During the past two decades, Iran has experienced a noteworthy growth in its biomedical research sector. At the same time, ethical concerns and debates resulting from this burgeoning enterprise has led to increasing attention paid to biomedical ethics. In Iran, Biomedical research ethics and research oversight passed through major periods during the past decades, separated by a paradigm shift. Period 1, starting from the early 1970s, is characterized by research paternalism and complete reliance (...) on researchers as virtuous and caring physicians. This approach was in concordance with the paternalistic clinical practice of physicians outside of research settings during the same period. Period 2, starting from the late 1990s, was partly due to revealing of ethical flaws that occurred in biomedical research in Iran. The regulatory and funding bodies concluded that it was not sufficient to rely solely on the personal and professional virtues of researchers to safeguard human subjects' rights and welfare. The necessity for independent oversight, emphasized by international declarations, became obvious and undeniable. This paradigm shift led to the establishment of research ethics committees throughout the country, the establishment of academic research centers focusing on medical ethics and the compilation of the first set of national ethical guidelines on biomedical research–one of the first and most important projects conducted by and in the MEHR. Although not yet arrived, ‘period 3’ is on its way. It is predictable from the obvious trends toward performance of high-quality clinical research and the appearance of a highly educated new generation, especially among women. (shrink)

The advancement of science requires the publication of research results so other scientists may examine, confirm, and build upon them, and the publishing ecosystem that mediates this process has undergone dramatic change over recent decades. This article takes a broad view of the biomedical research publishing system from its origins in the 17th century to the present day. It begins with a story from the author’s lab that illustrates a scientist’s complex interactions with the publishing system and (...) then reviews the history, growth, and evolution of scientific publishing, including several recent disruptive developments: the digital transformation, the open access (OA) movement, the creation of “predatory journals,” and the emergence of preprint archives. Each has influenced scientific peer review and editorial decision-making, two processes critical to the conduct of medical and scientific research and culture. After briefly discussing concerns about the impact of politics on editorial decision-making, the article closes with thoughts on the future evolution of this publishing ecosystem, which will impact the biomedical research ecosystem that depends upon it. Beyond accelerated speed and improved access to publications, the community should prioritize research aimed at further enhancing the quality and impact of published research, the core goal of the scientific enterprise. [End Page 358]. (shrink)

Before any citizen enters the role of scientist, medical practitioner, lawyer, epidemiologist, and so on, each and all grow up in a society in which the categories of human differentiation are folk categories that organize perceptions, relations, and behavior. That was true during slavery, during Reconstruction, the eugenics period, the two World Wars, and is no less true today. While every period understandably claims to transcend those categories, medicine, law, and science are profoundly and demonstrably influenced by the embedded folk (...) notions of race and ethnicity. (shrink)

abstractBiomedical research in the United States has contributed enormously to science and human health and is conducted in several thousand institutions that vary widely in their histories, missions, operations, size, and cultures. Though these institutional differences have important consequences for the research they conduct, the organizational taxonomy of US biomedical research has received scant systematic attention. Consequently, many observers and even participants are surprisingly unaware of important distinguishing attributes of these diverse institutions. This essay provides a (...) high-level taxonomy of the institutional ecosystem of US biomedical research; illustrates key features of the ecosystem through portraits of eight institutions of varying age, size, culture, and missions, each representing a much larger class exhibiting additional diversity; and suggests topics for future research into the research output of institutional types that will be required to develop novel approaches to improving the function of the ecosystem. (shrink)

The target article by Wiggins and Wilbanks (2019) reports on the history and typology of the models of citizen science emerging in health and biomedical research with the rapid dispersion and repur...

Contrary to concerns of some critics, we present evidence that biomedical research is not dominated by a small handful of model organisms. An exhaustive analysis of research literature suggests that the diversity of experimental organisms in biomedical research has increased substantially since 1975. There has been a longstanding worry that organism‐centric funding policies can lead to biases in experimental organism choice, and thus negatively impact the direction of research and the interpretation of results. Critics (...) have argued that a focus on model organisms has unduly constrained the diversity of experimental organisms. The availability of large electronic databases of scientific literature, combined with interest in quantitative methods among philosophers of science, presents new opportunities for data‐driven investigations into organism choice in biomedical research. The diversity of organisms used in NIH‐funded research may be considerably lower than in the broader biomedical sciences, and may be subject to greater constraints on organism choice. (shrink)

