Variation in Ethics Approval and Contract Execution Processes and Regulatory Timelines in an International Observational Study of Mechanical Ventilation Discontinuation Practices: A Nested Study
CCCF ePoster library. Rizvi L. Oct 2, 2017; 198209
Leena Rizvi
Leena Rizvi
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Abstract
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Variation in Ethics Approval and Contract Execution Processes and Regulatory Timelines in an International Observational Study of Mechanical Ventilation Discontinuation Practices: A Nested Study

Rizvi, Leena 1; Griffin, Katherine 2; Burns, Karen 1, Zytaruk, Nicole 3; Sykes, Jenna 2; Cook, Deborah 3 



1 Department of Critical Care Medicine, St. Michael's Hospital, Toronto, Cancada; 2 Department of Respirology, St. Michael's Hospital, Toronto, Canda; 3 Department of Critical Care, St. Joseph’s Healthcare, Hamilton, 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. While 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 the IOS trial, an international prospective observational trial conducted in 6 geographical regions (Canada, the UK, Europe, India, Australia and New Zealand, and the USA).
 
Goals and Objectives:
In this study, we aimed to describe variation, within and among the 6 geographical regions, with respect to the type of ethics and regulatory approval processes required.  We also 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 a questionnaire to gather the information required to address our objectives. The questionnaire was administered to the lead research team member of each center who participated in the International Observational Study. The questionnaire was administered using SurveyMonkey®. Questionnaire were provided via email to non-responding sites.  If the centre did not complete the survey via SurveyMonkey® after the initial 2 requests, or by request of the respondent.
 
Results:
Across regions, central ethics approval took significantly longer to obtain than site who submitted through a local ethics board (176 days vs 42 days).  Contracts took significantly longer in regions with presumably established research infrastructure and consortia.  Time to contract execution took almost as long as obtaining a central ethics approval (~3.6 to ~4.4 months) and took longer than obtaining local REB approval on average.  Key reasons for sites to discontinue participation in the IOS trial included: lack of human resources (staff/RC/workload), ethics approval processes, loss to follow-up, and PI related reasons. Insufficient funding was reported only by 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% additional sites to achieve the target number of participating centers and enrolled patients.

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