Objectives. To document the prevalence of ethical requirements in the instructions for authors of journals that published randomized clinical trials (RCTs) in 2005. Design. Using a validated computerized search strategy for retrieving abstracts of RCTs, we retrieved 13 184 references from 2056 journals. These journals were divided into journals that had published > 30 RCTs in 2005, and those that had published fewer. We included all the former and a random sample of the latter journals in the analysis. Measurements. (...) Coders retrieved the instructions for authors for each journal. The coders identified whether 15 ethical requirements were present in each of the instructions, calculated the age of the journal, and determined where it was published. Results. Only 51% of journals required that authors document review by an ethics committee, only 55% required declaration of conflicts of interest, and only 33% required documentation of informed consent. Overall, 48% of instructions required three or fewer of 15 ethics items. Journals publishing many RCTs each year had more ethical requirements (P <0.001), older journals had more requirements (P <0.012), as did journals published in the US (P <0.001). Journals published in Europe had fewer (P <0.001). However, in multiple regression analyses involving the journal's age, location of publication, and number of RCTs published, only publishing many RCTs was associated with having more ethical requirements (P <0.001). Conclusions. Many journals do not require important elements of research ethics in their instructions for authors. Ethical requirements are less common in the many journals that publish few clinical trials each year, journals that have often been overlooked in prior studies of journal ethics. Keywords: Randomized clinical trials, ethical instructions, publication ethics, journal requirements. (shrink)

Bioethics, Volume 36, Issue 2, Page 162-169, February 2022.

The purpose of this article is to show that animal rights are not necessarily at odds with the use of animals for research. If animals hold basic moral rights similar to those of humans, then we should consequently extend the ethical requirements guiding research with humans to research with animals. The article spells out how this can be done in practice by applying the seven requirements for ethical research with humans proposed by Ezekiel Emanuel, David Wendler and Christine (...) Grady to animal research. These requirements are i) social value, ii) scientific validity, iii) independent review, iv) fair subject selection, v) favorable risk-benefit ratio, vi) informed consent, and vii) respect for research subjects. In practice, this means that we must reform the practice of animal research to make it more similar to research with humans, rather than completely abolish the former. Indeed, if we banned animal research altogether, then we would also deprive animals of its potential benefits – which would be ethically problematic. (shrink)

Since aesthetic experience is vital for the protection of nature, I address the relationship between environmental aesthetics and environmentalism. I first review two traditional positions, the picturesque approach and formalism. Some environmentalists fault the modes of aesthetic appreciation associated with these views, charging they are anthropocentric, scenery-obsessed, superficial, subjective, and/or morally vacuous. In light of these apparent failings of traditional aesthetics of nature, I suggest five requirements of environmentalism: that aesthetic appreciation of nature should be acentric, environment-focused, serious, objective (...) and morally engaged. I then examine two contemporary positions concerning appropriate aesthetic appreciation of nature, the aesthetics of engagement and scientific cognitivism, assessing each in terms of the requirements of environmentalism. (shrink)

In this paper, I challenge a familiar argument -- a composite of arguments in the literature -- for the view that “Why be moral?” is a pseudo-question. I do so by refuting a component of that argument, a component that is not only crucial to the argument but important in its own right. That component concerns the status of moral reasons in replies to “Why be moral?”; consequently, this paper concerns reasons and rationality no less than it concerns morality. The (...) work I devote to those topics shows not only that the argument I address is unsound, but that the conclusion of that argument is false. “Why be moral?” is no pseudo-question. (shrink)

