This article outlines the main tenets of affect theory and links these to Sloterdijk’s spherology. Where affect foregrounds prepersonal energies and posthuman impulses, spherology provides a lens for considering how humans congregate in constantly reconfiguring socialities in their pursuit of legitimacy and immunity. The article then explores the relevance of “affective spheres” for contemporary social science research. The article’s main argument here is that research of contemporary organisational and professional practices must increasingly be spherogenic, or seeking to build “affective spheres.” (...) The basis of this argument are the in situ complexity and fast-changing nature of practices, and the increasing challenges involved in objectifying or ‘freezing’, and analysing or dissecting such practices. The article draws for its case study on a video-reflexive project conducted in a U.S. health service. The article concludes that the notion of research as spherogenics counterbalances the conventional methodological emphasis on a predetermined stance —whether neutral or political—in our construction and enactment of social science research. (shrink)

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)

In this article we describe our approach to understanding wrongdoing in medical research and practice, which involves the statistical analysis of coded data from a large set of published cases. We focus on understanding the environmental factors that predict the kind and the severity of wrongdoing in medicine. Through review of empirical and theoretical literature, consultation with experts, the application of criminological theory, and ongoing analysis of our first 60 cases, we hypothesize that 10 contextual features of the medical environment (...) (including financial rewards, oversight failures, and patients belonging to vulnerable groups) may contribute to professional wrongdoing. We define each variable, examine data supporting our hypothesis, and present a brief case synopsis from our study that illustrates the potential influence of the variable. Finally, we discuss limitations of the resulting framework and directions for future research. (shrink)

This article develops a model of informed consent for fresh oöcyte donation for stem cell research, during in vitro fertilisation (IVF), by building on the importance of patients’ embodied experience. Informed consent typically focuses on the disclosure of material information. Yet this approach does not incorporate the embodied knowledge that patients acquire through lived experience. Drawing on interview data from 35 patients and health professionals in an IVF clinic in Australia, our study demonstrates the uncertainty of IVF treatment, and the (...) tendency for patients to overestimate their chances of success prior to the experience of treatment. Once in active treatment, however, patients identify their oöcytes as both precious and precarious. We argue that it is necessary to formally include embodied experience as a source of knowledge in informed consent procedures, both for gratuitous donation and for egg-sharing regimes. We recommend that at least one full cycle of IVF be completed before approaching women to divert eggs away from their own fertility treatment. (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)

Drawing on work done in the area of health services research, this article outlines a view of discourse analysis that approaches discourse as a co-accomplished process involving researcher and research-participant. Without losing sight of the analytical-critical-reflexive moments that have typified discourse analytical endeavours, this article explores a form of DA that moves from discourse as object to be collected and processed away from where it is practised, towards discourse as dynamically emerging reality shared by practitioner-participants and researchers, and as flexible (...) means to intervene in the quality and safety of care practices. The article begins with highlighting the productive potential of discourse research in health. The ethics informing this mode of DA, the article goes on to explain, is interested and trustful ‘entanglement’ with those who populate this field of practice and structure it with discourse. Elsewhere referred to as ‘experience-based enquiry’, the initiative to reframe discourse research as a mode of intervention involves keeping practitioners’ interpretations and analysts’ questions, critiques and conclusions in tension. The article argues that this approach capitalizes on the intrinsically reflexive, dialogic and emergent nature of discourse. To illustrate these issues, the article presents two case studies drawn from recent projects that have manifested these researcher and practitioner-participant dynamics. The article concludes that, as emergent practice, the analysis of discourse benefits from entanglement with the people and the contexts where discourse is produced. Here, analysis vacillates between a feedback device that enables both research participants and researchers to re-appraise their and each other’s practices, and a knowledge production device that generalizes about these practices and the changes to these practices that result from the research. (shrink)

Sex differences in aggressive behavior are probably adaptive but the costs and benefits of risky aggression to women and men may be different from those suggested in Campbell's target article. Moreover, sex differences are more likely to reflect differences in the costs of aggression to females and males rather than differences in its benefits.

1The opinions contained in this article are those of the authors and should not be construed as policies of the American Medical Association.