Guidance

The Office of Research and Ethics is responsible for ensuring that the research conducted at Eastern Health meets the NHMRC National Statement on Ethical Conduct in Human Research. The office provides administrative support to the Eastern Health Human Research Ethics Committee (HREC) and Subcommittee. The HREC and Subcommittee are responsible for providing ethical and scientific review of research projects and serve to protect the welfare of research participants. In addition, The Office of Research and Ethics ensures that all research at Eastern Health is conducted in line with Eastern Health research governance policy. Research governance refers to a framework that ensures research is conducted responsibly, safely and is scientifically and ethically sound. Research governance considers the legal compliance, financial management, accountability and risk management associated with a research project.

The Office of Research and Ethics is currently developing new guidance and is currently transitioning all project submissions to be conducted via Ethical Review Manager (ERM). The below information is general guidance regarding submissions.

For assistance with ERM please refer to the Applicant user guide to ERM prior to contacting the office.

For any queries or further information regarding submission please contact the Eastern Health Office of Research and Ethics: ethics@easternhealth.org.au

New Submissions

Please complete the Level of Risk Checklist located in Quick Links to Forms and Templates to determine level of risk and subsequent application.

New Ethics application

Negligible/Low Risk Research

All submissions are to be made online via Ethical Review Manager (ERM).
Complete and submit via ERM a Human Research Ethics Application (HREA). *NOTE: Eastern Health does not accept the LNR VIC application.
Complete and submit via ERM ‘sub-forms’ a Site Specific Assessment (SSA) *NOTE: An SSA is not required if the study is not going to be conducted at an Eastern Health site.
Send an email direct to ethics@easternhealth.org.au quoting the ERM Project ID to advise the Office of Research and Ethics that a submission has been made via ERM
The application will be reviewed by the Eastern Health Human Research Ethics Subcommittee, please see below for meeting dates.

Greater than Low Risk (High Risk) Research

All submissions are to be made online via Ethical Review Manager (ERM).
Complete and submit via ERM a Human Research Ethics Application (HREA)
Complete and submit via ERM ‘sub-forms’ a Victorian Specific Module (VSM)
Complete and submit via ERM ‘sub-forms’ a Site Specific Assessment (SSA)
*NOTE: An SSA is not required if the study is not going to be conducted at an Eastern Health site.
Send an email direct to ethics@easternhealth.org.au quoting the ERM Project ID to advise the Office of Research and Ethics that a submission has been made via ERM
The application will be reviewed by the full Eastern Health HREC, please see below for HREC meeting dates.

Research Governance Applications for multi-site projects under the National Mutual Acceptance (NMA) scheme (formerly known as SERP)

All submissions are to be made online via Ethical Review Manager (ERM).

Complete and submit the SSA via ERM ‘sub-forms’
Send an email to ethics@easternhealth.org.au quoting the ERM Project ID to advise the Office of Research and Ethics that a submission has been made via ERM.

If you are not the owner of the project on ERM and need to submit an SSA you will need to contact the owner of the project to share and add you as a collaborator. The owner should create the SSA on your behalf and share this to you giving you all permissions (Read, write, submit, share, create sub-forms) so you can complete and submit the SSA.

Quality Assurance/Audit application

Complete the internal Quality Assurance/Audit application located in Quick Links to Forms and Templates and submit via email to ethics@easternhealth.org.au

Case Reports

Case reports on their own are not considered research and as such do not require ethics approval. By their nature, Case Reports are considered to be of educational value to clinicians.

Journals encourage authors to include the patient perspective in the article, therefore, the presentation of the case report will often involve an interaction with the patient.

Authors must gain consent from the patient using the Case Report Consent Form. If it is not possible to gain consent e.g. the person has passed away, consent should be sought from the patient’s next of kin. Refer to Privacy at Eastern Health for further information.

Patient details should be de-identified prior to submission for publication. Publication of any personal information about an identifiable living patient requires explicit consent.

Post Approval Submissions

Post approval submissions are to be completed via ERM ‘sub-forms’ under the HREA (ethics) or SSA (research governance). There is exception to this with safety reporting, progress reporting and change of personnel which can be completed on internal forms and submitted via email.

For studies with current ethical approval that have not been registered on ERM (or online forms previously) where researchers need to submit new post approval documentation, researchers are required to complete a Legacy Application Replacement Form (LARF) on ERM which will allow submission via ERM. The LARF form does not require approval and once created will allow immediate submission. This will include all negligible/low risk applications completed and submitted on the old Eastern Health Low/Negligible Risk Research Application.

If you are unsure if your application has been registered on ERM please contact the office.

Amendments, Breaches & Notifications

Complete and submit via ERM ‘sub-forms’.
Any amended documents (i.e. PICF, Protocol) are required to be uploaded with tracked changes.
Send an email to ethics@easternhealth.org.au quoting the ERM Project ID & Local Reference Number to advise the Office of Research and Ethics that a submission has been made via ERM.
All breaches (protocol deviations) regardless of seriousness are required to be submitted to the Office of Research & Ethics. Non-serious breaches can be reported in a quarterly summary.

Safety Reporting

Studies sponsored by Eastern Health (such as Eastern Health investigator initiated) are required to report all safety events. Externally sponsored studies are required to report any serious events that are related to the Investigational Product (IP). The seriousness of the event will determine how the report is submitted:

Adverse Events (AE), Adverse Reactions (AR) & Serious AE/AR are to be reported on the internal Safety Report form only located in Quick Links to Forms and Templates and are to be submitted via email to ethics@easternhealth.org.au quoting the local reference number in the subject line
Significant Safety Issues (SSI), Suspected Unexpected Serious Adverse Reactions (SUSAR), Urgent Safety Measures (USM) and Annual Safety Reports are to be submitted via ERM
- For Ethics applications (HREA) complete via the Safety Report form located under ‘sub-forms’
- For Research governance applications (SSA) complete via the Site Notification Form located under ‘sub-forms’ and attach the reviewing HREC acknowledgement
- Send an email to ethics@easternhealth.org.au quoting the ERM Project ID & Local Reference Number to advise the Office of Research and Ethics that a submission has been made via ERM.

Progress Reporting

Complete and submit via ERM Progress Report under ‘sub-forms’
Send an email to ethics@easternhealth.org.au quoting the ERM Project ID & Local Reference Number to advise the Office of Research and Ethics that a submission has been made via ERM.

Complete the internal Progress Report form located in Quick Links to Forms and Templates and submit via email to ethics@easternhealth.org.au quoting the Local Reference in the subject line

For multi-site studies (research governance applications) a site progress report should be submitted that covers Eastern Health activity only. The overall study/reviewing HREC report is not required.

Change of Personnel

Complete and submit a Change of Personnel Form located in Quick Links to Forms and Templates to add, remove or amend personnel
For new personnel submit a Curriculum Vitae (CV)

*NOTE not required if a CV has already been submitted to the office within the past 2 years

For new personnel who are external to Eastern Health and have access to identifiable Eastern Health data complete and submit Confidentiality Agreement located in Quick Links to Forms and Templates
Submit via email to ethics@easternhealth.org.au quoting the Local Reference in the subject line

Human Research Ethics Committee Meeting Dates

Meeting Dates