Starting your project

Before you start developing your project, it is important to understand whether you are conducting human research, undertaking a quality assurance activity (QA) or preparing a case report, as these projects have different review requirements and different ongoing responsibilities.

What is human research?

The National Statement defines research on page six. Human research is when the research “is conducted with or about people, or their data or tissue” (p. 7). This would include active participation (e.g., recruiting participants to undergoing medical testing or to take part in an interview), as well as other human involvement (e.g., observing people; accessing their information, including publicly available information; and using human specimens, such as organs, tissues, and fluids). 

If you are conducting human research, you must not commence any research activity until you have approval from an NHMRC registered HREC. At Mater, the HREC must be certified. 

Mater has two review paths for obtaining HREC approval for your study. The two paths are based on the level of risk of your project, as well as any specific vulnerabilities (as identified in the National Statement):

• Lower Risk

Lower risk human research may have a risk of discomfort to research participants, other people (such as a group or community), or to society, but there is no risk of harm to anyone. These research studies are reviewed by a sub-Committee of the MML HREC. Due to the vulnerabilities of some groups of people and data, the NS requires some research proposals to be reviewed by the full HREC, even if there are no risks of harm. For example, if your proposed study involves using personal information in medical research or personal health information, then the full MML HREC must review the proposal. 

• Higher Risk 

Where there are risks of harm to participants,  other people (such as a group or community), or to society, the research proposal must be reviewed by the full MML HREC. The MML HREC meets once a month. For further information about the timing of these meetings, please refer to the calendar. 

Human Research Exempt from Ethical Review 

There are some specific types of human research that the NS says does not require ethical review. Institutions (eg. Mater) have a responsibility to confirm that only research that meets the requirements is exempted from ethical review. Therefore, Mater employees who are proposing to do human research that they believe is exempt from ethical review, are required to submit their research protocol for consideration by the MML HREC Chair who will determine whether the proposal meets the requirements for an exemption under s5.1.17 of the NS.

What is a quality assurance (QA) project?

Ethical Considerations in Quality Assurance and Evaluation Activities (2014), explains that the primary purpose of a QA project is to understand a service that an individual or organisation provides, or to evaluate, monitor, or improve its quality. In general, these kinds of projects do not require ethical review (eg. by the MML HREC), but sometimes an institution (eg. Mater) may consider it appropriate to conduct an ethical review (eg. if the project may infringe on someone’s privacy or reputation, if it involves control groups, or targeted analysis of a vulnerable group). For a full list of potential ‘triggers’ for ethical review, please see p. 2-3 of the Ethical Considerations in QA and Evaluation Activities guide. 
 
If you wish to publish findings or outcomes from your QA project, you must receive confirmation from the MML HREC Chair prior to publication. Even though you do not need this confirmation to conduct the activity, there may be other institutional requirements, and you should speak to the Mater Privacy Office and the QA department of the relevant department.

What is a case report?

A case report typically involves a detailed description of the symptoms, diagnosis, and treatment of  1-3 patients when there is something unusual or novel about the case. For a Mater employee to publish a case report, they must have approval from the MML HREC Chair. There may also be privacy or departmental requirements – researchers are encouraged to reach out to Mater Privacy Office and/or relevant Head of Department. 

If Mater is the only site
It is recommended that you apply to the Mater Misericordiae Limited Human Research Ethics Committee. 

If Mater is one site of a multi-site study
Mater Misericordiae Ltd is not a signatory on the National Mutual Acceptance (NMA) agreement for single ethical review of multi-centre research. This means, if your study is multi-site, there may be additional HREC approval and/or indemnity requirements. Please contact Mater Research Agreements for advice via 07 3163 8008 or email.

• If your study involves Mater and only Queensland Health and/or QIMR Berghofer, please submit to the Mater Misericordiae Limited Human Research Ethics Committee.
• If your study involves Mater and other external sites, please reach out to Mater Research Agreements to discuss your options. 

Approval from another NHMRC-certified HREC
If you have approval from another NHMRC-certified HREC, the HREC should have advised if they were able to review for the Mater site. If the HREC was unable to review for the Mater site, you will need to submit to the Mater Misericordiae Limited Human Research Ethics Committee before research can commence at Mater. The review may not have been able to be completed due to indemnities or required Catholic-wording in your participant materials. If you have submitted to another HREC via ERM, copy your submission to simplify your application to Mater. 

National Guidelines and Resources

View guidelines and resources:

• National Statement on Ethical Conduct in Human Research
• 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  

The process for preparing and submitting your application depends on the type of project you are doing (human research, exempt human research, or QA or case report). 

For all human research studies being conducted at Mater, you will also require Mater Research Governance site authorisation before you can commence any research activity. Please contact Mater Research Governance with any questions about how to obtain site authorisation.

Human Research

 All human research (excluding those eligible for an exemption) that are being submitted to MML HREC must be submitted on a Human Research Ethics Application (HREA) via the online platform, ERM. (If you have completed your HREA in hrea.gov.au, then this form can be imported into ERM.)

Only the Principle Investigator’s signature is required on the HREA.

All study documents relevant to your project should be uploaded to the HREA.

All studies will require:

• A protocol
• The Principal Investigators (PI) CV.

Some examples of other types of documents your study might require are: 

• Participant Information and Consent Form (Guidelines for drafting a PICF, Mater LNR PICF Template, NHMRC PICF templates)
• Recruitment materials 
• Data collection tools and case report forms.

