Researchers, including students, who wish to undertake research involving human subjects, must obtain approval from the relevant committee before commencing the studies.
All non-clinical applications are to be submitted to the Human Research Ethics Committee (the Committee) or the Low Risk Panel with the following exceptions. If non-clinical research will involve (a) any sites under the control of SA Health; or (b) participants or data accessed through a site controlled by SA Health an application will need to be submitted to one of the SA Health Human Research Ethics Committees (HRECs) listed on the SA Health Human Research Ethics Committee List web page.
All clinical research applications are to be submitted to the Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC), or other SA Health HREC where relevant. While Flinders University does not have oversight over the SAC HREC, located at Flinders Medical Centre, an agreement exists whereby SAC HREC ethics approval is automatically accepted by the University.
Note - Researchers planning to undertake non-clinical or clinical research involving an interstate Public Health Organisation (PHO) should obtain advice from the PHO regarding requirements that need to be met in that jurisdiction.
Further information about the scope and nature of the Committee can be found in the SBREC terms of reference.
New ethics applications can be submitted via ResearchNow Ethics and Biosafety.
Approvals will be generally accepted from all HRECs registered with the National Health and Medical Research Council (NHMRC), as listed on their website.
Ethical approvals from overseas ethical review bodies may be accepted where the Flinders researcher is able to demonstrate that the ethical framework and policy used to approve the intended research in the reviewing country satisfies the ethical principles outlined in the National Statement on Ethical Conduct in Human Research 2007 (Updated 2018).
It is a requirement that modifications/amendments approved by the original approving HREC that involve (a) an extension of time; and/or (b) changes to participants to be recruited (i.e., change in participant population) should be notified to the Committee before the new participant pool are recruited. These modifications do not need to be reviewed by the Committee.
You must not commence with the modification until all approvals have been granted.
Final reports must be submitted to the original approving HREC, and a copy of the final report is to be uploaded to the HREC Cross-Institutional Approval Form in ResearchNow Ethics & Biosafety. Please request the Ethics Officer to unlock the form so you can upload the final report.
If the Committee decides it has not received adequate information to make a decision, an application may be considered as Not Approved – Resubmit. The applicants will be provided with comments from the Committee and a request to amend and resubmit the application for consideration at the next meeting.
If the Committee decides that further information is required before full approval can be given, an application may be considered as Approval Pending – Minor Changes or Approval Pending – Major Changes. To address the Committee’s comments, please
Your response will be reviewed out of session.
It is the responsibility of the researcher to ensure that all necessary reporting requirements associated with their ethics approval are met. Failure to meet the reporting requirements of the Committee may result in withdrawal of ethics approval, suspension of projects and other disciplinary action.
Over the duration of a project, circumstances may change, and it may become necessary to modify your ethics approval. In the event that there are changes to a project which has previously been approved by the Committee or the Low Risk Panel, a Modification Request Form must be submitted. Modification forms can be accessed by logging into ResearchNow Ethics & Biosafety through your Okta dashboard. After receipt of this form, the Human Ethics Officer will unlock the project application form so that it can be modified.
Applications for modifications are reviewed by a rolling review process and can be submitted at any time (i.e. not subject to closing dates).
Following final ethics approval, researchers needing to recruit participants can have their approved recruitment advertisement listed on the University's participate in research studies webpage.
All recruitment methods must be approved by the reviewing HREC.
The use of personal websites and social media pages for recruitment is not allowed by the Committee.
However, researchers can establish professional websites and social media pages for recruitment. A researcher should note on these pages that they are a Flinders University researcher, and state that they have approval for the study from, e.g., the 'Flinders University Human Research Ethics Committee'. Researchers can set up these pages without requiring permission from the University, as long as a human research ethics committee has approved this recruitment approach for the particular study.
In compliance with the National Statement on Ethical Conduct in Human Research 2007 (Updated 2018), researchers are required to submit an annual report of progress.
Annual reports are due on the anniversary of the date on which the project received ethics approval. If an annual report of progress is not received by this time, ethics approval can be withdrawn, and the researcher will receive notification that the project must be suspended if this is the case. The project may then only resume following the submission and approval of a new application to the Committee. The Annual/Final Report Form can be accessed by logging into ResearchNow Ethics & Biosafety through your Okta dashboard.
Researchers are required to submit a final report to the Committee following completion of the project or at the expiry of the human ethics approval, depending on which event occurs first. The Annual Report Form can be accessed by logging into ResearchNow Ethics & Biosafety through your Okta dashboard.
An unexpected adverse event is an event that was not foreshadowed in the application approved by the Committee. Unexpected adverse events may affect the continued ethical acceptability of the project and must be reported within 24 hours of the event. The Unexpected Adverse Events Report Form can be accessed by logging into ResearchNow Ethics & Biosafety through your Okta dashboard.
Complaints can be lodged by anyone about any Flinders University research ethics projects. Complaints can be forwarded to the RDS Ethics Officers, the Chair of the Committee, or to any other contacts that may be listed in the Participant information sheet.
If your project was approved under the old Ethics approval system and it will not expire on or before 31 December 2020, you will need to transfer your existing approved application to the new system. During this process you will also be able to modify your approved application as required.
Please contact the Ethics office via email human.researchethics@flinders.edu.au if you need to modify a previously approved SBREC project that will be completed before 31 December 2020 and, therefore, does not need to be transferred to the new system.
Researchers, including students, who wish to undertake research involving human subjects must obtain approval from the relevant committee before commencing the studies.
All clinical research applications are to be submitted to the Southern Adelaide Clinical HREC (SAC HREC). Flinders University is not responsible for clinical human research.
The following templates should be used in the preparation of your application to the Human Research Ethics Committee.
Templates
One-on-one meetings are regularly scheduled so that any Flinders’ researcher can directly access bespoke advice and support from an RDS team member.
For more information and to book a meeting, visit RDS Connect - one-on-one meetings with Research Development and Support.
Meeting number
|
Closing date 5:00pm Monday |
Meeting date 1:00pm - 5:00pm |
01/22 | Monday 24 January | Monday 7 February |
02/22 | Monday 21 February | Monday 7 March |
03/22 | Monday 21 March | Monday 4 April |
04/22 | Monday 18 April | Monday 2 May |
05/22 | Monday 23 May | Monday 6 June |
06/22 | Monday 20 June | Monday 4 July |
07/22 | Monday 25 July | Monday 8 August |
08/22 | Monday 22 August | Monday 5 September |
09/22 | Monday 26 September | Monday 10 October |
10/22 | Monday 24 October | Monday 7 November |
11/22 | Monday 28 November | Monday 12 December |
To ensure inclusion on the agenda for a meeting listed above, applications must be submitted in ResearchNow Ethics & Biosafety by 5.00pm on the closing date.
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