What is the relationship between scientific research and ethics? Some think that science should be free from ethical and political considerations. _Biomedical Research and Beyond_ argues that ethical guidance is essential for all forms of inquiry, including biomedical and scientific research. By addressing some of the most controversial questions of biomedical research, such as embryonic research, animal research, and genetic enhancement research, the author argues for a rich moral framework for the (...) ethics of inquiry, based on the ideal of human flourishing. He then looks at other areas of inquiry, such as journalistic ethics, and military investigation, to see how similar they are to the ethics of scientific research. Finally, he looks at the virtues that must play a role in any life that is devoted to research and inquiry as a vocational commitment. (shrink)

What proper role should considerations of risk, particularly to research subjects, play when it comes to conducting research on human enhancement in the military context? We introduce the currently visible military enhancement techniques (1) and the standard discussion of risk for these (2), in particular what we refer to as the ‘Assumption’, which states that the demands for risk-avoidance are higher for enhancement than for therapy. We challenge the Assumption through the introduction of three categories of (...) enhancements (3): therapeutic, preventive, and pure enhancements. This demands a revision of the Assumption (4), alongside which we propose some further general principles bearing on how to balance risks and benefits in the context of military enhancement research. We identify a particular type of therapeutic enhancements as providing a more responsible path to human trials of the relevant interventions than pure enhancement applications. Finally, we discuss some possible objections to our line of thought (5). While acknowledging their potential insights, we ultimately find them to be unpersuasive, at least provided that our proposal is understood as fully non-coercive towards the candidates for such therapeutic enhancement trials. (shrink)

The United States Department of Defense has, for at least 20 years, held the stated intention to enhance active military personnel (“warfighters”). This intention has become more acute in the face of dropping recruitment, an aging fighting force, and emerging strategic challenges. However, developing and testing enhancements is clouded by the ethically contested status of enhancements, the long history of abuse by military medical researchers, and new legislation in the guise of “health security” that has enabled the Department (...) of Defense to apply medical interventions without appropriate oversight. This paper aims to reconcile existing legal and regulatory frameworks on military biomedical research with ethical concerns about military enhancements. In what follows, we first outline one justification for military enhancements. The authors then briefly address existing definitional issues over what constitutes enhancement before addressing existing research ethics regulations governing military biomedical research. Next, they argue that two common justifications for rapid military innovation in science and technology, including enhancement, fail. These justifications are (a) to satisfy a compelling military need and (b) strategic dominance. The authors then turn to an objection that turns on the idea that we need not have these justifications if warfighters are willing to adopt enhancement, and argue that laissez-faire approaches to enhancement fail in the context of the military due to pressing and historically significant concerns about coercion and exploitation. The paper concludes with what is referred to as the “least-worst” justification: Given the rise of untested enhancements in civilian and military life, we have good reason to validate potential enhancements even if they do not satisfy reasons (a) or (b) above. (shrink)

Many of the same fundamental principles and regulations that govern civilian biomedical research also apply to research conducted by the US Military. Despite these similarities, the conduct of research by the US Military has additional requirements designed to preserve service members’ informed consent rights, ethical standards and information that may be deemed classified. Furthermore, there are also additional rules and regulations associated with potential research to be done in a combat setting. Before conducting (...) battlefield research, many unique circumstances must be considered to include: (1) the current legal and regulatory requirements for advanced informed consent (2) the tactical situations, and the ability to adequately document in the “austere” environment (3) the need to provide improved drugs and devices for combat casualty care and (4) the special nature of the superior-subordinate relationship. This paper discusses historical background, regulatory oversight, ethical implications and release of information as it pertains to research conducted by the US Military. (shrink)

This paper presents an overview of the key ethical questions of performing gene editing research on military service members. The recent technological advance in gene editing capabilities provided by CRISPR/Cas9 and their path towards first-in-human trials has reinvigorated the debate on human enhancement for non-medical purposes. Human performance optimization has long been a priority of military research in order to close the gap between the advancement of warfare and the limitations of human actors. In spite of (...) this focus on temporary performance improvement, biomedical enhancement is an extension of these endeavours and the ethical issues of such research should be considered. In this paper, we explore possible applications of CRISPR to military human gene editing research and how it could be specifically applied towards protection of service members against biological or chemical weapons. We analyse three normative areas including risk–benefit analysis, informed consent, and inequality of access as it relates to CRISPR applications for military research to help inform and provide considerations for military institutional review boards and policymakers. (shrink)

