Returning genetic research results to relatives raises complex issues. In order to inform the U.S. debate, this paper analyzes international law and policies governing the sharing of genetic research results with relatives and identifies key themes and lessons. The laws and policies from other countries demonstrate a range of approaches to balancing individual privacy and autonomy with family access for health benefit, offering important lessons for further development of approaches in the United States.

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.

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women9s Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial (...) protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. (shrink)

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...) Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)

The development of technologies for the biopreservation of infectious organisms requires careful analysis of benefits and risks. This article reviews the regulatory landscape and oversight responsibilities in the United States in respect to pathogen biopreservation. Focused on two globally significant pathogens, Cryptosporidium and Plasmodium, the article explores advantages and potential risks of biopreservation concerning biosafety, biosecurity and biocontainment.

This paper advances a new paradigm in clinical ethics education that not only emphasizes development of individual cli but also focuses on the institutional context within which health care professionals work. This approach has been applied to the goal of improving the care provided to critically and terminally ill adults. The model has been adopted by about thirty hospitals and nursing homes; additional institutions will soon join the program, entitled Decisions Near the End of Life. Here, we describe the history (...) and rationale for this approach, its goals, pedagogical assumptions, and design. (shrink)

At this point, I think it is fair to say that most of us know someone—a family member, a coworker, a friend, a student—who is resisting getting a vaccine against COVID-19. Frankly, this amazes me. I was recently discussing this with a friend—"Rebecca"—when to my utter shock, she confessed to me that she "does not trust the vaccine" and is not planning to get one until there is more certainty of its efficacy and safety. While there are many things (...) that stood out to be in this conversation, what stood out to me was a particular comment she made; she said to me: "The thing is, I'm a skeptic, and you're not."I admit, this comment threw me for a loop. How could I, a feminist bioethicist who has dedicated a good chunk of... (shrink)

The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Yet the revised rule is not as radical as it might seem. During the 1970s, judges started using the standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed consent to the harmful procedures. In its influential Belmont Report, the National Commission (...) recommended application of a “reasonable volunteer standard” to guide IRBs evaluating research disclosures. Evidence also suggests that IRBs often invoke the reasonable person standard in deliberations about consent forms. But past application of the standard has been informal and uneven. Robust application of the reasonable person standard will require researchers and IRBs to learn more about what ordinary people want and need to know about the studies they are invited to join. Input from people with personal experience as study participants could be particularly useful to this effort. (shrink)

The Covid‐19 pandemic has exposed four myths in bioethics. First, the flood of bioethics publications on how to allocate scarce resources in crisis conditions has assumed authorities would declare the onset of crisis standards of care, yet few have done so. This leaves guidelines in limbo and patients unprotected. Second, the pandemic's realities have exploded traditional boundaries between clinical, research, and public health ethics, requiring bioethics to face the interdigitation of learning, doing, and allocating. Third, without empirical research, the success (...) or failure of ethics guidelines remains unknown, demonstrating that crafting ethics guidance is only the start. And fourth, the pandemic's glaring health inequities require new commitment to learn from communities facing extraordinary challenges. Without that new learning, bioethics methods cannot succeed. The pandemic is a wake‐up call, and bioethics must rise to the challenge. (shrink)

In the article “On Avoiding Deep Dementia,” Norman Cantor defends a position that I suspect many readers share. In my years writing and speaking on advance directives and dementia, I've found that most people support one of two positions. They are convinced either that advance choices should control the treatment dementia patients receive or that the welfare of a person with dementia should sometimes take priority over earlier choices. As Cantor points out, I support the second position.I agree with several (...) of Cantor's arguments. Where Cantor and I part ways is over the degree of control that advance directives should exert over the care of persons with moderate dementia. Although I don't welcome the prospect of living with dementia, I believe that people with the condition should be represented in the debate over treatment standards. It's not surprising that many, perhaps most, people unaffected by dementia think that their preferences should control the care they would receive as dementia patients. But people taking this position are neglecting the concerns and interests they may have as dementia patients. (shrink)

