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Ethical issues considered in Tamil Nadu Leprosy Vaccine Trial

MD Gupte, DK Sampath


For more than eight years, we have been involved in a massive field-based comparative leprosy vaccine trial in Tamil Nadu, covering some 300,000 people. The study is supported by the Indian Council of Medical Research. The trial was launched in January 1991, and the study protocol was approved shortly before the publication of International Guidelines for Epidemiological Studies. This paper will discuss various ethical issues raised by these international guidelines in the context of the trial.

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