Thursday, May 14, 2009

The unbearable lightness of international research law

I am on a number of bioethics and research ethics listservs, mailing lists and have set up a couple of google alerts. This means that I tend to get news of everything bioethical that has been freshly posted on the web at least three times. When something comes out in a major journal, then this number increases. So when George Annas' piece on the globalization of clinical trials and informed consent appeared in the New England Journal of Medicine this week, I had my hands full: even friends had sent copies or links.

The title of Annas' piece was inviting, but after reading it (twice) I felt a bit deflated. Annas starts by remarking that the situation of a decade ago, well-publicized concerns were raised about the ethics of medical research in developing countries, and these concerns have not gone away. However, he goes on to write the controversial case of pharmaceutical giant Pfizer in Nigeria has dredged up some legal opinions that might, in the future, have enough bite to provide protections for participants in international research.

To be more specific, Pfizer is accused of conducting medical research in 1996 in Nigeria involving children, where informed consent was not properly (or at all) obtained from the parents, and according to families involved, some of the children were rendered blind, deaf, paralyzed, brain-damaged or dead. In January 2009, the US Court of Appeals for the Second Circuit reversed a prior trial decision that dismissed a lawsuit against Pfizer. What matters, according to Annas, is the basis of the Second Circuit's reversal: the court's arguments implied that getting informed consent from research participants (or proxy decision-makers) constitutes a norm of customary international law, and on this point the court relied on the Nuremberg Code, the International Covenant on Civil and Political Rights, the Declaration of Helsinki and CIOMS. Moral of the story: if you conduct medical experiments without consent (anywhere and including in developing countries), then you stand a chance of being sued in courts around the world for violating an international human rights norm.

Maybe. The Pfizer court case has not been tried, so it is not clear yet whether the Second Circuit will actually decide the case in terms of international human rights law -- so far, they have only created the possibility for making such a judgment. And this comes at a time when international (human rights) laws are not exactly striking fear in the hearts of the ruthless. There is the torture question. There is the illegal invasion question. Since World War II, many international codes have been floating around, some have been made law in some countries and used in some international tribunals, but the question is open whether these developments have made a real dent in the abuse of the weak by the powerful. Someone should research the track record. Because if unconsented medical research can only be deterred by means of a (new) international human rights norm that might (more than a decade later) be applied, and that is supposed to provide substantial protections for research participants in developing countries, then the world is in far worse shape than I thought.


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