IMPORTANT
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 relevant Flinders University Committee. Any Clinical Research applications are to be submitted to the Southern Adelaide Clinical HREC.

Application forms, guidelines, example forms and templates relating to the following are available at Guidelines, Forms and Templates.

 


Application Submission Process


New Applications – Low / Negligible Risk (Non-Clinical Research Only)

IMPORTANT
Applications submitted via the low/negligible risk process that are not deemed to be low or negligible risk by the SBREC Chair will be allocated to the full SBREC for review. The SBREC meeting date for this review will depend on the application submission date and the time taken by the Chair or Deputy Chair to assess the risk level.

Assessing your research as low / negligible riskThe National Statement on Ethical Conduct in Human Research (current version) identifies three levels of risk outlined below for social and behavioural (non-clinical) research projects. New applications that meet any of the following definitions may not need to be reviewed by the full Social and Behavioural Research Ethics Committee (SBREC).

  • Exempt Research - Research is deemed to be exempt from any ethical review if it is negligible risk (as defined below) and involves the use of existing collections of data or records that contain only non-identifiable data about human beings (National Statement - paragraph 5.1.22)
  • Negligible Risk Research - Research is deemed to be 'negligible risk research' when it poses no foreseeable risk of harm or discomfort.  Where the risk, even if unlikely, is more than inconvenience the research is not negligible risk (National Statement - paragraph 2.17)
  • Low Risk Research - Research is deemed to be 'low risk' when the only foreseeable risk is one of discomfort.  Where the risk, even if unlikely, is more serious than discomfort the research is not low risk (National Statement - paragraph 2.1.6)

 

Applying for ethics approval for low / negligible risk research

  1. Download and complete the ‘Application Form’; which now includes both the risk assessment and the application form.

    Applicants will be asked to indicate whether the application is being submitted as a negligible risk, low risk or greater than low risk application; or a deferral response on the front page.
  2. Submit a signed electronic version of your application, including all associated attachments (e.g, Letter of Introduction for student projects, Information Sheet, Consent Form, research tools such as questionnaires, interview or focus group questions etc) as a single PDF file, to the Social and Behavioural Research Ethics Committee.

Researchers from the Discipline of Psychology should add ‘Psychology’ to the subject line of the email submission sent to the committee.

 

Approval process for low / negligible risk applications

Applicants are asked to indicate on the application form whether the application is being submitted as negligible, low or greater than low risk. Following submission, the SBREC Chairperson or Deputy Chairperson will risk assess the application and applicants will be notified whether their application will reviewed by the full committee, SBREC Low Risk Sub-Committee, or Psychology Ethics Sub-Committee (PESC).

 

Discipline of Psychology Applications

Applications submitted by researchers from the Discipline of Psychology.

  • Applications deemed to be negligible risk will be reviewed by the SBREC Chair out-of-session via an expedited process without involvement of the PESC. Applicants can expect to receive a response from the Chair within 2-weeks from notification of review process.
  • Applications deemed to be low risk will be reviewed by the Psychology Ethics Sub-Committee (PESC) via an expedited process. Applicants can expect to receive a response from PESC within 2 weeks from notification of review process.

 

Non-Psychology Applications

Applications submitted by researchers not from the Discipline of Psychology.

  • Applications deemed to be negligible risk will be reviewed by the SBREC Chair out-of-session via an expedited process. Applicants can expect to receive a response from the Chair within 2 weeks from notification of review process.
  • Applications deemed to be low risk will be reviewed by the SBREC Low Risk Sub-Committee. Applicants can expect to receive a response from the Sub-Committee within 4 to 5 weeks after submission depending on the volume of low risk applications currently under review. Applications are reviewed in the order of receipt.  

New Applications - Non Low / Negligible risk (Non-Clinical Research Only)

IMPORTANT
As all application forms are periodically updated, we strongly recommend you re-download forms from the relevant website each time you submit a new application to ensure you are using the current version.

Applying for ethics approval (Non-Clinical Research)

  1. Download and complete the ‘Application Form’; which now includes both the risk assessment and the application form. From 1 July 2018 ALL applicants are now required to complete the shortened risk assessment section in addition to the full application form.
  2. Submit a signed electronic version of your application, including all associated attachments (e.g, Letter of Introduction for student projects, Information Sheet, Consent Form, research tools such as questionnaires, interview or focus group questions etc) as a single PDF file, to the Social and Behavioural Research Ethics Committee.

Applying for ethics approval using the Human Research Ethics Application (HREA) Form (Non-Clinical Research)

The Social and Behavioural Research Ethics Committee (SBREC) also accepts submissions prepared using the Human Research Ethics Application (HREA) Form (which has replaced the National Ethics Application Form – NEAF).

  1. Complete the HREA form online at the HREA website.
  2. Save the form plus all required attachments as a PDF file.
  3. Submit the signed electronic application as a single PDF file to the Social and Behavioural Research Ethics Committee.

