In the past few years, a second phase of biomedical ethics in Japan has begun to surface with a succession of governmental guidelines and laws regulating biomedical technology. Although this rush of guidelines exemplifies a heightened awareness concerning ethical standards for healthcare research, it also invites several practical, political, and procedural problems.

Science is an activity of the human intellect and as such has ethical implications that should be reviewed and taken into account. Although science and ethics have conventionally been considered different, it is herewith proposed that they are essentially similar. The proposal set henceforth is to create a new ethics rooted in science: scientific ethics. Science has firm axiological foundations and searches for truth and knowledge. Hence, science cannot be value neutral. Looking at standard scientific principles, it (...) is possible to construct a scientific ethic, which can be applied to all sciences. These intellectual standards include the search for truth, human dignity and respect for life. Through these it is thence achievable to draft a foundation of a ethics based purely on science and applicable beyond the confines of science. A few applications of these will be presented. Scientific ethics can have vast applications in other fields even in non scientific ones. (shrink)

This research explores the perspectives of academic physicists from three national contexts concerning their roles and responsibilities within the realm of science. Using a dataset comprised of 211 interviews with scientists working in China, the United States, and the United Kingdom, the study seeks to explain whether and in what manner physicists conceptualize scientific ethics within a global or national framework. The empirical findings bring to light disparities across nations in the physicists’ perceptions of what constitutes responsible mentorship and (...) engagement in public service. These cross-national variations underscore the moral agency of physicists as they navigate the ethical standards embraced by the global scientific community vis-à-vis those that are specific to their respective national contexts. The study’s empirical insights may carry significant implications for both policymakers and ethicists, underscoring the imperative of soliciting and acknowledging the perspectives of academic scientists working and living in disparate national contexts when formulating comprehensive science ethics frameworks. Such inclusive and context-aware approaches to shaping ethics in science can contribute to the cultivation of a more robust and universally relevant ethical foundation for the scientific community. (shrink)

Recital 33 GDPR has often been interpreted as referring to ‘broad consent’. This version of informed consent was intended to allow data subjects to provide their consent for certain areas of research, or parts of research projects, conditional to the research being in line with ‘recognised ethical standards’. In this article, we argue that broad consent is applicable in the emerging field of Computational Social Science (CSS), which lies at the intersection of data science and social science. However, (...) the lack of recognised ethical standards specific to CSS poses a practical barrier to the use of broad consent in this field and other fields that lack recognised ethical standards. Upon examining existing research ethics standards in social science and data science, we argue that they are insufficient for CSS. We further contend that the fragmentation of European Union (EU) law and research ethics sources makes it challenging to establish universally recognised ethical standards for scientific research. As a result, CSS researchers and other researchers in emerging fields that lack recognised ethical standards are left without sufficient guidance on the use of broad consent as provided for in the GDPR. We conclude that responsible EU bodies should provide additional guidance to facilitate the use of broad consent in CSS research. (shrink)

Conducting marine mammal research can raise several important ethical issues. For example, the continuation of whaling for commercial purposes despite the international moratorium provides opportunities for scientists to obtain data and tissue samples. In 2021 we analysed 35 peer-reviewed papers reporting research based on collaborations with Icelandic whalers. Results highlighted little consideration or understanding of the legal and ethical issues associated with the deliberate killing of whales amongst those researchers, funding bodies, universities and journals involved. Ethical statements (...) were rarely provided. Those that were written were incomplete. Whilst research using whaling data may seem acceptable to some, it often becomes hard to justify when subject to scrutiny by the media and the public. Thus, there is a particular danger of reputational harm for early career researchers who may become unwittingly involved in such activities. Here we also consider the broader variety of ethical issues raised by non-lethal research (both historical and recent) on marine mammals including tagging and biopsy. We discuss instances where study animals were harmed or even killed and where the public mistook tags for harpoons. Without clear guidelines, reviewers and journal editors are put in an impossible position when considering whether to reject papers on ethical grounds. We propose that for such studies, universities, funders, journals, and permit issuers must require ethical assessments and that journals more effectively implement their existing policies on publishing ethical statements. The professional marine mammal societies need to work together to produce modern ethical guidance. Such guidance should require transparency in the provenance of data and samples while including advice on law, welfare issues, involvement of local scientists, and offshoring. Furthermore, it should require appraisal of and justification for the absolute necessity of invasive procedures. As is already the case in biomedical disciplines, ethical statements should be required in marine mammal science. (shrink)

Research on human cadavers is an important mechanism of scientific progress and comprises a large industry in the United States. However, despite its importance and influence, there is little ethical or regulatory oversight of cadaver-based research. This lack of transparency raises important ethical questions. Thus, this paper serves as a call for ethicists and regulators to pay increased attention to cadaver research. I argue that cadaver research ought to be considered a subset of human subjects research and (...) held accountable to higher ethical standards. After describing current practices, I argue that oversight of cadaver research as a form of human subjects research is appropriate because cadaver research is similar to other types of human research, participants in cadaver research incur risks of harm, and a current lack of oversight has allowed the cadaver industry to entice research participation through ethically questionable practices. This paper urges greater dialogue among human subjects research ethicists and regulators about what constitutes appropriate protections for participants in cadaver research. (shrink)

Ethics codes of a number of scientific societies across different disciplines promulgate ethical standards for responsible conduct in research and other professional activities. The content of these codes of ethics are compared on key dimensions of research, service or practice, and teaching in terms of the range and specificity of the activities these codes cover, and in the degree to which they are educational, aspirational or regulatory in purpose. The role of professional associations in educating, regulating, monitoring, (...) and sanctioning their membership is also discussed. (shrink)

