Human Research Ethics Committee

The St Vincent's Hospital Melbourne Human Research Ethics Committee (HREC) is fully constituted and operates in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007), including all updates.

The HREC reviews studies such as :

  • Non-interventional
  • Qualitative
  • Laboratory or basic science 
  • Observational studies
  • Clinical research involving drugs, devices This includes both experimental agents, and those approved for use by the Therapeutic Goods Administration (TGA)
  • Non-standard clinical interventions. This includes both experimental agents, and those approved for use by the TGA.

Committee Information   

HREC - Terms of Reference 2019

HREC - Committee Composition 2019

 

HREC Meeting dates:

2019 HREC Submission Dates/ Closing Dates

 
HREC provides ethical review to research projects for conduction at the following sites:

  • St Vincent's Hospital, Fitzroy campus
  • St George's, Kew   
  • Caritas Christi campus  
  • Prague House campus
  • Cambridge House
  • DePaul House  
  • St Vincent's Private Hospital*
  • Any other site that does not have access to an institutional HREC

*Researcher are required to submit a Governance application to St Vincent's Private Hospital once ethics approval has been granted by SVHM HREC. 

 

Responsibilities of the Chief Principal Investigator (CPI),  Principal Investigator and Sponsor

 

Important Notices

Important Changes 2019

St Vincent’s Hospital (Melbourne) Site Specific Guidelines

The SVHM RGU has updated the site-specific guidelines document. The document can be located under the New Ethics Application Tab. The RGU advises all researchers/sponsor to read the document before completing an ethics submission. 

Important Changes 2018

Electronic Signature

Electronic signature is now accepted by the SVHM Research Governance Unit.

Wet ink signature will still be mandatory for the following documents:

  • Indemnities
  • Clinical Trial Research Agreements and Collaboration Agreements
  • All legal documents

The responsibility of submitting an application, amendment, safety report and annual progress report

The Research Governance Unit would like to inform all researchers that for all commercially sponsored studies, it will be the responsibility of the Research Coordinator or Principal Investigator to submit all applications including annual safety and progress report to the Research Governance Unit. 

This is to ensure that the research team has oversight of the conduct of the study. 

 

Ethics Review Manager (ERM)

On the 16 July 2018, Victoria transitioned from Online Forms to the new ERM system for Ethics and Governance submissions.

SVHM RGU understands that ERM is a new system and Researchers may be encountering issues performing submissions (for Ethics and Governance Applications and Amendments) to the RGU office.

The RGU Office would like to inform Researchers that if you encounter issues with submissions via ERM, you may submit your application via the alternative method below:

  • Generate a hard copy of the ERM form and scan form
  • Submit a hard copy of all study documents to the Research Governance Unit.

Please refer to the New Ethics and Governance Tab below for the number of hard copies required.

If researchers continue to encounter issues with the ERM system please contact the ERM IT Helpdesk on:

Tel: +61 2 9037 8404 (available from 9am to 5pm AEDT Mon to Fri)

E-mail: helpdesk@infonetica.net

 

New Forms

The Research Governance Unit has made changes to the following forms:

 

The RGU will still accept the old Changing Members Form until the end of August 2018

 

Good Clinical Practice Certificate

GCP Certificates will need to be submitted when making an Ethics or Governance Application to SVHM RGU for the following study personnel:

  • Multi-Site Submission without SVHM as a study site – GCP Certificate of the Coordinating Principal Investigator only
  • St Vincent’s Hospital Melbourne as a study site –GCP Certificate of the Principal and all Associate Investigators

 

New Ethics Applications

Please ensure the following guidelines are followed when completing your application:

 

HREC Review

To submit for HREC review, all application documents must be submitted in both hard copies and electronic copy by the following closing date:

For All First In Human Drug/Device Studies Submission needs to be made 2 weeks before the Submission/Closing Dates.

Please ensure the following standard templates are used when completing your application. Please submit 1 electronic copy of ALL documentation to research.ethics@svhm.org.au and the following in hard copy:


Ethics Cover Letter and Checklist - 1 hard copy


Fee Form - 1 signed hard copy


Human Research Ethics Application Form (HREA Form)  - 1 signed original and 2 copies


Victorian Specific Module - 1 signed original and 2 copies


Medical Physicist Letter  - 1 signed original and 2 copies

Please submit one of the following: 

  • Medical Physicist Report:  If the use of Ionising radiation in a research is additional to standard care at SVHM, The research team must provide a independent assessment Medical Physicist Report conducted by a Medical Physicist.

