the national statement on ethical conduct in human research (2023)

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National statement on ethical conduct in human research 2023

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Ethical Responsibilities

The national statement on ethical conduct in human research.

The 2023 National Statement on Ethical Conduct in Human Research takes effect 1 January 2024. Meanwhile, the current National Statement on Ethical Conduct in Human Research (2007, updated 2018) sets out the national standards for ethical design, review and conduct of human research. Compliance with the National Statement is a prerequisite for receipt of National Health and Medical Research Council and Australian Research Council Funding. In addition, the National Statement sets national standards for use by any individual, institution or organisation conducting human research. This includes human research undertaken by governments, industry, private individuals, organisations, or networks of organisations. The National Statement is organised around the values of respect, research merit and integrity, justice, and beneficence.

Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (2018) provides a set of principles to ensure research is safe, respectful, responsible, high quality and of benefit to Aboriginal and Torres Strait Islander people and communities. The Guidelines define six core values — spirit and integrity, cultural continuity, equity, reciprocity, respect, and responsibility. Keeping research on track II describes how the values and principles can be put into practice in research.

The National Mutual Acceptance (NMA) Scheme

Since 1 May 2020, researchers have been able to apply for ethical review of linked data studies through a number of specialist NMA Human Research Ethics Committees (HRECs). The National Mutual Acceptance (NMA) Data Linkage Guide sets out the application process, the specialist NMA data linkage HRECs, and the jurisdictions and/or specific cultural or populations being studied which are excluded from the NMA. The NMA Data Linkage Guide and other relevant documents available to download can be found here .

NHMRC maintains a list of all registered Human Research Ethics Committees in Australia

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Welcome to the Human Research Ethics Application (HREA)

Hrea has been updated to reflect the revise d national statement on ethical conduct in human research (2023) ..

Submissions of applications for ethics review from public hospital Human Research Ethics Committees may need to be made using ERM , REGIS or Research GEMS (external links). For further information, please see NHMRC's website .

For FAQs , a How-to Guide and technical assistance on the HREA system, please consult the HREA resources page .

Ethics resources, national statement on the ethical conduct in human research (2023), australian code for the responsible conduct of research (2018).

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The National Statement on Ethical Conduct of Human Research 2023

The National Statement on Ethical Conduct of Human Research 2023 (National Statement) was released during 2023 and now applies to all human research and related activities at James Cook University as of 1 January 2024. The new edition of the National Statement has revised Chapter 2.1 Risks and Benefits and Section 5 - Governance that will result in changes to:

New HREC Chair Appointed 2024

We would like to welcome to the role of Chair of the JCU HREC, Professor Anthony Leicht . Professor Leicht has significant research experience as a researcher in Sports and Exercise Science and is a previous long-term member and Deputy-Chair of the JCU HREC.

Are you interested in becoming a member of the JCU Human Research Ethics Committee

If you think you'd be interested in becoming a member of the JCU HREC or want to know more about our committee members do?

Email [email protected] or call 07 4781 6543 for more information

What is human research?

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 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 or published or unpublished source or database.

The James Cook University Human Research Ethics Committee (HREC) reviews all research and teaching applications in accordance with the National Statement on Ethical Conduct in Human Research (2023) .

HREC Application Process

Hrec application review, hrec application guide, what research and other activities involving humans require ethical review.

The James Cook University Human Research Ethics Committee (HREC) reviews all research and teaching applications in accordance with the National Statement on Ethical Conduct in Human Research (2023)

What activities require ethical review? All human research projects conducted at the University (both in JCU-Australia and JCU-Singapore), or by staff and students of the University, must undergo ethical review. The JCU HREC will accept applications from all JCU staff and students, and adjunct staff but only where the research is being conducted under JCU’s auspices.

The National Statement on Ethical Conduct in Human Research defines human research as ‘ research that is conducted with or about people, their data or tissue’ , and may involve human participation in:

Surveys, interviews or focus groups.
Comparing or investigating psychological, physiological or medical research.
Clinical trials.
Observation by researchers.
Researchers having access to oral histories, personal documents or other materials.
The collection and use of body organs, tissues or fluids (eg skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens, etc.) or their exhaled breath.
Access to their information (identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database.

Undergraduate Student Projects: Undergraduate students conducting small research projects involving human participants as part of their course assessment will need to ethical review for these projects. However, in some cases it may be possible for the lecturer in charge of the subject to submit a single ethics application for the course to cover these smaller projects. Please contact the ethics team to confirm requirements for your proposed projects.

Teaching activities: Teaching activities that involve physiological or psychosocial experiments, taking of tissue or blood samples, administration of any substances, any stressful activities, recording of any personal information and administration of surveys require ethics approval to be obtained.

Exempt Research: The National Statement allows certain human research to be exempted from ethical review, under certain circumstances.

If you plan to carry out human research using only existing data or records and non-identifiable data, please email the ethics team with a short description of your planned research and we can make the assessment about an exemption and also provide you with a Letter of Exemption from the HREC for your records and future reference.

