Human ethics applications

All CDU researchers (employees, honorary appointees or visitors) and research students must obtain approval through the CDU-HREC for research involving human subjects or their data, once the methodology of the research project, the oversight of its conduct, and the requirements of any third parties are fully understood. The ethics proposal must explain how the research will be conducted ethically and with minimal risks to participants.

The University is committed to minimising risk to participants, researchers, third parties and the institution itself whilst ensuring review processes are efficient, constructive and proportional to the sensitivities and risks associated with individual projects.

Human research ethics review processes are undertaken through either the Executive Review pathway or the Committee Review pathway depending on the nature of the project and its intended participants.

For more information regarding these two pathways, refer to the Submission of new proposals.

Review exemptions

Some research projects that utilise existing, publicly available non-identifiable data and which are of negligible risk may be eligible for exemption as per Chapter 5.1 of the National Statement. A letter of Exemption can also be sought from the CDU-HREC where required.

Reciprocal applications

CDU is committed to recognising approvals by other properly registered ethics committees by means of reciprocal approvals.

Projects which already have ethical clearance approval from another HREC but which involve CDU staff or students as investigators must seek reciprocal approval from the CDU-HREC.

Please complete the reciprocal application form and attached all relevant supporting documentation

Further information regarding this executive review process is available under the Frequently Asked Questions.

First Nations research

Research that relates to First Nation peoples of Australia should be informed by First Nations research ethics principles outlined in AIATSIS Code of Ethics for Aboriginal and Torres Strait Islander Research and the National Health and Medical Research Council (NHMRC) Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (2018). All Indigenous research requires full HREC review.

Executive review

Projects that pose only a negligible risk, i.e., no more than an inconvenience, and that do not involve any procedures or participants that require full CDU-HREC approval may be eligible for consideration under the Executive Review Pathway.

Under the Executive Review Pathway, projects are reviewed by the Chair of the CDU-HREC, rather than the full CDU-HREC.

Such proposals can be submitted at any time independent of the advertised submission deadlines, using the same form and process indicated below.

Committee review

Projects posing a greater than negligible risk or that involve research categories requiring full HREC review as specified in the National Statement will be reviewed by the full CDU-HREC.

Submission deadlines and meeting dates are listed under the meeting dates tab. Late submissions will be forwarded to the next scheduled CDU-HREC review.

The same ethics proposal form is used for both the Executive and Committee review pathways.

CDU-HREC Application Form

To submit a proposal for ethical review by the CDU-HREC, please complete the online application form.

Read all questions carefully and ensure that your answers are concise, explaining your project methods clearly and simply, identifying and addressing any potential ethical issues associated with the project.

Instructions for using the CDU-HREC online application form

• All relevant answers must be completed.
• Depending on your response to a given answer, additional information may be required.
• You will be unable to continue until the required answers have been completed. Progress on this form can be saved and completed at a later stage.
• When selecting 'save and continue later', a link will be generated which can be emailed to you. This will allow you to return to complete the form. This will also allow you to share the form with others to complete certain parts of the form.
• Please review the checklist at the end of this form carefully, to ensure the application is complete. This will assist with a more timely review.
• Ensure that all supporting documentation is attached to the online application. There is an option to attach documents at the end of this form.
• Workflows: Workflows have been enabled with this form to facilitate authorisations and signatures as follows:

1. Section16: Authorising Declaration: Please add the Project Title and email address of the Authorising Officer (College Dean or duly appointed agent). Complete the form and attach documents. Complete the remainder of the form and click 'submit'. This will be sent to the email address provided in Section 16 for the Authorising Officer to complete and sign.
2. Once the Authorising Officer has signed, they must click 'submit'. This will create the next workflow.
3. The final workflow will be sent to the Principal Investigator to complete the application checklist and submit the completed application. Once the Principal Investigator clicks submit after all the above workflows are complete, the application will automatically be sent to ethics@cdu.edu.au in PDF format, along with all relevant attachments. A copy of the application will also be emailed to the PI listed on the application form.

If you have any difficulties with the form, please contact the ethics team. For the declarations and authorisation please ensure that all workflows are sent to the correct delegates.

