No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

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.

It was thus the combination of observational and experimental approaches that ultimately led to confirmation of the outgrowth theory. The observational method was essential for defining various possible methods of nerve fiber development. The multicellular, protoplasmic bridge and outgrowth theories were each postulated to explain purely observational evidence. However, the lack of truly suitable equipment and techniques to study the developing nervous system made it impossible to agree on a single theory on this basis alone. The experimental method provided a (...) means of choosing between these theories. Without the preceding observations that had led to the formulation of various hypotheses, however, the experimental approach might not have been so successful, for the power of this method is more of selection than of generation.Therefore it is impossible to weigh separately the contributions of the observational and experimental approaches to the question of nerve fiber development. Both were necessary for the ultimate acceptance of the outgrowth theory. *** DIRECT SUPPORT *** A8402051 00004. (shrink)

The history of cosmology is often understood in terms of the development of modern science, but Asian cosmological thought and practice touched on many aspects of life, including mathematics, astronomy, politics, philosophy, religion, and art. Because of the deep pervasion of cosmology in culture, many opportunities arose for transmissions of cosmological ideas across borders and innovations of knowledge and application in new contexts. Taking a wider view, one finds that cosmological ideas traveled widely and intermingled freely, being frequently reinterpreted by (...) scholars, ritualists, and artists and transforming as they overlapped with ideas and practices from other traditions. This book brings together ten diverse scholars to present their views on these overlapping cosmologies in Asia. (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)

The explanatory challenge of sentience is known as the “hard problem of consciousness”: How does subjective experience arise from physical objects and their relations? Despite some optimistic claims, the perennial struggle with this question shows little evidence of imminent resolution. In this article I focus on the “why” rather than on the “how” of sentience. Specifically, why did sentience evolve in organic lifeforms? From an evolutionary perspective this question can be framed: “What adaptive problem(s) did organisms face in their evolutionary (...) past and how were those challenges met? I argue that sentience was a critical component of the adaptive solution (i.e., adopting an agentic stance) to increasingly complex and unpredictable demands placed on vertebrates approximately 500 million years ago (the so-called Cambrian explosion). One consequence of taking an agentic stance is that it freed the organism from its neural moorings, positioning it within phenomenal space outside its brain. (shrink)

Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both (...) health care and legal actors to address and manage those liability risks. (shrink)

This article discusses the relation between environment and participation in the context of different stages of political modernisation. We focus on the dynamics of environmental policy on the one hand, and the organisation of political participation on the other. The central argument is that participation is inextricably linked to environmental issues, but that their relation differs substantially over the various stages of the institutionalisation of environmental policy. While in the 1970s supplementary forms of participation dominated, the societalisation and marketisation of (...) environmental policies from the late 1980s has given rise to new opportunities for participation, implying a more rule-altering potential. (shrink)

In Two Minds is a practical casebook of problem solving in psychiatric ethics. Written in a lively and accessible style, it builds on a series of detailed case histories to illustrate the central place of ethical reasoning as a key competency for clinical work and research in psychiatry. Topics include risk, dangerousness and confidentiality; judgements of responsibility; involuntary treatment and mental health legislation; consent to genetic screening; dual role issues in child and adolescent psychiatry; needs assessment; cross-cultural and gender issues; (...) rational and irrational suicide; shared decision making in multi-agency teams, and the growing role of the user's voice in psychiatry. Key ethical concepts are carefully introduced and explained. The text is richly supported by detailed guides for further reading. There are separate chapters on teaching psychiatric ethics, including a sample seminar, and on writing a research ethics application. Each case history and discussion is followed by a critical commentary from a practitioner with relevant experience. Jim Birley adds a comparative international perspective on psychiatric ethics. Cartoons by Johnny Cowee provide punchy counterpoint! In Two Minds is the sister volume to the third edition of Sidney, Paul Chodoff and Steven Green's highly successful Psychiatric Ethics. In providing a bridge between theory and practice, it will be essential reading for everyone concerned with improving standards in mental health care. (shrink)

Introduction Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general. Methods Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative. Results 123 youth completed the questionnaire (mean age=15 (...) years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly. Conclusions Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking. (shrink)

Corporate image is a function of organizational signals which determine the perceptions of various stakeholders regarding the actions of an organization. Because of its relationship to the actions of an organization, image has been studied as an indicator of the social performance of the organization. Recent research has determined that social performance has direct effects on the behaviors and attitudes of the organization's employees. To better understand these effects, this study develops and empirically tests a model which links corporate leaders' (...) actions, employees' perceptions of corporate image, and the employees' level of association with the organization. The effects of managing the social environment of an organization on its employees' perceptions of image, attitudes, and intended behaviors are discussed. (shrink)

Corporate image is a function of organizational signals which determine the perceptions of various stakeholders regarding the actions of an organization. Because of its relationship to the actions of an organization, image has been studied as an indicator of the social performance of the organization. Recent research has determined that social performance has direct effects on the behaviors and attitudes of the organization's employees. To better understand these effects, this study develops and empirically tests a model which links corporate leaders' (...) actions, employees' perceptions of corporate image, and the employees' level of association with the organization. The effects of managing the social environment of an organization on its employees' perceptions of image, attitudes, and intended behaviors are discussed. (shrink)

If stem cell-based therapies are developed, we will likely confront a difficult problem of justice: for biological reasons alone, the new therapies might benefit only a limited range of patients. In fact, they might benefit primarily white Americans, thereby exacerbating long-standing differences in health and health care.

