Depending on the changes requested, amendments may require draft reviews, updated ethics approval, updated approval from data custodians, and updated approval from research governance bodies.
When applying for an amendment it is important to consider the changes requested and the levels of review required, as this can affect timeframes for processing an amendment.
WA Health Central HREC and the RGO approval
The following amendments require review and approval from the WA Health Central HREC and the RGO, and can usually be made directly through the Research Governance Service (RGS) located within the RGO:
- participant information/consent
- contact details
- project timelines
- project personnel.
Any of the above amendments should first be discussed with the WA Health Central HREC and RGO.
Data custodian, WA Health Central HREC and RGO approval
The following amendments require draft review, data custodian approval, WA Health Central HREC approval, and RGO approval:
- linkage updates
- extraction updates, including data refreshes
- addition of variables
- addition of new datasets
- data location
- repurpose of data for one project in a different project
- amendments to project aims, design or methodology.
Any of the above amendments should first be discussed with the ISPD Client Services team.
Please note that as with all data requests, reviews of data amendments are iterative by nature and requests may take several rounds of review before the specifications or parameters are deemed feasible.