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Human Research Ethics

Overview

To conduct research at Mater Health Services (MHS) it is a requirement that you obtain approval from an NHMRC certified Human Research Ethics Committee (HREC).

The MHS HREC has been certified by the NHMRC as a lead committee under the HoMER initiative. Researchers requiring information about single ethical review for multi-centre research should refer to the central coordinating service and MOU for single ethical review of clinical trials (NSW Health, QLD Health, VIC Department of Health and SA Health) for further information and access the MOU Checklist for Coordinating Pricipal Investigators to submit with HREC applications.

Multi-centre research is reseach that is conducted at more than one site or conducted by researchers who are affiliated with more than one institution (university and hospital) or student research (university and hospital). Student research includes, undergraduate, postgraduate and PhD research for the purpose of a higher degree.

At the conclusion of its deliberations the Committee recommends ethical approval / or not, dependant upon scientific validity and ethical viability.

Researchers are required to complete a site-specific assessment for research governance purposes to gain authorisation to commence the research. 

The Committee is constituted in accordance with the National Health and Medical Research Council's National Statement on Ethical Conduct in Human Research (NHMRC, 2007).

HREC Terms of Reference

Standard Operating Procedures

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.

 

Resources, forms and documents

Resources, forms and documents regarding HREC.

Mater HREC Application Requirements

 

Mater HREC Guidelines

Managing your approved project 

Managing your approved project

Researchers have ongoing obligations throughout the duration of their project. This includes notifying HREC if a project does not commence or is discontinued.

Minimum obligations

Researchers are obligated to provide the following information to Mater HREC:

  • Annual progress report due on the anniversary of your approval date must be submitted to the Mater HREC and any relevant Governance Office
  • Amendments to the project when any of the following occur:
    • new investigators are appointed
    • changes are being made to the study including the approved documentation

Ongoing obligations

Researchers are required to notify Mater HREC of any changes or amendments to the study.

Researchers are also required to provide Mater HREC and any relevant Governance Office with an annual progress report due on the anniversary of your approval date.

Link to resources:

 

New to the ethics review process 

New to the ethics review process

In this section you will find more detailed information about the Human Research Ethics Review process at Mater.

If you require more information, or if the information provided on this page does not fully answer your questions, please contact the Mater Research Ethics Office.

About human research ethics at Mater

Mater promotes high standards in the responsible conduct of research. Principally, the national statement on ethical conduct in human research outlines the requirements as recommended by the National Health and Medical Research Council (NHMRC) of Australia.

Other relevant codes include the Australian Code for the Responsible Conduct of Research (NHMRC), the Code of Ethical Standards for Catholic Health and Aged Care Services in Australia and Values and Ethics - Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research (NHMRC).

Why is human research ethics review important? 

There are several reasons why human research ethics are important.

First, adhering to good principles in research promote the aims of research, such as contributing to generalisable knowledge. Secondly, research ethics promote the values that are essential to ensure researchers protect the wellbeing of participants, cooperate and collaborate with their peers, associates and other stakeholders.

This promotes trust, mutual respect, justice and fairness. And importantly, research ethics provides a framework to ensure accountability of researchers to the community (Resnik, 2011, www.niehs.nih.gov/research/resources/bioethics/whatis)

The protection of the rights and interests of subjects of research has been recognised in:

  • The Nuremberg Code (1949), (developed following the revelation of unethical research practices during the Second World War)
  • The World Medical Assembly’s Declaration of Helsinki (first printed 1965; last revised 2008).
  • In Australia a Statement on Human Experimentation has been developed based on the Declaration of Helsinki.

For more information, please refer to the National Statement on Ethical Conduct in Human Research (2007) for the conduct of ethical research in Australia.

Other relevant codes include:

When is ethics approval needed? 

The National Statement on Ethical Conduct in Human Research (2007) defines human research as follows:

“Human research is conducted with or about people, or their data or tissue. Human participation in research is therefore to be understood broadly, to include the involvement of human beings through:

  • taking part in surveys, interviews or focus groups
  • undergoing psychological, physiological or medical testing or treatment
  • being observed by researchers
  • researchers having access to their personal documents or other materials
  • the collection and use of their body organs, tissues or fluids (e.g. skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath
  • access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.”

It is important to note that this includes research that the participants themselves are not aware of. An understanding of the levels of risk defined by the National Statement will help you to assess if your proposal requires ethical approval.

About research protocols 

For information about writing a research protocol, please contact the research development officer, Shana Chancellor. schallenor@mmri.mater.org.au

Assessing the level of risk 

Categories of risk

The National Statement (2007) categorises potential risks to research participants as follows:

  1. Harms such as pain (including physical, psychological, social, economic and legal harms, and the devaluation of personal worth)
  2. Discomforts (such as the measurement of blood pressure or anxiety induced by an interview). If discomfort becomes distress, then it is considered to be harm.
  3. Inconveniences (such as filling in a form).

Please review the section on harms, discomforts and inconveniences in the National Statement to assess the potential risks of your research proposal.

The ethical review of research takes into account the varying level of risk to which participants are exposed:

  1. Negligible risk: research in which there is no foreseeable risk of harm or discomfort and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk (NS2.1.7).
  2. Low risk: research in which the only foreseeable risk is one of discomfort. Research in which the risk for participants is more serious than discomfort is not low risk (NS 2.1.6).

HREC exempt research

The National Statement allows research to be exempted from ethical review if it is both:

  1. Negligible risk research
  2. Involves existing collections of non-identifiable data (NS 5.1.22 b).

Your project may also be outside the scope of Mater HREC if it does not involve human participation in research. Please remember that human research is broadly defined to include, for example, researchers having access to existing patient records.

Research involving more than low risk

All research involving more than low risk must be reviewed by HREC.

