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 the following steps:
- Download and complete a project modification request from the Human Ethics Templates and Forms webpage.
- Provide a detailed description within project modification request form of the changes to be made to the approved human research project and list the documents that have been revised as a result.
- Reflect the modifications in the corresponding sections of the project description.
- 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 to be submitted via email to firstname.lastname@example.org by the submission closing date. For further information please contact the Human Ethics Office.
- The submission email is to include the HC reference number, and indication that the submission is a modification and the approving HREAP or HREC in the subject of the email.
- The Chief Investigator should submit the modification request with all other investigators copied in on the submission email. If this is not possible a listed investigator, study coordinator or research assistant may submit a modification on behalf of the Chief Investigator. If this occurs the Chief Investigator and all other investigators are to be copied in on the submission email. If a student is to make a modification submission, they must provide an email or letter of support from their supervisor confirming they have reviewed and approved of the proposed changes.
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|