Governing stem cell banks and registries: emerging issues.

The expansion of national and international research efforts in stem cell research is increasingly paired with the trend of establishing stem cell banks and registries. In jurisdictions crossing the spectrum of restrictive to liberal stem cell policies, banks and registries are emerging as an essential resource for transnational access to quality-controlled and ethically sourced stem cell lines. In this study, we report the preliminary findings of a survey of stem cell banks participating in the International Stem Cell Forum's International Stem Cell Banking Initiative (ISCBI). The questionnaire circulated to all ISCBI members addressed both general issues surrounding research policies (e.g., national policies regulating the permissibility of conducting embryonic stem cell research (hESCR)) and, more specifically, issues relating to the governance of stem cell banking projects. The results of the questionnaire were complemented by scholarly research conducted by the authors. This article provides an overview of the current international hESC banking landscape (I). For this purpose, the policy and governance approaches adopted in the surveyed stem cell banks at the national level will be analyzed and areas of convergence and variance will be identified (II). It is beyond the scope of this paper to provide a comprehensive analysis of the wide range of possible governance approaches, policy responses, and their implications. However, we want to provide a starting point for discussion surrounding key questions and challenges as concerns provenance, access, and deposit of hESC lines (III). Finally, while our analysis is focused on research grade hESCs, the lessons to be gleaned from this examination will encourage further thought, analysis, and research into the issues raised in the banking and governance of other sources of stem cell lines (e.g., SCNT, parthenogenesis, iPs) (IV).

Policy interoperability in stem cell research: demystifying harmonization.

Scientific developments in the field of stem cell research continue to emerge at incredible speed and so too has the contentious debate surrounding their broad implications. Though economic, socio-ethical and legal concerns remain, at both national and international forums; we are witnessing a departure from an "embryo-centric" approach, to one that is focused on the globalization of research and to the ensuing need for policy interoperability. The common response to the challenges associated with the meaning, scope, and ethical significance of variance in national policies, is a call for the creation of uniform legal and ethical standards. However, this call towards policy convergence on the fundamental ethical and governance principles underpinning policies choices has led to confusion and to the mystification of the notion of harmonization. In this article we aim demystify the notion of policy harmonization in the context of stem cell research. We will do so by surveying the diverse elements to be harmonized. We will then present the problems of policy interoperability in the context of the globalization of SC research, in order to propose that the goal of harmonization in this field lies in the identification of prospective strategies to foster seamless cross-jurisdictional collaboration. Finally, policy interoperability will be analyzed through the lens of a range of policy approaches addressing the cross-jurisdictional transfer of hESC lines with the aim of demonstrating that the apparent ethical-political-legal divide in some contexts largely vanishes once we grasp the notion of harmonization and identify points of convergence.

The use of fresh embryos in stem cell research: ethical and policy issues.

Fresh embryos resulting from in vitro fertilization, including many of poor quality, can provide sources of human embryonic stem cell lines. We consider why some donate such embryos for this research, address relevant ethical and policy issues, and present core guidelines for fresh embryo donation based on those of Canada.

Monetary payments for the procurement of oocytes for stem cell research: In search of ethical and political consistency.

The debate on both the appropriateness of allowing healthy women to provide oocytes for research use and the use of financial incentives is increasingly reduced to a confrontation between ethics, science, and the welfare of women. It is plausible that the expansion of national and international research efforts, paired with the growing trend toward liberalizing stem cell research policies, will inevitably result in increased demand for the materials needed to conduct such research. The scarcity of human reproductive materials that are available for research generates concerns over, the emergence of a "black market", an increase in financial incentives for donors, and the appropriateness of current regulatory frameworks that aim to safeguard donors. In this article we explore the conceptual models for categorizing oocyte donors and analyze the use of financial incentives as well as the compensation models proposed and implemented in various jurisdictions. Finally, we propose the adoption of a mixed model that both respects altruism and provides a feasible solution to an issue that could be situated only in the context of the overall acceptability of providing financial rewards to donors of human reproductive materials for assisted reproductive technologies.

To clone alone: the United Nations' Human Cloning Declaration.

The United Nations labored for almost four years to create a treaty governing human cloning. In 2005 that effort was abandoned, and instead the United Nations' General Assembly adopted a "Declaration on Human Cloning".

Beyond the permissibility of embryonic and stem cell research: substantive requirements and procedural safeguards.

This report provides a comparative analysis of the regulation of embryonic stem cells and cloning research in 50 countries. The development of international stem cell consortia involving the exchange of materials, data and knowledge presumes 'policy know-how' on the varying positions and governing regulations of the various partners; knowledge is essential for the feasibility of such international collaborative projects. Across the spectrum of restrictive-to-liberal policies, requirements regarding the justification for or the setting of substantive limits on (i) embryo use and/or (ii) destruction in research are often present. These goals justify the regulation, the control and even the prohibition of embryonic stem cell and cloning research. Moreover, irrespective of whether a country adopts a restrictive or a liberal approach, there is significant symmetry in both the substantive and the procedural requirements. Procedural safeguards provide another layer of protection and control over the research. In reality, such safeguards may have a greater systemic impact than the substantive requirements. They can be subdivided into three broad categories: (i) safeguards relating to the stage of embryonic development, (ii) safeguards relating to the donors of blastocysts, gametes, embryos and somatic cells and (iii) requirements for research governance.

To clone alone: The United Nations´ Human Cloning Declaration

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Preimplantation genetic diagnosis: an overview of socio-ethical and legal considerations.

Preimplantation genetic diagnosis (PGD) permits the selection of embryos of a particular genotype prior to implantation. As a reproductive technology involving embryo selection, PGD has become associated with considerable controversy. This review examines some of the ethical, legal, and social issues raised by PGD. Relevant ethical considerations include the status of the embryo and the interests and duties of the parents. On a social policy level, considerations of access as well as the impact of this technology on families, women, and physician's duties also warrant consideration. An analysis of these issues in the context of using PGD for selecting embryos unaffected by a serious disorder and for sex selection is presented. We also present a brief survey of PGD-related regulatory schemes in several countries, including the United Kingdom and the United States.

Regulatory approaches to reproductive genetic testing.

This report analyses the ethical and legal aspects of reproductive genetic testing in 11 countries (Australia, Austria, Canada, France, Germany, India, Israel, Japan, The Netherlands, Switzerland and the UK). The legal status of reproductive genetic testing in the countries under analysis is difficult to generalize due to the different regulatory systems adopted. These approaches are a reflection of the legal traditions and cultural and socio-religious beliefs which inform and shape public policy on assisted reproductive technologies and genetic testing. We divide approaches into two groups: public ordering (legislative, top-down approach) and private ordering (non-legislative, bottom-up approach). Even limiting our analysis to a number of countries that span the range from restrictive to pragmatic approaches, there is remarkable symmetry in both the (i) substantive requirements (i.e. gravity, health indications generally) and (ii) procedural safeguards (i.e. informed consent, counselling, confidentiality, civil status, oversight and accreditation) surrounding reproductive genetic testing. Indeed, irrespective of whether a country adopts a prohibitive or a permissive approach through legislation or self-regulation or a mix of both, the ultimate decision is--and should continue to be--a medical one. Nowhere is this more evident than in the substantive requirements.