Double standards are widespread throughout biomedicine, especially in research on reproductive health. One of the clearest cases of double standards involves the feminine gendering of reproductive responsibility for contraception and the continued lack of highly effective, reversible methods for cisgender men. While the biomedical establishment accepts diversity and inclusion as important social values for clinical trials, their continued use of inequitable standards undermines their ability to challenge unfair social hierarchies by developing male contraception. Thus, the gender/sex bias present (...) in contraceptive research raises the “New Demarcation Problem”: If we accept that values can and will play important roles in science, how can we nevertheless distinguish positive influences of values from more corrosive bias? I argue that biomedical researchers ought to aim their clinical trials at equity and utilize methodologies that actually achieve that aim. More specifically, I contend that we can avoid the problem of double standards by gender/sex in contraceptive research by utilizing more equitable standards. My demarcation strategy captures dynamic interplay between values and their effects, with direct policy implications for institutions conducting, funding, and evaluating clinical trials. For male contraceptive trials, this involves shifting risk assessment from an individual model to a shared model for sexual partners. (shrink)

The use of racial categories in biomedicine has had a long history in the United States. However, social hierarchy and discrimination, justified by purported scientific differences, has also plagued the history of racial categories. Because “race” has some correlation with biological and genetic characteristics, there has been a call not to “throw the baby out with the bathwater” by eliminating race as a research or clinical category. I argue that race is too undefined and fluid to be (...) useful as a proxy for biology or genetics. (shrink)

During the late 1940s and 1950s, radioisotopes became important resources for biological and medical research. This article explores the strategies used by French researchers to get access to this material, either from the local Atomic Energy Commission (CEA) or from suppliers in the United States or United Kingdom. It focuses on two aspects of this process: the transatlantic circulation of both isotopes and associated instrumentation; the regulation of use and access by the administrative bodies governing research in France. (...) Analyzing the investigations conducted within laboratories associated either with the atomic energy agency or with the local National Institute of Health (INH), the paper discusses the part played by the new tools in the postwar transformation of biomedical research. It contrasts the INH successful development of biological studies and metabolic tracing with the mixed results of CEA in advancing cancer radiotherapy, thus highlighting locally defined "normal paths" to radiobiology. (shrink)

Whether due to simplicity or hypocrisy, the question of access to patient data for biomedical research is widely seen in the public discourse only from the angle of patient privacy. At the same time, the desire to live and to live without disability is of much higher value to the patients. This goal can only be achieved by extracting research insight from patient data in addition to working on model organisms, something that is well understood by many (...) patients. Yet, most biomedical researchers working outside of clinics and hospitals are denied access to patient records when, at the same time, clinicians who guard the patient data are not optimally prepared for the data’s analysis. Medical data collection is a time- and cost-intensive process that is most of all tedious, with few elements of intellectual and emotional satisfaction on its own. In this process, clinicians and bioinformaticians, each group with their own interests, have to join forces with the goal to generate medical data sets both from clinical trials and from routinely collected electronic health records that are, as much as possible, free from errors and obvious inconsistencies. The data cleansing effort as we have learned during curation of Singaporean clinical trial data is not a trivial task. The introduction of omics and sophisticated imaging modalities into clinical practice that are only partially interpreted in terms of diagnosis and therapy with today’s level of knowledge warrant the creation of clinical databases with full patient history. This opens up opportunities for re-analyses and cross-trial studies at future time points with more sophisticated analyses of the same data, the collection of which is very expensive. (shrink)

The ways in which other animal species can be informative about human biology are not exhausted by the traditional picture of the animal model. In this paper, I propose to distinguish two roles which laboratory organisms can have in biomedical research. In the more traditional case, organisms act as surrogates for human beings, and as such are expected to be more manageable replicas of humans. However, animal models can inform us about human biology in a much less straightforward (...) way, by being used as measuring devices—what I call their instrumental role. I first characterize this role and provide criteria for it, before illustrating it with some examples from biomedical research, especially cancer research. In such an instrumental role, phenotypes are not expected to phenocopy human phenomena, but instead have the purely instrumental value of detecting or measuring differences. I argue that the instrumental role is more prevalent than might first be suspected, and that some characteristics of contemporary biomedical research are increasingly shifting the use of laboratory organisms to the instrumental role. Finally, in light of the distinction proposed, I discuss the meaning of the expression “animal model”. (shrink)

