This Article discusses the history of informed consent, critically analyzes this principle, and suggests an alternative approach to informed consent. Part II explores the concept of informed consent, including its philosophical bases, its implementation through FDA regulations, and current proposals on how to protect the principle in drug testing conducted abroad. Part III performs a critical analysis of the principle of informed consent; first providing an empirical examination of the realities of Third World human subject research, and then questioning both the coherence of an abstract “right” to informed consent, as well as the possibility of truly autonomous “consent” to such research. In Part IV, this Article suggests an alternative approach based on the principle of distributive justice, in which pharmaceutical companies ensure that the communities that bear the risks of clinical studies also enjoy the medical benefits of such research. Finally, Part V provides a brief conclusion and reflects on the implications of this critique.
Beyond Nuremberg: A Critique of Informed Consent in Third World Human Subject Research
25 J.L. & Health
available at http://engagedscholarship.csuohio.edu/jlh/vol25/iss1/6