This article reviews recent developments in health care law, focusing on the engagement of law as a partner in health care innovation. The article addresses: the history and contents of recent United States federal law restricting the use of genetic information by insurers and employers; the recent federal policy recommending routine HIV testing; the recent revision of federal policy regarding the funding of human embryonic stem cell research; the history, current status, and need for future attention to advance directives; the (...) recent emergence of medical–legal partnerships and their benefits for patients; the obesity epidemic and its implications for the child’s right to health under international conventions. (shrink)

The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided to (...) largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections, and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation. (shrink)

Capitalizing on the hype surrounding stem cell research, numerous clinics around the world offer “stem cell therapies” for a variety of medical conditions. Despite questions about the safety and efficacy of these interventions, anecdotal evidence suggests a relatively large number of patients are traveling to receive these unproven treatments — a practice called “stem cell tourism.” Because these unproven treatments pose risks to individual patients and to legitimate translational stem cell research, stem cell tourism has generated substantial policy concern and (...) inspired attempts to reduce these risks through the development of guidelines for patients and medical practitioners. This paper examines the roles and responsibilities of physicians in patients' home countries with respect to patients' decisions to try unproven stem cell therapies abroad. Specifically, it examines professional guidance from two organizations — the American Medical Association and the International Society for Stem Cell Research — and assesses physicians' professional and legal obligations to patients considering unproven stem cell therapies. Then, drawing on qualitative interviews conducted with patients who traveled abroad for unproven stem cell treatments, it explores the roles that physicians actually play in patients' decisions and compares these actual roles with their professional and legal responsibilities. The paper concludes with a discussion of strategies to help improve the guidance physicians provide to patients considering unproven treatments. (shrink)

In its Advanced Notice of Proposed Rule Making (ANPRM), the U.S. Department of Health and Human Services proposed substantial changes to how biospecimen research is treated under the regulations governing human subjects research. Currently, much of this research can be conducted without consent because it may not be considered “human subjects” research, is considered exempt, or consent may be waived. Responding to criticisms that scientific changes have made biospecimen research riskier than contemplated when the Common Rule was last amended, the (...) ANPRM proposes to require written consent for biospecimen research, even if they have been stripped of identifiers or initially collected for a non-research purpose. The ANPRM's recognition of these risks is consistent with relatively recent NIH recommendations that research projects involving genetics, genomics, or biospecimen repositories should consider getting a Certificate of Confidentiality to provide additional protections to participants where breach of confidentiality is typically the primary risk. Ironically, the ANPRM proposals may make it more difficult to provide these protections. Our paper explores the implications of the conflicting requirements of the Certificate and the ANPRM proposals and makes recommendations for achieving the dual goals of appropriate consent and adequate confidentiality protections. (shrink)

The federal Certificate of Confidentiality plays an important role in research on sensitive topics by authorizing researchers to refuse to disclose identifiable research data in response to subpoenas in any legal setting. However, there is little known about how effective Certificates are in practice. This article draws on our legal and empirical research on this topic to fill this information gap. It includes a description of the purpose of Certificates, their legislative and regulatory history, and a summary of the few (...) reported and unreported cases that have dealt with Certificates. In addition, we outline other statutory confidentiality protections, compare them to the Certificate's protections, and analyze some of the vulnerabilities of a Certificate's protections. This analysis allows us to make specific recommendations for strengthening the protections afforded to research data. (shrink)

This study examined how research conducted at several federally funded institutions designated as Clinical Research Centers or Specialized Programs of Research Excellence addressed the issues of consent, control over biological materials, confidentiality, and disclosure of results in protocols and consent forms for genetic research with stored biological materials. Although a majority of the documents reviewed addressed most of the issues raised in the research ethics literature, topics identified in the literature that were missing include the return of research results, the (...) right to withdraw from research involving biological materials, and the consent of children when they become legal adults. If typical, these findings suggest greater educational efforts may be needed to prompt investigators and IRBs to consider these and other issues that were either not addressed in the protocols or consent forms or were addressed inadequately. (shrink)

This article reviews recent developments in health care law, focusing on controversy at the intersection of health care law and culture. The article addresses: emerging issues in federal regulatory oversight of the rapidly developing market in direct-to-consumer genetic testing, including questions about the role of government oversight and professional mediation of consumer choice; continuing controversies surrounding stem cell research and therapies and the implications of these controversies for healthcare institutions; a controversy in India arising at the intersection of abortion law (...) and the rights of the disabled but implicating a broader set of cross-cultural issues; and the education of U.S. health care providers and lawyers in the theory and practice of cultural competency. (shrink)

