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)

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)

(2013). An Unbiased Response to the Open Peer Commentaries on “Does Consent Bias Research?”. The American Journal of Bioethics: Vol. 13, No. 4, pp. W1-W4. doi: 10.1080/15265161.2013.769824.

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.

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)

Since the fourth century, B.C.E., the Oath of Hippocrates has been the starting point in analyzing the obligations of physicians to protect the privacy and confidentiality interests of their patients. The pertinent provision of the Oath reads as follows: “What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account must be spread abroad, I will keep to myself, holding such things shameful (...) to be spoken about.”This part of the Oath is subject to more than one interpretation, but its commonly accepted meaning provides the ethical foundation for the physician’s duty of confidentiality. The Oath expressly declares that a physician’s obligation of confidentiality applies beyond matters of medical care. At a time when there were no hospitals or physician offices, patients received medical care in their homes or in public places. Physicians treating patients in their homes could be expected to see and hear a wide range of activities that might be considered embarrassing, immoral, or even illegal. (shrink)

This paper gives an analysis of the adverbial quantifiers exemplified in “I regretted it every time I had dinner with him.” Sentences of this kind display what I call a ‘matching effect’; they are true if every event in the denotation oftime I had dinner with him can be matched with an event regretting that dinner event. They are thus truth-conditionally equivalent to sentences of the form “There are at least as many As as Bs.” The difficulties of giving a (...) compositional interpretation to sentences of this form have been discussed in, e.g., Boolos 1981. I first show that the matching effect is semantic and not pragmatic. I then give an analysis of these sentences in a neo-Davidsonian framework, interpreting the adverbials as quantifiers over events. Syntactically they are analyzed as objects of a null preposition. This allows a simple compositional semantic interpretation in which the null preposition is interpreted exactly as other prepositions are by Davidson (1967), namely as denoting a function from the event argument of the matrix verb to the prepositional object. The matching effect then follows automatically. I extend the analysis to account for other sentences which directly instantiate the schema “For every A there is a B” and its equivalents, and show how the matching effect follows in general from the functional nature of thematic roles and prepositions. (shrink)

Rabbis of thirteenth-century Spain were often exposed to two traditions, that of Northern France-Germany and that of Moslem Spain. Until now, the dominant discussion of how they balanced the contrast has been Bernard Septimus' analysis of Nahmanides (Ramban), who managed to draw fruitfully on both. Rabbenu Yonah b. Abraham of Gerona, Ramban's only slightly less famous relative, presents a useful counterexample.Rabbenu Yonah's early works reflect an almost-total immersion in Northern French ways of thinking and writing. Only gradually does he engage (...) ideas from Moslem Spain, suggesting that the mixing of the two traditions in his later writings resulted from years of slow growth and exposure to such Moslem Spanish authors as Rif, R. Bahye ibn Paquda, and Maimonides.His example suggests that how to react to these differing influences was a continuing issue for these rabbis, and that tracking it offers an important key to understanding the intellectual history of the rabbis of that era. (shrink)

Upon entering the White House in 1933, President Franklin D. Roosevelt faced an ailing economy in the throes of the Great Depression and rushed to transform the country through recovery programs and legislative reform. By 1934, he began to send professional photographers to the state of West Virginia to document living conditions and the effects of his New Deal programs. The photographs from the Farm Security Administration Project not only introduced “America to Americans,” exposing a continued need for government intervention, (...) but also captured powerful images of life in rural and small town America.New Deal Photographs of West Virginia, 1934-1943 presents images of the state's northern and southern coalfields, the subsistence homestead projects of Arthurdale, Eleanor, and Tygart Valley, and various communities from Charleston to Clarksburg and Parkersburg to Elkins. With over one hundred and fifty images by ten FSA photographers, including Walker Evans, Marion Post Wolcott, Arthur Rothstein, and Ben Shahn, this collection is a remarkable proclamation of hardship, hope, endurance, and, above all, community. These photographs provide a glimpse into the everyday lives of West Virginians during the Great Depression and beyond. (shrink)

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.

