Background In their paper “Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better” Petrova and Barclay highlight concerns with the health research regulatory environment in the UK. Discussion As long-standing chairs of NHS research ethics committees, researchers, and also academics in research ethics, we are also often frustrated with the regulatory process in the UK. However, we think that Petrova and Barclay’s analysis is misleading because it conflates research (...) ethics with governance and funding processes, thus failing to adequately distinguish between the national coordinating function of the Health Research Authority, local research governance processes, and interactions with research sponsors and/or the Clinical Research Network. (shrink)

Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals ( n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focussed upon this, concentrating more on written (...) material. We propose ways this interactive conversation can be documented, and the process of checking understanding improved. (shrink)

In this paper, we review recent neuroimaging investigations of disorders of consciousness and different disciplines' understanding of consciousness itself. We consider potential tests of consciousness, their legal significance, and how they map onto broader themes in U.S. statutory law pertaining to advance directives and surrogate decision-making. In the process, we outline a taxonomy of themes to illustrate and clarify the variance in state-law definitions of consciousness. Finally, we discuss broader scientific, ethical, and legal issues associated with the advent of neuroimaging (...) for disorders of consciousness and conclude with policy recommendations that could help to mitigate confusion in this realm. (shrink)

BackgroundWe conducted a survey to identify what types of health/medical research could be exempt from research ethics reviews in Australia.MethodsWe surveyed Australian health/medical researchers and Human Research Ethics Committee members. The survey asked whether respondents had previously changed or abandoned a project anticipating difficulties obtaining ethics approval, and presented eight research scenarios, asking whether these scenarios should or should not be exempt from ethics review, and to provide comments. Qualitative data were analysed thematically; quantitative data in R.ResultsWe received 514 responses. (...) Forty-three per cent of respondents to whom the question applied, reported changing projects in anticipation of obstacles from the ethics review process; 25% reported abandoning projects for this reason. Research scenarios asking professional staff to provide views in their area of expertise were most commonly exempted from ethics review ; scenarios involving surplus samples and N-of-1 studies were most commonly required to undergo ethics review. HREC members were 26% more likely than researchers to require ethics review. Need for independent oversight, and low risk, were most frequently cited in support of decisions to require or exempt from ethics review, respectively.ConclusionsConsiderable differences exist between researchers and HREC members, about when to exempt from review the research that ultimately serves the interests of patients and the public. It is widely accepted that evaluative research should be used to reduce clinical uncertainties—the same principle should apply to ethics reviews. (shrink)

We examined whether midazolam impairs short-term/working memory processes. We hypothesize that prior dissociations in midazolam’s effects on short-term/working memory tasks and episodic memory tasks arise because midazolam has a larger effect on episodic memory processes than on short-term/working memory processes. To examine these issues, .03 mg/kg of participant’s bodyweight of midazolam was administered in a double-blind placebo-controlled within-participant design. Performance on the digit span and category generation/recall tasks was examined. The results of Experiment 1 demonstrated that: midazolam impaired performance on (...) the digit span task; midazolam did not impair performance on the category generation task; midazolam impaired performance on the category recall task; and midazolam’s effect on category recall was four times as large as its effect on digit span. The results of Experiment 2 demonstrated that midazolam did not impair digit span performance when the digit span task was administered at a later time. These results suggest that midazolam can impair short-term/working memory processes, but these effects are substantially smaller than midazolam’s effect on episodic memory processes. Moreover, they demonstrate that conscious awareness of materials during study is not sufficient to produce episodic memory. (shrink)

_Arguing about Metaethics_ collects together some of the most exciting contemporary work in metaethics in one handy volume. In it, many of the most influential philosophers in the field discuss key questions in metaethics: Do moral properties exist? If they do, how do they fit into the world as science conceives it? If they don’t exist, then how should we understand moral thought and language? What is the relation between moral judgement and motivation? As well as these questions, this volume (...) discusses a wide range of issues including moral objectivity, truth and moral judgements, moral psychology, thick evaluative concepts and moral relativism. The editors provide lucid introductions to each of the eleven themed sections in which they show how the debate lies and outline the arguments of the papers. _Arguing about Metaethics_ is an ideal resource text for students at upper undergraduate or postgraduate level. (shrink)

