Research Ethics

The CHREC agreed that it would be in the best interests of our patients, and respectful of the CHREC resources, for principal investigators to continue to inform the committee of all clinically relevant adverse events. Principal Investigators are the experts in their patient population and understand whether an event they are witnessing in a patient is common for that disease population or whether it might be related to the treatment on trial. 

For that reason, we continue with the process of principal investigators advising the CHREC of any clinically relevant events, as they occur, for any clinical trial under CHREC review. Principal investigators will also continue to inform the sponsor of all clinically relevant adverse events.

A new Monash Partners Site Specific Assessment Form Addendum is currently being trialed. For more information, please read the letter from Professor Paul Myles. We would appreciate your feedback on the form. 

• Letter from Professor Paul Myles 
• Monash Partners Site Specific Assessment Form Addendum

Feedback can be sent to hrec@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 - 21 December 2018 - 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 Ethics Committee 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 Admin 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 SAEs Form - To be used for reporting Serious Adverse Events (SAE) . 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 agreemnet is needed between collaborators, complete this pre-approved template for expedited execution.