A widely accepted framework governs biomedical research and the practice of medicine in the civilian sector, but no such framework exists to guide the military in how it should treat its own personnel. Civilian bioethical principles are unsuitable because of fundamental differences between civilian and military core values. This paper proposes a framework for military bioethics. It begins by describing core military values, articulating how they differ from civilian goals and values, and explaining how (...) these differences limit the ability of civilian bioethical principles to govern military biomedicine. The paper then puts forward a set of more appropriate principles for the military and discusses how these principles apply in three main areas of controversy within military bioethics: the use of military personnel as research subjects; the deployment use of biomedical agents; and the obligations of military physicians toward their own troops. (shrink)

In the late 1960s Van Rensselaer Potter, a biochemist and cancer researcher, thought that our survival was threatened by the domination of military policy makers and producers of material goods ignorant of biology. He called for a new field of Bioethics—“a science of survival.” Bioethics did develop, but with a narrower focus on medical ethics. Recently there have been attempts to broaden that focus to bring biomedical ethics together with environmental ethics. Though the two have many differences—in habits (...) of thought, scope of concern, and value commitments—in this paper we argue that they often share common cause and we identify common ground through an examination of two case studies, one addressing drug development, the other food production. (shrink)

In this paper we make a proposal for reforming biomedical research that is aimed to align re-search more closely with the so-called fair-share principle according to which the proportions of global resources as-signed to different diseases should agree with the ratios of human suffering associated with those diseases.

In a military-sponsored research project begun during the Second World War, inmates of the Stateville Penitentiary in Illinois were infected with malaria and treated with experimental drugs that sometimes had vicious side effects. They were made into reservoirs for the disease and they provided a food supply for the mosquito cultures. They acted as secretaries and technicians, recording data on one another, administering malarious mosquito bites and experimental drugs to one another, and helping decide who was admitted to (...) the project and who became eligible for early parole as a result of his participation. Thus, the prisoners were not simply research subjects; they were deeply constitutive of the research project. Because a prisoners time on the project was counted as part of his sentence, and because serving on the project could shorten ones sentence, the project must be seen as simultaneously serving the functions of research and punishment. Michel Foucault wrote about such mixed mechanisms in his Discipline and punish. His shining example of such a transparent and subtle style of punishment was the panopticon, Jeremy Benthams architectural invention of prison cellblocks arrayed around a central guard tower. Stateville prison was designed on Benthams model; Foucault featured it in his own discussion. This paper, then, explores the power relations in this highly idiosyncratic experimental system, in which the various roles of model organism, reagent, and technician are all occupied by sentient beings who move among them fluidly. This, I argue, created an environment in the Stateville hospital wing more panoptic than that in the cellblocks. Research and punishment were completely interpenetrating, and mutually reinforcing. (shrink)

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by social/communicative difficulties and perseverative behaviours. While research on autism has flourished recently, few studies have been conducted on the disorder in non‐Western contexts. In low‐ and middle‐income countries (LMICs), biomedical research on autism is required to better understand the needs of the population and to develop contextually appropriate interventions. However, autistic individuals are a vulnerable study population and LMICs present with various considerations. While the presentation of autism (...) is heterogeneous, stigma is a common social consequence affecting research. Drawing specifically on the South African context, the ethical intersections of these issues are discussed, along with the limitations of the current informed consent process. Community engagement is recommended as an adjunct to informed consent to ensure that biomedical research is conducted in a more inclusive way. Practical pointers are provided for implementing systematic support for conducting community engagement alongside biomedical research. (shrink)

