Faculty Bibliography

Improving the management of potential organ donors in the intensive care unit could meet an important public health goal by increasing the number and quality of transplantable organs. However, randomized clinical trials are needed to quantify the extent to which specific interventions might enhance organ recovery and outcomes among transplant recipients. Among several barriers to conducting such studies are the absence of guidelines for obtaining informed consent for such studies and the fact that deceased organ donors are not covered by extant federal regulations governing oversight of research with human subjects. This article explores the underexamined ethical issues that arise in the context of donor management studies and provides ethical guidelines and suggested regulatory oversight mechanisms to enable such studies to be conducted ethically. We conclude that both the respect that is traditionally accorded to the prior wishes of the dead and the possibility of postmortem harm support a role for surrogate consent of donors in such randomized controlled trials. Furthermore, although recipients will often be considered human subjects under federal regulations, several ethical arguments support waiving requirements for recipient consent in donor management randomized controlled trials. Finally, we suggest that new regulatory mechanisms, perhaps linked to existing regional and national organ donation and transplantation infrastructures, must be established to protect patients in donor management studies while limiting unnecessary barriers to the conduct of this important research.

Caplan talks about the importance of the Patient Protection and Affordable Care Act, which became law on March 23, 2010. Not a single Republican in the House or Senate voted in favor of either bill. In fact the Republicans used health-reform legislation to great effect in getting a good number of the Democrats who had supported it thrown out of office in the midterm elections. It is not clear why many Republicans hate this bill--other than that it strikes many of them as an extension of government power. Put aside the fact that the potpourri of programs in the US already make the government the biggest player by far in American health care, and no member of the GOP seriously proposes to privatize any of these