Required attachments:

Please submit electronically all required attachments with the submission of the proposal, the can be used to ensure the completeness of your application. A sample of the CDU-HREC Application form and Guide to Completing the Online Application form can be found here under "Guides/Resources".

Research that relates to First Nations peoples of Australia should be informed by First Nations research ethics principles outlined in AIATSIS guidelines Code of Ethics for Aboriginal and Torres Strait Islander Research (2020) and the National Health and Medical Research Council (NHMRC) Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (2018). All research, including secondary data, that could have a potential impact on First Nations People research requires full HREC review.

In accordance with the national guidelines, the CDU-HREC requires the establishment of an agreement between researchers and relevant Peoples and communities for all First Nations research, prior to seeking ethical clearance.

To support CDU researchers in establishing a draft agreement with First Nations Peoples and communities, the CDU-HREC has provided a template agreement  (DOCX, 249.07 KB)that may be adapted to the context of individual projects.

The CDU-HREC have recently commenced developing guidelines for the consistent review and support of First Nations Research applications. We recommend reviewing the document (below) which provides further information regarding the following:

• Definition of First Nations Research
• Submission requirements
• Review criteria
• Doing an Aboriginal and Torres Strait Islander Research Agreement (ATSIRA) well
• Exceptions when ATIRA may not be needed
• Applications that are not First Nations research but may entail issues of significance for First Nations peoples.

If you have any further questions or concerns, please refer to our Frequently Asked Questions (PDF, 695.32 KB).

Contact us

Research Ethics & Integrity team

E: ethics@cdu.edu.au 
T: 08 8946 6063.

As established in the CDU-HREC Terms of Reference, the CDU-HREC meets a minimum of six times a year to review and discuss proposal submissions.

For a submission to be considered at a CDU-HREC meeting it must be received by the ethics office by the corresponding submission date. Only complete submissions received by the applicable deadline will be considered at the upcoming meeting. Incomplete or late submissions may be deferred to the following meeting.

Please note: Projects posing no more than negligible ethical risk may be eligible for Executive Review. Such applications can be submitted any time outside the CDU-HREC submission dates. If the Executive Review process determines the proposal is greater than negligible risk, the proposal will be reviewed at the next available CDU-HREC meeting.

For more information about Executive Review and risk assessment please see Submissions of new proposals and our FAQ sections.

CDU-HREC 2024 meeting dates:

CDU-HREC Membership

Expressions of Interest 

CDU-HREC are now accepting Expressions of Interest for the following categories to join our committee: 

The National Statement sets out the minimum membership specifications of a HREC and the CDU-HREC Terms of Reference provide further information.

Human Research Ethics training workshops

The Office of Research and Innovation provides Research Enhancement Program workshops throughout the year for researchers and students including introductory and targeted human research ethics and integrity workshops.

If you would like to request a specific or tailored workshop or training with the ethics team, please complete the ORI Workshop/Training Request Form and a member of the team will contact you to discuss your request.

Please also see the Research and Innovation Calendar for upcoming events and key dates.

**COMING SOON!! In the second half of 2024, ethics and integrity training modules will be available through Learnline.

Free online human ethics training modules designed for researchers and members of human research ethics committees are available at:

• http://mq.edu.au/ethics_training/
• http://www.uow.edu.au/research/rso/ethics/human/training/

There are a number of resources and further information under Essential reading.

Program ethics approval is available to cover multiple investigations that utilise similar research designs/methods and that pose the same level of risk. These investigations can be covered by a single application submitted to the CDU-HREC.

Certain CDU undergraduate and postgraduate coursework (UG/PG Coursework) projects may constitute human research that require HREC oversight as established by the National Statement.

To ensure that the requirement to seek ethics approval does not delay the commencement of undergraduate and postgraduate coursework projects, unit conveners or other relevant staff can obtain program ethics approval/s for the unit. This provides prior omnibus approval/s for the projects conducted in the unit. Each specific student project is then managed as a variation to the program approval.

The PDF document below explains how coursework units or courses involving research training at CDU can take advantage of proportionate review through Program Ethics Approvals (PDF, 419.28 KB).