Participant information and Consent Form - 3 hard copies

Different templates are available on the Department of Health website. Please use the template(s) that are appropriate for the type of research you are conducting.

  • Non-Interventional   
  • Interventional
  • Participant Partner Pregnancy

Documentation of Version and Date

Participant Information and Consent Form Footer needs to include the Version and Date . Please see below for recommendation:

Site Specific        -   [Protocol No.] [Site] Specific PICF [type eg. Main / Optional genetic] Ver x.x Date dd/mm/yyyy 

Master Template -   [Protocol No.] National Mutual Acceptance PICF  [type eg. Main / Optional genetic] Ver x.x Date dd/mm/yyyy   


Protocol or Research Plan - 2 hard copies


Investigator Brochure (drug & device studies) - 2 hard copies


Budget - 3 hard copies


Surveys/Questionnaires - 3 hard copies


Form of Indemnity for Clinical Trials - 3 signed originals

For clinical trials where SVHM is providing premises for the conduct of the study and/or HREC review.

SVHM Indemnified Party Details

St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Victoria 3065, ABN 22 052 110 755 


Clinical Trial Notification Form - 1 hard original

For use of unapproved therapeutic goods under the Clinical Trial Notification (CTN) scheme. The following are the St Vincent's Hospital Melbourne details to be entered into the CTN:

HREC Name:  St Vincent's Hospital Melbourne Human Research Ethics Committee EC00343
HREC Contact Officer:  Dr. Tam Nguyen, Executive Officer of Research
HREC Contact Number:    03 9231 2394
HREC Contact Email:     research.ethics@svhm.org.au
   
Approving Authority:   St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, VIC 3065
Approving Authority Officer :  Dr. Megan Robertson, Director of Research
Contact Number:      03 9231 2394
Contact Email:   research.ethics@svhm.org.au

Certificate of Insurance (as applicable) - 1 hard copy


Curriculum Vitae(s) - 1 hard copy


** Incomplete applications will not be accepted, and will be returned to the research team.
 

Collation

Please ensure applications are collated prior to submission to allow distribution to HREC members.
The original copy of each document should be clipped together in one bundle using a bulldog clip or similar. Please mark original documents as “original” in the top right hand corner as these will be kept on file.

Remaining 2 copies should be collated in bundles, with each including a single copy of all documents including the application form/s, the Participant Information and Consent Form(s) and any other documents required for submission. These documents must also be clipped together using a bulldog clip or similar. This will ensure each HREC member receives a copy of each document.
 
 

Applications should be submitted to:

Office Location:

Level 5, Building E (Aikenhead Wing)
27 Victoria Parade
Fitzroy VIC 3065

Mailing Address:

St Vincent's Hospital Melbourne
Research Governance Unit
PO Box 2900 Fitzroy VIC 3065

 

For further information, please contact the Research Governance Unit on 03 9231 3924 or email research.ethics@svhm.org.au

New Governance Applications

After Ethics approval has been obtained from an accredited HREC for your project, Governance authorisation must be obtained before conducting your research at St Vincent's Hospital Melbourne. Research must not commence until governance authorisation has been granted. 

There is no closing date for Governance Applications. Applications must be complete at the time of submission.

Please ensure the following guidelines are followed when completing your application:

For further information on Research Governance, please refer to the Department of Health's Research Governance and Site Specific Assessment Process and Practice document. This guide is used to assist all sectors involved in clinical trials to  understand the processes used to meet the regulatory requirements for clinical trial research in Australia.
 

For governance applications, please submit 1 electronic copy of ALL documentation to research.ethics@svhm.org.au and the following in hard copy:


Research Governance Cover Letter and Checklist - 1 hard copy


Fee Form- 1 signed hard copy


HREC Approval Letter - 1 hard copy


Human Research Ethics Application Form (HREA Form)  - 1 signed original 


Site Specific Assessment Form- 1 signed original


Victorian Specific Module - 1 signed original 


Medical Physicist Letter  - 1 signed original 

Reviewing HREC Approved Master Participant Information and Consent Form - 1 hard copy


St Vincent's Hospital Melbourne Specific Participant Information and Consent Form - 1 hard copy 

  • Based on the Reviewing HREC Approved Master  Participant Information and Consent Form
  • Both tracked and clean SVHM Specific Participant Information and Consent Form Version are required for submission 