This volume addresses a wide variety of moral concerns regarding slavery as an institutionalized social practice. By considering the slave's critical appropriation of the natural rights doctrine, the ambiguous implications of various notions of consent and liberty are examined. The authors assume that, although slavery is undoubtedly an evil social practice, its moral assessment stands in need of a more nuanced treatment. They address the question of what is wrong with slavery by critically examining, and in some cases endorsing, certain (...) principles derived from communitarianism, paternalism, utilitarianism, and jurisprudence. (shrink)

Topics in Cognitive Science, Volume 14, Issue 3, Page 550-573, July 2022.

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed and regulated in (...) the United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (shrink)

Aworkshop was held August 26–28, 2015, by the Earth- Life Science Institute (ELSI) Origins Network (EON, see Appendix I) at the Tokyo Institute of Technology. This meeting gathered a diverse group of around 40 scholars researching the origins of life (OoL) from various perspectives with the intent to find common ground, identify key questions and investigations for progress, and guide EON by suggesting a roadmap of activities. Specific challenges that the attendees were encouraged to address included the following: What key (...) questions, ideas, and investigations should the OoL research community address in the near and long term? How can this community better organize itself and prioritize its efforts? What roles can particular subfields play, and what can ELSI and EON do to facilitate research progress? (See also Appendix II.) The present document is a product of that workshop; a white paper that serves as a record of the discussion that took place and a guide and stimulus to the solution of the most urgent and important issues in the study of the OoL. This paper is not intended to be comprehensive or a balanced representation of the opinions of the entire OoL research community. It is intended to present a number of important position statements that contain many aspirational goals and suggestions as to how progress can be made in understanding the OoL. The key role played in the field by current societies and recurring meetings over the past many decades is fully acknowledged, including the International Society for the Study of the Origin of Life (ISSOL) and its official journal Origins of Life and Evolution of Biospheres, as well as the International Society for Artificial Life (ISAL). (shrink)

In his comments, Richard Fumerton carefully develops two fundamental concerns with my views, which he interprets sympathetically, and almost entirely correctly. Before turning to these concerns, though, I must make one point about his concise opening statement of my principal claims. As I hope is clear from my précis, perceptual experiences provide reasons for empirical beliefs not simply in virtue of sharing demonstrative content with them. The key idea is that a person cannot properly grasp the objective content of these (...) experiences—that is, he cannot actually have experiences of particular things in the mind-independent world around him—without understanding that his apprehension that things are thus and so out there is in part due to the fact that they are. He therefore recognizes the relevant content as his epistemic openness to the way things objectively are. This is clearly central to my overall position. (shrink)

Three studies were conducted to explore the psychological determinants of COVID-deterrent behaviors. In Study 1, using data collected and analyzed both before and after the release of COVID-19 vaccines, mask-wearing, other preventative behaviors like social distancing, and vaccination intentions were positively related to assessments of the Coronavirus Behavioral Health Mindset ; belief in the credibility of science; progressive political orientation; less use of repressive and more use of sensitization coping; and the attribution of COVID-19 safety to effort rather than ability, (...) powerful forces, fate, or luck. In Study 2, favorable COVID-19 vaccination intentions were related to greater willingness to work, lower emotional distress, and greater customer experience mindset. Study 3 examined the personality and motives of individuals who volunteered to help deliver COVID-19 inoculations to the local community. The vaccine-giving volunteers, especially those with prosocial motives, had high CVBHM scores, belief in the credibility of science, low use of repressive coping, greater attribution of COVID-19 protection to effort, low likelihood of voting conservative, were older, and had more education than others. The majority of public health volunteers expressed prosocial motives to help people or join a cause, but many expressed the personal motives of getting the COVID-19 vaccination for themselves, conveying a public image of compassion, or structuring time. Based on the three research studies, a COVID-19 Mindset Hierarchy model is proposed to integrate the results. (shrink)

fusion theory challenges efforts to see theory as inhibiting by presenting an approach that is innovative, eclectic, and subtle in order to draw out competing and constellating ideas and opinions. This collected volume of essays examines fusion theory and demonstrates how the theory can be applied to the reading of various works of Indian English novelists.