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Skip Navigation LinksSTV > Research > Governance > Mutual Acceptance (via Eastern Seaboard)

Mutual Acceptance (via Eastern Seaboard) 

Reviewing HREC - Ethics
Accepting HREC  - Governance

 

St Vincent’s Hospital (Melbourne) is a certified HREC as part of:

  • The Eastern Seaboard initiative (encompassing VIC, NSW and QLD)

 

As part of this initiative, multicentre research activities require ethical approval from a single HREC only.  All remaining centres involved will then accept the ethical approval, and undertake a site specific Governance Review, via an SSA submission.

 

Please see the Consultative Council for Human Research Ethics SERP website for additional information regarding the Eastern Seaboard Initiative (including the Memorandum of Understanding which details the certified HRECs), and how to register an application for review via this pathway.  

 

Submitting a Mutual Acceptance Application to St Vincent’s Hospital HREC for Ethical Review

All documents must be submitted for review via all three of the following methods:

  1. Hard copy (see below for required numbers)
  2. E-mailed to research.ethics@svhm.org.au and;
  3. Upload via the Online Forms website

Documents must be submitted by the closing date :

 

Applications to the St Vincent’s HREC for Ethical Review

For HREC review, please submit the following documents in hard copy: 

Document

Number of hard copies required

Cover Sheet and Fee Form

1

National Ethics Application Form (including one Victorian Specific Module if a Victorian Site is participating in the study)

1 signed original + 2 copies
Participant Information and Consent Form (Master Version)
For Victorian sites, the Victorian Master Template must be used; for other states, it is recommended that the Victorian Master be used however all jurisdictionally appropriate templates may used.

3

St Vincent’s Hospital Site Specific Participant Information and Consent Form (if the research is to be conducted at STV)

 3

Investigators Brochure (or Product Information)

 2
Clinical Protocol

 2
Budget

 1
Questionnaires etc

 3
Indeminity - HREC Review Only  
CTN Form (for each participating site where ethical approval is being sought)

1 CTN form for each participating site
Privacy Declaration for External Researchers (as applicable)

1 signed original 

 

If the Applicant is from St Vincent's Hospital, the following is also required for concurrent governance review:

 

Document

Number of hard copies required
St Vincent’s Site Specific Participant Information and  Consent Form

 3
Site Specific Assessment Form (SSA)

 3
Clinical Trial Agreement

 3
Indemnity - Standard (for STV)

 3
Insurance Certificate

 1

Submitting a Governance Application (Site Specific Assessment) to St Vincent’s Hospital

Once ethical approval has been obtained from a certified centre, a site specific application must be submitted to the St Vincent’s Hospital Research Governance Unit for governance authorisation.

 

All SSA documents must be submitted for review via all three of the following methods:

  1. Hard copy (see below for required numbers)
  2. E-mailed to research.ethics@svhm.org.au and;
  3. Uploaded via the Online Forms website.

Documents can be submitted at any time, but applications must be complete. 

 

For SSA applications, please submit the following in hard copy:

Document

Number of hard copies required

Cover Sheet and Fee Form

1
Certified HREC Approval Letter (listing St Vincent’s as an approved site)

1
Site Specific Assessment Form (SSA)

1

National Ethics Application Form and Victorian Specific Module

1
Participant Information and Consent Form (St Vincent’s Hospital Site Specific)

1
Participant Information and Consent Form (Approved Master Version)

1
Investigators Brochure (or Product Information)

1
Clinical Protocol

1
Budget

1
Questionnaires etc

1

St Vincent’s Hospital CTN Form (with page 8 signed by the approving HREC)

1
Privacy Declaration for External Researchers (As applicable)

1 signed originals
Form of Indemnity - Standard (for STV)

 3 signed originals 
Site Specific Clinical Trial Agreement

 3 signed originals
Certificate of Insurance

1 

 

For general enquires regarding Mutual Acceptance or Online Forms, please call the Central Coordinating Office on (03) 9092 1981, e-mail multisite.ethics@dhs.vic.gov.au or visit the Consultative Council for Human Research Ethics website.
 
 
 
  

41 Victoria Parade, Fitzroy VIC 3065, Australia. Phone: (03) 9288 2211