Informed consent documentation for total artificial heart technology.

[Extract]
The supply of human donor hearts is very small. According to the United Network for Organ Sharing (www.UNOS.org) there are
approximately 4,100 patients waiting for a human donor heart in the United States at any point in time, yet only approximately 2,200 human hearts are donated each year. While clinically effective, bridging devices such as left ventricular assist systems actually cause the UNOS waiting list to swell. Various educational efforts have been implemented in an attempt to expand the donor pool, yet the allograft shortfall continues. Total artificial heart (TAH) implantation has been attempted in the past; however, technical and ethical complexities abounded. Nonetheless, endeavors to address the ongoing deficit of human donor hearts continue and new designs of total artificial heart technology are in the early stages of human clinical trials. Because this technology is beginning to reemerge, clinical investigators need to be prepared to deal with the ethical complexities of informed consent for these trials. Reflecting on the past and looking to the future, guidance is offered in preparing informed consent documentation for human clinical trials of artificial replacement
heart technology.

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This article is reprinted with permission from the Japanese
Society for Artificial Organs, (2001) 4:273–277.