Recent discussions among lawyers, philosophers, policy researchers and athletes have focused on the potential threat to privacy posed by the World Anti-Doping Agency’s (WADA) whereabouts requirements. These requirements demand, among other things, that all elite athletes file their whereabouts information for the subsequent quarter on a quarterly basis and comprise data for one hour of each day when the athlete will be available and accessible for no advance notice testing at a specified location of their choosing. Failure to (...) file one’s whereabouts, or the non-availability for testing at said location on three occasions within any 18-month period constitutes an anti-doping rule violation that is equivalent to testing positive to a banned substance, and may lead to a suspension of the athlete for a time period of between one and two years. We critically explore the extent to which WADA’s whereabouts requirements are in tension with existing legislation on privacy, with respect to UK athletes, who are simultaneously protected by UK domestic and EU law. Both UK domestic and EU law are subject to the European Convention on Human Rights (ECHR) Article 8, which establishes a right to “respect for private and family life, home and correspondence”. We critically discuss the centrality of the whereabouts requirements in relation to WADA’s aims, and the adoption and implementation of its whereabouts rules. We conclude that as WADA’s whereabouts requirements appear to be in breach of an elite athlete’s rights under European workers’ rights, health & safety and data protection law they are also, therefore, in conflict with Article 8 of the ECHR and the UK Human Rights Act 1998. We call for specific amendments that cater for the exceptional case of elite sports labour if the WADA requirements are to be considered legitimate. (shrink)

Investment Management makes heavy ethical demands which are not an optional add‐on, but part of the job of being a financial agent and fiduciary. The author is founder and President of Skandia Fonds, the Norwegian mutual funds management company affiliated with Skandia Group which pioneered the concept of green mutual funds in Norway. This paper was delivered at the Sixth Annual Conference of the European Business Ethics Network, held in Oslo last month. Its views are those of the author, and (...) do not necessarily represent his company's policy. (shrink)

Two separate regulatory regimes govern research with adults who lack capacity to consent in England and Wales: the Mental Capacity Act (MCA) 2005 and the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Regulations”). A service evaluation was conducted to investigate how research ethics committees (RECs) are interpreting the requirements. With the use of a coding scheme and qualitative software, a sample of REC decision letters where applicants indicated that their project involved adults who lacked mental capacity was (...) analysed. The analysis focuses on 45 letters about projects covered by the MCA and 12 letters about projects covered by the Regulations. The legal requirements for involving incapacitated adults in research were not consistently interpreted correctly. Letters often lacked explicitness and clarity. Neither consent nor assent from third parties is a legally valid concept for purposes of the MCA, yet they were suggested or endorsed in 10 post-MCA letters, and there was evidence of confusion about the consultee processes. The correct terms were also not consistently used in relation to clinical trials. Inappropriate use of terms such as “relative” had the potential to exclude people eligible to be consulted. Unless the correct terms and legal concepts are used in research projects, there is potential for confusion and for exclusion of people who are eligible to be consulted about involvement of adults who lack capacity. Improved clarity, explicitness and accuracy are needed when submitting and reviewing applications for ethical review of research in this area. (shrink)

The consent process for publication of clinical images in medical journals varies widely. The extent of this variation is not known. It is also not known whether journals follow their own stated best practices or the guidance of the International Committee of Medical Journal Editors. We assessed consent requirements in a sample of 10 top impact factor general medicine journals that publish clinical images, examining variability in consent requirements for clinical image publication and congruence of requirements (...) with the recommendations of the ICMJE. Clinical image consent requirements varied widely from journal to journal. None of the studied journals, even amongst n = 4 ICMJE members or n = 8 journals who self-report adherence to ICMJE guidelines, comply with all of the recommendations of the ICMJE. Half of studied journals require a journal-specific consent form. Among top medical journals there is significant heterogeneity in consent requirements for clinical images. Variability of consent requirements is neither practical nor rational; inconsistent requirements create uncertainty for authors, present impediments to dissemination of scholarship, and undermine a shared professional understanding of how best to protect patient privacy. We propose adopting a standardized consent form and process for publication of identifiable images in medical journals, with uniform elements and explicit definitions. (shrink)

