In the Critique of Pure Reason, Immanuel Kant offers a revolutionary approach to cognition, wherein cognition can be understood as an action carried out by a cognitive agent. But giving the subject such an active role raises questions about Kant’s ability to account for objective cognition. In this paper, I will argue that the cognitive autonomy thesis central to Kant’s model renders it unable to account for the normativity required for objective cognition, and that G.W.F. Hegel makes just this criticism (...) in the Desire section of his Phenomenology of Spirit. Hegel proposes an alternative: some basic intersubjective structure must be built into cognition on a fundamental level. For Hegel, the possibility of disagreement is an a priori requirement for objective cognition in general. (shrink)

Some research is too risky to be conducted on anyone whose life expectancy is more than a few hours. Yet sometimes, the research can still be carried out using subjects who are brain dead or are soon to undergo a terminal wean, and who have articulated values that inclusion in the study can honor. So argues a team of ethicists and researchers at M.D. Anderson Cancer Center, where such research was recently undertaken.

Even appropriate, ethically sound recommendations can generate angst. In this case, the principal investigator is concerned about the ethics consult recommendation to not inform the participan...

Some research is too risky to be conducted on anyone whose life expectancy is more than a few hours. Yet sometimes, the research can still be carried out using subjects who are brain dead or are soon to undergo a terminal wean, and who have articulated values that inclusion in the study can honor. So argues a team of ethicists and researchers at M.D. Anderson Cancer Center, where such research was recently undertaken.

BackgroundAlthough patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the patient-preferred presentation (...) of important information in consent forms for these trials.MethodsThe study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH information); Window consents were analyzed for the location(s) of information stating the trial may delay SOC surgery (delay information). Participants were asked about their preferred placement of the information in their own trial’s consent form. The location of information in the consent forms was compared to the participants’ suggestions for placement. Results34 [17 FIH; 17 Window] of 42(81%) cancer patients approached participated. 25 consents [20 FIH; 5 Window] were analyzed. 19/20 FIH consent forms included FIH information, and 4/5 Window consent forms included delay information. 19/20(95%) FIH consent forms contained FIH information in the risks section 12/17(71%) patients preferred the same. Fourteen (82%) patients wanted FIH information in the purpose, but only 5(25%) consents mentioned it there. 9/17(53%) Window patients preferred delay information to be located early in the consent, before the “Risks” section. 3/5(60%) consents did this.ConclusionsDesigning consents that reflect patient preferences more accurately is essential for ethical informed consent; however, a one-size fits all approach will not accurately capture patient preferences. We found that preferences differed for FIH and Window trial consents, though for both, patients preferred key risk information early in the consent. Next steps include determining if FIH and Window consent templates improve understanding. (shrink)

The child was 2 years, 8 months old and weighed 25 pounds, one-fifth the weight of her mother, for whom she was to be the bone marrow donor. The mother had suffered a relapse of acute myelogenous leukemia; her physicians recommended a bone marrow transplant. The child was the closest human leukocyte antigen match and thus the best donor candidate for her mother's transplant.

In this paper, I argue that the role of values in theory selection is an important issue within medical education. I review the underdetermination argument, which is the idea within philosophy of science that the data serving as evidence for theories are by themselves not sufficient to support a theory to the exclusion of alternatives. There are always various explanations compatible with the data, and we ultimately appeal to certain values as our grounds for choosing one theory over another. I (...) explore some of the ways contemporary feminist philosophers have chosen to grapple with the problem of underdetermination and proposed solutions to systematize how values might be incorporated into theory choice, drawing primarily from the work of Helen Longino and Elizabeth Anderson. I conclude by discussing how value‐laden inquiry should be incorporated within medical education to promote reflection towards medicine’s normative underpinnings. (shrink)

Multiple groups, including the National Bioethics Advisory Commission, the American Society of Clinical Oncology, the National Coalition of Comprehensive Cancer Centers, Workgroup 6 of the Summit Series on Cancer, PRIM&R, the Bell Report, and prominent ethicists have called for replacing the current system of local institutional review with central review for multisite national trials. We argue that this need is particularly acute in pediatric oncology, as shown by the experience of the Children's Oncology Group.

