Informed consent in research to improve the number and quality of deceased donor organs.
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.
University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
Michael M
MM
Rey
Lorraine B
LB
Ware
Michael A
MA
Matthay
Gordon R
GR
Bernard
Amy L
AL
McGuire
Arthur L
AL
Caplan
Scott D
SD
Halpern
D035843:Biomedical Research / Q000941:ethics*; D002102:Cadaver; D016638:Critical Illness / Q000401:mortality; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence*; D007362:Intensive Care Units; D008297:Male; D020380:Needs Assessment; D016377:Organ Transplantation / Q000941:ethics / Q000331:legislation & jurisprudence; D019724:Presumed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D016032:Randomized Controlled Trials as Topic; D014019:Tissue Donors / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000600:supply & distribution*; D009927:Tissue and Organ Procurement / Q000941:ethics / Q000331:legislation & jurisprudence / Q000379:methods / Q000458:organization & administration*; D017749:Total Quality Management; D014481:United States