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

Animal research has long been a source of biomedical aspirations and moral concern. Examples of both hope and concern are abundant today. In recent months, as is common practice, monkeys have served as test subjects in promising preclinical trials for an Ebola vaccine or treatment 1 , 2 , 3 and in controversial maternal deprivation studies. 4 The unresolved tension between the noble aspirations of animal research and the ethical controversies it often generates motivates the present issue (...) of the Cambridge Quarterly of Healthcare Ethics. As editors of this special section, we hope that these original and timely articles will push the professional discussion of animal research ethics in a positive direction that will benefi t research scientists and others interested in moral problems in animal research. We also look forward to a day when animal research will genuinely meet both appropriate scientifi c and appropriate ethical criteria—criteria that themselves can be improved by critical scrutiny. Animal research—that is, the use of live animals as experimental subjects in biomedical and behavioral fi elds of learning—has been deeply entrenched for well over half a century. One signal development was the enactment in the late 1930s of federal product safety legislation in the United States and other nations that required animal testing of food, drugs, and medical devices prior to use by human subjects or consumers. 5 Another development was the publication of codes of research ethics that called for animal research prior to human research. The Nuremberg Code, published by an American military tribunal in 1947–48 after scrutiny of Nazi medical atrocities, stated that experiments involving the use of human subjects should be " based on the results of animal experimentation. " 6 The Declaration of Helsinki, fi rst published in 1964, reaffi rmed this assumption and added, rather imprecisely, that " the welfare of animals used for research must be respected. " 7 Against the background of such statements, the institutionalization and widespread acceptance of animal research in the twentieth century rested on two basic assumptions, one factual and one moral. The factual assumption was that animal research is suffi ciently reliable as a basis for predicting the effects of drugs, products, and other materials on human beings that animal trials can be expected to yield signifi cant scientifi c conclusions and medical benefi ts to humanity. (shrink)

In this paper we make a proposal for reforming biomedical research that is aimed to align re-search more closely with the so-called fair-share principle according to which the proportions of global resources as-signed to different diseases should agree with the ratios of human suffering associated with those diseases.

This paper addresses the appropriate role for public input into priority setting for federal funding of biomedical research and development. The public should be involved in priority setting because researchers should be publicly accountable, because the public has a right to oversee government activities, and because public input is needed to assess normative questions related to the burden of disease and health care needs. On the other hand, political factors arising from public input can also hamper the governmentÕs (...) ability to allocate funds according to the burden of disease or to promote the progress of biomedical science. When it comes to public input into R & D priority setting, more is not necessarily better. What is needed is the right balance of public and expert decision making with respect to the setting of biomedical R & D priorities. (shrink)

BackgroundThe use of great apes (GA) in invasive biomedical research is one of the most debated topics in animal ethics. GA are, thus far, the only animal group that has frequently been banned from invasive research; yet some believe that these bans could inaugurate a broader trend towards greater restrictions on the use of primates and other animals in research. Despite ongoing academic and policy debate on this issue, there is no comprehensive overview of the reasons (...) advanced for or against restricting invasive research with GA. To address this gap, we conducted a systematic review of the reasons reported in the academic literature on this topic.MethodsSeven databases were searched for articles published in English. Two authors screened the titles, abstracts, and full texts of all articles. Two journals specialized in animal ethics, and the reference lists of included articles were subsequently also reviewed.ResultsWe included 60 articles, most of which were published between 2006 and 2016. Twenty-five articles argued for a total ban of GA research, 21 articles defended partial restrictions, and 14 articles argued against restrictions. Overall, we identified 110 reason types, 74 for, and 36 against, restricting GA research. Reasons were grouped into nine domains: moral standing, science, welfare, public and expert attitudes, retirement and conservation, respect and rights, financial costs, law and legal status, and longer-term consequences.ConclusionOur review generated five main findings. First, there is a trend in the academic debate in favor of restricting GA research that parallels worldwide policy changes in the same direction. Second, in several domains (e.g., moral standing, and respect and rights), the reasons were rather one-sided in favor of restrictions. Third, some prominent domains (e.g., science and welfare) featured considerable engagement between opposing positions. Fourth, there is low diversity and independence among authors, including frequent potential conflicts of interests in articles defending a strong position (i.e., favoring a total ban or arguing against restrictions). Fifth, scholarly discussion was not the norm, as reflected in a high proportion of non-peer-reviewed articles and authors affiliated to non-academic institutions. (shrink)

A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.