Access to investigational drugs is a concern to patients and regulatory agencies. In order to determine potential trial participants’ views on access to investigational drugs, we surveyed one hundred people who had been referred to a phase I clinical trial. Most respondents indicated that patients had a right to investigational drugs, that the drugs should be offered only in the context of research, that getting access to these drugs is too hard, and that knowing the right people and being persistent (...) increased the likelihood of gaining access. Respondents did not think that investigational drugs should be given to anyone who wanted them, or that physicians were aware of the latest investigational agents. They most frequently recommended two allocation criteria: offering investigational drugs to those who would benefit most or were most needy; and allocating them to maximize scientific advancement. Respondents who understood the purpose of the trial were more likely to choose the second criterion. (shrink)

In general, we endorse Aggleton & Brown's thesis that the neuroanatomy of amnesia comprises two functionally distinct systems, but we are disappointed in the lack of detail regarding the critical functional contribution of the hippocampus. We also take issue with the characterization of the cortical areas surrounding the hippocampus, particularly the decreased emphasis on the cortical input to the hippocampus.

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

Health, ethics and COP27 On the 20 November 2022, the United Nations Climate Change COP27 announced a breakthrough agreement to provide ‘loss and damage’ funding for resource-poor countries seriously affected by climate change. 1 The establishment of the funding stream acknowledges, and attempts to address, one of many thorny ethical issues driven by climate change – to what extent countries that have benefited economically from past emissions of greenhouse gases owe reparative obligations to countries who have contributed minimally to climate (...) change but are most at risk of its harms? One of the many reasons why this is such an important breakthrough is that it brings into the centre of climate policy-making questions of global – and intergenerational – justice and fairness. It acknowledges the critical importance of ethics in climate change deliberations. It is probably fair to say that climate change policy has been dominated to... (shrink)

Legal battles continue in the UK over the Government’s plans to transport asylum seekers arriving on British shores to Rwanda in East Africa. Originally announced as a system for ‘processing’ asylum seekers, the Government has subsequently made it clear that there would not be an option for asylum seekers to return to the UK. The arrangement forms part of a deal between the UK and Rwanda, with the UK promising to invest £120 m in economic growth and development in Rwanda, (...) along with financing the cost of the ‘offshored’ asylum operation.1 The Government states that the policy is designed to break the business model of people traffickers involved in facilitating hazardous trips across the Channel in small, overcrowded and unseaworthy craft, leading to multiple drownings. Critics argue that the policy will do nothing to stop desperate people from seeking refuge in the UK, that transferring already traumatised people to Rwanda – which has been criticised for its human rights record – is inhumane and potentially outwith international law. Medical bodies, including the BMA, along with refugee organisations have expressed serious concerns about the health impact of such a system of ‘offshoring’. An equivalent system in Australia has been notorious for the devastating health impacts on those ‘offshored’ to the Pacific islands of Manus and Naura. Unusually in the UK the offshoring proposals have been greeted by unanimous condemnation by the Church of England. The lawfulness of the process is also subject to question. On the 14 July, a plane carrying a small number of asylum seekers to Rwanda was halted shortly before take-off following an intervention by the European Court of Human Rights. The ECtHR, part of the Council of Europe, of which the UK is still a member, said an Iraqi man known as KN faced ‘a real …. (shrink)

Research involving recently deceased humans that are physiologically maintained following declaration of death by neurologic criteria—or ‘research involving the recently deceased’—can fill a translational research gap while reducing harm to animals and living human subjects. It also creates new challenges for honouring the donor’s legacy, respecting the rights of donor loved ones, resource allocation and public health. As this research model gains traction, new empirical ethics questions must be answered to preserve public trust in all forms of tissue donation and (...) in the practice of medicine while respecting the legacy of the deceased and the rights of donor loved ones. This article suggests several topics for immediate investigation to understand the attitudes and experiences of researchers, clinical collaborators, donor loved ones and the public to ensure research involving the recently deceased advances ethically. (shrink)

Over the course of its history, feminist standpoint theory has encountered a number of problems which reveal divisions among its supporters over certain fundamental philosophical commitments. This chapter sketches a phenomenological account of perception that can begin to address these problems, drawn largely from Maurice Merleau-Ponty’s Phenomenology of Perception. Merleau-Ponty can help us resolve these issues by providing an account of perspectival perception wherein a multiplicity of different perceptual standpoints all nonetheless put us in touch with a single external world, (...) and in which some standpoints may be better than others when it comes to accessing certain features of this world. For Merleau-Ponty, the proliferation of standpoints need not lead us into an unacceptably relativistic framework, as long as we are able to conceive of each of these standpoints as giving whoever occupies it access to some particular aspect of a singular, real, shared world. (shrink)

In December 2022, the Office of the National Data Guardian (NDG)1 for health and social care in England published new guidance: What do we mean by public benefit? Evaluating public benefit when health and adult social care data is used for purposes beyond individual care.2 Research in the UK consistently demonstrates that for the public to consider a secondary use3 of health and care data appropriate and acceptable, it must deliver a benefit back to the public.4 The aim of the (...) guidance is to help organisations to interpret and demonstrate the public good from their work more comprehensively, accurately, and consistently. The guidance defines and standardises the concept of public benefit to enable clearer interpretation and understanding. It aims to support better public benefit evaluations by: As the guidance is underpinned by a detailed dialogue with the public on what counts as a public benefit, it is hoped that following it will …. (shrink)

