The High Costs of Getting Ethical and Site-Specific Approvals for Multi-Centre Research

Abstract

<p><strong>Background</strong></p> <p>Multi-centre studies generally cost more than single-centre studies because of larger sample sizes and the need for multiple ethical approvals. Multi-centre studies include clinical trials, clinical quality registries, observational studies and implementation studies. We examined the costs of two large Australian multi-centre studies in obtaining ethical and site-specific approvals.</p> <p><strong>Methods</strong></p> <p>We collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget.</p> <p><strong>Results</strong></p> <p>The total costs of gaining approval were 38 % of the budget for a study of 50 centres (mean cost AUD $6960 per site) and 2 % for a study of 11 centres (mean cost AUD $2300 per site). Seventy-five and 90 % of time was spent on repeated tasks, respectively, and many time-consuming tasks, such as reformatting documents, did nothing to improve the study design or participant safety.</p> <p><strong>Conclusions</strong></p> <p>Improvements have been made to the ethical approval application system, but more gains could be made without increasing risks of harm to research participants. We propose that ethical review bodies and individual sites publish statistics on how long they take to process approvals which could then be nationally benchmarked.</p>