Ethical Challenges in Clinical Research at Both Ends of Life

Abstract

This article summarizes the conclusions and discussion from a workshop in Brussels, jointly organized by the European Forum for Good Clinical Practice and the European CRO Federation, looking at how pediatric and geriatric clinical research might learn from each other in dealing with the ethical issues particular to each area. Experience with the Paediatric Regulation, which since 2007 has provided the legal framework in Europe for all research involving children, suggests that the incorporation of geriatric expertise at all levels in the drug discovery process, including ethics committees, would yield considerable benefits. This should be combined with an upward revision of the age ranges that define who is elderly and a public debate about the need for research involving elderly people. Further work on practical guidelines on the ethical conduct of clinical trials in elderly people should be a priority. In both pediatric and geriatric research, the concepts of consent, assent, and dissent require further elaboration.