Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.

BACKGROUND: The offer of return of research results to study participants has many potential benefits. The current study examined the offer of return of research results by analyzing consent forms from 2 acute lymphoblastic leukemia studies of the 235 institutional members of the Children's Oncology Group. METHODS: Institutional review board (IRB)-approved consent forms from 2 standard-risk acute lymphoblastic leukemia studies (Children's Cancer Group [CCG] 1991 and Pediatric Oncology Group [POG] 9407) were analyzed independently by 2 reviewers. RESULTS: The authors received (...) replies from 202 of the 235 institutions that were contacted (85%). One hundred eighty-one institutions had CCG 1991 (n = 96) or POG 9905 (n = 85) protocols that were approved by an IRB. Most institutions provided contact information for the principal investigator (n = 175; 97%) and a member of the institution's research services office (n = 154; 85%). Only 5 (2.8%) institutions provided an indication of a participant's right to receive a summary of research results; most of these institutions provided details on how (n = 5) or when (n = 5) this was to occur. All of these institutions (n = 162; 89.5%) provided a specific statement offering new information that might affect a participant's decision to continue to participate in a study. Only 2 institutional consent forms offered participants the option to receive research results, and only 10 (5.5%) consent forms contained an unambiguous, specific statement offering to provide new information after the study was closed. CONCLUSIONS: Few institutional review board-approved consent forms explicitly indicate the right of research recipients to receive a summary of the results of the research in which they have participated. (shrink)

PURPOSE: The offer to return a summary of results to participants after the conclusion of clinical research has many potential benefits. The authors determined current practice and attitudes and needs of researchers in establishing programs to return results to research participants. METHODS: An Internet survey of all 236 principal investigators (PIs) of the Children's Oncology Group in May 2002 recorded PI and institutional demographics, current practice, and perceived barriers to and needs of PIs for the creation of research results programs. (...) RESULTS: One hundred fifty (63.8%) PIs responded. Few institutions (n = 5) had established, comprehensive programs to offer the return of results. PIs indicated that major impediments to the implementation of such programs are the preparation of lay summaries, time constraints, the task of contacting participants, and potential distress for the participants. PIs identified the following facilitators to the establishment of a program in their own institution: lay summaries, web site, preparation of an oncologist's summary, and financial credits. There was no clear consensus as to when the results should be shared: 30% indicated after the study was closed and 24% indicated at the time of publication of results. A substantial proportion of respondents opposed or strongly opposed the implementation of a universal offering of results to research participants. CONCLUSIONS: Few Children's Oncology Group institutions have programs that offer the return of results to research participants. Significant barriers and facilitators to this process have been identified. (shrink)

Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research Consortium. The authors then (...) negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death. (shrink)

My strategy is to examine a recent trend in philosophical discussions of responsibility, a trend that tries, but I think ultimately fails, to give an acceptable analysis of the conditions of responsibility. It fails due to what at first appear to be deep and irresolvable metaphysical problems. It is here that I suggest that the condition of sanity comes to the rescue. What at first appears to be an impossible requirement for responsibility---the requirement that the responsible agent have created her- (...) or himself---turns out to be the vastly more mundane and non controversial requirement that the responsible agent must, in a fairly standard sense, be sane. (shrink)

Bioethics has paid surprisingly little attention to the special problems faced by women and to feminist analyses of current health care issues other than ...

Background Dynamic consent has been proposed as a process through which participants and patients can gain more control over how their data and samples, donated for biomedical research, are used, resulting in greater trust in researchers. It is also a way to respond to evolving data protection frameworks and new legislation. Others argue that the broad consent currently used in biobank research is ethically robust. Little empirical research with cohort study participants has been published. This research investigated the participants’ opinions (...) of adding a dynamic consent interface to their existing study. Methods Adult participants in the Extended Cohort for E-health, Environment and DNA longitudinal cohort study who are members of the EXCEED Public and Participant Engagement Group were recruited. Four focus groups were conducted and analysed for thematic content. Discussion topics were derived from a review of the current literature on dynamic consent. Results Participants were in favour of many aspects of a dynamic consent interface, such as being able to update their information, add additional data to their records and choose withdrawal options. They were supportive provided it was simple to use and not intrusive. Participants expressed a markedly high level of trust in the study and its investigators and were unanimously happy with their current participation. No strong support was found for adding a dynamic consent interface to EXCEED. Conclusions Trust in the study researchers was the strongest theme found. Openness and good data security were needed to retain their trust. While happy to discuss dynamic consent, participants were satisfied with the current study arrangements. There were indications that changing the study might unnecessarily disturb their trust. This raised the question of whether there are contexts where dynamic consent is more appropriate than others. This study was limited by the small number of participants who were committed to the study and biased towards it. More research is needed to fully understand the potential impact of adding a dynamic consent interface to an existing cohort study. (shrink)

