Ethical conduct in clinical research
The National Statement on Ethical Conduct in Human Research.
This is a set of guidelines for any researcher in Australia conducting research with human participants. The guidelines are also relevant to those involved in ethical review, research governance, or study participants. The National Statement promotes ethical human research that involves participants being accorded respect and protection. The National Statement clarifies the roles and responsibilities of institutions and researchers (in the design, conduct and dissemination of results of human research), and review bodies (i.e. the Human Research Ethics Committee). The National Statement should be used when designing, reviewing and conducting research that involves human participants in Australia.
ICH-GCP
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has a set of guidelines called Good Clinical Practice (GCP). ICH-GCP is a harmonised international standard for the design, conduct, monitoring, auditing, recording, analysing, and reporting of clinical trials that involve human participants. It is based on the principle that clinical trials should be conducted ethically. These ethical principles have their origin in the Declaration of Helsinki. Good Clinical Practice (GCP) is: “A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.” Study staff must complete and maintain up-to-date appropriate and accredited ICH-GCP training.
The Australian Code for the Responsible Conduct of Research
A code to guide institutions and researchers in responsible research practices. This Code is a reference for people outside the research community who require information on the standards expected in the responsible conduct of research within Australia; and was developed for universities and other public sector research institutions.