Authors endure considerable hardship carrying out biomedical research, from generating ideas to completing their manuscripts and submitting their findings and data to a journal. When researchers submit to journals, they entrust their findings and ideas to editors and peer reviewers who are expected to respect the confidentiality of peer review. Inherent trust in peer review is built on the ethical conduct of authors, editors and reviewers, and on the respect of this confidentiality. If such confidentiality is breached by (...) unethical reviewers who might steal or plagiarize the authors’ ideas, researchers will lose trust in peer review and may resist submitting their findings to that journal. Science loses as a result, scientific and medical advances slow down, knowledge may become scarce, and it is unlikely that increasing bias in the literature will be detected or eliminated. In such a climate, society will ultimately be deprived from scientific and medical advances. Despite a rise in documented cases of abused peer review, there is still a relative lack of qualitative and quantitative studies on reviewer-related misconduct, most likely because evidence is difficult to come by. Our paper presents an assessment of editors’ and reviewers’ responsibilities in preserving the confidentiality of manuscripts during the peer review process, in response to a 2016 case of intellectual property theft by a reviewer. Our main objectives are to propose additional measures that would offer protection of authors’ intellectual ideas from predatory reviewers, and increase researchers’ awareness of the responsible reviewing of journal articles and reporting of biomedical research. (shrink)

In this paper we make a proposal for reforming biomedical research that is aimed to align research more closely with the so-called fair-share principle according to which the proportions of global resources assigned to different diseases should agree with the ratios of human suffering associated with those diseases.

BackgroundExisting research on perceptions of plagiarism and cultural influences mainly focuses on comparisons between the Western World and the Eastern World. However, possible differences within the Western World have hardly been assessed, especially among biomedical academics. The authors compared perceptions of plagiarism among European biomedical researchers who participated in an online survey.MethodsThe present work is based on the data collected in a previous online survey done in 2018 among biomedical researchers working in leading European and Chinese (...) universities. Respondents based in Europe were grouped into three geographical regions and their responses were analyzed using logistic regression analysis with adjustments for demographic factors.ResultsData were available from 810 respondents. In addition to their generally similar responses, different perceptions of plagiarism were observed among respondents in the three European regions. In summary, among the three European regions, Nordic respondents identified the most types of practices as plagiarism. Compared to the southern respondents, Nordic and northwestern respondents were more likely to consider less evident practices as plagiarism, such as Rephrasing another person’s work without crediting the source [aORN|S 1.99, aORS|NW 0.50 ] and With permission from the original author, using another’s text without crediting the source [aORN|S 3.16, aORS|NW 0.26 ]. In contrast, the southern respondents were the most inclined to recognize recycling of one’s previously rejected research proposal as plagiarism.ConclusionsIn spite of a generally similar response pattern, the present study indicates different perceptions of plagiarism among European biomedical researchers. These intra-European differences should be considered when addressing plagiarism. (shrink)

In a military-sponsored research project begun during the Second World War, inmates of the Stateville Penitentiary in Illinois were infected with malaria and treated with experimental drugs that sometimes had vicious side effects. They were made into reservoirs for the disease and they provided a food supply for the mosquito cultures. They acted as secretaries and technicians, recording data on one another, administering malarious mosquito bites and experimental drugs to one another, and helping decide who was admitted to (...) the project and who became eligible for early parole as a result of his participation. Thus, the prisoners were not simply research subjects; they were deeply constitutive of the research project. Because a prisoner’s time on the project was counted as part of his sentence, and because serving on the project could shorten one’s sentence, the project must be seen as simultaneously serving the functions of research and punishment. Michel Foucault wrote about such ‘mixed mechanisms’ in his Discipline and punish. His shining example of such a ‘transparent’ and subtle style of punishment was the panopticon, Jeremy Bentham’s architectural invention of prison cellblocks arrayed around a central guard tower. Stateville prison was designed on Bentham’s model; Foucault featured it in his own discussion. This paper, then, explores the power relations in this highly idiosyncratic experimental system, in which the various roles of model organism, reagent, and technician are all occupied by sentient beings who move among them fluidly. This, I argue, created an environment in the Stateville hospital wing more panoptic than that in the cellblocks. Research and punishment were completely interpenetrating, and mutually reinforcing. (shrink)

