shelters, and others went to the military registration and enlistment offices to fight against Russian aggressors for the life, independence, and sovereignty of Ukraine.We hurried to work, committed to performing our duties. Our medical laboratory serves more than 750 hospitals in Ukraine. Despite fear and uncertainty, we walked to the lab, taking our children and alarm case1 with documents and essential things. Months later, people asked us why we went to the laboratory instead of leaving the city or even the country. At that moment, our [End Page 155] professional duties were an anchor linking us to each other against fear and panic. Our responsibility to provide patients and physicians with the results of blood testing, pathology, and molecular reports outweighed our fears of the war. We had to complete the testing of all the samples delivered to the laboratory to provide our customers—who include children, pregnant women, diabetic and cancer patients—with data essential for identifying accurate diagnoses and effective treatments. So we spent the first days of the war in the laboratory. At the same time, we had obligations and responsibilities to our staff as well. We had to consider how to manage our employees’ protection along with continuous laboratory services provided under endless air alarms and bombings. Many healthcare facilities in eastern regions and around Kyiv were affected by missiles or completely destroyed. Of our sixty laboratory offices around Ukraine, ten were damaged or abandoned due to occupation. Several of our fleet cars were also damaged and riddled with bullets. Many employees in the regional offices in Melitopol, Kherson, Mariupol, Chernihiv, and in suburbs of Kyiv such as Bucha and Irpin lost their homes as a result of massive military operations or occupation. Dozens of our employees joined the Ukrainian armed forces to defend civilians and fight against aggressors. Many others became volunteers, involved in blood donation, medical care for the wounded, cooking, and serving the troops. And still, we had to continue our work and protect our staff at the same time. We also helped each other by sharing our goods, medication, homes, cars, warmth, and support. Some pathologists stayed at the workplace for several days moving between pathology stations, microscopes and shelters, and sleeping on the floor but continuing to work.Our main challenge was the regular terroristic attacks on healthcare facilities situated far away from the front line, which in fact, violated international humanitarian law regarding respect for human rights during armed conflicts. During the first weeks of the war, the magnitude of military aggression, massive bombing, and air attacks undermined the healthcare system and endangered laboratory staff and patients. We prioritized protective measures. Some of our laboratory staff and facilities were evacuated from Kyiv to Lviv in western Ukraine. The partial relocation of our laboratory to Lviv was also driven by the displacement of several million Ukrainians to the western part of the country.We were able to arrange relatively safe accommodations for our laboratory employees and their families in Lviv. Under strikes and alarms, our... (shrink)

One frequent argument in the debate over federal funding of human embryo research is the slippery slope argument. Slope arguments can be of several types: either logical, empirical, or full (a combination of logical and empirical slope arguments, with an additional psychological premise). A full slope argument against human embryo research suggests that funding embryo reseach could undermine current protections for human subjects research, erode respect for persons with disabilities, and encourage eugenics practices. While the Panel commissioned by the (...) class='Hi'>National Institutes of Health to issue funding guidelines regarding human embryo research acknowledges some slippery slope concerns, the Panel's final report fails to address such concerns in any depth. Given this failure seriously to address these valid concerns, federal funding of embryo research should not proceed at this time. Keywords: embryo, human, slippery slope CiteULike Connotea Del.icio.us What's this? (shrink)

Recent guidelines from the US National Institutes of Health (NIH) mandate the inclusion of adequate numbers of women in clinical trials. Ought such standards to apply internationally? Walzer's theory of justice is brought to bear on the problem, the first use of the theory in research ethics, and it argues for broad application of the principle of adequate representation. A number of practical conclusions for research ethics committees (RECs) are outlined. Eligibility criteria in clinical trials ought to (...) be justified by trial designers. Research ethics committees ought to question criteria that seem to exclude unnecessarily women from research participation. The issue of adequate representation should be construed broadly, so as to include consideration of the representation of the elderly, persons with HIV, mental illness and substance abuse disorders in clinical research. (shrink)

BackgroundPromoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate within (...) academic bioethics literature seeking to define the benefits, the beneficiaries, and the scope of obligations for providing these benefits. Although this debate may be indicative of willingness at the international level to engage with the responsibilities of researchers involved in global health research, it remains unclear which forms of benefits or beneficiaries should be considered. International and local research ethics guidelines are reviewed here to delineate the guidance they provide.MethodsWe reviewed documents selected from the international compilation of research ethics guidelines by the Office for Human Research Protections under the US Department of Health and Human Services.ResultsAccess to interventions being researched, the provision of unavailable health care, capacity building for individuals and institutions, support to health care systems and access to medical and public health interventions proven effective, are the commonly recommended forms of benefits. The beneficiaries are volunteers, disease or illness affected communities and the population in general. Interestingly however, there is a divide between "global opinion" and the views of particular countries within resource poor settings as made explicit by differences in emphasis regarding the potential benefits and the beneficiaries.ConclusionAlthough in theory benefit sharing is widely accepted as one of the means for promoting the social value of international collaborative health research, there is less agreement amongst major guidelines on the specific responsibilities of researchers over what is ethical in promoting the social value of research. Lack of consensus might have practical implications for efforts aimed at enhancing the social value of global health research undertaken in resource poor settings. Further developments in global research ethics require more reflection, paying attention to the practical realities of implementing the ethical principles in real world context. (shrink)

In recent years, the changing landscape for the conduct and assessment of research and of researchers has increased scrutiny of the reward systems of science. In this context, correcting the research record, including retractions, has gained attention and space in the publication system. One question is the possible influence of retractions on the careers of scientists. It might be assessed, for example, through citation patterns or productivity rates for authors who have had one or more retractions. This is an emerging (...) issue today, with growing discussions in the research community about impact. We have explored the influence of retractions on grant review criteria. Here, we present results of a qualitative study exploring the views of a group of six representatives of funding agencies from different countries and of a follow-up survey of 224 reviewers in the US. These reviewers have served on panels for the National Science Foundation, the National Institutes of Health, and/or a few other agencies. We collected their perceptions about the influence of self-correction of the literature and of retractions on grant decisions. Our results suggest that correcting the research record, for honest error or misconduct, is perceived as an important mechanism to strengthen the reliability of science, among most respondents. However, retractions and self-correcting the literature at large are not factors influencing grant review, and dealing with retractions in reviewing grants is an open question for funders. (shrink)

Scarce healthcare resources can be allocated in many ways. The National Institute for Health and Clinical Excellence in the UK focuses on the size of the benefit relative to costs, yet we know that there is support among clinicians and the general public for reducing inequalities in health. This paper shows how the UK general public trade-off these sometimes competing objectives, and the data we gather allow us to show the weight given to different population groups, for (...) example, 1 extra year of life in full health to someone who would otherwise die at the age of 60 years is worth more than twice as much as an additional year of life to someone who would otherwise die at the age of 70 years. Such data can help inform the rationing decisions faced by all healthcare systems around the world. (shrink)

There is significant evidence that the health needs of women and minorities have been neglected by a medical research community whose agendas and protocols tend to focus on more advantaged segments of society. In response, the National Institutes of Health and Food and Drug Administration in the United States have recently issued new policies aimed at increasing the utilization of women in clinical studies. As well, the U.S. Congress passed the NIH Revitalization Act of 1993, which (...) specifically mandates increased inclusion of women and racial and ethnic groups in clinical studies. On the face of it, such gender and race-specific policies would appear to be morally problematic because traditionally ethics opposes the use of sex or race as legitimate criteria for distributions of benefits or burdens in social policies. Hence, these policies pose some significant moral questions. Feminist ethics provides us with a framework for evaluating such policies because of its readiness to recognize that socially and politically significant factors such as sex and race are morally relevant in setting public policy. Of course, feminist ethics does not simply endorse all appeals to sex and race but only the policies in which attention to such factors will contribute to social justice. In this essay, I Identify some of the Important ethical questions that a feminist ethics perspective raises about research policies devised to promote the Inclusion of women in clinical studies. (shrink)

Wendell Stephenson argues in this issue of The journal that the National Institutes of Health's standards for the treatment of laboratory animals fail to give any guidance concerning human well-being nor do they balance human well-being and animal well-being. Stephenson fails, however, to demonstrate how such a balance is to be known. In arguing for reform he implies greater state control without showing that such control would improve the situation. Indeed there are good reasons to think that (...) such control may be harmful. Keywords: animal well-being, economics, human well-being, state control, Stephenson CiteULike Connotea Del.icio.us What's this? (shrink)

