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 his paper “Scientific research is a moral duty”, John Harris argues that individuals have a moral duty to participate in biomedical research by volunteering as research subjects. He supports his claim with reference to what he calls the principle of beneficence as embodied in the “rule of rescue” , and the principle of fairness embodied in the prohibition on “free riding” . His view that biomedical research is an important social good is (...) agreed upon, but it is argued that Harris succeeds only in showing that such participation and support is a moral good, among many other moral goods, while failing to show that there is a moral duty to participate in biomedical research in particular. The flaws in Harris’s arguments are detailed here, and it is shown that the principles of beneficence and fairness yield only a weaker discretionary or imperfect obligation to help others in need and to reciprocate for sacrifices that others have made for the public good. This obligation is discretionary in the sense that the individuals are free to choose when, where, and how to help others in need and reciprocate for earlier sacrifices. That Harris has not succeeded in claiming a special status for biomedical research among all other social goods is shown here. (shrink)

As biomedical research with volunteers was expanded in the United States, the rule of subject selection, constituting scientific and ethical criteria, was generated in 1981 to resolve selection bias in research. Few historical studies, however, have investigated the role of this new hybrid rule in institutional review systems. This paper describes how bioethics commissions and federal agencies have created the subject selection rule based on the concept of justice. I argue that the standardization of this rule as (...) temporal measures, linked with risk-benefit assessment, has reformed the review mechanism, specifically investigators’ modification of research plans, thereby developing justice as balancing. (shrink)

The primary aim of biomedical research is to discover and develop new knowledge to advance human medicine. Frequently a ‘mouse model’ is taken to be a necessary step towards understanding a disease, biological mechanism or intervention. We argue for caution with respect to the mouse model: theoretical reasons, meta-analyses of empirical data, and viable alternatives all support a more restricted use of animals in laboratories than is current practice. On its own terms, a utilitarian scientific justification for (...) using animals in biomedical research converges more closely with welfarist claims than is usually recognised. (shrink)

Background Compensating participants of biomedical research is a common practice. However, its proximity with ethical concerns of coercion, undue influence, and exploitation, demand that participant compensation be regulated. The objective of this paper is to discuss the current regulations for compensation of research participants in Malawi and how they can be improved in relation to ethical concerns of coercion, undue influence, and exploitation. Main text In Malawi, national regulations recommend that research subjects be compensated with a (...) stipend of US$10 per study visit. However, no guidance is provided on how this figure was determined and how it should be implemented. While necessary to prevent exploitation, the stipend may expose the very poor to undue influence. The stipend may also raise the cost of doing research disadvantaging local researchers and may have implications on studies where income stipend is the intervention under investigation. We recommend that development and implementation of guidelines of this importance involve interested parties such as the research community and patient groups. Conclusion Compensating human research subjects is important but can also act as a barrier to voluntary participation and good research efforts. Deliberate measures need to be put in place to ensure fair compensation of research participants, avoid their exploitation and level the field for locally funded research. (shrink)

The unsafe behavior of construction workers is one of the most important and direct causes of safety accidents. Managers usually develop effective incentives aimed at regulating worker safety behavior. Due to the large number of workers in construction projects, there are multiple differences in fairness preference, risk preference and ability level, which will lead to the complex effect of the traditional mechanism to regulate workers’ safety behavior. In order to improve the effectiveness of incentive measures for worker safety (...) behavior, this paper takes into account the multiple differences of individual workers’ fairness preference, risk preference and ability level, based on the tournament mechanism to construct a competition incentive model. By designing a tournament reward and salary distribution for heterogeneous workers, the occurrence of unsafe behaviors can be reduced. The study found that in terms of the optimal level of safety investment, workers with risk aversion attitude generally invest higher than that of workers with risk preference, no matter whether they have a strong fairness preference or not; In terms of the distribution of tournament rewards, workers with a risk aversion attitude and a higher level of fairness preference need to be given higher incentives. (shrink)

In this paper, I explore the ethics of subject selection in the context of biomedical research. I reject a key principle of what I shall refer to as the standard view. According to this principle, investigators should select participants so as to minimise aggregate risk to participants and maximise aggregate benefits to participants and society. On this view, investigators should exclude prospective participants who are more susceptible to risk than other prospective participants. I argue instead that investigators should (...) select subjects in accordance with an alternative principle: formal equality of opportunity. According to this principle, investigators must treat all prospective participants the same unless differential treatment is warranted by the scientific goals of the study or the need to promote participants' medically related interests. All prospective participants (1) who meet the scientifically defined eligibility criteria and (2) for whom participation is consistent with their medically related interests should have an equal, formal opportunity to participate in the study. Prospective participants should not be excluded simply because they are more susceptible to risk than others. (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)

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.