Intrinsic value and animal integrity are two key concepts in the debate on the ethics of the genetic engineering of laboratory animals. These concepts have, on the one hand, a theoretical origin and are, on the other hand, based on the moral beliefs of people not directly involved in the genetic modification of animals. This ‘external’ origin raises the question whether these concepts need to be adjusted or extended when confronted with the moral experiences and opinions of people directly involved (...) in the creation or use of transgenic laboratory animals. To answer this question, 35 persons from the practice of biomedical research who are directly involved in genetic engineering (scientists, biotechnicians, animal caretakers and laboratory animal scientists) were interviewed. They were asked to give their moral opinion on different aspects of the genetic engineering of animals and to react to statements about the concepts of intrinsic value and animal integrity. Analysis of the interviews showed that, contrary to what is often assumed, the respondents embraced these concepts, even those senses that (more) specifically apply to genetic engineering. And although the respondents raised some objections that go beyond issues of animal welfare, these objections could quite well be expressed in terms of the concepts of intrinsic value and animal integrity. In short, the results of the present study strongly suggest that these concepts do not have to be adjusted or extended in the light of the moral experiences and opinions from practice. (shrink)

The paper discusses the possibility that the benefits of pharmacogenomics will not be distributed equally and will create orphan populations. I argue that since these inequalities are not substantially different from those produced by ‘traditional’ drugs and are not generated with the intention to discriminate, their production needs not be unethical. Still, the final result is going against deep-seated moral feelings and intuitions, as well as broadly accepted principles of just distribution of health outcomes and healthcare. I thus propose two (...) provisos that would prevent the most offensive outcomes and moderate the scope of the produced inequalities. The first proviso rejects pharmacogenomics innovations that worsen existing group inequalities and aggravate the disadvantage of communities with a history of discrimination. The second proviso requires that there is a strategy in place to even out as much as possible the distribution of benefits in the future and that a system of compensations is in place for pharmacogenomic orphans. Given that only one moral problem generated by pharmacogenomics has been tackled, the list of provisos might be expanded when other issues are considered. (shrink)

This paper examines medical scientists’ accounts of their rediscoveries and reassessments of old materials. It looks at how historical patient files and brain samples of the first cases of Alzheimer’s disease became reused as scientific objects of inquiry in the 1990s, when a genetic neuropathologist from Munich and a psychiatrist from Frankfurt lead searches for left-overs of Alzheimer’s ‘founder cases’ from the 1900s. How and why did these researchers use historical methods, materials and narratives, and why did the biomedical (...) community cherish their findings as valuable scientific facts about Alzheimer’s disease? The paper approaches these questions by analysing how researchers conceptualised ‘history’ while backtracking and reassessing clinical and histological materials from the past. It elucidates six ways of conceptualising history as a biomedical matter: scientific assessments of the past, i.e. natural scientific understandings of ‘historical facts’; history in biomedicine, e.g. uses of old histological collections in present day brain banks; provenance research, e.g. applying historical methods to ensure the authenticity of brain samples; technical biomedical history, e.g. reproducing original staining techniques to identify how old histological slides were made; founding traditions, i.e. references to historical objects and persons within founding stories of scientific communities; and priority debates, e.g. evaluating the role particular persons played in the discovery of a disease such as Alzheimer’s. Against this background, the paper concludes with how the various ways of using and understanding ‘history’ were put forward to re-present historic cases as ‘proto-types’ for studying Alzheimer’s disease in the present. (shrink)

The Experiment Must Continue is a beautifully articulated ethnographic history of medical experimentation in East Africa from 1940 through 2014. In it, Melissa Graboyes combines her training in public health and in history to treat her subject with the dual sensitivities of a medical ethicist and a fine historian. She breathes life into the fascinating histories of research on human subjects, elucidating the hopes of the interventionists and the experiences of the putative beneficiaries. Historical case studies highlight (...) failed attempts to eliminate tropical diseases, while modern examples delve into ongoing malaria and HIV/AIDS research. Collectively, these show how East Africans have perceived research differently than researchers do and that the active participation of subjects led to the creation of a hybrid ethical form. By writing an ethnography of the past and a history of the present, Graboyes casts medical experimentation in a new light, and makes the resounding case that we must readjust our dominant ideas of consent, participation, and exploitation. With global implications, this lively book is as relevant for scholars as it is for anyone invested in the place of medicine in society. (shrink)