The tobacco industry first began to promote the idea that a minority of smokers are 'genetically predisposed' to lung cancer in the 1950s. We used tobacco industry documents available as a result of litigation to investigate the role of the tobacco industry in funding the 'scientific bandwagon' described by Fujimura, in which genetics has come to dominate the cancer research agenda. From 1990-1995 inclusive, 52% of the project funding allocated by British American Tobacco's Scientific Research Group went to genetic research, (...) mainly based in universities and at one cancer charity. The largest project involved a pharmacogenetic research unit, based in a UK medical school, which was established with the help of tobacco industry PR consultants in 1988. The unit received half its project funding from the industry in 1992. Its main aim was to identify a minority of smokers who are supposedly 'genetically susceptible' to lung cancer, so that smoking cessation measures could be targeted at them. This aim was adopted and promoted by influential scientists at the US National Institutes of Health and the UK Medical Research Council in the late 1980s, in the run up to the Human Genome Project.BAT's research funds were also used to counter claims by others to have identified a unique 'genetic fingerprint' for tobacco smoke in lung cancer cells. We conclude that the tobacco industry has played a significant role in shaping research agendas, in particular, by promoting the idea that individual genome screening would be of benefit to public health. (shrink)

Levels of Analysis in Psychopathology draws research from psychiatry, philosophy, and psychology to explore the variety of explanatory approaches for understanding the nature of psychiatric disorders both in practice and research. The fields of psychiatry and clinical psychology incorporates many useful explanatory approaches and this book integrates this range of perspectives and makes suggestions about how to advance etiologic theories, classification, and treatment. The editors have brought together leading thinkers who have been widely published and are well-respected in their area (...) of expertise, including several developers of the Diagnostic and Statistical Manual of Mental Disorders and authors of the US National Institute of Mental Health's Research Domain Criteria Project (RDoC). Each main chapter has a commentary provided by one of the other authors and an introduction written by one of the editors to create an accessible, interdisciplinary dialog. (shrink)

In the wake of two recent developments in stem cell research, it is a fitting time to reassess the claim that stem cells will radically transform the concept and function of medicine. The first is the U.S. Food and Drug Administration’s decision in January 2009 to approve Geron Corporation’s Phase I clinical trial using human embryonic stem cells for patients with spinal cord injuries. The second is the National Institutes of Health’s decision to permit federal funding of (...) research using donated IVF human embryos in their July 2009 Guidelines on Human Stem Cell Research. We are now poised to see whether stem cell research can deliver on what it promises. However, what exactly does it promise and how? Moreover, who is doing the promising? Turning to the use of metaphor can help us to answer these questions and enable us to develop a better appreciation of the unique features of promised stem cell therapies. Indeed, metaphors have exerted profound influence in medicine, and it is fitting that we seek new metaphors for new therapies where appropriate. In this case, other metaphors such as magic bullets or the Holy Grail cannot capture what is unique about stem cells. Accordingly, I propose a new metaphor: the stem cell superhero. Stem cell superheroes are characterized by the following traits: they are seemingly capable of fighting the evil of virtually all disease and they seem to be our only hope of doing so, although to summon them we must make difficult moral choices. In the course of assessing the merits of three recent yet covert references to the superhero metaphor, I conclude that this powerful new paradigm employs a problematic logic, but that the aspiration as such is a good one. (shrink)

What is bioethics to do when it strives to assess the quality of its research and scholarship and when it needs to justify its work to prospective funders, especially a funder like the National Institutes of Health that privileges empirical discovery? In “A Conceptual Model for the Translation of Bioethics Research and Scholarship,” Debra Mathews and colleagues take an important first step at advancing an answer. The authors describe what they call a translational process, whereby bioethics “outputs” (...) are translated into changes of three types: in thinking, practice, and policy. It goes nearly without saying that bioethics research and scholarship must be held accountable for changes in thinking. What raison d'etre do we have if not to deepen thinking, question assumptions, and encourage ourselves and others to examine hard issues from novel approaches? Assuredly it is hard to assess quality, and even harder to assess specific changes in thinking for which high-quality scholarship may be responsible, but it is a necessary goal and one for which we should strive without reservation. Bioethics should also affect policy and practice. We should document how it does and the extent to which it does as often and as prominently as possible. However, let us be wary of pinning too much on practice and policy changes as the primary way of establishing bioethics’ worth. (shrink)