BackgroundEthics in biomedical research is still a fairly new concept in Africa. This work aims to assess the knowledge, attitude and experiences of Beninese researchers with regard to the national ethical regulatory framework of biomedical research in Benin.MethodsThis was a cross-sectional and descriptive study, involving all the researchers fulfilling the inclusion criteria. Data were collected through a face-to-face interview using a questionnaire and analysed. Proportions and means were calculated with their confidence intervals and standard deviations, respectively.ResultsOf (...) the 110 participants included in the study, 40.9% were medical lecturers and 71.1% had been involved in more than 10 biomedical research as researcher. Less than three quarters were able to correctly quote the basic principles from Belmont report. The quarter of them knew the attributions of the National Ethics Committee for Health Research and 38.2%, the content of the legislation on health research ethics in Benin. The common ethical rules were known by 69.1% of the participants. A quarter of participants said they always present the study’s briefing note to their study participants and 62.7% said they systematically request informed consent. For those who do not present the briefing note to participants, the main reasons provided were the researchers’ difficulties in writing the note in plain language and the participants’ limitation in understanding it.ConclusionsThe foundations of a good ethical framework for health research exist in Benin. However, the deployment and use of the various legal texts deserve to be improved. (shrink)

In this paper, we discuss the processes of racialisation on the example of biomedical research. We argue that applying the concept of racialisation in biomedical research can be much more precise, informative and suitable than currently used categories, such as race and ethnicity. For this purpose, we construct a model of the different processes affecting and co-shaping the racialisation of an individual, and consider these in relation to biomedical research, particularly to studies on hypertension. (...) We finish with a discussion on the potential application of our proposition to institutional guidelines on the use of racial categories in biomedical research. (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.

Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services, to require that investigators follow the same rules for conducting human research., though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission (...) for the Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission was appointed in 1974 as part of the National Research Act in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study. (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.

Background Structured training in research integrity, research ethics and responsible conduct of research is one strategy to reduce research misconduct and strengthen reliability of and trust in scientific evidence. However, how researchers develop their sense of integrity is not fully understood. We examined the factors and circumstances that shape researchers’ understanding of research integrity. Methods This study draws insights from in-depth, semi-structured interviews with 33 researchers in the life sciences and medicine, representing three seniority levels (...) across five research universities in Switzerland. Results The results of this study indicate that early education, moral values inculcated by the family and participation in team sports were the earliest influences on notions of honesty, integrity and fairness among researchers. Researchers’ personality traits, including degree of ambition and internal moral compass, were perceived as critical in determining the importance they attributed to conducting research with high ethical standards. Positive and negative experiences in early research life also had a significant impact on their views regarding research integrity. Two thirds of the study participants had not received any formal training in research integrity. Their awareness of training opportunities at their institutions was also limited. Conclusion Age-appropriate development of honesty and integrity starts as early as primary education. Research integrity training should be offered from the bachelors level and continue throughout the entire professional life of researchers. Although these courses may not imbue researchers with integrity itself, they are essential to improving the research culture, reinforcing integrity norms, and discouraging researchers who lack personal integrity from engaging in research misconduct. (shrink)

Three recent research reports by Topping and Trickey, by Fair and colleagues, and by Gorard, Siddiqui and Huat See have produced data that support the conclusion that a Philosophy for Children program of one-hour-per-week structured discussions has a marked positive impact on students. This article presents data from a follow up study done three years after the completion of the study reported in Fair et al.. The data show that the positive gains in scores on the Cognitive Abilities Test (...) were still present and had not faded after three years. Given the strength of these confirmations of the positive durable impact of the P4C program of structured discussions and given the relatively low cost of implementing the P4C program, it is recommended that it become a standard part of the school curriculum. (shrink)

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

As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as (...) those on fair inclusion and vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change. (shrink)

As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as (...) those on fair inclusion and vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change. (shrink)

Discourse about the use of animals in biomedical research usually focuses on two issues: its empirical and moral use. The empirical issue asks whether the use of nonhumans in experiments is required in order to get data. The moral issue asks whether the use of nonhumans can be defended as matter of ethical theory. Although the use of animals in research may involve a plausible necessity claim, no moral justification exists for using nonhumans in situations in which (...) we would not use humans. (shrink)

