Clinical Trials

Quick Links

• Greater than Low Risk Single-Site Application Guide
• Greater than Low Risk Multi-Site Governance Submission Guide
  
• Review Process Summary for Research Involving Greater than Low Risk Research

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Applying for a Barwon Health reference number

All applications submitted to Barwon Health for review are required to generate a reference number via the Barwon Health Research Reference Number Generator (please open with Google Chrome).

Please ensure that the Barwon Health reference number is quoted at the time of your submission.

For all research that involves greater than low risk, ethical review by a formally constituted Human Research Ethics Committee (HREC) is required. Researchers are required to complete and submit a full application to the Barwon Health (BH) HREC for review and approval. 

Gauging risk involves taking into account:

• The kinds of harm, discomfort, or inconvenience that may occur
• The likelihood of these occurring
• The severity of any harm that may occur.

Harms include:

• Physical harms; including injury, illness, pain
• Psychological harms; including feelings of worthlessness, distress, guilt, anger, fear
• Social harms; including damage to social networks or relationships with others, discrimination
• Economic harms; including the imposition of direct or indirect costs on participants
• Legal harms; including discovery and prosecution of criminal conduct.

Review process for greater than low risk research

1. Review by the Research Review Committee (RRC)

The primary purpose of the RRC is to review all research projects for scientific merit and methodological validity, and to make recommendations to the BH HREC. The BH HREC delegates authority to the RRC to approve low risk projects. Projects that are approved through the RRC shall be noted and ratified at the following HREC meeting.

2. Review by the BH HREC

The BH HREC is a formally constituted HREC accredited by the NHMRC. The primary purpose of the BH HREC is to ensure that human research undertaken at Barwon Health, and affiliated institutions, exemplifies the highest ethical standards and complies with NHMRC guidelines and statutory requirements of State and Federal legislation. Projects that have been reviewed by the RRC, revised where necessary and accepted for HREC review, are then submitted to the BH HREC.

The RRC and BH HREC meet monthly - meeting and submission close dates can be found on the Committees, meetings and dates webpage.

3. Research governance review

Research governance is the framework through which institutions are accountable for the research they allow to be conducted under their auspices.

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

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 for departments. The SSA is used for assessing the suitability of a site at which the research is to be conducted. The SSA is available to complete on Ethics Review Manager (ERM).

Principal Investigators are required to seek sign off from any department(s) providing support or services to the research project, as well as department head sign off.

All research projects submitted to BH HREC receive simultaneous governance review. 

How to prepare a greater than low risk research application

If you think your research fits into the greater than low risk category, please follow the steps outlined on the greater than low risk application guide found at the top of this page.

Please note: All researchers are expected to have read and be familiar with the National Statement on Ethical Conduct in Human Research and the Australian Code for the Responsible Conduct of Research, and to comply with these guidelines in the conduct of research.