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.
- Modifications are to be submitted via iRECS by 5pm on a Tuesday weekly. Submission instructions are provided below.
Legacy Modification Instructions
- Send an email to humanethics@unsw.edu.au and request that the project is unlocked for modification. Ensure that you include your HC reference number.
-
Login to iRECS.
-
Navigate to your work area.
-
In the search bar enter the project reference number or HC reference number.
-
Select the project once located.
-
Navigate to the new application/modification request section.
-
Select the “Legacy Modification” option.
-
Detail any modifications in the legacy modification section.
-
You need to reflect any revisions in your previously approved project description of if relevant the recruitment materials, participant information statement, consent form or data collection tools. You need to upload tracked and clean versions of the documents.
-
Select the completeness check and complete any additional information required.
-
submit the form.
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.