Indian study of women with cervical lesions called unethical

BMJ 1997; 314 doi: (Published 12 April 1997) Cite this as: BMJ 1997;314:1065
  1. Ganapati Mudur
  1. New Delhi

    Doctors in India are questioning the ethics of a study which observed the natural course of precancerous uterine cervical lesions without treatment in women who had not given written consent to take part. In at least nine women the lesions progressed to invasive cancer, and 62 women developed carcinoma in situ of the cervix before they were treated.

    In an attempt to study rates of progression of uterine cervical dysplasias to malignancy, the Indian Council of Medical Research during 1976-88 allocated 1158 women with varying degrees of cervical dysplasias to long term follow up. The development of carcinoma in situ was defined as the end point for treatment.

    Written consent is necessary, whatever the population


    The investigators, from the Institute of Cytology and Preventive Oncology in New Delhi, said that they did not obtain written consent on the grounds that most of the women in the study were illiterate and that written consent was not mandatory when the study was launched. The study has helped India evolve screening guidelines for the national cancer control …

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