Guide to parallel submission for Research Ethics and Governance applications
Ethics Administration
Research Governance
Step 1
Early consultation (i.e. 4-8 weeks before submission) with both the reviewing HREC and the Research Governance Officer (RGO) is recommended.
Step 2 (a)
Researcher submits project to HREC Coordinator via ERM
- HREA or LNR form
- Study Protocol (mandatory)
- PICF (Participant Information Consent Form) (where required)
- Questionnaire (if to be used)
- Letter of Support
- Researcher CV’s
- Other supporting documentation e.g., surveys, questionnaires, posters (where required)
Step 2 (b)
Researcher generates SSA via ERM
Step 2 (c)
Legal Assessment
Researcher consults with RGO / Contracts Manager to determine whether a legal contract is required, including:
- CTRA (Clinical Trial Research Agreement)
- Research Collaboration Agreement (Metro North template, BDHP)
- Student Placement Deeds
- Facility Access
Step 2 (d)
Study Budget
Researcher consults with Research Business Manager/ Facility Departmental Business Managers to review and sign the research budget:
Step 3
HREC reviews submission and provides feedback to researcher (including Waiver of Consent, if appropriate)
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Step 3 (a)
Researcher responds to HREC feedback and receives HREC final approval
Step 3 (b)
If Waiver of Consent is granted by the HREC, researcher to consult with RGO on whether a Public Health Act (PHA) application is required, then once approved, submits the approval letter to the Research Governance Office
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Step 4
Researcher receives Letter of Authorisation from the Facility’s Authorised Person to be able to commence the study.
Step 5
Researcher commences research and submits Commencement form to HREC Coordinator and the Research Governance Office at each of the sites that the study will be conducted