Single site Greater than 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.
Where the risk of your research, even if unlikely, is more serious than discomfort, the research is greater than low risk (National Statement, 2023).
Consider the following when gauging the risks of your research:
- The kinds of harm, discomfort, or inconvenience that may occur
- The likelihood of these occurring
- The severity of any harm that may occur such as:
- Physical harms; including injury, illness, pain
- Psychological harms; including feelings of worthlessness, distress, guilt, anger, fear
- Social harms; including damage to social networks or relationships with others, discrimination
- Economic harms; including the imposition of direct or indirect costs on participants
- Legal harms; including discovery and prosecution of criminal conduct.
If you’re not sure whether your research is suitable for a greater than 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 Greater then Low Risk projects require ethical review by a formally constituted Human Research Ethics Committee (HREC). Researchers are required to complete and submit a full application to the Barwon Health Human Research Ethics Committee (BH HREC) for review and approval. 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
- Human Research Ethics Application (HREA) form – complete via Ethics Review Manager (ERM). 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 templates here: PICF template, PLS template
- Curriculum Vitae of all members of the research team - click for template
- Peer Review Form required for all high risk projects except commercially sponsored clinical trials - 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
- Declaration by Head of Department - click for declaration template (download)
- Site Specific Assessment (SSA) – complete via Ethics Review Manager (ERM). 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
- Annexure A - required for Deakin University led studies - click for Annexure A template (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: Wednesday, 13 March 2024