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.

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of (...) research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)

I väntan på den engelska Festschriften, den definitiva biografin eller de självförhärligande memoarerna kommer här för första gången en samling porträtt av den internationellt mest uppmärksammade svenska statsvetaren, den kontroversielle samhällsdebattören Bo Rothstein. Få samhällsforskare har med sådan intensitet tagit universitetens tredje uppgift till intäkt för att ifrågasätta gängse uppfattningar om sakernas tillstånd i riket. Många är de läsare, tittare eller åhörare som knappast kunnat undgå att beröras av hans synpunkter på allt från metoo till tiggeri, något färre är (...) nog de som på allvar tagit del av hans forskningsresultat om korruption och statsförvaltning. I denna bok tecknar ett tjugotal svenska forskare, författare och vänner sin bild av forskaren, debattören och livsnjutaren Bo Rothstein."--Back cover. (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)

In the United States, final amendments to the Federal Policy for the Protection of Human Subjects (“the Common Rule”) were published on January 19, 2017, and they will take effect on January 21, 2019. One of the most widely discussed provisions is that for the first time, federal regulations governing research with humans authorize the use of broad consent for future, unspecified research on individually identifiable biospecimens and associated data. Many questions have been raised about broad consent, including what effect (...) it will have on research and whether it adequately protects the interests of research participants.There are lessons to be learned for the U.S. and other countries by looking to countries that already have experience with broad consent for biobank collection and with the storage and subsequent use of the biospecimens and data. This article describes how broad consent works in five countries—Canada (in Quebec), Israel, Nigeria, Taiwan, and the United Kingdom—and with different types of biobanks: national biobanks, federated biobanks, and regional biobanks. Evaluating the provisions and challenges of the broad consent approaches in these countries can inform policies for this increasingly used approach to biobank regulation. (shrink)

: Can passing antidiscrimination laws ever be a bad idea? Yes, if broad policy reform is abandoned in favor of genetic-specific legislation. But in spite of its serious flaws, both in concept and in practice, genetic-specific legislation is sometimes worth passing anyway—sometimes a bad idea is reasonable.

DNA identification is being used in ever-widening ways, including databases of greater scope, familial and lowstringency searches, and DNA dragnets. After examining the law enforcement and privacy interests, the article concludes that forensic DNA uses must be consistent with privacy and civil liberties.

Can passing antidiscrimination laws ever be a bad idea? Yes, if broad policy reform is abandoned in favor of genetic‐specific legislation. But in spite of its serious flaws, both in concept and in practice, genetic‐specific legislation is sometimes worth passing anyway.

In the post-genome world of biomedical research, an increasingly common research strategy is to focus on large repositories of biological specimens. There are now several well-known efforts to compile vast collections of biological materials, reanalyze extant samples, collect new ones, and link the samples to medical records. The significant issues of law, ethics, and policy raised by these research activities usually are heightened when commercial enterprises play a leading role in accumulating and distributing the samples. Emerging companies are not only (...) compiling repositories for their own use, but some companies are positioning themselves to act as intermediaries, developing vast biobanks for sale to a wide range of other researchers. (shrink)

Perceived behavioral integrity involves the employee’s perception of the alignment of the manager’s words and deeds. This meta-analysis examined the relationship between perceived behavioral integrity of managers and the employee attitudes of job satisfaction, organizational commitment, satisfaction with the leader and affect toward the organization. Results indicate a strong positive relationship overall (average r = 0.48, p<0.01). With only 12 studies included, exploration of moderators was limited, but preliminary analysis suggested that the gender of the employees and the number of (...) levels between the employee and the manager are potential moderators of the relationship. In the current sample of studies, country where the research was conducted did not seem to have any moderating effects. In addition to suggesting further investigation of potential moderators, we call for research that examines the relationship between behavioral integrity and outcomes that include individual behavior and organizational performance. (shrink)

The seemingly interminable debates about health care reform in the last few years have focused mainly on health care access, quality, and cost. Debates on the medical malpractice component of the issue have focused almost entirely on cost. The familiar arguments in favor of limiting liability include the financial and health costs of defensive medicine; decreased physician supply in certain specialties and geographic areas; excessive awards; and high transaction costs, including attorney and expert witness fees. The equally familiar arguments in (...) favor of maintaining tort liability include the need to promote civil justice, deter substandard care, identify incompetent practitioners, and encourage systemic quality improvement.Numerous studies have explored the possible effects of damage caps and other measures on malpractice premiums, health care costs, and other financial endpoints. One relatively under-examined aspect of the issue is how federal legislation expanding access to health care might alter the number of medical malpractice claims. With the enactment of the Patient Protection and Affordable Care Act of 2010, it is especially appropriate to consider what effect, if any, the new law will have on the rate of medical malpractice claims. (shrink)

Throughout, the emerging theory of aspect is extensively compared with alternative theories, and the book concludes with general reflections on the semantic ...

