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Ongoing Management of Low and Negligible Risk Research

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Amendments | Safety Reporting | Reports | Submission Requirements | Fees | Notification of Review Outcome

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


The requirements for the submission of post-approval documentation are detailed below.

All submissions must:

  • Include the LNR reference number
  • Comply with the submission instructions


  • Must be approved prior to implementation

Changes to research protocol, conduct or direction of the study.

If applicable

  • Revised PICF(s)
  • Revised recruitment methods/advertising documents
  • Revised data collection tools

Include in the amendment request:

  • Justification for this request
  • Ethical issues that may arise as a result of the changes
  • If existing participants are to be re-consented and the number of participants (where the amendment includes a revised PICF)

All revised documents must include:

  • Tracked changes (including additions and deletions)
  • A revised version and date

Changes to Research Personnel

Include a brief CV (full CV not required) for all new researchers who have not previously submitted a research CV

Investigator CV Template available

Request to extend the approval or to re-activate the approval granted


Include in amendment form:

  • Original ex pected completion date
  • New expected completion date
  • Justification for why this request is required


Adverse Events / Incidents occurring to participants

Incidents resulting in harm must be notified to the Office for Research within 24 hours.

Reporting in VHIMS may be required


Annual Report

Failure to submit an annual report by the September agenda closure deadline each year may result in approval being withdrawn.

The reporting period is the financial year. 

An interim report covering less than 12 months will be required for some projects in the first year. This should cover from the approval date until 30 June. 

Final Report

Submit a final report if project discontinued prior to completion or at the conclusion of the research projects

Submission Requirements

Post-approval submissions are to be submitted electronically. Click here for HREC submission deadlines and meeting dates for 2018.

Ensure electronic files are labelled according to the Requirements for Naming Electronic Documents.

Email completed submission to ResearchEthics@phcn.vic.gov.au. Include LNR reference number in email subject line.

Scanned signatures are acceptable as long as the original signed documents can be provided on request (such as during an audit).

Research submissions will be returned if they do not comply with the submission requirements.


Fees are not applicable for review of Low Risk applications unless the project is commercially sponsored. 

Notification of Review Outcome

The outcome of the HREC review will be emailed by the Office for Research within 7 days of the meeting. 

Research amendments must not be implemented until notification of approval has been received.