Advance directive of probands in pharmaceutical research : A medical ethics discussion

Abstract

In the fourth Act on the amendment of pharmaceutical legal and other regulations in November 2016, the legislature has designated the proband advance directive based on the instrument of patient advance directive to enable group beneficial research with persons not capable of giving consent. This article describes the existing conditional need for group beneficial research and presents the problem of the decisive instrument for advance directives at the center of the considerations. The features of the proband advance directive concluded by the legislature stand in opposition to a successful implementation, particularly due to the necessary concrete clarification content far in advance for informed research participants. This article describes solution possiblities, which refer to the realization of the instrument of a proxy research authorization as well as the consideration of an advance research planning based on the advance care planning.