Population-Based Clinical Sudies Using Routinely Collected Data in Hong Kong, China: A Systematic Review of Trends and Established Local Practices

Background: Routinely collected health data are increasingly used in clinical research. No study has systematically reviewed the temporal trends in the number of publications and analyzed different aspects of local research practices and their variations in Hong Kong, China, with a specific focus on research ethics governance and approval. Methods: PubMed was systematically searched from its inception to March 28, 2023, for studies using routinely collected healthcare data from Hong Kong. Results: A total of 454 studies were included. Between 2000 and 2009, 32 studies were identified. The number of publications increased from 5 to 120 between 2010 and 2022. Of the investigator-led studies using the Hospital Authority (HA)’s cross-cluster data (n = 393), 327 (83.2%) reported receiving ethics approval from a single cluster/universitybased REC, whereas 50 studies (12.7%) did not report approval from a REC. For use of the HA Data Collaboration Lab, approval by a single hospital-based or University-based REC is accepted. Repeated submission of identical ethics applications to different RECs is estimated to cost HK$4.2 million yearly. Conclusions: Most studies reported gaining approval from a single cluster REC before retrieval of cross-cluster HA data. Substantial cost savings would result if repeated review of identical ethics applications were not required.