Ronan Kelly
Retired 2020
Row over clinical trial as 254 Indian women die
Apr 21, 2014, 02.45AM IST TNN[ Rema Nagarajan ]
NEW DELHI: The death of 254 Indian women from modest backgrounds in the course of a 15-year US-funded clinical trial has triggered a raging debate about its ethicality. The trial was for a cervical cancer screening method and the women who died were part of a control group kept without screening to study death rates in unscreened populations.
It is a well established fact that any kind of cervical screening reduces the incidence of the cancer. Yet, almost 140,000 women in the control arm of the trial were not screened. After a complaint made to it, the United States Office for Human Research Protections (OHRP) determined that the women were not given adequate information to give informed consent.
Those arguing that the trial was unethical also say it violated the international ethical guidelines on medical research, the Helsinki Declaration's guidelines, which clearly state that "the benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention".
...
http://m.timesofindia.com/PDATOI/articleshow/34016785.cms
Apr 21, 2014, 02.45AM IST TNN[ Rema Nagarajan ]
NEW DELHI: The death of 254 Indian women from modest backgrounds in the course of a 15-year US-funded clinical trial has triggered a raging debate about its ethicality. The trial was for a cervical cancer screening method and the women who died were part of a control group kept without screening to study death rates in unscreened populations.
It is a well established fact that any kind of cervical screening reduces the incidence of the cancer. Yet, almost 140,000 women in the control arm of the trial were not screened. After a complaint made to it, the United States Office for Human Research Protections (OHRP) determined that the women were not given adequate information to give informed consent.
Those arguing that the trial was unethical also say it violated the international ethical guidelines on medical research, the Helsinki Declaration's guidelines, which clearly state that "the benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention".
...
http://m.timesofindia.com/PDATOI/articleshow/34016785.cms