Discourse about the use of animals in biomedical research usually focuses on two issues. The first, which I will refer to as the “necessity issue,” is empirical and asks whether the use of nonhumans in experiments is required in order to gather statistically valid information that will contribute in a significant way to improving human health. The second, which I will refer to as the “justification issue,” is moral and asks whether the use of nonhumans in biomedical (...) research, if necessary as an empirical matter, can be defended as a matter of ethical theory.If it is not necessary as an empirical matter to use animals in research, then there is no need to inquire about moral justification. Therefore, I examine the necessity issue first. The argument that it is necessary to use nonhumans in biomedical research, though flawed, is at least plausible, unlike our necessity arguments for other animal uses. I then discuss the justification issue and conclude that we cannot morally justify using nonhuman animals in research. (shrink)

Three recent research reports by Topping and Trickey, by Fair and colleagues, and by Gorard, Siddiqui and Huat See have produced data that support the conclusion that a Philosophy for Children program of one-hour-per-week structured discussions has a marked positive impact on students. This article presents data from a follow up study done three years after the completion of the study reported in Fair et al.. The data show that the positive gains in scores on the Cognitive Abilities Test (...) were still present and had not faded after three years. Given the strength of these confirmations of the positive durable impact of the P4C program of structured discussions and given the relatively low cost of implementing the P4C program, it is recommended that it become a standard part of the school curriculum. (shrink)

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)

Three recent research reports by Topping and Trickey, by Fair and colleagues, and by Gorard, Siddiqui and Huat See have produced data that support the conclusion that a Philosophy for Children program of one-hour-per-week structured discussions has a marked positive impact on students. This article presents data from a follow up study done three years after the completion of the study reported in Fair et al.. The data show that the positive gains in scores on the Cognitive Abilities Test (...) were still present and had not faded after three years. Given the strength of these confirmations of the positive durable impact of the P4C program of structured discussions and given the relatively low cost of implementing the P4C program, it is recommended that it become a standard part of the school curriculum. (shrink)

Definition of the problem Biomedical research based on big data offers immense benefits. Large multisite research that integrates large amounts of personal health data, especially genomic and genetic data, might contribute to a more personalized medicine. This type of research requires the transfer and storage of highly sensitive data, which raises the question of how to protect data subjects against data harm, such as privacy breach, disempowerment, disenfranchisement, and exploitation. As a result, there is a trade-off (...) between reaping the benefits of big-data-based biomedical research and protecting data subjects’ right to informational privacy. Arguments Blockchain technologies are often discussed as a technical fix for the abovementioned trade-off due to their specific features, namely data provenance, decentralization, immutability, and access and governance system. However, implementing blockchain technologies in biomedical research also raises questions regarding consent, legal frameworks, and workflow integration. Hence, accompanying measures, which I call enablers, are necessary to unleash the potential of blockchain technologies. These enablers are innovative models of consent, data ownership models, and regulatory models. Conclusion Blockchain technologies as a technical fix alone is insufficient to resolve the aforementioned trade-off. Combining this technical fix with the enablers outlined above might be the best way to perform biomedical research based on big data and at the same time protect the informational privacy of data subjects. (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)

Conflicts of interest held by researchers remain a focus of attention in clinical research. Biases related to these relationships have the potential to directly impact the quality of healthcare by influencing decision-making, yet conflicts of interest remain underreported, inconsistently described, and difficult to access. Initiatives aimed at improving the disclosure of researcher conflicts of interest are still in their infancy but represent a vital reform that must be addressed before potential biases associated with conflicts of interest can be mitigated (...) and trust in the impartiality of clinical evidence restored. In this review, we examine the prevalence of conflicts of interest, evidence of the effects that disclosed and undisclosed conflicts of interest have had on the reporting of clinical evidence, and the emerging approaches for improving the completeness and consistency of disclosures. Through this review of emerging technologies, we recognize a growing interest in publicly accessible registries for researcher conflicts of interest and propose five desiderata aimed at maximizing the value of such registries: mandates for ensuring that researchers keep their records up to date; transparent records that are made available to the public; interoperability to allow researchers, bibliographic databases, and institutions to interact with the registry; a consistent taxonomy for describing different classes of conflicts of interest; and the ability to automatically generate conflicts of interest statements for use in published articles. (shrink)

