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)

Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.

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.

Both bioethics and law have governed human genomics by distinguishing research from clinical practice. Yet the rise of translational genomics now makes this traditional dichotomy inadequate. This paper pioneers a new approach to the ethics of translational genomics. It maps the full range of ethical approaches needed, proposes a “layered” approach to determining the ethics framework for projects combining research and clinical care, and clarifies the key role that return of results can play in advancing translation.

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)

First published in 1985, the _Handbook for Achieving Gender Equity Through Education_ quickly established itself as the essential reference work concerning gender equity in education. This new, expanded edition provides a 20-year retrospective of the field, one that has the great advantage of documenting U.S. national data on the gains and losses in the efforts to advance gender equality through policies such as Title IX, the landmark federal law prohibiting sex discrimination in education, equity programs and research. Key features include:_ (...) Expertise_ – Like its predecessor, over 200 expert authors and reviewers provide accurate, consensus, research-based information on the nature of gender equity challenges and what is needed to meet them at all levels of education._ Content Area Focus_ – The analysis of gender equity within specific curriculum areas has been expanded from 6 to 10 chapters including mathematics, science, and engineering._ Global/Diversity Focus_ – Global gender equity is addressed in a separate chapter as well as in numerous other chapters. The expanded section on gender equity strategies for diverse populations contains seven chapters on African Americans, Latina/os, Asian and Pacific Island Americans, American Indians, gifted students, students with disabilities, and lesbian, gay, bisexual, and transgender students. _ Action Oriented_ – All chapters contain practical recommendations for making education activities and outcomes more gender equitable. A final chapter consolidates individual chapter recommendations for educators, policymakers, and researchers to achieve gender equity in and through education._ New Material_ – Expanded from 25 to 31 chapters, this new edition includes: *more emphasis on male gender equity and on sexuality issues; *special within population gender equity challenges ; *coeducation and single sex education; *increased use of rigorous research strategies such as meta-analysis showing more sex similarities and fewer sex differences and of evaluations of implementation programs; *technology and gender equity is now treated in three chapters; *women’s and gender studies; *communication skills relating to English, bilingual, and foreign language learning; and *history and implementation of Title IX and other federal and state policies. Since there is so much misleading information about gender equity and education, this _Handbook_ will be essential for anyone who wants accurate, research-based information on controversial gender equity issues—journalists, policy makers, teachers, Title IX coordinators, equity trainers, women’s and gender study faculty, students, and parents. (shrink)

Based on the experiences of anthropologists and others who document abuses and serve as expert witnesses, case studies from around the world offer insight into reparations proceedings; the ethical struggles associated with attempts to secure reparations; the professional and personal risks to researchers, victims, and human rights advocates; and how to come to terms with the political compromises of reparations in the face of the human need for justice.".

While making P4C much more easily disseminated, short-term weekend and weeklong P4C training programs not only dilute the potential laudatory impact of P4C, they can actually be dangerous. As well, lack of worldwide standards precludes the possibility of engaging in sufficiently high quality research of the sort that would allow the collection of empirical data in support the efficacy of worldwide P4C adoption. For all these reasons, the authors suggest that P4C advocates ought to insist that programs of a minimum (...) of five philosophy courses be accepted as the recognized standard for any teacher to legitimately claim that she is teaching Philosophy for Children. (shrink)

This book includes essays on writers from the 1840s to the 1890s, well known writers such as Anne Bronte, Wilkie Collins and Bram Stoker, lesser known writers such as Geraldine Jewsbury, Charles Reade, Margaret Oliphant, George Moore, Sarah Grand and Mary Ward. The contributors explore important thematic concerns: the relation between private and public realms; gender and social class; sexuality and the marketplace; and male and female cultural identity.

