Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

Recent developments in biotechnology and genetic research are raising complex ethical questions concerning the legitimate scope and limits of genetic intervention. As we begin to contemplate the possibility of intervening in the human genome to prevent diseases, we cannot help but feel that the human species might soon be able to take its biological evolution in its own hands. 'Playing God' is the metaphor commonly used for this self-transformation of the species, which, it seems, might soon be within our grasp. (...) In this important new book, Jurgen Habermas - the most influential philosopher and social thinker in Germany today - takes up the question of genetic engineering and its ethical implications and subjects it to careful philosophical scrutiny. His analysis is guided by the view that genetic manipulation is bound up with the identity and self-understanding of the species. We cannot rule out the possibility that knowledge of one's own hereditary factors may prove to be restrictive for the choice of an individual's way of life and may undermine the symmetrical relations between free and equal human beings. In the concluding chapter - which was delivered as a lecture on receiving the Peace Prize of the German Book Trade for 2001 - Habermas broadens the discussion to examine the tension between science and religion in the modern world, a tension which exploded, with such tragic violence, on September 11th. (shrink)

The debate over whether germ-line genetic engineering is justified on the basis of the consent or presumed consent of future generations is mired in philosophical confusion. Because of this, the principle of informed consent fails to provide a reason to restrict germ-line genetic engineering. Most recent bioethicists ground the consent requirement on individual autonomy. While conceptually coherent, the notion of individual autonomy also fails to provide a reason for prohibiting germ-line genetic engineering. Moreover, it offers little in the way of (...) useful guidance for regulating genetic engineering. I argue, however, that respect for autonomy in the sense of moral agency – the ability to reflect on moral considerations and conform one’s behavior to those reflections – provides a principle that can be used for a nuanced evaluation of proposals for genetic engineering. (shrink)

CRISPR germline editing therapies hold unprecedented potential to eradicate hereditary disorders. However, the prospect of altering the human germline has sparked a debate over the safety, efficacy, and morality of CGETs, triggering a funding moratorium by the NIH. There is an urgent need for practical paths for the evaluation of these capabilities. We propose a model regulatory framework for CGET research, clinical development, and distribution. Our model takes advantage of existing legal and regulatory institutions but adds elevated scrutiny at each (...) stage of CGET development to accommodate the unique technical and ethical challenges posed by germline editing. (shrink)