The Travesty of Informed Consent: Case of HPV Vaccination “Demonstration Projects”

Sarojini N., Anjali Shenoi | MFC Bulletin February-July 2011 | Pg 29

The Human Papilloma Virus (HPV) vaccination ‘Demonstration Projects’ were conducted in Andhra Pradesh and Gujarat by PATH International (an American NGO), in collaboration with Indian Council of Medical Research (ICMR) and the State Governments of Andhra Pradesh and Gujarat, since 2007. Following reports of deaths, adverse events and violation of ethics, including fact-finding investigations carried out in Khammam district in Andhra Pradesh by concerned groups and Smt. Brinda Karat (MP), the ‘Post-licensure observation study of HPV vaccination: demonstration project’ was suspended in April 2010. At the same time, the Ministry also appointed a Committee to enquire into these “Alleged irregularities in the conduct of studies using HPV vaccine” with a time frame of three months to submit its report.

Almost 10 months later in February 2011, an interim report submitted by the Committee and was made public after a demand from the members of Standing Committee on Health in Parliament. The Committee has identified several deficiencies in the planning and implementation of the project, however, failing to fix responsibility for any of these violations on any individual or agency. In this article we would address one of the key concerns raised by the members of the Committee is related to the way the consent was obtained for the implementation of the Demonstration project. The report establishes that, “The legality and morality of the circular of the Government of Andhra Pradesh authorizing the Hostel Wardens and Head Masters to sign the consent on behalf of the minor girls included in the study is questionable.

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