Demystifying human research ethics committee applications.

ABSTRACT

BACKGROUND: The National Health and Medical Research Council's National Statement on Ethical Conduct in Human Research and updated Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research provide guidance for primary care researchers. OBJECTIVE: This paper describes a step-by-step approach to ethics applications for research projects in primary care for new or inexperienced researchers, or those new to primary care research. DISCUSSION: Domains that may enhance ethics applications include increased consumer involvement; comprehensive literature reviews; evidence of researcher training in ethical research and clinical trials; the use of online platforms for participant information, consent processes and surveys; and consideration of the risks of genomic research or research in subpopulations. This paper discusses steps required when preparing ethics applications to ensure the community, clinicians and researchers are protected.