Academic journal article Journal of Law and Health

Beyond Nuremberg: A Critique of "Informed Consent" in Third World Human Subject Research

Academic journal article Journal of Law and Health

Beyond Nuremberg: A Critique of "Informed Consent" in Third World Human Subject Research

Article excerpt

I. INTRODUCTION: FROM NUREMBERG TO KANO

 A. The Birth of Informed Consent
 B. Global Challenges to Informed Consent
 C. Proposal for a Critique of Informed Consent in Third
    World Research

II. THE PRINCIPLE OF INFORMED CONSENT: THEORY, POLICY,
    AND ADVOCACY

 A. The Theoretical Bases of Informed Consent
 B. The FDA's Informed Consent Policies for Foreign
    Research
 C. The Advocacy for Informed Consent in Third World
    Research

III. A CRITIQUE OF INFORMED CONSENT IN THIRD WORLD
     HUMAN SUBJECT RESEARCH

 A. A Contextualization of Third Worm Research
 B. A Critique of the Right to Informed Consent in Third
    Worm Research
 C. A Critique of the Possibility of Informed Consent in
    Third Worm Research

IV. BEYOND INFORMED CONSENT: DISTRIBUTIVE JUSTICE IN
    THIRD WORLD HUMAN SUBJECT RESEARCH

V. CONCLUSION: TOWARD A "KANO CODE".

The hidden Yes in you is stronger than all Nos and Maybes that afflict you and your age like a disease--Friedrieh Nietzsehe (1)

I. INTRODUCTION: FROM NUREMBERG TO KANO

A. The Birth of lnformed Consent

The principle of "informed consent" forms one of the "basic ethical protections for research involving human participants." (2) Informed consent requires that a human subject of scientific research "willingly verif[y] his/her willingness to participate in a particular treatment, after having been informed of all aspects which are pertinent to that treatment and relevant to the subject's participation." (3) Governments around the world have adopted a variety of regulations (4) that articulate and enforce this "oldest and most universally accepted ethical standard in research." (5) In the United States, the Federal Food, Drug, and Cosmetic Act (FD&C) mandates that scientists who test new drugs first inform human subjects about the experimental nature of the studies and obtain their consent. (6) The U.S. Food and Drug Administration (FDA), the federal agency charged with administering and enforcing the FD&C, (7) has promulgated a series of regulations to implement this requirement. (8)

The informed consent requirement originated in the Nuremberg Trials following World War II. (9) Under the Third Reich in Germany, Nazi scientists conducted a variety of involuntary and often fatal medical experiments on concentration camp inmates, (10) mainly Jews, Roma, and Slavs. (11) After the war ended, the United States prosecuted twenty Nazi scientists (12) before the International Military Tribunal in Nuremberg, Germany for war crimes and crimes against humanity. (13) Ultimately, seven of the Nazi scientists were sentenced to death and eight to varying prison terms (14) As part of its final judgment, the Tribunal promulgated a set of ten principles, later known as the "Nuremberg Code," that provided the first international rules for scientific research on human subjects. (15) The Nuremberg Code's first and most important principle (16) directed:

   The voluntary consent of the human subject is absolutely essential.
   This means that the person involved should have legal capacity to
   give consent; should be so situated as to be able to exercise free
   power of choice ... and should have sufficient knowledge and
   comprehension of the elements of the subject matter involved as to
   enable him to make an understanding and enlightened decision. (17)

Later international guidelines, such as the World Medical Association's 1964 "Declaration of Helsinki," (18) provided further direction for medical researchers. Nevertheless, the Nuremberg Code "remains the most authoritative legal and ethical document governing international research standards." (19) Supreme Court Justice William Brennan once remarked, "[t]he medical trials at Nuremberg in 1947 deeply impressed upon the world that experimentation with unknowing human subjects is morally and legally unacceptable." (20)

B. Global Challenges to Informed Consent

The globalization of the pharmaceutical industry, especially the clinical testing process for new drugs, (21) has undermined enforcement of the informed consent requirement. …

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