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.

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.

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.

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.

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)

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...

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)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

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)

Clinical trials for acute conditions such as myocardial infarction and stroke pose challenges related to informed consent due to time limitations, stress, and severe illness. Consent processes shou...

PURPOSE: There is an increasing demand for researchers to provide research results to participants. Our aim was to define an appropriate process for this, based on needs and attitudes of participants. METHODS: A multicenter survey in five sites in the United States and Canada was offered to parents of children with cancer and adolescents with cancer. Respondents indicated their preferred mode of communication of research results with respect to implications; timing, provider, and content of the results; reasons for and against (...) providing results; and barriers to providing results. RESULTS: Four hundred nine parents (including 19 of deceased children) and 86 adolescents responded. Most parents (n = 385; 94.2%) felt that they had a strong right to research results. For positive results, most wanted a letter or e-mail summary (n = 238; 58.2%) or a phone call followed by a letter (n = 100; 24.4%). If the results were negative, phone call (n = 136; 33.3%) or personal visits (n = 150; 36.7%) were preferred. Parents wanted the summary to include long-term sequelae and suggestions for participants (n = 341; 83.4%), effect on future treatments (n = 341; 83.4%), and subsequent research steps (n = 284; 69.5%). Understanding the researcher was a main concern about receiving results (n = 145; 35.5%). Parents felt that results provide information to support quality of life (n = 315; 77%) and raise public awareness of research (n = 282; 68.9%). Adolescents identified similar preferences. CONCLUSION: Parents of children with cancer and adolescents with cancer feel strongly that they have a right to be offered research results and have specific preferences of how and what information should be communicated. (shrink)

PURPOSE: The offer to return research results to participants is increasingly recognized as an ethical obligation, although few researchers routinely return results. We examined the needs and attitudes of parents of children with cancer and of adolescents with cancer to the return of research results. METHODS: Seven experts in research ethics scored content validity on parent and adolescent questionnaires previously developed through focus group and phone interviews. The questionnaires were revised and provided to 30 parents and 10 adolescents in a (...) tertiary care oncology setting. RESULTS: The content validity index for individual questions and the overall questionnaires scored as 0.86 for both questionnaires. All 30 parents and 10 adolescents who agreed to participate returned questionnaires. The majority (>95%) indicated that they had a strong or very strong right to receive results. Letter or e-mail was a satisfactory means to return results described as good or neutral (66% parents, 100% adolescents) but more participants wished face-to-face disclosure of results with negative implications (50% parents, 60% adolescents). Very few wanted results disseminated through a Web site. The majority acknowledged the need for peer-review before disclosure (60% of adolescents and parents) but did not want "to be the last to know." CONCLUSIONS: Our data suggest that pediatric oncology patients and parents of children with cancer strongly feel that they have a right to research results, and that they wish to receive these in a timely manner. (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)

Background: Low rates of participation of adolescents and young adults (AYAs) in clinical oncology trials may contribute to poorer outcomes. Factors that influence the decision of AYAs to participate in health research and whether these factors are different from those that affect the participation of parents of children with cancer. Methods: This is a secondary analysis of data from validated questionnaires provided to adolescents (>12 years old) diagnosed with cancer and parents of children with cancer at 3 sites in Canada (...) (Halifax, Vancouver, and Montreal) and 2 in the United States (Atlanta, GA, and Memphis, TN). Respondents reported their own research participation and cited factors that would influence their own decision to participate in, or to provide parental authorization for their child to participate in health research. Results: Completed questionnaire rates for AYAs and parents were 86 (46.5%) of 185 and 409 (65.2%) of 627, respectively. AYAs (n = 86 [67%]) and parents (n = 409 [85%]) cited that they would participate in research because it would help others. AYAs perceived pressure by their family and friends (16%) and their physician (19%). Having too much to think about at the time of accrual was an impediment to both groups (36% AYAs and 47% parents). The main deterrent for AYAs was that research would take up too much time (45%). Nonwhite parents (7 of 56 [12.5%]) were more apt to decline than white parents (12 of 32 [3.7%]; P < .01). Conclusions: AYAs identified time commitment and having too much to think about as significant impediments to research participation. Addressing these barriers by minimizing time requirements and further supporting decision-making may improve informed consent and impact on enrollment in trials. (shrink)

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

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)

"Patient advocates can help make research more ethical, but advocacy raises ethical issues of its own.

