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 LR sub-committee have been delegated authority by the Board of Directors at Epworth and have executive authority conferred upon them to fulfil the role and carry out the functions detailed in the HREC and sub-committee Terms of Reference.


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 does not currently participate in the National Mutual Acceptance (NMA) system, therefore all research projects to be conducted at Epworth must be reviewed by the Epworth HealthCare HREC or the LR Sub-Committee.


Advanced notice, June 2017 HREC meeting

 

Please be aware that there will be limit to the number of new submissions accepted for the June HREC meeting due to regulatory commitments being undertaken by Epworth HREC.

 

If you plan to submit a new study for ethical review in June please contact us as early as possible to discuss.


Low risk ethics applications will not be affected.


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 ethics officer

Helen Christensen

Phone 03 9426 8806


Research administration officer

Kerrie Lawrence

Phone 03 9426 8630


HREC email enquiries and submissions

HREC@epworth.org.au


Research governance officer

Sara Goodman

Phone 03 9936 8205


Governance email enquires and submissions

EC-ResearchGovernance@epworth.org.au


Physical address

Ground Floor, Pelaco Building

21-31 Goodwood Street

Richmond Vic 3121


Postal address

Mailbox #4 

Epworth HealthCare

89 Bridge Road

Richmond VIC 3121


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
​Commercially sponsored protocol amendments $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

 

2017 submission deadlines and meeting dates


Advanced notice, June 2017 HREC meeting


Please be aware that there will be limit to the number of new submissions accepted for the June HREC meeting due to regulatory commitments being undertaken by Epworth HREC. If you plan to submit a new study for ethical review in June please contact us as early as possible to discuss. 

Low risk ethics applications will not be affected.


Initial submission

Initial submission requirements


All new project submissions to the ethics committees and governance office must be submitted, reviewed and processed through Velos eCompliance.

 

Full HREC submission requirements 


Ethics document

Must be submitted by the meeting deadline. 

​Submission checklist

 


  • Required for all submissions.

Epworth ethics form


  • Completed and submitted through Velos eCompliance.


Radiation safety review
and VSM section 4
(if applicable)

 
  • Section 4 of the VSM must be submitted for ALL studies that involve exposure to radiation, the VSM template can be downloaded from the Department of Health website.


​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)
 

  • Epworth PICF guidance document.


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


​Investigator CV

 

Governance documents

Epworth governance form

  • Although this is a governance document please submit with the ethics application as it will assist with the ethical review of the project.

  • Completed and submitted through Velos eCompliance.


 

  • 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.

​Submission checklist


  • Required for all submissions.


Epworth ethics form

  • Completed and submitted through Velos eCompliance.


​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)

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.

 
Investigator CV


 

Governance documents

Epworth governance form
  • Although this is a governance document please submit with the ethics application as it will assist with the ethical review of the project.

  • Completed and submitted through Velos eCompliance.

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.


 

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 by the research ethics officer as authorised under the Epworth HealthCare Human Research Ethics Committee (HREC), Sub-Committee & Research Governance delegation and authorisation protocol. The decision to review submissions outside of a meeting will be decided on a case-by-case basis by the HREC chairperson and research ethics officer.

 

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.

 

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;

Problem reports

SAEs SUSAR, USADE, Line Listings, Protocol Deviations/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 Adverse Events (SAEs) for Epworth HealthCare participants should be submitted to the relevant committee within 24 hours when possible (unless otherwise agreed with the HREC or Research Development & Governance Department);

  • 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 deviations (a departure from the approved protocol that does not result in harm or risk to the trial participant and does not have the potential to significantly affect the study outcomes) should be submitted to the relevant committee by the submission deadline.

  • 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.

  • SUSAR and USADE Line Listings should be submitted on a 6 monthly basis (unless otherwise agreed with the HREC or Research Development & Governance Department);


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.


 

Velos eCompliance



Velos eCompliance is the new online platform for research ethics and governance review administration which has been implemented at Epworth HealthCare. All new project submissions to the ethics committees and governance office will be submitted, reviewed and processed through Velos eCompliance.


All post-approval submissions to the ethics committees and governance office are required to be submitted via email and not through the Velos eCompliance application.


Access


Velos access request form and submit to research@epworth.org.au


Support


Velos user manual


If you still have questions after consulting the Velos user manual or feel that you would benefit from a training session please contact the Research Development & Governance team.

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