Governance

Governance of research occurs at multiple levels.

The ethical conduct of research and the responsibilities of investigators undertaking human research are governed by the National Statement on Ethical Conduct in Human Research (2007) incorporating all updates as at May 2015 and more specifically for clinical trials by the Notes for Guidance for Good Clinical Practice (or GCP). These two documents provide the framework within which ethics committees' work, while the Human Research and Ethics Committee (HREC) provides the oversight of governance at the local level.

An important focus of both ethics and governance is participant safety. Clinical trials require procedures for monitoring and ensuring participant safety, and reporting and investigation of adverse events, including whether or not a study should continue to recruit. Researchers’ responsibilities in this area are also covered by the GCP guidelines.

Another governance issue relates to intellectual property. The ownership of protocols and research projects may sometimes be a source of conflict, especially in large research groups, multi-organisational collaborations and academic institutions. Students and post-graduates also have rights with regard to intellectual property and credit for research for which they have been responsible, and these may need to be specifically protected.

Expert legal assistance may be needed in developing contracts and confidentiality agreements for research collaboratives. Copyrighting of protocols and research instruments may also be appropriate.

Last updated 20 January 2017