Ethical and scientific review

Ethical and scientific review of projects reviewed under SERP including NMA is undertaken by one of the accredited reviewing HRECs. More information about these review systems is available from  https://www.clinicaltrialsandresearch.vic.gov.au 

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

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.

All applications must be submitted through ERM Applications.

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. 

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

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.

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.