 

Approval process for ethics applications (Non-Clinical Research)

Applicants can expect to receive formal notification from the full Committee 4 to 5 weeks following submission.

Please note that applicant notifications may be delayed during times of high committee workload. Please contact one of the Executive Officers if the need for a committee response becomes urgent.

 


New Applications (Clinical Research Only)

IMPORTANT
As all application forms are periodically updated, we strongly recommend you re-download forms from the relevant website each time you submit a new application to ensure you are using the current version.

All applications for ethics approval relating to clinical research involving human subjects should be directed to The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC). Further information on the scope and nature of the SAC HREC, and the submission process can be found on the SAC HREC website.

 


New Applications – Research involving the veteran community

IMPORTANT
As all application forms are periodically updated, we strongly recommend you re-download forms from the relevant website each time you submit a new application to ensure you are using the current version.

If your research project involves contact with the veteran community please see the information here for the Flinders University process in relation to these applications.

 


Class-based Research Projects (Non-Clinical Research Only)

IMPORTANT
As all application forms are periodically updated, we strongly recommend you re-download forms from the relevant website each time you submit a new application to ensure you are using the current version.

Applying for ethics approval for a Class Project (Non-Clinical Research Only)

It is the responsibility of the Topic Coordinator submitting an ethics application for a Class-based Research Project to ensure that the application is presented as a class-based project, rather than as individual research proposals. 

Further information on how to ensure that your application is presented as a class-based project can be found in the Class-based Project Application Guidelines and the Example Class-based Project Application Form.

Please note that class-based projects still allow for individual students to conduct different research activities within the overall framework of the research project.

 

Managing the ethics approval of a Class Project

You may wish to add more students onto the research project, for example, if SBREC has approved the project to run over several years and you wish to add the next cohort of students onto the project. To do this, all you need to do is email the Executive Officer with a request to add more students. Please ensure that you provide a list of names and student numbers.

If any other changes are being made to the research protocol, or you would like to request an extension of time, a SBREC modification request will also need to be sent to the Executive Officer.

 


Previous approval from another Human Research Ethics Committee (Non-Clinical Research Only)

In accordance with the National Statement on Ethical Conduct in Human Research (2007) (paragraph 5.3) Flinders University accepts ethics approvals from NHMRC registered Australian non-Flinders Human Research Ethics Committees (HRECs), for social and behavioural (non-clinical) research projects involving Flinders researchers.

If you have previously received approval from a registered HREC (see below) you must submit a copy of your external ethics application that has been approved, together with any supporting documentation, and your ethics approval notice, as a single PDF file to the SBREC Executive Officer. A full review will not be undertaken; however the Chair will look over the application out-of-session before it is accepted.

If you have obtained approval from the Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC), you do not need to provide any documentation to the University. You will automatically be covered by Flinders University.

 

Australian Based HRECs

Approvals will be accepted from all HRECs registered with the NHMRC, as listed here

 

HRECs Based in Other Countries

Approvals 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).

 

Managing ethics approval from an approved non-Flinders HREC

  • Modification Requests
    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 emailed to the SBREC before the new participant pool are recruited. These modifications do not need to be reviewed by the SBREC or the Chair. :The information provided ensure that the ethics expiry date is accurate on our database; and allows the Executive Officer’s to confirm that no-one will be recruited from any organisation under the banner of the Southern Adelaide Local Health Network (SALHN).

    All other modification requests do not have to be submitted to the SBREC.

  • Final Reports must be submitted to the original approving HREC, and a copy of the final report must also be emailed to the committee via human.researchethics@flinders.edu.au. Final reports do not need to be reviewed by the committee or the Chair, they will only be used to update our database to indicate that the project has been completed.

 


Deferred Applications

IMPORTANT
As all application forms are periodically updated, we strongly recommend you re-download forms from the relevant website each time you submit a new application to ensure you are using the current version.

In some cases, the Social and Behavioural Research Ethics Committee (SBREC) may decide it has not received adequate information to make a decision. A deferral notice will be provided, which will include comments from the Committee and a request to amend and resubmit your application for consideration at the next meeting.

  1. Download and complete the Deferral Response Form.
  2. Revise the Application Form you initially submitted for ethics approval, including updating all signature pages, as per your deferral notice. Please note that if you are a student researcher the amended application will also need to be signed by your supervisor.
  3. Submit a signed electronic version of your application as a single PDF file directly to the Social and Behavioural Research Ethics Committee, together with any required documentation or amendments, prior to the submission deadline.

 


Conditionally Approved Applications

In most cases, the Social and Behavioural Research Ethics Committee (SBREC) will conditionally approve an application subject to specified changes being made to the application before final approval is given and the project can commence. If your project has received Conditional Approval you must submit your response as a single PDF file. Your response will be reviewed by the SBREC Chair out of session.

  1. Download and complete the Conditional Approval Response Form.
  2. Submit an electronic version of the completed form as a single PDF file to the Social and Behavioural Research Ethics Committee, including any required documentation.

 


Further resources you may find useful…