Research ethics and governance
Our role and responsibility
High quality, ethical research is beneficial for patients, health professionals, and the whole community.
The Cabrini Research Governance Office (CRGO) is responsible for ensuring that:
- ethically sound research is promoted and conducted at Cabrini;
- the research affirms the mission and values of Cabrini and teachings of the Catholic Church; and
- ethical standards are maintained in research projects to protect the interests of the research participants, the investigator and the institution.
About us
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.
Seeking ethics and governance approval for higher risk studies
Research assessed as higher risk must be reviewed by an NHMRC-certified Human Research Ethics Committee (HREC) that is a member of the National Mutual Acceptance (NMA) Scheme.
Cabrini is a member of Monash Partners and recommends Monash Health or Alfred Health to obtain HREC approval, or to review a multicentre project that may be exempt from HREC review. Cabrini will accept the HREC approval of other NHMRC-certified HRECs for studies appropriate to Cabrini.
The level of risk of your proposed research will determine which path is required to seek approval to conduct your study at Cabrini. Ethics and governance approval must be secured before any research can commence. Please review the CRGO Handbook for steps in obtaining ethics and governance approval. Contact CRGO via researchgovernance@cabrini.com.au
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 Governance Policy
- Cabrini Research Clinical Trials COVID-19 Response
Resources
- Low Risk & Governance Review Application Form – To determine whether this form is appropriate for your application, first complete the Level of Risk Checklist. The Level of Risk Checklist is designed to aid researchers in determining the level of risk of their projects. If you have obtained external HREC approval and require site governance at Cabrini, you must submit an HREA and VSM alongside the Low Risk & Governance Review Application Form.
- Site Specific PICF Checklist – This checklist contains Cabrini’s preferred site-specific wording and assists researchers in preparing a locally compliant PICF or PIS.
- Project Resourcing and Costing Template – Must be completed if projects need to use Cabrini resources or have support from departments, e.g. health information services, pharmacy and oncology. Sections not required can be deleted.
- 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.
- 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 Audit Tool – To be used for all new database / registry applications to ensure it adds value to Cabrini and does not duplicate data already collected.
- Research Agreements Guide – Review this guide for any projects involving collaboration between Cabrini and an external institution.
- Monash Partners Research Collaboration Agreement Template – If a written agreement is needed between collaborators, complete this pre-approved template for expedited execution.
- Monash Partners Research Collaboration Agreement Guidelines – Requirements for use and instructions for completion.
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 (coming soon)
- Informed consent in research policy (coming soon)
- Honorary researcher appointments