Documentation of Version and Date

Participant Information and Consent Form Footer needs to include the Version and Date . Please see below for recommendation:

Site Specific        -   [Protocol No.] SVHM Specific PICF [type eg. Main / Optional genetic] Ver x.x Date dd/mm/yyyy 


Protocol or Research Plan - 1 hard copy


Investigator Brochure (drug & device studies) - 1 hard copy


Budget - 1 hard copy


Surveys/Questionnaires - 1 hard copy


Form of Indemnity for Clinical Trials - 3 signed originals

For clinical trials where SVHM is providing premises for the conduct of the study and/or HREC review

SVHM Indemnified Party Details 

St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Victoria 3065, ABN 22 052 110 755 


Clinical Trial Research Agreement (CTRA) - 3 signed originals

For commercially sponsored, multi-site clinical trials.

OR

Research Collaboration Agreement (RCA) - 3 signed originals

For investigator initiated, multi-site non-clinical trials

Please insert following SVHM details in the Research Agreement:

Name of Institution: St Vincent's Hospital (Melbourne) Limited
Address: 41 Victoria Parade, Fitzroy VIC 3065
ABN : 22 052 110 755

Please note that only the Director of Research and the Executive Officer can sign off on behalf of the institution, the principal investigator does not have the authority to sign off on behalf of the institution.  

Clinical Trial Notification Form - 1 hard copy

For use of unapproved therapeutic goods under the Clinical Trial Notification (CTN) scheme. The following are the St Vincent's Hospital Melbourne details to be entered into the CTN:

Approving Authority: St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, VIC 3065
Approving Authority Officer : Dr. Megan Robertson, Director of Research
Contact Number: 03 9231 2394
Contact Email:    research.ethics@svhm.org.au

Certificate of Insurance (as applicable) - 1 hard copy


Curriculum Vitae(s) - 1 hard copy


Investigator's GCP Certificate  - 1 hard copy


Applications should be submitted to:

Office Location:

Level 5, Building E (Aikenhead Wing)
27 Victoria Parade
Fitzroy VIC 3065

Mailing Address:

St Vincent's Hospital Melbourne
Research Governance Unit
PO Box 2900 Fitzroy VIC 3065

 

For further information, please contact the Research Governance Unit on 03 9231 3924 or email research.ethics@svhm.org.au

Post Approval Amendment – HREC Review (SVHM is the reviewing HREC)

  • All amendments must be reviewed and approved by the HREC before they are undertaken.

    Please note that when submitting an amendment, 1 hard copy and 1 electronic copy must be submitted to the Research Governance Unit at the following:

    Email: research.ethics@svhm.org.au

    Location/address:

    Office Location:

    Level 5, Building E (Aikenhead Wing)
    27 Victoria Parade
    Fitzroy VIC 3065

    Mailing Address:

    St Vincent's Hospital Melbourne
    Research Governance Unit
    PO Box 2900 Fitzroy VIC 3065

     

    Change of Principal Investigator Change of Principal Investigator 

     

    IF COMMERCIALLY SPONSORED:

    • Updated HREC Review Form of Indemnity - 3 partially executed originals 
    • Updated CTRA partially executed originals (ONLY FOR SVHM PI)
    • Updated CTN Form 

    Changing Members of a Research Team (Associate Investigator and Research Coordinator)


    Updated Protocol and/or Investigator's Brochure


    Updated Participant Information and Consent Form (PICF)


    Updated Participant Facing Documents


    Addition of Sites 

     

    IF COMMERCIALLY SPONSORED:


    Addition of Satellite/Service Sites 

     

    IF COMMERCIALLY SPONSORED:


    For further information, please contact the Research Governance Unit on 03 9231 2394 or email research.ethics@svhm.org.au

  • Post Approval Amendment – Governance Review (SVHM is a participating site)

    All amendments must be reviewed and approved by the HREC before they are undertaken.

    Please note that when submitting an amendment, 1 hard copy and 1 electronic copy must be submitted to the Research Governance Unit at the following:

    Email: research.ethics@svhm.org.au

    Location/address:

    Office Location:

    Level 5, Building E (Aikenhead Wing)
    27 Victoria Parade
    Fitzroy VIC 3065

    Mailing Address:

    St Vincent's Hospital Melbourne
    Research Governance Unit
    PO Box 2900 Fitzroy VIC 3065

     

    The following documents are required when submitting an amendment. The number of hard copy documents are listed below as some cases require 3 copies of legal documents must be submitted.

