Analysis of the compliance of informed consent documents with good clinical practice guideline.

BACKGROUND Informed consent document plays an integral part in the process of obtaining informed consent. Although India is fast gaining repute as a preferred clinical trial destination, only few studies have evaluated the compliance of informed consent documents with the Indian Good Clinical Practice guideline. METHODS Retrospective analysis of consent documents submitted to the institutional ethics committee during the periods January 2007-July 2008 and August 2008-December 2009, for the inclusion of 14 essential information elements outlined in the Indian Good Clinical Practice guideline was carried out. Cumulative scores were given for compliance with the guideline and for vernacular translations of the consent documents. RESULTS Majority of the informed consent documents analyzed were for academic projects in both periods. There was marked improvement in the documents in terms of compliance with Indian GCP in the period 2008-09. The mean cumulative score for consent documents for academic projects increased significantly from 7.00 ± 0.25 in 2007-08 to 8.57 ± 0.16 in 2008-09. The mean score for consent documents for pharmaceutical sponsored studies also increased from 10.23 ± 0.17 in 2007-08 to 11.31 ± 0.32 in 2008-09. Additionally, greater number of consent documents had been translated into vernacular language in the period 2008-29. CONCLUSIONS The increased compliance with the good clinical practice guideline and improvement in the mean cumulative scores in 2008-09 was probably the outcome of greater awareness amongst the clinical researchers within the institute.