A robust body of literature analyzes the shift of academic science toward more business-oriented models. This paper presents the findings of an empirical study investigating basic scientists’ attitudes toward publicly funded basic research at the Harvard Medical School and affiliated institutions. The study finds that scientists at the Harvard Medical School construe publicly funded basic research as inquiries that, whether use oriented or not, must be governed by the cognitive and social norms of the traditional mode of knowledge production. They (...) recognize that academic science is vulnerable to access by external capital but maintain that it remains distinct from research done in the private sector. Overall, the study demonstrates that important segments of academia have preserved a traditional approach to knowledge production, which is yet to be transformed by the entrepreneurial turn. (shrink)

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. (shrink)

In an article in this journal, Katherine Drabiak argues that green lighting genome editing of human embryos is contrary to “fundamental human rights law.” According to the author, genome editing of human embryos violates what we should recognize as a fundamental human right to inherit a genome without deliberate manipulation. In this reply article, we assess Drabiak's legal analysis and show methodological and substantive flaws. Methodologically, her analysis omits the key international legal instruments that form the so‐called International Bill of (...) Rights and thus fails to provide a full and accurate account of the fundamental international human rights standards. Substantively, Drabiak invokes, as a basis for prohibiting gene editing of human embryos, a legal standard (the rights and integrity of the future child) that is unknown to international law. Contrary to Drabiak's account, genome editing of human embryos is not prohibited under international law. Indeed, the right to health and the right to benefit from scientific progress may be interpreted as the basis of a legal duty to provide equality of access to germline gene editing, once determined it is beneficial and safe to use. (shrink)

Human genetic research databases cast a new light on the controversial issue of which uses of the human body are morally permissible. More specifically, banking human tissue raises issues relating to the ownership of the samples that the participants have donated, to the ownership of the data that are derived through processing the donated samples, and to the management arrangements that better balance the interest of genetic research with the protection of participants' rights. Winickoff & Winickoff suggest that the charitable-trust (...) model is a superior legal arrangement for biobanking compared with private biobanking. This paper critically assesses Winickoff & Winickoff's claim by highlighting some areas of implementation where such a model could be problematic. The charitable trust is certainly an advantageous arrangement because (1) it favors the separation between control and use of the samples, (2) it provides a procedural mechanism that facilitates the participation donor groups in the biobank management and (3) it mediates the different interests that are affected. On the other hand, the charitable-trust model leaves unresolved several issues--among them the ownership of the sample, the right of withdrawal, access and funding mechanism. I conclude that further theoretical and empirical analysis is required in the area. (shrink)

The governance of human (germline) genome modification at the international and transnational level -- The regulation of human germline genome modification in Canada (E Kleiderman) -- The regulation of human germline genome modification in the United States (Kerry Macintosh) -- The regulation of human germline genome modification in Mexico (M Medina Arellano) -- The regulation of human germline genome modification in Europe (J Almqvist, C Romano) -- The regulation of human germline genome modification in the United Kingdom (J Lawford Davies) (...) -- The regulation of human germline genome modification in Germany (T Faltus). (shrink)