    Updated Protocol and/or Investigator's Brochure


    Updated Participant Information and Consent Form (PICF)


    Updated Participant Facing Documents


    Change of SVHM Principal Investigator

     

    IF COMMERCIALLY SPONSORED:

    • Updated Standard Form of Indemnity - 3 partially executed originals
    • Updated CTRA  - 3 partially executed originals
    • Updated CTN Form 

    Change of SVHM Research Team Members


    For further information, please contact the Research Governance Unit on 03 9231 2394 or email research.ethics@svhm.org.au

     

    Annual Reporting Requirements

    In 2017 the Research Governance Unit (RGU) implemented a new system for the submission of annual progress reports that will save significant time and resources for research staff and RGU staff.

    Annual progress reports for research projects will be due on a single date in the year instead of the anniversary of the HREC approval date. The date chosen is the 01 May.

    The completion and submission of an annual report is part of the conditions of ethical approval for all projects.

    Failure to submit progress reports within 45 days following the 01 May submission deadline may lead to a suspension of the ethical approval for the study.

    All annual reports should be submitted using one or more of the following templates as applicable:

    Documents

    • Progress Report - Project Form (HREC)

    • Project Final Report/Site Closure Report (HREC)

    • Progress Report - Site Form (RGO)

    • These documents can be downloaded from the Department of Health website

      How to Submit

      Once signed by the Sponsor/CRO, or the Coordinating Principal Investigator (CPI) for a multi-site project, or the Principal Investigator (PI) for a single-site project, forward electronically to the RGU.

      For further information, please contact Lily Woods, Research Integrity and Compliance Assistance on 03 9231 3910 or email svhm.ResearchAnnualR@svha.org.au

      Annual Reports for projects that have been approved in January to April in any year do not need to be submitted until 01 May the following year.

    Safety Reporting

    NHMRC Update November 2016

    In November 2016, the NHMRC released the Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods. 

    This guidance specifically addresses the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving investigational medicinal products (IMPs) and investigational medical devices (IMDs) for trials conducted under the Clinical Trial Exemption (CTX) or Clinical Trial Notification (CTN) schemes. The Guidance is also broadly applicable to all clinical trials involving therapeutic goods.


    Definitions

    1) What is an Adverse Reaction?

    Any untoward and unintended response to an investigational medicinal product related to any dose administered.

    2) What is a Serious Adverse Event (SAE)?

    Any adverse event/adverse reaction that results in:

    • Death,
    • Life-threatening, requires hospitalisation or prolongation of existing hospitalisation,
    • Results in persistent or significant disability or incapacity
    • Congenital anomaly or birth defect

    3) What is a Suspected Unexpected Serious Adverse Event?

    An adverse reaction that is both serious and unexpected. It is also not consistent or with the investigator brochure or product information. 

    4) What is a Significant Safety Issue (SSI)?

    A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.  A SSI can be a SAE that is associated with the study (Definitely related, Probably related and Possibly related).

    • A serious adverse event that could be associated with the trial procedures and that requires modification of the conduct of the trial
    • A hazard to the patient population, such as lack of efficacy of an IMP used for the treatment of a life-threatening disease.
    • A major safety finding from a newly completed animal study (such as carcinogenicity)
    • A temporary halt/termination of a trial for safety reasons
      Recommendations of the Data Safety Monitoring Board, where relevant for the safety of participants, such as an increase in frequency or severity of an expected adverse reaction
    • Single case events (e.g. toxic epidermal necrolysis, agranulocytosis, hepatic failure) that lead to an urgent safety measure.

    5) What is a Urgent Safety Measure (USM)?

    A measure required to be taken in order to eliminate an immediate hazard to a participant’s health or safety. Note: This type of significant safety issue can be instigated by either the investigator or sponsor and can be implemented before seeking approval from HRECs or institutions.



    Safety Reporting Requirements

    1) In the event of a Serious Adverse Event (SAE ) Investigators are required to report to Sponsor within 24 hours of becoming aware of the SAE.

