Faculty Bibliography

Deadly Choices: How the Anti-Vaccine Movement Threatens Us All, by Paul A. Offit, and The Panic Virus: A True Story of Medicine, Science, and Fear, by Seth Mnookin, is reviewed

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.

BACKGROUND: Transmission of human immunodeficiency virus and hepatitis C to transplant recipients has drawn attention of the use of allografts from seronegative donors at increased risk for blood-borne viral infection (DIRVI). METHODS: We performed a cohort study of 7803 kidney transplant recipients whose kidneys were recovered through one of two organ procurement organizations from 1996 to 2007. Detailed organ procurement organization data on donor risk factors were linked to recipient data from the Organ Procurement and Transplantation Network. RESULTS: Median recipient follow-up was 3.9 years. Three hundred sixty-eight (5%) patients received DIRVI kidneys, a third of which were procured from donors with a history of injection drug use or commercial sex work. Compared with standard criteria kidney recipients, DIRVI kidney recipients were more likely to be human immunodeficiency virus positive or black. In multivariable Cox regression, using DIRVI recipients as the reference, recipients of standard criteria donor kidneys had lower mortality (hazard ratio [HR] 0.71, P<0.01) and no difference in death-censored allograft failure (HR 1.09, P=0.62), whereas recipients of expanded criteria donor kidneys had no significant difference in mortality (HR 0.98, P=0.83) but a higher allograft failure rate (HR 1.93, P<0.01). High-quality data on posttransplant recipient viral testing were not available. CONCLUSIONS: DIRVI kidney recipients experienced higher mortality than standard criteria kidney recipients. This finding could be explained if sicker patients received DIRVI kidneys (i.e., residual confounding) or the less likely possibility of undetected transmission of viral infections. Given the limitations of registry data used in this analysis, prospective studies are needed to further elucidate these findings.