There is much discussion in the media and some of the scientific literature of how many of the conclusions from scientific research should be doubted. These critiques often focus on studies – typically in non‐experimental spheres of biomedical and social sciences – that search large datasets for novel correlations, with a risk that inappropriate statistical evaluations might yield dubious conclusions. By contrast, results from experimental biological research can often be interpreted largely without statistical analysis. Typically: novel observation(s) (...) are reported, and an explanatory hypothesis is offered; multiple labs undertake experiments to test the hypothesis; interpretation of the results may refute the hypothesis, support it or provoke its modification; the test/revise sequence is reiterated many times; and the field moves forward. I illustrate this experimental/non‐experimental dichotomy by examining the contrasting recent histories of: (a) our remarkable and growing understanding of how several inositol‐containing phospholipids contribute to the lives of eukaryote cells; and (b) the difficulty of achieving any agreed mechanistic understanding of why consuming dietary supplements of inositol is clinically beneficial in some metabolic diseases. (shrink)

In the Name of Progress: The Dark Side of Medical Research is a comprehensive exploration of the dark side of medical progress, examining a series of unethical medical experiments conducted over the past century. This book delves into notorious cases like the Tuskegee Syphilis Study, the Guatemala Syphilis Experiment, and the Holmesburg Prison experiments, among others, to shed light on the ethical violations and exploitation that occurred under the guise of scientific advancement. Each chapter methodically uncovers the disturbing details (...) of these studies, analyzing the impact on the victims and the long-term effects on public trust and medical ethics. By providing a critical examination of the ethical breaches in historical medical research, this book emphasizes the importance of informed consent, the protection of vulnerable populations, and the need for stringent ethical standards in medical studies. It aims to educate and provoke thoughtful discussion on the balance between scientific discovery and ethical conduct, highlighting the necessity of safeguarding human rights in medical research and the importance of maintaining ethical integrity in the pursuit of scientific knowledge. (shrink)

This paper addresses three questions central to the ethical analysis of risks and potential benefits in human subjects research: 1. How was the ethical analysis of risk understood by the members of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission)? 2. What conceptual framework should guide the ethical analysis of risk? 3. What changes to U.S. regulations would the implementation of such a framework require?

The repeal of the Eighth Amendment was a turning point in Irish social history, especially in relation to the Catholic Church. But abortion is not a settled matter and it will continue to generate controversy. Likewise, issues such as surrogacy and assisted dying will give rise to sharp differences of opinion. Legislation that seeks to address bioethical issues such as these will inevitably provoke demands for amendments or repeal. By examining developments in biomedical science, Irish law and some (...) central aspects of Catholic moral teaching, Don O'Leary builds a thorough analysis of the controversies relating to: contraception, abortion, IVF, surrogacy, human embryonic stem cell research, assisted suicide, church control of healthcare services. Biomedical Controversies in Catholic Ireland is essential reading for anyone who wishes to understand the historical background, ethical arguments and scientific advances that will inform debates about morality and social policy in the coming years. -- (from amazon.com). (shrink)

Traditionally, biomedical research has been devoted to improvement in the understanding and treatment or prevention of disease. Building on the knowledge generated by the long history of disease-oriented research, the next few decades will witness an explosion of biomedical enhancements to make people faster, stronger, smarter, less forgetful, happier, prettier, and live longer (Turner et al. 2003; Vastag 2004; Rose 2002). As with other biomedical interventions, research to assess the safety and efficacy of (...) these enhancements in humans should be conducted before their introduction into clinical practice.1 However, various concerns regarding the ethics of enhancement research could be raised. Those who .. (shrink)

1. Biomedical sciences are fast-growing fields with unprecedented speed of research outputs, especially in the quantities of papers. Philosophers aiming to study ongoing biomedical changes face cha...

We have been studying cognition and learning in research laboratories in the field of biomedical engineering. Through our combining of ethnography and cognitive-historical analysis in studying these settings we have been led to understand these labs as comprising evolving distributed cognitive systems and as furnishing agentive learning environments. For this paper we develop the theme of 'models-in-action,' a variant of what Knorr Cetina has called 'knowledge-in-action.' Among the epistemically most salient objects in these labs are so called "model (...) systems," which are designs that blend engineering with the study and use of biological systems for purposes of simulative model-based reasoning. We portray the prevalent design-orientation in this engineering specialty and how the prevailing activity of cell-culturing in these labs transitions into a design activity for the bio-medical engineers, leading them to work with 'wet' devices. We discuss how devices, 'wet' and 'dry,' situate model-based understandings and how they participate in model systems in these labs. Models tend to come in clusters or configurations, and the model systems in these labs are epistemically salient junctures of interlocking models. Model systems in these labs evolve thereby consolidating what we want to call a 'fabric of interlocking models,' which functions as point of stability and departure in these labs. We convey a taste of such a 'fabric' for a tissue-engineering lab. We conjecture that through this 'fabric' extended developments in technology and methodology have a 'situated' presence in the workings of these labs. (shrink)

