Human Rights and Bioethics: Regulating Global Pharmaceutical Research

The role,content, and effectiveness of international ethical rules concerning research on human subjects has been the subject of continuing debate. An alternative is to recognize research without informed consent as a violation of international human rights law which would permit, among other things, injured subjects in other countries to sue researchers and their sponsors in the United States for damages under the Alien Tort Statute (ATS) caused by violation of the consent rule.

In January, 2009 the Second Circuit Court of Appeals approved of this approach in Abdullahi v. Pfizer. The court (2 to 1) concluded that the informed consent requirement of the Nuremberg Code has become a part of customary international law of sufficient clarity to be the foundation of a ATS suit by Nigerian subjects against Pfizer for alleged violations of the norm by Pfizer antibiotic researchers during a 1996 meningitis epidemic centered in Kano, Nigeria. The implications of this case for all U.S. pharmaceutical companies engaged in human studies research will be examined and compared with alternative ethical guideline approaches to human subject protection.