Issues with the Term “Responsibility”

Abstract

In a brief review of the philosophical underpinnings of the ethics in science from Kant’s categorical imperative to Fichte, Professor Poser outlined the main elements of the term “responsibility”, which represents a complex situation. He described responsibility not only as a retrospective term in the sense of being responsible for past actions, but also as a prospective term which is directed into the future. He defined the responsible subject as the actor who in society (and in drug development) is replaced by a system of actors, each of whom takes responsibility according to his degree of involvement. “Informed consent” also turns a study subject into a responsible person, i.e. a carrier of responsibility. Expert panels are also actors in shared responsibility. The current ethical view holds that the activity for which responsibility is taken is governed by the intent of the action. Difficulties arise when unintended and unpredictable consequences of an intended activity occur. This raises questions about what is unpredictable and who is responsible if a consequence is unpredictable. The party to whom responsibility is owed, the object of responsibility, is an historically limited situation. It may be an individual, the law, society, God, future generations, or the totality of reasoning individuals. The reason for the existence of the concept of responsibility, finally, is based on values. These values may be functional, ethical, economic, or they may be based on other principles, such as conscience.

Professor Poser interpreted the Helsinki declaration as an extension of Kant’s principles. The declaration states that the risk taken by a human subject should be in a reasonable relationship to the value of the trial or experiment and that the rights or the human subject to physical integrity must be maintained. He closed by citing the Hippocratic dictum: nihil nocere, bonum facere.

Clearly, these complex philosophical concepts determine how society perceives issues related to drug development and to drug risks and how society reacts both in an ethical and a legal sense.