Research ethics and governance

 

Research ethics


Ethical reviews of projects are conducted by the Epworth HealthCare Human Research Ethics Committee (HREC) and the HREC low risk (LR) sub-committee to ensure that research conducted at Epworth complies with the guidelines set out in the National Statement for Ethical Conduct of Human Research and the Australian Code for the Responsible Conduct of Research.

 

The HREC and its LR sub-committee have been formed under the auspices of the National Health and Medical Research Council (NHMRC) who provide leadership and advice regarding research governance in Australia.

 

Epworth is currently in the process of updating our policies and procedures to be able to accept ethical review under the National Mutual Acceptance (NMA) scheme. Please contact us for further information.


Research related complaints

 

If you have a complaint in regards to a research project being conducted at Epworth HealthCare  please refer to the Epworth research-related complaints protocol. You can also contact the research ethics officer by phone 03 9426 8806 or email HREC@epworth.org.au for more information.


Research governance


Research conducted at Epworth HealthCare must be governed through every stage of the project to ensure the principles, requirements and standards of research are upheld. 


Research governance addresses the protection of research participants, the safety and quality of research, privacy and confidentiality, financial probity, legal and regulatory matters, risk management and monitoring arrangements whilst promoting good research culture and practice.


Research misconduct

 

If you are a researcher and wish to lodge a complaint regarding the conduct of research at Epworth HealthCare please contact the research governance officer on 03 9936 8205 or email EC-ResearchGovernance@epworth.org.au for more information.


Contacts

Research Development and Governance Unit

EC-ResearchGovernance@epworth.org.au

EC-HREC@epworth.org.au


Gerlinda Amor (Tuesday, Thursday)

Phone 03 9936 8058


Kyle Heffernan 

Phone 03 9936 8205


Helen Christensen

Phone 03 9426 8806


Kerrie Lawrence

Phone 03 9426 8630

 

Physical address

Ground Floor, Victor Smorgon Building

185 – 187 Hoddle Street​

Richmond Vic 3121


Postal address

Mailbox #21

Victor Smorgon Building

185 – 187 Hoddle Street​

Richmond VIC 3121​

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Review fees

 

Full HREC review fees

​Type of study

​ Fees

​New submissions – commercially sponsored $4,500 + GST

New submissions - partially funded  (including commercial funding, grant funded, non-commercially sponsored/collaborative group and internal applications)


$3,500 + GST
​Internal applications - unfunded

Nil
External applications - unfunded $2,500 + GST​
​Student researchers - internal

​Nil
​Major amendments - commercially sponsored​ $1,000 + GST
 
Low & negligible risk reviews fees

​Type of study

​Fees

​New submissions initiated by a non-Epworth HealthCare investigators or commercially sponsored studies   
​$250 - $1,000
  + GST
 

A review fee invoice will be sent to the sponsor contact listed on the submission. Please ensure the correct contact person is listed in the application.


Ethics committee meeting dates

Submission Documents

Submission Documents
 

Full HREC submission required documents


Ethics document

Must be submitted by the meeting deadline. 

Human Research Ethics Application Form (HREA)



Radiation safety review 

 

​Victorian Specific Module
  • ​​Researchers are required to complete a Victorian Specific Module (VSM) for any research at a site in Victoria to address legislative requirements laid down by the Victorian State Government.
  • The Victorian Specific Module form can be found on the Department of Health website.
  • The Department of Health website also has a document providing guidance on filling out the VSM​.
​Protocol


  • Ensure that all study protocols have a version number and date applied to the document before submission.

Investigator's Brochure or Product Information sheet
(if applicable)

  • Each investigational product will require an Investigator's Brochure (IB) or Product Information (PI) sheet to be submitted.
  • If available, product information should be obtained from the TGA website

Epworth Participant Information and Consent Form(s)
 


​Participant material
(if applicable)
 
  • Data collection tools, advertising material, questionnaires, letter of invitation/letter to GP, participant diaries  and participant wallet cards


​​Waiver of consent (if applicable)



Governance documents

Site Specific Amendment (SSA) form


Researcher Credentialling Documents
  • ​Researcher Credentialling Form​
  • CV that is at most 3 years old, written on the Epworth Researcher CV template​.
  • Visiting Medical Officers who wish to be a Principal investigator on a study are required to sign a VMO Researcher Agreement.
  • External Research Students or External Research Contractors require a signed agreement.
  • Good Clinical Practice (GCP) training is mandatory for all Principal Investigators at Epworth, and highly recommended for all researchers.​ Epworth employees may be eligible to undertake GCP through Monash Partners.
  • Any Visiting Medical Officers or external researchers may have to provide evidence of their medical insurance. 
 

