Background The number of coauthors in the medical literature has increased over the past 50 years as authorship continues to have important academic, social and financial implications.Aim and method The study aim was to determine the prevalence of honorary authorship in biomedical publications and identify the factors that lead to its existence. An email with a survey link was sent anonymously to 9283 corresponding authors of PubMed articles published within 1 year of contact.Results A completed survey was obtained from (...) 1246 corresponding authors, a response rate of 15.75%. One-third admitted that they had added authors who did not deserve authorship credit. Origin of the study from Europe and Asia , study type as case report/case series and increasing number of coauthors were found to be the associated factors on multivariate analysis. Journal impact factor was also found to be associated with honorary authorship for those who self-reported honorary authorship and 5.60 for those who did not report unjust authorship, p=0.05). In retrospect, 75% of the authors indicated that they would remove unjustified names from the authorship list. Reasons for adding honorary authors were complimentary , to avoid conflict at work , to facilitate article acceptance , and other .Conclusions Honorary authorship is relatively common in biomedical publications. Researchers should comply with the International Committee of Medical Journal Editors’ criteria for authorship. (shrink)

Scientific journals may incur scientific error if articles are tainted by research misconduct. While some journals’ ethical policies, especially those on conflicts of interest, have improved over recent years, with some adopting a uniform approach, only around half of biomedical journals, principally those with higher impact factors, currently have formal misconduct policies, mainly for handling allegations. Worryingly, since a response to allegations would reasonably require an a priori definition, far fewer journals have publicly available definitions (...) of misconduct. While some journals and editors’ associations have taken significant steps to prevent and detect misconduct and respond to allegations, the content, visibility of and access to these policies varies considerably. In addition, while the lack of misconduct policies may prompt and maintain a de novo approach for journals, potentially causing stress, publication delays and even legal disputes, the lack of uniformity may be a matter of contention for research stakeholders such as editors, authors and their institutions, and publishers. Although each case may need an individual approach, I argue that posting highly visible, readily accessible, comprehensive, consistent misconduct policies could prevent the publication of fraudulent papers, increase the number of retractions of already published papers and, perhaps, reduce research misconduct. Although legally problematic, a concerted approach, with sharing of information between editors, which is clearly explained in journal websites, could also help. Ideally, journals, editors’ associations, and publishers should seek consistency and homogenise misconduct policies to maintain public confidence in the integrity of biomedical research publications. (shrink)

Law journals permit submission of scholarly manuscripts to multiple journals concurrently, but biomedical journals strictly forbid submission of manuscripts to more than one journal at a time. Law journals may then compete for the publication of manuscripts. This article examines whether the single-submission requirement of biomedical journals may constitute restraint of trade in violation of Section 1 of the Sherman Antitrust Act.

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union (Eastern EU) and South-East European countries (South-East Europe) that are not members of (...) the European Union.The most common ethical issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors’ conflicts of interest and registration of clinical trialswere the least common ethical policies. Three aspects were significantly morecommon in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation.On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences amongbiomedical journals’ ethical policies calls for further research and active measuresto harmonize policies across journals. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals’ ethical policies calls for further research and active measures to harmonize policies across journals. (shrink)