This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work was reproduced from the original artifact, and remains as true to the original work as possible. Therefore, you will see the original copyright references, library stamps (as most of these works have been housed in our most important libraries around the world), and other notations in the work. This work is in the public domain (...) in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. As a reproduction of a historical artifact, this work may contain missing or blurred pages, poor pictures, errant marks, etc. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant. (shrink)

The legal environment -- Regulation of nursing practice -- Nurses in legal actions -- Standards of care -- Defenses to negligence or malpractice -- Prevention of malpractice -- Nurses as witnesses -- Professional liability insurance -- Accepting or refusing an assignment/patient abandonment -- Delegation to unlicensed assistive personnel -- Patients' rights and responsibilities -- Confidential communication -- Competency and guardianship -- Informed consent -- Refusal of treatment -- Pain control -- Patient teaching and health counseling -- Medication administration -- Clients (...) with AIDS and HIV testing -- Abusive situations -- Reproductive services -- Restraints -- Emergency psychiatric admissions -- Organ and tissue donation and transplantation -- Discharge against medical advice -- The medical record and documentation standards -- Electronic health information and communications -- Interdependent nursing functions: verbal orders and telenursing -- Event reporting and compliance -- Quality and safety in nursing practice -- Forensic issues -- Employer and employee rights -- Contracts -- Corporate liability -- Employment contracts and unionization -- Employment status liability -- Staffing issues and floating -- Americans with Disabilities Act -- Employees with AIDS/HIV infection and exposure to bloodborne pathogens -- Impaired nurses -- Sexual harassment in the workplace -- Violence in the workplace -- Intentional torts -- Environmental health and safety -- Ethical decision making -- Professional boundaries and patient relationships -- Moral courage and patient advocacy -- Social media and online professionalism -- Reporting illegal, unethical, or unsafe conduct -- Maternal versus fetal rights -- Futility of care -- Advance directives and end-of-life decisions -- Assisted suicide. (shrink)

Only human beings have a rich conceptual repertoire with concepts like tort, entropy, Abelian group, mannerism, icon and deconstruction. How have humans constructed these concepts? And once they have been constructed by adults, how do children acquire them? While primarily focusing on the second question, in The Origin of Concepts , Susan Carey shows that the answers to both overlap substantially. Carey begins by characterizing the innate starting point for conceptual development, namely systems of core cognition. Representations of core (...) cognition are the output of dedicated input analyzers, as with perceptual representations, but these core representations differ from perceptual representations in having more abstract contents and richer functional roles. Carey argues that the key to understanding cognitive development lies in recognizing conceptual discontinuities in which new representational systems emerge that have more expressive power than core cognition and are also incommensurate with core cognition and other earlier representational systems. Finally, Carey fleshes out Quinian bootstrapping, a learning mechanism that has been repeatedly sketched in the literature on the history and philosophy of science. She demonstrates that Quinian bootstrapping is a major mechanism in the construction of new representational resources over the course of childrens cognitive development. Carey shows how developmental cognitive science resolves aspects of long-standing philosophical debates about the existence, nature, content, and format of innate knowledge. She also shows that understanding the processes of conceptual development in children illuminates the historical process by which concepts are constructed, and transforms the way we think about philosophical problems about the nature of concepts and the relations between language and thought. (shrink)

Wakefield’s harmful dysfunction analysis asserts that the concept of medical disorder includes a naturalistic component of dysfunction and a value component, both of which are required for disorder attributions. Muckler and Taylor, defending a purely naturalist, value-free understanding of disorder, argue that harm is not necessary for disorder. They provide three examples of dysfunctions that, they claim, are considered disorders but are entirely harmless: mild mononucleosis, cowpox that prevents smallpox, and minor perceptual deficits. They also reject the proposal that dysfunctions (...) need only be typically harmful to qualify as disorders. We argue that the proposed counterexamples are, in fact, considered harmful; thus, they fail to disconfirm the harm requirement: incapacity for exertion is inherently harmful, whether or not exertion occurs, cowpox is directly harmful irrespective of indirect benefits, and colorblindness and anosmia are considered harmful by those who consider them disorders. We also defend the typicality qualifier as viably addressing some apparently harmless disorders and argue that a dysfunction’s harmfulness is best understood in dispositional terms. (shrink)

First published in 2002. Routledge is an imprint of Taylor & Francis, an informa company.

