Research governance authorisation: the next frontier.

Area of Science:

• Health Services Research
• Medical Informatics
• Public Health Policy

Background:

• Real-world medicine use, benefits, and harms are of significant interest.
• Routinely collected data, like electronic medical records, offer valuable insights.
• Optimizing medicine use and health outcomes requires efficient research processes.

Purpose of the Study:

• To describe the process and challenges of obtaining ethical and governance approval for a hospital-based research project.
• To identify bottlenecks in research authorization, specifically site-specific agreements.
• To provide recommendations for improving research governance processes in Queensland.

Main Methods:

• The study assessed three key approval aspects: ethics, site-specific assessment (SSA), and Public Health Act (PHA) assessment.
• Data collection involved tracking the time taken for each approval stage.
• The research focused on a project initiated in Queensland, Australia.

Main Results:

• The total time to secure all approvals exceeded one year (371 days).
• Ethics and PHA approvals were relatively quick (16 days each).
• Site-specific assessments (SSA) were the major bottleneck, taking 98-274 days across five hospital sites, due to opaque and inconsistent processes.

Conclusions:

• The current research governance process, particularly SSA, is inefficient and hinders timely medical research.
• Recommendations include standardizing low/negligible risk SSA processes across Local Hospital Networks (LHNs).
• Streamlining governance mirrors recent successes in ethics approval processes to facilitate crucial health research.