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

  • Clinical Commentary
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Abstract

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.

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Authors and Affiliations

  1. School of Medicine, University of Maryland, 10 South Pine Street, Baltimore, MD, 21201, USA

    Henry J. Silverman

  2. Medical University of Vienna, Vienna, Austria

    Christiane Druml

  3. University Hospital Henri Mondor, Assistance Publique-Hôpitaux de Paris, Creteil, France

    Francois Lemaire

  4. Children’s Hospital of Philadelphia, Philadelphia, Pa., USA

    Robert Nelson

Authors
  1. Henry J. Silverman
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  2. Christiane Druml
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  3. Francois Lemaire
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  4. Robert Nelson
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Correspondence to Henry J. Silverman.

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Silverman, H.J., Druml, C., Lemaire, F. et al. The European Union Directive and the protection of incapacitated subjects in research: an ethical analysis. Intensive Care Med 30, 1723–1729 (2004). https://doi.org/10.1007/s00134-004-2367-5

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  • DOI: https://doi.org/10.1007/s00134-004-2367-5

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