Please note that if your proposal requests a waiver of consent for the use of personal information in medical research, or personal health information, then you must also submit it to HREC

Deciding whether your research is low risk

Assess your level of risk by answering questions outlined on our website. If you answer yes to any of the questions, then your research is likely to be more than low risk and should not be submitted as a low risk application.

Preparing your research submission 

Step 1

Prepare your research protocol, including a precise and succinct literature review. Read more about what should be included in a research protocol.

Step 2

Read the relevant sections of the National Statement on Ethical Conduct in Human Research. Include information about:

  1. how you will justify your study
  2. the potential burdens, risks and benefits to participants and the community that you have identified
  3. how you will collect, store and analyse any data in your research protocol.

Step 3

Decide which Human Research Ethics Committee you would like to submit your ethics application to. Find out their requirements by going to their website or by contacting their Research Ethics Office. Each HREC has different requirements including the number of hardcopies required, and the submission and meeting dates. Read more about Mater’s HREC requirements.

Step 4

Assess the level of risk of your study and prepare the relevant documents.

The Mater HREC and Research Governance (REGU) Review Process 

Click to enlargeHuman Research Ethics Committee members and Scientific Advisory Committee members are unpaid and volunteer a significant amount of time each month to ensure the research processes at Mater function effectively and efficiently.

Respectfully, it is the responsibility of each researcher to ensure that this valuable contribution is used appropriately. The Research Ethics and Governance review processes are regulatory in nature and separate from clinical research support activities. They do not replace peer review.

Approval time

The length of time from submission of a research application to the researcher receiving a decision depends on a number of factors including:

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

Submission timeframes

  1. Submission times for full ethics review start from the HREC closing date (Day 0). Complete applications not requiring changes are approved within 21 days.
  2. Low to Negligible Risk Submissions can be received at any stage and generally applications not requiring changes are approved within 14 days;
  3. It is each researcher's responsibility to ensure their submission is complete as incomplete submissions are not tabled for the HREC.

If you require more information about support for researchers, please email Mater Research Ethics.

Closing dates

The closing dates for research submissions are listed on our website.

Experienced with ethics submission but new to Mater HREC review 

Mater HREC application requirements

Mater HREC review processes has been certified by the NHMRC.

Review of Research Proposals

In general all proposals that do not qualify for a waiver of approval, expedited review, or a review under exceptional circumstances (as per below at section 4.5) must be submitted to the MHS HREC for approval as per the MHS HREC Standard Operating Procedures. Where a deficiency is identified by the MHS HREC or additional information is required, the MHS HREC may authorise the committee Chairperson or another delegate to approve the proposal executively when the committee Chairperson or delegate is satisfied that the deficiency has been addressed or the additional information has been provided.

Waiver of Approval, Expedited and Exceptional Review of Review of Research Proposals between MHS HREC Meetings

In general all research studies must be submitted to the MHS HREC for approval, however, study protocols may be eligible for approval between MHS HREC meetings if they fall within five categories:

There are five other categories of review:

1. Waiver of Mater HREC review

In recognition of the Memorandum of Understanding between several State jurisdictions and Mater Health Services, the Mater HREC acknowledges the previous ethics review of studies that have been granted approval by the HRECs of other NHMRC certified Institutions where approval has been granted after December 2nd 2011. These studies are granted a 'waiver from Mater HREC review'.

*Projects that fall into this category do not need to be reviewed by Mater HREC and may proceed straight to Governance.

You do not need to submit for ethics review at Mater.

2. Expedited review in recognition of prior ethics approval

In recognition of the NHMRC guidelines (National Statement Chapter 5.3) on minimising duplication of ethics review processes, research studies approved by a Human Research Ethics Committee whose institutional processes relating to multi-centre single ethical review have been certified under the national certification scheme, and where the approval is still current, will receive an expedited review.

3. Expedited review

Under qualifying circumstances, a request for an expedited review may be made through the Mater HREC Coordinator to the Chairperson or Deputy Chairperson.

Submissions that may qualify for an expedited review include:

  • Very minor amendments to approved studies where there is no added risk, burden or inconvenience to research participants. Examples of this may include adding an Associate Investigator;
  • Extensions of approval on studies that have fulfilled the ongoing monitoring requirements of the Mater HREC, and where the extension is justified.

4. Exceptional circumstances

Under qualifying circumstances a submission for a review under exceptional circumstances can be made through the Mater HREC Coordinator to the Chairperson or Deputy Chairperson. Submissions that may qualify for a review under exceptional circumstances include:

  • Studies requiring an urgent review on the basis of maintaining, improving, sustaining or ensuring patient wellbeing and safety
  • Studies requiring an urgent review to identify, reduce, expose or eliminate a real or potential risk or burden to participant safety or wellbeing
  • Where it is necessary to eliminate an immediate hazard to the research participants.

Low risk and negligible risk review

Mater HREC has established a process for research projects eligible for low risk review. These applications will be reviewed by two members of Mater HREC or its advisory committee, and Mater HREC's Chairperson will aim to make a decision on the project in 10-14 days from submission of a valid application.

Experienced in submitting projects for Mater HREC review 

Experienced in submitting projects for Mater HREC review

You are required to comply with the conditions of the Mater HREC approval as outlined in the approval letter.

Minimum obligations

  • Annual progress report due on the anniversary of your approval date must be submitted to the Mater HREC and any relevant governance office/s
    • new investigators are appointed
    • changes are being made to the study including the approved documentation.

Ongoing obligations

Researchers are required to notify the Mater HREC of any changes or amendments to the study.

Researchers are also required to provide the Mater HREC and any relevant governance office/s with an annual progress peport due on the anniversary of your approval date

Link to resources