Austin E. Duncan-Jones; Definition of Identity of Structure, Analysis, Volume 2, Issue 1-2, 1 October 1934, Pages 14–18, https://doi.org/10.1093/analys/2.1-2.14.

Pragmatic comparative effectiveness randomized controlled trials evaluate the effectiveness of one interventions under real-world clinical conditions. The results of ceRCTs are often directly generalizable to everyday clinical practice, providing information critical to decision-making by patients, clinicians, and healthcare policymakers. The PRECIS-2 framework identifies nine domains that serve to score a trial on a continuum between very explanatory to very pragmatic. According to the framework, pragmatic trials may have one or more of the following features: there are fewer eligibility criteria for (...) participants, in an... (shrink)

Quality and service improvement (QSI) research employs a broad range of methods to enhance the efficiency of healthcare delivery. QSI research differs from traditional healthcare research and poses unique ethical questions. Since QSI research aims to generate knowledge to enhance quality improvement efforts, should it be considered research for regulatory purposes? Is review by a research ethics committee required? Should healthcare providers be considered research participants? If participation in QSI research entails no more than minimal risk, is consent required? The (...) lack of consensus on answers to these questions highlights the need for ethical guidance. Three distinct approaches to classifying QSI research in accordance with existing ethical principles and regulations can be found in the literature. In the first approach, QSI research is viewed as distinct from other types of healthcare research and does not require regulation. In the second approach, QSI research falls within regulatory guidelines but is exempt from research ethics committee review. In the third approach, QSI research is deemed to be part of the learning healthcare system and, as such, is subject to a different set of ethical principles entirely. In this paper, we critically assess each of these views. While none of these approaches is entirely satisfactory, we argue that use of the ethical principles governing research provides the best means of addressing the numerous questions posed by QSI research. (shrink)

Climate change is a wicked problem with causes and consequences overlapping with other wicked problems and no single solution (Hulme 2015). For example, the frequent droughts associated with climate change exacerbate another major problem facing humanity as we enter the Anthropocene: how to produce adequate food to feed a growing population without increasing pollution or “more food with low pollution (MoFoLoPo)” (Davidson et al. 2015). Soils represent an intersection of these two wicked problems, because they are integral to food production (...) through agriculture and also are an important component of global climate models. Recent focus in the field of soil carbon cycling has facilitated a transformation in our understanding of the processes that control this important resource. This understanding is critical to responding to both wicked problems. (shrink)

Good listening is an essential element in the provision of quality healthcare (Attree 2001). Good listening also supports accurate diagnosis, patient adherence to medical recommendations, and stron...

The literature on affective determinants of physical activity is growing rapidly. The present paper aims to provide greater clarity regarding the definition and distinctions among the various affect-related constructs that have been examined in relation to PA. Affective constructs are organized according to the Affect and Health Behavior Framework, including: affective response to PA; incidental affect; affect processing; and affectively charged motivational states. After defining each category of affective construct, we provide examples of relevant research showing how each construct may (...) relate to PA behavior. We conclude each section with a discussion of future directions for research. (shrink)

Answering important public health questions often requires collection of sensitive information about individuals. For example, our understanding of how HIV is transmitted and how to prevent it only came about with people's willingness to share information about their sexual and drug-using behaviors. Given the scientific need for sensitive, personal information, researchers have a corresponding ethical and legal obligation to maintain the confidentiality of data they collect and typically promise in consent forms to restrict access to it and not to publish (...) identifying data.The interests of others, however, can threaten researchers' promises of confidentiality when legal demands are made to access research data. In some cases, the subject of the litigation is tightly connected to the research questions, and litigants' interest in the data is not surprising. Researchers conducting studies on tobacco or occupational or other chemical exposures, for example, are relatively frequent targets of subpoenas. (shrink)

Earp, Lewis, and Hart write about the racism entrenched in policies criminalizing drug use and possession and describe the disparate impact that these policies have on certain racialized com...

Increasingly, clinical research is evaluated on the quality of its statistical analysis. Traditionally, statistical analyses in clinical research have been carried out from a ‘frequentist’ perspective. The presence of an alternative paradigm – the Bayesian paradigm – has been relatively unknown in clinical research until recently. There is currently a growing interest in the use of Bayesian statistics in health care research. This is due both to a growing realization of the limitations of frequentist methods and to the ability of (...) Bayesian methods explicitly to incorporate prior expert knowledge and belief into the analyses. This is in contrast to frequentist methods, where prior experience and beliefs tend to be incorporated into the analyses in an ad hoc fashion. This paper outlines the frequentist and Bayesian paradigms. Acute myocardial infarction mortality data are then analysed from both a Bayesian and a frequentist perspective. In some analyses, the two methods are seen to produce comparable results; in others, they produce different results. It is noted that in this example, there are clinically relevant questions that are more easily addressed from a Bayesian perspective. Finally, areas in clinical research where Bayesian ideas are increasingly common are highlighted. (shrink)

