Post approval information

Post approval information

Both HREC approval and Bendigo Health authorisation is required for all amendments to previously approved research. The Principal Investigator is responsible for ensuring that amendments are submitted to Bendigo Health via ERM at least twelve weeks prior to implementation using the appropriate Post Approval form related to your submission.

Major amendments are defined as those that involve any changes to existing documents, new versions of existing documents or additional documents, including those listed below:

  • Protocol
  • Participant Information and consent forms
  • Questionnaires, advertisements.  

Minor amendments are defined as those that do not involve any changes to existing documents, or additional documents.

Monitoring Research

Bendigo Health has ultimate responsibility for ensuring that its approved research is monitored. Primarily this is done by reviewing research progress reports which are generally required annually and on completion or discontinuation of a project. As a report of findings is required, project completion includes all data collection and analysis. Progress reports should be submitted via ERM. It is expected that researchers will also send in copies of any publications, conference abstracts (with details) and presentations arising from the research. Finally, Bendigo Health encourages researchers to present their findings to the Bendigo Health unit or area in which the research was conducted.

Request for extension to HREC approval

Researchers may wish to extend their project beyond the original period for which the research was approved. The approval period is shown on the approval letter sent from the HREC at the commencement of the research. The need for an extension can arise from unforeseen consequences including difficulties with participant recruitment or the deferral of studies of key researchers. In cases where research is unlikely to be completed by the end of the approval period, researchers should apply for a request for an extension to HREC approval. This should be completed as an amendment via ERM at least 12 weeks prior to the expiry of your project.

Auditing

As part of its monitoring responsibilities, the HREC conducts an auditing program on approved projects, regardless of their nature. The purpose of this program is to ensure that research conducted at Bendigo Health is being conducted as per project protocol and in compliance with Bendigo Health’s Conduct of Research Policy. Once a project has been selected for auditing the Research Manager will notify the Principal Investigator and advise them of the requirements. 

A project may be selecting for an audit for a number of reasons, including:

  • Random Selection
  • Following a protocol violation, safety event or change in risk level
  • Following a complaint
  • Following an unsatisfactory Progress Report or the failure to submit a Progress Report.

Researchers are encouraged to complete the Bendigo Health Research Team-New Team Checklist and the Researcher Self-Accreditation Checklist.

Please submit to [email protected]

Documentation Required

  • For major amendments and site notifications please send 1 copy of all documents
  • All applications must be collated and individual documents stapled. Double sided printing is preferred. Failure to do this will result in delay.

HREC and Governance Fees

A GST of 10% will be applied to all external projects (that is, where the Principal Investigator is not a Bendigo Health staff member). 

Fees should not be sent with your application. On receipt of your application you will be invoiced for the appropriate fee. 

Contact details

Research Manager 
In the first instance all enquiries should be directed to:
Ms Sally McCarthy
Bendigo Health Research Manager
03 5454 6412 
[email protected] 

Mailing address
Bendigo Health
PO Box 126
Bendigo VIC 3552

Contact Us
Location

100 Barnard Street, Bendigo, VIC, 3550

Phone

03 5454 6000

Email

[email protected]