David Magnus

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.

There are many kinds of clinical trials. The regulatory framework within which most drug development takes place appears to be the one that is to be applied to the development of novel stem cell-based clinical trials. In the standard drug development model, appropriate pre-clinical research is conducted, and investigators or research sponsors submit an investigational new drug application to the Food and Drug Administration.If approved, typical clinical trials start with Phase I, which is usually a trial to determine the maximum tolerable dose of a drug. Phase I trials are often referred to as “safety studies” because the primary goal of Phase I research is to determine if an intervention is safe.

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.