A modification request is to be submitted to the approving HREC or HREAP if revisions are made to an approved Human Research Project. The following are examples of revisions that would require a modification submission:
- Revisions made to the procedures outlined in the approved project description or clinical trial protocol.
- Changes to the recruitment process.
- Revisions to the inclusion/exclusion criteria.
- Revisions to the consent process
- Modifications made to the recruitment materials or participant information statement and consent form.
- Addition of new recruitment materials or the way in which the research will be advertised.
- Addition or removal of participant groups, study sites, recruitment locations.
- Changes to the personnel listed in the ethics application form.
To prepare a modification submission for review researchers are required to complete this via iRECS.
Please ensure that the amendment includes the following (as applicable):
- Reflect the modifications in the corresponding sections of the project description (for legacy projects).
- Provide tracked versions of any amended documents demonstrating the revisions made, followed by a clean version of each document. Add version numbers or dates to each document. Add version numbers or dates to each document.
- Provide any new documentation or supporting information relevant to the modification submission.
Modifications are reviewed weekly by an executive of the approving Human Research Advisory Panel or Human Research Ethics Committee.
|Committee or Panel Name||Submission Closing Deadline||Meeting Date|
|HREC A||5pm, Tuesday||Thursday|
|HREC B||5pm, Tuesday||Thursday|
|Negligible Risk - HREAP Executive||5pm, Tuesday||Following Tuesday|
|HREAP A||No set deadline||As required|
|HREAP B||5pm, Tuesday||Following Tuesday|
|HREAP C||No set deadline||As required|
|HREAP D||5pm, Tuesday||Following Tuesday|
|HREAP E||5pm, Thursday||Following Tuesday|
|HREAP F||No set deadline||As required|
|HREAP G||5pm, Tuesday||Following Tuesday|
|HREAP H||5pm, Tuesday||Following Tuesday|
Amendments beyond the scope of a standard modification review may require consideration by the full HREAP or HREC. In these instances, they will be tabled for review at the next available meeting (see Closing dates).
Amendment requests are considered to be a significant modification for:
- Extension requests for a period of more than 12 months.
- Significant changes to the aims and objectives of the study or the study design that were not considered by the full HREAP/HREC.
- Additions of methodologies, participant cohorts or amendments to the recruitment or consent strategies that present risks to the participants, the research team, or the wider community that were not previously considered by the HREAP/HREC.
- Additions of new treatments or changes to the safety profile of any investigational medical devices/products.