A political discourse of peace marked the distribution and use of radioisotopes in biomedical research and in medical diagnosis and therapy in the post-World War II period. This occurred during the era of expansion and strengthening of the United States' influence on the promotion of sciences and technologies in Europe as a collaborative effort, initially encouraged by the policies and budgetary distribution of the Marshall Plan. This article follows the importation of radioisotopes by two Spanish research groups, (...) one in experimental endocrinology and one in molecular biology. For both groups foreign funds were instrumental in the early establishment of their laboratories. The combination of funding and access to previously scarce radioisotopes helped position these groups at the forefront of research in Spain. (shrink)

The existing literature on the development of recombinant DNA technology and genetic engineering tends to focus on Stanley Cohen and Herbert Boyer's recombinant DNA cloning technology and its commercialization starting in the mid-1970s. Historians of science, however, have pointedly noted that experimental procedures for making recombinant DNA molecules were initially developed by Stanford biochemist Paul Berg and his colleagues, Peter Lobban and A. Dale Kaiser in the early 1970s. This paper, recognizing the uneasy disjuncture between scientific authorship and legal invention (...) in the history of recombinant DNA technology, investigates the development of recombinant DNA technology in its full scientific context. I do so by focusing on Stanford biochemist Berg's research on the genetic regulation of higher organisms. As I hope to demonstrate, Berg's new venture reflected a mass migration of biomedical researchers as they shifted from studying prokaryotic organisms like bacteria to studying eukaryotic organisms like mammalian and human cells. It was out of this boundary crossing from prokaryotic to eukaryotic systems through virus model systems that recombinant DNA technology and other significant new research techniques and agendas emerged. Indeed, in their attempt to reconstitute 'life' as a research technology, Stanford biochemists' recombinant DNA research recast genes as a sequence that could be rewritten thorough biochemical operations. The last part of this paper shifts focus from recombinant DNA technology's academic origins to its transformation into a genetic engineering technology by examining the wide range of experimental hybridizations which occurred as techniques and knowledge circulated between Stanford biochemists and the Bay Area's experimentalists. Situating their interchange in a dense research network based at Stanford's biochemistry department, this paper helps to revise the canonized history of genetic engineering's origins that emerged during the patenting of Cohen-Boyer's recombinant DNA cloning procedures. (shrink)

Instead of arguing for a specific animal model, Striedter will review the history and philosophy of animal models in biomedical research, examining their various advantages and limitations.

In the field of bioethics, scholars have begun to consider carefully the impact of structural issues on global population health, including socioeconomic and political factors influencing the disproportionate burden of disease throughout the world. Human rights and social justice are key considerations for both population health and biomedical research. In this paper, I will briefly explore approaches to human rights in bioethics and review guidelines for ethical conduct in international health research, focusing specifically on health research (...) conducted in resource-poor settings. I will demonstrate the potential for addressing human rights considerations in international health research with special attention to the importance of collaborative partnerships, capacity building, and respect for cultural traditions. Strengthening professional knowledge about international research ethics increases awareness of ethical concerns associated with study design and informed consent among researchers working in resource-poor settings. But this is not enough. Technological and financial resources are also necessary to build capacity for local communities to ensure that research results are integrated into existing health systems. Problematic issues surrounding the application of ethical guidelines in resource-poor settings are embedded in social history, cultural context, and the global political economy. Resolving the moral complexities requires a commitment to engaged dialogue and action among investigators, funding agencies, policy makers, governmental institutions, and private industry. (shrink)

This paper challenges the presumed triumph of laboratory life in the history of twentieth-century biomedical research through an exploration of the relationships between laboratory, clinic, and field in the regional understanding and treatment of allergy in America. In the early establishment of allergy clinics, many physicians opted to work closely with botanists knowledgeable about the local flora in the region to develop pollen extracts in desensitization treatments, rather than rely upon pharmaceutical companies that had adopted a principle (...) of standardized vaccines beholden to bacteriology that gave no thought to the particularities of place where their products were to be sold. Natural historical sciences like plant ecology and systematics furnished important knowledge, resources, and practices in establishing a medical marketplace for allergy in America. And botanists similarly profited from biomedicine and allergic bodies in extending their network of knowledge about the plant world. (shrink)