In On Not Expecting Too Much from Narrative, Lamarque (2004) challenges theories of narrative identity. For while narrativity might tell us something of interest about our selves, the requirements for this would be so strong that theories of narrative identity would not be able to meet them. In contrast, he identifies minimal conditions for narrativity, so that our identity could be of a narrative nature as well. But in that case, the concept of narrativity would be so weak that (...) it would hardly be able to tell us anything about ourselves. I first examine Lamarque's criticism of narrative concepts of identity. He shows that stories, understood in a minimal sense, are not found but told and that they establish a temporal relationship between at least two events. I then examine the concept of teleological explanations of action. Considering the problem of deviant causal chains that causalists are confronted with, they are at least a serious alternative to causal explanations of action. By doing that, I also attempt to render plausible the irreducibility of teleological explanations of action to causal ones. Subsequently, I outline some features of teleological explanations of action. Finally, I defend the idea that teleological explanations of action are essentially narrative explanations of action because they meet Lamarque's minimal conditions of narratives. I then make the case that these kinds of narratives are not trivial with respect to our personal identity but, on the contrary, are the prerequisite under which we can perceive ourselves as rational agents. (shrink)

Nonpharmaceutical interventions to minimize the transmission of the severe acute respiratory syndrome coronavirus 2 are necessary because we currently lack a vaccine or specific treatments. Healthcare facilities have adopted visitor restrictions and masking requirements. These interventions should be evaluated as public health measures, focusing on their efficacy, the availability of less-restrictive alternatives, and the minimization of the burdens and their balance with the benefits. These interventions, as well as exceptions, can be justified by the same analysis. For example, visitor (...) restrictions are sound, as are exceptions for women in labor, adults with disabilities, minor children, and individuals who are dying. In implementing these policies, specific rules are preferable to general principles because they are more efficient and reduce possible bias. There should, however, be appeal mechanisms and retrospective review processes. Evaluating requests for medical exemptions to masking requirements is particularly difficult, given the prevalence of nonmedical objections, false claims of medical exemptions, and a lack of objective medical criteria. Requiring written statements by licensed healthcare providers that undergo subsequent substantive review may therefore be justified. (shrink)

In april 1872, with the caisson at a depth of seventy-odd feet and still no bedrock, two men died. The strain for Roebling was nearly unbearable, as his wife later said. On May 18, a third man died, and that same day Roebling made the most difficult and courageous decision of the project. Staking everything — the success of the bridge, his reputation, his career - he ordered a halt. The New York tower, he had concluded, could stand where it (...) was, at a depth of 78 feet 6 inches, not on bedrock, but on “hardpack” sand. From examinations of the strata he had determined to his own satisfaction that no movement had occured at the level since the time of deposit millions of years in the geologic past; so, he said, it was “good enough to found upon”. (shrink)

The problem of collecting, analyzing and evaluating evidence on adverse drug reactions (ADRs) is an example of the more general class of epistemological problems related to scientific inference and prediction, as well as a central problem of the health-care practice. Philosophical discussions have critically analysed the methodological pitfalls and epistemological implications of evidence assessment in medicine, however they have mainly focused on evidence of treatment efficacy. Most of this work is devoted to statistical methods of causal inference with a special (...) attention to the privileged role assigned to randomized controlled trials in Evidence Based Medicine. Regardless of whether the RCT’s privilege holds for efficacy assessment, it is nevertheless important to make a distinction between causal inference of intended and unintended effects, in that the unknowns at stake are heterogonous in the two contexts. This point has been emphasized by epidemiologists in the last decade. Their main focus is methodological, and regards the fact that bias and confounding do not affect studies on intended and unintended effects in the same way. However, deeper concerns ground the intuition for such a distinction; these are related to the constraints which we impose on evidence and their epistemological justification. My thesis is that such constraints ought to be understood to be different in the case of evidence for risk vs. benefit assessment. I present the recent debate on the causal association between acetaminophen and asthma in order to illustrate the point at issue. (shrink)

Results of a comprehensive simulation study are reported investigating the effects of sample size, test length, number of attributes and base rate of mastery on item parameter recovery and classification accuracy of four DCMs. Effects were evaluated using bias and RMSE computed between true parameters and estimated parameters. Effects of simulated factors on attribute assignment were also evaluated using the percentage of classification accuracy. More precise estimates of item parameters were obtained with larger sample size and longer test length. Recovery (...) of item parameters decreased as the number of attributes increased from three to five but base rate of mastery had a varying effect on the item recovery. Item parameter and classification accuracy were higher for DINA and DINO models. (shrink)

