Indian study of women with cervical lesions called unethical

In India, critics are questioning the ethics of a 1976-88 study undertaken by the Indian Council of Medical Research that observed the natural course of cervical lesions in 1158 women without offering treatment until cancer developed. At least 9 of the subjects developed invasive cancer, and 62 developed cervical cancer. Researchers state that they failed to gain the women's informed consent because most of the women were illiterate and because informed consent was not mandatory when the study began. It is alleged that the researchers also failed to inform the women about the potentially cancerous nature of their lesions or to offer them treatment at the outset of the study. The researchers claim that the women were given verbal explanations of the situation. Ethics experts note that "illiteracy is not stupidity" and should not be used as an excuse for failing to obtain informed consent. During the observation period, 10 women with severe dysplasias were lost to follow-up (and, therefore, possibly to eventual treatment). Critics note that all of the women with severe dysplasia should have received immediate treatment.