The aim of the article is to answer the question of the importance of legal education in ensuring legal ethics and the moral compass of a person by understanding the most important aspects of it. Methods applied include theoretical-scientific analysis, systematic and critical review of scientific literature and other relevant sources, normative and critical analysis of ethical principles in the context of legal education, empirical-quantitative and qualitative analysis of scholarly articles. According to the main thesis of this (...) article, the integration of ethics into legal education can enhance moral development of future lawyers and improve their ability to serve justice. This paper traces the historical neglect of ethics in legal education and argues for its central place in modern studies. For lawyers to serve justice, a well-defined moral compass is essential. Several conclusions are drawn in this article, and first of all it is believed that universities will have to realise that a good lawyer is not only a professionally competent lawyer, because that is not enough in today’s world. Even if it is a personal journey, universities cannot stand aside, the future lawyer must be helped to grow. What is much more important is not so much the codes of ethics but how our moral compass works and what path it can point us down. To avoid getting lost, law schools could teach future lawyers how to empower their moral compass and find their way around. Each law teacher should have to find ways to teach the key virtues of a lawyer’s moral compass (e.g., wisdom, fortitude, temperance, and justice), how to help law students grow and not burn out in difficult situations. As our empirical research shows, the best scholarly articles on legal education discuss the elements of legal ethics. It is recognised that the ethics of lawyers is increasingly becoming an issue that goes beyond the professional aspects, and it is the university that must contribute to the development of the moral compass. (shrink)

The paper reports two studies exploring the relationship between scholars’ self-reported publication pressure and their self-reported scientific misconduct in research. In Study 1 the participants ( N = 423) were scholars representing various disciplines from one big university in Poland. In Study 2 the participants ( N = 31) were exclusively members of the management, such as dean, director, etc. from the same university. In Study 1 the most common reported form of scientific misconduct was honorary authorship. The (...) majority of researchers (71%) reported that they had not violated ethical standards in the past; 3% admitted to scientific misconduct; 51% reported being were aware of colleagues’ scientific misconduct. A small positive correlation between perceived publication pressure and intention to engage in scientific misconduct in the future was found. In Study 2 more than half of the management (52%) reported being aware of researchers’ dishonest practices, the most frequent one of these being honorary authorship. As many as 71% of the participants report observing publication pressure in their subordinates. The primary conclusions are: (1) most scholars are convinced of their morality and predict that they will behave morally in the future; (2) scientific misconduct, particularly minor offenses such as honorary authorship, is frequently observed both by researchers (particularly in their colleagues) and by their managers; (3) researchers experiencing publication pressure report a willingness to engage in scientific misconduct in the future. (shrink)

Scientists have the ability to influence policy in important ways through how they present their results. Surprisingly, existing codes of scientific ethics have little to say about such choices. I propose that we can arrive at a set of ethical guidelines to govern scientists’ presentation of information to policymakers by looking to bioethics: roughly, just as a clinician should aim to promote informed decision-making by patients, a scientist should aim to promote informed decision-making by policymakers. Though this may (...) sound like a natural proposal, I show it offers guidance that conflicts with standard scientific practices. I conclude by considering one cost of the proposal: that it would prevent scientists from acting as advocates in a way that is currently common in certain fields. I accept that the proposal would restrict scientists’ political advocacy rights, but argue that the benefits of adopting it — promoting democratic governance — justify the restriction. (shrink)

There is considerable interest in the use of neuroimaging techniques for forensic purposes. Memory detection techniques, including the well-publicized Brain Fingerprinting technique (Brain Fingerprinting Laboratories, Inc., Seattle WA), exploit the fact that the brain responds differently to sensory stimuli to which it has been exposed before. When a stimulus is specifically associated with a crime, the resulting brain activity should differentiate between someone who was present at the crime and someone who was not. This article reviews the scientific literature (...) on three such techniques: priming, old/new, and P300 effects. The forensic potential of these techniques is evaluated based on four criteria: specificity, automaticity, encoding flexibility, and longevity. This article concludes that none of the techniques are devoid of forensic potential, although much research is yet to be done. Ethical issues, including rights to privacy and against self-incrimination, are discussed. A discussion of legal issues concludes that current memory detection techniques do not yet meet United States standards of legal admissibility. (shrink)

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's body of regulations, and information sheets by the Department (...) of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”. (shrink)

Teaching of responsible conduct of research is largely predicated on the assumption that there are accepted standards of conduct that can be taught. However there is little evidence of consensus in the scientific community about such standards, at least for the practices of authorship, collaboration, and data management. To assess whether such differences in standards are based on disciplinary differences, a survey, described previously, addressing standards, practices, and perceptions about teaching and learning was distributed in (...) November 2010 to US faculty from 50 graduate programs for the biomedical disciplines of microbiology, neuroscience, nursing, and psychology. Despite evidence of statistically significant differences across the four disciplines, actual differences were quite small. Stricter measures of effect size indicated practically significant disciplinary differences for fewer than 10 % of the questions. This suggests that the variation in individual standards of practice within each discipline is at least as great as variation due to differences among disciplines. Therefore, the need for discipline-specific training may not be as important as sometimes thought. (shrink)

In medical practice and research it is necessary to consider the rights of the researcher or physician and of the subject or patient, to conform to scientific standards and to examine the appropriateness with respect to laws and moral values. Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research on human subjects. Research of no scientific value is also against ethical principles. To obtain (...) valid and reliable results from biomedical research, it is a scientific and ethical obligation to make use of the science of statistics. Therefore, for research to be evaluated using biostatistics intensively from ethical and scientific points of view, a biostatistics expert is necessary on research ethics committees. Developments in Turkey are used as examples. (shrink)

