In a clinical trial designed to test the feasibility of launching an HPV vaccine immunization program in India, four of the 23,000 girls aged 10-14 that were vaccinated died. After the deaths occurred last year, many in India accused the government of allowing the public to be test subjects for dangerous vaccines. But the deaths turned out to be unrelated to the vaccine, according to a committee of three scientists from the All India Institute of Medical Sciences (AIIMS) in New Delhi. In the course of their investigation, the committee did uncover serious ethical lapses associated with the trial, including the recruitment of participants from vulnerable tribal populations, failure to attain proper consent, and improper recording of adverse events. Furthermore, the entire trial appeared to be misclassified as an observational study, when in fact it was a clinical trial, which is subject to different regulations.

Vishwa Katoch,...

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