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 at any time. However, it is suggested that both applications be submitted simultaneously, to allow concurrent review.
All submissions must contain the following completed forms/documents:
- Research Governance Checklist
- 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: http://monashhealth.org/research/human-research-ethics/essential-information-for-all-new-applications/application-guidance-for-site-specific-assessments-for-monash-health-hrec-approved-studies/
In addition, the final version of the Monash Health Site Specific Participant Information and Consent Form/s must be emailed to email@example.com along with the Monash Health HREC Reference Number, so that an electronic barcode may be inserted on the final approved document/s. The final approved Monash Health Site Specific Participant Information and Consent Form/s will then be emailed to the researcher at the same time as the letter of Site-Specific Authorisation. The barcode will ensure that a scanned copy of the Participant Information and Consent Form/s are placed under the Legal Tab on the Participant’s Scanned Medical Record. Researchers will still be required to complete an orange alert for each participant.
For further information, please contact Michael Kios, Research Governance Manager on 9594 4606 or Ms Brinda Kinakkal, Site Specific Authorisation Coordinator on 9594 2075.