Cancer is a singular cellular state, the emergence of which destabilises the homeostasis reached through the evolution to multicellularity. We present the idea that the onset of the cellular disobedience to the metazoan functional and structural architecture, known as the cancer phenotype, is triggered by changes in the cell's external environment that occur with ageing: what ensues is a breach of the social contract of multicellular life characteristic of metazoans. By integrating old ideas with new evidence, we propose that with (...) ageing the environmental information that maintains a multicellular organisation is eroded, rewiring internal processes of the cell, and resulting in an internal shift towards an ancestral condition resulting in the pseudo‐multicellular cancer phenotype. Once that phenotype emerges, a new local social contract is built, different from the homeostatic one, leading to tumour formation and the foundation of a novel local ecosystem. (shrink)

Filling a gap in scholarship on 19th- and 20th-century religious thought, this book discusses the philosophy and theology of the influential Marburg School in Germany before 1914, focusing on the writings of Hermann Cohen, its leader, and on the Ritschlian theologian Wilhelm Herrmann, Karl Barth's teacher. In addition, Fisher examines Barth's earliest writings and clarifies the little-known liberal phase of Barth's theology.

Language’s intentional nature has been highlighted as a crucial feature distinguishing it from other communication systems. Specifically, language is often thought to depend on highly structured intentional action and mutual mindreading by a communicator and recipient. Whilst similar abilities in animals can shed light on the evolution of intentionality, they remain challenging to detect unambiguously. We revisit animal intentional communication and suggest that progress in identifying analogous capacities has been complicated by (i) the assumption that intentional (that is, voluntary) production (...) of communicative acts requires mental-state attribution, and (ii) variation in approaches investigating communication across sensory modalities. To move forward, we argue that a framework fusing research across modalities and species is required. We structure intentional communication into a series of requirements, each of which can be operationalised, investigated empirically, and must be met for purposive, intentionally communicative acts to be demonstrated. Our unified approach helps elucidate the distribution of animal intentional communication and subsequently serves to clarify what is meant by attributions of intentional communication in animals and humans. (shrink)

Cognitive Science, Volume 46, Issue 2, February 2022.

This case details the new product development and approval of Posilac®, an animal drug product pioneered by the Monsanto Company. The product is a genetically engineered hormone known as bovine somatotropin (BST) and was targeted for sale to dairy farmers to enhance the milk production of their herds. At the time of its development and subsequent introduction to the market, Posilac® represented one the first applications of genetic engineering in food production and as such, it became a lightning rod for (...) controversy. As Monsanto sought approval for this product from the U.S. Food and Drug Administration (FDA), it encountered vigorous opposition from a variety of consumer and trade interests. The (A) case recounts the arduous approval process and explains how industry and public policy debates largely focused on issues of product labeling. (shrink)

This case details the new product development and approval of Posilac®, an animal drug product pioneered by the Monsanto Company. The product is a genetically engineered hormone known as bovine somatotropin (BST) and was targeted for sale to dairy farmers to enhance the milk production of their herds. At the time of its development and subsequent introduction to the market, Posilac® represented one the first applications of genetic engineering in food production and as such, it became a lightning rod for (...) controversy. As Monsanto sought approval for this product from the U.S. Food and Drug Administration (FDA), it encountered vigorous opposition from a variety of consumer and trade interests. The (A) case recounts the arduous approval process and explains how industry and public policy debates largely focused on issues of product labeling. (shrink)

This case details the new product development and approval of Posilac®, an animal drug product pioneered by the Monsanto Company. The product is a genetically engineered hormone known as bovine somatotropin (BST) and was targeted for sale to dairy farmers to enhance the milk production of their herds. At the time of its development and subsequent introduction to the market, Posilac® represented one the first applications of genetic engineering in food production and as such, it became a lightning rod for (...) controversy. As Monsanto sought approval for this product from the U.S. Food and Drug Administration (FDA), it encountered vigorous opposition from a variety of consumer and trade interests. The (A) case recounts the arduous approval process and explains how industry and public policy debates largely focused on issues of product labeling. (shrink)

Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption, involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal decision-making study (...) nested in a Thai acute HIV research cohort. In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks. These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach. (shrink)

De Marco and colleagues claim that the standard account of invasiveness as commonly encountered ‘...does not capture all uses of the term in relation to medical interventions 1 ’. This is open to challenge. Their first example is ‘non-invasive prenatal testing’. Because it involves puncturing the skin to obtain blood, De Marco _et al_ take this as an example of how an incision or insertion is not sufficient to make an intervention invasive; here is a procedure that involves an incision, (...) but it is regarded as non-invasive. However, this ignores the context, and the term should really be understood in reference to the fetus. It is hard to believe healthcare professionals regard taking blood to measure, for example, ferritin levels as invasive but taking blood to look for fragments of fetal DNA as not. If anyone uses the term thinking it is not invasive to the mother, the... (shrink)