Ethical and regulatory aspects of cell and tissue banking

Abstract

Human tissue and cell transplant medicine raises ethical, legal and societal implications (ELSI), affecting all stakeholders in the transplant process. Informed consent, the central ethical issue, ensures voluntary altruistic donation but relies on adequate transparent communication of potential risks to the donor, including psychological effects, loss of property rights and commercialisation. Specific issues related to saviour siblings, cord blood banking and deceased donation are introduced. Recipients require just access and regulation of safe processing to secure healthy transplants and to guarantee confidentiality without compromising traceability. Society benefits from altruistic donation can be increased through education campaigns, cross-border exchange programmes and regulation of trafficking. European regulatory instruments deal with consent and protect the vulnerable, e.g. minors, who lack capacity to consent. European directives lay down mandatory procedures for safe practices, for procurement organisations and tissue establishments, to ensure maintenance of quality control, traceability and data privacy. The European General Data Protection Regulation (GDPR) allows data sharing with third countries provided adequate safeguards are in place. However, stakeholders prefer guidelines, rather than legislation, as these offer up-to-date scientific information. Complex issues concerning the emerging technology of cellular therapies, including stem cells, are addressed, outlining the interrelationship of ethical and regulatory issues with ease of traceability for different products. Future transplant medicine relies on potential donors being aware of new technologies, local policies, guidelines and legislation regarding transplantation practices, so education campaigns and ongoing public dialogue are essential.