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

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.

Cabrini abides by the following research directives:

• The National Statement on Ethical Conduct in Human Research issued by the National Health and Medical Research Council (NHMRC) in 2007 and subsequent updates;
• other relevant Commonwealth and State legislation; and
• Catholic Health Australia’s Code of Ethical Standards for Catholic Health and Aged Care Services in Australia (2001).

Cabrini's former Human Research Ethics Committee (CHREC) closed on 31 December 2019.  The Cabrini Research Governance Office was introduced in 2020, offering review of low or negligible risk projects, and site governance for single or multi-site projects with a moderate to high  level of risk.  Human Research Ethics Committee Review of moderate to high risk studies can be sought via Monash Partners HRECs through Monash Health HREC and Alfred Health HREC.   To enable concurrent governance review, please send your application (which can include an HREA and VSM) and supporting documentation to researchgovernance@cabrini.com.au.

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, below, for next steps.

If you need to complete your GCP or refresh you GCP certificate, please refer to Monash Partners - GCP Arrangements for 2020.

We continue to work on refining our low risk and governance processes to enable good user experience and facilitative research start up.  Your feedback is important to us.  Please let us have your comments via researchgovernance@cabrini.com.au.  

CRGO Handbook 

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

• Cabrini Research Governance Handbook - 20 July 2021
• Cabrini Research Governance Policy
• Appendix A – Risk Review Policy
• Appendix B – Level of Review Flow Chart

Attachments 

• Attachment 1 - Full Review Application Form- No longer required at Cabrini. 

• Attachment 2 - Low Risk & Governance Review Application Form - To determine whether this form is appropriate for your application, first complete Attachment 4 Level of Risk Checklist.  If you have obtained external HREC approval and require site governance at  Cabrini, you may submit an HREA and VSM alongside Attachment 2.

• Attachment 3 - Project Resourcing and Costing Template  - Must be completed if projects need to use Cabrini resources or have support from departments, e.g. pharmacy and oncology. Sections not required can be deleted.

• Attachment 4 - Level of Risk Checklist - This checklist is designed to aid researchers in determining the level of risk of their projects. Applicable to low-risk, negligible risk and quality assurance projects.

• Attachment 5 - Confidentiality Agreement - No longer in use. External researchers must now obtain an honorary appointment if access to Cabrini data is required. Email researchgovernance@cabrini.com.au for more information.

• Attachment 6 - Progress Report - As per terms of approval of projects, 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.

• Attachment 7 - 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.

• Attachment 8 - 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.

• Attachment 9 - Events to Be Noted Form - To be used for reporting protocol deviations and violations.

• Attachment 10 - Serious Adverse Events Reporting Form - To be used for reporting Serious Adverse Events (SAEs).  Please refer to the CRGOHandbook for SAE reporting guidelines. Rows can be added or delete.

• Attachment 11 - 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.

• 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.

• Monash Partners Site Specific Assessment Form Addendum - Form being trialled by Monash Partners. Feedback can be sent to researchgovernance@cabrini.com.au.