Submitting an Ethics Application

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Submitting an 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

The NH HREC only accepts applications that are on the approved templates found at the Department of Health, Victoria website.

NOTE: For a high risk research project to be approved and implemented at a Northern Health campus, a Northern Health staff member must be included as part of the research team on the project.

If a multi-site research project has received ethical approval by a NHMRC accredited Human Research Ethics Committee under the National Mutual Acceptance system only step 15 ‘Complete a Research Governance Application’ needs to be completed.

Steps for submitting a high risk ethics application to the NH HREC & Governance Application
 

1. Review the application closing dates and HREC meeting dates Mandatory
2. Provide a Project Protocol Mandatory
3. Project Finance Mandatory
4. Complete a National Ethics Application Form (NEAF) Mandatory
5. Complete a Victorian Specific Module (VSM) Mandatory
6. Prepare Curriculum Vitae (CV) for the research team Mandatory
7. Research Agreement & Indemnity If required
8. Insurance If required
9. Complete a Participant Information & Consent Form (PICF) If required
10. Clinical Trial Notification If required
11. Prepare the HREC Application Cover Letter If required
12. Complete the Ethics Fee form Mandatory
13. Submit hardcopy documents Mandatory
14. Submit an electronic copy Mandatory
15. Complete a Research Governance Application Mandatory

 


1.  Review the application closing dates and HREC meeting dates

The HREC meets once every 2 months with application closing dates one month prior to the meeting dates.

For further information on the NH HREC submission and meeting dates, please click here.


2. Provide a Project Protocol - Mandatory

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. For investigator initiated projects that have not been peer reviewed, a Biostatistician review may be requested. We suggest that Northern Health investigators contact our in-house Biostatistician to assist you with your project design.

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


3. Project Finance - Mandatory

All projects must have a detailed budget submitted as part of the application, either in an agreement/contract between Northern Health and an external Sponsor/Collaborator. For Investigator Initiated trials and internal projects, the Protocol template or budget template must be completed and signed by the Head of Department where the project is being conducted.

To download a copy of the Northern Health Research Project Budget Template, please click here.


4. Complete a National Ethics Application Form (NEAF) - Mandatory

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

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

Click here to open the ‘Tips for e-submission’


Click here to access the new ‘online forms’ handbook



5. Complete a Victorian Specific Module (VSM) - Mandatory

All high risk projects will require the VSM to be completed and submitted. For projects receiving ethical approval from a HREC outside of Victoria, it is recommended that the Victorian site complete the VSM.
Section 4 of the VSM must be completed for all projects that involve ionising radiation, including ionising radiation that is deemed as standard care. When completing Section 4, refer to the Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes (2005)  (Latest update).

For multi-site approval where a Lead HREC has been nominated, Section 4 of the VSM must be completed specifically for NH and signed off by the NH Radiation Safety Officer and Principal Investigator. All other sections of the VSM can be completed by the Lead Site.

Studies which include procedures involving exposure to ionising radiation deemed to be additional to Standard Care must: Studies which include procedures involving exposure to ionising radiation deemed to be additional to Standard Care must:

  • Submit a Medical Physicist Radiation Dose and Risk Assessment for each site at which the radiation is deemed to be additional to standard care. (See requirements of Medical Physics Radiation Dose and Risk Assessment)
  • If the Medical Physicist report indicates that the radiation dose has exceeded the dose constraints as outlined in the National Code of Practice, verification of the dose calculations must be undertaken by a second Medical Physicist. This is the responsibility of the medical physicist
  • Include the recommended specific wording from the Medical Physicist’s in the ‘risks’ section of the NH specific PICF template.

Guidelines on completing the VSM can also be found at this website.


 6. Prepare Curriculum Vitae (CV) for the research team - Mandatory

A 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.

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


All NH Coordinating Principal Investigators / Principal Investigators and research coordinators/nurses working on clinical drug/device trials are required to submit a current Good Clinical Practice certificate as part of the application.


7. Research Agreement & Indemnity – If required

Research agreements are required when the Sponsor is external to Northern Health.

Details for Northern Health contracts:

Northern Health
185 Cooper St, Epping VIC 3076

ABN: 42 986 169 981

Medicines Australia standard contracts will not be accepted where changes to any clause within the contract have not been approved by the Department of Health (VIC, QLD, SA & QLD). Northern Health approved contract clauses are not to be change without approval from Northern Health Legal Counsel.

