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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:

 

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.

Post-Approval Submissions

All post-approval submissions including amendments, progress reports, adverse events etc. must now be submitted through ERM. They can no longer be submitted by email.  

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.

The instructions on our website will be updated to reflect these changes.  

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.

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
  • Be submitted via ERM Applications

AMENDMENTS

  • Must be approved prior to implementation

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

  • Amendment Request 

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 re-activate the approval granted

  • Amendment Request

 

Include in amendment form:

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

SAFETY REPORTS

Adverse Events / Incidents occurring to participants

  • Project Notification Form 

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

Reporting in VHIMS may be required

PROGRESS REPORTS

Annual Report

  • Project Progress 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

  • Project Final Report

Submit a final report if the project discontinued prior to completion or at the conclusion of the research projects. Include details of publications and/or presentations arising from the project. 

Submission Requirements

Post-approval submissions are to be submitted electronically via ERM Applications. Call Kim Sherry on 9784 2680 to make a time to call in or email Kim, KimSherry@phcn.vic.gov.au if you need assistance with setting up your application in ERM.

Click here for HREC submission deadlines and meeting dates for 2018.

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

Fees

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.