Ethical issues associated with the determination of patient selection criteria for total artificial heart technology

Background: The supply of human donor hearts continues to fall short of clinical need. While various educational efforts have been employed to encourage organ donation, there are only approximately 2,200 human hearts donated each year, yet there are approximately 4,100 patients waiting for a human donor heart at any point in time. In an effort to address the ongoing shortfall of human donor hearts, scientists have designed several experimental artificial hearts intended for permanent implantation, yet the transfer of this technology from animal to human use presents ethical challenges when developing patient selection criteria. Methods: Reflecting on the goals of research as well as principles of research ethics, an ethical analysis of seven potential patient subgroups was conducted in an effort to identify ethically problematic variables for a human clinical trial of total artificial heart technology. Results: Three of seven patient subgroups were identified as having ethically problematic variables that warrant caution against their inclusion in human clinical trials of total artificial heart technology. These three subgroups are as follows: 1) patients who cannot be weaned from extracorporeal support after bypass surgery; 2) patients of the Jehovah's Witness faith; 3) patients chosen based upon a categorical age limit. Conclusion: Clinical trial participants must be selected not by their medical status alone, but also with ethical reflection and consideration of psychological and social variables. Three patient subgroups have been identified that present variables that are ethically troublesome enough so as to warrant the exclusion of these subgroups from trial participation.