This research investigates the development of transferable - "adaptive" expertise. The study contrasts problem-solving performance of two kinds of experts (business consultants and restaurant managers) on novel problems at the intersection of their two domains, as well as a group of novices (non-business undergraduates). Despite a lack of restaurant experience, consultants performed better than restaurant managers and undergraduates, even though the problems concerned a restaurant. Process measures suggest this was due to the use of more theoretical reasoning. Analyses show this (...) resulted from differences in work experience and not other factors (e.g., education). We discuss aspects of experience that might be responsible for development of theoretical understanding and, thus, expertise that transfers to novel problems. One possible explanation, consistent with existing research from multiple approaches, is that to transfer to novel problems, experience must include substantive variability. The social context of learning may also play a role. (shrink)

In this collection, white women philosophers engage boldly in critical acts of exploring ways of naming and disrupting whiteness in terms of how it has defined the conceptual field of philosophy. Focuses on the whiteness of the epistemic and value-laden norms within philosophy itself, the text dares to identify the proverbial elephant in the room known as white supremacy and how that supremacy functions as the measure of reason, knowledge, and philosophical intelligibility.

Integrated information systems are increasingly used in schools, and the advent of the technology-rich classroom requires a new degree of ongoing classroom assessment. Able to track web searches, resources used, task completion time, and a variety of other classroom behaviors, technology-rich classrooms offer a wealth of potential information about teaching and learning. This information can be used to track student progress in languages, STEM, and in 21st Century skills, for instance. However, despite these changes, there has been little change in (...) the kind of data made available to teachers, administrators, students, and parents. Measuring and Visualizing Learning in the Information-Rich Classroom collects research on the implementation of classroom assessment techniques in technology-enhanced learning environments. Building on research conducted by a multinational and multidisciplinary team of learning technology experts, and specialists from around the globe, this book addresses these discrepancies. With contributions from major researchers in education technology, testing and assessment, and education psychology, this book contributes to a holistic approach for building the information infrastructure of the 21st Century school. (shrink)

I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

What precisely do we mean by respect? How should we adjudicate between conflicting demands of respect? What obstacles stand in the way of respect? The papers contained in this international anthology were presented at the North American Association of the Community of Inquiry conference in Vancouver, Canada, in June 2012, and were the outcome of in-depth and interdisciplinary discussions around the various aspects of respect. The book is an exacting and exciting analysis of the notion of respect - an analysis (...) that has the potential to have lasting and extensive practical consequences. (shrink)

The dominant, individualistic understanding of autonomy that features in clinical practice and research is underpinned by the idea that people are, in their ideal form, independent, self-interested and rational gain-maximising decision-makers. In recent decades, this paradigm has been challenged from various disciplinary and intellectual directions. Proponents of ‘relational autonomy’ in particular have argued that people’s identities, needs, interests – and indeed autonomy – are always also shaped by their relations to others. Yet, despite the pronounced and nuanced critique directed at (...) an individualistic understanding of autonomy, this critique has had very little effect on ethical and legal instruments in clinical practice and research so far. In this article, we use four case studies to explore to what extent, if at all, relational autonomy can provide solutions to ethical and practical problems in clinical practice and research. We conclude that certain forms of relational autonomy can have a tangibl... (shrink)

These essays apply influential, pathbreaking psychological studies about women's lives to literature. In their analyses of fictional portraits, contributors both challenge and confirm psychological theories about female identity, about 'connection/separation' as developmental catalysts, and about the impact of gender on 'voice,' moral decision-making, and epistemology in relation to classical and contemporary literary texts, written by both women and men.

Background: Genomic analysis may reveal both primary and secondary findings with direct relevance to the health of probands’ biological relatives. Researchers question their obligations to return findings not only to participants but also to family members. Given the social value of privacy protection, should researchers offer a proband’s results to family members, including after the proband’s death? Methods: Preferences were elicited using interviews and a survey. Respondents included probands from two pancreatic cancer research resources, plus biological and nonbiological family members. (...) Hypothetical scenarios based on actual research findings from the two cancer research resources were presented; participants were asked return of results preferences and justifications. Interview transcripts were coded and analyzed; survey data were analyzed descriptively. Results: Fifty-one individuals (17 probands, 21 biological relatives, 13 spouses/partners) were interviewed. Subsequently, a mailed survey was returned by 464 probands, 1,040 biological family members, and 399 spouses/partners. This analysis highlights the interviews, augmented by survey findings. Probands and family members attribute great predictive power and lifesaving potential to genomic information. A majority hold that a proband’s genomic results relevant to family members’ health ought to be offered. While informants endorse each individual’s choice whether to learn results, most express a strong moral responsibility to know and to share, particularly with the younger generation. Most have few concerns about sharing genetic information within the family; rather, their concerns focus on the health consequences of not sharing. Conclusions: Although additional studies in diverse populations are needed, policies governing return of genomic results should consider how families understand genomic data, how they value confidentiality within the family, and whether they endorse an ethics of sharing. A focus on respect for individual privacy—without attention to how the broad social and cultural context shapes preferences within families—cannot be the sole foundation of policy. (shrink)