Evidence suggests that psychedelics bring about their therapeutic outcomes in part through the subjective or qualitative effects they engender and how the individual interprets the resulting experiences. However, psychedelics are contraindicated for individuals who have been diagnosed with certain mental illnesses, on the grounds that these subjective effects may be disturbing or otherwise counter-therapeutic. Substantial resources are therefore currently being devoted to creating psychedelic substances that produce many of the same biological changes as psychedelics, but without their characteristic subjective effects. (...) In this article, we consider ethical issues arising from the prospect of such potential “nonsubjective” psychedelics. We are broadly supportive of efforts to produce such substances for both scientific and clinical reasons. However, we argue that such nonsubjective psychedelics should be reserved for those special cases in which the subjective effects of psychedelics are specifically contraindicated, whereas classic psychedelics that affect subjective experience should be considered the default and standard of care. After reviewing evidence regarding the subjective effects of psychedelics, we raise a number of ethical concerns around the prospect of withholding such typically positive, meaningful, and therapeutic experiences from most patients. (shrink)

The practice of research is full of ethical challenges, many of which might be addressed through the teaching of responsible conduct of research . Although such training is increasingly required, there is no clear consensus about either the goals or content of an RCR curriculum. The present study was designed to assess community standards in three domains of research practice: authorship, collaboration, and data management. A survey, developed through advice from content matter experts, focus groups, and interviews, was (...) distributed in November 2010 to U.S. faculty from 50 graduate programs for each of four different disciplines: microbiology, neuroscience, nursing, and psychology. The survey addressed practices and perceived standards, as well as perceptions about teaching and learning. Over 1,300 responses yielded statistically significant differences in responses to nearly all questions. However the magnitude of these differences was typically small, leaving little reason to argue for community consensus on standards. For nearly all questions asked, the clear finding was that there was nothing approaching consensus. These results may be useful not so much to teach what the standards are, but to increase student awareness of the diversity of those standards in reported practice. (shrink)

How can the history of research ethics be expanded beyond the standard narrative of codification—a story that does not reach back beyond World War II—without becoming so broad as to lose all distinctiveness? This article proposes a history of research ethics focused on the “scientific self,” that is, the role-specific identity of scientists as typically described in terms of skills, competencies, qualities, or dispositions. Drawing on three agenda-setting texts from nineteenth-century history, biology, and sociology, the article argues that the (...) “revolutions” these books sought to unleash were, among other things, revolts against inherited conceptions of scientific selfhood. They tried to redefine the scientific self in their respective fields of inquiry by advocating particular catalogs of virtues or character traits. These ideals of selfhood, their contested nature notwithstanding, translated into practice in so far as they influenced hiring and selection policies and found their way into educational systems. The project of reclaiming the scientific self as an important subject of study in the history of research ethics is not an antiquarian pursuit, but related to an ethical question faced by scientists today: How are their scientific selves being shaped by funding schemes, research evaluation protocols, and academic hiring policies? (shrink)

BackgroundThis paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs’ service to the subject of the clinical trial.MethodsWe retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by (...) REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC’s files and electronic archives.ResultsAlmost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval.ConclusionsPreventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials’ final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits. (shrink)

The Joint Research Centre (JRC) is the European Commission’s in-house science and knowledge service, employing a substantial staff of scientists devoted to conducting research to provide independent scientific advice for EU policy. Focussed on various research areas aligned with EU priorities, the JRC excels in delivering scientific evidence for policymaking and has published numerous science-for-policy reports and scientific articles. Drawing on a scientific integrity statement, surveys among JRC’s research staff, and thematic discussions with JRC’s research leaders, (...) the JRC has developed a comprehensive Scientific Integrity and Research Ethics (SIRE) framework, including instruments, procedures, and guidelines to ensure high standards and independence in its research. Key components of the SIRE framework include a Scientific Integrity Officer, an Editorial Review Board, a Research Ethics Board, and guidelines for responsible conduct of research. This article provides an overview of the JRC’s SIRE framework and how it was developed, emphasising the importance of maintaining independence, integrity, and ethics in scientific research that supports EU policy. The article also discusses potential gaps in the framework and where additional efforts may be needed, comparing with the recent U.S. National Science and Technology Council report on Protecting the Integrity of Government Science. (shrink)

Results of studies that cast doubt on the safety of genetically modified crops have been published since the first GM crop approval for commercial release. These ‘alarming studies’ challenge the dominant view about the adequacy of current risk assessment practice for genetically modified organisms. Subsequent debates follow a similar and recurring pattern, in which those involved cannot agree on the significance of the results and the attached consequences. The standard response from the government—a reassessment by scientific advisory bodies—seems insufficient (...) to bring the debate to a satisfactory closure. The recurrence of the same debate every time an alarming study is published shows that science alone cannot solve the problem. We believe that further analysis is needed to investigate if and how we can prevent this repetitive cycle that creates frustration amongst all stakeholders. In this paper, we analyse the dynamics behind discussions which occur following alarming studies. We will use a selection of representative alarming GMO case studies to underpin our claim that it is likely that there will be a permanent difference in view of opinion that cannot be solved with more data or new facts. The current strategy of more research is a pitfall that is unlikely to solve this issue. Instead, the focus of the GM crop discussion should shift towards managing permanent different viewpoints and providing a platform for a broader conversation on agriculture and food production. (shrink)

