Conflict of Interest and the CREATE-X Trial in the New England Journal of Medicine

There is an increasing emphasis on clear disclosure of conflict of interest in medical communities, following repeated scientific frauds in clinical trials. However, incomplete COI statements continue to be prevalent in the medical community, as appears to have occurred in the Capecitabine for Residual Cancer as Adjuvant Therapy (CREATE-X) trial, which was recently published in the New England Journal of Medicine. The authors of the article did not clearly report the roles of the Japan Breast Cancer Research Group, a sponsor and funder of the study, although a majority of the Japanese authors served in important positions in the organization. Furthermore, the conflict of interest related to Chugai Pharmaceutical Company, a Japanese distributor of capecitabine, was not correctly disclosed. More transparent statements of conflict of interest and clarification of sponsors and funders’ roles, as well as rigorous review by academic journals are required to fairly interpret the findings of clinical trials, including and beyond the single case of the CREATE-X trial.     

Aspects of Morality and Law Enforcement in Today’s Science in Post-Soviet Countries

Many reports independently confirm that even more than a quarter of a century after the collapse of the Soviet Union, the results of research and development in those countries that were under its influence are insufficient in comparison to the rest of the world. Given that human intelligence is not distributed unevenly and that science is a powerful driving force for the future of an economy, there is a hidden problem, which, if it can be resolved, may release great economic potential. The first generation of researchers from Armenia, Czech Republic, Georgia, Slovakia and Ukraine, who successfully completed their education after the political revolution, were surveyed. The survey revealed many similarities with regards to ethics, but that there is mounting evidence that the main cause of the current situation is the state of the local legal systems. The conclusion was drawn that a conceptual change in staffing within the relevant legal systems is required to release potential and stimulate wealth creation.     

Establishing Sensible and Practical Guidelines for Desk Rejections

Publishing has become, in several respects, more challenging in recent years. Academics are faced with evolving ethics that appear to be more stringent in a bid to reduce scientific fraud, the emergence of science watchdogs that are now scrutinizing the published literature with critical eyes to hold academics, editors and publishers more accountable, and a barrage of checks and balances that are required between when a paper is submitted and eventually accepted, to ensure quality control. Scientists are often under increasing pressure to produce papers in an increasingly stringent publishing environment. In such a climate, timing is everything, as is the efficiency of the process. Academics appreciate that rejections are part of the fabric of attempting to get a paper published, but they expect the reason to be clear, based on careful evaluation of their work, and not on superficial or unsubstantiated excuses. A desk rejection occurs when a paper gets rejected even before it has entered the peer review process. This paper examines the features of some desk rejections and offers some guidelines that would make desk rejections valid, fair and ethical. Academics who publish are under constant pressure to do so quickly, but effectively. They are dependent on the editors’ good judgment and the publisher’s procedures. Unfair, unsubstantiated, or tardy desk rejections disadvantage academics, and editors and publishers must be held accountable for wasting their time, resources, and patience.     

Environmental Decision Making on Acid Mine Drainage Issues in South Africa: An Argument for the Precautionary Principle

This paper examines the issue of acid mine drainage in South Africa and environmental decision making processes that could be taken to mitigate the problem in the context of both conventional risk assessment and the precautionary principle. It is argued that conventional risk assessment protects the status quo and hence cannot be entirely relied upon as an effective tool to resolve environmental problems in the context of South Africa, a developing country with complex environmental health concerns. The complexity of the environmental issues is discussed from historical and political perspectives. An argument is subsequently made that the precautionary principle is an alternative tool, and its adoption can be used to empower local communities. This work, therefore, adds to new knowledge by problematising conventional risk assessment and proposing the framing of the acid mine drainage issues in a complex and contextual scenario of a developing country—South Africa.     

