Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

Most human societies have undergone much greater change over the last few decades, or even years, than in the preceding millennia. This is partly due to the emergence of various phenomena in medici...

Networks for the exchange and/or sharing of genetic data are developing in many countries. We focus here on the situations in the US and France. We highlight some recent and remarkable differences between these two countries concerning the mode of access to, and the storage and use of genetic data, particularly as concerns two-sided markets and dynamic consent or dynamic electronic informed consent. This brief overview suggests that, even though the organization and function of these two-sided markets remain open to (...) criticism, dynamic e-IC should be more widely used, especially in France, if only to determine its real effectiveness. (shrink)

This essay is composed of five stories written by practicing physicians about their patients. Each clinical story describes a challenging ethical condition–potential abuse of medical power, gravely ill and probably over-treated newborns, iatrogenic narcotic addiction, deceived dying people. Rather than singling out one ethical conflict to resolve or adjudicate, the authors attempt, through literary methods, to grasp the singular experiences of their patients and to act according to the deep structures of their patients' lives. Examining these five stories with simple (...) literary tools–attention to narrative frames, time, plot, and desire–reveals the mechanisms through which acts of writing and reading contribute to clinical clarity and ethical actions. (shrink)