    2) Sponsor on becoming aware of the reported SAE made by Investigators will be required to notify HREC and TGA based on the type of SAE and the associated timeline as described below:

    Parties to notify

    Action

    Timeline

    Review

    Investigator

     

    HREC

     

    Institutional RGO

    (for events that involve the institutional participant)

     

    TGA

    USM

    Within 72 Hour of measures being taken

    The HREC is not required to approve USMs but may consider whether any proposed actions are appropriate

    SSI involving notification of an amendment

    Within 15 Calendar days of Sponsor being aware of the issue

    Sponsors should submit to the HREC an amendment relating to any revised trial documentation, without undue delay

    Temporary halt of a trial for safety reasons

    Within 15 Calendar days of the Sponsor decision to halt the trial

    Where it is necessary to seek ethical review of related actions (e.g. informing participants or arranging continuing care and follow-up), a letter describing these actions should be submitted to the HREC within 15 calendar days of the temporary halt

    Early Termination of a trial for safety reasons

    Within 15 Calendar days of the Sponsor decision to halt the trial

    *If St Vincent’s Hospital Melbourne is nominated as the trial sponsor, St Vincent’s Hospital Melbourne will assume the Sponsor responsibility and abide by the above SAE reporting timeline.

    All  Safety Reports for St Vincent’s Hospital Melbourne RGU must be signed by the Chief Principal Investigator or Principal Investigator and submitted electronically to sae.clinicaltrial@svha.org.au

    The Safety Report Form can be downloaded from the Department of Health website: https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/monitoring-reporting

     

    Frequently Asked Questions (FAQs)

    1) Who is now responsible for submitting Safety Report?

    Answer: The Sponsor is responsible for reporting a safety event to the reviewing HREC in accordance to with the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC 2016)
    The Site PI needs to provide a copy to the site RGO as required if it involves the site participant.       

    2) Do I need to submit AEs and SAEs that are unrelated?

    Answer: It is not a requirement to report and submit AES and SAEs that are unrelated to HREC.

    3) Do I need to submit AEs and SAEs that are related?

    Answer: AEs and SAEs that are listed on the investigator’s brochure will not need to be submitted to the HREC.

    4) For related SAEs that do not fall under the definitions of USM, SSI in the NHMRC guidelines, do they need to be submitted? And what’s the reporting timeframe?

    Answer:  For related SAEs that do not fall under the definitions of USM and SSI in the NHMRC guidelines, they do not have to report to the SVHM HREC committee. Site will need to inform Sponsor about the SAE and have the communication documented in the study folder.

     

    How to submit a Safety Report Form :

    • Download the Safety Report Form
    • Have Principal Investigator sign the form
    • Include the following information:
      - Symptoms experienced
      - Possible cause
      - Action taken
      - Outcome
    • Please submit 1 electronic copy ONLY to: SAE.ClinicalTrial@svha.org.au 
      - with subject header eg: HREC-D xxx/xx Patient ID xxxxx – (causality)

    NB: Hand written reports will not be accepted


    Suspected unexpected Serious Adverse Reactions (SUSAR) and Unanticpated Serious Adverse Device Effect (USADE) Reporting Requirements 

    SUSARs: An adverse reaction that is both serious and unexpected. 

    USADE: Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report

    SUSAR and USADEs will need to be reported to the Therapeutic Goods Australia (TGA). 

    SUSARs and USADEs that involve St Vincent's participant will need to be reported to the SVHM HREC

     

    Frequently Asked Questions (FAQs)

    1) Who is now responsible for submitting SUSARs and USADEs?

    Answer: Sponsor is required to report all SUSARs to the Therapeutic Goods Australia. The HREC will not require the Sponsor to submit the SUSARs except for participants that involves St Vincent's Hospital, Melbourne participants.

    2) Do I need to submit SUSARs and Six monthly line listings to HREC?

    Answer: SVHM HREC will not require SUSARs and six monthly line listings to be submitted.

    4) What if Sponsor is required by their global policies mandating the reporting of individual case of SUSARSsand six monthly line listing to HREC?

    Answer: St Vincent’s Hospital, Melbourne HREC will accept and acknowledge the individual case of SUSARS and six monthly line listing if it mandated in the Sponsor global policies.