We carry out a systematic study of decidability for theories of real vector spaces, inner product spaces, and Hilbert spaces and of normed spaces, Banach spaces and metric spaces, all formalized using a 2-sorted first-order language. The theories for list turn out to be decidable while the theories for list are not even arithmetical: the theory of 2-dimensional Banach spaces, for example, has the same many-one degree as the set of truths of second-order arithmetic.We find that the purely universal and (...) purely existential fragments of the theory of normed spaces are decidable, as is the ∀∃ fragment of the theory of metric spaces. These results are sharp of their type: reductions of Hilbertʼs 10th problem show that the ∃∀ fragments for metric and normed spaces and the ∀∃ fragment for normed spaces are all undecidable. (shrink)

Volume 20, Issue 8, August 2020, Page W12-W13.

What role does audience uptake play in determining whether a speaker refuses or consents to sex? Proponents of constitution theories of uptake argue that which speech act someone performs is largely determined by their addressee’s uptake. However, this appears to entail a troubling result: a speaker might be made to perform a speech act of sexual consent against her will. In response, we develop a social constitution theory of uptake. We argue that addressee uptake can constitute a speaker’s utterance of (...) ‘no’ as a speech act of consent under some conditions, but that this does not prevent us from judging that an addressee committed rape. Second, we claim that addressee uptake is not the only form of uptake that matters—the uptake of other members of the discursive community matters too, and can override the addressee’s uptake, constituting the speaker’s utterance as the speech act it was intended to be. (shrink)

At the time of writing, the UK Government’s ‘Illegal Migration Bill’1 had started progressing through the House of Commons. The Bill will enable the removal of people who have come to the UK seeking asylum by ‘illegal’ routes, including via the dangerous Channel crossing in small boats.2 That duty would apply whether a person makes a protection claim, human rights claim or is a victim of modern slavery or human trafficking. Asylum seekers risk crossing the Channel because there are very (...) few, if any, safe and lawful ways to reach the UK. At least 60% of the people who have made the crossing last year would be recognised as refugees through the asylum process.3 The Bill will also give the UK Secretary of State a follow up duty to deny people arriving by ‘illegal’ routes access to the asylum system and to permanently deny them legal status in the UK, this includes leave to remain and citizenship. On the 24 March, the Council of Europe Commissioner for Human Rights wrote to both Speakers of the UK parliament, stating ‘… the Bill would have serious consequences both for the rights of refugees, asylum seekers and migrants in the UK, and for the upholding of the UK’s international obligations more generally. The UNHCR [UN Refugee Agency] has already stated that the Bill is in clear breach of the UK’s obligations under the 1951 …. (shrink)

In previous Ethics briefings 1 we have highlighted the developments in the case of Bell & Another v the Tavistock and Portman NHS Foundation Trust. The case concerned a judicial review of the practice of prescribing puberty blocking treatment to children and young people at the Gender Identity Development Service managed by the Tavistock and Portman NHS Foundation Trust. The Court of Appeal in its judgement2 found the Trust’s practices to be lawful, and overturned previous guidance given by the High (...) Court which had contradicted the 'Gillick principle' regarding whether a child or young person could consent to medical treatment, without the consent of its parent. Despite this legal success, concerns over the GIDS continued. In September, NHS England commissioned an independent and wide-ranging review of gender identity services for children and young people led by Dr Hilary Cass, past president of the Royal College of Paediatrics and Child Health. Dr Cass’s Interim review, published in March,3 has resulted in a decision by NHS England to close the GIDS at the Trust by Spring 2023, and replace it with regional centres at existing children’s hospitals offering more 'holistic care' with ’strong links to mental health services’. It is proposed that regional centres will be established at Great Ormond Street Hospital, and Alder Hey Children’s NHS Foundation Trust. Dr Cass was critical of the clinic’s failure to collect sufficient data on the impact of puberty blockers in under-16s. …. (shrink)

The office of the United nations high commissioner for human rights (OHCHR): serious human rights abuses against the Uyghur people in Xinjiang, China Very close to midnight on the 31 August 2022, minutes before Michelle Bachelet’s four-year term as UN Commissioner for Human Rights came to an end, her office finally succeeded in publishing her long-delayed report into serious human rights violations in the Xinjiang province in China. According to The Guardian newspaper, papers leaked in July of the same year (...) showed sustained efforts by China to prevent the report’s release, and Bachelet has subsequently spoken of the intense pressure she was put under by the Chinese to prevent the report’s publication. 1 The report is sobering. 2 It is explicit that the Peoples’ Republic of China (PRC) has committed systematic violations of fundamental human rights against the Uyghur and other Turkic Muslim minorities in Xinjiang... (shrink)

