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)

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.

This study investigates the effectiveness of pedagogical practices used to teach business ethics. The business community has greatly increased its demands for better ethics education in business programs. Educators have generally agreed that the ethical principles of business people have declined. It is important, then, to examine how common methods of instruction used in business ethics could contribute to the development of higher levels of moral judgment competence for students. To determine the effectiveness of these methods, moral judgment competence levels (...) for undergraduate and graduate students from three institutions were measured and compared based upon the pedagogical method used in a business class. Significant differences were found for moral reasoning and moral competence scores depending on the method used for ethics instruction. Students in classes with more highly integrated ethics coverage scored higher in moral reasoning and moral competence. (shrink)

Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.

Oversight of human gene transfer research presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human gene (...) transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology. (shrink)

Health care reform proposals threaten to exacerbate tensions physicians already face in trying to balance traditional duties to individual patients against increasing pressure to serve broader societal and institutional goals. To cope with reform, medical ethics must clarify physicians' moral obligations, change existing ethical codes, and develop an ethics of institutions.

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)

Technology has outpaced the capacity of researchers performing research on human participants to interpret all data generated and handle those data responsibly. This poses a critical challenge to existing rules governing human subjects research. The technologies used in research to generate images, scans, and data can now produce so much information that there is significant potential for incidental findings, findings generated in the course of research but beyond the aims of the study. Neuroimaging scans may visualize the entire brain and (...) even the entire head; computed tomography colonography research may visualize the entire torso, from the base of the lungs to the pubis; genetics studies may reveal “extra” and sometimes unwanted information about the family, such as misattributed paternity and undisclosed adoption; and genomic microarray research increasingly involves whole-genome analysis revealing an individual’s complete genotype, with enormous potential for uncovering unexpected information about an individual’s genetics and risks of developing future conditions. (shrink)

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.

ponsibilities compounds these challenges. This article presents an overview of research and standards of practice regarding children's participation in research and healthcare decisions. Further research on children's competence to participate in healthcare decisions is recommended. Reasons for and against children's increased involvement in healthcare decisions are included. There is a preponderance of support for involving children in the process, and a dearth of well-articulated reasons to exclude them....

How could it happen that the very processes intended to assure ethical research in Australia might, themselves, undermine good research practice?This paper describes one PhD candidate’s recent experiences of multicentre review for a Human Research Ethics Committee approved, low/negligible risk, qualitative study, at the crossroad of health services research and organisational research.A retrospective review of international literature about multi-centre review processes revealed that many of these experiences were not unique and might have been expected, notwithstanding Australian efforts at harmonisation of (...) multi-centre review. This paper examines not only the burden of red-tape that was applied to a small doctoral study, but also the way in which the red-tape threatened the anonymity of potential study participants and risked exposing them to undue pressure and distress.These experiences support the view that harmonisation initiatives have not yet developed as the Australian National Health and Medical Research Council may have hoped and that further attention is needed to harmonise research governance processes. (shrink)

Volume 20, Issue 8, August 2020, Page 41-43.

This article examines two questions pertaining to the extension of infertility treatment to postmenopausal women. First, what concepts and principles of infertility practice apply to assisted reproduction for the postmenopausal patient? Second, what role should these concepts play in the development of an ethical justification for extending women's reproductive lives past the menopausal boundary? The argument offered here supports their claim to infertility services on the basis of the formal principle of justice, which requires that similar cases be treated similarly. (...) The cases of many postmenopausal patients are argued to be relevantly similar to classes of patients who already receive assistance in reproduction. (shrink)

A Skeptical View of the Liberal Peace reflects on the place of democracy in the global community. The article pays particular attention to the widespread assumption that there is an inherent relationship between democracy and peace, and that peace most assuredly is derived from democracy itself. I find these assertions to be highly questionable and overstated. Reflection on the philosophy which underpins these claims can only be helpful for international relations. In particular, given the United States’ apparent imperialistic urge to (...) force democracies on other nations as Iraq, the article seems especially timely. (shrink)

This piece explores the proposition that environmental restoration is the only acceptable alternative to a world left with diminishing natural regions. The article reviews the ethical debate concerning the moral obligation of humankind to restore regions that have been stripped of their resources. It demonstrates thatthrough the assistance of both legislative and technological measures nature can be renewed to spawn healthy ecosystems when permitted to do so. Furthermore, the article claims that the restoration thesis is proven by the paradigm of (...) the Adirondack region – a region that was once clear-cut and enabled to restore itself through both rewilding and the “Forever Wild” clause in the New York State Constitution. The article is particularly timely and provocative given the current Bush Administration’s environmental policies. (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)

The goal of this paper is to show that Callahan's reasons for withholding life extending care cannot be made out exclusively in terms of contemporary notions of distributive justice and fair allocation. I argue that by relying on a notion of justice which links the merit of the individual with the fairness of a social pattern of shares, Callahan imputes vice to the elderly as he denies them eligibility for life-prolonging care. Aristotle's doctrine of the mean is a useful tool (...) for character evaluation. One can speak meaningfully of a proper disposition of a person of a certain type (an elderly person) with respect to the good of continued life. I claim that the mean of one's disposition with respect to the good of continued life would be relative to one's age group, and would be determined by that principle by which an elderly person of practical wisdom would determine it. This leads to very different conclusions than those drawn by Callahan. (shrink)

The Moral Economies of American Authorship argues that the moral character of authors became a kind of literary property within mid-nineteenth-century America's expanding print marketplace, shaping the construction, promotion, and reception of texts as well as of literary reputations.

The problem of incidental findings in human subjects research—findings of potential health importance to the research participant that the researcher stumbles upon while pursuing the aims of the research—may at first seem of minor significance. The number and potential gravity of incidental findings force researchers to face difficult questions. The most fundamental of these is whether researchers have any duty to identify, evaluate, and disclose these findings to the research participant. This is a profound challenge to the structure of bioethics (...) and health law. Both fields approach the world of research and the world of medical care very differently. Neuroimaging research can yield a high number of incidental findings. Bioethics and health law must now reconstitute the traditional vision of researcher duties to bring the researcher back into a relationship with the research participant. (shrink)

Advanced biopreservation technologies using subzero approaches such as supercooling, partial freezing, and vitrification with reanimating techniques including nanoparticle infusion and laser rewarming are rapidly emerging as technologies with potential to radically disrupt biomedicine, research, aquaculture, and conservation. These technologies could pause biological time and facilitate large-scale banking of biomedical products including organs, tissues, and cell therapies.

This paper reports on a recent symposium seminar series entitled ‘Governing genetic databases – collection, storage and use’ hosted by the Ethox Centre at the University of Oxford. It outlines the inadequacy of the current UK framework for governing genetic databases and biobanks and some of the implications of this. It then briefly describes and reflects on each of the five symposium papers.