This collection addresses a post-WWII shift in the hierarchy of scientific explanations, where the highest goal moves from reductionism towards some ...

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act Privacy Rule and the Federal Policy for Protection of Human Subjects. Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other (...) federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU–US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations. (shrink)

The book is an investigation of the semantics of numericals, counting and measuring, and its connection to the mass/count distinction from a theoretical and crosslinguistic perspective. It reviews some recent major linguistic results in these topics, and presents the author's new research including in-depth case studies of a number of typologically unrelated languages.

In much of the current academic and public discussion, conspiracy theories are portrayed as a negative phenomenon, linked to misinformation, mistrust in experts and institutions, and political propaganda. Rather surprisingly, however, philosophers working on this topic have been reluctant to incorporate a negatively evaluative aspect when either analyzing or engineering the concept conspiracy theory. In this paper, we present empirical data on the nature of the concept conspiracy theory from five studies designed to test the existence, prevalence and exact form (...) of an evaluative dimension to the ordinary concept conspiracy theory. These results reveal that, while there is a descriptive concept of conspiracy theory, the predominant use of conspiracy theory is deeply evaluative, encoding information about epistemic deficiency and often also derogatory and disparaging information. On the basis of these results, we present a new strategy for engineering conspiracy theory to promote theoretical investigations and institutional discussions of this phenomenon. We argue for engineering conspiracy theory to encode an epistemic evaluation, and to introduce a descriptive expression—such as ‘conspiratorial explanation’—to refer to the purely descriptive concept conspiracy theory. (shrink)

Consensus around what constitutes researcher conflicts of interest (COIs) and awareness of their influence on our research are two critical steps in ensuring the integrity of our science. In this research, data were collected from individual scholars via 2 surveys 5 years apart and from journals and associations to examine the level of social consensus and moral awareness among scholars, journals, and associations regarding researcher COIs. Although we observed increases in level of social consensus and moral awareness between 2012 and (...) 2017, results still revealed limited agreement about what relationships constitute a COI and limited awareness about the presence of and the ethical issues surrounding COIs. Although all journals and associations we examined supported COI disclosure, most did not provide researchers with detailed COI-related information, guidance, or disclosure tools. Limited social consensus and moral awareness regarding COIs is problematic because it inhibits the recognition, disclosure, and management of COIs and limits ethical decision making. We need to continue and enhance discussions about COIs and aim to create consensus and awareness where we do not have it with the goal of reducing potential scientific misconduct related to COIs. (shrink)

Contingency is the presence of non-actualized possibility in the world. Fatalism is a view of reality on which there is no contingency. Since it is contingency that permits agency, there has traditionally been much interest in contingency. This interest has long been embarrassed by the contention that simple and plausible assumptions about the world lead to fatalism. I begin with an Aristotelian argument as presented by Richard Taylor. Appreciation of this argument has been stultified by a question pertaining to the (...) source of necessity and possibility and a closely related one regarding the nature of metaphysics itself. Answering these questions reveals the crucial issue here, to wit, necessity and possibility in a temporal world. This issue is investigated through an important later criticism of Taylor by David Foster Wallace. Wallace’s critique is significant because it brings to the fore the pivotal notion for understanding contingency in a temporal world, that of synchronic possibility, the idea that incompatible states of affairs are possible at a single moment. This notion provides the basis of distinguishing two systematic accounts of truth, modality and time: two metaphysics of contingency. On one account, Taylor’s Aristotelian argument is straightforwardly valid and compelling; on the other, it is fallacious. In closing, I present reasons why the former account, supporting the Aristotelian views of time and truth, is correct and make some comments to ameliorate this conclusion. (shrink)