BackgroundAlthough the peer review process is believed to ensure scientific rigor, enhance research quality, and improve manuscript clarity, many investigators are concerned that the process is too slow, too expensive, too unreliable, and too static. In this feasibility study, we sought to survey corresponding authors of recently published clinical research studies on the speed and efficiency of the publication process.MethodsWeb-based survey of corresponding authors of a 20% random sample of clinical research studies in MEDLINE-indexed journals with Ovid MEDLINE entry (...) dates between December 1 and 15, 2016. Survey addressed perceived manuscript importance before first submission, approximate first submission and final acceptance dates, and total number of journal submissions, external peer reviews, external peer reviewers, and revisions requested, as well as whether authors would have considered publicly sharing their manuscript on an online platform instead of submitting to a peer-reviewed journal.ResultsOf 1780 surveys distributed, 27 corresponding authors opted out or requested that we stop emailing them and 149 emails failed (e.g., emails that bounced n = 64, returned with an away from office message n = 70, or were changed/incorrect n = 15), leaving 1604 respondents, of which 337 completed the survey (21.0%). Respondents and non-respondents were similar with respect to study type and publication journals’ impact factor, although non-respondent authors had more publications (p = 0.03). Among respondents, the median impact factor of the publications’ journal was 2.7 (interquartile range (IQR), 2.0–3.6) and corresponding authors’ median h-index and number of publications was 9 (IQR, 3–20) and 27 (IQR, 10–77), respectively. The median time from first submission to journal acceptance and publication was 5 months (IQR, 3–8) and 7 months (IQR, 5–12), respectively. Most respondents (62.0%, n = 209) rated the importance of their research as a 4 or 5 (5-point scale) prior to submission. Median number of journal submissions was 1 (IQR, 1–2), external peer reviews was 1 (IQR, 1–2), external peer reviewers was 3 (IQR, 2–4), and revisions requested was 1 (IQR, 1–1). Sharing manuscripts to a public online platform, instead of submitting to a peer-reviewed journal, would have been considered by 55.2% (n = 186) of respondents.ConclusionCorresponding authors have high perceptions of their research and reported requiring few manuscript submissions prior to journal acceptance, most commonly by lower impact factor journals. (shrink)

Publication ethics is an important aspect of both the research and publication enterprises. It is particularly important in the field of biomedical science because published data may directly affect human health. In this article, we examine publication ethics policies in biomedical journals published in Central and Eastern Europe. We were interested in possible differences between East European countries that are members of the European Union and South-East European countries that are not members of the European Union. The (...) most common ethical issues addressed by all journals in the region were redundant publication, peer review process, and copyright or licensing details. Image manipulation, editors’ conflicts of interest and registration of clinical trials were the least common ethical policies. Three aspects were significantly more common in journals published outside the EU: statements on the endorsement of international editorial standards, contributorship policy, and image manipulation. On the other hand, copyright or licensing information were more prevalent in journals published in the Eastern EU. The existence of significant differences among biomedical journals’ ethical policies calls for further research and active measures to harmonize policies across journals. (shrink)

Bibliographic negligence, i.e. omission of citation of the relevant work of other researchers, is possibly the most common type of research misconduct, leading to unfair loss of priority of authorship and undermining the reward system of science. We report a case of bibliographic negligence which we recently suffered from a leading biomedical journal. The case is discussed in the context of the editorial policy of the journal and of relevant ethical guidelines. Scientific journals should develop codes of conduct (...) for citations. In addition, the implications and consequences of bibliographic negligence deserve thorough investigation. (shrink)

The range and types of performance metrics has recently proliferated in academic settings, with bibliometric indicators being particularly visible examples. One field that has traditionally been hospitable towards such indicators is biomedicine. Here the relative merits of bibliometrics are widely discussed, with debates often portraying them as heroes or villains. Despite a plethora of controversies, one of the most widely used indicators in this field is said to be the Journal Impact Factor. In this article we argue that much of (...) the current debates around researchers’ uses of the JIF in biomedicine can be classed as ‘folk theories’: explanatory accounts told among a community that seldom get systematically checked. Such accounts rarely disclose how knowledge production itself becomes more-or-less consolidated around the JIF. Using ethnographic materials from different research sites in Dutch University Medical Centers, this article sheds new empirical and theoretical light on how performance metrics variously shape biomedical research on the ‘shop floor.’ Our detailed analysis underscores a need for further research into the constitutive effects of evaluative metrics. (shrink)

The number of articles published in open access journals has increased dramatically in recent years. Simultaneously, the quality of publications in these journals has been called into question. Few studies have explored the retraction rate from OAJs. The purpose of the current study was to determine the reasons for retractions of articles from OAJs in biomedical research. The Medline database was searched through PubMed to identify retracted publications in OAJs. The journals were identified by the Directory (...) of Open Access Journals. Data were extracted from each retracted article, including the time from publication to retraction, causes, journal impact factor, and country of origin. Trends in the characteristics related to retraction were determined. Data from 621 retracted studies were included in the analysis. The number and rate of retractions have increased since 2010. The most common reasons for retraction are errors, plagiarism, duplicate publication, fraud/suspected fraud and invalid peer review. The number of retracted articles from OAJs has been steadily increasing. Misconduct was the primary reason for retraction. The majority of retracted articles were from journals with low impact factors and authored by researchers from China, India, Iran, and the USA. (shrink)