It is correctly asserted that the intensity of the current debate over the use of animals in biomedical research is unprecedented. The extent of expressed animosity and distrust has stunned many researchers. In response, researchers have tended to take a strategic defensive posture, which involves the assertion of several abstract positions that serve to obstruct resolution of the debate. Those abstractions include the notions that the animal protection movement is trivial and purely anti-intellectual in scope, that all science (...) is good (and some especially so), and the belief that an ethical consensus can never really be reached between the parties. (shrink)

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)

The post‐genomics era promises a revolution characterized by precision medicine and the integration of genomics into almost every area of biomedical research. At the same time, there are concerns that if care is not taken, the genomics revolution may widen global inequities in science and health. In Africa, these concerns are primarily linked to the underrepresentation of African populations in genomics research, limited genomics research capacity in Africa and associated macro‐level justice issues such as benefit sharing, (...) inequitable international research collaborations, and the contribution of genomics to the health and research priorities of Africa. Addressing these concerns requires an in‐depth reflection on how the ideals of global justice and equity may be advanced in genomics research. To contribute to the limited but growing scholarship on global genomics equity, especially in the African context, we performed a conceptual analysis of three accounts of justice and governance namely, Ubuntu, shared health governance and global governance of health, with the aim of identifying principles that could inform genomics governance in Africa. We used a convergence approach in the conceptual analysis, resulting in the identification of nine principles namely: solidarity, furthering the ideals of health justice, reciprocity, shared decision‐making, shared resources, shared responsibility, mutual trust, transparency, and mutual collective accountability. Examples of how the principles may be applied are provided. We recommend that these principles should form the foundation of any mechanism that seeks to systematically advance justice, fairness and equity in genomics research in Africa and more broadly, global health and science equity. (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)

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

‘Neuroeconomics’ can be broadly defined as the research of how the brain interacts with the environment to make decisions that are functional given individual and contextual constraints. Deciphering such brain-environment transactions requires mechanistic understandings of the neurobiological processes that implement value-dependent decision making. To this end, a common empirical approach is to investigate neural mechanisms of reward-based decision making. Flexible updating of choices and associated expected outcomes in ways that are adaptive for a given task (or a given (...) set of tasks) at hand relies on dynamic neurochemical tuning of the brain’s functional circuitries involved in the representation of tasks, goals and reward prediction. Empirical evidence as well as computational theories indicate that various neurotransmitter systems (e.g., dopamine, norepinephrine, and serotonin) play important roles in reward-based decision making. In light of the apparent aging-related decline in various aspects of the dopaminergic system as well as the effects of neuromodulation on reward-related processes, this article focuses selectively on the literature that highlights the triadic relations between dopaminergic modulation, reward-based decision making, and aging. Directions for future research on aging and neuroeconomoics are discussed. (shrink)

Medical explanations have often been thought on the model of biological ones and are frequently defined as mechanistic explanations of a biological dysfunction. In this paper, I argue that topological explanations, which have been described in ecology or in cognitive sciences, can also be found in medicine and I discuss the relationships between mechanistic and topological explanations in medicine, through the example of network medicine and medical genetics. Network medicine is a recent discipline that relies on the analysis of various (...) disease networks in order to find organizing principles in disease explanation. My aim is to show how topological explanations in network medicine can help solving the conceptual issues that pure mechanistic explanations of the genetics of disease are currently facing, namely the crisis of the concept of genetic disease, the progressive geneticization of diseases and the dissolution of the distinction between monogenic and polygenic diseases. However, I will also argue that topological explanations should not be considered as independent and radically different from mechanistic explanations for at least two reasons. First, in network medicine, topological explanations depend on and use mechanistic information. Second, they leave out some missing gaps in disease explanation that require, in turn, the development of new mechanistic explanations. Finally, I will insist on the specific contribution of topological explanations in medicine: they push us to develop an explanation of disease in general, instead of focusing on single explanations of individual diseases. This last point may have major consequences for biomedical research. (shrink)

Both a significant body of literature and the case study presented here show that digital knowledge repositories struggle to attract the needed level of data and knowledge contribution that they need to be successful. This happens also to high profile and prestigious initiatives. The paper argues that the reluctance of researchers to contribute can only be understood in light of the highly competitive context in which research careers need to be built nowadays and how this affects researchers’ quality of (...) life. Competition and managerialism limit the discretion of researchers in sharing their results and in donating their working time. A growing corpus of research shows that academic researchers are increasingly overworked and highly stressed. This corroborates the point that the room for undertaking additional tasks with future and uncertain benefits is very limited. The paper thus recommends that promoters of digital knowledge repositories focus on the needs of the researchers who are expected to contribute their knowledge. In order to treat them fairly and to ensure the success of the repositories, knowledge sharing needs to be rewarded so as to improve the working conditions of contributors. In order to help implementing this researcher-centred approach, the paper proposes the idea of expediential trust: rewards for contributing should be such that rational, self-interested researchers would freely decide to contribute their knowledge and effort trusting that this would make them better off. (shrink)

