Melbourne School of Population Health Human Ethics Advisory Group
For research involving humans that is conducted by staff and students within the school, an ethics application must be completed and submitted via THEMIS to the Melbourne School of Population Health Human Ethics Advisory Group (HEAG).
The HEAG's role is to conduct a technical and ethical review of applications (and in some cases, provide approval) before they are submitted to one of the Human Ethics Sub-Committees (HESC).
The HEAG will be looking for; adherence to guidelines, clear aims, feasibility, good design, justification, significance, risks, and benefits.
Applications to HEAG should be written in language that an educated layperson could be expected to understand, avoiding the use of technical jargon wherever possible or explaining it if its use is absolutely necessary.
In most cases, the HEAG makes a recommendation of approval to the HESC (Human Ethic Sub-Committee), but the full proposal is subject to HESC review, and may only be approved by the HESC.
- Application is considered by HEAG. If recomended for approval,
- Application is considered by HESC. If approved,
- Investigators can begin research
Applications that must be submitted to the HESC (after being recommended for approval by the HEAG) include:
- Project application (the most commonly used application for research involving humans)
- Program applications (for use by departments seeking ethical approval for a program of research encompassing multiple research projects)
- Major changes to already approved projects (amendments should be submitted initially to HEAG for endorsement, then forwarded to the relevant HESC for approval)
- Registering projects that have already received external ethics approval (If a project has received ethics approval from another institution, the HREC will register the project at University of Melbourne. These requests should be submitted initially to HEAG for endorsement)
In some cases, the University's HREC (Human Research Ethics Committee, the overarching body beneath which HESCs and HEAGs sit) has granted HEAG delegated authority to approve applications:
- Application is considered by HEAG. If approved,
- Investigators can begin research.
- HEAG will send copy of project to HESC for records.
Applications that can be approved by HEAG include:
- Minimal Risk (Research that is of low risk to participants and researchers may be approved via an minimal risk review process through the HEAG. In these cases HEAG provides final approval. These applications do not need to be submitted to the HREC for approval). 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 for resubmission as a Project Application).
- Minor 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 will not carry the project our of Minimal Risk status).
- Project-within-Program applications (Once a Program Application has been approved by the HESC, the HEAG may then 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 of a particularly high-risk or sensitive nature.