-
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 user or technical issues or assistance needed with ERM, please refer to https://www.clinicaltrialsandresearch.vic.gov.au/ethical-review-manager prior to contacting our office. This link provides information, training and contacts relating to ERM. Feel free to contact our office ethics@easternhealth.org.au if you have any governance issues.
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 in https://www.easternhealth.org.au/research-ethics/guidance/quick-links-to-forms-and-templates to determine level of risk and subsequent application.
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 can be located here: https://www.easternhealth.org.au/research-ethics/guidance/quick-links-to-forms-and-templates
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 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.
- 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
-----------------------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
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.
Human Research Ethics Sub Committee Meeting Dates
Currently there are no specific dates/deadlines due to current environment. Please submit as usual, and there is an approximate 2-4 week turnaround at present
Human Research Ethics Committee Meeting Dates
Meeting Dates
- 17 February 2022 Submission deadline: 31 January 2022
- 17 March 2022 Submission deadline: 28 February 2022
- 14 April 2022 Submission deadline: 28 March 2022
- 19 May 2022 Submission deadline: 29 April 2022
- 16 June 2022 Submission deadline: 27 May 2022
- 21 July 2022 Submission deadline: 01 July 2022
- 18 August 2022 Submission deadline: 29 July 2022
- 15 September 2022 Submission deadline: 26 August 2022
- 20 October 2022 Submission deadline: 30 September 2022
- 17 November 2022 Submission deadline: 24 October 2022
- 08 December 2022 Submission deadline: 21 November 2022
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.
- Any ERM Technical or User issues are to be referred to here: https://vic.review.ethicalreviewmanager.com/Personalisation/DisplayPage/4 . 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.
- Posted
- Last Modified: Friday, March 25, 2022
Eastern Health is committed to ensuring the communities we service receive care that is responsive to their cultural and language needs.
Eastern Health acknowledges the Traditional Owners of the land on which its services operate, and pays respect to their Elders past, present and emerging. Eastern Health is committed to achieving equality in health status between Aboriginal and Torres Strait Islander peoples and non-indigenous Australians.
Eastern Health is an inclusive healthcare service.
Get Connected