Scientific societies can have a powerful influence on the professional lives of scientists. Using this influence, they have a responsibility to make long-term commitments and investments in promoting integrity in publication, just as in other areas of research ethics. Concepts that can inform the thinking and activities of scientific societies with regard to publication ethics are: the “hidden curriculum” (the message of actions rather than formal statements), a fresh look at the components of acting with integrity, deviancy as (...) a normally occurring phenomenon in human society, and the scientific community as an actual community. A society’s first step is to decide what values it will promote, within the framework of present-day standards of good conduct of science and given the society’s history and traditions. The society then must create educational programs that serve members across their careers. Scientific societies must take seriously the implications of the problem; set policies and standards for publication ethics for their members; educate about and enforce the standards; bring the issues before the members early and often; and maintain continuing dialogue with editors. (shrink)

Formalizing shared ethical standards is an activity of scientific societies designed to achieve a collective goal of promoting ethical conduct. A scientist who is faced with the choice of becoming a “whistleblower” by exposing misconduct does so in the context of these ethical standards. Examination of ethics policies of scientific societies which are members of the Council of Scientific Society Presidents (CSSP) shows a breadth of purpose and scope in these policies. Among (...) the CSSP member societies, some ethics policies chiefly present the ethical culture of the community in an educational context and do not have enforcement procedures. Other policies are more comprehensive and include standards for certification, procedures for addressing ethical issues, and established sanctions. Of the 36 member societies of CSSP that have developed a code or adopted a code of another professional society, 18 specifically identified a responsibility to expose ethical misconduct, demonstrating an acknowledgment of the possible critical role of the whistleblower in addressing ethical issues. Scientific societies may revise their ethics codes based upon experience gained in addressing cases of ethical misconduct. In most cases, the action of a whistleblower is the initial step in addressing an ethics violation; the whistleblower may either be in the position of an observer or a victim, such as in the case of someone who discovers that his or her own work has been plagiarized. The ethics committee of a scientific society is one of several possible outlets through which the whistleblower can voice a complaint or concern. Ethical violations can include falsification, fabrication, plagiarism and other authorship disputes, conflict of interest and other serious violations. Commonly, some of these violations may involve publication in the scientific literature. Thus addressing ethical issues may be intertwined with a scientific society’s role in the dissemination of new scientific results. For a journal published by a scientific society, the editor can refer at some point to the ethics committee of the society. Whereas, in the case of a journal published by a commercial publisher, the editor may be without direct support of the associated scientific community in handling the case. The association of a journal with a scientific society may thus direct a whistleblower towards addressing the issue within the scientific community rather than involving the press or talking to colleagues who may gossip. A formal procedure for handling ethics cases may also discourage false accusers. Another advantage of handling complaints through ethics committees is that decisions to contact home institutions or funding agencies can be made by the ethics committee and are not the responsibility of the whistleblower or the editor of the journal. The general assessment is that the establishment of ethics policies, especially policies covering publication in society journals, will promote a culture supportive of whistleblowers and discouraging to false accusers. (shrink)

The aim of the article is to explain the relationship between the ethical evaluation of scientific research involving personal data and the assessment of compliance with data protection law. The article presents the mutual relationship between the protection of personal data and scientific activity from a dogmatic perspective, the legal regulation of the processing of personal data in scientific research, and the so-called research exceptions that apply when data are processed for scientific research. It also (...) covers the importance of meeting the ethical requirements of scientific research in order to profit from the indicated exceptions. Finally, it provides a comparison between the ethical and the legal systems of personal data protection in research (objectives, criteria, authorities, and procedures). (shrink)

Results of studies that cast doubt on the safety of genetically modified crops have been published since the first GM crop approval for commercial release. These ‘alarming studies’ challenge the dominant view about the adequacy of current risk assessment practice for genetically modified organisms. Subsequent debates follow a similar and recurring pattern, in which those involved cannot agree on the significance of the results and the attached consequences. The standard response from the government—a reassessment by scientific advisory bodies—seems insufficient (...) to bring the debate to a satisfactory closure. The recurrence of the same debate every time an alarming study is published shows that science alone cannot solve the problem. We believe that further analysis is needed to investigate if and how we can prevent this repetitive cycle that creates frustration amongst all stakeholders. In this paper, we analyse the dynamics behind discussions which occur following alarming studies. We will use a selection of representative alarming GMO case studies to underpin our claim that it is likely that there will be a permanent difference in view of opinion that cannot be solved with more data or new facts. The current strategy of more research is a pitfall that is unlikely to solve this issue. Instead, the focus of the GM crop discussion should shift towards managing permanent different viewpoints and providing a platform for a broader conversation on agriculture and food production. (shrink)

This article discusses the possibilities and pitfalls of constructing a code of ethics for university professors. Professional, educational, legal, and policy questions regarding the goals, format, and content of an academic ethics code are raised and a series of aspirational principles and enforceable standards that might be included in such a document are presented for discussion and debate.

A Scientific Integrity Consortium developed a set of recommended principles and best practices that can be used broadly across scientific disciplines as a mechanism for consensus on scientific integrity standards and to better equip scientists to operate in a rapidly changing research environment. The two principles that represent the umbrella under which scientific processes should operate are as follows: Foster a culture of integrity in the scientific process. Evidence-based policy interests may have legitimate roles (...) to play in influencing aspects of the research process, but those roles should not interfere with scientific integrity. The nine best practices for instilling scientific integrity in the implementation of these two overarching principles are Require universal training in robust scientific methods, in the use of appropriate experimental design and statistics, and in responsible research practices for scientists at all levels, with the training content regularly updated and presented by qualified scientists. Strengthen scientific integrity oversight and processes throughout the research continuum with a focus on training in ethics and conduct. Encourage reproducibility of research through transparency. Strive to establish open science as the standard operating procedure throughout the scientific enterprise. Develop and implement educational tools to teach communication skills that uphold scientific integrity. Strive to identify ways to further strengthen the peer review process. Encourage scientific journals to publish unanticipated findings that meet standards of quality and scientific integrity. Seek harmonization and implementation among journals of rapid, consistent, and transparent processes for correction and/or retraction of published papers. Design rigorous and comprehensive evaluation criteria that recognize and reward the highest standards of integrity in scientific research. (shrink)