Laymen and philosophers alike find it counterintuitive to consent to the assertion that “it is sometimes right not to follow the requirements of morality”. This may be because the conventions of ordinary language do much to encourage the view that “morally ought to do” functions as an equivalent for “what one ought to do all things considered”. In this paper I will argue against such an equivalence and attempt to shake the holders of the prevailing view, that moral reasons (...) are always overriding, from their dogmatism. The primary theses of this paper are (1) there is no acceptable ordering of reasons for acting--not between types of reasons nor within the category of moral reasons, and (2) moral reasons are not unconditional or unexceptionable.The body of this paper will include a discussion of various versions of the prevailing view (that reasons do have an order with moral reasons as overriding all reasons). I will make some brief remarks about several forms of simplification or reductionism which provide fertile ground for the prevailing view, specifically (a) efforts to transform ‘the all things considered ought’ into a ‘moral ought’ and (b) three efforts to offer a single principle as the basis of moral reasoning. Then I will attempt to reveal flaws in two contemporary expressions of the prevailing view; those of D.Z. Phillips and Kurt Baier. The bulk of my efforts will be directed at demonstrating the conditionality and overrideability of moral reasons. In the process I will also attempt to illuminate the attractiveness of the, if I am correct, mistaken but prevailing view. And finally a moral will be drawn. (shrink)

The priority that Tessman’s argument gives to phenomenological and neuropsychological explanations of moral requirements entails a fundamental shift in our understanding of these. Two central problems of normative theory come together in Tessman’s account. The first arises when an agent’s sense of requirement clashes with what a systematic theory prescribes. The second arises when neuropsychological accounts fail to fit the prescription. Tessman argues that no account successfully resolves moral dilemmas such that ought always implies can, and she argues that (...) neuropsychology explains our sense of impossible requirements. This explanation eliminates the role of a prescriptive theory in explaining an agent’s sense of requirement. (shrink)

Whether pattern-parsing mechanisms are specific to language or apply across multiple cognitive domains remains unresolved. Formal language theory provides a mathematical framework for classifying pattern-generating rule sets (or “grammars”) according to complexity. This framework applies to patterns at any level of complexity, stretching from simple sequences, to highly complex tree-like or net-like structures, to any Turing-computable set of strings. Here, we explored human pattern-processing capabilities in the visual domain by generating abstract visual sequences made up of abstract tiles differing in (...) form and color. We constructed different sets of sequences, using artificial “grammars” (rule sets) at three key complexity levels. Because human linguistic syntax is classed as “mildly context-sensitive,” we specifically included a visual grammar at this complexity level. Acquisition of these three grammars was tested in an artificial grammar-learning paradigm: after exposure to a set of well-formed strings, participants were asked to discriminate novel grammatical patterns from non-grammatical patterns. Participants successfully acquired all three grammars after only minutes of exposure, correctly generalizing to novel stimuli and to novel stimulus lengths. A Bayesian analysis excluded multiple alternative hypotheses and shows that the success in rule acquisition applies both at the group level and for most participants analyzed individually. These experimental results demonstrate rapid pattern learning for abstract visual patterns, extending to the mildly context-sensitive level characterizing language. We suggest that a formal equivalence of processing at the mildly context sensitive level in the visual and linguistic domains implies that cognitive mechanisms with the computational power to process linguistic syntax are not specific to the domain of language, but extend to abstract visual patterns with no meaning. (shrink)