Biomedical researchers claim there is significant biomedical information about humans which can be discovered only through experiments on intact animal systems (AMA p. 2). Although epidemiological studies, computer simulations, clinical investigation, and cell and tissue cultures have become important weapons in the biomedical scientists' arsenal, these are primarily "adjuncts to the use of animals in research" (Sigma Xi p. 76). Controlled laboratory experiments are the core of the scientific enterprise. Biomedical researchers claim these should be (...) conducted on intact biological systems, whole animals. By observing the effects of various stimuli in non-human animals, we can form legitimate expectations about the likely effects of these stimuli in humans. Perhaps more importantly, we can understand the biomedical condition's causal mechanisms. (shrink)

This book is the result of a three-year study undertaken by a multidisciplinary working party of the Institute of Medical Ethic (UK). The group was chaired by a moral theologian, and its members included biological and ethological scientists, toxicologists, physicians, veterinary surgeons, an expert in alternatives to animal use, officers of animal welfare organizations, a Home Office Inspector, philosophers, and a lawyer. Coming from these different backgrounds, and holding a diversity of moral views, the members produced the agreed report as (...) a result of detailed and rigorous discussions. The book sets out facts about animal experiments and about animal abilities to experience pain, distress and anxiety. There is a detailed examination of the moral claims related to the benefits likely to accrue from animal research, and of strategies for weighing these benefits against the harm caused to animals, in order to decide whether particular research projects ought or ought not to proceed. This leads to consideration of the statutory and non-statutory controls which safeguard standards in such research. The final section explores a variety of philosophical arguments about the use of animals in research, and offers a philosophical justification for the Working Party's more practical conclusions. Written in clear, nontechnical language, this book is accessible to lay people as well as to scientists. It is the first such document to emerge from a meeting of people with such widely differing views on this highly controversial subject, and represents a major contribution towards informing and raising the quality of contemporary debate. The book is unique in drawing together material and ideas never before found in one volume. It will interest a broad spectrum of readers, from ethicists and animal rights advocates to scientific researchers and laboratory administrators, along with general readers concerned about this compelling issue. (shrink)

Music-based interventions (MBI) have become increasingly widely adopted for dementia and related disorders. Previous research shows that music engages reward-related regions through functional connectivity with the auditory system, but evidence for the effectiveness of MBI is mixed in older adults with mild cognitive impairment (MCI) and Alzheimer’s disease (AD). This underscores the need for a unified mechanistic understanding to motivate MBIs. The main objective of the present study is to characterize the intrinsic connectivity of the auditory and (...) class='Hi'>reward systems in healthy aging individuals with MCI, and those with AD. Using resting-state fMRI data from the Alzheimer’s Database Neuroimaging Initiative, we tested resting-state functional connectivity within and between auditory and reward systems in older adults with MCI, AD, and age-matched healthy controls (N = 105). Seed-based correlations were assessed from regions of interest (ROIs) in the auditory network (i.e., anterior superior temporal gyrus, posterior superior temporal gyrus, Heschl’s Gyrus), and the reward network (i.e., nucleus accumbens, caudate, putamen, and orbitofrontal cortex). AD individuals were lower in both within-network and between-network functional connectivity in the auditory network and reward networks compared to MCI and controls. Furthermore, graph theory analyses showed that the MCI group had higher clustering and local efficiency than both AD and control groups, whereas AD individuals had lo... (shrink)

We surveyed 1005 postdoctoral fellows by questionnaire about ethical matters related to biomedical research and publishing; 33% responded. About 18% of respondents said they had taken a course in research ethics, and about 31% said they had had a course that devoted some time to research ethics. A substantial majority stated willingness to grant other investigators, except competitors, access to their data before publication and to share research materials. Respondents’ opinions about contributions justifying authorship of (...) research papers were mainly consistent but at variance with those of many biomedical journal editors. More than half said they had observed what they considered unethical research practices. To increase the chances of getting a grant funded, 27% said they were willing to select or omit data to improve their results; to make publication of their work more likely or to benefit their career, 15% would select or omit data and 32% would list an undeserving author. Of respondents who thought they had been unfairly denied authorship on a paper, or been listed with or asked to list an undeserving author, 75% said they would be willing to list an undeserving author (P<0.001). Having taken a course dealing with research ethics had no effect on stated willingness to select or omit data or to fabricate data in the future, but was positively associated with willingness to grant undeserved authorship (P<0.04). Although these results do not controvert research demonstrating the effectiveness of ethics courses during professional education, they indicate that the research environment is a powerful component of a trainee’s experience and ethical development. (shrink)

