The Role of Clinical Equipoise and Practical Considerations in Deciding Whether to Continue to Provide a Drug on an Open-Label Extension Study for an “Unapproved Indication”

摘要

“Doing” bioethics in our pluralistic society presents great challenge. As we do not agree on where we come from and where we are going and what the good, the valuable, and the right are or what the proper authority is—we do not agree on a content-rich, consensus bioethics. For this reason, research ethics is done predominately at law and public policy. Research ethics, at least the modus vivendi (the way of living with a compromise that allows disputing sides to move forward) that has been established at law and public policy, is usually determined in the realm of regulation and compliance. The thin foundation on which research ethics is based is an ethic of permission. This ethic of permission comes fromthe English commonlawor Lockean tradition of forbearance rights (Engelhardt 1996).Though there has been a movement to develop a more content-rich ethic based on a particular cosmopolitan, European view of human rights (Trotter 2009), this has not yet become the standard at law and public policy and therefore is not the realm in which research ethics is encountered in the United States (Cherry 2009). Beyond the ethic of permission, it is difficult to claim an ethical obligation in clinical research (basic values such as truth telling, authorship, and freedom from fraud can fall into this ethic of permission based on forbearance rights). Though one can make a deep ethical argument in this case from a particular moral narrative, such a narrative will not be convincing to all and likely should not be grounds to compel others to follow a directive based on nonshared values and judgments.