Single site Low Risk Applications
Single site research projects include research projects that use data/specimens/or seek participants from one site only.
Your project is single site if you are asking Barwon Health to review the project for one site only. Barwon Health is considered a single site, which includes all Barwon Health owned locations such as Barwon Health North and McKellar Centre.
Low risk research is where 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, 2007 – updated 2018). If you’re not sure whether your research is suitable for a low risk application, please visit the how to prepare an application page or download and complete the ‘Level of Risk Checklist’. You may also contact [email protected] with any queries.
Single site Low Risk projects are reviewed by Barwon Health Human Research Ethics Committee (HREC). Please visit the HREC page for meeting dates and submission deadlines.
Read all of the points in the process (including information drop-downs) before commencing with your application. Note that the numbering system is arbitrary and that multiple steps can be undertaken in parallel to save you time.
All application submission, feedback, correspondence, information requests and approvals occur within Ethical Review Manager (ERM).
Step 1. Generate a Barwon Health Reference Number
Generate a reference number for your project via the Barwon Health Research Reference Number Generator if you have not already done so.
Please ensure that your Barwon Health reference number is quoted at the time of your submission and included on the cover page of your protocol.
Step 2. Prepare ethics application documents
- HREA form – complete via Ethics Review Manager (ERM) – Select 'HREA Form' from drop down 'Form' menu (include signatures from principal investigator, associate investigators, Head of Department)
- Victorian Specific Module (VSM) – for research projects with a site in Victoria, the VSM is required document. This can be completed and submitted in ERM.
- Protocol - click for template (download)
- Participant Information and Consent Form (PICF) or Plain Language Statement (PLS) (download)
- Research Data Management Plan Checklist (download) - see Guidelines on Research Data and Records Management Policy
- Curriculum Vitae of all members of the research team - click for template
- Peer Review Form for student projects only - click for proforma and process (downloads)
Plus supplementary documents
- Waiver of Consent application (download) - please complete the Waiver of Consent Checklist to confirm requirements
- Authorship Record Form Template (download) - see Guidelines on Collaborative Research and Authorship
- Supporting Documents (surveys, questionnaires, etc) - these can be set up in REDCap for secure electronic data capture
If you are experiencing difficulty with ERM, please see the Victorian Clinical Trials and Research ERM training tools page
Step 3. Prepare governance application documents
- Head of Department Signoff Declaration of support (download)
- Site Specific Assessment (SSA) – not applicable if researcher is Barwon Health employed. Note: Departmental signoff can be obtained on the SSA
- Research agreements - See research agreements page to determine if required
- If a Deakin University led study, an Annexure A is required (download). Please upload to ERM partially executed (with DU signature) and RDU will secure Barwon Health Executive signature once approved.
- Fee Payment Form if the project has funding – see Fees page to confirm requirements
Step 4. Submit your application
- Please refer to our document naming guidelines before submitting your application
- Ensure signatures are included for all investigators and Head of Department - see ERM signature guide.
- Submit your complete application (containing all supporting documents and signatures) via Ethics Review Manager (ERM) by clicking the ‘Submit’ button
Step 5. Review of your application
- Once submitted, your application will be reviewed by the Barwon Health Human Research Ethics Committee (BH HREC). Please refer to the submission close and meeting dates of the BH HREC on the Barwon Health HREC page. You will be prompted via email (address linked to your ERM account) to log into ERM and view any feedback, correspondence, and approvals relating to your application. If further information is requested, you need to update the HREA form and/or upload/update any documents and re-submit your application via ERM.
Contact RDU with any queries or concerns
RDU is here to help. If you are not sure where to start or have a question regarding your research project, email us at [email protected] and a member of the RDU team will get back to you within 24 hours. If you have a current application underway, please ensure you include your Barwon Health reference number in your enquiry.
Last Modified: Thursday, 01 June 2023