Steps to follow to apply
1. Do I Need Independent Review?
- Decide whether the research meets the requirements of the National Statement on Ethical Conduct in Human Research (2007) and is ethically acceptable before it begins.
- Does the research have more than a low level of risk as defined in the National Statement Chapter 2, paragraph 2.1.6?
Yes – the research must be reviewed by an HREC.
No – the research may be reviewed under other processes described in the National Statement Chapter 5.2, paragraphs 5.1.18 to 5.1.21; or, exempted from ethical review as described in the National Statement paragraphs 5.1.22 and 5.1.23.
Click here for information regarding quality assurance or improvement activities, clinical audit activities etc.
2. Register in eProtocol
- All applications for review are submitted through our eProtocol online system. Before an application can be started a registration request to be an eProtocol user will need to be submitted and processed.
Click here for details regarding how to register.
Click here to access the ‘How to Register’ video tutorial.
3. Prepare Application Documentation
- All study documents must be attached into the application for the Committee’s review. All applications must have attached a Protocol/Project Plan detailing all aspects of the study.
Click here for a list of documents for a clinical trial.
Click here for a list of documents for a non-clinical trial.
Click here for guidance on what to include in a Protocol document for a clinical trial.
Click here for guidance on what to include in a Protocol/Project Plan document for a non-clinical trial.
Click here for guidance for what to include in a Participant Information & Consent Form.
Click here to access the Sample Participant Information Sheet.
Click here to access the Sample Consent Form.
4. Logon to eProtocol
- Once the registration request has been processed log on to eProtocol at bellberry.com.au.
Click here for further guidance in the eProtocol User Guide for Investigators
5. Create a New Application
- Complete the online application form
- Attach study documentation
Click here to access further guidance on Working with Applications.
6. Submit Application
- All applications must be submitted via eProtocol two weeks prior to a meeting.
- The deadline for consideration for the next Agenda is 5pm every Wednesday.
- The application will be reviewed and, if incomplete, it will be returned to the site with Return Notes detailing what needs to be included.
- You will receive notification once your study has been assigned to a Committee meeting.
- Notification emails will be sent throughout the review process.
7. Respond to the Committee’s Comments
- After the HREC has reviewed your study, comments will be sent in eProtocol by 5pm on the Friday following the Wednesday meeting.
- Respond to each of the comments from the Committee in eProtocol.
- Attach tracked and clean versions of any updated documents and clean versions of any
new documents into the application.
- Submit to HREC.
8. Study Approval
- Once the HREC is satisfied that all requirements have been met and all regulatory
documents have been received, the approval of the study will be processed.
- A notification email will be sent to the study contacts advising that the Approval Letter is
available in eProtocol.
- If a study is rejected, a letter will be issued via email.