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)

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)

From the earliest days of the Human Genome Project, the holy grail of genomics was the ability to perform whole-genome sequencing quickly, accurately, and relatively inexpensively so that the benefits of genomics would be widely available in clinical settings. Although the mythical $1,000 genome sequence seemed elusive for many years, next-generation sequencing technologies and other recent advances clearly indicate that inexpensive whole-genome sequencing is at hand.Whole-genome sequencing has demonstrable value in elucidating the genetic etiology of rare disorders, in identifying atypical (...) variants in common diseases, in determining pharmacogenomically appropriate drugs and dosages, in performing tumor genome sequencing, and in aiding other clinical applications for the diagnosis and treatment of individuals who are symptomatic or whose family health history places them at substantial risk. Undoubtedly, the clinical applications of wholegenome sequencing will increase in the future. (shrink)

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)

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)

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

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)

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 financial disputes involving research, the parties are traditionally individual researchers and their institutions, biotech and pharmaceutical companies, and other entities engaged in the commercial development of biomedical research. Occasionally, research subjects claim that researchers have misled them or misappropriated their biological materials to derive financial gain. The best known example is the case of Moore v. Regents of the University of California, decided in 1990.With new developments in genomics, large-scale repositories of tissue and other biological specimens are increasingly important. (...) Biobanks have been established by various researchers, commercial entities, health-care institutions, and even entire countries. Individuals who contribute specimens almost always retain no commercial interest in any resulting research and language to that effect is now customarily included in informed consent documents signed at the time the specimen is given. Suppose, however, that the research subjects actually collect the specimens themselves, recruit the researcher, and provide financial support for the research. (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)

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)

Each year individuals are required to execute millions of authorizations for the release of their health records as a condition of employment, applying for various types of insurance, and submitting claims for benefits. Generally, there are no restrictions on the scope of information released pursuant to these compelled authorizations, and the development of a nationwide system of interoperable electronic health records will increase the amount of health information released. After quantifying the extent of these disclosures, this article discusses why it (...) is important to limit disclosures of health information for nonmedical purposes as well as how it may be possible to do so. (shrink)

Laws in the 20 jurisdictions studied for this project display many similar approaches to protecting privacy in biobank research. Although few have enacted biobank-specific legislation, many countries address biobanking within other laws. All provide for some oversight mechanisms for biobank research, even though the nature of that oversight varies between jurisdictions. Most have some sort of controlled access system in place for research with biobank specimens. While broad consent models facilitate biobanking, countries without national or federated biobanks have been slow (...) to adopt broad consent. International guidelines have facilitated sharing and generally take a proportional risk approach, but many countries have provisions guiding international sharing and a few even limit international sharing. Although privacy laws may not prohibit international collaborations, the multi-prong approach to privacy unique to each jurisdiction can complicate international sharing. These symposium issues can serve as a resource for explaining the sometimes intricate privacy laws in each studied jurisdiction, outlining the key issues with regards to privacy and biobanking, and serving to describe a framework for the process of harmonization of privacy laws. (shrink)

In the early 1970s, Congress considered enacting comprehensive privacy legislation, but it was unable to do so. In 1974, it passed the Privacy Act, applicable only to information in the possession of the federal government. In the intervening years, other information privacy laws enacted by Congress, such as the Health Insurance Portability and Accountability Act, have been weak and sector specific. With the explosion of information technology and the growing concerns about an absence of effective federal privacy laws, the legal (...) focus has shifted to the states. Signaling a new direction in state data privacy and consumer protection law, the California Consumer Privacy Act establishes important rights and protections for California residents with regard to the collection, use, disclosure, and sale of their personal information. The CCPA is certain to spur similar legislation and to affect national and international businesses that collect data from California's residents. Understanding the new law is important for all data‐driven industries, including health care. (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.