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)

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. 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. 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. 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)

Non-consensual organ procurement from prisoners in China raises serious questions regarding the ethics of Chinese transplant research. In their article, published in this issue of JME, Higgins and colleagues address these questions through the lens of publication ethics. They argue that, ‘while there are potentially compelling justifications for use [of unethical research] under some circumstances, these justifications fail when unethical practices are ongoing’.1 Consequently, they recommend non-publication of Chinese transplant research and call for a mass retraction of the articles identified (...) in their review.2 To support their argument, Higgins and colleagues appeal to internationally recognised guidelines from the WHO3 and the World Medical Association, which assert that ‘executed prisoners must not be considered as organ and/or tissue donors’ due to the inability to acquire valid consent.4 Failing to declare an immediate publishing moratorium for transplant research involving prisoners in China, they argue, ‘undermines efforts to stop transplant-related human rights abuses, taints the evidence base, and renders those who publish and use the research complicit in the continuing harm’.5 We agree with Higgins and colleagues that non-consensual organ procurement from prisoners in China is a crime against humanity. Ongoing human rights violations in Chinese prisons are well documented and universally condemned. We also agree that the subsequent use of data acquired from unethical research is morally complex. Nonetheless, Higgins and colleagues’ arguments leave us with three …. (shrink)

This thesis addresses the tension in pragmatic cluster-randomized trials between their social value and the requirement to respect the autonomy of research participants. Pragmatic trials are designed to evaluate the effectiveness of treatments in real-world settings to inform clinical decision-making and promote cost-efficient care. These trials are often embedded into clinical settings and ideally include all patients who would receive the treatments under investigation as a part of routine care. Trialists increasingly adopt cluster-randomized designs—in which intact groups, such as hospitals (...) or clinics, are allocated randomly to study interventions—to simplify the inclusion of all patients. But including all-comers conflicts with the requirement to obtain written informed consent from research participants. Since informed consent is central to respecting patient autonomy, the question arises: how can the ends of autonomy and pragmatism be served simultaneously? Some philosophers argue that patients have an obligation to participate in clinical research and that this may negate consent requirements. I argue that while there may be grounds for a prima facie obligation for patients to participate in clinical research, no compelling argument has demonstrated that the obligation is enforceable. Others assert that broad application of a waiver of consent will facilitate the conduct of pragmatic cluster-randomized trials. I demonstrate that this proposal sharply conflicts with the historical origins of the waiver. I articulate a novel moral foundation for the use of a waiver of consent and show that when trials evaluate treatments delivered directly to patients, the autonomy interests at stake for participants are too substantial to permit its use. My solution draws a distinction between consent requirements in existing policy and consent as an autonomous authorization. As many pragmatic cluster-randomized trials are conducted in primary care settings with no research staff, I argue that patient autonomy can be promoted and protected using clinical-style consent, in which health providers seek verbal informed consent from patients and document it in the electronic health record. This approach has been associated with high rates of recruitment and, thus, may satisfy both requirements for social value and respect for autonomy. (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)

Volume 19, Issue 10, October 2019, Page 101-103.

ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a (...) waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001).DiscussionNot obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research. (shrink)

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)

The increasing use of cluster randomised trials in low-resource settings raises unique ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials is the first international ethical guidance document specific to cluster trials, but it is unknown if it adequately addresses issues in low-resource settings. In this paper, we seek to identify any gaps in the Ottawa Statement relevant to cluster trials conducted in low-resource settings. Our method is to analyse a prototypical cluster trial conducted (...) in a low-resource setting with the Ottawa Statement; to identify ethical issues in the design or conduct of the trial not captured adequately and to make recommendations for issues needing attention in forthcoming revisions to the Ottawa Statement. Our analysis identified six ethical aspects of cluster randomised trials in low-resource settings that require further guidance. The forthcoming revision of the Ottawa Statement should provide additional guidance on these issues: streamlining research ethics committee review for collaborating investigators who are affiliated with other institutions; the classification of lay health workers who deliver study interventions as health providers or research participants; the dilemma experienced by investigators when national standards seem to prohibit waivers of consent; the timing of gatekeeper engagement, particularly when researchers face funding constraints; providing ancillary care in health services or implementation trials when a routine care control arm is known to fall below national standards and defining vulnerable participants needing protection in low-resource settings. (shrink)

Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially (...) in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. Semi-structured interviews with key stakeholders, across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications. (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)

This article traces disagreements about the genetic effects of low-dose radiation exposure as waged by James Neel, a central figure in radiation studies of Japanese populations after World War II, and Yuri Dubrova, who analyzed the 1986 Chernobyl nuclear power plant accident. In a 1996 article in Nature, Dubrova reported a statistically significant increase in the minisatellite DNA mutation rate in the children of parents who received a high dose of radiation from the Chernobyl accident, contradicting studies that found no (...) significant inherited genetic effects among offspring of Japanese A-bomb survivors. Neel’s subsequent defense of his large-scale longitudinal studies of the genetic effects of ionizing radiation consolidated current scientific understandings of low-dose ionizing radiation. The article seeks to explain how the Hiroshima/nagasaki data remain hegemonic in radiation studies, contextualizing the debate with attention to the perceived inferiority of Soviet genetic science during the Cold War. (shrink)

