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A4586 - Variation in Ethics Approval and Contract Execution Processes in an International Observational Study of Mechanical Ventilation Discontinuation Practices: A Nested Study
Author Block: K. Burns1, K. Griffin2, J. Sykes2, N. Zytaruk3, D. J. Cook4, L. Rizvi1; 1Critical Care, St Michaels Hospital, Toronto, ON, Canada, 2Respirology, St Michaels Hospital, Toronto, ON, Canada, 3St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada, 4Faculty of Health Sciences, McMaster Univ Medical Ctr, Hamilton, ON, Canada.
Introductions: While research involving investigational drugs and medical devices must adhere to standardized guidelines proposed by the International Conference on Harmonization (ICH) and the Tri-council Policy Statement II (TCPS2), regulatory standards for purely observational research are less well defined and likely vary widely on both national and international levels. Although interest in international collaborations is increasing, little is documented about the regulatory challenges encountered to bringing global collaborations to fruition. We surveyed centers that participated in an International Observational Study (IOS) of mechanical ventilation discontinuation practices conducted in 6 geographic regions (Canada, the UK, Europe, India, Australia and New Zealand, and the USA). In this study, we aimed to describe variation, within and among the 6 regions, with regard to the ethics and regulatory approval processes required. We calculated the total time required for (i) ethics and regulatory approvals (ii) contract execution and (iii) site initiation of data collection. Within and among regions we identified important predictors of time to ethics approval and contract execution. Finally, we identified logistical reasons why centres/ICUs decided not to participate after initially agreeing to participate. Methods: We developed an electronic questionnaire (using SurveyMonkey®) to gather information to address our objectives. The questionnaire was administered to the lead research team member of each center who participated in the IOS. Questionnaires were provided via email to non-responding sites. Results: Across regions, central ethics approval took significantly longer to obtain than local ethics board approval (176 days vs 42 days). Contracts took significantly longer in regions with presumably established research infrastructure and consortia. On average, time to contract execution took almost as long as obtaining a central ethics approval (~3.6 to ~4.4 months) and longer than obtaining local ethics approval. Key reasons for sites to discontinue participation in the IOS study included lack of human resources (staff/RC/workload), ethics approval processes, loss to follow-up, and principal investigator-related reasons. Insufficient funding was reported by only 5.6% sites in this funded study. Conclusion: Compared to the planned study duration and anticipated number of sites, large-scale observational studies may require greater resources, longer time horizons and recruitment of up to 41% more sites to achieve the target number of participating centers and enrolled patients.