Almost all ethical guidelines and legislative policies concerning biomedical research involving human subjects contain provisions about relevance of research for the participating populations, informed consent, adequate care for research induced injuries and several other safeguards but the poor continue to suffer. Globalization has further aggravated poor people’s vulnerability by exposing them to international markets. Since the developing countries are abode of higher population of the poor they have become the unholy mines of this human ore for (...) researchers. In this paper I examine various dimensions of poverty and analyze the international ethical responses in the area of biomedical research involving human subjects in order to determine their adequacy to protect the poor against exploitation and misuse and conclude that in view of the poor’s inherent and extreme vulnerability and the failure of ethical pronouncements to protect them from misuse and exploitation, they should be excluded from being enrolled as research subjects. (shrink)

Extramural funding provides major support for biomedical research in academia, and National Institutes of Health (NIH) grants often constitute direct evaluation criteria for promotions and tenure. Therefore, NIH budget trends influence long‐term scientific strategies and career decisions, as well as the progress of science itself. Our analysis of the last 37 years of NIH awards, however, reveals that the success rate of grant applications submitted for funding is negatively related to the total yearly amount of (inflation‐adjusted) NIH extramural (...) expenditure. Instead, as might be expected, the ratio between available funding and the number of submission directly predicts the probability of winning support in any given year. We purport that the considerable success rate variability can be parsimoniously explained by a proportional but delayed reaction of the number of applications to budget fluctuations. As a counterintuitive consequence, grant proposals conceived during lean periods might stand the best chance of success. BioEssays 29:933–936, 2007. © 2007 Wiley Periodicals, Inc. (shrink)

Authors endure considerable hardship carrying out biomedical research, from generating ideas to completing their manuscripts and submitting their findings and data (as is increasingly required) to a journal. When researchers submit to journals, they entrust their findings and ideas to editors and peer reviewers who are expected to respect the confidentiality of peer review. Inherent trust in peer review is built on the ethical conduct of authors, editors and reviewers, and on the respect of this confidentiality. If such (...) confidentiality is breached by unethical reviewers who might steal or plagiarize the authors’ ideas, researchers will lose trust in peer review and may resist submitting their findings to that journal. Science loses as a result, scientific and medical advances slow down, knowledge may become scarce, and it is unlikely that increasing bias in the literature will be detected or eliminated. In such a climate, society will ultimately be deprived from scientific and medical advances. Despite a rise in documented cases of abused peer review, there is still a relative lack of qualitative and quantitative studies on reviewer-related misconduct, most likely because evidence is difficult to come by. Our paper presents an assessment of editors’ and reviewers’ responsibilities in preserving the confidentiality of manuscripts during the peer review process, in response to a 2016 case of intellectual property theft by a reviewer. Our main objectives are to propose additional measures that would offer protection of authors’ intellectual ideas from predatory reviewers, and increase researchers’ awareness of the responsible reviewing of journal articles and reporting of biomedical research. (shrink)

Current debates surrounding the virtues and shortcomings of randomization are symptomatic of a lack of appreciation of the fact that causation can be inferred by two distinct inference methods, each requiring its own, specific experimental design. There is a non-statistical type of inference associated with controlled experiments in basic biomedical research; and a statistical variety associated with randomized controlled trials in clinical research. I argue that the main difference between the two hinges on the satisfaction of the (...) comparability requirement, which is in turn dictated by the nature of the objects of study, namely homogeneous or heterogeneous populations of biological systems. Among other things, this entails that the objection according to which randomized experiments fail to provide better evidence for causation because randomization cannot guarantee comparability is mistaken. (shrink)

The current situation in medicine has been described as a crisis of credibility, as the profit motive of industry has taken control of clinical trials and the dissemination of data. Pharmaceutical companies maintain a stranglehold over the content of medical journals in three ways: (1) by ghostwriting articles that bias the results of clinical trials, (2) by the sheer economic power they exert on journals due to the purchase of drug advertisements and journal reprints, and (3) by the threat of (...) legal action against those researchers who seek to correct the misrepresentation of study results. This paper argues that Karl Popper's critical rationalism provides a corrective to the failure of academic freedom in biomedical research. (shrink)

Authors, reviewers, and editors have critical responsibilities to ensure the validity and utility of published biomedical research.