Former NAACP chapter head Rachel Dolezal's attempted transition from the white to the black race occasioned heated controversy. Her story gained notoriety at the same time that Caitlyn Jenner graced the cover of Vanity Fair, signaling a growing acceptance of transgender identity. Yet criticisms of Dolezal for misrepresenting her birth race indicate a widespread social perception that it is neither possible nor acceptable to change one's race in the way it might be to change one's sex. Considerations that support transgenderism (...) seem to apply equally to transracialism. Although Dolezal herself may or may not represent a genuine case of a transracial person, her story and the public reaction to it serve helpful illustrative purposes. (shrink)

Proofs are central, and unique, to mathematics. They establish the truth of theorems and provide us with the most secure knowledge we can possess. It is thus perhaps unsurprising that philosophers once thought that the only value proofs have lies in establishing the truth of theorems. However, such a view is inconsistent with mathematical practice. If a proof’s only value is to show a theorem is true, then mathematicians would have no reason to reprove the same theorem in different ways, (...) yet this is a practice they frequently engage in. This suggests that proofs can have a wide variety of values. My purpose in this chapter is to provide a survey of some of them. I will discuss how proofs can have practical value, for example, by helping mathematicians to make new discoveries or learn new mathematical tools, and how they can have abstract value, for example, by being beautiful or explanatory. I will also explore the relationships between different proof values. (shrink)

Emerging from the internationally recognised Theorising Normalcy and the Mundane conference series, the chapters in this book offer wide-ranging critiques of that most pervasive of ideas, 'normal'. In particular, they explore the precarious positions we are presented with and, more often than not, forced into by 'normal', and its operating system, 'normalcy' (Davis, 2010). They are written by activists, students, practitioners and academics and offer related but diverse approaches. Importantly, however, the chapters also ask, what if increasingly precarious encounters with, (...) and positions of, marginality and non-normativity offers us a chance (perhaps the chance) to critically explore the possibilities of 'imagining otherwise'? The book questions the privileged position of 'non-normativity'; in youth and unpacks the expectation of the 'normal' student in both higher and primary education. It uses the position of transable people to push the boundaries of 'disability', interrogates the psycho-emotional disablism of box-ticking bureaucracy and spotlights the 'urge to know' impairment. It draws on cross-movement and cross-disciplinary work around disability to explore topics as diverse as drug use, The Bible and relational autonomy. Finally, and perhaps most controversially, it explores the benefits of (re)instating 'normal'. By paying attention to the opportunities presented amongst the fissures of critique and defiance, this book offers new applications and perspectives for thinking through the most ordinary of ideas, 'normal'. (shrink)

: Aanerud's project is to develop an account of white antiracist mothering, using a model of maternal duty to raise antiracist white children. The author sets this project in the context of historic constructions of white mothering in the twentieth century and then contrasts the need for an exploration of white mothers raising white children against the literature of white mothers' raising children of color and mothers of color raising their own children, Once this distinction is made, Aanerud uses Collins's (...) account of racial ethnic mothering as a springboard into her discussion of antiracist white mothering of white children. (shrink)

Traditionally, social entities (i.e., social properties, facts, kinds, groups, institutions, and structures) have not fallen within the purview of mainstream metaphysics. In this chapter, we consider whether the exclusion of social entities from mainstream metaphysics is philosophically warranted or if it instead rests on historical accident or bias. We examine three ways one might attempt to justify excluding social metaphysics from the domain of metaphysical inquiry and argue that each fails. Thus, we conclude that social entities are not justifiably excluded (...) from metaphysical inquiry. Finally, we ask how focusing on social entities could change the character of metaphysical inquiry. We suggest that starting from examples of social entities might lead metaphysicians to rethink the assumption that describing reality in terms of intrinsic, independent, and individualistic features is preferable to describing it in terms of relational, dependent, and non-individualistic features. (shrink)