Liz JacksonEducation University of Hong KongNel Noddings is known around the world for her contributions to philosophy and philosophy of education. Her work on caring and relational ethics broke ne...

Data are lacking with regard to participants' perspectives on return of genetic research results to relatives, including after the participant's death. This paper reports descriptive results from 3,630 survey respondents: 464 participants in a pancreatic cancer biobank, 1,439 family registry participants, and 1,727 healthy individuals. Our findings indicate that most participants would feel obligated to share their results with blood relatives while alive and would want results to be shared with relatives after their death.

The informed consent process for genetic testing does not commonly address preferences regarding disclosure of results in the event of the patient's death. Adults being tested for familial colorectal cancer were asked whether they want their exome sequencing results disclosed to another person in the event of their death prior to receiving the results. Of 78 participants, 92% designated an individual and 8% declined to. Further research will help refine practices for informed consent.

Incidental fndings of potential medical signifcance are seen in approximately 5-8 percent of asymptomatic subjects and 16 percent of symptomatic subjects participating in large computed tomography colonography studies, with the incidence varying further by CT acquisition technique. While most CTC research programs have a well-defned plan to detect and disclose IFs, such plans are largely communicated only verbally. Written consent documents should also inform subjects of how IFs of potential medical signifcance will be detected and reported in CTC research studies.

A one-of-a-kind reference to the international vocabulary of the humanities This is an encyclopedic dictionary of close to 400 important philosophical, literary, and political terms and concepts that defy easy—or any—translation from one language and culture to another. Drawn from more than a dozen languages, terms such as Dasein (German), pravda (Russian), saudade (Portuguese), and stato (Italian) are thoroughly examined in all their cross-linguistic and cross-cultural complexities. Spanning the classical, medieval, early modern, modern, and contemporary periods, these are terms that (...) influence thinking across the humanities. The entries, written by more than 150 distinguished scholars, describe the origins and meanings of each term, the history and context of its usage, its translations into other languages, and its use in notable texts. The dictionary also includes essays on the special characteristics of particular languages—English, French, German, Greek, Italian, Portuguese, Russian, and Spanish. Originally published in French, this one-of-a-kind reference work is now available in English for the first time, with new contributions from Judith Butler, Daniel Heller-Roazen, Ben Kafka, Kevin McLaughlin, Kenneth Reinhard, Stella Sandford, Gayatri Chakravorty Spivak, Jane Tylus, Anthony Vidler, Susan Wolfson, Robert J. C. Young, and many more.The result is an invaluable reference for students, scholars, and general readers interested in the multilingual lives of some of our most influential words and ideas. Covers close to 400 important philosophical, literary, and political terms that defy easy translation between languages and cultures Includes terms from more than a dozen languages Entries written by more than 150 distinguished thinkers Available in English for the first time, with new contributions by Judith Butler, Daniel Heller-Roazen, Ben Kafka, Kevin McLaughlin, Kenneth Reinhard, Stella Sandford, Gayatri Chakravorty Spivak, Jane Tylus, Anthony Vidler, Susan Wolfson, Robert J. C. Young, and many more Contains extensive cross-references and bibliographies An invaluable resource for students and scholars across the humanities. (shrink)