Scientific misconduct can jeopardize scientific progress and destroy the credibility and reputation of academic institutions and their faculty and students; ultimately it can compromise scientific integrity and result in a loss of confidence for the entire scientific community. Only recently in Japan has scientific misconduct become a central public topic. This increased attention to the topic, in turn, has highlighted a paucity of ethical standards within the Japanese scientific community and a lack (...) of an apt process for conflict resolution. In this brief report, we first provide an overview of several high-profile cases of scientific misconduct recently uncovered in Japan. Next we consider how a recent rise in competition within the academic and scientific communities is possibly related to a concurrent increase in reported cases of scientific misconduct. Last, after discussing what actions have already been taken, we recommend further actions needed to deal with the problem of scientific misconduct in Japan. (shrink)

Multiple authorship is the universal solution to multi-tasking in the sciences. Without a team, each with their own set of expertise, and each involved mostly in complementary ways, a research project will likely not advance quickly, or effectively. Consequently, there is a risk that research goals will not be met within a desired timeframe. Research teams that strictly scrutinize their modus operandi select and include a set of authors that have participated substantially in the physical undertaking of the research, in (...) its planning, or who have contributed intellectually to the ideas or the development of the manuscript. Authorship is not an issue that is taken lightly, and save for dishonest authors, it is an issue that is decided collectively by the authors, usually in sync with codes of conduct established by their research institutes or national ministries of education. Science, technology and medicine publishers have, through independent, or sometimes coordinated efforts, also established their own sets of guidelines regarding what constitutes valid authorship. However, these are, for the greater part, merely guidelines. A previous and recent analysis of authorship definitions indicates that the definitions in place regarding authorship and its validity by many leading STM publishers is neither uniform, nor standard, despite several of them claiming to follow the guidelines as set forward by the International Committee of Medical Journal Editors or ICMJE. This disparity extends itself to ghost and guest authorship, two key authorship-related issues that are examined in this paper to assess the extent of discrepancies among the same set of STM publishers and what possible influence they might have on publishing ethics. (shrink)

There are widely held premises that suicide is almost exclusively the result of mental illness and there is “strong evidence for successfully detecting and managing suicidality in healthcare”. In this context, ‘zero-suicide’ policies have emerged, and suicide risk assessment tools have become a normative component of psychiatric practice. This essay discusses how suicide evolved from a moral to a medical problem and how, in an effort to reduce suicide, a paternalistic healthcare response emerged to predict those at high risk. The (...) evidence for the premises is critiqued and shown to be problematic; and it is found that strong paternalistic interventions are being used more often than acknowledged. Using a Principles approach, the ethics of overriding autonomy in suicide prevention is considered. Ethical concerns are identified with the current approach which are potentially amplified by the use of these risk assessments. Furthermore, it is identified that the widespread use of risk assessments in health settings is equivalent to screening without regard to the ethical principles of screening. The essay concludes that this is unethical; that we should abandon the use of standardized suicide risk assessments and ‘zero-suicide’ policy; and that this may improve outcomes. (shrink)

This article summarizes the recommendations concerning robotics as issued by the Commission for the Ethics of Research in Information Sciences and Technologies (CERNA), the French advisory commission for the ethics of information and communication technology (ICT) research. Robotics has numerous applications in which its role can be overwhelming and may lead to unexpected consequences. In this rapidly evolving technological environment, CERNA does not set novel ethical standards but seeks to make ethical deliberation inseparable from scientific activity. (...) Additionally, it provides tools and guidance for researchers and research institutions. (shrink)

The Hwang affair, a dramatic and far reaching instance of scientific fraud, shocked the world. This collective national failure prompted various organizations in Korea, including universities, regulatory agencies, and research associations, to engage in self-criticism and research ethics reforms. This paper aims, first, to document and review research misconduct perpetrated by Hwang and members of his research team, with particular attention to the agencies that failed to regulate and then supervise Hwang’s research. The paper then examines the research ethics (...) reforms introduced in the wake of this international scandal. After reviewing American and European research governance structures and policies, policy makers developed a mixed model mindful of its Korean context. The third part of the paper examines how research ethics reform is proactive (a response to shocking scientific misconduct and ensuing external criticism from the press and society) as well as reactive (identification of and adherence to national or international ethics standards). The last part deals with Korean society’s response to the Hwang affair, which had the effect of a moral atomic bomb and has led to broad ethical reform in Korean society. We conceptualize this change as ethical modernization, through which the Korean public corrects the failures of a growth-oriented economic model for social progress, and attempts to create a more trustworthy and ethical society. (shrink)

Many journals in the physical sciences require authors to submit assurances of compliance with human subjects and other research ethics standards. These requirements do not cover all disciplines equally, however. In this paper we report on the findings of a survey of perceptions of ethical and managerial problems from journal editors in political science and related disciplines. Our results show that few journals in political science require assurance statements common to journals for other scientific disciplines. We offer (...) some reasons for this as well as some recommendations for implementing ethical assurance safeguards for political science. (shrink)

