Clinical Trial Research Support Hub

Research governance is the broad range of regulations, principles and standards of good practice that are in place to ensure participants are protected and quality is assured across all aspects of clinical research.  It is a mechanism for ensuring that all human research complies with the relevant ethical and legal standards. 

Ethical review and site assessment are two distinct processes relating to the ethical approval and institutional authorisation of research involving humans. They are both elements of research governance and are essential components of designing, setting up, conducting, monitoring, and reporting of clinical trial research.

A full outline of the ethics and governance requirements are detailed on the Barwon Health Research Development Unit (RDU) website. This site provides tools and advice to support Clinical Trial Researchers through the process of applying for and receiving ethics and governance approval.

 

1. Ethical Review of Clinical Trial Research

There are two types of ethical review available for clinical trial research. The type you select depends on whether your project is to be conducted at a single site or over multiple sites.

For a single site project, Barwon Health can act as the sole reviewing Human Research Ethics Committee (HREC). More information on the requirements for submission can be found on the RDU website.

For multisite human research projects, an initiative known as the National Mutual Acceptance (NMA) was introduced in 2015, to reduce duplication of scientific and ethical review in publicly funded health organisations. For NMA, the HREC conducting the review must be certified under the NHMRC National Certification Scheme, and also a Certified Reviewing HREC under the NMA scheme.  A list of these certified HRECs that you can submit to in Victoria are below.

• Alfred Health
• Austin Health - Office for Research
• The Royal Melbourne Hospital/Melbourne Health
• Peter MacCallum Cancer Centre
• The Royal Children's Hospital Melbourne
• Monash Health
• St Vincent's Hospital (Melbourne)

The NMA system is governed in Victoria by the Department of Health (DOH) Coordinating Office for Research. More information regarding NMA, including principles of operation, guidance documents and monitoring and reporting frameworks can be found on the DOH Coordinating Office website: Clinical Trials and Research

  

2. Governance

Research Governance is the responsibility of the institution where the research is being conducted. This is because research governance encompasses ethical review and institutional considerations, regarding the research project; in the context of the institution's policies, strategic priorities, expertise, resources, contractual arrangements, financial issues and approach to risk management.

The process that allows the institution to apply these considerations to clinical trial research, or any research project, is known as Site-Specific Assessment (SSA).

More information regarding the process of Site Specific Assessment, including submitting SSA via Ethics Review Manager (ERM) can be found on the DOH Coordinating Office Home page Clinical Trials and Research and the Barwon Health Research Development Unit (RDU) website.

To help you with the process of Ethics and Governance, a list of Tips has been collated by Barwon Health clinical trial managers. 

View Barwon Health Tips for Ethics and Governance submissions here.