Stem cell banking: between traceability and identifiability

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

From Banking to International Governance: Fostering Innovation in Stem Cell Research

Stem cell banks are increasingly recognized as an essential resource of biological materials for both basic and translational stem cell research. By providing transnational access to quality controlled and ethically sourced stem cell lines, stem cell banks seek to foster international collaboration and innovation. However, given that national stem cell banks operate under different policy, regulatory and commercial frameworks, the transnational sharing of stem cell materials and data can be complicating. This paper will provide an overview of the most pressing challenges regarding the governance of stem cell banks, and the difficulties in designing regulatory and commercial frameworks that foster stem cell research. Moreover, the paper will shed light on the numerous international initiatives that have arisen to help harmonize and standardize stem cell banking and research processes to overcome such challenges

Mind the Gap : Policy Approaches to Embryonic Stem Cell and Cloning Research in 50 Countries

[À l'origine dans / Was originally part of : CRDP - Droit, biotechnologie et rapport au milieu

Mending the gaps: ethically sensitive cells and the evolution of European stem cell policy

The past decades witnessed the slow evolution of Europe's heterogeneous stem cell (SC) policy and substantial scientific advances in the field. Parallel to these developments, professional organizations have grown in influence. With the recently revised International Society for Stem Cell Research's Guidelines as a backdrop, we address the evolution of SC policies in 46 European countries and discuss how they fare against evolving ethical standards, societal views, and scientific advances. We identify areas of convergence, divergence, and the suitability of extant governance mechanisms to meet their stewardship roles. Europe represents a rich case study as it encompasses a wide range of policy approaches present worldwide. Comparative studies provide an opportunity to promote insight into national frameworks and to foster international harmonization

Modeling policy development: examining national governance of stem cell-based embryo models

Researchers can now coax human pluripotent stem cells to imitate the structure and spontaneous self-organization of the developing human embryo. Although these stem cell-based embryo models present an advantageous alternative to embryo research, they also raise ethical and policy challenges. In 2021, the International Society for Stem Cell Research revised its Guidelines for Stem Cell Research and Clinical Translation, providing contemporaneous best practices for ethical conduct in the field. The Guidelines complement national governance frameworks; however, they also contain contentious and aspirational norms that might catalyze change in research practice and in the enactment of national policies. Using a sample of 11 research-intensive countries, the authors compare research policy frameworks against the International Society for Stem Cell Research Guidelines to showcase how developments in global and national policies might affect stem cell-based embryo model research governance and illustrate fertile areas for ethical reflection and policy development

Model consent clauses for rare disease research

Background: Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, there is a need for model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ethical and legal use of data sources and participants' overall protection. Methods: A global Task Force was set up to develop model consent clauses specific to rare diseases research, that are comprehensive, harmonized, readily accessible, and internationally applicable, facilitating the recruitment and consent of rare disease research participants around the world. Existing consent forms and notices of consent were analyzed and classified under different consent themes, which were used as background to develop the model consent clauses. Results: The IRDiRC-GA4GH MCC Task Force met in September 2018, to discuss and design model consent clauses. Based on analyzed consent forms, they listed generic core elements and designed the following rare disease research specific core elements; Rare Disease Research Introductory Clause, Familial Participation, Audio/Visual Imaging, Collecting, storing, sharing of rare disease data, Recontact for matching, Data Linkage, Return of Results to Family Members, Incapacity/Death, and Benefits. Conclusion: The model consent clauses presented in this article have been drafted to highlight consent elements that bear in mind the trends in rare disease research, while providing a tool to help foster harmonization and collaborative efforts

Stem Cell Research Funding Policies and Dynamic Innovation: A Survey of Open Access and Commercialization Requirements

# The Author(s) 2014. This article is published with open access at Springerlink.com Abstract This article compares and contrasts the pressures of both open access data sharing and commercialization policies in the context of publicly funded embryonic stem cell research (SCR). First, normative guidelines of international SCR orga-nizations were examined. We then examined SCR funding guidelines and the project evaluation criteria of major funding organizations in the EU, the United Kingdom (UK), Spain, Canada and the United States. Our survey of policies revealed subtle pressures to commercialize research that include: in-creased funding availability for commercialization opportuni-ties, assistance for obtaining intellectual property rights (IPRs) and legislation mandating commercialization. In lieu of open access models, funders are increasingly opting for limited sharing models or “protected commons ” models that make the research available to researchers within the same region or those receiving the same funding. Meanwhile, there still is need for funding agencies to clarify and standardize terms such as “non-profit organizations ” and “for-profit research,” as more universities are pursuing for-profit or commercial opportunities. Keywords Stemcell research(SCR).Humanembryonicstem cells (hESC). Induced pluripotent stem cells (iPSC). Open access. Data sharing. Commercialization Abbreviations hESC human embryonic stem cells iPSC induced pluripotent stem cells IPRs intellectual property rights MTA material transfer agreement SCR stem cell research SLA simple letter agreement TTO technology transfer offic