Feminist standpoint theory is a variety of feminist epistemology that has been active since the 1980s. Its two central tenets are (1) that knowledge is necessarily situated within a socio-political context, and (2) that certain socio-political positions or standpoints are epistemically privileged when it comes to “reveal[ing] the truth of social reality” (Hekman 1997). Over the course of its history, standpoint theory has encountered a number of problems which have revealed divisions among its supporters over certain fundamental philosophical commitments. In (...) this paper, I sketch out a phenomenological account of perception that can begin to address these problems, drawn largely from Maurice Merleau-Ponty’s Phenomenology of Perception. There are two major issues that I believe a Merleau-Pontyan view of perception can help alleviate. One is that there has never been a thorough articulation of a theory of perception underlying standpoint theory’s central claims. This is surprising, since arguments in favor of standpoint theory often emphasize that occupying a certain standpoint enables one to see the world differently (see Hartsock 1983, among others). The other problem is the complex tension between standpoint theory’s two central theses. Positing that knowledge is necessarily situated seems to make it difficult to account for one single reality about which some particular group could be epistemically privileged (Hekman 1997). Merleau-Ponty can help us resolve these issues by providing an account of perspectival perception wherein a multiplicity of different perceptual standpoints all nonetheless put us in touch with a single "external" world. Merleau-Ponty’s account also explains how it could be that some standpoints are better than others when it comes to accessing certain features of this world. For Merleau-Ponty, it is not a problem if each perspective is incomplete, partial, or even apparently conflicting with other perspectives. The proliferation of standpoints need not lead us into an unacceptably relativistic framework, as long as we are able to conceive of each of these standpoints as giving whoever occupies it access to some particular aspect of a singular, real, shared world. (shrink)

This essay describes and critically evaluates a co-operative educational program to train Ugandan health care workers in bioethics. It describes one bottom-up effort, a week-long intensive workshop in bioethics provided by the authors to health care professionals in a developing country—Uganda. We will describe the background and circumstances that led to the organization of the workshop, and review its planning, design, curriculum, and outcome. We will focus especially on measures taken to make the workshop relevant for the audience of Ugandan (...) professionals, and describe lessons learned after two presentations of the workshop. Finally, we will discuss the strengths and weaknesses of such a format, and its potential value in raising bioethical expertise in developing countries. (shrink)

This paper argues that there exists a collective epistemic state of ‘Broad Medical Uncertainty’ regarding the effectiveness of many medical interventions. We outline the features of BMU, and describe some of the main contributing factors. These include flaws in medical research methodologies, bias in publication practices, financial and other conflicts of interest, and features of how evidence is translated into practice. These result in a significant degree of uncertainty regarding the effectiveness of many medical treatments and unduly optimistic beliefs about (...) the benefit/harm profiles of such treatments. We argue for an ethical presumption in favour of openness regarding BMU as part of a ‘Corrective Response’. We then consider some objections to this position, including concerns that public honesty about flaws in medical research could undermine trust in healthcare institutions. We suggest that, as it stands, the Anti-Corrective Response is unconvincing. (shrink)

Biological ontologies are used to organize, curate, and interpret the vast quantities of data arising from biological experiments. While this works well when using a single ontology, integrating multiple ontologies can be problematic, as they are developed independently, which can lead to incompatibilities. The Open Biological and Biomedical Ontologies Foundry was created to address this by facilitating the development, harmonization, application, and sharing of ontologies, guided by a set of overarching principles. One challenge in reaching these goals was that the (...) OBO principles were not originally encoded in a precise fashion, and interpretation was subjective. Here we show how we have addressed this by formally encoding the OBO principles as operational rules and implementing a suite of automated validation checks and a dashboard for objectively evaluating each ontology’s compliance with each principle. This entailed a substantial effort to curate metadata across all ontologies and to coordinate with individual stakeholders. We have applied these checks across the full OBO suite of ontologies, revealing areas where individual ontologies require changes to conform to our principles. Our work demonstrates how a sizable federated community can be organized and evaluated on objective criteria that help improve overall quality and interoperability, which is vital for the sustenance of the OBO project and towards the overall goals of making data FAIR. Competing Interest StatementThe authors have declared no competing interest. (shrink)

Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase (...) 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules. (shrink)