This essay traces the history of premenstrual syndrome in French, British, and American medical literature from 1950 to 2004. Aetiological theories, treatments and diagnostic criteria have varied over time and place, reflecting local conditions and changing notions of objectivity and evidence. During the 1970s researchers in each nation utilised different research strategies to overcome variation and contradictory results characteristic of PMS research. Since the 1980s, attempts have been made to standardise research internationally through prospective daily rating (...) questionnaires that diagnose and measure PMS. Amidst controversy, a psychiatric reformulation of the syndrome was included in the Diagnostic and Statistical Manual of Mental Disorders . While the diagnostic criteria for this psychiatric category, now called premenstrual dysphoric disorder , are widely accepted for research purposes, efforts to transfer them to medical practice have been less successful. PMDD remains a contested disease construct. (shrink)

This paper explores the laborious and intimate work of turning bodies of research animals into models of human patients. Based on ethnographic research in the interdisciplinary Danish research centre NEOMUNE, we investigate collaboration across species and disciplines, in research aiming at improving survival for preterm infants. NEOMUNE experimental studies on piglets evolved as a platform on which both basic and clinical scientists exercised professional authority. Guided by the field of multi-species research, we explore the social (...) and material agency of research animals in the production of human health. Drawing on Anna Tsing’s concept of “collaborative survival”, we show that sharing the responsibility of the life and death of up to twenty-five preterm piglets fostered not only a collegial solidarity between basic and clinical scientists, but also a transformative cross-fertilization across species and disciplines—a productive “contamination”—facilitating the day-to-day survival of piglets, the academic survival of scientists and the promise of survival of preterm infants. Contamination spurred intertwined identity shifts that increased the porosity between the pig laboratory and the neonatal intensive care unit. Of particular significance was the ability of the research piglets to flexibly become animal-infant-patient hybrids in need of a united effort from basic and clinical researchers. However, ‘hybrid pigs’ also entailed a threat to the demarcation between humans and animals that consolidates the use of animals in biomedical research, and efforts were continuously done to keep contamination within spatial limits. We conclude that contamination facilitates transformative encounters, yet needs spatial containment to materialize bench-to-bedside translation. (shrink)

The label ‘Translational Research’ (TR) has become ever more popular in the biomedical domain in recent years. It is usually presented as an attempt to bridge a supposed gap between knowledge produced at the lab bench and its use at the clinical bedside. This is claimed to help society harvest the benefits of its investments in scientific research. The rhetorical as well as moral force of the label TR obscure, however, that it is actually used in very (...) different ways. In this paper, we analyse the scientific discourse on TR, with the aim to disentangle and critically evaluate the different meanings of the label. We start with a brief reconstruction of the history of the concept. Subsequently, we unravel how the label is actually used in a sample of scientific publications on TR and examine the presuppositions implied by different views of TR. We argue that it is useful to distinguish different views of TR on the basis of three dimensions, related to (1) the construction of the ‘translational gap’; (2) the model of the translational process; and (3) the cause of the perceived translational gap. We conclude that the motive to make society benefit from its investments in biomedical science may be laudable, but that it is doubtful whether the dominant views of TR will contribute to this end. (shrink)

There is a long history of women being underrepresented in biomedical and health research. Specific women’s health needs have been, and in some cases still are, comparatively neglected areas of study. Concerns about the health and social impacts of such bias and exclusion have resulted in inclusion policies from governments, research funders, and the scientific establishment since the 1990s. Contemporary understandings of foregrounding sex and gender issues within biomedical research range from women’s rights to (...) inclusion, to links between human rights, women’s health and sustainable development, and the increasing scientific and funding expectation for studies to consider the sex and gender implications of research design, results and impact. However, there are also exploitation issues to consider when foregrounding the inclusion of women as research participants, especially for research ethics committees and institutional review boards. A hidden risk is that exploitative research designs and practices may be missed, particularly by reviewers who may not have a nuanced understanding of gender-based harm. Utilizing contemporary case studies of ethics dumping, this paper highlights some of the concerns, and makes recommendations for IRBs/research ethics reviewers to help ensure that essential research is undertaken to the highest ethical standards. (shrink)