United States ethicist Ronald M Green approaches the issue of embryo research (ER) in the very accessible form of a “philosophical memoir” (xv). Reporting in detail from his experience of serving on several high level ethics advisory boards, focusing mostly on his membership of the National Institutes of Health’s (NIH) 1994 human embryo research panel, Green portrays both the functioning of this increasingly more influential form of institutionalised ethics, as well as the social and political dynamics governing (...) its (in)effectiveness. The author also covers extensive ground regarding the subject matter of ER itself and familiarises the reader with the technical issues and conceptual conundrums (potentiality, moral status, harming future persons) involved. Green states in the title of The Human Embryo Research Debates: Bioethics in the Vortex of Controversy, that he is concerned with a plurality of debates. Examining the discourse in the US, he first deals with the different areas in which ER is debated: of the book’s eight chapters, chapters one and four stress the relevance of ER for the fields of in vitro fertilisation (IVF) research, the study of birth defects, and the development of contraceptive methods. Chapter 6 deals with the relation of ER to reproductive cloning; Green formulates a comprehensive …. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Why We StayVladyslava Kachkovska, Iryna Dudchenko, Anna Kovchun, and Lyudmyla PrystupaFunding. Vladyslava Kachkovska, MD, PhD is supported by the Loyola University Chicago– Ukrainian Catholic University Bioethics Fellowship Program, funded by the National Institutes of Health Fogarty International Center (D43TW011506).We are a group of physicians and professors in the Department of internal medicine at Sumy State University in Ukraine, located 20 miles from the border with Russia. (...) We have been working together for ten years and, against the background of the war, have become more than colleagues, more than a hematologist, an allergist, a pulmonologist and a rheumatologist. We are now one organism that works for the benefit of patients, coordinating humanitarian supplies, teaching medical students, and at the same time worrying incredibly about our children, but trying to maintain our psychological homeostasis.Over the past year and a half, we have learned many things. Dividing everything that surrounds us into primary and secondary concerns, we learn how to live without electricity during the winter and how to preserve the water supply. We realize material possessions are not important, as at any moment you may lose everything. After covering the basic needs of our families, we do not try to save money, but rather the opposite: we spend all the rest on drugs and supplies for those who are in need now. Of all that we have learned, one thing we have not learned is indifference, which is not possible during this time of constant loss of acquaintances, colleagues, and friends. We find balance only in our constant work. We have patients with medically complex conditions, and we prioritize them and their needs.Our multidisciplinary teamwork before the war brought us great pleasure: interesting clinical cases and successful work with our patients, frequent training abroad, scientific research, and work with medical students and residents.On February 24, 2022, our priorities changed. In addition, each of us faced a dilemma: whether to take our children to a safe place or stay. Balancing our emotional experiences and work is challenging, but mutual support, daily communication, and a heavy workload help us maintain a sense of normalcy. Still, we are sure this “normal” is adapted to our conditions and will not apply in peacetime. Moreover, since the beginning of the war, we have experienced dissonance between our established moral and bioethical principles, our virtues, and the main goal of medicine—preserving human life and dignity—with the surrounding events caused by the war. Daily deaths of Ukrainian civilians and soldiers, innocent children, domestic animals, abuse, rape of women, children, and older adults, demonstrative torture, the humiliation of human dignity, and criminal behavior of the enemy have altered our worldview. We are challenged by the central ethical and Christian dilemma, which our generation is unlikely to cope with—to accept everything we are going through and forgive.During the last year, we have noticed that the occupation, life in the border area, and daily shelling affect our patients, dividing them into two main groups. The first group includes patients with complex psychological issues who are looking for a physical explanation for their symptoms. This group in particular overloads the healthcare system. Since few mental health specialists are [End Page 158] available for consultations, other physicians often have to act as psychologists to reassure these patients. The second group of patients are those who do not seek medical help because they believe that their health problems are simply caused by the constant stress of war and thus they are indifferent to their health and ignore symptoms such as weakness, weight loss, chronic pain, or enlarged lymph nodes.Every day we work with patients whose lives have been negatively affected by war. Each has stories about the loss of loved ones, the loss of homes, or constant emotional stress related to relatives who are currently fighting in the armed forces. These stories cannot leave us indifferent. We live this experience together with our patients, in reality and not in the abstract, and we feel their emotions. To do otherwise would be impossible in our realities. In addition to qualified medical care, we take on the duties of psychologists because sometimes, this is the... (shrink)

