Research governance: current knowledge among clinical researchers.

Abstract

OBJECTIVE: To characterise the understanding of good clinical research practice (GCRP) among clinical researchers. DESIGN, PARTICIPANTS AND SETTING: Survey of all staff within the largest clinical research group (Critical Care and Neurosciences) of a non-government research institute affiliated with a major children's hospital, between 1 April and 31 May 2007. MAIN OUTCOME MEASURES: Staff's role and research activity; knowledge of relevant guidelines and translation into practice; GCRP training; and experience of research audits. RESULTS: 122 of 154 research staff (79%) responded and were divided into three categories: clinicians (45%); research students/junior researchers (32%); and researchers (23%). While 60% of researchers reported they had read (at least in part) the two key Australian documents (the National statement on ethical conduct in human research and the Australian code for the responsible conduct of research), only 36% of clinicians and 30% of students/junior researchers stated they had done so. GCRP, such as obtaining consent and document storage, was only partially understood. 13% of all respondents had experienced a research project audit and 10% had undertaken formal GCRP training. Reasons given for the lack of GCRP training included insufficient resources, no training provided, and no time. 79% of staff felt that research auditing was important and 74% would like more education in GCRP. CONCLUSIONS: Many clinical researchers are unaware of all the responsibilities involved in GCRP. A formal mandatory training program and GCRP auditing would be likely to improve practice.