Editorial: A shockingly unethical trial

Published in The Hindu on May 16, 2011

The question whether all human clinical trials undertaken in India are conducted ethically has been answered. The final report of the three-member committee appointed by the central government to go into the alleged irregularities in the conduct of the human papilloma virus (HPV) vaccine trial reveals gross ethical violations. The trial, suspended since March 2010, was carried out by the Program for Appropriate Technology and Health (PATH), an NGO, in collaboration with the Andhra Pradesh and Gujarat governments and the Indian Council of Medical Research. It was conducted on nearly 23,500 girls in the 10-14 years age group in Khammam district (Andhra Pradesh) and Vadodra (Gujarat). The “casual approach,” which saw the informed consent forms, the most sacrosanct trial documents, being filled “very carelessly” with “incomplete and probably inaccurate” information is shocking. In Andhra Pradesh, nearly 2,800 consent forms were signed by a hostel warden or headmaster, as the ‘guardian’. The justification: the parents were not easily reachable! That being the case, and since it was a research study and not an emergency, should such children have been enrolled at all? What ethical justification can there be for the warden or headmaster acting as a “legally acceptable representative” to meet the requirements of the 1945 Schedule Y of Drugs and Cosmetics Rules? Since students have “reduced autonomy,” the fact that teachers played a “primary role” in explaining and “obtaining consent” meant that the consent was obtained under duress, in a legally untenable way.

The trial came under scrutiny following a public outcry over the death of seven children. Although the cause of the deaths was found to be unrelated to vaccination, the incident revealed a total failure of the mechanism to monitor the ‘volunteers’ for both serious and non-serious adverse events following vaccination. There was a five-month delay in reporting a death, while two deaths in Khammam district went unreported. Ironically, while measuring and reporting the adverse events after vaccination were the “primary end points of the study,” the Principal and Co-Principal investigators failed to report all such events to the sponsor within a day, as required under the Drugs and Cosmetics Rules. That widespread transgressions of prescribed procedures and norms have been detected in conducting the trial, despite the apex medical body being a part of it, and that the investigating committee has done little by way of fixing responsibility, sends out a highly damaging message.