Good clinical research practice: what is it and is it possible in the intensive care unit?
With the growing quest for answers to vexing dilemmas in critically ill patients, more intensive care units are embarking on clinical research. This places increasing importance on Good Clinical Research Practice (GCRP), a set of guidelines drawn up by the Pharmaceutical Industry to assist investigators in conducting ethical, reliable scientific studies. GCRP is a combination of good basic management skills allied to ethical principles for scientific research. Based on the principles of the Declaration of Helsinki, it consists of three tenets: patient protection (ethics), credible data (science) and data control. This article describes GCRP specifically relating it to the intensive care situation, illustrating some of the concepts with practical examples. With a minimum of extra time and effort these basic principles can be integrated as routine into all research projects.
Scribante
J
J
Intensive Care Unit, Baragwanath Hospital, University of Witwatersrand, Soweto, South Africa.
Lipman
J
J
Saadia
R
R
D002986:Clinical Trials as Topic / Q000592:standards*; D003422:Critical Care; D004992:Ethics, Medical; D019983:Guideline Adherence; D006801:Humans; D007362:Intensive Care Units; D017410:Practice Guidelines as Topic; D012107:Research Design