Protecting challenge study participants in low and middle income settings.

With India only just emerging out of a period of extreme concern and apprehension over clinical trials, the introduction of Controlled Human Infection Model (CHIM) studies calls for the need to proceed with caution, particularly with regard to protection of participants; especially vulnerable populations. In the Indian context, persons can be vulnerable due to circumstances of poverty, ignorance about clinical research and lack of access to education and healthcare. This paper will look at possible ways to provide protection to participants, starting with review and selection, through the trial period and after it is completed.