This monograph consists of five parts: (1) introductory material including a conference overview; (2) papers presented at an international symposium on the topic of ethical issues in disability and rehabilitation as a section of the Annual Conference of the Society for Disability Studies; (3) responses to the symposium, prepared by four of the participants; (4) selected additional papers which offer views from perspectives or cultures not represented at the Denver conference; and (5) an annotated international bibliography. Representatives from 10 countries (...) discussed ethical issues and decision making in disability and rehabilitation. Conference papers include: "Genetic Engineering--The New Eugenics? Evolving Medical Attitudes towards the Quality of Life" (Hugh Gallagher);"Description of the Decision-Making Project" (Daryl Evans); "Treatment and Nontreatment Decisions with Respect to Extremely Premature, Very Low Birthweight Infants (500-750g)" (Ernle Young); "Allocation of Resources and Distributive Justice" (John Mather); "Quality Assurance as an Aid to Ethical Decision Making in Disability Management: Lessons from Recent Ethical Issues Involving Disadvantaged Groups in New Zealand" (Peter Gow); "Disability and Ethical Issues: A Point of View from the Netherlands" (Yolan Koster-Dreese); "Who Shall Live or How Shall They Live? Consumer and Professional Perspectives on Treatment/Non-Treatment Decisions" (Joseph Kaufert and Patricia Kaufert); and "Debates across Social Movements on Reproductive Technologies, Genetic Engineering, and Eugenics" (Theresia Degener). Conference commentaries include: "The Meeting of Disability and Bioethics: A Beginning Rapprochement" (Adrienne Asch); "A Plea for More Dialogue: Commentary on Ethics Conference" (Robert Slater); "Healing Our Wounds" (Martha Lentz Walker); "Theories and Values: Ethics and Contrasting Perspectives on Disability" (Harlan Hahn); and "Current Example of Ethical Dilemma" (Susan Lacetti). Selected additional papers include: "High-tech Medicine Is Basic Care" (Frederick Abrams); "Prevention of Disabilities as a Medical Question" (G. Schioler); "The Ethics of Disability Prevention: A Parent's Point of View" (Mrs. J. Baker); "A Reference Matrix for Issues of Life and Personhood" (Mike Miles); "Nazi Scientists and Ethics of Today" (Isabel Wilkerson); "Ethical and Policy Issues in Rehabilitation Medicine (Hastings Center Report)" (Arthur Caplan et al.); and "Differing Approaches to Prevention of Disability and Treatment of Impaired Infants Creates Controversies Worldwide" (Barbara Duncan). (JDD). (shrink)

Using 452 letters sent in 1990 to Wellesley College over a student petition objecting to the choice of Barbara Bush as the graduation speaker, this article explores how an attempt to expand the boundaries of elite women's political behavior created a cultural and symbolic battle that centered upon the content of education, women's “manners” and civility, and their implications for elite women's participation in the broader Hobbesian social contract for citizenship. The article demonstrates that social class in its gendered (...) form is essential to understanding the construction of citizenship. (shrink)

Intelligent design creationism (ID) is a religious belief requiring a supernatural creator's interventions in the natural order. ID thus brings with it, as does supernatural theism by its nature, intractable epistemological difficulties. Despite these difficulties and despite ID's defeat in Kitzmiller v. Dover Area School District (2005), ID creationists' continuing efforts to promote the teaching of ID in public school science classrooms threaten both science education and the separation of church and state guaranteed by the U. S. Constitution. I examine (...) the ID movement's failure to provide either a methodology or a functional epistemology to support their supernaturalism, a deficiency that consequently leaves them without epistemic support for their creationist claims. My examination focuses primarily on ID supporter Francis Beckwith, whose published defenses of teaching ID, as well as his other relevant publications concerning education, law, and public policy, have been largely exempt from critical scrutiny. Beckwith's work exhibits the epistemological deficiencies of the supernaturally grounded views of his ID associates and of supernaturalists in general. I preface my examination of Beckwith's arguments with (1) philosopher of science Susan Haack's clarification of the established naturalistic methodology and epistemology of science and (2) discussions of the views of Beckwith's ID associates Phillip Johnson and William Dembski. Finally, I critique the religious exclusionism that Beckwith shares with his ID associates and the implications of his exclusionism for public policy. (shrink)