    The following are the timeline for reporting to the TGA for Sponsor:

    Type of SUSAR   Reporting timeline to TGA
    Fatal or life-threatening Australia SUSARs   Within 7 calendar days
    All other Australian SUSARs   Within 15 calendar days

     


    Annual Safety Report Requirement

    An Annual Safety Report is required to be submitted to St Vincent’s Hospital  Melbourne HREC for review and acknowledgment: SAE.ClinicalTrial@svha.org.au  

    * The Annual Safety Report is to be submitted yearly based on the Ethics Approval date given to the study *

    The report should include:

    • a brief description and analysis of new and relevant findings
    • for Investigational Medicinal Product (IMPs) not on the Australian Register of Therapeutic Goods, a brief analysis of the safety
    • profile of the IMP and its implications for participants taking into account all available safety
    • data and the results of relevant clinical or non-clinical studies
    • a brief discussion of the implications of the safety data to the trial’s risk-benefit ratio
    • a description of any measures taken or proposed to minimise risks

    Development Safety Update Report (DSUR) and the Executive Summary of safety information produced for international regulators can serve as the Annual Safety Report  (a full DSUR is not required). The timing of the annual safety report may be aligned with the reporting cycles of global companies or aligned with the annual progress sent to HREC.

    The Annual Safety Report Form can be downloaded from the Department of Health website: https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/monitoring-reporting

    If you have any queries please contact the Research Governance Unit on (03) 9231 2394 or Research.Ethics@svhm.org.au

     


     

    Administrative SOPs

    Chapter 1. Values and Principles of Ethical Conduct

    1.1 - Application of Values and Principles of Ethical Conduct

    Chapter 2. Risk, Benefit and Consent

    2.1 - Assessment of Risks and Benefits  
    2.2 - Obtaining and Honouring Consent
    2.3 - Qualifying or Waiving Conditions 

    Chapter 3. Ethical Considerations Specific to Research Methods

    3.1 - Qualitive Methods
    3.2 - Databanks
    3.3 - Interventions and Therapies
    3.4 - Human Tissue Samples
    3.5 - Human Genetics
    3.6 - Human Stem Cells         

    Chapter 4. Ethical Considerations Specific to Participants

    4.1 Ethical Consideration Specific to Participants

    Chapter 5. Research Governance and Ethical Review

    5.1 - Low Risk Research
    5.2 - Composition of the Committee
    5.3 - Appointment of HREC Members
    5.4 - Induction of New HREC Members
    5.5 - Responsibilities of HREC Members
    5.6 - Training for HREC Members
    5.7 - Documentation and Record Management
    5.8 - Research Misconduct
    5.9 - Making and Communicating Decisions
    5.10 - Expert Opinion
    5.11 - Minimising Duplication of Ethical Review
    5.12 - Conflicts of Interest
    5.13 - Monitoring of Approved Research
    5.14 - Complaints Handling
    5.15 - Timelines for Ethical Review
    5.16 - Reporting and Accountability
    5.17 - Fees and Charges
    5.18 - Collaborative Research Groups
    5.19 - Training Researchers
    5.20 - Management of Research Data and Primary Materials
    5.21 - Authorised Prescriber Endorsement
    5.22 - Ionising Radiation
    5.23 - SERP
    5.24 - Legal Review
    5.25 - Quality Assurance
    5.26 - Safety Reporting
    5.27 - Standard Operating Procedures

    Serious Breaches

    NHMRC 2018 Update

    The NHMRC has introduced a new document called “Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018”

    The European Union (EU) Clinical Trials Regulation (536) introduced the term ‘serious breach’ to describe the sub-set of deviations that should be reported to review bodies and the Integrated Addendum to ICH E6 R1: Guidelines for Good Clinical Practice (ICH E6 R2) requires the sponsor to perform a root cause analysis for ‘noncompliance [deviations] that significantly affect or has the potential to significantly affect human subject protection or reliability of trial reults.

    Although GCP requires all deviations to be reported to the trial sponsor, not all deviations need to be reported to the reviewing bodies.

    HRECs only need to be made aware of the small sub-set of deviations that have a significant impact on the continued safety or rights of participants, or the reliability and robustness of the data generated in the clinical trial (hereinafter referred to as serious breaches).

    Serious breaches occurring at a site should also be reported by the investigator to their institution, as they may impact on medico-legal risk, the responsible conduct of research, or adherence to contractual obligations

    HRECs only need to be made aware of the small sub-set of deviations that have a significant impact on the continued safety or rights of participants, or the reliability and robustness of the data generated in the clinical trial (hereinafter referred to as serious breaches).

     

    Serious breaches occurring at a site should also be reported by the investigator to their institution, as they may impact on medico-legal risk, the responsible conduct of research, or adherence to contractual obligations.


    Definition of Serious Breachs:

    A breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree:

    a) The safety or rights of a trial participant, or

    b) The reliability and robustness of the data generated in the clinical trial.


