The Cabrini Human Research Ethics Committee helps 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
The Cabrini Human Research Ethics Committee (CHREC) reports directly to the Cabrini Board. It reviews and approves research projects conducted at Cabrini that involve human participants. It is chaired by Dr Margaret Staples and managed by Jennifer Burden.
Our Human Research Ethics Committee ensures 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.
It conducts its business in accordance with 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.
CHREC dates are available in the CHREC Handbook.
The new National Health and Medical Research Council (NHMRC) guidelines for Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (November 2016) were discussed at the January meeting of the Cabrini Human Research Ethics Committee (CHREC).
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.
As a result, we will continue with our current process where principal investigators advise the CHREC of any clinically relevant events, as they occur, for any studies being conducted at Cabrini. Principal investigators will also continue to inform the sponsor of all clinically relevant adverse events.
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 - January 2017 - PDF
- Appendix A – Risk Review Policy PDF
- Appendix B – Level of Review Flow Chart PDF
- Attachment 1 Application Form- Cabrini’s own application form for full Ethics Committee review. Only relevant sections should be completed, irrelevant sections can be deleted. We 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 Form - 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 Documents to Be Presented Form - To be used if submitting additional/amended documents after the initial project submission, including protocols, participant information and consent forms, IBs, questionnaires etc.
- Attachment 8 Admin Changes Form - To be used for all changes to study personnel, dates, contact details, logistics and other issues which raise no ethical concerns.
- 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.