Clinical Translation of Bio-Artificial Pancreas Therapies:Ethical, Legal and Psychosocial Interdisciplinary Considerations and Key Recommendations

The field of regenerative medicine offers potential therapies for Type 1 Diabetes, whereby metabolically active cellular components are combined with synthetic medical devices. These therapies are sometimes referred to as “bioartificial pancreases.” For these emerging and rapidly developing therapies to be clinically translated to patients, researchers must overcome not just scientific hurdles, but also navigate complex legal, ethical and psychosocial issues. In this article, we first provide an introductory overview of the key legal, ethical and psychosocial considerations identified in the existing literature and identify areas where research is currently lacking. We then highlight two principal areas of concern in which these discrete disciplines significantly overlap: 1) individual autonomy and 2) access and equality. Using the example of beta-cell provenance, we demonstrate how, by harnessing an interdisciplinary approach we can address these key areas of concern. Moreover, we provide practical recommendations to researchers, clinicians, and policymakers which will help to facilitate the clinical translation of this cutting-edge technology for Type 1 Diabetes patients. Finally, we emphasize the importance of exploring patient perspectives to ensure their responsible and acceptable translation from bench to body.</p

Early-Phase Clinical Trials of Bio-Artificial Organ Technology:A Systematic Review of Ethical Issues

Regenerative medicine has emerged as a novel alternative solution to organ failure which circumvents the issue of organ shortage. In preclinical research settings bio-artificial organs are being developed. It is anticipated that eventually it will be possible to launch first-in-human transplantation trials to test safety and efficacy in human recipients. In early-phase transplantation trials, however, research participants could be exposed to serious risks, such as toxicity, infections and tumorigenesis. So far, there is no ethical guidance for the safe and responsible design and conduct of early-phase clinical trials of bio-artificial organs. Therefore, research ethics review committees will need to look to related adjacent fields of research, including for example cell-based therapy, for guidance. In this systematic review, we examined the literature on early-phase clinical trials in these adjacent fields and undertook a thematic analysis of relevant ethical points to consider for early-phase clinical trials of transplantable bio-artificial organs. Six themes were identified: cell source, risk-benefit assessment, patient selection, trial design, informed consent, and oversight and accountability. Further empirical research is needed to provide insight in patient perspectives, as this may serve as valuable input in determining the conditions for ethically responsible and acceptable early clinical development of bio-artificial organs

The Development and Evolution of Organ Transplantation. An Ethical and Legal Inquiry into the Clinical Translation of Transplant Immunobiology

EThOS - Electronic Theses Online ServiceGBUnited Kingdo

Points mean prizes:priority points, preferential status and directed organ donation in Israel

The introduction of Israel’s new Organ Transplantation Act in 2010 has enabled the development of a unique priority point system aimed at motivating individual’s to donate their organ. The priority point system rewards those who are willing to donate an organ with preferential status and an increased chance of receiving a donor organ, should they come to be in need of one. Preliminary evidence suggests it has considerable public support among Israelis, who appear willing to redress the challenge posed by those who are willing to accept an organ but not willing to donate. Since the Act’s introduction Israel has witnessed record numbers signing donor cards and there has been a significant increase in the actual numbers of transplants. One aspect of the new Israeli system that has hitherto not much been considered is its tendency towards a communitarian model of organ donation and the implications this change in emphasis may have for the existing ‘opt-in’ model based upon autonomy and consent. Gil Siegel draws our attention to this aspect when he sets out his defence of a proposal he refers to as ‘directed organ donation to other registered donors’, which encourages community responsibility without affecting the established commitment to consent and individual freedom. This commentary provides a brief overview of the new Act and its priority point system. It also examines Siegel’s proposal and considers the implications it may have for equity and justice, personal choice and dispositional authority. It is argued that although the proposal brings with it several inevitable hurdles for policy makers these are not insurmountable. Rather, its extraordinary potential to save life and avoid suffering should prompt urgent action at policy level. If such a scheme was successfully implemented in Israel it would represent a landmark change in organ donation and allocation policy, and set an example from which we all could learn