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.