Clinical Research Case Studies

The Case of the HPV vaccination project for Informed Consent violations in clinical trials in India

The States of Andhra Pradesh and Gujarat launched a research project for the vaccination against the human papilloma virus (HPV) in 2009 which cause cervical cancer. Adolescent girls between the ages of 10 “14 in the States of Andhra Pradesh and Gujarat were to be vaccinated. The vaccines were provided by GlaxoSmithKline and Merck. The project was designed and executed by PATH (Program for Appropriate Technology in Health) and funding was received from the Bill & Melinda Gates Foundation. In April 2010, however, the Government of India suspended the program due to several violations of ethical standards by PATH which were widely reported by human rights organizations but by that time, 24,000 girls were already vaccinated.

A parliamentary enquiry committee in 2011,found that the process of informed consent was inadequate (especially questioning the fact that school head masters signed consent forms on behalf of the children, calling it wrongful authorization). Informed consent is the process in which trial volunteers are informed about the nature, significance, implications and risks of the trial and their participation in the trial is voluntary and hence cannot be forced to participate in the trial.

The HPV vaccination project was intended to benefit the Indian population. In August 2013, a second parliamentary committee severely condemned PATH as it concluded that its sole aim has been to promote the commercial interests of HPV vaccine manufacturers who would have reaped windfall profits had PATH been successful in getting the HPV vaccine included in the UIP [universal immunization program] of the Country. (72nd Report, Department of Health Research, Ministry of Health and Family Welfare, Para. 7.13).

Women’s health activists decided to take the case to court and in January 2013 they filed a public interest petition (PIL) at the Indian Supreme Court. Since then, the Court has urged the Indian government to advance the regulatory framework on clinical trials and improve its system of approval of licenses.

The lack of informed consent and the lack of monitoring constitute violations of the right to be free from cruel, inhuman or improper treatment and the right to health. It has been recognized that states may breach their international human rights law obligations where such abuse can be attributed to them, or where they fail to take appropriate steps to prevent, investigate, punish and redress abuse from private actors. The Indian Supreme Court ruling in the HPV case could order such investigation, provide access to an effective remedy, and thus increase the protection of trial subjects.