Biomedical ontologies exist to serve integration of clinical and experimental data, and it is critical to their success that they be put to widespread use in the annotation of data. How, then, can ontologies achieve the sort of user-friendliness, reliability, cost-effectiveness, and breadth of coverage that is necessary to ensure extensive usage? Methods: Our focus here is on two different sets of answers to these questions that have been proposed, on the one hand in medicine, by the SNOMED CT (...) community, and on the other hand in biology, by the OBO Foundry. We address more specifically the issue as to how adherence to certain development principles can advance the usability and effectiveness of an ontology or terminology resource, for example by allowing more accurate maintenance, more reliable application, and more efficient interoperation with other ontologies and information resources. Results: SNOMED CT and the OBO Foundry differ considerably in their general approach.Nevertheless, a general trend towards more formal rigor and cross-domain interoperability can be seen in both and we argue that this trend should be accepted by all similar initiatives in the future. Conclusions: Future efforts in ontology development have to address the need for harmonization and integration of ontologies across disciplinary borders, and for this, coherent formalization of ontologies is a prerequisite. (shrink)

Biomedical moral enhancement, or BME for short, aims to improve people’s moral behaviors through augmenting, via biomedical means, their virtuous dispositions such as sympathy, honesty, courage, or generosity. Recently, it has been challenged, on particularist grounds, however, that the manifestations of the virtuous dispositions can be morally wrong. For instance, being generous in terrorist financing is one such case. If so, biomedical moral enhancement, by enhancing people’s virtues, might turn out to be counterproductive in terms of people’s (...) moral behaviors. In this paper, we argue, via a comparison with moral education, that the case for the practice of biomedical moral enhancement is not weakened by the particularists’ stress on the variable moral statuses of the manifestations of our virtues. The real challenge from the particularists, we argue, lies elsewhere. It is that practical wisdom, being essentially context-sensitive, cannot be enhanced via biomedical means. On the basis of this, we further argue that BME ought to be used with great caution, for it may wrongly enhance, for instance, a terrorist financier’s generosity, a robber’s courage, or an undercover detective’s honesty. Finally, we sketch how boundaries can be set on the use of BME, and address some potential objections to our position. (shrink)

Prominent thinkers such as Jurgen Habermas and Michael Sandel are warning that biomedical enhancements will undermine fundamental political values. Yet whether biomedical enhancements will undermine such values depends on how biomedical enhancements will function, how they will be administered and to whom. Since only few enhancements are obtainable, it is difficult to tell whether these predictions are sound. Nevertheless, such warnings are extremely valuable. As a society we must, at the very least, be aware of developments that (...) could have harmful consequences. Indeed, if important values were to be jeopardized, we should take appropriate measures to protect them. This paper focuses on four central values: solidarity, personal responsibility, equality and autonomy. It delineates the conditions under which biomedical enhancements would undermine these values. It also details the circumstances under which these values would be unaffected by enhancements as well as those under which they would be promoted. Specifying these conditions is valuable; it would enable society to prepare appropriate ethical guidelines and policy responses in advance. (shrink)

Peer review of manuscripts for biomedical journals has become a subject of intense ethical debate. One of the most contentious issues is whether or not peer review should be anonymous. This study aimed to generate a rich, empirically-grounded understanding of the values held by journal editors and peer reviewers with a view to informing journal policy. Qualitative methods were used to carry out an inductive analysis of biomedical reviewers’ and editors’ values. Data was derived from in-depth, open-ended (...) interviews with journal editors and peer reviewers. Data was “read for” themes relevant to reviewer anonymisation and interactions among editors, reviewers, and authors. Editors and peer reviewers provided three arguments that would support a more open and interactive peer-review process. First, a number of participants emphasised the importance of not only ensuring the scientific quality of published research but also nurturing their colleagues and supporting their communities. Second, many spoke about the ongoing moral responsibilities that reviewers and editors felt toward authors. Finally, participants spoke at length about their enjoyment of social interactions and of the value of collective, rather than isolated, reasoning processes. Whether or not journal editors decide to allow anonymous review , the values of editors and reviewers need to be seriously addressed in codes of publication ethics, in the management of biomedical journals, and in the establishment of journal policies. (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.