For further details on the documents required, please refer to the MML HREC Application Checklist for full details.

Lower risk studies: These studies are reviewed by a sub-committee (two members, plus the Chair) of the MML HREC between HREC meetings. The aim is for a decision or feedback within 10-14 days of receipt of a valid application. 

 Higher risk studies and studies requiring full HREC review (eg. studies that involve a request for a waiver of consent): These studies are reviewed at a HREC meeting which occur once a month. View the latest calendar here for upcoming meeting dates, and to determine  closing dates for review submission. The aim is for a decision or feedback to be provided by close of business on the Friday following the meeting. 

 Benchmark timeframes: The length of time from submission of a research application to the researcher receiving a final decision depends on a number of factors including completeness and quality of submission, and time taken by researchers to respond to concerns and requests raised by the committee/sub-committee. 

Exempt Research

If your study meets the criteria for exemption from ethical review, then you must submit a ‘Research Exempt from HREC review’ form in ERM. You are required to justify how your study meets the criteria for an exemption and upload a protocol. The MML HREC Chair will then decide whether your project meets the requirements. You must receive a confirmation letter from the MML HREC Office prior to commencing any research activity. The aim is for a decision within 10-14 days of a valid submission. 

Quality assurance projects and case reports

Quality assurance (QA) projects include service evaluations, clinical audits and quality improvement activities.

QA projects and case reports are submitted for review via ERM on the Mater Quality Assurance Projects and case reports form.

For QA projects you will need to upload:

• Quality assurance project plan
• Evidence of Head of Department support
• Project Lead's CV
• Any other relevant documents (e.g. information sheets, data collection tools, surveys, measurement standards, etc).

For case reports you will need to upload:

• Case report project plan
• Case report consent form
• Evidence of head of department support
• Project lead's CV
• Any other relevant documents 
• Case report consent form - signed and redacted.

On receipt of your confirmation, you are required to contact the Mater Privacy Office prior to commencing your project. The aim is for a decision within 10-14 days of a valid submission.  

Submissions requiring full HREC review

What happens after I submit my application?

Your application will be reviewed in the lead up to the HREC meeting and discussed at the meeting. Minutes are prepared in the days following and a review of your application will be emailed to the CPI and cc’d to the Contact Person by the Friday following the meeting.  If changes are required, an explanation of how to respond will be included in the email.  If no changes are required, an approval letter will be sent.  If the application cannot be approved a letter of rejection will be sent.

Benchmark timeframe

The benchmark for receipt of an ethical decision is 60 days from receipt of a valid ethics application.  The length of time from submission of a research application to the researcher receiving a decision depends on a number of factors including:

• Completeness of the submission.
• Quality of the submission (including the quality of the research protocol, quality of the HREA and other documentation, correct adherence to policies regarding accessing, maintaining and storing data and/or tissue etc.).
• Time taken by researchers to respond to HREC concerns and requests.

Low or negligible risk submissions

Low or negligible risk applications are able to be reviewed between HREC meetings. The MML HREC process for low-risk review includes review by two members of the MML HREC or its advisory committee as well as by the Chairperson with the aim for a decision to be made within 10-14 days from receipt of a valid application.

Waiver of consent

If you are not seeking consent from participants to use their data for a secondary purpose (research), justification for a waiver of consent should be provided as part of your application.  This should refer to the value of the research, the risk and burden to participants in seeking their consent and should be based on the information outlined in Chapter 2.3 of the National Statement (page 21) and Section 95A of the Privacy Act (page 23-24, D.5).

A request for waiver of consent must be considered by the full HREC. Applications that require a waiver of consent will be added to the agenda for the next scheduled HREC meeting.

The Mater Human Research Ethics Committee (HREC) has been certified by the NHMRC as a lead committee under the HoMER initiative. The Committee is constituted in accordance with the National Health and Medical Research Council's National Statement on Ethical Conduct in Human Research 2023.

Mater is certified by the National Health and Medical Research Council (NHMRC) 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 Terms of Reference
HREC Office Standard Operating Procedures
HREC Committee Composition

HREC Meeting Dates

View the 2024 HREC calendar of meeting dates and closing dates for submissions.

Waivers of consent granted for 2022

Download the list of research projects that were granted a waiver of consent in 2022

The 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. 

Completing your Site-Specific Assessment (SSA)

Applications to the Mater Research Governance Office are submitted using Ethics Review Manager (ERM). 

You do not have to wait for ethics approval to submit your site-specific assessment (SSA) form. However, site authorisation cannot be granted until ethics approval is obtained. Please use the SSA checklist to assist with your application. 

Please note: documents submitted to MML HREC do not need to be provided with your SSA. 

Research Agreements 

Research projects involving parties external to Mater require a legal agreement. All agreements must be processed by the Mater Research Agreements Office. Please email the Research Agreements Office to discuss requirements. 

Agreements may be complex so it is best to start the process as soon as possible. The Mater Research Governance Office cannot authorise a project until all agreement requirements are satisfied.

Review timeframe

The review benchmark for the Mater Research Governance Office is 33 days to authorisation.

This excludes:

• researchers responding to questions*  
• execution of agreements
• HREC review and approval
• other Mater-specific approvals

_{*Prompt reply will facilitate timely review.}

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

View schedule of fees for research administration