Ethics applications in Australian health services: a novel scoring system.

Abstract

BACKGROUND Ethics approval is an essential prerequisite to conducting a human research study, as required by the Declaration of Helsinki. While there is a need for a thorough review process to prevent unethical research, the resulting administrative workload required for applications is substantial and this is often multiplied in multi-centre studies.

AIM To assess research ethics application processes across all Health Services in Australia

METHOD All Australian health service websites were systematically assessed for Ethics requirements. Data collected included application types and processes, meeting dates and timeframes. The ethics application process of each health service is objectively scored using our novel scoring system (Table 1).

RESULTS Whilst most hospitals run HREC only (53.8%), there are also a few hospitals without any meetings (7.7%), hence relying on the HREC from other hospitals to provide ethics approval (Figure 1). The number of documents requested for the same category of research (Full Ethics/HREC vs SSA vs LNR vs QA) varied widely between health services despite (Figure 2). In particular, there are health services requiring more than 5 documents simply to conduct Quality Assurance activities. Most health services organise 7 to 11 HREC meetings a year.

CONCLUSION The research ethics application process in Australia is widely variable between health services. We propose a scoring system which objectively describes the current status of research ethics applications across Australia