Quality assurance activities: Quality assurance activities do not require ethical review, however they must be carried out according to ethical principles. For information on ethics in quality assurance activities read the NHMRC’s Ethical considerations in quality assurance and evaluation activities , and researchers are encouraged to read Section 2(e) Triggers for consideration of ethical review when deciding whether they need to request ethical review. If you feel that your research is a Quality Assurance activity, please send an email to the ethics team for an assessment and letter of confirmation.

If your research involves Aboriginal and Torres Strait Islander peoples, please click here .

Unsure whether your research needs ethical review? If you plan to conduct research involving human participants, their data or information but are unsure whether your research needs ethical review, please check with the Ethics Office before beginning your work, as retrospective approvals cannot be provided.

Complaints, Concerns and Feedback

If you have any concerns, or wish to lodge a complaint about a human research project carried out by JCU, see the complaints processes below.

How to prepare and submit an application

Researchers intending to apply for ethical clearance for their research should:

Familiarise themselves with the National Statement and related guiding documents
Read the HREC's Application Guide
Undertake Training in Human Research Ethics

Human Ethics Advisors are academic employees of James Cook University who review ethics applications for teaching and research involving human participants in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research, 2007 . The Advisors are nominated for appointment by the Dean of College and review ethics applications in broad discipline areas and provide advice to academic staff and students on ethics matters.

The Advisor’s role is to offer advice on a draft of your application in relation to the National Statement and assist you to understand what is required before your application is submitted to the Human Research Ethics Committee (HREC) for review. The Advisor provides a recommendation to the HREC on the application. Advisors also review amendments to ethics applications for approval by the HREC.

Click here for the full list of Human Ethics Advisors at JCU.

External HREC Approvals Acknowledgement

If you are working on or conducting a human research project that has been approved by another Human Research Ethics Committee, you don't have to also submit an application to the JCU HREC but you do have to notify the Ethics Office. We can then acknowledge the external HREC's approval.

Please complete the Cover Sheet for External HREC Approvals document below and submit it with:

The completed Cover Sheet for External HREC Approvals (DOCX, 230 KB)
A copy of the ethics application that was approved including Participant Information Sheet and Consent Form, and any supporting documents (except CVs)
A copy of any comments from the external HREC and the response to the comments (if applicable)
A copy of the approval notice issued by the external HREC

Submit all the documents to [email protected] and your external HREC approval can be acknowledged by the Human Ethics Officer.

If you are doing human research in an Education Queensland facility/school, please refer to the information provided in the link below:

Research in Education Queensland Schools

Forms and Downloads

HREC Documents

Human Research Ethics Application Form (DOCX, 163 KB)
JCU Human Research Ethics Application Guide (PDF, 720 KB)
JCU Information Sheet (DOCX, 230 KB)
JCU Informed Consent Form (DOCX, 231 KB)
Amendment Form (DOCX, 112 KB)
Report Form Human Research Ethics (DOCX, 114 KB)
Human Research Ethics Adverse Event Form
Cover Sheet for External HREC Approvals (DOCX, 230 KB)

Ethics Advisor Review Report

Human Ethics Advisor Review Form (DOCX, 16 KB)

JCU HREC Terms of Reference

Meeting Dates and Deadlines

Click here for the meeting and closing dates for Human Ethics Applications for 2024.

Any ethics application received after the closing date to Human Ethics Advisors will be held over to the next meeting of the Human Research Ethics Committee (HREC). Meetings are held on the middle Tuesday of each month. There is no January HREC meeting.

HREC decisions will be released seven to ten working days after the meeting date. Most applications will receive a conditional approval at the meeting, but the HREC may request further details or amendments from applicants or a resubmission of an application to the next meeting. In planning your research project, please allow a maximum of two months for passage of your application from submission to approval.

Low/Negligible risk ethics applications can be submitted at any time as they are reviewed on a continual basis.

Complaints and Adverse Events

To lodge a complaint or raise a concern about the ethical conduct of a research project please contact:

Human Ethics Officer

Research and Innovation Services

James Cook University

Townsville, Qld, 4811

Email: [email protected]

Ph: (07) 4781 5011

Complaints and Concerns:

If you receive a complaint about the conduct of a project (from any source, internal or external), the Human Ethics Officer or Human Ethics Advisor must immediately be advised. If the Human Ethics Officer or Human Ethics Advisor receives a complaint about any project, the researcher will be contacted. The HREC will follow up and investigate all complaints and take corrective action where necessary.

Complaints or Enquiries about your HREC Application or Review Outcome:

If an applicant is concerned by the way a human ethics application was processed or by a decision of the HREC, in the first instance, please contact the Human Ethics Officer or the Human Ethics Advisor of the project. If concerns remain unresolved after discussing the issue with the Human Ethics Officer or Human Ethics Advisor, the matter may be referred to the Chair, HREC for advice and action.

Adverse Events:

The HREC must be promptly notified of any unexpected adverse or serious events that may impact participant welfare or the conduct of the project. The Human Ethics Officer or Human Ethics Advisor of the study should be contacted to report such incidences and a Adverse Event Report Form completed and submitted..

Contact the Research and Innovation Services Human Ethics Team

You can contact the Ethics Team by emailing [email protected]

Or by calling the Human Ethics Officer on +61 7 4781 6575

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