The European Union Directive and the protection of incapacitated subjects in research: an ethical analysis

Objective: We perform an ethical analysis of European Union Directive 2001/20/EC on the simplification and harmonization of guidelines regarding good clinical practice in the conduct of clinical trials involving drugs. Background: The Directive provides guidance on protecting incapacitated subjects who participate in drug clinical trials. Such guidance promotes society's obligations of beneficence because the participation of incapacitated subjects in research is crucial in advancing the understanding and treatment of serious diseases. The Directive requires proxy consent for incapacitated subjects which adheres to the principle of respect for persons. The Directive also recommends additional safeguards to further protect subjects against exploitation and harm. These include respect for the assent and dissent of incapacitated subjects and the "necessity" and "subject-condition" requirements. Results: While these essential protection mechanisms are commendable, the Directive fails to endorse other safeguards that have been recommended by other research ethics guidelines, especially for riskier research. The Directive's silence regarding research in the emergency setting frustrates the principle of beneficence because the lack of guidance might prove to be a barrier for the conduct of such potentially beneficial research. Conclusions: We conclude that the European Directive fails in many respects to promote several important ethical principles in research involving incapacitated subjects.