Type of Sponsorship Research Agreement Form Indemnity Forms
                                                   COMMERCIAL TRIALS                
Commercially Sponsored Trial of a Pharmaceutical Clinical Trial Research Agreement – Standard Form
Available on Medicines Australia website
Standard Indemnity Form on Medicines Australia website
Commercially Sponsored Trial of a Device Clinical Investigation Research Agreement – Standard Form
Available on Medical Technology Association of Australia website
Standard Indemnity Form for a Clinical Investigation on Medical Technology Association of Australia website
Contract Research Organisation (CRO) acting as the local Sponsor Clinical Trial Research Agreement – CRO specific
Available on Medicines Australia website
Standard Indemnity Form on Medicines Australia website
                                                      NH RESEARCH STUDIES
Collaborative or Cooperative Research Group (CRG) Clinical Trial Research Agreement – CRG specific
Available on Medicines Australia website
Both the CRG and IIS standard agreements have the same general ‘liability and insurance’ clause.
The intent of the clause is that each party is liable for its acts and omissions in relation to the conduct of the study. Therefore indemnity forms not required.
Investigator Initiated Study (IIS) Clinical Trial Research Agreement – IIS specific
Available from the Coordinating Office for Clinical Trial Research, Department
As above

 Sourced: Medicines Australia website, accessed Apr16

Approved Northern Health agreements:

Memorandum of Understanding to be used for low risk research or quality improvement project collaborations that do not involve a financial transaction between parties.

To download a copy of the Northern Health Memorandum of Understanding, click here.

Simple Collaborative Agreement used for investigator initiated research that involves a financial transaction between parties.

To download a copy of the Northern Health Collaborative Agreement, click here.

Material Transfer Agreement to be used where NH provides external parties with materials such as tissue samples obtained by NH, and NH's only role is to provide this material and is not involved as a collaborator in the research project.

To download a copy of the Northern Health Material Transfer Agreement, click here.

Clinical Patient Folder (CPF) confidentiality / access form, to be used when non Northern Health researchers wishing to access the Clinical Patient Folders (this includes monitors and students)

To download a copy of the Northern Health Clinical Patient Folder Confidentiality Access Form, please click here.

 If you think your research project requires a different agreement, contact ethics | at | nh.org.au


8. Insurance– If required

Insurance

For commercially and externally sponsored clinical trials, submit a copy of the Sponsor’s insurance certificate.


9. Complete a Participant Information & Consent Form (PICF) – If required

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.

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


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.


10. Clinical Trial Notification – If required

The Therapeutic Goods Administration (TGA) runs the CTN scheme which allows unapproved therapeutic goods to be lawfully supplied for experimental purposes in humans.

If your research involves a drug or device, please refer to the TGA website for information on determining if you require a CTN and how to lodge one.

The Sponsor is responsible for lodging a CTN, where Northern Health is the Sponsor, the CTN must be lodged via the Northern Health Office of Research & Ethics. Download the template below and ensure all the information required to lodge a CTN is completed prior to making an appointment for lodging.

To download a copy of the TGA CTN template, please click here.


11. Prepare the HREC Application Cover Letter - Mandatory

The HREC application cover letter is to be completed and submitted as part of the application.

The Ethics Checklist found on the same page is not required to be submitted but is a good tool which can be used by the researcher to ensure that your application is complete.


12. Complete the Ethics Fee form - Mandatory

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.


13. Submit hardcopy documents - Mandatory

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

  • HREC Application Cover Letter
  • NEAF (complete with HREC no. & signed)
  • SSA (complete with NH Department Manager signature)
  • Protocol
  • VSM
  • Two page CV for CPI & NH research team (signed and dated)
  • Ethics Fee Form (project will not be reviewed until payment has been received)

The HREC application must be submitted by 4pm on the closing day and will not be accepted after this time.

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

Rita Wong
Ethics & Research Governance Officer

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


14. Submit an electronic copy

Submit an electronic copy of the HREC application by 4pm on the closing day to:

ethics | at | nh.org.au

The email subject line must contain:

• HREC no.
• Project Title


15. Complete a Research Governance Application

A research governance application must be submitted if NH is a site where the research project will be conducted. Note campuses within  Northern Health will be covered under a ‘site’ application; eg: Research to be conducted at Craigieburn Health Service and Bundoora Extended Care will only require one ‘site’ application.

Governance applications can be reviewed and approved at any time and are not required 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 in Australian on-line forms for research
  2. Complete all site specific documents, eg: PICF and external correspondence to be placed on NH template, VSM section 4 for ionising radiation (if applicable), etc.
  3. Upload all site specific documents onto the SSA via on-line forms
  4. Complete the Research Governance Cover Letter
  5. Complete the Ethics Fee Form
  6. For projects approved by a HREC other than NH: send one hardcopy of all current documents and the HREC approval letter for these documents plus site specific documents (original signatures) to:
    Rita Wong
    Ethics & Research Governance Officer

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

Click of the following links to download a copy of the:

Northern Health Ethics Fee Form

Northern Health PICF template

NH Letterhead

Approval to examine records for the purpose of research
Note: external researchers wishing to access NH patient records must complete this form