Ethics

Application pack for the Human Research Ethics Committee

To apply for ethics clearance, for renewal of ethics clearance or to submit a final report to the Human Research Ethics Committee, please download or read the following guidelines, complete the form and submit your completed application, including relevant attachments and signatures, the Ethics Administration Officer, Office of Research & Innovation. Applications and reports must be submitted two weeks before the next meeting of the HREC.

Essential reading
Applications for ethics clearance
Renewals and final reports
Variations

To get an idea of how long the ethics clearance process will take, please see time frame for clearance.

See also special notes for projects involving Menzies School of Health Research/DCHS and for projects involving DEET.

Essential reading

NHMRC National Statement on Ethical Conduct in Human Research - 2007 (This is the revised National Statement, issued 18 April 2007)
Joint NHMRC/AVCC Australian Code for the Responsible Conduct of Research (.pdf) (issued 29 August 2007)
NHMRC Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research - 2003 (.pdf)
NHMRC
The Commonwealth Privacy Act - 1988
- NHMRC Guidelines Under Section 95 of the Privacy Act 1988
- NHMRC Guidelines Under Section 95A of the Privacy Act 1988
Australian Institute of Aboriginal and Torres Strait Islander Studies Guidelines for Ethical Research in Indigenous Studies (.pdf)
The Northern Territory Information Act - 2002
Charles Darwin University Human Ethics Guidelines (.pdf) (under review)
CDU HREC Guidelines (.pdf) (under review)

Note: You will need Adobe Acrobat Reader to view pdf files. Get Adobe Acrobat reader.

Applications for new proposals

Staff research and postgraduate degree research

Ethics applications for Staff research and postgraduate research degree research need to go directly to the CDU HREC.

The new on-line National Ethics Application Form (NEAF) has replaced the former CDU Human Research Ethics Committee (HREC) application form. It is now compulsory to use the NEAF to submit applications for HREC clearance
Access the application form
Please note that initially to access the form you will need to "Create New User" and anyone you wish to view your application, for example supervisors, will also need to set up an account. A link to create a new user is near the top left hand side of the page when you enter the NEAF website. Please contact the Executive Officer if you require assistance: cdu-ethics@cdu.edu.au.
Some pointers for using NEAF - Keep an eye on this link as more helpful hints are added (includes links to the slide handouts from the NEAF Training Session held on Thursday, 8 March 2007)
Attachments - Don't forget - you will need to provide original hardcopy signature pages and any other required attachments:
- plain language statement(s)/information sheet(s)
- consent form(s)
- Letters of support - provide a letter from each organisation involved in the project which confirms that they know about the project and are happy to be involved with it
CDU HREC Application Checklist (.pdf).

Undergraduate and postgraduate coursework degree ethics application

NB: Undergraduate and Postgraduate coursework degree ethics applications need to go through the Faculty Ethics Committees. Please check with your Faculty Committee about which form you will need to submit
Proforma: Application for Ethics Clearance for Research Components within Units (.pdf).

Consent forms and plain language statements

Notes on Plain Language Statements/Information Sheets (.pdf) [Draft]
Examples of Consent Form (.pdf) and Information Sheet/Plain Language Statement (.pdf) - Please note that these are examples only
They are .pdf documents and are not intended as on-line forms. Every project has different requirements, and you will need to create your own consent forms and information sheets for each project
Please note the standard wording for contact re concerns about the project is as follows: If, during the course of the project, you have any concerns about the project or the researcher, you may contact the Ethics Administration Officer of the Charles Darwin University Human Research Ethics Committee, who is not connected with this project and who can pass on your concerns to appropriate officers within the University. The Ethics Administration Officer can be contacted on 1800 466 215 or by email: cdu-ethics@cdu.edu.au. This should be included on the information sheet after the contact details for the researcher.

Renewals and final reports

Ethical clearance is granted for a period of one year. Researchers whose projects extend beyond the period of approval should submit a progress report in 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 is required on completion of the project. 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 addressed. See Section 8 of the CDU HREC Guidelines.

Notes/checklist

Don't forget to provide your project reference number on the form
Mark clearly whether this is a renewal application or a final report for the project
Please submit a hard copy of the form with original signatures of the researcher and the supervisor
In the case of staff research, the supervisor is the researcher's Head of School/Dean/Director.

Applications for Annual Renewal of Clearance and Final Reports need to be submitted on this form: Final report/renewal.

Variations

There is no pro forma for advising the HREC of variations to projects. Details of significant variations or modifications need to be advised in writing (email is sufficient) to the Ethics Administration Officer for approval by the Committee. See Section 8 of the CDU HREC Guidelines.

Notes

Projects involving Menzies School of Health Research and/or NT Department of Health and Community Services (DCHS)

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

b) Where such applications also involve CDU staff and/or facilities, when clearance is given by the HREC of the NT DHCS/MSHR, the applicant needs to submit a copy of the clearance notice along with a copy of their approved application and any attachments to the CDU HREC.

Projects involving Department of Employment, Education and Training (DEET)

If part or all of your research will be conducted within the Department of Employment, Education and Training (DEET), including within schools, you must have prior approval from DEET. It is advised that researcher apply to the HREC and DEET at approximately the same time to avoid unnecessary delays in their research. For more information regarding Applications to Conduct Research within DEET, please go to the DEET website.

Time frame for clearance

Applications will normally take a minimum of four weeks from the 'applications due' date to be approved and for the project to receive ethics clearance and may take up to two meetings, depending on whether further information or clarification is required by the committee. Meetings are approximately 7 weeks apart which means that from the time you submit to the time you receive clearance could be up to 11 weeks.

It is recommended then, that researchers and research students start the ethics process as soon as possible prior to their expected research commencement date to avoid delays and that they plan the ethics process into their research timelines. Research students may need to start the ethics process very soon after commencing their candidature.

You can increase your chances of gaining approval after just one meeting by having your application checked by your supervisor or a mentor/ colleague with experience in the ethics clearance process.

Common reasons for delay include:

Failing to fill in Section 4.9 (Research involving Aboriginal and Torres Strait Islander peoples) when the project requires it.
Failing to include letters of consent/ permission from relevant organisations or communities.
Failing to include clearance from NT DEET for research within that dept, (e.g. within schools).
Failing to obtain the neccesary signatures.

For more details on the ethics clearance process please contact the Ethics Administration Officer.