Fitting a square peg into a round hole?: imposing informed consent and post-trial obligations on United States sponsored clinical trials in developing countries.

A rural Chinese province recently reported a nearly forty percent increase in H. Pylori bacterium infections after a 1994 National Cancer Institute (“NCI”) study was conducted in the region. The study began in 1988 after the NCI partnered with Chinese researchers to: (1) determine the prevalence of H. Pylori bacteria, the leading cause of stomach ulcers and a risk-raising factor for stomach cancer, and (2) discover whether dietary supplements could successfully prevent these infections. Unbeknownst to the NCI, Chinese research standards changed in 1991. The endoscopes used to collect stomach samples from study participants were wiped off with antiseptic rather than soaked and sterilized after each exam. When news of the outbreak came to light, scientists disagreed over the manner in which study participants should be informed. The Chinese maintained that the infection’s origin was unknown, whereas the NCI wanted to acknowledge the infection’s probable correlation with study participation.