    Reporting of Serious Breaches by the Sponsor

    Sponsors have the primary responsibility of determining whether any suspected breach meets the definition of a serious breach.

    Sponsor is required to:

    • Report serious breaches to the Reviewing HREC within 7 calendar days of confirming a serious breach has occurred and provide follow-up reports when required.
    • Notify the TGA and the reviewing HREC if the serious breach leads to the closure of the site.
    • Report to the TGA any serious breach that involves a defective product that may have wider implications for the supply chain for that marketed product:
      • Commercial sponsors report to the TGA using existing product surveillance processes
      • Non-commercial sponsors (e.g. universities) may either report to the TGA directly or to the Marketing Authorisation Holder/manufacturer (who would report to the TGA). 

    Reporting of Serious Breaches by Third Parties

    A third party refers to any entity (other than the trial sponsor) wishing to report a suspected breach.

    A third party (e.g. trial sites) may identify a serious breach and report it directly it to the reviewing HREC. 

    This would usually be appropriate if:

    • The investigator/institution has good evidence that a serious breach has occurred but the sponsor disagrees with their assessment and is unwilling to notify the HREC
    • The investigator/institution has become aware that the sponsor may have committed a serious breach.

    How to Report Serious Breaches to HREC

    There are 2 Serious Breaches form available via the Department of Health Victoria:

    1. Serious Breach Report Form (Sponsor)
      • This form must be completed by the sponsor when reporting a serious breach to the Human Research Ethics Committee (HREC) or when a sponsor is providing additional/follow-up information following notification by an individual / institution of a confirmed serious breach.
    2. Suspected Breach Report Form (Third Party)
      • This form must be completed when a third party (e.g. individual / institution) wishes to report a suspected breach of Good Clinical Practice or the protocol. This should be reported directly to the reviewing HREC without reporting through the sponsor.

    Please use the appropriate Serious Breach Report Form, via the below link:

    https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/monitoring-reporting


    How to Report Non - Serious Breaches to RGO

    There are 2 Serious Breaches form available via the Department of Health Victoria:

    1. Non-serious Breach - Deviation Report
      • The sponsor in collaboration with the site Principal Investigator should complete this form to report a non-serious breach - deviation.A copy of this report should be provided to the Research Governance Officer (RGO) at the Principal Investigator’s site. 

    Additional Information on Serious Breaches

    For more information on Serious Breaches, please download the "Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018" from the link below:

    https://www.nhmrc.gov.au/about-us/publications/safety-monitoring-and-reporting-clinical-trials-involving-therapeutic-goods

    If you have any queries please contact the Research Governance Unit on 9231 2394 or e-mail research.ethics@svhm.org.au

    Authorised Prescriber Scheme

    What is an Authorised Scheme?

    There are circumstances where patients may require access to medicines, biologicals or medical devices that have not been approved for supply by the TGA.

    The Authorised Prescriber scheme allows authorised medical practitioners to supply specific unapproved therapeutic goods to a specific class of patients, without seeking approval or notification on an individual patient, as is the case with the Special Access Scheme.

    What are the Requirements to be an Authorised Prescriber?

    To be an Authorised Prescriber the medical practitioner must have:
    •    the training and expertise appropriate for the condition being treated and the proposed use of the product
    •    the Authorised Prescriber must be able to best determine the needs of the patient
    •    to monitor the outcome of therapy.

    How do medical practitioners become an Authorised Prescriber?

    The following are the steps to becoming an Authorised Prescriber:

    1)    Obtain HREC Approval or Specialist College endorsement
    2)    Submit an application to TGA
    3)    Receive decision letter from TGA

     


    Authorised Prescriber Application To SVHM HREC

    Please submit 1 electronic and Hard copy of ALL documentation to research.ethics@svhm.org.au and the following in hard copy:

    In accordance to the TGA Authorized Prescriber Scheme Guidance document V3.0 Date July 2017. This can be obtained form the following website:
    https://www.tga.gov.au/authorised-prescriber-scheme


    a)    Fee Form  


    b)    New Application for Authorised Prescriber Cover Sheet 


    c)    Letter to the HREC 

    Submit a Letter that details the following

    • Name of Prescriber applying to be a Authorised Prescriber
    • Qualifications, specialty, training and experience 
    • Details of the indication for which the good will be used
    • Clinical justification for its use
    • Approved treatments for the same indication:
      • have they been attempted?
      • why are they inappropriate?
      • will they be attempted prior to prescribing the unapproved good?
      • why is the proposed unapproved good a more appropriate treatment?
    • Details of the site(s) at which the goods will be used 
    • How the risk associated with the use of an unapproved good will be managed
      • the monitoring that will be undertaken
      • the process of investigating and reporting adverse event

