Comparison of good clinical practice compliance and readability ease of the informed consents between observational and interventional clinical studies in the Emirates.

BACKGROUND: Expansion of clinical trials activity into emerging regions has raised concerns regarding participant rights and research ethics. Increasing numbers of observational studies are now conducted in developing economies, including the United Arab Emirates.

MATERIALS AND METHODS: This study compares the content of information provided, Good Clinical Practice (GCP) guideline compliance, and readability of informed consent forms (ICFs) for observational compared to interventional studies.

RESULTS: GCP compliance for observational studies averaged at 79.5% + 6.8%, significantly (P < 0.001) lower than 92.2 + 5.0 percent for interventional studies. Readability ease and readability-grade level were assessed with Flesch-Kincaid scales. Results indicated higher readability grade-level 12.4 + 0.4 (P < 0.001) and lower readability Flesch-Kincaid reading ease score 35.7 + 3.6 for observational studies, as compared to 10.3 + 1.6 and 47.8 + 7.4 for interventional studies.

CONCLUSION: Mandatory training for investigators is essential to provide readability ease and GCP compliance for the ICFs for the local population.