The 'Gamer's Dilemma' is the problem of why some actions occurring in video game contexts seem to have similar, albeit attenuated, kinds of moral significance to their real-world equivalents, while others do not. In this paper, I argue that much of the confusion in the literature on this problem is not ethical but metaphysical. The Gamer's Dilemma depends on a particular theory of the virtual, which I call 'inflationary', according to which virtual worlds are a metaphysical novelty generated almost exclusively (...) by video games. Actions performed in virtual worlds really belong to the kinds of action they appear to—'virtual murder' is a kind of murder. Inflationary theories are contrasted with 'deflationary' theories which, in effect, consider video games purely as systems for generating images, and thus the gamer as a consumer of media images. Inflationary theories struggle to explain why video games produce this unique metaphysical novelty; deflationary theories fail to do justice to the intuition that there is some significant difference between the gamer and the consumer of other media forms. In place of either, I sketch a theory of the gamer as performer, primarily by analogy with stage and cinema actors, which I suggest captures more of the moral complexity of the gamer's action. (shrink)

Aanerud's project is to develop an account of white antiracist mothering, using a model of maternal duty to raise antiracist white children. The author sets this project in the context of historic constructions of white mothering in the twentieth century and then contrasts the need for an exploration of white mothers raising white children against the literature of white mothers’ raising children of color and mothers of color raising their own children, Once this distinction is made, Aanerud uses Collins's account (...) of racial ethnic mothering as a springboard into her discussion of antiracist white mothering of white children. (shrink)

Aanerud's project is to develop an account of white antiracist mothering, using a model of maternal duty to raise antiracist white children. The author sets this project in the context of historic constructions of white mothering in the twentieth century and then contrasts the need for an exploration of white mothers raising white children against the literature of white mothers’ raising children of color and mothers of color raising their own children, Once this distinction is made, Aanerud uses Collins's account (...) of racial ethnic mothering as a springboard into her discussion of antiracist white mothering of white children. (shrink)

In this article, we outline a novel approach to understanding the role of responsibility in health promotion. Efforts to tackle chronic disease have led to an emphasis on personal responsibility and the identification of ways in which people can ‘take responsibility’ for their health by avoiding risk factors such as smoking and over-eating. We argue that the extent to which agents can be considered responsible for their health-related behaviour is limited, and as such, state health promotion which assumes certain forms (...) of moral responsibility should be avoided. This indicates that some approaches to health promotion ought not to be employed. We suggest, however, that another form of responsibility might be more appropriately identified. This is based on the claim that agents have prudential reasons to maintain their health, in order to pursue those things which make their lives go well—i.e. that maintenance of a certain level of health is rational for many agents, given their pleasures and plans. On this basis, we propose that agents have a self-regarding prudential responsibility to maintain their health. We outline the implications of a prudential responsibility approach to health promotion. (shrink)

Human Rights Education (HRE) has traditionally been articulated in terms of cultivating better citizens or world citizens. The main preoccupation in this strand of HRE has been that of bridging a gap between universal notions of a human rights subject and the actual locality and particular narratives in which students are enmeshed. This preoccupation has focused on ‘learning about the other’ in order to improve relations between plural ‘others’ and ‘us’ and reflects educational aims of national identity politics in citizenship (...) education. The article explores the learning of human rights through narratives in relations, drawing on Hannah Arendt and Sharon Todd. For this re-thinking of relations in learning human rights, the article argues that HRE needs to address both competing historical narratives on the drafting of the Universal Declaration on Human Rights (UDHR) as well as unique life narratives of learners. (shrink)

In Working Virtue: Virtue Ethics and Contemporary Moral Problems, leading figures in the fields of virtue ethics and ethics come together to present the first ...

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)

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)

(No abstract is available for this citation).