Ethical violations in HPV vaccine trials, says committee

SciDev Net

Fuente: The Hindu

20 may 2011 | EN

[NEW DELHI] An expert committee set up to investigate the conduct of studies using human papillomavirus (HPV) vaccines in India has reported large-scale ethical violations.

Members of the committee said since the project proposal involved research on human participants it should have followed “all the guidelines and statutory requirements applicable to research on human participants”, the daily The Hindu reported.

Concern was expressed by members at unacceptable and prolonged delays in the reporting of adverse events and deaths, and a lack of independent monitoring systems.

“There has been direct contact with the human participants, they have administered an intervention which is not part of a prescribed prevention and have expected adverse events,” members reported.

The committee comprised S.S. Aggarwal, former director of the Sanjay Gandhi Post-graduate Institute of Medical Sciences, S.P. Agarwal, former director-general of health services, and Suneeta Mittal, head of obstetrics and gynaecology at the All-India Institute of Medical Sciences (AIIMS) in New Delhi. They were assisted by a three-member sub-committee.

Members said there was a need for specific and separate legislation covering all aspects of biomedical and health research involving human participants and that statutory status should be given to the guidelines of the Indian Council of Medical Research.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.