International research, sponsored by for-profit companies, is regularly criticised as unethical on the grounds that it exploits research subjects in developing countries. Many commentators agree that exploitation occurs when the benefits of cooperative activity are unfairly distributed between the parties. To determine whether international research is exploitative we therefore need an account of fair distribution. Procedural accounts of fair bargaining have been popular solutions to this problem, but I argue that they are insufficient to protect against exploitation. (...) I argue instead that a maximin principle of fair distribution provides a more compelling normative account of fairness in relationships characterised by extreme vulnerability and inequality of bargaining potential between the parties. A global tax on international research would provide a mechanism for implementing the maximin account of fair benefits. This model has the capacity to ensure fair benefits and thereby prevent exploitation in international research. (shrink)

Educational institutions have a responsibility not only to provide a solid theoretical background on scientific phenomena, but to also frame them within the wider social context and highlight their numerous ethical implications. It is fundamental that tomorrow’s scientists be encouraged to develop an informed and critical approach towards scientific issues that, as in the case of animal experimentation, bring undeniable advantages to our society while carrying highly controversial moral implications. However, despite the considerable social and scientific relevance of the use (...) of animal models in biomedical research, there is a scarcity of scholarly literature exploring the topic from a pedagogical standpoint. The case study presented in this paper aims to investigate the effectiveness of role play simulation in promoting critical understanding of the use of animal models in biomedical research and its ethical implications. A simulation was set up in which first year undergraduate students took the role of delegates to a conference purportedly organised by the United Nations Ethics Office. The simulation included two electronic voting sessions, an open debate, and a keynote lecture. Post-session feedback indicated that most students found the simulation more engaging than a conventional lecture. A comparison of self-assessment questionnaires compiled at the start and at the end of the session indicated that students’ understanding of, and confidence in, the topic of animal experimentation had considerably increased after taking part in the simulation. (shrink)

Educational institutions have a responsibility not only to provide a solid theoretical background on scientific phenomena, but to also frame them within the wider social context and highlight their numerous ethical implications. It is fundamental that tomorrow’s scientists be encouraged to develop an informed and critical approach towards scientific issues that, as in the case of animal experimentation, bring undeniable advantages to our society while carrying highly controversial moral implications. However, despite the considerable social and scientific relevance of the use (...) of animal models in biomedical research, there is a scarcity of scholarly literature exploring the topic from a pedagogical standpoint. The case study presented in this paper aims to investigate the effectiveness of role play simulation in promoting critical understanding of the use of animal models in biomedical research and its ethical implications. A simulation was set up in which first year undergraduate students took the role of delegates to a conference purportedly organised by the United Nations Ethics Office. The simulation included two electronic voting sessions, an open debate, and a keynote lecture. Post-session feedback indicated that most students found the simulation more engaging than a conventional lecture. A comparison of self-assessment questionnaires compiled at the start and at the end of the session indicated that students’ understanding of, and confidence in, the topic of animal experimentation had considerably increased after taking part in the simulation. (shrink)

Many in the international development community have embraced the randomized controlled field experiment, akin to a biomedical clinical trial for social interventions, as the new “gold evidential standard” in program impact evaluation. In response, critics have called upon the method’s advocates to consider the moral dimensions of randomization, leading to a debate about the method’s ethics. My research intervenes in this debate by empirically investigating how researchers manage the perception of randomization in the field. Without the possibility of (...) a placebo, researchers rhetorically and materially frame the experiment differently for the control and treatment groups. Three technologies allow for this differential framing: geographic separation, temporal delay, and public randomization ceremonies. Geographic separation is a “technology of opacity” designed to obscure unequal resource distribution by disentangling the intervention and research components of the experiment for the control group. The latter two are technologies of transparency designed to expose the element of randomization but downplay conditions that may affect participant buy in. All three technologies work to preclude collective definitions of fair resource allocation, yet they are not fully successful in preventing modes of confrontation and resistance that lie outside of the experiment’s framing. (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)