Background Ethical and scientific principles require that clinical trials address an important question and have the resources needed to complete the study. However, there are no clear standards for review that would ensure that these principles are upheld.Methods We conducted semi-structured interviews with a convenience sample of nineteen experts in clinical trial design, conduct, and/or oversight to elucidate current practice and identify areas of need with respect to ensuring the scientific value and feasibility of clinical trials (...) prior to initiation and while ongoing. We used a priori and grounded theory to analyze the data and constant comparative method to induce higher order themes.Results Interviewees perceived determination of scientific value as the responsibility of the investigator and, secondarily, other parties who review or oversee research. Interviewees reported that ongoing trials are rarely reevaluated due to emerging evidence from external sources, evaluation is complex, and there would be value in the development of standards for monitoring and evaluating evidence systematically. Investigators, IRBs, and/or data monitoring committees (DMCs) could undertake these responsibilities. Feasibility assessments are performed but are typically inadequate; potential solutions are unclear.Conclusions There are three domains where current approaches are suboptimal and in which further guidance is needed. First, who has the responsibility for conducting scientific review, whether it be the investigator, IRB, and/or DMC is often unclear. Second, the standards for scientific review (e.g., appropriate search terms, data sources, and analytic plan) should be defined. Third, guidance is needed on the evaluation of ongoing studies in light of potentially new and evolving evidence, with particular reference to evidence from outside the trial itself. (shrink)

Both human research and animal research operate within established standards and procedures. Although the human research environment has been criticized for its sometimes inefficient and imperfect process, reported abuses of human subjects in research served as the impetus for the establishment of the Nuremberg Code, Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the resulting Belmont Report. No similar, comprehensive and principled effort has addressed the use of animals (...) in research. Although published policies regarding animal research provide relevant regulatory guidance, these policies have not emerged from the process of specifying consistent and reasoned ethical principles. The lack of a fundamental effort to explore the ethical issues and principles regarding the use of animals in research has led to unclear and disparate policies. Recent studies have increased our understanding of animal cognition and emotion, suggesting that animals' potential for experiencing a wide variety of harms, such as pain and fear, is greater than has been previously appreciated. Furthermore, relationships between methods of captivity and certain laboratory procedures and the resulting adverse physical, social and psychological effects have been established. In light of this information, current protections may need to be reconsidered and modified. This paper explores the historical convergence and divergence in the creation of human and animal research guidelines, as well as opportunities to align ethical frameworks with new scientific discoveries. (shrink)

COVID-19 is compromising all aspects of society, with devastating impacts on health, political, social, economic and educational spheres. A premium is being placed on scientific research as the source of possible solutions, with a situational imperative to carry out investigations at an accelerated rate. There is a major challenge not to neglect ethical standards, in a context where doing so may mean the difference between life and death. In this paper we offer a rubric for considering the (...) ethical challenges in COVID-19 related research, in the form of an ethics toolkit for global research developed at the University of Edinburgh in collaboration with more than 200 global researchers from around the world. This toolkit provides a framework to support confrontation of ethical conflicts through the integrated and iterative analysis of Place, People, Principles and Precedents, throughout the research journey. Two case analyses are offered to exemplify the utility of the toolkit as a flexible and dynamic tool to promote ethical research in the context of COVID-19. (shrink)

Ethics and Values in Psychotherapy examines the ways in which the ethical convictions of both therapist and client contribute to the practical process of psychotherapy. Practitioners are increasingly focusing on the issue of their extensive--and often problematic--ethical influence on clients as they attempt to agree on guidelines and standards for professional practice. Alan C. Tjeltveit argues that any discussion of ethical practice in psychotherapy must be carried out in connection with traditional ethical theories. The author (...) draws on scientific, clinical, and philosophical approaches to address issues such as: the role of therapy in society; the goals and outcomes of psychotherapy; techniques and practices; the existence and operation of values; and the intellectual and social context in which therapy takes place. This comprehensive study is a significant contribution to the debate on the ethical character of psychotherapy. (shrink)

Revised to reflect the current status of scientific and professional theory, practices, and debate across all facets of ethical decision making, this latest edition of Celia B. Fisher's acclaimed book demystifies the American Psychological Association's (APA) Ethical Principles of Psychologists and Code of Conduct. The Fifth Edition explains and puts into practical perspective the format, choice of wording, aspirational principles, and enforceability of the code. Providing in-depth discussions of the foundation and application of each ethical standard (...) to the broad spectrum of scientific, teaching, and professional roles of psychologists, this unique guide helps practitioners effectively use ethical principles and standards to morally conduct their work activities, avoid ethical violations, and, most importantly, preserve and protect the fundamental rights and welfare of those whom they serve. This edition retains and expands upon the critical content of the previous editions to help readers apply the Ethics Code to contemporary social issues in the conduct of responsible psychological science and practice. (shrink)

BackgroundClinical ethics consultations can be complex interventions, involving multiple methods, stakeholders, and competing ethical values. Despite longstanding calls for rigorous evaluation in the field, progress has been limited. The Medical Research Council proposed guidelines for evaluating the effectiveness of complex interventions. The evaluation of CEC may benefit from application of the MRC framework to advance the transparency and methodological rigor of this field. A first step is to understand the outcomes measured in evaluations of CEC in healthcare settings. ObjectiveThe (...) primary objective of this review was to identify and map the outcomes reported in primary studies of CEC. The secondary objective was to provide a comprehensive overview of CEC structures, processes, and roles to enhance understanding and to inform standardization.MethodsWe searched electronic databases to identify primary studies of CEC involving patients, substitute decision-makers and/or family members, clinicians, healthcare staff and leaders. Outcomes were mapped across five conceptual domains as identified a priori based on our clinical ethics experience and preliminary literature searches and revised based on our emerging interpretation of the data. These domains included personal factors, process factors, clinical factors, quality, and resource factors. ResultsForty-eight studies were included in the review. Studies were highly heterogeneous and varied considerably regarding format and process of ethical intervention, credentials of interventionist, population of study, outcomes reported, and measures employed. In addition, few studies used validated measurement tools. The top three outcome domains that studies reported on were quality, process factors, and clinical factors. The majority of studies examined multiple outcome domains. All five outcome domains were multidimensional and included a variety of subthemes.ConclusionsThis scoping review represents the initial phase of mapping the outcomes reported in primary studies of CEC and identifying gaps in the evidence. The confirmed lack of standardization represents a hindrance to the provision of high quality intervention and CEC scientific progress. Insights gained can inform the development of a core outcome set to standardize outcome measures in CEC evaluation research and enable scientifically rigorous efficacy trials of CEC. (shrink)