Placing the future centre stage as a way of understanding cognition is gaining attention in psychology. The general modern label for this is “prospection” which refers to the process of representing and thinking about possible future states of the world. Several theorists have claimed that episodic and prospective memory, as well as hypothetical thinking (mental simulation) and conditional reasoning are necessary cognitive faculties that enable prospection. Given the limitations in current empirical efforts connecting these faculties to prospection, the aim of (...) this mini review is to argue that the findings show that they are sufficient, but not necessary for prospection. As a result, the short concluding section gives an outline of an alternative conceptualisation of prospection. The proposal is that the critical characteristics of prospection are the discovery of, and maintenance of goals via causal learning. (shrink)

Domestic violence is a growing societal concern that often spills over into the workplace. However, employers are not recognizing the spillover of domestic violence as a workplace issue. This is problematic considering the serious financial, legal, and ethical consequences for organizations. We analyzed six cases involving domestic violence that were litigated under specific legal bases: Violence Against Women Act, discrimination laws including Title VII, Family and Medical Leave Act, Americans with Disabilities Act, Social Security Disability, Occupational Safety and Health Act, (...) and associated state and municipal ordinances. We chose cases that illustrate the problems of companies meeting the legal standards but not necessarily reaching ethical expectations. Our approach is congruent with the perspective that both legal and ethical analyses should be used in organizational decision making. We suggest for future research the analysis of additional litigated cases, other ethical perspectives, and additional sources of data. In addition, we suggest that companies who are striving for corporate social responsibility should integrate the ethical treatment of domestic violence victims. (shrink)

Zusammenfassung Die Rekrutierung von geeignetem Personal stellt eine der essentiellen Aufgaben von Organisationen dar. Es entstehen hierbei sowohl Suchkosten für den Arbeitgeber als auch für den Arbeitnehmer. Der Arbeitnehmer sucht eine adäquate Stelle, welche seinen Fähigkeiten entspricht. Der Arbeit­geber hingegen benötigt einen Bewerber, welcher die Anforderungen der Stelle erfüllt. Aufgrund der Heterogenität der Sportanbieter stellt sich die Frage, welche Anforderungen in Berufsfeldern des Sportmanagements verlangt werden. Um diese Frage zu beantworten, wurden Stellenanzeigen hinsichtlich der angeführten Qualifikationen codiert und quantitativ analysiert. (...) Die cluster­analytischen Ergebnisse weisen branchenspezifische Profiltypologien für einzelne Berufsfelder nach. (shrink)

Background Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. Discussion The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel (...) to considerable amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises. Summary Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm); to society (to ensure good quality research is conducted); and to researchers (to treat their proposals with just consideration and respect). To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration. (shrink)

Background Factors that could potentially act as facilitators and barriers to successful recruitment strategies in perinatal clinical trials are not well documented. The objective was to assess lay persons’ understanding of the informed consent for randomized clinical trial in emergency obstetric and newborn care. Methods This was a qualitative study conducted among survivors of severe obstetric complications who were attending the post-natal clinic of Kawempe National Referral Hospital, Uganda, 6–8 weeks after surviving severe obstetric complications during pregnancy or childbirth. The (...) study that involved 18 in-depth interviews was conducted from June 1, 2019 to July 6, 2019. The issues explored included perceptions of the purpose and necessity to conduct such research how research-related information would be disclosed, and what could be the potential benefits and risks of participation. The data was analyzed by thematic analysis. Results Respondents felt that research was necessary to investigate the cause, prevention or complications of an illness, especially as much was known about some pregnancy and newborn complications. Most believed that the emergency contexts affects whether and what prospective participants may understand if information about research was disclosed. Whereas they did not see the value of procedures like randomization, they felt that if these and any other procedures necessary should be done transparently and fairly. The decisions to participate would significantly be influenced by possibility of risk to the unborn baby or the newborn. Solidarity was an important influence on decision-making. Conclusions Respondents valued participation in RCTs in emergency obstetric and newborn care. However, they expressed concerns and valued openness, transparency and accountability with regard to how clinical trials information is disclosed and the decision-making process for clinical trial participation. While autonomy and solidarity are contradictory values, they complement each other during decision-making for informed consent. (shrink)