  • If a commercially sponsored study the budget in the research agreement will be sufficient.


Research agreement
(if applicable)
 

  • A fully executed document must be submitted before governance authorisation can be granted.

  • If the document is not on a standard Medical Technology Association of Australia (MTAA) or Medicines Australia (MA) template, the agreement must be reviewed by Epworth general counsel before execution.

  • If a study is not commercially sponsored but involves a collaboration between Epworth and another institution a research collaboration agreement should be in place before commencement to ensure each party is aware of their rights and responsibilities in relation to its conduct. e.g. Clinical Trials Research Agreement, Collaborative Agreement, NHMRC Multi-Institution Agreement.


Standard Indemnity
(if applicable)

  • If the document is not on a standard MTAA or MA template, the indemnity must be reviewed by Epworth general counsel before execution.

  • A fully executed document must be submitted before governance authorisation can be granted.


​Certificate of currency (insurance)


  • Although this is a governance document please submit with the ethics application, as the certificate must be sent to the Epworth insurers for approval.


​Department/Clinical Institute sign off
 

  • Once all aspects of the governance review have been completed the research development and governance office will obtain endorsement from the director of your department or clinical institute.


CTN
 

  • ​As a minimum a copy of the draft eCTN application must be provided as part of initial submission.

  • If your project is investigator initiated and Epworth is to act as the sponsor the eCTN details form must also be submitted.

 
 

Low Risk Sub-Committee submission requirements


Ethics documents

Must be submitted by the meeting deadline.

Human Research Ethics Application form (HREA)


​Protocol


  • Ensure that all study protocols have a version number and date applied to the document before submission.


​Epworth Participant Information and Consent Form/s (PICF)

(if applicable)

Victorian Specific Module
  • ​​Researchers are required to complete a Victorian Specific Module (VSM) for any research at a site in Victoria to address legislative requirements laid down by the Victorian State Government.
  • The Victorian Specific Module form can be found on the Department of Health website.
  • The Department of Health website also has a document providing guidance on filling out the VSM​.​

Waiver of consent

(if applicable)


​Participant material

(if applicable)


  • Data collection tools, advertising material, questionnaires, letter of invitation/letter to GP, participant diaries and participant wallet cards.

 
Researcher Credentialling Documents
  • Researcher Credentialling Form​
  • CV that is at most 3 years old, written on the Epworth Researcher CV template​.
  • Good Clinical Practice (GCP) certificate
  • Any Visiting Medical Officers or external researchers may have to provide evidence of their medical insurance.
  • External researchers may also have to go through the Honorary Research Affiliate process, if applicable.​
Investigator CV


 

Governance documents

Site Specific Amendment (SSA) form
Site budget

  • If a commercially sponsored project the budget in the research agreement will be sufficient.

Research agreement
(if applicable)
 

  • If a study involves a collaboration between Epworth and another institution or commercial sponsor a research agreement should be in place before commencement of the project to ensure each party is aware of their rights and responsibilities in relation to its conduct. e.g. Clinical Trials Research Agreement, Collaborative Agreement, NHMRC Multi-Institution Agreement.

  • A fully executed document must be submitted before governance authorisation can be granted.

 
Department/Clinical Institute notification
  • Once all aspects of the governance review have been completed the research development and governance office will notify the director of your department or clinical institute.


 

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Amendments


All post-approval submissions to the ethics committees and governance office are required to be submitted via email to HREC@epworth.org.au.


Administrative updates may be reviewed outside of a meeting as decided on a case-by-case basis.

 

Documents

Amendment form
  • The amendment form template can be downloaded from the Department of Health website

  • The amendment form MUST be signed by the Epworth PI prior to submission.


Tracked and clean copy of all updated documents
  • Documents must be saved in a PDF format.

