Adapting Preclinical Benchmarks for First-in-Human Trials of Human Embryonic Stem Cell-Based Therapies.

Unlabelled: : As research on human embryonic stem cell (hESC)-based therapies is moving from the laboratory to the clinic, there is an urgent need to assess when it can be ethically justified to make the step from preclinical studies to the first protocols involving human subjects. We examined existing regulatory frameworks stating preclinical requirements relevant to the move to first-in-human (FIH) trials and assessed how they may be applied in the context of hESC-based interventions to best protect research participants. Our findings show that some preclinical benchmarks require rethinking (i.

Ethical norms and the international governance of genetic databases and biobanks: findings from an international study.

This article highlights major results of a study into the ethical norms and rules governing biobanks. After describing the methodology, the findings regarding four topics are presented: (1) the ownership of human biological samples held in biobanks; (2) the regulation of researchers' use of samples obtained from biobanks; (3) what constitutes "collective consent" to genetic research, and when it is needed; and (4) benefit sharing and remuneration of research participants. The paper then summarizes key lessons to be drawn from the findings and concludes by reflecting on the importance of such empirical research to inform future governance norms and practices.

Moral status revisited: the challenge of reversed potency.

Moral status is a vexing topic. Linked for so long to the unending debates about ensoulment and the morality of abortion, it has recently resurfaced in the embryonic stem cell controversy. In this new context, it should benefit from new insights originating in recent scientific advances.

Current anti-doping policy: a critical appraisal.

Background: Current anti-doping in competitive sports is advocated for reasons of fair-play and concern for the athlete's health. With the inception of the World Anti Doping Agency (WADA), anti-doping effort has been considerably intensified. Resources invested in anti-doping are rising steeply and increasingly involve public funding.

The European embryonic stem-cell debate and the difficulties of embryological Kantianism.

As elsewhere, the ethical debate on embryonic stem cell research in Central Europe, especially Germany and Switzerland, involves controversy over the status of the human embryo. There is a distinctive Kantian flavor to the standard arguments however, and we show how they often embody a set of misunderstandings and argumentative shortcuts we term"embryological Kantianism."We also undertake a broader analysis of three arguments typically presented in this debate, especially in official position papers, namely the identity, continuity, and potentiality arguments.