Should DBS for Psychiatric Disorders be Considered a Form of Psychosurgery? Ethical and Legal Considerations

Deep brain stimulation (DBS), a surgical procedure involving the implantation of electrodes in the brain, has rekindled the medical community’s interest in psychosurgery. Whereas many researchers argue DBS is substantially different from psychosurgery, we argue psychiatric DBS—though a much more precise and refined treatment than its predecessors—is nevertheless a form of psychosurgery, which raises both old and new ethical and legal concerns that have not been given proper attention. Learning from the ethical and regulatory failures of older forms of psychosurgery can help shed light on how to address the regulatory gaps that exist currently in DBS research. To show why it is important to address the current regulatory gaps within psychiatric DBS, we draw on the motivations underlying the regulation of earlier forms of psychosurgery in the US. We begin by providing a brief history of psychosurgery and electrical brain stimulation in the US. Against this backdrop, we introduce psychiatric DBS, exploring current research and ongoing clinical trials. We then draw out the ethical and regulatory similarities between earlier forms of psychosurgery and psychiatric DBS. As we will show, the factors that motivated strict regulation of earlier psychosurgical procedures mirror concerns with psychiatric DBS today. We offer three recommendations for psychiatric DBS regulation, which echo earlier motivations for regulating psychosurgery, along with new considerations that reflect the novel technologies used in DBS.     

Science as a Matter of Honour: How Accused Scientists Deal with Scientific Fraud in Japan

Practices related to research misconduct seem to have been multiplied in recent years. Many cases of scientific fraud have been exposed publicly, and journals and academic institutions have deployed different measures worldwide in this regard. However, the influence of specific social and cultural environments on scientific fraud may vary from society to society. This article analyzes how scientists in Japan deal with accusations of scientific fraud. For such a purpose, a series of scientific fraud cases that took place in Japan has been reconstructed through diverse sources. Thus, by analyzing those cases, the social basis of scientific fraud and the most relevant aspects of Japanese cultural values and traditions, as well as the concept of honour which is deeply involved in the way Japanese scientists react when they are accused of and publicly exposed in scientific fraud situations is examined.     

Maker Cultures and the Prospects for Technological Action

Supported by easier and cheaper access to tools and expanding communities, maker cultures are pointing towards the ideas of (almost) everyone designing, creating, producing and distributing renewed, new and improved products, machines, things or artefacts. A careful analysis of the assumptions and challenges of maker cultures emphasizes the relevance of what may be called technological action, that is, active and critical interventions regarding the purposes and applications of technologies within ordinary lives, thus countering the deterministic trends of current directions of technology. In such transformative potential, we will explore a set of elements what is and could be technological action through snapshots of maker cultures based on the empirical research conducted in three particular contexts: the Fab Lab Network, Maker Media core outputs and initiatives such as Maker Faires, and the Open Source Hardware Association (OSHWA). Elements such as control and empowerment through material engagement, openness and sharing, and social, cultural, political and ethical values of the common good in topics such as diversity, sustainability and transparency, are critically analysed.     

Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine

Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.     

Inhibition in aging: What is preserved? What declines? A meta-analysis

Aging has been assumed to go along with deficient inhibitory processes in cognitive performance. According to this inhibition deficit hypothesis, older adults are less able to suppress or ignore irrelevant thoughts and actions than young adults are. This hypothesis has been investigated in a large number of studies. We conducted a meta-analysis to determine whether there is an inhibition deficit in older age and whether this deficit is general or task-specific. We selected 176 studies in which young and older adults were tested on tasks commonly assumed to measure inhibition (i.e., the color Stroop, flanker, Simon, stop-signal, go/no-go, global–local, positive and negative compatibility tasks, as well as the paradigm assessing n-2 repetition costs in task switching). For most tasks (i.e., the color Stroop, flanker, and local tasks, as well as the n-2 repetition costs), the results speak against an inhibition deficit in older age. Only in a few tasks (i.e., the go/no-go and stop-signal tasks), older adults showed impaired inhibition. Moreover, for four tasks (i.e., the Simon, global, positive and negative compatibility tasks), the results suggest that more studies are necessary to draw a firm conclusion. Together, the present findings call into question the hypothesis of a general inhibition deficit in older age.