The National Center for Biomedical Ontology is now in its seventh year. The goals of this National Center for Biomedical Computing are to: create and maintain a repository of biomedical ontologies and terminologies; build tools and web services to enable the use of ontologies and terminologies in clinical and translational research; educate their trainees and the scientific community broadly about biomedical ontology and ontology-based technology and best practices; and collaborate with a variety of groups who develop (...) and use ontologies and terminologies in biomedicine. The centerpiece of the National Center for Biomedical Ontology is a web-based resource known as BioPortal. BioPortal makes available for research in computationally useful forms more than 270 of the world's biomedical ontologies and terminologies, and supports a wide range of web services that enable investigators to use the ontologies to annotate and retrieve data, to generate value sets and special-purpose lexicons, and to perform advanced analytics on a wide range of biomedical data. (shrink)

Biomedical enhancements, the applications of medical technology to make better those who are neither ill nor deficient, have made great strides in the past few decades. Using Amartya Sen's capability approach as my framework, I argue in this article that far from being simply permissible, we have a prima facie moral obligation to use these new developments for the end goal of promoting social justice. In terms of both range and magnitude, the use of biomedical enhancements will mark (...) a radical advance in how we compensate the most disadvantaged members of society. (shrink)

The relation between biomedical knowledge and clinicalknowledge is discussed by comparing their respectivestructures. The knowledge of a disease as a biologicalphenomenon is constructed by the interaction of factsand theories from the main biomedical disciplines:epidemiology, diagnostics, clinical trial, therapydevelopment and pathogenesis. Although these facts andtheories are based on probabilities andextrapolations, the interaction provides a reliableand coherent structure, comparable to a Kuhnianparadigma. In the structure of clinical knowledge,i.e. knowledge of the patient with the disease, notonly biomedical knowledge contributes to (...) the structurebut also economic and social relations, ethics andpersonal experience. However, the interaction betweeneach of the participating ``knowledges'' in clinicalknowledge is not based on mutual dependency andaccumulation of different arguments from each, as inbiomedical knowledge, but on competition and partialexclusion. Therefore, the structure of biomedicalknowledge is different from that of clinicalknowledge. This difference is used as the basis for adiscussion in which the place of technology,evidence-based medicine and the gap between scientificand clinical knowledge are evaluated. (shrink)

In Japan, modern biomedical ethics emerged in the early 1980s. One of the main triggers was the nationwide debate on organ transplantation and brain death. A lengthy process of academic, religious, and political discussion concerning organ transplantation, lasting well over a few decades, resulted in the enactment of the Organ Transplantation Law in 1997.1 The defining of death and other bioethical issues, including death with dignity and euthanasia, were also stimulating topics throughout the latter end of the twentieth century. (...) For instance, the death-with-dignity movement, which started around the late 1960s, developed into a hospice/palliative-care movement by the end of the 1980s. (shrink)

Prominent thinkers such as Jurgen Habermas and Michael Sandel are warning that biomedical enhancements will undermine fundamental political values. Yet whether biomedical enhancements will undermine such values depends on how biomedical enhancements will function, how they will be administered and to whom. Since only few enhancements are obtainable, it is difficult to tell whether these predictions are sound. Nevertheless, such warnings are extremely valuable. As a society we must, at the very least, be aware of developments that (...) could have harmful consequences. Indeed, if important values were to be jeopardized, we should take appropriate measures to protect them. This paper focuses on four central values: solidarity, personal responsibility, equality and autonomy. It delineates the conditions under which biomedical enhancements would undermine these values. It also details the circumstances under which these values would be unaffected by enhancements as well as those under which they would be promoted. Specifying these conditions is valuable; it would enable society to prepare appropriate ethical guidelines and policy responses in advance. (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)

