A primer for clinical researchers in the emergency department: part I: ethical and regulatory background.

Research is an important part of emergency medicine and provides the scientific underpinning for optimal patient care. Although increasing numbers of emergency physicians participate in research activities, formal research training is currently neither part of emergency physician training in Australia nor easily available for clinicians interested in clinical research. In a two-part series, which is targeted at part-time clinical researchers in the ED, we set out and explain the key elements for conducting high-quality and ethical research. In Part I, we describe important underlying ethical principles for research in humans and explain key regulatory processes and documents pertaining to good clinical research practice in Australia. The ethics of research in children as a particularly vulnerable group will also be addressed. Part II will address important elements of research science and conduct.