Learn more about Post Approval processes.
In addition to providing Ethical Review and Governance Approval, Monash Health ensures that all research is conducted in accordance with the National Statement on Ethical Conduct in Human Research (2023) and the Australian Code for the Responsible Conduct of Research (NHMRC 2021). This information below provides information on important topics such as Adverse Events, Serious Breaches, Annual Reporting Requirements as well as Reporting Complaints and the process of amending projects.
For electronic submissions:
– Researchers must submit all submissions through ERM at https://au.forms.ethicalreviewmanager.com/Account/Login. Please note, that this excludes Progress and Final Reports or Site Closure Reports, which should be submitted via Microsoft Forms.
– After lodging the submission, please send an email to research@monashhealth.org to inform the team about the amendment.
– In the email, please include the ERM Review Reference and Monash Health Reference, along with the study title. List the documents, including their versions and dates, in the body of the email.
– For Amendment Requests, attach the completed amendment request form along with all revised documents containing track changes (e.g., Protocol, Participant Information and Consent Form, Investigator’s Brochure, etc.). If applicable, also include the fee form as an attachment to the email.
– The only hard copy documents required are the HREC Review Form of Indemnity/Standard Indemnity or Agreement, as many commercial sponsors prefer a wet ink signature.
