Abstract
Stem cell banks are increasingly seen as an essential resource of biological materials for both basic and translational research. Stem cell banks support transnational access to quality-controlled and ethically sourced stem cell lines from different origins and of varying grades. According to the Organisation for Economic Co-operation and Development, advances in regenerative medicine are leading to the development of a bioeconomy, 'a world where biotechnology contributes to a significant share of economic output'. Consequently, stem cell banks are destined to constitute a pillar of the bioeconomy in many countries. While certain ethical and legal concerns are specific to the nature of stem cells, stem cell banking could do well to examine the approaches fostered by tissue banking generally. Indeed, the past decade has seen a move to simplify and harmonize biological tissue and data banking so as to foster international interoperability. In particular, the issues of consent and of traceability illustrate not only commonalities but the opportunity for stem cell banking to appreciate the lessons learned in biobanking generally. This paper analyzes convergence and divergence in issues surrounding policy harmonization, transnational sharing, informed consent, traceability and return of results in the context of stem cell banks.
Highlights
Since the pioneering isolation and culture of human embryonic stem cells over a decade ago, a new era of clinical promise in regenerative medicine has emerged
According to the Organisation for Economic Cooperation and Development, advances in regenerative medicine and stem cells are leading to the development of a bioeconomy: ‘a world where biotechnology contributes to a significant share of economic output’ [3]
Most policies tend to call for stem cell banks to adopt protocols governing the disclosure and management of such information back to Conclusions While this overview has attempted to trace the routes taken and the lessons learned for stem cell banking by comparison with biobanking generally, challenges remain for both
Summary
Since the pioneering isolation and culture of human embryonic stem cells over a decade ago, a new era of clinical promise in regenerative medicine has emerged. It is interesting to note that tissue banks and stem cell banks are encountering issues similar to those found in international biobanking generally; these issues include institutional governance, respect of autonomy and privacy, uses of samples, and so on Both face similar challenges of ensuring safety through traceability, while protecting the autonomy and privacy of donors. In the specific context of stem cell research and banking, the scientific, ethical and policy implications of mandating return of results have seldom been addressed When they have been, the possibility of returning individual or general research results is part of the informed consent process. Most policies tend to call for stem cell banks to adopt protocols governing the disclosure and management of such information back to
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