On the received view, the Representational Theory of Measurement reduces measurement to the numerical representation of empirical relations. This account of measurement has been widely criticized. In this article, I provide a new interpretation of the Representational Theory of Measurement that sidesteps these debates. I propose to view the Representational Theory of Measurement as a library of theorems that investigate the numerical representability of qualitative relations. Such theorems are useful tools for concept formation that, in turn, is one crucial aspect (...) of measurement for a broad range of cases in linguistics, rational choice, metaphysics, and the social sciences. (shrink)

This paper provides a methodological analysis of Libertarian Paternalism, as put forward in the book Nudge by Richard Thaler and Cass Sunstein (Yale University Press, 2008). Libertarian Paternalism aims to use the accumulated findings of behavioural economics in order to assist decision-makers to make better choices. The philosophical debate about this proposal has focused on normative issues with regards to this proposal. This paper analyses Libertarian Paternalism descriptively and points out four methodological conditions for successful Nudges. On that basis, a (...) methodological critique of Libertarian Paternalism is mounted: the success conditions suggest that Nudges might be even harder to implement and to justify than commonly assumed in the philosophical debate. (shrink)

In ‘Rethinking Disease’, Powell and Scarffe1 propose what in effect is a modification of Jerome Wakefield’s2 3 harmful dysfunction analysis of medical disorder. The HDA maintains that ‘disorder’ is a hybrid factual and value concept requiring that a biological dysfunction, understood as a failure of some feature to perform a naturally selected function, causes harm to the individual as evaluated by social values. Powell and Scarffe accept both the HDA’s evolutionary biological function component and its incorporation of a value component. (...) Their proposed ‘new twist’ is to revise the value component: ‘Our proposed definition of disease is as follows: a biomedical state is a disease only if it implicates a biological dysfunction that is, or would be, properly disvalued’. So, they propose that a disorder is a ‘properly disvalued dysfunction’ rather than a ‘harmful dysfunction’, an approach they term ‘thickly normative’ in contrast to the thin normative approach of the HDA. There has been a surge of interest recently in better understanding the ‘harm’ component of the HDA. Powell and Scarffe’s analysis is a helpful contribution to this discussion. We focus here exclusively on their proposal regarding the analysis of the concept of disorder and ignore many important related issues that the authors address, ranging from prioritising resource allocation between disorders and non-disorders to whether the concept of disorder should be replaced by a generic welfarist concept. The resolution of these additional issues depends on first understanding ‘disorder’. The authors’ proposed changes to the HDA also deserve evaluation because the HDA, which has been endorsed by leading nosologists,4 plays an influential role in nosological debate across categories of disorder ranging, for example, from sexual paraphilias5 to psychopathy.6 A basic problem is that Powell and Scarffe misinterpret …. (shrink)

In this important book, Susan Hurley sheds new light on consciousness by examining its relationships to action from various angles. She assesses the role of agency in the unity of a conscious perspective, and argues that perception and action are more deeply interdependent than we usually assume. A standard view conceives perception as input from world to mind and action as output from mind to world, with the serious business of thought in between. Hurley criticizes this picture, and considers (...) how the interdependence of perceptual experience and agency at the personal level (of mental contents and norms) may emerge from the subpersonal level (of underlying causal processes and complex dynamic feedback systems). Her two-level view has wide implications, for topics that include self-consciousness, the modularity of mind, and the relations of mind to world. The self no longer lurks hidden somewhere between perceptual input and behavioral output, but reappears out in the open, embodied and embedded in its environment. Hurley traces these themes from Kantian and Wittgensteinian arguments through to intriguing recent work in neuropsychology and in dynamic systems approaches to the mind, providing a bridge from mainstream philosophy to work in other disciplines. Consciousness in Action is unique in the range of philosophical and scientific work it draws on, and in the deep criticism it offers of centuries-old habits of thought. (shrink)

We confront the philosophical literature on fair division problems with axiomatic and game-theoretic work in economics. Firstly, we show that the proportionality method advocated in Curtis is not implied by a general principle of fairness, and that the proportional rule cannot be explicated axiomatically from that very principle. Secondly, we suggest that Broome’s notion of claims is too restrictive and that game-theoretic approaches can rectify this shortcoming. More generally, we argue that axiomatic and game-theoretic work in economics is an indispensable (...) ingredient of any theorizing about fair division problems and allocative justice. (shrink)

I examine Kant’s claim in part one of Religion within the Boundaries of Mere Reason that moral reform requires both a ‘change of heart’ and gradual reformation of one’s sense (R, 6: 47). I argue that Kant’s conception of moral reform is neither fundamentally obscure nor is it as vulnerable to serious objections as several commentators have suggested. I defend Kant by explaining how he can maintain both that we can choose our moral disposition via an intelligible choice and that (...) we become good through a continuous struggle. I then provide an interpretation of how moral reform occurs in the phenomenal realm. (shrink)

First published in 2002. Routledge is an imprint of Taylor & Francis, an informa company.