Science education is generally perceived as a key facilitator in cultivating a scientifically literate society. In the last decade, however, this conventional wisdom has been challenged by evidence that greater scientific literacy and critical thinking skills may in fact inadvertently aggravate polarization on scientific matters in the public sphere. Supporting an alternative “scientific update hypothesis,” in a series of studies (total N = 2087), we show that increased science’s epistemology literacy might have consequential population-level effects on the (...) public’s alignment with scientific results. In one exploratory study and a pre-registered national online survey, we first show that understanding scientific epistemology predicts refusal of pseudoscientific beliefs and higher scores in a methodology of science test. We also find and replicate a propensity for epistemologically literate citizens to endorse the norm of belief updating and the communicated scientific consensus following both ideologically congruent and incongruent scientific results. Notably, after 2 months of first being presented with scientific results on politically controversial issues, a one standard deviation higher score in epistemological literacy is associated with a 14% increase in the odds of individuals switching their beliefs to align with the scientifically communicated consensus. We close by discussing how, on the face of ideological incongruity, a general understanding of scientific epistemology might foster the acceptance of scientific results, and we underscore the need for a more nuanced appreciation of how education, public comprehension of scientific knowledge, and the dynamics of polarization intersect in the public sphere. (shrink)

Even though the 3Rs are widely accepted as ethical standards when evaluating research projects using animals as experimental subjects, the ethical status of the 3Rs still remains to be clarified. The 3Rs were not derived from any ethical theory, but they represented an attempt to increase humanity to animal experimentation and at the same time to improve validity of scientific data . The aim of the present article was to provide an ethical analysis of (...) the 3Rs through Engelhardt's bioethics theory . The analysis revealed the 3Rs fitted to some extent Engelhardt ethical values. But the analysis also revealed some internal contradictions between the 3Rs and Engelhardt's ethical vaules. Although the 3Rs are still valuable tools in animal ethical evaluation, the present analysis suggests that some ethical issues still remain to be clarified. (shrink)

Fundamental questions in value sensitive design include whether and how high-tech products/artefacts could embody values and ethical ideals, and how plural and incommensurable values of ethical and social importance could be chosen rationally and objectively at a collective level. By using a humanitarian cargo drone study as a starting point, this paper tackles the challenges that VSD’s lack of commitment to a specific ethical theory generates in practical applications. Besides, it highlights how mainstream ethical approaches usually (...) related to VSD are incapable of solving main ethical dilemmas raised by technological design for well-being in democratic settings. Accordingly, it is argued that VSD’s ethical-democratic import would substantially be enhanced by the espousal of a procedural ethics stance and the deliberative approach to value and welfare entailed by Amartya Sen’s capability approach. Differently from rival ethical–political theories, its normative and meta-ethical foundations better handle human diversity, value-goal pluralism, conflicting vested interests as well as the epistemic-moral disagreements typical of contemporary complex democracies. Particularly, Sen’s capability approach procedural-deliberative tenets result in an “objective-impartial” choice procedure selecting a “hierarchy” of plural incommensurable values and rational goals thus, suitable to validate an applied science such as welfare-oriented technological design in concrete social environments. Conclusions suggest that refining VSD with a capability-based procedural approach to ethics fosters the concern for democracy and social justice while preserving vital scientific-technical standards. Major advantages are at an applied level to delivering ethically and socially justified, but yet highly functional technologies and high-tech products/artefacts. (shrink)

Recognizing that students are fundamentally engaged in a process of learning and self-development, ethical review of sub-doctoral student research should be proportionate to that objective. A student's tutor has the pedagogical role and an ethics committee should not interfere with that relationship other than to seek to avoid harms unforeseen by either the student or tutor. Underpowered or other statistically or methodologically flawed sub-doctoral research should not however, in general, be regarded as ethically concerning. With the proviso that no (...) subject is harmed the student can be allowed to learn such lessons as their mistakes may afford them. (shrink)

ln the Netherlands, as in other Western countries, there is a great time lag between the evidence of the carcinogenicity of asbestos (1949) and the launching of first legislation that reduces the occupational exposure (1971) and finally, the complete ban of the production and application of asbestos (1993). So, between 1949 and 1970 there was a serious health risk while effective protective regulations were lacking. This implied a serious ethical dilemma for occupational health professionals: according to their code of (...) ethics, they ought to contribute to a safe and healthy working environment while companies are not strictly obliged to do so. This study explores retrospectively the position of health and safety professionals with regard to asbestos between 1930 and 1990; specifically with respect to the prevention of harmful health effects for exposed workers, which is a central value in their professional ethics. It turns out that the associations of safety and health professionals did not promulgate any position on the prevention of harm due to asbestos. Nor did the uncertainty about the health impact of asbestos obviously cause an ethical dilemma for individual professionals. Professionals were usually involved in discussions on diagnostic methods of asbestos exposure in the human body (X-ray or detection in sputum), the existence of safe limits, the scientific basis of risk assessment and effective prevention strategies. Only a single professional was seeking attention to the severe health risks and advocated for preventive action. (shrink)

