Human Research Ethics Committee

The NHMRC's National Statement on Ethical Conduct in Human Research 2023 defines human research as that "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:

• Clinical trials
• 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 (eg 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(in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database."

Research involving humans at QIMR Berghofer is assessed and approved by the QIMR Berghofer Human Research Ethics Committee (QIMR Berghofer-HREC) to ensure maintenance of ethical standards and compliance with regulatory guidelines. The QIMR Berghofer-HREC is committed to the ethical conduct of research involving humans by following the National Statement on Ethical Conduct in Human Research 2023.

Current HREC membership covers all categories of representation identified as relevant in the NHMRC National Statement on Ethical Conduct in Human Research, 2023.

QIMR Berghofer’s HREC meets about 10 times per year and has ultimate responsibility for the approval of all human research undertaken at the Institute. The HREC is guided in its deliberations by the Human scientific sub-committee and the Clinical Trials Protocol Committee. The Clinical Trial Protocol Committee reviews and provides advice to the HREC about clinical trials, and the Human Scientific Sub-Committee reviews non clinical trials and provides advice to the HREC.

The QIMR Berghofer HREC operates in reference to the following:

• NHMRC National Statement on Ethics Conduct in Human Research, 2023 incorporating subsequent updates
• Australian Privacy Principles (APPs)
• Australian Code for the Responsible Conduct of Research
• Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (August 2018)
• NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods, November 2016

QIMR Berghofer is currently certified by the NHMRC under the National Approach to Single Ethical Review for the categories below. The aim of this certification is to promote consistent review, and reduce duplication of ethics reviews, across jurisdictions.

• Clinical trials Phase I, II, III and IV
• Clinical interventional research other than clinical trials
• Population health and/or public health
• Qualitative research
• Mental health
• Other health and medical research: Laboratory research using human tissue samples.

Research participants, members of the public or researchers may inquire, express concerns or make a formal complaint(s) about research project(s), conduct of research or HREC review process or decisions. Matters are addressed promptly and sensitively as guided by Chapter 5.7 in the National Statement on Ethical Conduct in Human Research, 2023, incorporating all updates.

The QIMR Berghofer HREC may receive complaint(s) related to:

• a process or processes
• a decision or decisions
• the nature or content of an approved research study
• researcher’s conduct
• how the study is being conducted
• other research related concerns.

Complaint(s) may be initiated by:

• research participants, their relatives, or other concerned parties
• researchers, including researchers involved in the approved or other studies
• institutions, organisations or other individuals with a direct or indirect interest in research approved by the QIMR Berghofer HREC.

The HREC Secretariat receives complaints and where possible, seeks to address complaint(s) swiftly in consultation with the HREC Chair, and will undertake further investigation as required.

Contact details for complaints:

HREC secretariat

T +61 7 33620117

E hrec.secretariat@qimrb.edu.au

M Locked Bag 2000, Royal Brisbane Hospital, Qld 4029