Your research ethics application will be considered and assessed by the Aboriginal Ethics Sub Committee one week prior to the Human Research Ethics Committee.

Upon receipt of a research ethics application, an email acknowledging receipt of the application by this office and notification of the research ethics application file reference number will be sent to the principal investigator of the research ethics application.

Please use this file reference number in all future correspondence with the Ethics Office. You will be notified of the Human Research Ethics Committee’s decision within 10 working days from the Human Research Ethics Committee’s meeting date.

You are required to lodge the following hardcopy documents to this office:

  • One signed, single-sided and paper-clipped original research application plus all associated documents attached as one document
  • Clinical trials: please provide clinical trial protocol, clinical trial notification and certificate of insurance liability
  • One electronic copy of the research ethics application plus associated documents forwarded to ethics administration. Please ensure that the attachments to the research ethics application is scanned and emailed through as one document only, not an email with multiple attachments.
Research involving Australian Defence members:

Researchers conducting research that involves Australian Defence members are required to obtain ethics approval through the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research as well as through the Australian Defence Human Research Ethics Committee prior to the commencement of any research activity.

Contact details for the Australian Defence Human Research Ethics Committee are:

Australian Defence Human Research Ethics Committee
Department of Defence
CP2-7-101
PO Box 7911
Canberra BC ACT 2610

Other possible supporting documentation that may be required:
  • From 1 March 2011, a Working With Children Clearance Notice is required for all who are working with or who will potentially be in contact with children in the Northern Territory (NT) in accordance to section 187 of the NT Care and Protection of Children Act. Research undertaken in other states or territories will have a similar requirement
  • Participant information sheets, next of kin/guardian information sheets, consent forms, guardian consent forms, assent forms
  • Letters of support from communities, government departments or agencies involved in the research study
  • Letter of support from the director, Department of Health Remote Health Services. Click here to download application.
  • Letters of support from Aboriginal health boards/corporations
  • Interview guides
  • Surveys or questionnaires
  • Letters of approval from ethics committees in other jurisdictions
  • Approval to access Department of Health data, data sets or medical records. Click here to download form.

Important:
Please note the following prior to submission of research ethics application:

  • The closing time of submissions is at 4:00pm (GMT +9:30 Darwin). Unfortunately, research ethics applications received after this time will not be accepted
  • Research ethics applications will not be accepted without complete signatures
  • Please refer to the construction guide for participant information sheet to ensure that it is correct.
Intention to lodge a research ethics application:

Researchers are required to email the ethics administrator four (4) weeks prior to close off day of your intent to lodge an application for ethics review. The email notification will ensure the investigator's research ethics application is logged as an agenda item for the following Ethics Committee meeting.

Research ethics applications lodged on close off day without prior notification will be listed for the next Ethics Committee meeting at the next deadline in two months' time.

The Human Research Ethics Committee (HREC) of the Northern Territory Department of Health and Menzies School of Health Research does not grant retrospective ethics approval. Commencement dates and timelines outlined in the research ethics application need to be correct prior to submission. (“A judgement that a human research proposal meets the requirements of this National Statement and is ethically acceptable must be made before research can begin and before full funding for the proposal is released" - page 8 of the National Statement on Ethical Conduct in Human Research).

Please allow sufficient time to complete a research ethics application.

Meeting dates of the Human Research Ethics Committee.

Plain Language:

Section 5.2.6 of the National Statement on Ethical Conduct in Human Research
A research ethics application should be completed in terminology readily understood by an informed layperson. The project, as described in the application, should be complete with no additional documentation required other than requested by the committee and listed in the checklist at the front of the application form.

Acronyms:
The first time an acronym is used in the application, the words must be written out in full, with the acronym placed in parentheses immediately after.

Permits to undertake research and enter remote communities:

Please ensure that Northern Land Council (NLC) research permits and approvals to enter lands and remote communities has been sought and attached with the research ethics application.

Part D Aboriginal and Torres Strait Islander health research:

Section 4.7 of the National Statement on Ethical Conduct in Human Research
Please ensure that Part D is completed. If it is not completed, the application will not be accepted.

Submission:

Please note that the submission closing dates are final.

The following documents must be received by the submission closing date by COB 4.00pm for an application to be considered at the Ethics Committee meetings:

  • One original signed, single-sided and paper-clipped research application plus all associated documents attached and stapled as a single document. (Clinical trials or complex research programs: please include a detailed scientific protocol, investigator’s brochure, insurance details, participant information sheet and participant consent form in addition to the above)
  • One electronic copy of the research ethics application plus associated documents forwarded to ethics administration. (Please ensure that the attachments to the research ethics application are scanned and emailed through as a single document only, not as an email with multiple attachments)

Please ensure that the original hardcopy application with original signatures is forwarded before the submission closing date to the:

Ethics administrator officer, Human Research Ethics Committee (HREC) of the Northern Territory Department of Health and Menzies School of Health Research
PO Box 41096
Casuarina NT 0811.

Items to note:
  • Hand written applications will not be accepted
  • Ensure that the track changes function is disabled. If it is functioning all text entered will be underlined. To disable, double click on the track changes icon on the tool bar.

If the principal investigator is not contactable on his or her normal phone number (as listed in the application) when the ethics committees convene, please supply additional details on how he or she may be contacted during the meeting times as listed above.

Please ensure that all attachments to the application are collated. It is the responsibility of the researcher to ensure that the application is complete, with all relevant documentation attached and this includes obtaining the signatures of the principal investigator, co-investigators and the sponsor/department head prior to submission. To assist, use the checklist provided by the HREC.

Applicants should have read, and be familiar with, the following documentation and ensure that the application is consistent with:

  • Australian Government Australian Code for the Responsible Conduct of Research, 2007
  • NHMRC National Statement on Ethical Conduct in Human Research, 2007
  • NHMRC Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research, 2003
  • The Commonwealth Privacy Act 1988. NHMRC has issued Guidelines Under Sections 95 and 95A of the Privacy Act 1988
  • The Northern Territory Information Act.
Interstate courier:

It is recommended that researchers submitting research ethics applications from another state or territory should post the original research ethics application the week before the deadline to enable the package to arrive on time.

Applications that arrive late will be reviewed at the next Ethics Committee meeting in two months time.

Northern Territory Department of Health:

All research studies conducted at the Royal Darwin Hospital (RDH) require a letter of support and signing off from the Executive Director of Medical Services Top End Health Services. Please contact the RDH medical clinical governance assistant on (08) 8922 6170.

Should you have any queries regarding the Human Research Ethics Committee, or its application form, please contact the Human Research Ethics Committee ethics administration at Menzies School of Health Research via email, phone: (08) 8946 8687  or fax: (08) 8946 8464.