Pascal’s paper indicates how far we have come. Now as then, however, there is a need to reflect from outside the cocoon of our agencies, institutions, and disciplines to behold the enterprise that shapes both our behavior and our interpretations of it. For the boundary separating propriety from impropriety continues to move. Just as science, and the knowledge it begets, continues to evolve, so must our collective standards. The lessons of time include this: ORI or biomedical research is (...) no island; each is connected to a body of practitioners who are accountable to a society that is ever-more skeptical of expert knowledge and the institutions entrusted with its development. We are participants in a process of continuous improvement , not occupants of a state of grace. For the good of the enterprise we cherish, it is best that we all remember that. (shrink)

The Human Genome Project is regarded by many as one of the major scientific achievements in recent science history, a large-scale endeavour that is changing the way in which biomedical research is done and expected, moreover, to yield considerable benefit for society. Thus, since the completion of the human genome sequencing effort, a debate has emerged over the question whether this effort merits to be awarded a Nobel Prize and if so, who should be the one to (...) receive it, as no more than three individuals can be selected. In this article, the HGP is taken as a case study to consider the ethical question to what extent it is still possible, in an era of big science, of large-scale consortia and global team work, to acknowledge and reward individual contributions to important breakthroughs in biomedical fields. Is it still viable to single out individuals for their decisive contributions in order to reward them in a fair and convincing way? Whereas the concept of the Nobel prize as such seems to reflect an archetypical view of scientists as solitary researchers who, at a certain point in their careers, make their one decisive discovery, this vision has proven to be problematic from the very outset. Already during the first decade of the Nobel era, Ivan Pavlov was denied the Prize several times before finally receiving it, on the basis of the argument that he had been active as a research manager rather than as a researcher himself. The question then is whether, in the case of the HGP, a research effort that involved the contributions of hundreds or even thousands of researchers worldwide, it is still possible to “individualise” the Prize? The “HGP Nobel Prize problem” is regarded as an exemplary issue in current research ethics, highlighting a number of quandaries and trends involved in contemporary life science research practices more broadly. (shrink)

In the past decade, philosopher Bernard Rollin points out, we have "witnessed a major revolution in social concern with animal welfare and the moral status of animals." Adopting the stance of a moderate, Harold Guither attempts to provide an unbiased examination of the paths and goals of the members of the animal rights movement and of its detractors. Given the level of confusion, suspicion, misunderstanding, and mistrust between the two sides, Guither admits the difficulty in locating, much less staying in, (...) the middle of the road. The philosophical conflict, however, is fairly clear: those who resist reform, fearing that radical change in the treatment of animals will infringe on their business and property rights, versus the new activists who espouse a different set of moral and ethical obligations toward animals. From his position as a moderate, Guither presents a brief history of animal protection and the emergence of animal rights, describes the scope of the movement, and identifies major players such as Paul and Linda McCartney and organizations such as People for the Ethical Treatment of Animals that are actively involved in the movement. He concentrates on what is actually happening in the 1990s, discussing in detail the possible consequences of the current debate for those who own, use, or enjoy animals in entertainment and leisure pursuits. A reference work for students in animal sciences and veterinary medicine, the book also poses questions for philosophers, sociologists, and public policymakers as well as animal owners, animal and biomedical researchers, and manufacturers and distributors of animal equipment and supplies. (shrink)

Although the first human embryonic stem cells were produced in 1998, the direction of U.S. policy on stem cell research was set nearly 20 years earlier when the recommendations of a congressionally established Ethics Advisory Board were ignored by the Reagan administration. Thus began an unprecedented and unparalleled 30-year-long history of political intrusions in an area of scientific and biomedical research that has measurable impacts on the health of Americans. Driving these intrusions were religiously informed public (...) policy positions that have usually escaped critical ethical analysis. Here I record my own encounters with this history of intrusions and the thinking behind them.My most abrupt encounter with the politics of stem cell research occurred on September 6, 2006, at a hearing of the Senate Subcommittee on Labor, Health and Human Services and Related Agencies, chaired by Senator Arlen Specter. Just a week before, scientists at Advanced Cell Technology, a small Massachusetts biotech company, had published a paper in the journal Nature in which they described a method for extracting stem cells from early human embryos while leaving the embryos intact and viable. As head of ACT’s Ethics Advisory Board, I had supported this research. (shrink)