The ethics of the Flexibility In duty hour Requirements for Surgical Trainees trial have been vehemently debated. Views on the ethics of the FIRST trial range from it being completely unethical to wholly unproblematic. The FIRST trial illustrates the complex ethical challenges posed by cluster randomised trials of policy interventions involving healthcare professionals. In what follows, we have three objectives. First, we critically review the FIRST trial controversy, finding that commentators have failed to sufficiently identify and address many of the (...) relevant ethical issues. The 2012 Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials provides researchers and research ethics committees with specific guidance for the ethical design and conduct of CRTs. Second, we aim to demonstrate how the Ottawa Statement provides much-needed clarity to the ethical issues in the FIRST trial, including: research participant identification; consent requirements; gatekeeper roles; benefit-harm analysis and identification of vulnerable participants. We nonetheless also find that the FIRST trial raises ethical issues not adequately addressed by the Ottawa Statement. Hence, third and finally, we raise important questions requiring further ethical analysis and guidance, including: Does clinical equipoise apply to policy interventions with little or no evidence-base? Do healthcare providers have an obligation to participate in research? Does the power-differential in certain healthcare settings render healthcare providers vulnerable to duress and coercion to participant in research? If so, what safeguards might be implemented to protect providers, while allowing important research to proceed? (shrink)

Recent research has pointed to the importance of the prenatal environment in the etiology of autism spectrum disorder (ASD) but the biological mechanisms which mitigate these environmental factors are not clear. Mitochondrial metabolism abnormalities, inflammation and oxidative stress as common physiological disturbances associated with ASD. Network analysis of the scientific literature identified several leading prenatal environmental factors associated with ASD, particularly air pollution, pesticides, the microbiome and epigenetics. These leading prenatal environmental factors were found to be most associated with inflammation, (...) followed by oxidative stress and mitochondrial dysfunction. Other prenatal factors associated with ASD not identified by the network analysis were also found to be significantly associated with these common physiological disturbances. A better understanding of the biological mechanism which mediate the effect of prenatal environmental factors can lead to insights of how ASD develops and the development of targeted therapeutics to prevent ASD from occuring. (shrink)

Background Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. Methods We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Results Our (...) review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. Conclusion The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs. (shrink)

Philosophy of Communication Ethics is a unique and timely volume that creatively examines communication ethics, philosophy of communication, and "the other.".

When William May first wrote Catholic Bioethics and the Gift of Human Life, his position was that to perform a craniotomy on a child to save the mother’s life constitutes a direct abortion and is not justifiable. In later editions, May rejected his earlier position in favor of one he originally argued against, most notably by Germain Grisez. The author maintains that the argu­ments surrounding craniotomies on the unborn are still of major relevance today, because they relate directly to certain (...) controversial techniques used to manage ectopic pregnancies. He also argues that May’s original conclusion ought to be upheld, and that May’s later conclusion places too much weight on the interior intention of the actor and not enough on the act itself. (shrink)

Post-market pharmaceutical surveillance or ‘pharmacovigilance’ relies on the reporting of suspected adverse drug reactions to regulatory databases. Recently, more ‘active’ methods that directly involve patients in identifying and reporting suspected adverse drug reactions have been suggested. This is different than traditional ‘passive’ methods, e.g., using databases without contacting patients directly. Though there are benefits to active pharmacovigilance, it is not without its potential risks. Here I highlight one of those risks – the nocebo effect. Nocebo effects are harms that are (...) thought to arise by conditioning or negative expectation. If a patient engaged in active pharmacovigilance is improperly motivated to seek out and report suspected adverse drug reactions, nocebo harms can occur. Not only is this a bioethical concern about harm, but it is also an epistemic or data-quality problem. Since nocebo effects are not due to the pharmacological properties of the drugs under investigation, nocebo effects reported as suspected adverse drug reactions constitute false positives in these databases. (shrink)

John Austin's classic work that has had a profound influence on the study of English and American law presents Austin's distinction between "positive law" (i.e.

‘Agathon and Eudaimonia in the Ethics of Aristotle’ is a response to an article on the meaning of Agathon in the Ethics of Aristotle, published by H. A. Pritchard in 1935. In this paper, Pritchard argued that Aristotle regarded Agathon to mean ‘conducive to our happiness’ and, consequently, that he maintained that every deliberate action stems, ultimately, from the desire to become happy. Austin finds fault with this view: first, Agathon in Aristotle does not have a single meaning, and a (...) fortiori not the one Pritchard suggested; secondly, if one had to summarise the meaning of ‘being agathon’ in one phrase, then ‘being desired’ cannot fulfil this function, for there are other objects of desire besides τό άγαθόν. (shrink)

The underreporting of suspected adverse drug reactions hinders pharmacovigilance. Solutions to underreporting are oftentimes directed at clinicians and health care professionals. However, given the recent rise of public inclusion in medical science, solutions may soon begin more actively involving patients. I aim to offer an evaluative framework for future possible proposals that would engage patients with the aim of mitigating underreporting. The framework may also have value in evaluating current reporting practices. The offered framework is composed of three criteria that (...) are bioethical, social-epistemic, and pragmatic: (i) patients should not be exposed to undue harms, e.g., nocebo effects; (ii) data should be collected, analyzed, and communicated prioritizing pharmacovigilance’s aims, i.e., free from industry bias; and (iii) proposals should account for existing and foreseeable pragmatic constraints like clinician ‘buy in’ and existing reporting infrastructure. Proposals to engage patients in pharmacovigilance that fulfil or address these criteria are preferable to those that do not. (shrink)