RDU, ethics and governance information

Research governance is the framework through which institutions are accountable for the research they allow to be conducted under their auspices. This framework demands compliance with laws, regulations, guidelines and codes of practice concerning the conduct of research in Australia. Good research governance encourages responsible conduct by researchers, promotes quality in research, and minimises the risk of harm for all involved. It should be accountable and transparent.

Elements of research governance

• Ethics approval
• Site consideration of the investigator’s skills, training and experience
• Site availability and suitability of facilities and resources for the proposed research
• Compliance with legislation, regulations, guidelines and codes of practice
• Legal and insurance (e.g.) consent, contracts, insurance and indemnity arrangements
• Policies and procedures for responsible research conduct and managing research misconduct
• Funding for the project, budgets, and financial management
• Reporting
• Alignment with Barwon Health Strategic Plan and Policies

Why do we need research governance?

Research governance is needed to:

• Safeguard participants in research
• Protect researchers/investigators/institutions (by providing a clear framework to work within)
• Enhance ethical and scientific quality
• Minimise risk
• Monitor practice and performance
• Maintain a climate in which responsible and ethical behaviour in research is expected

Site Specific Assessment (SSA) form

The key document that assists good research governance is the Site Specific Assessment (SSA) form.

The SSA addresses the research governance associated with research applications including resources, study budget details, site-specific policies and declarations from departments. The SSA is used for assessing the suitability of a site at which the research is to be conducted.

The SSA should be completed via Ethics Review Manager (ERM).

SSA Signatures

• Head of Department
• Supporting Department(s) providing support or services to the research project
• In the advent of a conflict of interest where the Principal Investigator is also the Head of Department, the Research Development Unit will accept a signature from the relevant Clinical Director.

All research contracts/agreements will be taken to the Research Management Committee for approval and subsequent signoff.

All research projects submitted to Barwon Health HREC receive simultaneous governance review.