Research Governance Review – Site Authorisation

• What is the purpose of Site Specific Authorisation?
  Site Specific Authorisation refers to the process of ensuring institutions are held accountable for research which is conducted and monitored at a site. It applies to all individuals involved in research and has been designed to promote good research practice, ensure accountability and reduce adverse incidents and the likelihood of poor performance and research misconduct.
• If I have HREC Approval, why do I need Site Specific Authorisation?
  Prior to commencing a Research Project, researchers require ethics and governance approval (commonly referred to as Site Authorisation). A Human Research Ethics Committee (HREC) provides ethics approval, whilst an institution provides Site Specific Authorisation for a study to be conducted at a particular site. Although an ethics committee may ethically approve a project, Site Specific Authorisation is required to ensure that a specific site has the personnel and resources to be able to conduct the research.
• Who will review the Site Specific Assessment application?
  The application for Site Specific Authorisation is reviewed by the Research Support Services team outside of the Monash Health Human Research Ethics Committee (HREC) meetings.
• Do the Monash Health HREC submission dates apply to Site Specific Assessment application?
  No, these dates do not apply to Site Specific Assessments.
• How will I know when my SSA Submission on ERM has been received by the Research Support Services?
  Once the Site Specific Assessment form has been submitted electronically on ERM, you must send a notification email specifying the ERM reference number to research@monashhealth.org to inform us of your submission.

Guidance for Site Specific Assessments for studies approved by Monash Health Ethics committee

If the Monash Health HREC is providing Ethics Review for this study, when can I submit the Site Specific Assessment (SSA) application?
The SSA application may be submitted at the same time as the HREC application or following submission to the HREC. However, it is suggested that both applications be submitted simultaneously, to allow concurrent review

Where can I find and submit the Site Specific Assessment (SSA) application?
The Site Specific Assessment (SSA) application can be found on the Ethical Review Manager (ERM) portal and is created as a sub-form of the Human Research Ethics Application (HREA) form

Submitting a Site Specific Assessment application for projects reviewed by an external Ethics committee

• Do you accept HREC Review Only Approval from other Human Research Ethics Committees?
  Yes, Monash Health does accept HREC review for projects which have been reviewed by a HREC that is both certified by the National Health and Medical Research Council (NHMRC) under the National Certification Scheme, and is a Certified Reviewing HREC under the National Mutual Acceptance (NMA) scheme.
• Where can I find and submit the Site Specific Assessment (SSA) application?
  The Site Specific Assessment (SSA) application can be found on the Ethical Review Manager (ERM) portal and is created as a sub-form of the Human Research Ethics Application (HREA) form if the reviewing HREC is from Victoria or Queensland.
• How do I submit an SSA for Monash Health if, the approving HREC did not use ERM?
  If the HREA form was not lodged on ERM, a Minimal Dataset Form (MDF) can be created on ERM to act as a HREA form. The Site Specific Assessment application can then be created as a sub-form of the MDF.
• If HREC Approval has been granted outside of the Monash Health HREC, when can I submit the Site Specific Assessment (SSA) application?
  The SSA application may be submitted after HREC Review Only Approval has been granted. A copy of the HREC Only Approval Letter listing Monash Health as a participating site along with all ethics approved documents must be submitted with the Site Specific documents. Site specific documents will include the SSA Application, participating supporting department approvals and an agreement.

Electronic Submission

Step 1
Researchers are asked to lodge new submissions via ERM https://au.forms.ethicalreviewmanager.com/Account/Login

Step 2 (this only applies to projects with HREC Review from another institution)
Please ensure that the HREC Approval(s), HREA, VSM and all the latest HREC approved documents are included in your SSA submission (Please note, we cannot access the HREA for other institutions on ERM).

Step 3
Following lodging the submission please send an email to research@monashhealth.org informing the team of the new submission.

In the email please include the following:

• The Project Title
• The ERM Project ID
• Monash Health Reference (if one has already been assigned)
• The Monash Health New Project Fee Form (if applicable)
• A list of the documents which will be submitted (including the document title, version, and date)
• The only documents required in hard copy, will be legal documents such as the HREC Review Only Form of Indemnity/Standard Form of Indemnity and Research Agreements if commercial sponsors prefer a wet ink signature. All agreements must be emailed to research@monashhealth.org to enable legal review prior to initiation of signing.