Human Research Ethics Approval Notification
All human research involving University of Adelaide staff or student researchers must be either approved by the University's Human Research Ethics Committee (HREC) or a HREC approved by the University.
University staff and students must notify the University of human research ethics approvals granted by other institutional HRECs. Notification of these approvals confirms projects have appropriate ethics approvals and staff, students and participants in projects are indemnified.
The human research ethics approval notification form combines the human research ethics approval notification process with applications to the Insurance Office for certificates of insurance. Notifications are made using Research Master.
Single ethical review within South Australia
The University of Adelaide accepts ethics approvals granted to its staff and students by the following five SA Health HRECs, or from another HREC if their ethics approval has been accepted by an SA Health HREC under the National Mutual Acceptance system:
- Royal Adelaide Hospital Ethics Committee
- Human Research Ethics Committee (The Queen Elizabeth Hospital, Lyell McEwin Hospital and Modbury Hospital)
- Women's and Children's Health Network Human Research Ethics Committee
- SA Health Human Research Ethics Committee
- The Southern Adelaide Clinical Human Research Ethics Committee (Flinders Medical Centre, Repatriation Hospital, Noarlunga Health Service, and Southern Mental Health)
In these cases, University researchers are required to notify the University. Additional ethics approval for the project from the University of Adelaide HREC is not required. Within the notification form, researchers will need to attach a PDF copy of the approval certificate.
Ethics approval from other HREC's
Researchers who have obtained human research ethics approval from any other NHMRC registered HREC must submit a notification before the commencement of their research as they may be required to also obtain University HREC approval.
Within the notification form, researchers will need to attach PDF copies of the approved application and approval certificate.
How to submit a notification
Formal notification to the University is required within fourteen days of receiving ethical approval from another HREC.
Creating a notification:
- Log into Research Master
- Under Ethics Applications, select 'Ethics Applications, Amendments and Notifications'
- Click 'create new'
- Click the abbreviation 'HRE Notification'
Completing the notification:
- Complete the pages in order as options on subsequent pages may change based on answers provided on earlier pages.
- At a minimum, all University researchers (staff and students) involved in the approved project should added to the notification form.
- If a project has approval from more than one HREC, details of multiple HREC approvals can be recorded in the one form. Approvals received through the National Mutual Acceptance Scheme or Site Specific Assessments do not need to be provided in the form.
- On the 'Project Overview' page, the research methods appropriate to the project must be selected. View the definitions of research methods for guidance on selecting the relevant research method(s).
After submission of the notification:
- During the review of the notification, further information may be requested by either the Human Research Ethics Secretariat or Legal and Risk Office. Researchers will be notified by email if this is required and instructed to log into Research Master to respond to comments raised.
- When the review of the notification is complete, researchers will receive an email outlining whether the notification has been accepted.
- In the notification form, the Review Outcome page provides information about the review decision, including if the notification has been accepted and if a separate ethics application to the University's HREC is required.
- The Review Outcome page also outlines what insurance certificates will be issued. These certificates will be issued by email.
- The University does not issue an additional approval number for notifications that have been accepted.
Notifications submitted prior to October 2017, will not be visible in Research Master 6. To view notifications submitted prior to this:
- Go to http://rme6-utility.adelaide.edu.au
- Log in using your University of Adelaide a-number and password
- Click "Human Research Ethics Approval Notifications".
Further guidance on how to access and search for these notifications is available in a quick reference guide.
Notifications submitted prior to October 2017 do not need to be re-submitted in Research Master 6 except where an extension and other amendments have been approved. See the section below on reporting requirements for more information.
Reporting requirements & extensions
University of Adelaide researchers with approval from another HREC must notify the HREC Secretariat by email of any changes to their project (further notifications are not required). This includes:
- any adverse events (these will also be reported to the University's Legal and Risk Office);
- any changes to the approval end date;
- new University researchers (staff or students) working on the project;
- changes to the number of participants involved in the project or changes to indemnity status;a project completion date when the project is completed.
Extension of approval
- If the primary approving Human Research Ethics Committee approved an extension of human research ethics approval but no other changes to the project have been made, email firstname.lastname@example.org with the new HREC approval expiry date. A new notification is not required.
- If the extension included approval of changes to the project, a new notification of human ethics approval is required to ensure the University has the correct information regarding the project. To submit the new notification, login to Research Master using your University user name and password; then under Online Forms go to Ethics Applications > Ethics Applications, Amendments and Notifications.
Insurance & indemnification
Notification of ethics approval ensures that staff, students and participants in a study have the appropriate indemnity insurance.
- Failure to notify the University of ethics approvals will result in a denial of compensation to a participant who alleges a bodily injury as a result of participating in the trial or study.
- Failure to notify may also impact the indemnity provided to the staff or student under the Medical Malpractice or Professional Indemnity insurance program.
- Human Research Ethics Approval Notifications are reviewed by the Insurance Office, Legal and Risk. The relevant insurance certificates will be issued by email.
Queries about insurance and indemnification in relation to your research activity or ethics approval should be directed to the University's Insurance Office:
P: +61 8 8313 4539