The ethics of regenerative medicine.

Most developments in regenerative medicine have in common that there are many uncertainties and knowledge gaps. These features make the evaluation of long-term consequences of the available options difficult and have consequences for the ethical issues raised. This paper presents an overview of ethical issues raised in regenerative medicine, using as a starting point a list of stakeholders and their interests. Ethical issues are introduced via a simplified account of a project that focuses on several difficult problems, as well as a conceptual framework consisting of the following key concepts: present situation, goals, difficulties on the road toward the goals, and strategies for dealing with the difficulties. The list of ethical issues discussed includes safety and efficacy, patient consent, information, professional responsibilities, as well as equity and fairness. The issues and the underlying values need to be clarified, specified, debated, and ranked in order of importance. A particular problem is that values sometimes clash: Certain values can be achieved only at the expense of others. If and when values clash, principles are available that can guide the decision making. The paper comments on two such principles with implications for the particular issue of patient access to experimental treatments: the precautionary principle and the principle of proportionality. The paper ends with some conclusions for the future.