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

A good deal has been written on the ethics of peer review, especially in the scientific and medical literatures. In contrast, we are unaware of any articles on the ethics of peer review in bioethics. Recognising this gap, we evaluate the extant proposals regarding ethical standards for peer review in general and consider how they apply to bioethics. We argue that scholars have an obligation to perform peer review based on the extent to which they personally benefit (...) from the peer review process. We also argue, contrary to existing proposals and guidelines, that it can be appropriate for peer reviewers to benefit in their own scholarship from the manuscripts they review. With respect to bioethics in particular, we endorse double-blind review and suggest several ways in which the peer review process might be improved. (shrink)

Clinical Study Agreements can have profound effects both on the protection of human subjects and on the independence of investigators to conduct research with scientific integrity. Sponsors, institutions, and even investigators may fail to give adequate attention to these issues in the negotiation of CSAs. Despite the key role of CSAs in structuring ethically important aspects of research, they remain largely unregulated and unreviewed for adherence to ethical norms. Academic institutions routinely enter into research contracts that fail to (...) meet adequate ethical standards. This is a failing that can have serious consequences.Accordingly, it is necessary that some independent body have the authority both to review research contracts for compliance with norms of subject protection and ethical integrity, and to reject studies that fail to meet ethical standards. Such review should take place prior to the start of research, not later. Because of its expertise and authority, the institutional ethics review board is the appropriate body to undertake such review. Much recent commentary has focused on contractual restrictions on the investigator’s freedom to publish research findings. The Olivieri experience, and that of other investigators, has brought freedom of publication issues into sharp focus. Clinical study agreements also raise a number of other ethical issues relating to human subjects and research integrity, however, including disclosures relating to patient safety, data analysis and reporting, budget, confidentiality, and premature termination of the study. This paper describes the ethical issues at stake in structuring such agreements and suggests ethical standards to guide institutional ethics review. (shrink)

When one wants to use citizen input to inform policy, what should the standards of informedness on the part of the citizens be? While there are moral reasons to allow every citizen to participate and have a voice on every issue, regardless of education and involvement, designers of participatory assessments have to make decisions about how to structure deliberations as well as how much background information and deliberation time to provide to participants. After assessing different frameworks for the relationship (...) between science and society, we use Philip Kitcher's framework of Well-Ordered Science to propose an epistemic standard on how citizen deliberations should be structured. We explore what potential standards follow from this epistemic framework focusing on significance versus scientific and engineering expertise. We argue that citizens should be tutored on the historical context of why scientific questions became significant and deemed scientifically and socially valuable, and if citizens report that they are capable of weighing in on an issue then they should be able to do so. We explore what this standard can mean by looking at actual citizen deliberations tied to the 2014 NASA ECAST Asteroid Initiative Citizen forums. We code different vignettes of citizens debating alternative approaches for Mars exploration based upon what level of information seemed to be sufficient for them to feel comfortable in making a policy position. The analysis provides recommendations on how to design and assess future citizen assessments grounded in properly conveying the historical value context surrounding a scientific issue and trusting citizens to seek out sufficient information to deliberate. (shrink)

Practical issues throughout scientific research can be found to have an ethical aspect. There is a gray area in which scientific error (“honest error”) may be difficult to distinguish from unacceptably poor research practice or an unethical failure to follow scientific norms. Further, there is no clear margin between deceptive practices which are widely accepted and those which must be considered fraudulent. Practical problems arise in matters of data management and presentation, authorship, publication practices, “grantsmanship”, and (...) rights of research trainees, as well as the well-recognized areas of human and animal experimentation. Beyond the gray areas, the legal definition of research misconduct is discussed in relation to research fraud, and the latest proposed definition of the Commission on Research Integrity is briefly reviewed. It is noted that the standards of ethical research are changing. Finally, there is a comment on the idea of institutional integrity in research, and the critical role of the mentor in transmitting research standards to the next generation. (shrink)

In the context of a public health emergency it is imperative to conduct research studies that will produce evidence rapidly while upholding ethical standards. The Ebola and Zika outbreaks highlighted the importance of devising agile processes for ethics review in emergencies, and international research ethics guidelines stress the duty to depart from standard processes for ethics review in emergency circumstances. However, before the COVID-19 pandemic it was not entirely clear what emergency procedures should look like. An additional challenge (...) is that while the same substantive ethical standards apply in emergency and non-emergency settings, deciding what these standards entail in the specific circumstances of a pandemic may be difficult. During the COVID-19 pandemic, challenges included identifying thresholds of social and scientific value, along with duties towards research participants, given the absence of therapeutic options; assessing continually changing risk–benefit profiles of studies, given rapidly emerging new evidence; developing appropriate informed consent processes, given lockdown scenarios; and even addressing the ethics of offering unproven interventions outside research settings. Additional issues raised during epidemics include devising feasible and meaningful community engagement strategies, mechanisms to ensure fairness in the distribution of the benefits that may result from research, and equitable and effective data-sharing plans that will inform pandemic response. Learning from these procedural and substantive challenges encountered in the ethics review of COVID-19 research is important for enhancing ethics preparedness for future emergencies. It can also potentially contribute to improving the ethics review of research in non-emergency circumstances. The seven cases in this chapter highlight ethical issues associated with ethics approval of multi-centre studies in pandemics, the need for careful consideration of the social and scientific value of research and challenges encountered when interventions are being transitioned from research to rollout, and issues that can arise when existing regulations and policies may limit capacities to appropriately adapt research to pandemic contexts. (shrink)