Human research ethics

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. More information regarding these two pathways can be found below under the submission of new proposals tab.

Review exemptions

Some research projects that utilise existing, 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. Further information regarding this Executive Review process is available under the FAQ section.

Indigenous research

Research that relates to Indigenous peoples of Australia should be informed by Indigenous research ethics principles outlined in AIATSIS guidelines (GERAIS 2012) 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

CDU-HREC Application Form

To submit a proposal for ethical review by the CDU-HREC, download the electronic form below.

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.

Submit an electronic version of the form to ethics@cdu.edu.au with all required attachments.

DO NOT electronically sign the document, modify the PDF or convert to a word document.

Instructions for downloading and using the CDU-HREC application form:

• Always download the latest version of the form from the CDU ethics webpage when submitting a new application.

• Download the form and ‘save as’ before filling out the form.

• Fill out the form using Adobe acrobat or reader as the form is not optimised for use with Apple preview or other PDF editing applications.

• Use the latest version of Adobe acrobat or reader to fill out the form as Some older computer systems and versions of Adobe Reader program can cause issues with saving, emailing and editing the form

If you have any difficulties with the form please contact the ethics team. For the declarations and authorisation pages, print and scan the two signed pages and attach to the submission email or type the relevant names and copy in signees to the submission email

Required attachments- please submit electronically all required attachments with the submission of the proposal, the CDU-HREC Application Checklist (DOC 40.5KB) can be used to ensure the completeness of your application.

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

To support CDU researchers in establishing a draft agreement with Aboriginal and Torres Islander Peoples and communities, the CDU-HREC has provided a template agreement that may be adapted to the context of individual projects.

If you have any questions or concerns, please refer to our Frequently Asked Questions or contact the Research Ethics & Integrity team via email: ethics@cdu.edu.au or phone: 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.

Please note that 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. For more information about Executive Review and risk assessment please see Submissions of new proposals and the Frequently Asked Questions sections.

CDU-HREC Membership

• Professor Marilynne Kirshbaum (Chair) - Category A
• Dr Bea Staley (Co-Deputy Chair) - Category F
• Dr Sue Smith (Co-Deputy Chair) - Category F
• Professor Reuben Bolt (Indigenous Leadership)
• Dr Kim Robertson (Indigenous Leadership)
• Ms Louise Gillett (Category B)
• Mr Rick Wallace (Category B)
• Mr Neil Ludvigsen (Category B)
• Ms Kathie Blair (Category C)
• Dr Shirley Grace (Category C)
• Dr Catherine Gittins (Category C)
• Ms Jenny Bradshaw (Category D)
• Mr Tony Jenner (Category D)
• Dr David Pohlmann (Category D)
• Ms Shelley Eder (Category E)
• Mr Alex Bowen (Category E)
• Dr Muhammad Saleem (Category F)

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 including human research ethics and integrity workshops.

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 on below, under Essential Reading and also under the Research Integrity and Ethics Resources Page.

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 430KB).

For the purpose of facilitating research ethics training, unit co-ordinators and other teaching staff may utilise a Coursework Program Ethics Template 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. Below guidelines and templates are provided to assist you with the development of your information sheet and informed consent form:

Proposals submitted without a ISP or 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 the 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 2.45MB), 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 tab 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 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.

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 submiting 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; and any attachments to the CDU-HREC, as per the reciprocal application process.

It is important to familiarise yourself with the following documents that you will need to refer to when completing your proposal.

National Health and Medical Research Council (NHMRC)

• NHMRC National Statement on Ethical Conduct in Human Research - 2007 (Updated 2018)
• Joint NHMRC/AVCC Australian Code for the Responsible Conduct of Research (issued 14 June 2018)
• NHMRC Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (issued August 2018)

Confidentiality, Privacy and Information Act

• The Northern Territory Information Act - 2002
• The Privacy Act - 1988
• NHMRC Guidelines Under Section 95 of the Privacy Act 1988
• NHMRC Guidelines Under Section 95A of the Privacy Act 1988

Indigenous Research

• Australian Institute of Aboriginal and Torres Strait Islander Studies Guidelines for Ethical Research in Indigenous Studies
• The Lowitja Institute - Research Ethics Hub

Please contact the CDU Research Integrity and Ethics team if you require assistance: ethics@cdu.edu.au.

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If you have any queries, please refer to our Frequently Asked Questions.

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:

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