These application instructions refer to studies which have been or will be reviewed by the Monash Health HREC and it is intended that the study will be conducted at Monash Health.
The application for Site-Specific Assessment may be submitted at the same time as the HREC application or following submission to the HREC. The application for authorisation is reviewed outside of the usual HREC meeting schedule and may be submitted by 5pm each Wednesday. However, it is suggested that both applications be submitted simultaneously, to allow concurrent review.
All submissions must contain the following completed forms/documents:
- Site Specific Assessment Form
- Monash Health Site Specific Participant Information and Consent Form
- Certificate of Insurance
- Monash Partners Certification by Head of Cardiology Department
- Monash Partners Certification by Head of Diagnostic Department
- Monash Partners General Service Request – Certification by Head of Supporting Department
- Monash Partners Certification by Head of Lung Function Department
- Monash Partners Certification by Head of Pathology Department
- Monash Partners Certification by Head of Pharmacy Department
If applicable, an approved agreement from the list of approved agreements: https://monashhealth.org/research/human-research-ethics/essential-information-for-all-new-applications/application-guidance-for-site-specific-assessments-for-monash-health-hrec-approved-studies/
- 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 firstname.lastname@example.org 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 legal documents such as the HREC Review Form of Indemnity/Standard Form of Indemnity and Research Agreements 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.