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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. [ABSTRACT FROM AUTHOR]

Summary: Innovative research in deceased donation and transplantation often presents ethical challenges for researchers and those responsible for ethical governance of research. These challenges have been recognized as potential barriers to the conduct of research. We review the literature to identify and describe ethical considerations that may cause confusion or uncertainty in the context of research involving potential deceased donors or deceased donor transplantation. We normatively examine these considerations and discuss their implications for the ethical conduct of research. In addition to the complexities of research involving critically ill, dying or recently deceased individuals, uncertainty may arise regarding the ethical status of various individuals who may be involved in research aimed at improving availability and outcomes of organ transplantation. Consequently, routine ethical guidelines for clinical research may fail to provide clear guidance with regards to the design, conduct and governance of some deceased donation or transplantation studies. Ethical uncertainty may result in delays or barriers to research, or neglect of important ethical considerations. Specific ethical guidance is needed to support research in deceased donation and transplantation as the ethical considerations that arise in the design and conduct of such research may not be addressed in the existing guidelines for human research. [ABSTRACT FROM AUTHOR]

The Human Transplantation ( Wales) Act became law in Wales in September 2013. The Act aims to increase deceased donor organ and tissue donation in Wales by introducing a 'soft opt-out' system to replace the previous requirement of express 'appropriate' consent under the Human Tissue Act 2004. Adults dying in Wales (with certain exceptions) will be 'deemed' to consent to donation, unless evidence of their objection is produced, and a duty is imposed on Ministers to promote transplantation and inform the public through awareness campaigns about how to choose the deemed status or opt out. Although a welcome development, these campaigns may obscure the effects of deemed consent, especially in the context of generally rising UK donation rates. There may also be problems of legal interpretation and of integration with the 'opt-in' laws in the rest of the UK. In the absence of any statutory duty to retrieve all lawfully donated organs, the apparently restricted influence of donor relatives is likely to remain effectively dominant. [ABSTRACT FROM AUTHOR]