  • For updated protocols and IB also include a summary of changes.

  • For Investigator's Brochure updates please ensure the PI includes a statement in the amendment form regarding the impact of the update on the conduct of the study.

  • Ensure that the version number and date on the document is also updated.


Change in study team 

  • For the addition of an associate investigator, also include a current CV
  • For a change in principal investigator, include a current CV and sign off from the Head of Department.

​​Waiver of consent (if applicable)
 

Continuing review

Annual Reports


All post-approval submissions to the ethics committees and governance office are required to be submitted via email to HREC@epworth.org.au.

 
Annual Reports are due on the anniversary of ethical approval at Epworth HealthCare. Continued ethical approval of a project is dependent on the submission of annual progress reports, non-compliance may result in withdrawal of ethical approval.
 

Documents

Annual report form


  • The annual report form template can be downloaded from the Department of Health website

  • The annual report form MUST be signed by the Epworth PI prior to submission.


​Additional documents


  • ​As required.


 

Correspondence


General
ethics and governance correspondence that should be submitted may include (but is not limited to):

  • eCTN acknowledgement;

  • Notification of projects opening/closing to accrual;

  • Notification of suspension of participant accrual;

  • Notification of the project being added to the radiation license;

  • Updated insurance certificates;

  • Indemnity or research agreement updates;

​​

Safety Reporting

Update to Safety Reporting Guidelines

 

The NHMRC updated "Safety Monitoring and Reporting in Clinical Trials involving Therapeutic Goods- November 2016​" guidelines mean that;

 

- It is not a requirement for sponsors or investigators t​o submit individual individual AEs, SAEs and LLRs to the Epworth HREC.

- It is a requirement that sponsors submit an annual safety report to the Epworth HREC. This report must include a clear summary of the evolving safety profile of the trial as well as evidence that the sponsor is conducting its ongoing safety monitoring appropriately.​

SUSAR's, USADE's and Protocol Violations


All post-approval submissions to the ethics committees and governance office are required to be submitted via email to HREC@epworth.org.au


The submission requirements will vary depending on the type of safety report being submitted:

  • Individual Serious Unexpected Suspected Adverse Reactions (SUSAR) or Unanticipated Serious Adverse Device Effects (USADE) for Epworth HealthCare participants must be submitted to the relevant committee within 24 hours when possible;

  • Protocol violations (a departure from the approved protocol, which may affect the safety of trial participants or the study outcomes) must be submitted to the relevant committee within 24 hours when possible.

Investigator-initiated studies

 
  • Protocol violation notifications should be reported to the research ethics officer and research governance officer immediately.

  • Urgent safety notifications should be reported to the research ethics officer, research governance officer and the TGA (where applicable) immediately.

  • Investigator-initiated study safety reporting may be required more frequently, as requested by HREC or the research development & governance department.

 

Documents

Appropriate safety report form
 

  • The safety report form MUST include an impact statement and be signed by the Epworth PI prior to submission.


​Additional documents
  • As required.


 

Study closure


All post-approval submissions to the ethics committees and governance office are required to be submitted via email to HREC@epworth.org.au.


Final reports should be submitted once the study has been closed at Epworth HealthCare. A study is regarded as closed when a closeout visit has been conducted by the sponsor or the last participant has completed project-related contact/no further access to medical records is required and all collected data have been analysed.

 

Documents

Epworth final report form

  • The final report form template can be downloaded from the Department of Health website

  • The final report form MUST be signed by the Epworth PI prior to submission.


​Additional documents
  • As required.


 

Study Application Process

Researchers should first contact the Research Governance and Development Unit (RGDU) and make an appointment to discuss the individual needs of their project. 


This will also be the point at which a study number and a review pathway will be assigned. N.B. There will no longer be a direct pathway to the HREC for researchers and all studies must come through the RGDU first. Please email EC-Research.Governance@Epworth.org​ to make an appointment.

Document naming convention

All documents submitted for ethical and governance review should follow this naming convention:

 
<Study Number> <Document Name> <Version Number and Date>_<clean/tracked*>
*if applicable

For Example: 672-15 Epworth PICF Version 1 dated 26 June 2015_tracked

Please ensure that the version number and date in the document title reflect the version number and date listed in the document.

Useful links