For the purpose of facilitating research ethics training, unit co-ordinators and other teaching staff may utilise a Coursework Program Ethics Template (DOCX, 63.2 KB) for students to complete.

An Information Sheet for Participants (ISP) and Informed Consent Form is required for most research projects. These documents are a vital part of your proposal that facilitate ethically sound informed, voluntary consent.

Guidelines and templates are provided to assist you with the development of your information sheet and informed consent form.

• Guide to the Information Sheet & Informed Consent Form for Research Participants (PDF, 182.89 KB)
• CDU-HREC Information Sheet for Participants (ISP) Template (DOCX, 493.67 KB)
• CDU-HREC Informed Consent Form Template (DOCX, 487 KB)

Proposals submitted without a ISP or Informed Consent Form where required, will not be accepted for review.

The ISP should be written in terms suitable for the intended audience, should include contact details of the researcher(s), the ethics team as well as any appropriate local, organisational or supervisory contacts.

As far as possible, institutional email/phone contacts should be used for any correspondence associated with the project and ISP and consent forms should have appropriate institutional branding. 

For more information regarding CDU branding of documents, please follow the CDU Brand Identity Guidelines.

The standard wording to be included on the Information Sheet for Participants  (usually at the end of the document) for contact regarding concerns about the project is as follows:

"If you have any questions or concerns that you do not want to direct to the researcher, you are invited to contact the Research Integrity and Ethics team on (08) 89466063, on the toll-free number, 1800 466 215 or by email, ethics@cdu.edu.au.

The Research Integrity and Ethics team can pass on any concerns to the CDU-HREC or other appropriate officers within the University."

Department of Education

If part or all of your research will be conducted within the Department of Education (DoE), including within schools, you must seek approval from the DoE.

For more information regarding the research approval process for research or evaluation to be conducted in NT government schools, please go to the DoE website or contact the Research and Evaluation Team at the NT Department of Education.

E: ResearchApps.DET@nt.gov.au 
T: (08) 8999 5829

For information regarding children in research, you can refer to the National Statement on Ethical Conduct in Human Research (2007) - Updated 2018 or the website for the international Ethical Research Involving Children (ERIC) project.

Multicentre research

Proposals requiring approval from other institutions should establish which HREC is the most appropriate and seek approval from that HREC first.

To apply for CDU approval for a protocol with prior approval by another NHMRC registered HREC you should complete the relevant parts of the CDU-HREC Application Form (PDF, 4.7 MB), provide the name of the approving HREC and submit the form along with a full copy of previously approved proposal along with all associated documentation and correspondence and a copy of the approval clearance notice from that HREC.

For projects involving the NT Department of Health or Menzies School of Health Research, see appropriate information below.

Other approvals

It is the Principal Investigator (P.I.)’s responsibility to ensure that any required permits, visas, student confirmation of candidature, institutional and safety approvals have been obtained prior to the commencement of the research project.

Clearance granted by the CDU-HREC constitutes research ethics approval only, in accordance with the National Statement.

Applications for Annual Reports and Final Reports need to be submitted to ethics@cdu.edu.au ahead of the anniversary of the ethics clearance date for the project.

Annual Reports are a mandatory requirement of all HREC approved projects, as set out by the NHMRC guidelines.

The Principal Investigator is required to submit a satisfactory annual report to the Ethics Office ahead of the anniversary of the approval date. Continuing approval is contingent on submission of a satisfactory annual progress report.

The annual report should give an overview of the work undertaken so far, including any ethical issues that arose, and whether and/or how they have been resolved.

Proposals requiring an extension of ethics approval should submit a renewal request either in the annual report or as a standalone request within sufficient time to obtain renewed clearance prior to the expiry date.

Researchers are required to maintain current clearance for their projects until they are completed.

A final report should be submitted on completion of all foreseeable aspects of a research study. This is normally following the completion of participant involvement, data analysis, principal manuscript preparation and stakeholder feedback.

The final report consists of a completed form with a summary of all major activities, results and outputs.

For staff, submission for publication of final results and for students, submission of the thesis, is generally accepted as the point of completion.

Renewal of clearance is based on the provision of a satisfactory progress report and confirmation that all ethical issues have been adequately addressed.

