Multi-site Research

 

Please note that this section does not apply to the following types of studies:

 

Important information for researchers 

As from 16 July 2018 the Ethics and Governance database and submission process has changed.  All applications and post approval documents will need to be created and submitted through the newly released Ethics Review Manager (ERM) Database for approval.  ERM replaces Online Forms.

New Applications

Instead of using Online Forms you will need to create and submit through ERM.  If you already have an Online Forms login and password it will transfer to ERM.  If your Online Forms login and password does not work, contact Helpdesk@infonetica.net

If you have not previously used Online Forms you will need to register in ERM.

Where do I find ERM?

https://au.forms.ethicalreviewmanager.com/

The staff from the Office for Research will be able to assist you.  Call Kim Sherry on 9784 2680 to make a time to call in or email Kim, KimSherry@phcn.vic.gov.au with your questions.

 

Peninsula Health is a participating organisation in the Streamlined Ethical Review Process (SERP) including National Mutual Acceptance (NMA) for eligible multi-site research projects.

As a participating organisation, Peninsula Health accepts the ethical and scientific review conducted by a Human Research Ethics Committee (HREC) certified by the National Health and Medical Research Council (NHMRC) that is accredited to review applications under the streamlined systems. 

The Peninsula Health HREC does not undertake ethical and scientific review under these systems.  The Manager Office for Research undertakes Research Governance/Site Specific Assessment (SSA) to determine if projects should be authorised to commence at Peninsula Health.  Submission deadlines are not applicable to SSA.

Ethical and Scientific Review

Ethical and scientific review of projects reviewed under SERP including NMA is undertaken by one of the accredited reviewing HRECs.

For multi-site clinical trials http://www.health.vic.gov.au/clinicaltrials/

For multi-site health and medical research http://www.health.vic.gov.au/healthandmedicalresearch/index.htm

Principal Investigators must be aware of their responsibilities under these review systems.

 

SSA Authorisation

Under SERP including NMA a multi-site research project cannot commence at Peninsula Health until:

  1. Approval has been granted by the reviewing HREC (Peninsula Health must be listed as an approved site); and
  2. Research governance/SSA authorisation has been issued by Peninsula Health.

SSA occurs once Reviewing HREC approval is granted, although some documents (such as Clinical Trial Research Agreements, Indemnity and Insurance documents) can be reviewed prior to final HREC approval.

 

Application for Research Governance/SSA Authorisation

All applications must be submitted through ERM Applications.

Guidance for completing applications through ERM is available from here.

A list of documents required for submission is available from here. Please note this document also contains details of the documentation required for post-approval submissions. 

 

Submission Requirements

Submit completed applications via ERM Applications, ensuring all supporting documents have been uploaded.

ERM’s electronic signature process is to be used for all required signatures, including Head of Department and Head/s of Supporting Department/s.  Original signatures are required on Agreements and Indemnity documents.

Submit hard copy documents to the Office for Research.  Documents required in hard copy include:

  • Required number of copies (as applicable) of
    • Agreement – signed by sponsor and Principal Investigator
    • Indemnity – signed by sponsor

 

Notification of Review Outcome

The Manager Office for Research undertakes Site Specific Assessment of the application and liaises with the principal investigator/study coordinator to ensure compliance with research governance requirements. 

Feedback and requests for information will be sent via ERM.

Multi-site research must not commence until a formal signed Site Authorisation Letter from Peninsula Health has been received.

 

After Approval

Researchers must comply with the monitoring and reporting requirements of

  • The Reviewing HREC; and
  • Peninsula Health

Requirements for post-approval changes and reporting are available from here.