My particular focus in this article is on getting clearer about what Nietzsche’s experimentalism entails. Some immediate resistance may form in response to this proposal, based on my use of the term experimentalism. As Walter Kaufmann has pointed out in a discussion of experimentalism, Nietzsche himself does not discuss his work using this concept; in the original German, Nietzsche uses the terms “Experiment” and “Versuch.”1 In light of this, two main concerns may be raised about my proposal that experimentalism is (...) worth some of our time and attention: whether it is necessary or helpful to focus discussion on yet another “ism” within Nietzsche scholarship and given that experimentalism is not Nietzsche’s.. (shrink)

In the UK, it has been proposed that alongside the current advice to abstain from alcohol completely in pregnancy, there should be increased screening of pregnant women for alcohol consumption in order to prevent instances of fetal alcohol spectrum disorder. The Scottish Intercollegiate Guidelines Network published guidelines in 2019 recommending that standardised screening questionnaires and associated use of biomarkers should be considered to identify alcohol exposure in pregnancy. This was followed in 2020 by the National Institute for Health and Care (...) Excellence Draft Quality Standard, which recommended that pregnant women should have information on their alcohol consumption recorded throughout their pregnancy and this information transferred to the child’s health records. Most recently, Public Health England has stated that the alcohol intake of all women should be recorded throughout pregnancy, not just at the initial booking appointment and that tools such as blood biomarkers and meconium testing should be researched in order to determine true prevalence rates of alcohol in pregnancy. We argue that this proposed enhanced screening undermines women’s autonomy and their legal right to be sufficiently informed to consent to screening. We argue that there is no evidence that this kind of screening will result in a reduction of fetal harm and there is a danger that undermining the autonomy of women and the trust relationship between women and healthcare professionals may even increase harm to future children. (shrink)

The conversation analytic view of context is often critiqued as being too narrow. In this article, we join the ongoing debate regarding conversation analysis and context by 1) synthesizing existing scholarly attempts at either conceptualizing or exploring the possibilities of combining CA and ethnography and 2) giving further considerations to whether or how resorting to talk-extrinsic data may be beneficial. We do so by providing four illustrative cases, with increasing complexity, from four different settings. In each case, an initial CA (...) analysis is followed up with an informal ethnographic interview with the participants. By offering some specificity to this ongoing methodological controversy regarding talk-extrinsic data, we aim to begin building a useful framework within which further discussions on analysis, context, and cross-fertilization may proceed. (shrink)

This paper examines Bergson’s position concerning the relation between memory and the immediate experience of change. I argue that Bergson’s view, which has not been discussed in significant detail in the literature, can shed new light upon recent debates on the topic. I approach this in three steps. First, I examine the “memory theory” of immediate temporal experience in its two main forms — a “traditional” version and a “modified” account — situating Bergson’s views vis-à-vis this distinction. Second, I explore (...) a contemporary defence of the memory theory and underline a limitation in this account. Finally, I focus on a feature of Bergson’s reflections on memory and temporal experience that can potentially address this limitation. (shrink)

This text is designed to teach students how to read and write proofs in mathematics and to acquaint them with how mathematicians investigate problems and formulate conjecture.

Paul Thompson's book The Spirit of the Soil first appeared in 1995, and has been re-issued in a new edition in 2017. This comment on the new edition addresses Thompson's argument concerning the pro...

In this essay I refer to eros as the force that plays on our bodies and connects us to the larger community of life, an embodied form of love that charges the will towards well-being. Analyzing the ways that eros can be engaged and expressed in the "commons" as a life sustaining force, I look to current, on-the-ground work being done in Detroit, MI where a grassroots network of artists, community-builders, educators and neighborhood folk are revitalizing their city. Linking this (...) work and the love I experienced with them to childhood experiences in my own homeplace in northern New York State, I argue for the development of eco-ethical consciousness within an erotic "poetics of place" where the natural world speaks to us within our interpretive, expressive efforts. Finally, in an explication of education as those generative relations that are specifically oriented towards well-being, I look to the relation among eros, language and the creation of the commons as a critical educational endeavor. If we are to stem the tide of ecological destruction now upon us, we will need educators in public schools who recognize and are able to create classroom practices that encourage an "eco-erosic love" and thus inspire students who can protect the fragile relationship of their human communities to the ecosystems upon which we depend. (shrink)