4. NT HREC standard application process.

1. Choose the appropriate ethics committee

2. Consult with the HREC admin office

• Discuss your project with the HREC admin office either via email or phone to confirm that you are using the correct form and process. (See section below on which form to use.)
• Intention to lodge: Please notify the HREC that you will be submitting an ethics application form. This should be at least two weeks before the submission deadline if submitting to the full HREC. Notification should be in the form of an email stating the name of the Chief Investigator and the title of the project. (See Important dates and deadlines below.)
• Applicants may request a preliminary administrative check before final submission if time permits i.e. at least a week before submission.

3. Important dates and deadlines ​

• The HREC of the NT Dept Health and Menzies will meet ten times per year and submission deadlines for those meetings are listed here. 

• The Low Risk Ethics Clearance Form may be submitted at any time.

• Full applications may be submitted at any time and those deemed to be low risk may be eligible to be Fast Tracked and reviewed out of session by either the Fast Track Sub-Committee or the Chair of the HREC. If not deemed to be low risk they will be transferred to the agenda of the next HREC meeting.

• All other applications should be received by 4.00pm on the submission closing day to guarantee inclusion on the agenda of the next meeting.

4. Which form to use and how to submit it

• WHO: To be used by those undertaking short term low risk clinical audits, case studies, and other internal quality assurance activities using routinely collected data that will be de-identified e.g. audits being undertaken by medical students, and registrars.
• WHEN: The Low Risk Ethics Clearance Form may be submitted at any time and will be reviewed by the Chair of the HREC usually within eight business days.
• HOW: Email one scanned, signed copy to the HREC admin office NTHREC@menzies.edu.au

• WHO: To be used by those undertaking any project, including other low risk projects, which have not qualified to use the other low risk form. This will include projects that are higher than low risk, clinical studies, epidemiological studies, evaluations, interviews, creation of registries, education, child development, and data linkage studies. 
• WHEN: See section above regarding deadlines.
• HOW: Email one scanned, signed copy including all attachments and supporting documents, preferably as one pdf file to the HREC admin office NTHREC@menzies.edu.au 

• WHAT: The Human Research Ethics Application (HREA) is the nationally accepted NHMRC form that replaced the NEAF in January 2017. 
• WHO: To be used by those undertaking multi-site projects where application to HRECs in other states or territories is required, e.g. interstate projects, and those who have already used the HREA elsewhere. 
• Although the HREA will be accepted by this HREC, we prefer the NT HREC Application Form. If approval is being sought only from this HREC or research is only being conducted in the NT including Central Australia, then please do not use the NHMRC HREA.
• NT MANDATORY REQUIREMENT : If submitting the HREA to an NT HREC for research to be carried out in the NT you must select the participant category for Aboriginal and Torres Strait Islander research and complete the relevant section of the HREA, unless you are specifically excluding this group of people. If you might incidentally include this group of people or their data, you should also select this category.  Please address the six core values in your response. If you are specifically excluding Aboriginal and Torres Strait Islander people this must be explained in the recruitment section. You may also opt to use Part D of the DoH-Menzies HREC Application Form to supplement Section 8 of the HREA.
• WHEN: See section above regarding deadlines
• HOW: The HREA can be accessed at www.hrea.gov.au. 
• Email one scanned, signed copy including all attachments and supporting documents (see below for types of supporting docs), preferably as one pdf file to the HREC admin office NTHREC@menzies.edu.au

5. Possible supporting documents 

• CV of chief investigator and student supervisors 
• Protocol 
• Stakeholder support 
• Site specific assessment/support e.g. Royal Darwin Hospital
  (See separate webpage for examples of stakeholder and site specific support and relevant contact information)
• Working with children clearance (Ochre card)
• Clinical trial notification/registration
• Clinical trial liability certificate of currency
• Participant Information sheets/plain language document
• Simplified site specific information sheets for complex multisite trials
• Consent Forms (Please contact Ethics team for details) 
• Clinical Data Collection Forms
• Interview guides
• Surveys
• Questionnaires
• Advertising posters and invitations to participate
• Wallet card for clinical trial participants
• Any other documents that will be used during the research
• Approval letters from other HRECs
• Permits to enter Aboriginal land for the purpose of research 
• Data Linkage: If applicable, projects intending to access linked data via SA NT DataLink require a ‘Letter of Feasibility’, signed by the Director of SA NT DataLink, to be submitted with their ethics application. Please contact: santdatalink@unisa.edu.au to request this letter at least six weeks in advance of the ethics application submission date.

6. Common Problems with ethics applications submitted for review

• Not referring to or adhering to the checklist in the application form
• Missing signatures
• Lack of stakeholder support and inadequate community consultation
• Inadequate explanation about project design or precisely what the researcher intends to do – flowcharts are useful
• Failure to list research sites
• Incorrectly classifying re-identifiable data as non-identifiable
• Use of jargon/technical terms rather than plain English 
• Lack of correct signatures inc. organisational governance
• Yes/No tick boxes on consent forms should only be used for items that are optional for participation
• Inadequately responding to questions related to research that might have an impact upon Indigenous People regardless of whether or not they are being directly targeted as participants
• Information Sheets missing correct contact details for HREC

7. What happens next?

• Upon receipt of the application, a reference number will be issued. This number should be used in all future correspondence relating to that application.
• Your application will be assessed briefly by the HREC Admin office and the HREC Chair to decide which process of review your application is suitable for.
• Low Risk Ethics Clearance/audit forms will be reviewed by the Chair of the HREC or the Fast Track sub-committee and researchers will usually be notified of the outcome within one to two weeks.
• Full HREC Application forms deemed to be low risk will go through the Fast Track process and be reviewed out of session by either the Chair or the Fast Track Sub-Committee. Researchers will usually be notified of the outcome within two to three weeks.
• All other applications will be reviewed by the HREC at its meeting approximately three weeks after the submission deadline and researchers will be notified of the outcome within ten business days following the meeting.
• Projects that have a qualitative component will be reviewed before the HREC meeting by the Qualitative Ethics Sub-Committee who will provide guidance to the HREC.
• Projects that involve Aboriginal and Torres Strait Islander people, either directly or indirectly, will be reviewed before the HREC meeting by the Aboriginal Ethics Sub-Committee who will provide guidance to the HREC.
• Projects will either be given full approval, conditional approval, not approved and resubmit, or not approved and do not resubmit. Requirements of these types of approval will be clearly outlined in the outcome letters.

• Most projects will be granted conditional approval after being reviewed. This means that the reviewers require clarification of certain issues and changes may need to be made to parts of the application or supporting documents. 
• Until these conditions have satisfactorily been responded to, full approval will not be granted and research cannot commence.
• Responses to conditional approval will be accepted at any time and researchers will usually be notified of the outcome within ten business days.
• Research should not commence until full approval has been granted. Research cannot commence with conditional approval.

8. Stakeholder, site support, and permits