Reports are processed via Executive Review and should be submitted outside of the CDU-HREC meeting submission dates.

There is no pro forma for advising the HREC of variations to projects. Details of variations or modifications from the original approved proposal and the rationale behind the request(s) need to be advised in writing (email is sufficient) to the CDU-HREC.

The request should include the project number and title the name of the P.I and any student investigators who are part of the project.

For changes in regards to project personnel, the names, contact details, qualifications and reasons for joining or leaving must be provided regarding all personnel. It is the responsibility of the P.I to ensure that all members of the team are adequately informed regarding the standard conditions of approval set out in the originally approved proposal.

The National Statement on Ethical Conduct in Human Research requires registered HRECs to regularly monitor all approved projects. To help ensure compliance the University has the following checkpoints in place.

• Annual Progress Reports: Reports are due on the anniversary of the approval date of your project. For example, if the project was approved on 8 January, the annual report is due by 8 January each year until the completion of the project. Annual reports are made through the online form.
• Final reports: On completion of the project the principal investigator is required to submit a final report. Final reports are made through the online form.
• Random audits: The ethics committee may undertake audits of the Projects it has approved as a mechanism for monitoring research. The audit confirms that the project is being conducted in accordance with its approval.

• Serious Adverse Events (SAE)/ suspected unexpected serious adverse reactions (SUSARs) are required to be submitted to the reviewing Ethics Committee within 72 hours of the event occurring. Serious Adverse Events should be submitted in writing to ethics@cdu.edu.au. A serious adverse event includes, but not limited to the following:

  - substantial deviations from a research protocol or project description

  - adverse effects of unexpected type, severity or frequency are encountered

  - unexpected effect on research participants (such as safety, unexpected risk)

  If you are unsure if an event or occurrence on the research project constitutes an SAE/SUSAR, please contact the ethics team to discuss on 08 8946 6063 or ethics@cdu.edu.au.

• Complaints: It is recommended that research participants discuss any concerns that may arise from their participation in the research with the researchers themselves. Please refer to the Research Ethics Policy for more information. However, if they wish to talk to an officer of the University who is not connected with the project, they can contact the Human Ethics Coordinator or the Director of Research and Innovation.

Where the CDU-HREC has reason to believe that continuance of a research project will compromise participants’ welfare or if the conditions of ethics approval for the project (including reporting requirements) are not being adhered to, the committee or HREC Chair will immediately seek to establish whether ethics approval and/or authorisation for the project should be suspended or withdrawn. 

Section 5.4.15 of the National Statement outlines that it may be unethical for a researcher to continue the research if: 

(a) there are or have been substantial deviations from a trial protocol or project description; 

(b) adverse effects of unexpected type, severity, or frequency are encountered; or 

(c) as the research progresses, its continuation would disadvantage some of the participants as determined by the researchers or others monitoring the research.

Where ethics approval for a research project is withdrawn: 

(a) the researcher, the Faculty DVC and, where possible, the participants should be informed of the withdrawal. 

(b) the researcher must promptly halt the research, make arrangements to meet the needs of participants and notify the CDU-HREC that these steps have been taken; and 

(c) continuation of the research project is subject to re-application and re-approval by the CDU-HREC.

Where a project involves the NT Department of Health or Menzies School of Health Research staff, facilities and/or data, the applicant should submit their application to the NT Department of Health and Menzies School of Health Research HREC for approval in the first instance, go to Menzies ethics.

Where such applications also involve CDU staff, students and/or facilities, the applicant needs apply for CDU reciprocal approval by submitting:

• a copy of the clearance notice (once granted by the NT Department of Health and Menzies School of Health Research HREC)
• a copy of their approved application
• any attachments to the CDU-HREC, as per the reciprocal application process.

Please review current policy, legislation and guideline.

If you have any queries, please refer to our Frequently Asked Questions (PDF, 399.36 KB)

If you are unable to find the answers to any queries, please contact the Ethics team of the Charles Darwin University Human Research Ethics Committee:

E: ethics@cdu.edu.au
T: (08) 8946 6063
T: 1800 466 215 (toll free)