Application guidance for Human Research Ethics Review of Clinical Research and Trial Projects
These instructions refer to all research projects that are submitted to the full Human Research Ethics Committee for review.
If it is intended to conduct the study at Monash Health, an application for Site Authorisation is also required.
Human Research Ethics Submission Documents:
- Human Research Ethics Application Form which is created on ERM: https://au.forms.ethicalreviewmanager.com/Account/Login
- Relevant sections of the Victorian Site Specific Module
- Participant Information and Consent Form – Please follow the Department of Health and Human Services Templates
- Study Protocol
- Investigator’s Brochure or Product Information (applies only to drug/device studies)
- Any questionnaires/letters of invitation/advertisements etc
- Medicine’s Australia HREC Review Form of Indemnity for Clinical Trials (if Monash Health is being asked to review for other institutions).
- If applicable, please also complete the Agreement for Ethical Review of Human Research Services
- Researchers are asked to lodge new submissions via ERM https://au.forms.ethicalreviewmanager.com/Account/Login
- Following lodging the submission please send an email to email@example.com informing the team of the new submission.
- In the email please advise of the ERM Reference and Monash Health Reference (if one has already been assigned) along with the study title.
- Attach the fee form (if applicable) to the email.
- The only documents required in hard copy, will be the HREC Review Form of Indemnity as many commercial sponsors prefer a wet ink signature.
For further information please refer to the Research Support Services contact list for the person/people able to assist with submission enquires and their availabilities. Please note that staff are able to meet with researchers prior to a submission but researchers will need to make an appointment first.