This book is about the mind and its connection to the brain. The first two chapters discuss the basic characteristics of the mind, and places it in historical context by noting trends in popular culture, and various people's ideas about the mind. This discussion ends by concluding that the most fruitful approach to studying the mind is a scientific approach that looks for connections between the mind and the brain. The last four chapters focus on the following specific principles: The (...) operation of the mind is hidden; Prediction is an important function of the mind; and Connectivity and communication between different areas of the mind are crucial for the mind's operation. An important feature of this discussion is that it is supported by empirical research, by briefly describing experiments. This book therefore goes beyond simply presenting conclusions, by elucidating the procedures and reasoning that led to those conclusions. The intent of the book is to give readers a feel for the latest scientific thinking about the mind, by focusing on basic principles that hold across many different functions of the mind. One key to marketing the book is to emphasize the fact that the writing makes a fascinating, but complex, subject accessible to the general reader. (shrink)

Traditional whistleblowing theories have purported that whistleblowers engage in a rational process in determining whether or not to blow the whistle on misconduct. However, stressors inherent to whistleblowing often impede rational thinking and act as a barrier to effective whistleblowing. The negative impact of these stressors on whistleblowing may be made worse depending on who engages in the misconduct: a peer or advisor. In the present study, participants are presented with an ethical scenario where either a peer or advisor engages (...) in misconduct, and positive and the negative consequences of whistleblowing are either directed to the wrongdoer, department, or university. Participant responses to case questions were evaluated for whistleblowing intentions, moral intensity, metacognitive reasoning strategies, and positive and negative, active and passive emotions. Findings indicate that participants were less likely to report the observed misconduct of an advisor compared to a peer. Furthermore, the findings also suggest that when an advisor is the source of misconduct, greater negative affect results. Post-hoc analyses were also conducted examining the differences between those who did and did not intend to blow the whistle under the circumstances of either having to report an advisor or peer. The implications of these findings for understanding the complexities involved in whistleblowing are discussed. (shrink)

While Dubourg and Baumard argue that predisposition toward exploration draws us to fictional environments, they fail to answer their titular question: “Why Imaginary Worlds?” Research in pretend play, psychological distancing, and theatre shows that being “imaginary” (i.e., any type of unreal, rather than only fantastically unreal) makes exploration of any fictional world profoundly different than that of real-life unfamiliar environments.

We propose a friendly amendment to integrative experiment design (IED), adversarial-collaboration IED, that incentivizes research teams from competing theoretical perspectives to identify zones of the design space where they possess an explanatory edge. This amendment is especially critical in debates that have high policy stakes and carry a strong normative-political charge that might otherwise prevent free exchange of ideas.

Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons. We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.

What does it mean to consider the world of AI through a Christian lens? Rapid developments in AI continue to reshape society, raising new ethical questions and challenging our understanding of the human person. Encountering Artificial Intelligence draws on Pope Francis’ discussion of a culture of encounter and broader themes in Catholic social thought in order to examine how current AI applications affect human relationships in various social spheres and offers concrete recommendations for better implementation. The document also explores questions (...) regarding personhood, consciousness, and the kinds of relationships humans might have with even the most advanced AI. Through these discussions, this book investigates the theoretical and practical challenges to interpersonal encounter raised by the age of AI. (AI Research Group for the Centre for Digital Culture of the Dicastery of Culture and Education of the Holy See). (shrink)

"The Blackwell Handbook of Perception" is ideal for upper level students looking for succinct overviews and for researchers wanting to know more about current ...

In this paper, we consider the licensing of and codes of ethics that affect the accountant not in public accounting, the potential for an accountant not in public accounting encountering an ethical conflict situation, and the moral responsibility of such accountant when faced with an ethical dilemma. We review an approach suggested by the National Association of Accountants for dealing with an ethical conflict situation including that association's position on whistleblowing. We propose another approach based on the work of De (...) George (1981), in which both internal and external whistleblowing are possible alternatives, for use by management accountants in an ethical conflict situation. Finally, we consider the implications of our analysis for management accounting. While most of the analysis centers on management accountants, we note the likely applicability of the analysis to accountants in the public sector. (shrink)

Traditional whistleblowing theories have purported that whistleblowers engage in a rational process in determining whether or not to blow the whistle on misconduct. However, stressors inherent to whistleblowing often impede rational thinking and act as a barrier to effective whistleblowing. The negative impact of these stressors on whistleblowing may be made worse depending on who engages in the misconduct: a peer or advisor. In the present study, participants are presented with an ethical scenario where either a peer or advisor engages (...) in misconduct, and positive and the negative consequences of whistleblowing are either directed to the wrongdoer, department, or university. Participant responses to case questions were evaluated for whistleblowing intentions, moral intensity, metacognitive reasoning strategies, and positive and negative, active and passive emotions. Findings indicate that participants were less likely to report the observed misconduct of an advisor compared to a peer. Furthermore, the findings also suggest that when an advisor is the source of misconduct, greater negative affect results. Post-hoc analyses were also conducted examining the differences between those who did and did not intend to blow the whistle under the circumstances of either having to report an advisor or peer. The implications of these findings for understanding the complexities involved in whistleblowing are discussed. (shrink)

Due to the wide array of phenomena that are of interest to them, psychologists offer highly diverse and heterogeneous types of explanations. Initially, this suggests that the question "What is psychological explanation?" has no single answer. To provide appreciation of this diversity, we begin by noting some of the more common types of explanations that psychologists provide, with particular focus on classical examples of explanations advanced in three different areas of psychology: psychophysics, physiological psychology, and information-processing psychology. To analyze what (...) is involved in these types of explanations, we consider the ways in which law-like representations of regularities and representations of mechanisms factor in psychological explanations. This consideration directs us to certain fundamental questions, e.g., "To what extent are laws necessary for psychological explanations?" and "What do psychologists have in mind when they appeal to mechanisms in explanation?" In answering such questions, it appears that laws do play important roles in psychological explanations, although most explanations in psychology appeal to accounts of mechanisms. Consequently, we provide a unifying account of what psychological explanation is. (shrink)