258: CHALLENGES IN INSTITUTIONAL APPROVAL PROCESS FOR A MULTINATIONAL STUDY: THE GLOBAL PARITY

Abstract

Introduction: Multicenter, multinational collaborative research has increased across differing resource capacities by country. Inconsistencies in ethical review processes is an under recognized resource limitation and in resource-limited settings across regions may lead to barriers to rapid deployment of important clinical studies. Methods: An ancillary prospective study of the global PARITY (pediatric acute critical illness study) point prevalence study of pediatric critical illness in resource-limited settings. We surveyed participating sites to explore ethical and board review processes. The aim of the study was to describe the time, costs, and barriers in obtaining institutional review board and ethics approval for a multinational, multicenter, non-interventional study in critically ill children involving low and middle-income countries. Results: Fifty-six centers completed the survey. Of those hospitals, 72% (n= 40) required a full board review of the global PARITY study prior to approval, and 17% (n=9) accepted an ethics approval from a separate institution. The frequency of institutional review board (irb) committee is variable between centers, 16% (n=9) weekly, 56% (n=31) meet every 1 – 2 month, 11% (n=6) every 3 – 6 month and in 16% (n=9) > six months. The IRB approval process took a median of 62 days (n=40; range 1-294 days). Sixteen centers (30%) reported costs associated with ethical review. The waived consent was approved by 71% (n=38) of the centers, and 23% (n=12) required a data sharing agreement. The protocol required translation to local language in 47% (n=26) centers, from which 25% (n=6) required a professional certificated translation. Of the centers surveyed, 32% (n=17) required a legal review of protocol or data sharing agreement. Conclusions: There is great variability in ethical review requirements and time of approval for a non-interventional multinational study of critically ill children in low and middle-income countries in both private and public hospitals. We show that this time resource must be considered when planning multinational studies. Enhancing the capacity for ethics and board review process across regions will allow for better matching of disease burden with clinical research and likely increase participation in this multicenter research.