Background Medical research in complementary and alternative medicine (CAM) has increased recently, raising ethical concerns about the moral status of CAM. Medical academic journals are responsible for conducting ethical review (ER) of manuscripts to protect the interests of human subjects and to make ethical results available before deciding to publish. However, there has been no systematic analysis of the ER in CAM journals. This study is aim to evaluate the current status of ethical requirements and compliance in CAM journals. (...) Methods This is a cross-sectional study. We reviewed instructions for authors (IFAs) of CAM journals included in the Journal Citation Reports (2021) (https://jcr.clarivate.com) for general information and requirements for ER. We also browsed the manuscripts regarding randomized controlled trials published by CAM journals in Q1 and Q2 section from January to June, 2023, to check the actual situation of ethical requirement. Descriptive statistics and Fisher’s exact test were used for statistical analysis. Results 27 journals and 68 manuscripts were ultimately included. 92.6% (25/27) IFAs included keywords of ER, indicating the presence of ethical considerations. However, no specific ER was required for CAM (n = 0). We categorized journals by Geographic origin, JCR section, Year of electronic JCR, Types of studies, % of OA Gold to explore the factors that could influence CAM journals to have certain ethical review policies. The results showed there was no statistical significance in certain ethical review policy in any classification of journals (p > 0.05). All RCT manuscripts included in the study generally met the requirements of the published journals for ethical review. Conclusions All IFAs discussed ER, but the content was scattered, unfocused, and there were no specific ER requirements regarding CAM. Although the manuscripts basically met the requirements of the journal, it was not possible to get closer to the process of ER in the manuscript. To ensure full implementation of these policies in the future, CAM journals should require authors to provide more details, or to form a list of items necessary for CAM ethical review. (shrink)

Internet of Things-based environments pose various challenges due to their anytime/anywhere computing, and the efficient cryptographic based key management is one of the major challenges in Internet of Things. The key management life cycle consists of initialization, key generation, key registration, key backup, key update, key recovery, and key revocation. Our contribution in this paper is to summarize the state-of-the-art key management schemes and techniques in different scenarios, such as mobile ad hoc networks, wireless sensor networks, and the Internet of (...) Things environments. Further different issues related specifically to the Internet of Things environment are discussed and the causes and effects pertaining to the security breach for Internet of Things are identified. Furthermore, in this research work, we develop a novel permutation of threshold and identity-based key management schemes for the Internet of Things environment and have proposed future directions to counteract the attacks on confidentiality, integrity, authentication, and availability of security services in the Internet of Things environment and identified the two key management schemes, that is, identity and threshold schemes for Internet of Things, to resolve Internet of Things key management issues and maximum possible security services effective implementation. We evaluate our scheme with the help of mathematical and statistical techniques. (shrink)

Perez-Rodriguez and de la Fuente (2017) assume that although human races do not exist in a biological sense (“geneticists and evolutionary biologists generally agree that the division of humans into races/subspecies has no defensible scientific basis,” they exist only as “sociocultural constructions” and because of that maintain an illusory reality, for example, through “racialized” practices in medicine. Agreeing with the main postulates formulated in the article, we believe that the authors treat this problem in a superficial manner and have failed (...) to capture the current state of the field of knowledge in science and the humanities. In our commentary, we want to highlight two main omissions, and to notice three important implications for “a postracial medicine.”. (shrink)

Midwest Studies In Philosophy, EarlyView.

Race and ethnicity are commonly reported variables in biomedical research, but how they were initially determined is often not described and the rationale for analyzing them is often not provided. JAMA improved the reporting of these factors by implementing a policy and procedure for doing so. However, still lacking are careful consideration of what is actually being measured when race/ethnicity is described, consistent terminology, hypothesis-driven justification for analyzing race/ethnicity, and a consistent and generalizable measurement of socioeconomic status. Furthermore, some studies (...) continue to use race/ethnicity as a proxy for genetics. Research into appropriate measures of race/ethnicity and socioeconomic factors, as well as education of researchers regarding issues of race/ethnicity, is necessary to clarify the meaning of race/ethnicity in the biomedical literature. (shrink)