A recent literature review of commentaries and ‘state of the art’ articles from researchers in psychiatric genetics (PMG) offers a consensus about progress in the science of genetics, disappointments in the discovery of new and effective treatments, and a general optimism about the future of the field. I argue that optimism for the field of psychiatric molecular genetics (PMG) is overwrought, and consider progress in the field in reference to a sample estimate of US National Institute of Mental (...) class='Hi'>Health funding for this paradigm for the years 2008 and 2009. I conclude that the amounts of financial investment in PMG is questionable from an ethical perspective, given other research and clinical needs in the USA. (shrink)

Today, one out of every six children suffers from some form of neurodevelopmental abnormality. The causes are mostly unknown. Some environmental chemicals are known to cause brain damage and many more are suspected of it, but few have been tested for such effects. Philippe Grandjean provides an authoritative and engaging analysis of how environmental hazards can damage brain development and what we can do about it. The brain's development is uniquely sensitive to toxic chemicals, and even small deficits may negatively (...) impact our academic achievements, economic success, risk of delinquency, and quality of life. Chemicals such as mercury, polychlorinated biphenyls, arsenic, and certain pesticides pose an insidious threat to the development of the next generation's brains. When chemicals in the environment affect the development of a child's brain, he or she is at risk for mental retardation, cerebral palsy, autism, ADHD, and a range of learning disabilities and other deficits that will remain for a lifetime.We can halt chemical brain drain and protect the next generation, however, and Grandjean tells us how. First, we need to control all of the 200 industrial chemicals that have already been proven to affect brain functions in adults, as their effects on the developing brain are likely even worse. We must also push for routine testing for brain toxicity, stricter regulation of chemical emissions, and more required disclosure on the part of industries who unleash hazardous chemicals into products and the environment. Decisions can still be made to protect the brains of future generations."In his crisply written, deeply documented book, Dr. Philippe Grandjean, renowned physician and public health specialist, describes the exquisite vulnerability of the developing human brain to toxic chemicals in the environment, a vulnerability that he ascribes to the brain's almost unimaginable complexity. Today, nearly one in 6 children is born with a neurodevelopmental disorder - a birth defect of the brain. One in 8 has attention deficit disorder. One in 68 is diagnosed with autism spectrum disorder. These rates are far higher than those of a generation ago, and, although they are less publicized, the problems are more prevalent than those caused by thalidomide in the 1960's. The increases are far too rapid to be genetic. They cannot be explained by better diagnosis. How then could they have come to be? Dr. Grandjean has a diagnosis -- the thousands of toxic chemicals that have been released to the environment in the past 40 years with no testing for toxicity. David P. Rall, former Director of the US National Institute of Environmental Health Sciences, once stated that 'If thalidomide had caused a ten-point loss of IQ rather than obvious birth defects of the limbs, it would probably still be on the market'. This is the core message of Dr. Grandjean's 'must read' book." - Philip J. Landrigan, Dean for Global Health, Ethel H. Wise Professor and Chairman and Director, Children's Environmental Health Center, Mount Sinai School of Medicine. (shrink)

The publication of DSM-5 has been accompanied by a fair amount of controversy. Amongst DSM’s most vocal ‘insider’ critics has been Thomas Insel, Director of the US National Institute of Mental Health. Insel has publicly criticised DSM’s adherence to a symptom-based classification of mental disorder, and used the weight of the NIMH to back a rival research strategy aimed at a more biology-based diagnostic classification. This strategy is part of Insel’s vision of a future, more preventative psychiatry in (...) which mental disorders are not only understood as biological disorders of the brain, but also as neurodevelopmental disorders. This paper examines the interest and merit of Insel’s views of mental and neurodevelopmental disorder for the philosophy of psychopathology, with a special focus of his neurodevelopmental model of schizophrenia. Pitman’s ‘moderate materialism’ will be used both as a philosophical lens through which to examine Insel’s position, as well as an example of a philosophical framework that may require updating and revision in the light of moves towards a neurodevelopmental conception of mental disorder. (shrink)