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot (...) end the debate about the merits of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless. (shrink)

Biomedical ontologies are considered a serious innovation for biomedical research and clinical practice. They promise to integrate information coming from different biological databases thus creating a common ground for the representation of knowledge in all the life sciences. Such a tool has potentially many implications for both basic biomedical research and clinical practice. Here I discuss how this tool has been generated and thought. Due to the analysis of some empirical cases I try to elaborate (...) how biomedical ontologies constitute a novelty also from an epistemological point of view. (shrink)

Finding an effective microbicide that could substantially lower women’s risk of acquiring HIV infection is an ethical imperative. Women and girls continue to be disproportionally affected by HIV in sub-Saharan Africa. Ethics guidelines for conducting preventive HIV microbicide trials call for steps that intertwine biomedical research and public health. Ethical considerations include adequate studies of the safety of microbicides, the use of placebo controls in future trials once a microbicide is shown to be effective, whether leftover microbicide from (...) a trial that demonstrated efficacy should be made available to the public or used in the control group of a future trial, what preventive measures and treatment should be provided for trial participants during and after the research, and what constitute ‘fair benefits’ to the community or country when a trial is completed. The Global Campaign for Microbicides conducted a study of the benefits being provided to participants in microbicide trials and others, and found substantial evidence that researchers and sponsors are meeting the obligations stated in ethical guidelines. A cautionary tale of an HIV prevention trial that was prematurely halted demonstrates the need for engagement with the community where trials are carried out. (shrink)

This volume assesses the ethical, quantitative, and qualitative questions posed by the current financing of biomedical research.

This paper discusses the hazards of regulating controversial biomedical research in light of the emergence of powerful, multi-national biotechnology corporations. Prohibitions on the use of government funds can simply force controversial research into the private sphere, and unilateral or multilateral research bans can simply encourage multi-national companies to conduct research in countries that lack restrictive laws. Thus, a net effect of government regulation is that research migrates from the public to the private sphere. Because (...) private research receives less oversight and external scrutiny than public research, it can threaten the welfare and rights of human subjects, scientific progress and openness, and the quality of the approval process for new biomedical technologies. In order to avoid the harmful effects of government regulation of biotechnology, society should promote meaningful discussion and dialogue among scientists, industry leaders, and the public before resorting to regulatory solutions. Legislative or executive initiatives should be applied with great discretion and care, and should be crafted in such a way that they protect public health and safety, promote scientific progress, and avoid the hazards of privatized research and polarized debates. (shrink)

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)

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

One of the fundamental ethical concerns about biomedical research is that it frequently exposes participants to risks for the benefit of others. To protect participants’ rights and interests in this context, research regulations and guidelines set out a mix of substantive and procedural requirements for research involving humans. Risk thresholds play an important role in formulating both types of requirements. First, risk thresholds serve to set upper risk limits in certain types of research. Second, risk (...) thresholds serve to demarcate risk categories that streamline risk-adapted systems of ethical oversight. But although risk thresholds play such an important role in research governance, there is a need both to better define the existing risk thresholds and to delineate new thresholds in order to develop more risk-adapted systems of research oversight. The present paper examines the existing minimal risk threshold and the surrounding debates with the goal of deriving a systematic approach to setting thresholds of research risk. (shrink)

An informed consent and voluntary assent in biomedical research with adolescents is contingent on a variety of factors, including adolescent and parent perceptions of research risk, benefit, and decision-making autonomy. Thirty-seven adolescents with asthma and their parents evaluated a high or low aversion form of a pediatric asthma research vignette and provided an enrollment decision; their perceptions of family influence over the participation decision; and evaluations of risk, aversion, benefit, and burden of study procedures. Adolescents and (...) their parents agreed on research participation decisions 74% of the time, yet both claimed ultimate responsibility for the participation decision. Both rated most study procedures as significantly more aversive than risky. Parents were more likely to rate aspects of the hypothetical study as beneficial and to provide higher risk ratings for procedures. Disagreements concerning research participation decisions and decision-making autonomy have implications for the exercise of voluntary assent in biomedical research. (shrink)

Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the establishment of standards for the protection of communities. We have developed such a strategy, based on five steps. (i) Identification of community characteristics relevant to the biomedical research setting, (ii) delineation of a typology of different types of communities using these characteristics, (iii) (...) determination of the range of possible community protections, (iv) creation of connections between particular protections and one or more community characteristics necessary for its implementation, and (v) synthesis of community characteristics and possible protections to define protections appropriate for each type of community. Depending on the particular community, consent and consultation, consultation alone, or no added protections may be required for research. (shrink)

