Alliance for Human Research Protection Advancing Voluntary, Informed Consent to Medical Intervention
"Does the FDA have the authority to trump the Declaration of Helsinki? "
However, as Dr. Goodyear points out, although not explicitly part of international or national law, the legal status of the Declaration of Helsinki and the Nuremberg Code are recognized. For example, both international codes were cited by several US courts: TD v NYS Office of Mental Health (1995); Grimes / Higgins v Kennedy Krieger, Court of Appeals of Maryland (2001) ; and in the recent US Court of Appeals, which ruled that the Declaration (and other conventions) constituted a sufficient customary norm to be considered binding in the Pfizer trovafloxacin case in January 2009. The court reversed a dismissal by a lower court of a lawsuit by families of children who had died or were injured in a Nigerian meningitis trial.
Thank you for that reference.