Governance

Research Governance

Research governance is a framework through which institutions are accountable for the scientific quality, ethical acceptability and safety of the research they sponsor or approve to be conducted.

The Southern Health Research Directorate provides governance across all Southern Health campuses including, Prince Henrys Institute, Southern Clinical School, Monash Institute of Medical Research and the Deakin - Southern Health Nursing Research Centre.

A number of developments have recently been introduced at a national and international level incorporating new standards to ensure research activities are conducted in accordance with sound research governance practices. These requirements are set out in:

  • the NHMRC National Statement on Ethical Conduct in Human Research (2007)
  • the Australian Code for the Responsible Conduct of Research (2007)
  • the Victorian Managed Insurance Authority guidelines
  • the Australian Council on Healthcare Standards.

All researchers at Southern Health must strive to conduct research in the manner indicated in the Southern Health Human Research Policy.

Auditing of Research Projects

The Southern Health Human Research Ethics Committees (HREC) are required to monitor all approved research in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007).

It is recommended that researchers audit their own project procedures for compliance annually using the Research Governance Self Auditing tool and it is recommended that this occur simultaneously when completing the Annual Project Report Form (Form 13).

Projects may be selected for auditing by the Research Directorate for a variety of reasons:

  • Human Research Ethics Committee review – following approval of a new protocol; as part of the approval process; or due to the classification of risk.
  • Random selection.
  • A complaint.
  • Annual report and/or Research Governance Auditing Tool return verification.

Auditing documents

Standard Operating Procedures to achieve Good Clinical Practice

The Southern Health Research Directorate has put in place Standard Operating Procedures (SOPs) to achieve good clinical practice (GCP) in clinical research. The aim of the SOPs is to provide the necessary tools to ensure that researchers at Southern Health are able to operate to International Clinical Harmonisation/Good Clinical Practice Guidelines (ICH GCP) standards by efficiently providing operating documentation.

What are Standard Operating Procedures?

A ‘SOP’ is a specific description of how to undertake a particular task. Where a SOP is in place it is expected that procedure would be followed as described by all of the relevant people referred to within the procedure. If a SOP is not followed this would be seen as a breach of process from the point of view of an audit or from a legal perspective.

All SOP documents are available on the PROMPT system on the Southern Health Intranet. 

Documents are also available to download below:

Contact us:
Research Directorate
Level 4, Main Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
T: 613 9594 4611
F: 613 9594 6306
Email

Research Governance Toolkit Training is now available, click here to find out more....

For assistance and further information please contact Micheleine Uhe, either by email or call us (03) 9594 4055. Micheleine is the Research Governance Officer and is in the office on Wednesday and Thursdays.