This article reviews recent developments in health care law, focusing on the engagement of law as a partner in health care innovation. The article addresses: the history and contents of recent United States federal law restricting the use of genetic information by insurers and employers; the recent federal policy recommending routine HIV testing; the recent revision of federal policy regarding the funding of human embryonic stem cell research; the history, current status, and need for future attention to advance directives; the (...) recent emergence of medical–legal partnerships and their benefits for patients; the obesity epidemic and its implications for the child’s right to health under international conventions. (shrink)

In this thorough compendium, nineteen accomplished scholars explore, in some manner the values they find inherent in the world, their nature, and revelence through the thought of Frederick FerrZ. These essays, informed by the insights of FerrZ and coming from manifold perspectives—ethics, philosophy, theology, and environmental studies, advance an ambitious challenge to current intellectual and scholarly fashions.

In this thorough compendium, nineteen accomplished scholars explore, in some manner the values they find inherent in the world, their nature, and revelence through the thought of Frederick Ferré. These essays, informed by the insights of Ferré and coming from manifold perspectives—ethics, philosophy, theology, and environmental studies, advance an ambitious challenge to current intellectual and scholarly fashions.

of Bernard E. Rollin , , from Notre Dame Philosophical Reviews.

Generic sentences (e.g., bare plural sentences such as “dogs have four legs” and “mosquitoes carry malaria”) are used to talk about kinds of things. Three experiments investigated the conceptual foundations of generics as well as claims within the formal semantic approaches to generics concerning the roles of prevalence, cue validity and normalcy in licensing generics. Two classes of generic sentences that pose challenges to both the conceptually based and formal semantic approaches to generics were investigated. Striking property generics (e.g. “sharks (...) bite swimmers”) are true even though only a tiny minority of instances have the property and thus pose obvious problems for quantificational approaches, and they also do not seem to characterize kinds in terms of the principled or statistical connections investigated in previous research ( Prasada and Dillingham, 2006 ; Prasada and Dillingham, 2009). The second class — minority characteristic generics (e.g. “ducks lay eggs”) — also poses serious problems for quantificational accounts, and appears to involve principled connections even though fewer than half of its instances have the relevant property. The experiments revealed three principal discoveries: first, striking generics involve neither principled nor statistical connections. Instead, they involve a causal connection between a kind and a property. Second, minority characteristic generics exhibit the characteristics of principled connections, which suggests that principled connections license the expectation that most instances will have the property, but do not require it. Finally, the experiments also provided evidence that prevalence and the acceptability of generics may be dissociated and provided data that are problematic for normalcy approaches to generics, and for the idea that cue validity licenses low prevalence generics. As such, the studies provided evidence in favor of a conceptually based approach to the semantics of generics ( Leslie, 2007 ; Leslie, 2008; see also Carlson, 2009). (shrink)

As exome and genome sequencing move into clinical application, questions surround how to elicit consent and handle potential return of individual genomic results. This study analyzes nine consent forms used in NIH-funded sequencing studies. Content analysis reveals considerable heterogeneity, including in defining results that may be returned, identifying potential benefits and risks of return, protecting privacy, addressing placement of results in the medical record, and data-sharing. In response to lack of consensus, we offer recommendations.

There is a growing literature on the concept of e-trust and on the feasibility and advisability of “trusting” artificial agents. In this paper we present an object-oriented model for thinking about trust in both face-to-face and digitally mediated environments. We review important recent contributions to this literature regarding e-trust in conjunction with presenting our model. We identify three important types of trust interactions and examine trust from the perspective of a software developer. Too often, the primary focus of research in (...) this area has been on the artificial agents and the humans they may encounter after they are deployed. We contend that the humans who design, implement, and deploy the artificial agents are crucial to any discussion of e-trust and to understanding the distinctions among the concepts of trust, e-trust and face-to-face trust. (shrink)

Do our lives have meaning? Should we create more people? Is death bad? Should we commit suicide? Would it be better if we were immortal? Should we be optimistic or pessimistic? Life, Death, and Meaning brings together key readings, primarily by English-speaking philosophers, on such 'big questions.'.