Mildred Cho

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.

In 2011, Ingmar Riedel‐Kruse's bioengineering laboratory at Stanford University publicized an application that uses paramecia for what the researchers termed “biotic games.” These games make use of living organisms, computer programs, and lab equipment to implement games like Pong, Pac‐man, and soccer. Gamesand related activities are often considered nonserious or trivial, whereas life, biological systems, and science are treated very seriously in moral analysis and public perception. The manipulation of living matter frequently engenders at least some controversy in the marketplace of ideas, and using living things in games is no exception. Some of the objections lodged against biotic games have appeared in the ethics literature on similar topics; however, the addition of an entertainment element introduces some objections distinct from those about similar cases, as the online comments vividly illustrate. We aim to explore and address the objections in this paper, using the comments to organize and launch the discussion. In scientific work, there is typically a presumption of some prospect of translation and application of generated knowledge for public benefit. In the case of biotic games, these applications are not self‐evident. Because of this, a serious analysis of the justifications, limitations, and features of biotic games is warranted. To this end, we outline key ethical limits that ought to be placed on these activities as well as the obligations that these activities generate for researchers, other professionals, and lay people who design, implement, use, and play them.

Background Machine learning (ML) is utilized increasingly in health care, and can pose harms to patients, clinicians, health systems, and the public. In response, regulators have proposed an approach that would shift more responsibility to ML developers for mitigating potential harms. To be effective, this approach requires ML developers to recognize, accept, and act on responsibility for mitigating harms. However, little is known regarding the perspectives of developers themselves regarding their obligations to mitigate harms.Methods We conducted 40 semi-structured interviews with developers of ML predictive analytics applications for health care in the United States.Results Participants varied widely in their perspectives on personal responsibility and included examples of both moral engagement and disengagement, albeit in a variety of forms. While most (70%) of participants made a statement indicative of moral engagement, most of these statements reflected an awareness of moral issues, while only a subset of these included additional elements of engagement such as recognizing responsibility, alignment with personal values, addressing conflicts of interests, and opportunities for action. Further, we identified eight distinct categories of moral disengagement reflecting efforts to minimize potential harms or deflect personal responsibility for preventing or mitigating harms.Conclusions These findings suggest possible facilitators and barriers to the development of ethical ML that could act by encouraging moral engagement or discouraging moral disengagement. Regulatory approaches that depend on the ability of ML developers to recognize, accept, and act on responsibility for mitigating harms might have limited success without education and guidance for ML developers about the extent of their responsibilities and how to implement them.

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.

Emerging biomedical technologies often raise new research ethics questions that have the potential to impact not just patients and families, but society as a whole. At the Stanford Center for Biomedical Ethics, we recognized the importance of a proactive approach to addressing the implications of biomedical research at an early stage. We have therefore established a new ethics consultation service for clinical and basic scientists. Our experiences suggest that demand for such services extends beyond academia to companies and funding institutions. The results of the pilot program also indicate that knowledge of scientific methods and process is important for consultants. Consultations resulted in modifications of study design, research procedures, consent forms, grant applications, publications, and institutional policies. Preliminary evaluations indicate that the researchers value the outcomes of these consultations and especially the delivery of concrete recommendations. Consultations are also useful to bioethicists and institutions as a way to identify areas of ethical concern to researchers