Informed consent documentation for total artificial heart technology

The supply of human donor hearts continues to fall short of clinical need. Educational efforts to increase organ donation have not been able to significantly narrow the shortfall of human hearts, and bridging devices such as left ventricular assist systems actually cause the United Network for Organ Sharing (UNOS) waiting list to swell. In an effort to address these matters, scientists continue the quest for a total artificial replacement heart for permanent implantation. Although the Jarvik-7 trials proved technically and ethically complex, this has not deterred research on this technology, and human clinical trials are on the horizon. One of the ethical challenges of this technology is obtaining informed consent. This analysis reflects on past trials and offers ethical guidance on preparing informed consent documentation for human clinical trials of total artificial replacement heart technology.