Starting your project
Before you start your research project at Mater, you need:
- Ethics approval from Mater Misericordiae Limited (“Mater”) HREC or another NHMRC-certified HREC with Mater Misericordiae Limited listed as an approved site
- Research Governance (site) authorisation
The ethics and research governance reviews are independent of each other but can occur in parallel.
Determining project type
It is important to understand whether you are conducting human research, undertaking a quality assurance (QA) activity or preparing a case report, as these projects have different submission requirements and ongoing responsibilities. If you are unsure whether your project is research or quality assurance, contact the Mater HREC office.
Human Research | Not Research | ||||
|---|---|---|---|---|---|
Lower Risk Research (LR) | Higher Risk Research (HR) | Research Exempt from Ethical Review | Quality Assurance (QA) | Case Report | |
Description | No risk of harm; potential risk of discomfort (±foreseeable burden)Refer to NS2.1 | Risk of harm (± foreseeable burden) Refer to NS2.1 | For a full list of research that may be eligible for exemption from ethics review Refer to NS5.1.15-5.1.17 | Clinical audits, service evaluations, quality improvement activities. Refer to Ethical Considerations in Quality Assurance and Evaluation Activities | Detailed description of the symptoms, diagnosis, and treatment of a patient Refer to Ethical Considerations in Quality Assurance and Evaluation Activities |
Review Process | Reviewed anytime by a MML HREC sub-committee.* | Reviewed by the MML HREC at the scheduled committee meeting | Reviewed anytime by the HREC Chair | Reviewed anytime by the HREC Chair | |
Requirements | Prior to commencement: HREC Approval and Research Governance authorisation | Prior to commencement: HREC Approval and Research Governance authorisation | Prior to commencement: Confirmation of exemption from the HREC Chair | Prior to publication: Confirmation from HREC Chair and Privacy Office approval. | |
Mater HREC ERM form | HREA | HREA | Mater: Research Exempt from HREC review | Mater Quality Assurance (QA) Projects and Case Reports | |
Mater RGO ERM form | SSA, Biomedical SSA, Waiver SSA | SSA, Biomedical SSA | Waiver SSA | N/A | |
| *All requests for a Waiver of Consent (WoC) will be reviewed by the Mater HREC at the scheduled committee meeting (NS 2.3.10) | |||||
Obtaining HREC approval
The Mater HREC is NHMRC-certified and constituted in accordance with the National Statement on Ethical Conduct in Human Research 2023.
Mater HREC is certified to review and approve studies in the following categories:
- clinical trials of drugs and devices: phase 0, I, II, III, IV
- clinical interventional research other than clinical trials
- qualitative health research
- mental health
- paediatric studies
- population health and/or public health research.
Committee Information
HREC Office Standard Operating Procedures
Waivers of Consent in the last reporting period
Can Mater HREC review my application?
To reduce duplication of HREC review it’s important to choose the correct HREC for your submission; this will largely depend on the sites involved.
Site/s | Can Mater HREC review my application? |
|---|---|
| Mater only | Yes - It is recommended to submit to Mater HREC. |
| Mater + QLD/NSW Public Health Organisations and/or QIMR-B | Yes – Mater HREC can review without any additional HREC indemnity requirements |
| Mater + any Public Health Organisations other than QLD/NSW | Recommended to contact a Queensland Health HREC |
| Mater + private institution/s | Yes – A HREC Indemnity may be required, please contact Mater HREC Office to discuss. |
Please use the HREA application checklist to assist you with your application. | |
Obtaining Research Governance (site) authorisation
Research governance review considers participant safety, site suitability, legal compliance, financial management, accountability, and risk management and ensures compliance with relevant institutional and national standards, and applicable laws.
Site-Specific Assessment (SSA)
Applications to the Mater Research Governance Office are submitted via ERM. If you have applied to Mater HREC for ethical approval, documents already submitted to Mater HREC do not need to be provided with your SSA.
You do not have to wait for ethics approval to submit your SSA form as reviews can be completed in parallel. However, site authorisation cannot be granted until ethics approval is obtained. Please use the SSA checklist to assist with your application.
Research Agreements
Research projects involving parties external to Mater may require a legal agreement. All agreements are processed by Mater Research Agreements. Please contact Mater Research Agreements to discuss requirements early as site authorisation cannot be granted until all agreement requirements are finalised.
Clinical Trials
Mater Priority Trial Reviews
Mater Research offers a fee-for-service express review to expedite site authorisation:
- Initial review within five business days of submission
- Aim to authorise within two to four weeks of submission
View further information about Mater Priority Trial Reviews.
View Mater Priority Trial Reviews submission checklist
View Mater Priority Trial Reviews workflow
Early Phase Clinical Trials Risk Assessment
The early phase clinical trials (EPCT) Risk Assessment is mandatory for Phase 1 clinical drug trials and pre-market pilot or pre-market pivotal clinical device trials conducted at Mater. It is designed to promote quality in research whilst minimising the risk of harm, through development of a risk assessment plan.
Mater Early Phase Clinical Trial Risk Assessment Forms are submitted through ERM. The application can be submitted prior to application for ethical approval and research governance authorisation, site authorisation cannot be granted until the Risk Assessment is endorsed by Mater.
Review timeframes
Mater HREC (HREA)
The review benchmark for NHMRC Certified HRECs is 60 days from receipt of a valid ethics application to approval. This excludes time for researchers responding to questions.
To facilitate a timely review, consideration should be paid to the following:
- completeness of the application
- quality of the application
- time taken to respond to review questions
- completeness of response to review questions (tracked change documents are required)
Mater RGO (SSA)
The review benchmark for Mater Research Governance Office (RGO) is 33 days from SSA submission to authorisation. This excludes time for:
- researchers responding to queries*
- execution of agreements
- HREC review and approval
- other Mater-specific approvals
*Prompt reply will facilitate timely review.
Resources
National Guidelines and Resources
- National Statement on Ethical Conduct in Human Research 2023
- Australian Code for the responsible conduct of research
- Ethical guidelines for research with Aboriginal and Torres Strait Islander Peoples
- ICH Guideline for Good Clinical Practice
- NHMRC Resources
- Guidelines approved under Section 95A of the Privacy Act 1988
- De-identification and the Privacy Act
- Ethical Considerations in Quality Assurance and Evaluation Activities
Mater Resources
Contact us
For further information about conducting human research at Mater please contact:
Mater Human Research Ethics Committee Office
Telephone: 07 3163 1585
Send an email
Mater Research Governance Office
Telephone: 07 3163 3769
Mater Research Agreements
Telephone: 07 3163 8008
Send an email