Big data and artificial intelligence (“AI”) promise to transform virtually all aspects of biomedical research and health care (Matheny et al. 2019), through facilitation of drug development, diagno...

The use of racial categories in biomedicine has had a long history in the United States. However, social hierarchy and discrimination, justified by purported scientific differences, has also plagued the history of racial categories. Because “race” has some correlation with biological and genetic characteristics, there has been a call not to “throw the baby out with the bathwater” by eliminating race as a research or clinical category. I argue that race is too undefined and fluid to be useful as a (...) proxy for biology or genetics. (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

McCradden et al. propose to close the “AI chasm” between algorithms and clinically meaningful application using the norms of evidence-based medicine and clinical research, with the rat...

There are deep divides over the use of racial and ethnic categories in biomedical research and its application in both medical and non-medical contexts. On one side of a roughly described dividing line are practitioners who need to use every piece of information at their disposal to solve pressing, realworld problems in real time, such as making clinical diagnoses or identifying perpetrators of crime. On the other side are scientists and policy makers committed to meeting a scientific and social need (...) for accuracy and thus trying to avoid miscategorization.As Jay Cohn describes in this issue, medical practitioners in particular have used racial and ethnic categories to “enhance diagnostic and therapeutic precision.” He argues for retaining this practice. The plea, motivated by genuine concern for patients, is to avoid “throwing the baby out with the bathwater.” However, Cohn and others mischaracterize the nature of the debate. The argument is not about whether differences among populations exist, or even whether differences among “races” exist. (shrink)

From its inception, genomics has been a speculative endeavor, fixated on a far-off horizon that would deliver on the promise of targeted diagnostics and individualized therapeutics (Fortun 2008). M...

With the growth of precision medicine research on health data and biospecimens, research institutions will need to build and maintain long-term, trusting relationships with patient-participants. While trust is important for all research relationships, the longitudinal nature of precision medicine research raises particular challenges for facilitating trust when the specifics of future studies are unknown. Based on focus groups with racially and ethnically diverse patients, we describe several factors that influence patient trust and potential institutional approaches to building trustworthiness. Drawing on (...) these findings, we suggest several considerations for research institutions seeking to cultivate long-term, trusting relationships with patients: Address the role of history and experience on trust, engage concerns about potential group harm, address cultural values and communication barriers, and integrate patient values and expectations into oversight and governance structures. (shrink)

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. It has been common practice among researchers to notify participants during the informed consent process that no individual results will be disclosed, “incidental” or otherwise. However, as genetic information obtained in research becomes orders of magnitude more voluminous, increasingly accessible online, and more informative, this precedent may no longer be appropriate. There is not yet consensus on (...) the responsibilities of researchers to disclose individual research results to research participants. Empirical research suggests that participants want to know individual research results. On the other hand, the increased resolution and power aforded by new genomic analyses may lead to fndings of statistical, but not necessarily clinical, signifcance. This paper addresses the issues to be considered in deciding whether and how to disclose “incidental” fndings or other fndings of clinical signifcance that arise in the course of human genomic and genetic research. What research results should be ofered, and what should not be ofered? For which research should individual results be ofered to research participants, when should they be ofered, how, and to whom? (shrink)

Human genetic and genomic research can yield information that may be of clinical relevance to the individuals who participate as subjects of the research. However, no consensus exists as yet on the responsibilities of researchers to disclose individual research results to participants in human subjects research. “Genetic and genomic research” on humans varies widely, including association studies, examination of allele frequencies, and studies of natural selection, human migration, and genetic variation. For the purposes of this article, it is defined broadly (...) to include analysis of DNA collected from humans that has implications for human health. This paper addresses both research results of individual research participants that may be an intended product of the research, as well as unanticipated, “incidental” findings. (shrink)

Recent experiments have been used to “edit” genomes of various plant, animal and other species, including humans, with unprecedented precision. Furthermore, editing the Cas9 endonuclease gene with a gene encoding the desired guide RNA into an organism, adjacent to an altered gene, could create a “gene drive” that could spread a trait through an entire population of organisms. These experiments represent advances along a spectrum of technological abilities that genetic engineers have been working on since the advent of recombinant DNA (...) techniques. The scientific and bioethics communities have built substantial literatures about the ethical and policy implications of genetic engineering, especially in the age of bioterrorism. However, recent CRISPr/Cas experiments have triggered a rehashing of previous policy discussions, suggesting that the scientific community requires guidance on how to think about social responsibility. We propose a framework to enable analysis of social responsibility, using two example.. (shrink)