BackgroundPlagiarism is considered as serious research misconduct, together with data fabrication and falsification. However, little is known about biomedical researchers’ views on plagiarism. Moreover, it has been argued – based on limited empirical evidence – that perceptions of plagiarism depend on cultural and other determinants. The authors explored, by means of an online survey among 46 reputable universities in Europe and China, how plagiarism is perceived by biomedical researchers in both regions.MethodsWe collected work e-mail addresses of (...) class='Hi'>biomedical researchers identified through the websites of 13 reputable universities in Europe and 33 reputable universities in China and invited them to participate in an online anonymous survey. Our questionnaire was designed to assess respondents’ views about plagiarism by asking whether they considered specific practices as plagiarism. We analyzed if respondents in China and Europe responded differently, using logistic regression analysis with adjustments for demographic and other relevant factors.ResultsThe authors obtained valid responses from 204 researchers based in China (response rate 2.1%) and 826 researchers based in Europe (response rate 5.6%). Copying text from someone else’s publication without crediting the source, using idea(s) from someone else’s publication without crediting the source and republishing one’s own work in another language without crediting the source were considered as plagiarism by 98, 67 and 64%, respectively. About one-third of the respondents reported to have been unsure whether they had been plagiarizing.Overall, the pattern of responses was similar among respondents based in Europe and China. Nevertheless, for some items significant differences did occur in disadvantage of Chinese respondents.ConclusionsFindings indicate that nearly all biomedical researchers understand (and disapprove of) the most obvious forms of plagiarism, but uncertainties and doubts were apparent for many aspects. And the minority of researchers who did not recognize some types of plagiarism as plagiarism was larger among China-based respondents than among Europe-based respondents. The authors conclude that biomedical researchers need clearer working definitions of plagiarism in order to deal with grey zones. (shrink)

According to some estimates, less than 10% of the world's biomedical research funds are dedicated to addressing problems that are responsible for 90% of the world's burden of disease. This paper explains why this disparity exists and what should be done about it. It argues that the disparity exists because: 1) multinational pharmaceutical and biotechnology companies do not regard research and development investments on the health problems of developing nations to be economically lucrative; and 2) governmental agencies (...) that sponsor biomedical research face little political pressure to allocate funds for the problems of developing nations. This paper argues that developed nations have an obligation to address disparities related to biomedical research funding. To facilitate this effort, developed countries should establish a trust fund dedicated to research on the health problems of developing nations similar to the Global AIDS Fund. (shrink)

Recent empirical evidence has demonstrated that research misconduct occurs to a substantial degree in biomedical research. It has been suggested that scientific integrity is also of concern in China, but this seems to be based largely on anecdotal evidence. We, therefore, sought to explore the Chinese situation, by making a systematic review of published empirical studies on biomedical research integrity in China. One of our purposes was also to summarize the existing body of research (...) published in Chinese. We searched the China National Knowledge Infrastructure, Wanfang Data, PubMed and Web of Science for potentially relevant studies, and included studies meeting our inclusion criteria, i.e. mainly those presenting empirically obtained data about the practice of research in China. All the data was extracted and synthesized using an inductive approach. Twenty-one studies were included for review. Two studies used qualitative methods and nineteen studies used quantitative methods. Studies involved mainly medical postgraduates and nurses and they investigated awareness, attitudes, perceptions and experiences of research integrity and misconduct. Most of the participants in these 21 studies reported that research integrity is of great importance and that they obey academic norms during their research. Nevertheless, the occurrence of research misbehaviors, such as fabrication, falsification, plagiarism, improper authorship and duplicate submission was also reported. Strengthening research integrity training, developing the governance system and improving the scientific evaluation system were areas of particular attention in several studies. Our review demonstrates that a substantial number of articles have been devoted to research integrity in China, but only a few studies provide empirical evidence. With more safeguard measures of research integrity being taken in China, it would be crucial to conduct more research to explore researchers’ in-depth perceptions and evaluate the changes. (shrink)