Research ethics and governance

The Cabrini Research Governance Office (CRGO) is located at the Patricia Peck Education and Research Precinct – 154 Wattletree Road, Malvern VIC 3144. CRGO offers ethical review for single site, lower risk research. CRGO will provide site specific governance review for HREC-approved research and other types of ethically approved multi-centre projects.

Cabrini abides by the following research directives:

• The National Statement on Ethical Conduct in Human Research (2023) issued by the National Health and Medical Research Council (NHMRC) and associated guidelines;
• Catholic Health Australia’s Code of Ethical Standards for Catholic Health and Aged Care Services in Australia (2001).
• Other relevant Commonwealth and State legislation

Ensure you are familiar with Cabrini’s Clinical Trial COVID-19 response which has adopted government recommendations.

Everything you need to complete a low risk or governance submission  

The CRGO Handbook will provide you with all the necessary information to complete a low risk or governance submission.

• Cabrini Research Governance Handbook 
• Cabrini Research Governance Fees
• Cabrini Research Clinical Trials COVID-19 Response

Resources

• Governance Pathways for Quality Assurance, Quality Improvement and Research Projects – Review this decision tree to determine the type of governance approval (and ethical review where applicable) your project requires.
• Risk Assessment Checklist – The Risk Assessment Checklist is designed to help a researcher determine the level of risk of their research project, and whether it is appropriate to be reviewed via Cabrini’s Non-HREC Review Pathway, or if it first requires NMHRC-certified HREC review.
• Lower Risk Non-HREC Review Application Form – This form is appropriate for projects that meet the Risk Assessment Checklist criteria as being lower risk research conducted only at Cabrini that are eligible for internal, Non-HREC review.
• Site Specific Assessment (Governance Review) Application Form – This form is used for projects with existing NHMRC-certified HREC approval that now require a Site Specific Assessment (SSA) – i.e. Cabrini governance review and approval – prior to any research conduct commencing at Cabrini.
• Quality Initiative Application Form – Use this form if your project qualifies for review via the CRGO QA/QI pathway. Seek pathway confirmation from CRGO before completing the form.
• Lower Risk Research Protocol Template – Use this template’s format and prompts to support study design of a new research project.
• Quality Initiative Protocol Template – Use this template’s format and prompts to support design of a new quality initiative.
• Explanatory Statement (Survey) Template – Use this template’s format and prompts to create an explanatory statement for quality or lower risk research projects involving survey or questionnaire distribution.
• Site Specific PICF Checklist – This checklist contains Cabrini’s preferred site-specific wording and assists researchers in preparing a locally compliant PICF or PIS.

• Department Resourcing and Costing Approval Form – Must be completed if projects need to use Cabrini resources or have support from departments, e.g. health information services, pharmacy and oncology.

• Progress Report – As per terms of approval, all researchers are required to submit periodic progress reports. This form can be used for the annual report and the final report – required when a project is completed.

• Request for Documents to be Approved Form – To be used if submitting additional/amended documents after project approval, e.g. protocols, participant information and consent forms, IBs, questionnaires, letters, memos, etc.

• Administrative Changes Form – To be used for all changes which raise no ethical concerns e.g. adding or removing investigators, dates, contact details, logistics and other administrative issues.

• Events to Be Noted Form – To be used for reporting protocol deviations/violations and serious breaches.

• Corrective and Preventative Action (CAPA) Plan – To document the issue, root cause analysis, corrective action and resolution related to serious breaches or clinical incidents that occur during the conduct of research.

• Safety Reporting Form – Cabrini – To be used for reporting Serious Adverse Events (SAEs). The Victorian Government’s Safety Report Form is also accepted. Please refer to the Safety Monitoring and Reporting in Research Policy for guidelines.

• Data Governance Checklist – To be completed for each database or registry held and governed by Cabrini Health and any Clinical Quality Registry seeking access to Cabrini Health patient information.
• Artificial Intelligence (AI) Usage Checklist – Research – To be completed for any research project involving use of a Cabrini-authorised AI system.

• Research Agreements Guide – Review this guide for any projects involving collaboration between Cabrini and an external institution.

• Researcher Training –  Good Clinical Practice (GCP) and Research Integrity – All researchers must possess current GCP certification and all principal investigators are required to undertake Research Integrity training.

• Victorian Research Translation Centres (VRTC) Research Collaboration Agreement Template – If a written agreement is needed between collaborators, complete this pre-approved template for expedited execution.
• Victorian Research Translation Centres (VRTC) Research Collaboration Agreement Guidelines – Instructions for completion of the VRTC research collaboration agreement template.

Policies and procedures

• Monitoring of research policy
• Research integrity and misconduct policy
• Safety monitoring and reporting in research policy
• Authorship and publication in research policy
• Research participants complaints and compliment procedure
• Data management, sharing and access policy
• Data classification and labelling standard 
• Informed consent in research guide
• Honorary researcher appointments