Guide to parallel submission for Research Ethics and Governance applications 2019-02-21T16:59:27+00:00

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

Documents required:

  • 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

Metro North Research Ethics and Governance Offices: visit our Contact Us Page