This paper examines how people anticipate negative emotion when faced with an uncertain outcome and try to manage their expectation. While extant research streams remain equivocal on whether managing expectation always succeeds, this research examines situations in which setting a low expectation can have an adverse emotional impact and ways to alleviate this negative emotional consequence. Using goal setting and false-feedback paradigm, we show that those who set low goals to manage expectation can end up feeling more disappointed than those (...) who set high goals (study 1), but this negative impact can be avoided when goals are reminded at feedback and when individuals are made aware of the inaccuracies in forecasting affect or are reminded of their initial goal (studies 1 and 2). (shrink)

In 2011, the Department of Health and Human Services proposed changes to the regulations that govern human subjects protection in federally funded research. The proposed changes involve modifying inclusion standards for minimal-risk research and removing the necessity of review from certain categories of noninvasive research. All studies would instead be required to comply with privacy protections as initiated by the Health Information Portability and Accountability Act . We argue that relying on HIPAA to protect participants from participation-related risks in noninvasive (...) research is insufficient to protect the autonomy and psychological health of potential research participants. Instead, we suggest a streamlined review format for these categories of research. (shrink)

Public investments in genomic and precision medicine have begun to yield clinically useful interventions, most recently, for example, two new, FDA-approved gene therapies for sickle cell disease (F...

Appeals to scrutinize the use of race and ethnicity as variables in genetics research notwithstanding, these variables continue to be inadequately explained and inconsistently used in research publications. In previous research, we found that published genetic research fails to follow suggestions offered for addressing this problem, such as explaining the basis on which these labels are assigned to populations. This study, an analysis of genetic research articles using race or ethnicity terms, explores possible features of journals that are associated with (...) improved reporting of race and ethnicity in genetic research. A journal’s expressed commitment to improving how race and ethnicity are used in genetic research, demonstrated by an editorial or in its instructions to authors, was the strongest predictor of following recommendations about reporting race and ethnicity. Journal impact factor had only a limited positive effect on attention to these issues, suggesting that editorial resources associated with higher impact factor journals are not sufficient to improve practices. Our findings reiterate that race and ethnicity variables are used inconsistently in genetic research, but also shed light on how journals might improve practices by highlighting the need for scientists to carefully scrutinize the use of these variables in their work. (shrink)

The US National Institute of Health’s Human Microbiome Project aims to use genomic techniques to understand the microbial communities that live on the human body. The emergent field of microbiome science brought together diverse disciplinary perspectives and technologies, thus facilitating the negotiation of differing values. Here, we describe how values are conceptualized and negotiated within microbiome research. Analyzing discussions from a series of interdisciplinary workshops conducted with microbiome researchers, we argue that negotiations of epistemic, social, and institutional values were inextricable (...) from the reflective and strategic category work that defined and organized the microbiome as an object of study and a potential future site of biomedical intervention. Negotiating the divergence or tension between emerging scientific and regulatory classifications also activated “values levers” and opened up reflective discussions of how classifications embody values and how these values might differ across domains. These data suggest that scholars at the intersections of science and technology studies, ethics, and policy could leverage such openings to identify and intervene in the ways that ethical/regulatory and scientific/technical practices are coproduced within unfolding research. (shrink)

Marcuse’s Challenge to Education, a collection of essays by scholars who have explicated his theories accompanied by unpublished lecture notes by Marcuse himself, examines his ground-breaking critique of education as well as his own pedagogical alternatives. This compilation provides an overview of the various themes of Marcuse's challenges to traditional education and connections with ideas of other radical thinkers ranging from Bloch and Freire to Freud and Lacan.

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial risks (...) and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access. (shrink)

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial risks (...) and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access. (shrink)

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)

Bioethics is reexamining how to implement diversity, equity, inclusion, and justice concerns into scholarship. However, bioethicists should question the categories used to define diversity. The act of categorization is value laden, and classification systems confer power and benefits and generate harms. For example, what conditions count as disabilities? We should consider the equity implications of offering only “male” and “female” options for self‐identification in health records. However, we should also interrogate all ideas about categorization, including how categories are formed, why (...) they are formed, and who decides. Bioethicists cannot comprehend fully what equity and justice mean for underrepresented, underserved, or marginalized people until there is an understanding of how the boundaries of marginalization are created. (shrink)

Examining the subtle forms of aggression, violence, and harassment that occur in our society and manifest in institutions and places of work, the expert contributors collected here describe the experience of social marginalization and expose how vulnerable individuals work to navigate exclusionary climates. This volume explores how bodies disrupt the status quo in multiple contexts and locations; provides insights into how institutions are structured and how practices that may cause harm are maintained; and, finally, considers progressive and proactive alternatives. This (...) book will be a key resource for academics and professionals in education, sociology, nursing, law, business and political science, as well as organizations and policymakers grappling with aggression in the workplace. (shrink)