All research projects must be submitted for ethical and research governance review before a project can be given approval to commence.
The Melbourne Health Human Research Ethics Committee is constituted and operated in accordance with the National Statement on Ethical Conduct in Human Research 2007.
The application process
- Complete all 15 steps to apply for HREC ethical review.
- Research that is considered low risk is where the risk of trial participants is not more serious than suffering discomfort. Find out more about low risk research projects. Steps 7, 10 and 11 are not required for Low Risk Reviews.
1. Obtain a Local HREC Project Number
Contact the Office for Research to obtain a Local HREC Project Number (example - 2015.001).
The Local HREC Project Number must appear in the top right-hand corner of all hard copies of each component of your application.
2. Obtain a multisite HREC number (multisite projects only)
Clinical trials and health and medical research projects
Call the Central Allocation System (CAS) for your project to be allocated to a reviewing HREC.
Central Allocation System telephone: (03) 9096 7395
Monday to Friday, 10am to 5pm EST.
This call will involve answering questions about your research and then you will be asked to provide relevant information. The call will take approximately 15 minutes.
CAS will provide you with a HREC reference number (example - HREC/11/MH/7).
Note that this number is different to a local HREC Project Number (example - 2015.001). Both these identifiers need to be documented on the submission.
5. Complete Ethics Checklist
Complete the Ethics Checklist. This should be completed by the coordinating principal investigator (CPI).
The CPI is the person who will submit the research project to the HREC on behalf of other sites and coordinate the ethical submission.
6. Complete NEAF or LNR
Access Online Forms and complete the relevant form - either the National Ethics Application Form (NEAF) or Low Negible Risk (LNR) form.
The Coordinating Office for Clinical Trial Research have released an Online Forms Handbook. Download a copy of the Online Forms Handbook to assist you with creating, completing and submitting ethics and research governance applications.
8. Provide a project protocol
Submit a detailed project protocol and any other documentation, such as:
- documents to be given to participants, such as letters of invitation, transcripts for telephone contact, questionnaires, patient diaries
- assessment tools
- advertising materials
- data collection sheets
Researchers may elect to use project protocol template for investigator initiated studies.
9. Complete participant information and consent forms
Complete a Participant Information and Consent Form (PICF) if the study involves participants from whom you are obtaining consent.
Different templates are available on the Department of Health website. Use the template(s) that are appropriate for the type of research you are conducting.
10. Submit the investigator's brochure
If conducting a drug or device clinical trial, submit one copy of the investigator's brochure (IB).
Low risk research projects
This step is not applicable to low risk research project.
11. Complete a Radiation Safety Officer report for research involving ionising radiation
Section 4 of the Victorian Specific Module must be submitted for all Victorian participating sites for which we are providing HREC review.
If exposure to ionising radiation is outside of standard care an RSO report must be submitted for each participating site for which we are providing HREC review.
For all sites outside of Victoria, submit either the RSO report (if radiation is outside of standard care) or the Notification to the Reviewing HREC for the use of Ionising Radiation in Research - Standard Care Form.
Find our more about ethical review of research projects involving ionising radiation.
Low risk research projects
This step is not applicable to low risk research projects.
13. Submit hard copy documents
Submit the signed, original application (single sided). No copies are required.
The HREC application must be submitted by 1pm deadline day and will not be accepted after this time.
Find our more about HREC submission dates and deadlines.
Make sure you submit:
- All original documents
- Complete with appropriate signatures
Submit the original application to:
Manager, Human Research Ethics Committee
Office for Research
14. Submit an electronic copy
Submit an electronic copy of the HREC application by 1pm deadline day to HRECSubmissions@mh.org.au.
The Local HREC Project Number must be included in both the email subject field and in the individual file names. Standard formats for naming files are outlined below.
To ensure the electronic copies submitted are easily identifiable, the format outlined below must be used for all electronic files. Do not include version numbers or dates in file names.
Projects submitted that do not follow these formats will not be considered and will be returned via email to sender.
NEAF YYYY.NNN (Example: If your project number is 2011.123, the file name should be NEAF 2011.123)
Participation and Information Consent Form (Word Format Only)
PICF YYYY.NNN (Example: PICF 2011.123)
PICF Master YYYY.NNN (Example: PICF Main 2011.123) - PICF for SERP studies
PICF Site Specific YYYY.NNN (Example: PICF Site Specific 2011.123) - PICF for SERP studies
PICF PG YYYY.NNN (Example: PICF PG 2011.123) - PICF for Pharmacogenetics studies
PICF PK YYYY.NNN (Example: PICF PK 2011.123) - PICF for Pharmacokinetic studies
PICF BM YYYY.NNN (Example: PICF BM 2011.123) - PICF for Bio Marker studies
PICF PR YYYY.NNN (Example: PICF PR 2011.123) - PICF for Person Responsible
PICF PPR YYYY.NNN (Example: PICF PPR 2011.123) - PICF for Person after Person Responsible
PICF PR consent to continue after PA YYYY.NNN (Example: PICF PR continuation after PA 2011.123) - PICF for Person Responsible consent to continue after Procedural Authorisation
PICF consent to continue after PA YYYY.NNN (Example: PICF consent to continue after PA 2011.123) - PICF consent to continue after Procedural Authorisation
Protocol (Word or PDF Format)
Protocol YYYY.NNN (Example: Protocol 2011.123)
Victorian Specific Module (Word or PDF Format)
VSM YYYY.NNN (Example: VSM 2011.123)
Questionnaires (Word or PDF Format)
Questionnaire (Abbreviated Name) YYYY.NNN (Example: Questionnaire (QOL) 2011.123)
Advertisement (Word or PDF Format)
Advertisement YYYY.NNN (Example: Advertisement 2011.123)
Investigators' Brochure (Word or PDF Format)
IB YYYY.NNN (Example: IB 2011.123)
Cover Letter (Word or PDF Format)
Cover Letter YYYY.NNN (Example: Cover Letter 2011.123)
HREC Checklist (Word or PDF Format)
HREC Checklist YYYY.NNN (Example: HREC Checklist 2011.123)
Participant Card (Word or PDF Format)
Participant Card YYYY.NNN (Example: Participant Card 2011.123)
Databank Registration Form (Word or PDF Format)
DBRG YYYY.NNN (Example: DBRF 2011.123)
Tissue Bank Registration Form (Word or PDF Format)
TBRF YYYY.NNN (Example: TBRF 2011.123)
If you have any other attachments please clearly state what they are and then add the project number YYYY.NNN
15. Complete Research Governance application
Finally, you need to complete an application for Research Governance, if RMH is a participating site.
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.
NOTE: For CTN Submissions
For externally sponsored CTN clinical trials (external sponsors may be commercial, a collaborative group or another hospital, etc)
Upon receipt of the HREC ethics approval from the reviewing HREC, external sponsors can lodge the CTN directly with the Therapeutic Goods Administration (TGA), online. Sponsors ares asked to provide the Melbourne Health Principal Investigator with a copy of the TGA's confirmation/acknowledgement of the CTN together with a PDF copy of the lodged CTN application to forward to HrecCorrespondence@mh.org.au as soon as this is available.
For Melbourne Health sponsored CTN clinical trials (ie investigator initiated trials where there is no external sponsor)
Upon receipt of governance approval letter from Melbourne Health, researchers must make an appointment with the Office for Research, Research Support Officer to lodge the CTN application online together. The fees associated with the CTN submission will be set against the applicable research cost centre.
Direct any questions about the CTN submission scheme to the Research Support Officer.
Contact us if you need an accessible version of a download.