No discussion of academic freedom, research integrity, and patient safety could begin with a more disquieting pair of case studies than those of Nancy Olivieri and David Healy. The cumulative impact of the Olivieri and Healy affairs has caused serious self examination within the biomedical research community. The first part of the essay analyses these recent academic scandals. The two case studies are then placed in their historical context—that context being the transformation of the norms of science through increasingly (...) close ties between research universities and the corporate world. After a literature survey of the ways in which corporate sponsorship has biased the results of clinical drug trials, two different strategies to mitigate this problem are identified and assessed: a regulatory approach, which focuses on managing risks associated with industry funding of university research, and a more radical approach, the sequestration thesis, which counsels the outright elimination of corporate sponsorship. The reformist approach is criticised and the radical approach defended. (shrink)

Ontology is one strategy for promoting interoperability of heterogeneous data through consistent tagging. An ontology is a controlled structured vocabulary consisting of general terms (such as “cell” or “image” or “tissue” or “microscope”) that form the basis for such tagging. These terms are designed to represent the types of entities in the domain of reality that the ontology has been devised to capture; the terms are provided with logical defi nitions thereby also supporting reasoning over the tagged data. Aim: This (...) paper provides a survey of the biomedical imaging ontologies that have been developed thus far. It outlines the challenges, particularly faced by ontologies in the fields of histopathological imaging and image analysis, and suggests a strategy for addressing these challenges in the example domain of quantitative histopathology imaging. The ultimate goal is to support the multiscale understanding of disease that comes from using interoperable ontologies to integrate imaging data with clinical and genomics data. (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)

Reflecting biomedical, technological and environmental issues of our modern society. The recent “Forum” section in Poiesis & Praxis Content Type Journal Article Category Editorial Pages 1-2 DOI 10.1007/s10202-011-0097-7 Authors Stephan Lingner, Europäische Akademie zur Erforschung von Folgen wissenschaftlich-technischer Entwicklungen Bad Neuenahr-Ahrweiler GmbH, Wilhelmstr. 56, 53474 Bad Neuenahr-Ahrweiler, Germany Journal Poiesis & Praxis: International Journal of Technology Assessment and Ethics of Science Online ISSN 1615-6617 Print ISSN 1615-6609 Journal Volume Volume 8 Journal Issue Volume 8, Number 1.

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.

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.

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)

Empirical evidence suggests that while people hold the capacity to control their data in high regard, they increasingly experience a loss of control over their data in the online world. The capacity to exert control over the generation and flow of personal information is a fundamental premise to important values such as autonomy, privacy, and trust. In healthcare and clinical research this capacity is generally achieved indirectly, by agreeing to specific conditions of informational exposure. Such conditions can be openly stated (...) in informed consent documents or be implicit in the norms of confidentiality that govern the relationships of patients and healthcare professionals. However, with medicine becoming a data-intense enterprise, informed consent and medical confidentiality, as mechanisms of control, are put under pressure. In this paper we explore emerging models of informational control in data-intense healthcare and clinical research, which can compensate for the limitations of currently available instruments. More specifically, we discuss three approaches that hold promise in increasing individual control: the emergence of data portability rights as means to control data access, new mechanisms of informed consent as tools to control data use, and finally, new participatory governance schemes that allow individuals to control their data through direct involvement in data governance. We conclude by suggesting that, despite the impression that biomedical big data diminish individual control, the synergistic effect of new data management models can in fact improve it. (shrink)

