Research Ethics Guidance

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 pathway.

Please complete a Research Protocol Template. All submissions for QA, Lower Risk or Greater Risk Projects require a Protocol to be completed and submitted with the application. The office has developed a QA Protocol Template and a Lower/Greater Risk Protocol Template – 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

Greater 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 [email protected]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.

Lower 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 [email protected]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.

Research Governance Applications

For multi-site projects under the National Mutual Acceptance (NMA) scheme.

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 [email protected]quoting the ERM Project ID to advise the Office of Research and Ethics that a submission has been made via ERM.
• For Clinical Registries ONLY, also submit the completed Clinical Registry Application Form which can be found at Quick Links To Forms And Templates | Eastern Health.

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). Information regarding ERM, including new accounts and use can be located above under ERM (Ethical Review Manager) Submissions.
• For all QA submissions please use the QA Protocol template that can be found at Quick Links to Forms and Templates.

• Send an email directly to [email protected] quoting the ERM Project ID to advise the Office of Research and Ethics that a submission has been made via ERM

Post approval submissions are to be completed via ERM ‘sub-forms’ under the HREA (ethics) or SSA (research governance). There is an exception to this, with local safety reporting for multi-site studies that are ethically approved by another HREC. The reporting 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 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 [email protected] 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:

• EXTERNALLY SPONSORED STUDIES – All serious events that are related to the Investigational Product (IP) are to be reported on the internal Safety Report form only located in Quick Links to Forms and Templatesand are to be submitted via email to [email protected] quoting the Eastern Health Local Reference Number in the subject line
• EASTERN HEALTH INVESTIGATOR INITIATED STUDIES – All 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 [email protected] quoting the Eastern Health 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 [email protected] quoting the ERM Project ID and the Eastern Health Local Reference Number, to advise the Office of Research and Ethics that a submission has been made via ERM.

Progress Reporting (Annual and Final)

• Complete and submit via ERM Progress Report under ‘sub-forms’
• Project Progress Report is required for studies approved by the Eastern Health HREC. If any other site/s, other than Eastern Health, have been approved by Eastern Health HREC, the Project Progress Report should cover all sites. In addition, a Site Progress Report is required for Eastern Health only activities / progress. The report is due by end of February each year covering preceding calendar year.
• For multi-site studies (research governance applications) a Site Progress Report should be submitted that covers Eastern Health only activities. For convenience to researchers, we accept the Site Progress Report being submitted at the same time the Project Progress Report is due per HREC’s requirement (generally on the anniversary of the ethics approval or pre-determined date). The Project Progress Report and related HREC acknowledgement are not required.
• Progress Project Reports for the previous calendar year are due annually on 28^th February.
• Send an email to [email protected]u quoting the ERM Project ID & Local Reference Number to advise the Office of Research and Ethics that a submission has been made via ERM.

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 ALL new personnel submit a current Curriculum Vitae (CV)* and where required current Good Clinical Practice training certificate. *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 will have access to identifiable Eastern Health data they will also need to complete and submit Confidentiality Agreement located in Quick Links to Forms and Templates
• Submit via email to [email protected]quoting in the subject line the Eastern Health Reference Number for the Study.
• Ensure that ALL current investigators have access to the study in ERM by assigning them a”role” and those that have left have been removed from the study in ERM.

A Clinical Registry is a structured collection of data, including clinical outcomes and process measures, for a defined clinical condition.  They include large externally hosted and maintained registries down to small locally-hosted registries maintained by Eastern Health personnel.  A Clinical Quality Registry (CQR) is larger in scale and likely to be state-wide, national or international in scope.

Any subsequent research studies arising from a Registry data collection must seek the appropriate ethics approval from the relevant Human Research Ethics Committee (HREC).

Multi-Site Registry

For registries approved by a HREC other than Eastern Health HREC, a Research Governance application will need to be made by submitting an SSA form for Eastern Health in ERM. In your application include all HREC approval letter/s, all approved current documents listed in the HREC approval letter/s, any applicable site specific documents (e.g., PICF, flyer, etc.), a research agreement and the completed Eastern Health Clinical Registry Form. Please send an advisory email to [email protected] upon ERM submission, quoting the ERM Project ID. Please note the approving HREC must be a certified reviewing HREC under the National Mutual Acceptance (NMA) Scheme. The Eastern Health Clinical Registry form can be found at Quick Links to Forms and Templates | Eastern Health.  Refer to the New Submissions sections on this webpage for SSA submission instructions.

Eastern Health Only Registry

For a registry with Eastern Health as the only site, please complete the Eastern Health Clinical Registry Form (and submit your protocol as a Lower Risk Ethics application in ERM . On submission, please send an advisory email to [email protected], quoting the ERM project ID. The Eastern Health Clinical Registry form can be found at Quick Links to Forms and Templates | Eastern Health. Refer to the New Submissions section on this webpage for Ethics application instructions.

Contact our office for more information or assistance at [email protected].

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                     [email protected]

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                     [email protected]

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 [email protected] AND [email protected]

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: [email protected]

Please contact our office if you require further assistance

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 [email protected]

• 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).

When submitting any documents, requests or enquiries to our office at, [email protected] 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.

Please advise via [email protected] of any new submissions.

The Eastern Health Subcommittee usually meets twice a month.

** Submission deadline: C.O.B. ‘One week’ prior to the meeting date. **

• 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.

GCP training requirement

The GCP guidelines apply to clinical research and detail the requirements for trial documentation, protocol amendments, requirements such as indemnity, reporting lines for adverse events and provision of medical care for trial participants.

Accredited training in Good Clinical Practice (GCP) is expected by pharmaceutical companies that initiate commercially sponsored clinical trials. The current Research at Eastern Health Policy explicitly states that all staff involved in clinical trials must have completed training.

All other staff are actively encouraged to undertake the training.

Recommended GCP Training Programs

Monash Partners

Monash Partners offers two Good Clinical Practice (GCP) courses: An Introduction to GCP Workshop and a GCP Refresher course, which are available for free to paid employees of the Monash Partners organisations only. Please check their website for more information and available dates at Good Clinical Practice (GCP) in Clinical Trials – Monash Partners

Genesis Research

The Genesis research services Good Clinical Practice (GCP) Course is designed to prepare both investigators and research staff for the conduct of clinical trials with human participants.

The course is self-paced and takes approximately 2 – 4 hours to complete. A personalised GCP training certificate will be available for download upon successful completion of the course.

Course enrolment fee is $10.

Good Clinical Practice (ICH GCP) Course – Genesis Research Services

A-CTEC

The Australian – Clinical Trials Education Centre (A-CTEC) provides free self-paced GCP training for its members. More information can be found at Home | ACTEC (myopenlms.net).