Public health is a dynamic field. Outbreaks of new diseases, as well as changing patterns of population growth, economic development, and lifestyle trends all may threaten public health and thus demand a public health response. As the practice of public health evolves, there is an ongoing need to reassess its scientific, ethical, legal, and social underpinnings. Such a reappraisal must consider the disagreement among public health officials, public health scholars, elected officials, and the public about the proper role of public (...) health and the distinctions, for example, between public health and clinical care, and public health and health promotion.In this article I will attempt to characterize the main points of contention as well as offer my own views regarding the proper scope of public health. Greater clarity and consensus on the meaning of public health are likely to lead to more efficient and effective public health interventions as well as increased public and political support for public health activities. (shrink)

In this paper we explore the interpretation of quantity expressions in Yudja, an indigenous language spoken in the Amazonian basin, showing that while the language allows reference to exact cardinalities, it does not generally allow reference to exact measure values. It does, however, allow non-exact comparison along continuous dimensions. We use this data to argue that the grammar of exact measurement is distinct from a grammar allowing the expression of exact cardinalities, and that the grammar of counting and the grammar (...) of measurement may use numerals with different, though related interpretations. As Yudja shows, the language of measurement is not automatically acquired along with the knowledge of exact numeral expressions. We show that the ‘gap’ between prelinguistic intuitions about quantity in terms of numerosity and counting, which is bridged by the learning of language expressing exact cardinality, is paralleled by a similar gap between prelinguistic intuitions about quantity on a continuous dimension and measuring: this gap too must be bridged by language which expresses exact measure values. Our results suggest that the enculturation process by which we develop skills to perform abstract operations in the domain of measurement is (1) language dependent and (2) distinct from the process by which we learn to perform abstract calculations in the cardinal domain. (shrink)

Public health is a dynamic field. Outbreaks of new diseases, as well as changing patterns of population growth, economic development, and lifestyle trends all may threaten public health and thus demand a public health response. As the practice of public health evolves, there is an ongoing need to reassess its scientific, ethical, legal, and social underpinnings. Such a reappraisal must consider the disagreement among public health officials, public health scholars, elected officials, and the public about the proper role of public (...) health and the distinctions, for example, between public health and clinical care, and public health and health promotion.In this article I will attempt to characterize the main points of contention as well as offer my own views regarding the proper scope of public health. Greater clarity and consensus on the meaning of public health are likely to lead to more efficient and effective public health interventions as well as increased public and political support for public health activities. (shrink)

A 'social trap' is a situation where individuals, groups or organisations are unable to cooperate owing to mutual distrust and lack of social capital, even where cooperation would benefit all. Examples include civil strife, pervasive corruption, ethnic discrimination, depletion of natural resources and misuse of social insurance systems. Much has been written attempting to explain the problem, but rather less material is available on how to escape it. In this book, Bo Rothstein explores how social capital and social trust (...) are generated and what governments can do about it. He argues that it is the existence of universal and impartial political institutions together with public policies which enhance social and economic equality that creates social capital. By introducing the theory of collective memory into the discussion, Rothstein makes an empirical and theoretical claim for how universal institutions can be established. (shrink)

Researchers increasingly rely on large data sets of health information, often linked with biological specimens. In recent years, the argument has been made that obtaining informed consent for conducting records-based research is unduly burdensome and results in ?consent bias.? As a type of selection bias, consent bias is said to exist when the group giving researchers access to their data differs from the group denying access. Therefore, to promote socially beneficial research, it is argued that consent should be unnecessary. After (...) analyzing the biostatistics evidence and bioethics arguments, the article concludes that (1) claims about the amount of consent bias are overstated; (2) commonly used statistical methods usually can account for consent bias; and (3) any residual effects of consent bias are below an acceptable level of imprecision and constitute a reasonable social cost for conducting ethically responsible research. (shrink)

Beginning in the 20th century, scientific research came to be dominated by a growing class of credentialed, professional scientists who overwhelmingly displaced the learned amateurs of an earlier time. By the end of the century, however, the exclusive realm of professional scientists conducting research was joined, to a degree, by “citizen scientists.” The term originally encompassed non-professionals assisting professional scientists by contributing observations and measurements to ongoing research enterprises. These collaborations were especially common in the environmental sciences, where citizen scientists (...) participated in counting wildlife and measuring environmental conditions. Later, patient groups began to play a more active role in supporting clinical trials and collecting health records from affected individuals. (shrink)