ABSTRACT: This article analyzes international law claims in human subject litigation, arguing that the failure of federal courts or Congress to oversee this kind of litigation by providing or recognizing a federal cause of action for research torts is an injustice. It is about two distinct and somewhat arcane areas of the law, international law and the law of human subjects research. Because they draw on different historical, social and conceptual frameworks, each has its own descriptive section in the article. In the first section, the author briefly describes international law and its place in the U.S. constitutional order. This section explains why international law claims are routinely rejected by the courts. In the second section, the author discusses the moral underpinnings of the research enterprise and explains how the values of science contradict the values of human rights and medicine.http://www.highbeam.com/doc/1G1-173187660.html
George Annas: (from the article)
" In Orwell's view, the key to a successful totalitarian system is
abolishing truth as objective reality ... The party's slogans in
1984 illustrate the concept of doublethink: "War is Peace, Freedom
is Slavery, and Ignorance is Strength." We tend to recognize these
pairings as nonsensical, and think we could never be victims of
such blatant propagandistic sloganeering. But even a cursory
history of modern human experimentation demonstrates the
pervasiveness of three doublespeak concepts: experimentation is
treatment, researchers are physicians, and subjects are patients.
Indeed, we have encapsulated all three into a "newspeak" word,
"therapeutic research" (although we retain a space between the c
and the r).
This doublespeak allows U.S. to use double standards as they suit
our purposes. It permits U.S. to treat truth as negotiable and then
allows U.S. to act irrationally. We act in the best interest of
patients. The experiment is justified as therapy or potential
therapy. But if the experiment produces harm, it was after all,
only an experiment and thus nonetheless a "success" because we
learned something from it that could benefit others. It should be
of only slight comfort that the term therapeutic research was not
invented by a totalitarian government, bat rather by physicians who
were responding to a legal condemnation of experiments performed
under the authority of a totalitarian government--the Nuremberg
Code.... (38)"
" Subject plaintiffs routinely try to raise federal claims in addition to their state claims. Federal claims generally fall into two categories. In the first category are claims under 42 USC [section] 1983 alleging violations of Fourteenth Amendment substantive and procedural due process rights; claims that subjects are third party beneficiaries of the assurance agreement between the Department of Health & Human Services and the research institution; claims either directly under the Common Rule, or under 42 USC [section] 1983 alleging violations of rights created under the Common Rule. The second category of claims arise under or derived from international documents. They include claims made under the Nuremberg Code, the Declaration of Helsinki, the International Covenant on Civil and Political Rights, and the putative human right to dignity. It is these claims that are the subject of this article.
Of the norms said to be international law, only the ICCPR, art. 7. has status as law. The Nuremberg Code, the Declaration of Helsinki, the CIOMS Code, the Belmont Report and other similar documents on their face only provide ethical standards and none of them are implemented as legal norms in any legal document. "
This gets even better and explains quite a bit:
"The research enterprise, a federal level undertaking, is regulated by a federal statute that does not recognize a cause of action for individuals tortiously injured in an experiment. Claimants for such injuries frequently and unsuccessfully attempt to make international law claims in federal courts. In very limited circumstances federal courts recognize a violation of the Fourteenth Amendment due process right to bodily integrity, but for the most part the federal judiciary sends the cases into stare courts to be litigated under state-based physician malpractice laws."
Comments
" In Orwell's view, the key to a successful totalitarian system is
abolishing truth as objective reality ... The party's slogans in
1984 illustrate the concept of doublethink: "War is Peace, Freedom
is Slavery, and Ignorance is Strength." We tend to recognize these
pairings as nonsensical, and think we could never be victims of
such blatant propagandistic sloganeering. But even a cursory
history of modern human experimentation demonstrates the
pervasiveness of three doublespeak concepts: experimentation is
treatment, researchers are physicians, and subjects are patients.
Indeed, we have encapsulated all three into a "newspeak" word,
"therapeutic research" (although we retain a space between the c
and the r).
This doublespeak allows U.S. to use double standards as they suit
our purposes. It permits U.S. to treat truth as negotiable and then
allows U.S. to act irrationally. We act in the best interest of
patients. The experiment is justified as therapy or potential
therapy. But if the experiment produces harm, it was after all,
only an experiment and thus nonetheless a "success" because we
learned something from it that could benefit others. It should be
of only slight comfort that the term therapeutic research was not
invented by a totalitarian government, bat rather by physicians who
were responding to a legal condemnation of experiments performed
under the authority of a totalitarian government--the Nuremberg
Code.... (38)"
http://findarticles.com/p/articles/mi_m6875/is_2_23/ai_n25017386/pg_6/
Of the norms said to be international law, only the ICCPR, art. 7. has status as law. The Nuremberg Code, the Declaration of Helsinki, the CIOMS Code, the Belmont Report and other similar documents on their face only provide ethical standards and none of them are implemented as legal norms in any legal document. "
"The research enterprise, a federal level undertaking, is regulated by a federal statute that does not recognize a cause of action for individuals tortiously injured in an experiment. Claimants for such injuries frequently and unsuccessfully attempt to make international law claims in federal courts. In very limited circumstances federal courts recognize a violation of the Fourteenth Amendment due process right to bodily integrity, but for the most part the federal judiciary sends the cases into stare courts to be litigated under state-based physician malpractice laws."