Submitting a Low Risk Ethics Application

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Submitting a Low Risk Ethics & Governance Application
 

Christmas Closure

The Northern Health Office of Research & Ethics will not be accepting any new high, low or audit applications for ethical review from Mon 5th December 2016 and will re-open on Mon 16th Jan 17. We wish you all a Merry Christmas and look forward to working with you in the New
 

If a multi-site research project that has received ethical approval by a NHMRC accredited Human Research Ethics Committee under the National Mutual Acceptance system will only need to complete step 8 ‘Complete a Research Governance Application’.

Steps for submitting a Low / Negligible risk ethics application to the NH LNREC & Governance Application
 

1. Prepare a Project Protocol Mandatory
2. Complete a Low and Negligible Risk Form (LNR Form) Mandatory
3. Complete a Participant Information & Consent Form (PICF) If required
4. Prepare Curriculum Vitae (CV) for the research team Mandatory
5. Complete the Ethics Fee form Mandatory
6. Submit hardcopy documents Mandatory
7. Submit an electronic copy Mandatory
8. Complete a Research Governance Application Mandatory



1. Prepare a Project Protocol

All projects require a detailed protocol and budget to be submitted as part of the application.

Researchers may wish to use the NH protocol template for investigator initiated projects.

To download a copy of the Northern Health Protocol template, please click here.



2. Complete a Low and Negligible Risk Form (LNR Form)

Access the Australian on-line forms for research website and complete the LNR VIC form and ensure that all documents to be submitted as part of the application are uploaded to the LNR application.

You may need to create an account if you have not used this website previously.

For ‘Online Forms’ tips on e-submissions, please click here to download a useful resource.



3. Complete a Participant Information & Consent Form (PICF)

Complete a PICF for studies that involve obtaining consent from potential participants using the Department of Health & Human Services, State Government of Victoria. There are various templates available and they are used as part of the National Mutual Acceptance system.

Once the consent form has been completed the whole document must be inserted into the Northern Health PICF template. This allows NH to scan the consent forms into the ‘Legal’ tab of the electronic patient medical record. Only PICFs for patients need to be placed on the NH PICF template.

Melbourne Health has a guide on writing a PICF which is an excellent resource for researchers and we would like to acknowledge and thank Melbourne Health Office for Research for linking to this guide.



4. Prepare Curriculum Vitae (CV) for the research team

A 1-2 page CV (signed and dated within the last year) for the Coordinating Principal Investigator, Principal and Associate investigator and research team at NH.

Researchers may wish to use the NH CV template.

All Principal Investigators and research coordinators/nurses at NH are required to submit a current Good Clinical Practice certificate.

To download a copy of the Northern Health CV Template, please click here.



5. Complete the Ethics Fee form

Download and complete the Ethics Fee form. Fees are payable up-front, at the time of initial submission of a research project.

To download a copy of the Northern Health Ethics Fee Form, please click here.



6. Submit hardcopy documents

One hardcopy with original signatures must be submitted. 
Mandatory documents to be submitted as part of the ethics application include:

  • LNR Form (complete with HREC no. & signed)
  • Protocol (including a budget)
  • CV for each investigator
  • Ethics Fee Form

Make sure you submit:

  • All original documents
  • Collated
  • Complete with appropriate signatures
  • All documents are named appropriately, include the project title, page numbers and date of revision.

Submit the original application to:

Brittany Szabo
Senior Advisor – Education and Research

Northern Centre for Health Education & Research (NCHER)
185 Cooper St,
Epping VIC 3076



7. Submit an electronic copy

Submit an electronic copy of the ethics application (including a scanned copy of the LNR and SSA form to show signatures) to:

lowriskresearch | at | nh.org.au   

The email subject line must contain:

• LNR number
•  Project Title


8. Complete a Research Governance Application

A research governance application must be submitted if NH is a site where the research project will be conducted.

Governance applications can be done at any time and do not have to be submitted on the HREC submission deadline day. However, early completion and submission of both HREC and Research Governance will ensure faster approval and earlier commencement of your project.

Steps to completing a Research Governance Application:

  1.  Complete a Site Specific Application form (SSA Form) in Australian on-line forms for research .
  2. Complete all site specific documents, eg: PICF and external correspondence to be placed on NH template, protocol etc.
  3. Complete Agreements / Contracts if required
  4. Upload all site specific documents onto the SSA via on-line forms
  5. Complete the Research Governance Cover Letter
  6. Complete the Ethics Fee Form
  7. For projects approved by a HREC other than NH: send one hardcopy of all documents submitted for ethical review plus site specific documents (original signatures) to:

    Rita Wong
    Ethics and Research Governance Officer

    The Northern Hospital
    Northern Centre for Health Education & Research (NCHER)
    185 Cooper St,
    Epping VIC 3076
  8. Send one electronic copy of all documents submitted as part of the application to:
    ethics | at | nh.org.au