The Ontology for Biomedical Investigations (OBI) is an ontology that provides terms with precisely defined meanings to describe all aspects of how investigations in the biological and medical domains are conducted. OBI re-uses ontologies that provide a representation of biomedical knowledge from the Open Biological and Biomedical Ontologies (OBO) project and adds the ability to describe how this knowledge was derived. We here describe the state of OBI and several applications that are using it, such as adding (...) semantic expressivity to existing databases, building data entry forms, and enabling interoperability between knowledge resources. OBI covers all phases of the investigation process, such as planning, execution and reporting. It represents information and material entities that participate in these processes, as well as roles and functions. Prior to OBI, it was not possible to use a single internally consistent resource that could be applied to multiple types of experiments for these applications. OBI has made this possible by creating terms for entities involved in biological and medical investigations and by importing parts of other biomedical ontologies such as GO, Chemical Entities of Biological Interest (ChEBI) and Phenotype Attribute and Trait Ontology (PATO) without altering their meaning. OBI is being used in a wide range of projects covering genomics, multi-omics, immunology, and catalogs of services. OBI has also spawned other ontologies (Information Artifact Ontology) and methods for importing parts of ontologies (Minimum information to reference an external ontology term (MIREOT)). The OBI project is an open cross-disciplinary collaborative effort, encompassing multiple research communities from around the globe. To date, OBI has created 2366 classes and 40 relations along with textual and formal definitions. The OBI Consortium maintains a web resource providing details on the people, policies, and issues being addressed in association with OBI. (shrink)

This paper examines medical scientists’ accounts of their rediscoveries and reassessments of old materials. It looks at how historical patient files and brain samples of the first cases of Alzheimer’s disease became reused as scientific objects of inquiry in the 1990s, when a genetic neuropathologist from Munich and a psychiatrist from Frankfurt lead searches for left-overs of Alzheimer’s ‘founder cases’ from the 1900s. How and why did these researchers use historical methods, materials and narratives, and why did the biomedical (...) community cherish their findings as valuable scientific facts about Alzheimer’s disease? The paper approaches these questions by analysing how researchers conceptualised ‘history’ while backtracking and reassessing clinical and histological materials from the past. It elucidates six ways of conceptualising history as a biomedical matter: (1) scientific assessments of the past, i.e. natural scientific understandings of ‘historical facts’; (2) history in biomedicine, e.g. uses of old histological collections in present day brain banks; (3) provenance research, e.g. applying historical methods to ensure the authenticity of brain samples; (4) technical biomedical history, e.g. reproducing original staining techniques to identify how old histological slides were made; (5) founding traditions, i.e. references to historical objects and persons within founding stories of scientific communities; and (6) priority debates, e.g. evaluating the role particular persons played in the discovery of a disease such as Alzheimer’s. Against this background, the paper concludes with how the various ways of using and understanding ‘history’ were put forward to re-present historic cases as ‘proto-types’ for studying Alzheimer’s disease in the present. (shrink)

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)

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)

An examination of the early history of Nobel Committee deliberations, coupled with a survey of discoveries for which prizes have been awarded to date – and, equally revealing, discoveries for which prizes have not been awarded – reveals a pattern. This pattern suggests that Committee members may have internalized the received, biomedical model and conferred awards in accord with the physicalistic premises that ground this model. I consider the prospect of a paradigm change in medical science and the possible (...) repercussions of such a change on the distribution of Nobel prizes within the domain of physiology or medicine. For expository purposes, I contrast a model based on a science of pathophysiology with one based on a science of pathopsychophysiology. I propose a means whereby members might minimize the potentially blinding effects of model-dependence and come to evaluate medical discoveries from an inter-model rather than an exclusively intra-model perspective. By bringing to light questions rarely asked and proposing answers, I seek to open a dialogue and furnish a vehicle by which the putative delimiting effects of model-dependence might be overcome. (shrink)

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)

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)

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)

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)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

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)

_The International Committee of Medical Journal Editors (ICMJE) is a working group of editors of selected medical journals that meets annually. Founded in Vancouver, Canada, in 1978, it currently consists of 11 member journals and a representative of the US National Library of Medicine. The major purpose of the Committee is to address and provide guidance for the conduct and publishing of biomedical research and the ethical tenets underpinning these activities. This advice is detailed in the Committee's (...) _ Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication (URM)._ Recently, the ICMJE has adopted an interventionist role to ensure transparency of conflict of interest revelations in the conduct and publication of industry supported research. It also pursues a policy for the lodgement with trial registries of specified details of Phase III clinical trials. Failure to comply would jeopardise publication of trial outcomes in ICMJE member journals. This policy has resulted in the coming on stream of trial registries, international agreement on trial minimal datasets and compliance with trial registration requirements._. (shrink)

