Human Research Ethics Committees help protect the interests of patients, researchers and Cabrini by maintaining high ethical research standards across all research projects and all levels of risk.

Cabrini Human Research Ethics Committee will close on 31 December 2019 as we will share Monash Partners HRECs through Monash Health and Alfred Health

Our Human Research Ethics Committees ensure 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
• ethical standards are maintained in research projects to protect the interests of the research participants, the investigator and the institution.

The National Statement on Ethical Conduct in Research Involving Humans issued by the National Health and Medical Research Council in 2007, other relevant Commonwealth and State legislation and regulations and Catholic Health Australia’s Code of Ethical Standards for Catholic Health and Aged Care Services in Australia apply at Cabrini.

Research projects at Cabrini will be processed through the Monash Health HREC and Alfred Health HREC.   To enable concurrent governance review, please send your application and supporting documentation to hrec@cabrini.com.au .

Research to be conducted at Cabrini must have both HREC and Governance approval before commencement. Please follow instruction for Governance submission in the CHREC Handbook, below.

We are working on refining the new HREC processes to enable good user experience and facilitative research start up.  Your feedback is important to us.  Please let us have your comments dmacdonald@cabrini.com.au.

CHREC Handbook 

The Handbook is the most important CHREC resource and contains all the information researchers need to complete a research proposal for submission. 

• Cabrini Human Research Ethics Committee Handbook - 26 September 2019 - PDF
• Appendix A – Risk Review Policy PDF
• Appendix B – Level of Review Flow Chart PDF

Attachments 

• Attachment 1 - Full Review Application Form- Cabrini’s own application form for full HREC review. Only relevant sections should be completed, irrelevant sections can be marked N/A. We will also accept the HREA and VSM, in which case attachment 2 must be completed as well.  

• 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.

• 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. Unneeded sections 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 project.

• Attachment 5 - Confidentiality Agreement - To be completed by non-Cabrini employees requesting access to identifiable patient data.

• 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 CHREC Handbook for SAE reporting guidelines. Rows can be added or deleted.

• 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 how to complete

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