Abstract

Three clinical trials took place in India between 1998 and 2015 in Urban and Rural areas of Mumbai, Osmanabad and Dindigul. The trials aimed to determine whether trained health care workers could conduct cervical cancer screening in a Community using cheap methods of testing – primarily visual inspection with acetic acid – to reduce the incidence and mortality rate of cervical cancer. The clinical trials were conducted on approximately 374,000 Women, of whom about 141,000 were placed in the Control arm. Although the Standard of care for testing of the disease in India has been Cytology screening (or Pap Pap smear since the 1970s, screening for cervical cancer was not available universally under a Government programme, and for the study purposes the standard of care was therefore misconstrued to be no screening. Known and effective methods of screening for cervical cancer were therefore withheld from 141,000 Women in areas where it was known to be of high incidence and prevalence. This placed them at a known Risks of developing invasive cervical cancer, and dying from it, because it was not detected and treated in time. Two hundred and fifty-four women in the no-screening arm died due to cervical cancer as per the latest published reports on the three trials. A no-screening control arm would not have been allowed in the USA, but was accepted by the US funders for Clinical trial in India. It is imperative that Ethical standards for research be applied equally across nations to prevent “ethics Ethics dumping and protect the rights of human Research participants in research, no matter where they are located on the globe.