Approval processes

What can the Melbourne School of Population and Global Health (MSPGH) Human Ethics Advisory Group (HEAG) approve and what must be approved by the University of Melbourne Human Ethics Sub-Committee (HESC)?

For Project and Program applications, the HEAG will make a recommendation of approval to the HESC, but the full proposal is subject to HESC review, and may only be approved by the HESC.

Approval process for applications that must be considered by HESC

Application is considered by HEAG. If recommended for approval,

Application is considered by HESC. If approved,

Investigators can begin research.

However, the HEAG can approve the following applications:

Minimal Risk: Research that is of low risk to participants and researchers may be approved via a Minimal Risk review process through the HEAG. In these cases, HEAG provides final approval. These applications do not need to be submitted to the HESC for approval. Please note that as part of the review process, HEAG is required to discuss whether a study is unquestionably Minimal Risk, and HEAG is required to reject ineligible applications and request resubmission as a Project Application.

Changes to applications already approved by the HEAG: HEAG can approve minor changes to projects, if the amendment is associated with a project previously approved via Minimal Risk review or as a Project-within-Program and the amendment adds no additional risk to participants or researchers

Project-within-Program applications: Once a Program Application has been approved by the HESC, the HEAG may approve projects that fit within the Program Application. HEAG reserves the right to consult with HESC as required if presented with Project-within-Program applications that contain material that is high-risk or sensitive in nature.

Types of applications reviewed by HESC after HEAG review:

Project Applications: the most commonly used application for research involving humans

Program Applications: for use by researchers seeking ethical approval for a program of research encompassing multiple research projects

Changes to already approved projects

Registering projects that have already received external ethics approval: If a project has received ethics approval from another institution, the HESC will register the project at the University of Melbourne.