The important ‘no-envy’ fairness criterion has typically been attributed to Foley and sometimes to Tinbergen. We reveal that Jan Tinbergen introduced ‘no-envy’ as a fairness criterion in his article “Mathematiese Psychologie” published in 1930 in the Dutch journal Mens en Maatschappij and translated as “Mathematical Psychology” in 2021 in the Erasmus Journal for Philosophy and Economics. Our article accompanies the translation: we introduce Tinbergen’s 1930 formulation of the ‘no-envy’ criterion, compare it to other formulations, and comment on its significance for (...) the fairness literature in philosophy and economics. (shrink)

Controversies about time discounting loom large in decisions about climate change. Prominently, a particularly controversial debate about time discounting in climate change decision-making has been conducted within climate economics, between the authors of Stern et al. and their critics :977–981, 2006; Weitzman in J Econ Lit XLV:703–724, 2007; Nordhaus in J Econ Lit XLV:686–702, 2007). The article examines the role of values in this debate. Firstly, it is shown that time discounting is a case in which values are key because (...) it is at heart an ethical problem. Secondly, it is argued that time discounting in climate economics is a case of economists making frequent and routine references to ethical values and indeed conduct ethical debates with each other. Thirdly, it is argued that there is evidence for deep and pervasive entanglement between facts and values in the prevalent methodologies for time discounting. Finally, it is argued that this means that economists have given up the ‘value-free ideal’ concerning time discounting, and discussed how the current methodology of time discounting in economics can be improved. (shrink)

The nature/nurture debate is not dead. Dichotomous views of development still underlie many fundamental debates in the biological and social sciences. Developmental systems theory offers a new conceptual framework with which to resolve such debates. DST views ontogeny as contingent cycles of interaction among a varied set of developmental resources, no one of which controls the process. These factors include DNA, cellular and organismic structure, and social and ecological interactions. DST has excited interest from a wide range of researchers, from (...) molecular biologists to anthropologists, because of its ability to integrate evolutionary theory and other disciplines without falling into traditional oppositions. The book provides historical background to DST, recent theoretical findings on the mechanisms of heredity, applications of the DST framework to behavioral development, implications of DST for the philosophy of biology, and critical reactions to DST. (shrink)

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)

This is a book about moral reasoning: how we actually reason and how we ought to reason. It defends a form of 'rule' utilitarianism whereby we must sometimes judge and act in moral questions in accordance with generally accepted rules, so long as the existence of those rules is justified by the good they bring about. The author opposes the currently more fashionable view that it is always right for the individual to do that which produces the most good. Among (...) the salient topics covered are: an account of the utilitarian function in society of generally accepted moral rules; a discussion of how we interpret existing moral rules and create new ones; and a defence of 'rule' utilitarianism against the charge that it either commits one to irrational rule worship, or collapses into a form of 'act' utilitarianism. This is a book about moral reasoning: how we actually reason and how we ought to reason. It defends a form of 'rule' utilitarianism whereby we must sometimes judge and act in moral questions in accordance with generally accepted rules, so long as the existence of those rules is justified by the good they bring about. (shrink)

Philosophical theories of fairness propose to divide a good that several individuals have a claim to in proportion to the strength of their respective claims. We suggest that currently, these theories face a dilemma when dealing with a good that is indivisible. On the one hand, theories of fairness that use weighted lotteries are either of limited applicability or fall prey to an objection by Brad Hooker. On the other hand, accounts that do without weighted lotteries fall prey to three (...) fairness paradoxes. We demonstrate that division methods from apportionment theory, which has hitherto been ignored by philosophical theories of fairness, can be used to provide fair division for indivisible goods without weighted lotteries and without fairness paradoxes. (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)

Instead he argues that there is an essence of comedy in the area of spirit rather than form, perspective rather than pattern. He draws upon the rich historical ensemble of types of comic figures, with a chapter devoted to each: the humorist, comedian, comic hero, rogue, trickster, clown, fool, underdog, and simpleton. He shows how each type incarnates a comic heroism in its own unique manner, offering a profound wisdom and philosophy of life.

(No abstract is available for this citation).

Genomic research may uncover results that have direct actionable benefit to the individual. An emerging debate is the degree to which researchers may have responsibility to offer results to the biological relatives of the research participant. In a companion study to one carried out in the United States, we describe the attitudes of Canadian Research Ethics Board chairs to this issue and their opinions as to the role of the REB in developing related policy.