Amendments & annual reports
Amendment approval process
Requests for Amendment are usually approved or recommended for approval by the Chair of the Melbourne School of Population and Global Health (MSPGH) Human Ethics Advisory Group (HEAG) out of session and don't require review at an MSPGH HEAG meeting. However, the Chair of the HEAG reserves the right to consult other members as appropriate.
Amendments to Minimal Risk and Project-within-Program Applications
Once approved, a formal letter will be sent to the responsible researcher. The Request for Amendment is sent by the MSPGH HEAG administrator to the Human Ethics Sub-Committee (HESC) for noting.
Amendments to Project and Program Applications
The MSPGH HEAG Administrator will notify researchers when HEAG has recommended an amendment for approval. The HEAG administrator will notify the HESC of this recommended approval. Once the HESC review is complete, researchers will be contacted by the HESC regarding the outcome. After approval is recommended by HEAG, enquiries should be directed to the HESC.
This help sheet provides more detailed information on the Themis amendment process:
The National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2007) requires Human Research Ethics Committees to monitor all research projects which have received ethics approval. This is to ensure that work is being undertaken in accordance with the approved protocol and that the rights and interests of those who have consented to take part as participants are protected. As part of the monitoring process, University researchers are to provide an annual report on projects for which they have ethics approval.
Human ethics annual reports are required for all research projects regardless of whether they are completed within the year of approval or whether they continue beyond that year.
Annual reports are now available to be submitted on-line via Themis Research Self Service - access via THEMIS and follow the prompts.
Gaining access to Themis, via a user name and password, will already be familiar to most researchers. If not, you will need to set up a THEMIS account.
For assistance with completing and submitting annual reports via Themis, use the relevant Quick Reference Card:
- All researchers listed on the approved ethics application will be able to access the Annual Report but you cannot access previous Annual Reports (please contact the Research Office via email if you require a copy)
- Save your work at every step
- If an additional researcher needs to be added, contact the Research Office via email, providing the researchers contact information, experience and skills
- If there have been changes made to your research, including these in the annual report may delay approval of the project for the coming year. It is recommended to enter your annual report first, then submit a request for amendment using the process above
- If you need to send the report to several people for their input, there are two ways to do this:
- All researchers listed on the approved ethics application can access the annual report in Themis. You could enter some of the information, save then ask other researchers to log in and enter details, or edit what has been entered; or
- Once you have gained access to your annual report in Themis, there is an option under Project Details (towards the top lend hand of the screen) called Full Report. Clicking on this will give you a PDF of the annual report.
If you have not used THEMIS before you will need to set up an account by going to http://accounts.unimelb.edu.au/ and following the prompts.
If you require any assistance with your amendment or annual report, please contact your Ethics Adviser:
Ethics Adviser and Executive Officer
Melbourne School of Population and Global Health
Email : firstname.lastname@example.org