Background: Since 1998, randomised trials in India funded by the US National Cancer Institute (NCI) and the Bill and Melinda Gates Foundation have compared cervical cancer death rates among 224,929 women offered cervical screening to those among 138,624 women offered no screening whatsoever. To date, at least 254 women in unscreened control groups have died of cervical cancer. The United States Office for Human Research Protections (OHRP) determined that the subjects in the studies were not given adequate information for the purpose of providing informed consent. The determinations of the OHRP contradict assurances given by other American medical and bioethical leaders.