Was the study protocol submitted for independent ethical review?
An independent ethical review was conducted by a committee conversant with local cultural norms and chaired by a retired judge of the Madras High Court. The committee included experts in leprosy, internal medicine and clinical pharmacology, an advocate and a representative of the community. The committees report was sent to a national advisory committee consisting of epidemiologists, leprosy experts and policy makers. The ethical committee was involved in collecting feedback from volunteers post-vaccination and by periodic review and field visits. It continues to be involved in monitoring the trial. Was the Phase III trial of efficacy preceded by a Phase II trial for safety? Before the large-scale vaccine trial was launched, Phase II trials of all the candidate vaccines, with a maximum of 300 volunteers, were conducted after obtaining permission from the Drugs Controller of India. The Phase II trials provided essential information on the vaccines short-term toxicity and possibly effica
Related Questions
- What if I need a new study, additional investigator, protocol amendment or request for continuing review reviewed before the regularly scheduled Board meeting?
- What if I just submitted a request for continuation to the IRB or a new study protocol and it is in currently in the review process?
- Where can I get a list of all of the study sections that review applications submitted to NIH?