Transplantation is becoming an increasingly more common approach to treatment of diseases of organ failure, making organ donation an important means of saving lives. Most world religions find organ donation for the purpose of transplantation to be acceptable, and some even encourage members to donate their organs as a gift of love to others. Recent developments, including artificial organs, transplants from nonhuman species, use of stem cells, and cloning, are impacting the field of transplantation. These new approaches should be discussed (...) with bioethical considerations in mind, particularly the notion of human beings as a unity of body and spirit. (shrink)

Biomedical moral enhancement is an idea which states that human moral intuitions and patterns may be artificially improved by biomedical means. The rationale which lies behind moral bioenhancement is rooted in the idea that humans – in a moral and behavioral sense – are not evolutionally adapted to current ecological challenges. This idea is discussed in the paper in relation to human space missions to Mars and beyond. Because the space environment is a hazardous environment, there are some (...) reasons to consider the idea of moral bioenhancement for the purposes of mission success and the safety of astronauts/space settlers. This paper discusses that idea in the context of a broader discussion on moral enhancement, moral bioenhancement related to earthly issues, and the idea of moral progress. (shrink)

Biomedical ethics in the FRG is still in an embryonic stage. The Hippocratic tradition of paternalism is still dominant, general debates on Weltanschauungen have not yet been replaced by case-study methods and other means of resolving conflicts more effectively in pluralistic societies. Issues such as IVF and embryo research are predominantly treated in legal rather than in moral terms. Some new developments in moral assessment of prenatal care and care of the dying are reported. Allocational disputes over the future (...) of welfare-state health care systems are likely to continue without any major moral or political decision being reached. (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)

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)

This article explores the issue of discoverability and abductive creativity in scientific cognition, focusing on the challenges faced by biopharmaceutical companies in their R&D organization. The author argues that these companies are generating “impoverished epistemic niches”, which threaten fundamental aspects of modern science. The author proposes the concept of epistemic irresponsibility, emphasizing the importance of “knowledge in motion” in multidisciplinary, interdisciplinary, and transdisciplinary scientific research. The increasing expansion of commodification and commercialization of science, marketing of technoscientific products, and the impoverishment (...) of epistemic niches seem to already threaten the flourishing of human creativity and successful abductive creative cognition in science. (shrink)

With the rapidly expanding catalogue of scientific publications, especially within the Biomedical Sciences field, it is becoming increasingly difficult for researchers to search for, read or even interpret emerging scientific findings. PubMed, just one of the current biomedical data repositories, comprises over 33 million citations for biomedical research, and over 2500 publications are added each day. To further strengthen the impact biomedical research, we suggest that there should be more synergy between publications and machines. By bringing (...) machines into the realm of research and publication, we can greatly augment the assessment, investigation and cataloging of the biomedical literary corpus. The effective application of machine-based manuscript assessment and interpretation is now crucial, and potentially stands as the most effective way for researchers to comprehend and process the tsunami of biomedical data and literature. Many biomedical manuscripts are currently published online in poorly searchable document types, with figures and data presented in formats that are partially inaccessible to machine-based approaches. The structure and format of biomedical manuscripts should be adapted to facilitate machine-assisted interrogation of this important literary corpus. In this context, it is important to embrace the concept that biomedical scientists should also write manuscripts that can be read by machines. It is likely that an enhanced human–machine synergy in reading biomedical publications will greatly enhance biomedical data retrieval and reveal novel insights into complex datasets. (shrink)

HTA and TA institutions at national parliaments (PTA) both share the same origin and of course have objectives and some of their methods in common. Nevertheless both TA branches developed in some distance during the 1970s and 1980s. Drawing on the case of biomedicine this paper outlines the differences between HTA and PTA, highlighting the “clinical perspective” of HTA and the “societal perspective” of PTA. It is shown that biomedicine which has developed rapidly during the last decade has hardly been (...) dealt with by HTA, whereas it ranked quite prominent on the agendas of PTA institutions. Biomedical technologies became a subject of policy making beyond the boundaries of health care politics since biomedicine is perceived as an ethical challenge to society and not only as a medical innovation that has to be assessed by clinical experts. It is argued that there may however be good reasons to integrate the HTA and the PTA perspective in future TA on biomedical technologies. (shrink)