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Submitting an Ethics Application
1. Choose which HREC to submit your application
Research projects requiring an ethical review and approval can be obtained by submitting an application via:
- Austin Health HREC for high risk projects*
- Austin Health Clinical Research Review Committee (CRRC) for negligible/low risk projects*
- NHORE for clinical audits considered research that only involve negligible risk
- Research Excellence (REx) Partner accredited multi-site HREC
- National Mutual Acceptance scheme for high and low risk multi-site projects.
Northern Health Office of Research & Ethics suggest that high and low risk projects that are Northern Health Investigator Initiated projects being conducted at Northern Health only, be submitted to Austin Health HREC for ethical review and approval.
*When submitting an application where Northern Health is the only site, please email email@example.com to ‘book’ your project for ethical review and follow the ‘single site submission’ process available on the Austin Health website.
Check the HREC website for:
- application closing and meeting dates;
- contact the HREC to book your submission date; and
- review the submission process.
Your submission should include the following documents.
2. Ethics Checklist (if required)
The Ethics Checklist may be optional, however, it may be useful for those researchers who are not familiar with submitting ethics applications.
3. Project Protocol – Mandatory
All Northern Health 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. If researchers wish to use another protocol template, then the one page budget template must be submitted. For investigator initiated projects that have not been peer reviewed, a Biostatistician review may be requested.
This Protocol template was provided to us by Austin Health Office for Research and we would like to acknowledge and thank them for allowing us to replicate and use this template
4. Complete a National Ethics Application Form (NEAF) / Low & Negligible Ethics Application Form (LNRNEAF)- Mandatory
Using ‘Ethical Review Manager (ERM)’ complete a HREA (high risk projects) or LNR Vic (low risk projects) and attach all documents to be submitted for ethical review.
You will need to create an account if you have not used this website previously.
5. Complete a Victorian Specific Module (VSM) – Mandatory (high risk projects)
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.
6. For research studies involing ionising radiation procedures
For projects that involve ‘Standard Care‘
Reviewing HREC is in Victoria:
- Complete a Radiation Standard Care Letter for each site.
- Submit the Letter to the reviewing HREC for review and approval.
Reviewing HREC is not in Victoria:
- Check the reviewing HREC website and follow the procedure for submitting standard of care project.
For projects that involve ‘Addition to Standard of Care‘
- Check the reviewing HREC website for additional documents to be completed.
- Obtain an independent Medical Physicist Risk Assessment report for each site by completing a ‘Medical Physics Risk Assessment Interventional, Diagnostic & Nuclear Medicine Procedures Supporting Information‘ form and send to an accredited Medical Physicists.
- Submit the Medical Physicist Risk Assessment report to the reviewing HREC.
7. 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.
8. Good Clinical Practice (GCP) Certification – Mandatory for Clinical Trials
It is a requirement for all NH Coordinating Principal Investigators / Principal Investigators (clinical drug/device trials) are required to submit a current Good Clinical Practice (GCP) certificate as part of the application
The minimum standard of GCP training accepted by NH is defined by TransCelerate Biopharma Inc.
Investigators who also work at other institutions should contact the relevant department to determine if they can access TransCelerate accredited GCP training at a more competitive rate.
Contact firstname.lastname@example.org for further inquiries.
9. HREC Review Only Indemnity Form
For use where the Indemnified Party is providing ethical review for a multicentre clinical Study where the ethical review will be adopted by hospitals, institutions or sites that are independent from the Indemnified Party, OR as a Reviewing HREC for a single centre study at a hospital or institution that is independent from the Indemnified Party. For use where the Indemnified Party is providing ethical review for a multicentre clinical Study where the ethical review will be adopted by hospitals, institutions or sites that are independent from the Indemnified Party, OR as a Reviewing HREC for a single centre study at a hospital or institution that is independent from the Indemnified Party.
All Northern Health high risk research projects that are being reviewed by an independent HREC will require a HREC Review Only Indemnity Form signed by the Sponsor of the research project. This form will be required to be submitted as part of the application. Multiple original signed copies may need to be submitted. Check the HREC website for how many originals are required to be submitted and ensure it includes one original copy to be returned to the Northern Health Principal Investigator.
Refer to the ‘Medicines Australia’ table below for further information on indemnity forms.
|Type of Sponsorship||Indemnity forms|
|Commercially sponsored trial of a pharmaceutical||Standard Indemnity form
available on Medicines Australia website
|Commercially Sponsored Trial of a device||Standard Indemnity form for a clinical investigation available on
Medical Technology Association of Australia website
|Contract Research Organisation (CRO)||Standard Indemnity form
available on Medicines Australia website
|NH RESEARCH STUDIES|
|Collaborative or Cooperative Research Group (CRG)||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)|
10. Insurance– If required
For commercially and externally sponsored clinical research, submit a copy of the Sponsor’s insurance certificate.
11. 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.
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.
12. Complete other relevant documents (if required)
Documents that are to be used as part of the trial may also be required for submission, eg: Letter to GPs, participant diaries, advertisements, etc.
Letters sent on behalf of the Northern Health research team will need to be placed on the Northern Health Letter template.
13. 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 Clinical Research Manager. Download the template below and ensure all the information required to lodge a CTN is completed prior to making an appointment for lodging.
The HREC may request a copy of the document that is to be submitted, however, the CTN should be lodged after ethical and research governance approval is received.
14. 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. Submissions that do not include a fee form will not be accepted.
To download a copy of the Austin Health New Application Fee form, click here.
For other HRECs, download the fee form directly from their internet page.