Abstract
Ethical misconduct in medical research dates back to 1 BC. Reports of ethical misconduct have been recorded throughout the centuries along with the various public reactions to manage these breaches. It was not until 1964 that a statement of ethical principles in the conduct of medical research was formalised. In Australia, the first Statement on Human Experimentation was released in 1966 and was based on The Declaration of Helsinki. Since then review of the Statement has lead to the current National Statement in Ethical Conduct in Research Involving Humans (1999).1 Prior to 2003, there was a call for identification of when quality projects should require independent ethical review as projects appeared to escape ethical review due to their guise as ‘quality projects’ while containing issues relating to privacy and confidentiality, burden and/or risk to patient, consent, overlap with research and broader implications such as the potential infringement of rights and reputation of the projects participants. In 2003 the NHMRC developed a publication providing advice to researchers and health care institutions on when quality projects should obtain independent ethical review. With the increasing amount of research and quality projects being undertaken within the emergency department environment and strengthening support to disseminate the results through conference presentations and publications, this paper aims to give a brief history of ethical misconduct and the development of the process for ensuring ethical conduct is undertaken during human research and quality projects. It will discuss the issues relating to when projects should obtain ethical review and issues relating to the need for ethical review when publishing results.
Published Version
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