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 has transitioned all project submissions to via Ethical Review Manager (ERM) with few exceptions (change of personnel, local safety report, Case Report and Clinical Quality Registry). The below information is general guidance regarding submissions.

User or technical issues or assistance with ERM. This link provides information, training and contacts relating to ERM.

The Office of Research and Ethics are users of ERM, as applicants are, albeit on a different / reviewer platform. The Office will not be able to access any ERM form until the project has been submitted, nor we are allowed / able to amend any responses on any ERM forms.

For any queries or further information regarding submission please contact the Eastern Health Office of Research and Ethics: ethics@easternhealth.org.au. Please provide us with an Eastern Health reference number, if possible, to speed up your enquiry.

New Submissions

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

Please complete a Research Protocol Template. All submissions for QA, Low risk or Greater than Low Risk Projects require a Protocol to be completed and submitted with the application. The office has developed one Protocol Template for QA and another for Low Risk or Greater than Low Risk Projects - please refer to Quick Links to Forms and Templates (easternhealth.org.au) to locate the required template under its respective research type.

New Ethics Applications

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 Victorian Specific Module (VSM) (if applicable)
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 directly 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 (Role) (Read, write, submit, share, create sub-forms) so you can complete and submit the SSA.

Additional information regarding ERM.

Quality Assurance/Audit application

All Quality Assurance and Audit Activities are now submitted only via Ethical Review Manager (ERM). For further information.

Post Approval Submissions

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

For studies with current ethical approval from EH HREC 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.

For multi-site studies (i.e., ethically approved by another HREC), an SSA with basic information is required. 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 with you giving you all permissions (Role) (Read, write, submit, share, create sub-forms) so you can complete and submit the SSA. In addition, a Minimal Dataset Form (MDF) may be required if the approving HREC is not using ERM. You will then be able to create and submit the SSA.

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.
All progress reporting as of 1-1-2022 must be submitted using Ethical Review Manager (ERM). Previous forms are now no longer accepted and will be returned. Further details can be located in Quick Links under ERM (Ethical Review Manager) Submissions.

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

Site Specific Information (CTRA, CTN and other Governance Documents)

Eastern Health Details

Logo: Please use new/current logo as of 2021.

Name of Institution: Eastern Health, a Body Corporate established under the Health Service Act 1988

ABN: 68 223 819 017

Address: 5 Arnold Street, Box Hill, Victoria 3128 Australia

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Eastern Health PICF Contact Details

Single Ethics Submissions – high risk / low risk submissions to Eastern Health HREC

Complaints contact person and reviewing HREC

Name Eastern Health Human Research Ethics Committee

Position Chairperson

Telephone 03 9895 3398

Email ethics@easternhealth.org.au

Governance Submissions (SERP) – multiple sites’ project approved under National Mutual Acceptance (NMA) initiative

Complaints contact person

Name Eastern Health Office of Research and Ethics

Position Manager

Telephone 03 9895 3398

Email ethics@easternhealth.org.au

PICF Footer - preferred formatting is 2 lines only, delete reference to global

Eastern Health Participant Information Consent Form version X dated DDMMYYYY

Based on Master ……. (do NOT alter, leave as is, per the master PICF)

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Clinical Trial Agreement

HREC / RGO Fee STANDARD clause:

“HREC and/or Research Governance Review (RGO) fees will be reimbursed on a pass-through basis as per the fees indicated on the HREC/RGO website at the time of each submission. Fees are payable to the institution (Eastern Health) so as to allow any review and/or approval to remain valid and avoiding future sanctions. HREC/RGO fees are not included in, nor part of the per patient payment, site or start-up fees,

There is propensity to assume HREC/RGO fees are part of other fees/budget, please to refer to any specific reference regarding this fee, in any contract/agreement, generally outside of budgets/table and its own clause.

Please forward the remittance details to accountsreceivable_FMIS@easternhealth.org.au AND ethics@easternhealth.org.au

CTN Details

Site Name: Eastern Health - xxx Hospital

…. …

Name of Approving Authority: Eastern Health

Approving Authority Contact Officer: Manager

Approving Authority Contact Position: Manager

Approving Authority Contact Phone: 03 9895 3398

Approving Authority Contact Email: ethics@easternhealth.org.au

Please contact our office if you require further assistance

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.

Documents to submit via email to ethics@easternhealth.org.au

Case report (draft or final, or a description at least) to be published – ensure no identifiable data in the report, eg patient’s name, date of birth, address, initials etc.
Signed consent form from patient / next of kin (NoK).

Submitting and Timelines

When submitting any documents, requests or enquiries to our office at, ethics@easternhealth.org.au it always helps with expediency of your request, if the Eastern Health Local Reference Number is quoted and/or additional information such as Title, PI Name, ERM Project ID or Protocol Number. Delays in your request can be expected without these details, also causing delays across the board.
Emails stating only “I have made a submission today” or references to things such as “my/our study” is unhelpful and time consuming to locate the said study. The Ethics Review Manager (ERM) is not perfect as we do not receive any notifications for submissions, and in some cases the submission itself on ERM is unclear until opened/downloaded/read through, before deciding which path it needs to take. Hence why we request for a courtesy email upon ERM submission, and courtesy emails listing what’s been submitted can be generally attended to more efficiently.

Timelines in the office are affected by, but not limited to the following:

Date/Time of submission and HREC meeting dates
Quality of submission – this refers to accurate and complete submissions
Volume of current submissions being received
Volume of content within a submission
Requirement re preparation, approval, signature of agreements, etc
Response times to submission queries
Resources at the time

We have specific timelines for each submission type we try to keep to and in most cases we do, given all the above taken into consideration. If you have a genuine need for a submission to be expedited please contact our office. This would need to be around the research and patients itself, and generally not things such as leave or wanting to bypass the process or order of submission.

Human Research Ethics Sub Committee Meeting Dates

Human Research Ethics Committee Meeting Dates

Meeting Dates: Please advise via ethics@easternhealth.org.au of any new submissions.

16 February 2023 Submission deadline: 30 January 2023
16 March 2023 Submission deadline: 27 February 2023
20 April 2023 Submission deadline: 3 April 2023
18 May 2023 Submission deadline: 1 May 2023
15 June 2023 Submission deadline: 29 May 2023
20 July 2023 Submission deadline: 03 July 2023
17 August 2023 Submission deadline: 31 July 2023
21 September 2023 Submission deadline: 4 September 2023
19 October 2023 Submission deadline: 2 October 2023
16 November 2023 Submission deadline: 30 October 2023
14 December 2023 Submission deadline: 27 November 2023

Submission Tips and Information

Check that any documents ready for submission have date and version numbers on them.
Where possible please quote the Eastern Health reference number on any correspondence. It will generally commence with E, S, SERP or LR.
Our timelines are dictated by completeness and quality of submissions, various guidelines, policies, resources and availability of the HREC committees.
Ethical Review Manager (ERM) does not advise us of in coming submissions. So a courtesy email regarding any submission would be appreciated.
ERM Technical or User issues. Our office is unable to assist with these issues, we do not have access to any submission until they are actually submitted.
Progress Reporting is mandatory and provides ongoing approval so research can continue. Failure to do so can result in suspension or withdrawal of research.
Our office is available via email and telephone (please leave a message if not answered), we are also available, online, via platforms such as Webex, Zoom etc.
Our office processes approximately 1500 submissions a year. We always endeavour to process these efficiently as possible, along with incoming enquiries and additional responsibilities of the office.