    The following are not justifications for the use of an unapproved good:

    • that the unapproved good is less expensive than any approved treatment
    • personal preference for an unapproved good

    d)    Information and Use Of Unapproved Goods

    Please provide the following details a description of Unapproved Treatment as below:

    Description

    Medicines

    Biologicals

    Medical Devices

    Trade Name

    Name of Biological

    Name of Medical Device

    Strength/concentration

    N/A

    N/A

    Dosage Form

    Dosage Range (if applicable)

    Active ingredient

    Sponsor

    If the good is approved for the indication in another jurdisction

    Use

    Route of Administration or type of sample for IVDs

    Duration of Treatment

    Safety

    Any known/expected adverse effects, risks and safety issues

    Related toxicology

    the unapproved good’s efficacy and expected benefits

     


    e)    Monitoring Information

    • how the medical practitioner will determine if the use is effective 
    • how the medical practitioner will determine whether an adverse event has occurred 
    • what monitoring is required
    • how it will be done
    • interval and duration of monitoring

    f)    Efficacy and safety 

    • the unapproved good’s efficacy and expected benefits 
    • any known/expected adverse effects,
    • risks and safety issues 
    • related toxicology

    g)    Evidence

    The application should contain appropriate sources of evidence to support the use of the unapproved good. The sources of evidence for data, with the highest level of significance first, in decreasing order are: 

    1. product information documents (of equivalent) (if the good is approved by an overseas regulator) 
    2. randomised controlled trials
    3. non-randomised controlled trials 
    4. individual case studies 
    5. consensus opinion of specialist colleges and societies

    h)    Global regulatory status (If available)

    The global regulatory status of the unapproved good may affect the level of evidence required in the application.


    i)    Informed consent 

    The use of unapproved goods is considered experimental. The Authorised Prescriber must obtain the informed consent of each patient for whom they prescribe the unapproved good.

    The Authorised Prescriber must advise patients in the Informed Consent of the following:

    • TGA has not have evaluated the unapproved good’s safety, quality and efficacy 
    • Possible benefits and risks of its use 
    • Possibility that there may be unknown side effects
    • Any alternative approved goods 

    It is best practice to obtain informed consent in writing using a standard form. 

    If the unapproved good is, however, derived from biological tissues including blood or plasma, the medical practitioner must obtain informed consent using the form available on the TGA website.


    j)    Up to Date Prescriber CV


    Applications should be submitted to:

    Office Location:

    Level 5, Building E (Aikenhead Wing)
    27 Victoria Parade
    Fitzroy VIC 3065

    Mailing Address:

    St Vincent's Hospital Melbourne
    Research Governance Unit
    PO Box 2900 Fitzroy VIC 3065

     

    For further information, please contact the Research Governance Unit on 03 9231 3924 or email research.ethics@svhm.org.au


    After HREC Approval had been granted 

    You will need to submit an application to the TGA for evaluation. This submission should include:

    a)    a completed Authorised Prescriber Scheme application form  (Obtained from the TGA Website) . Ensure the indication listed on this form is the indication. 

    b)    HREC letter of approval or a letter of endorsement from a specialist college, including a declaration that all necessary documentation has been reviewed

    Reporting Requirements of an Authorised Prescriber

    Requirements for being an Authorised Prescriber

    • Six monthly Periodic Reporting -  to both the TGA and  HREC
      • Number of patients treated during the six-month period. 
        • This needs to be sent within one month after the reporting period.
        • The report must be sent even if no patients have been treated.
    • Reporting adverse events and product defects
      • Report any adverse event or product defect related to the unapproved good to us within 15 calendar days of learning of it.

    What are the Roles and Responsibilities of the Medical Practitioners?

    Please refer to the TGA Website.

     

    Forms

    St Vincent's Hospital, Melbourne RGU uses the Department of Health VIC standard template for Ethics and Governance and Post Approval application: 

     

    a) HREC Application Forms and Participant Information Sheet:

    https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/how-to-make-an-hrec--for-clinical-trials 

     

    b) Site Specific and Research Governance Forms: 

    https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/site-specific-assessment-and-research-governance-in-clinical-trials

     

    c) Post Approval Research Project Forms:

    https://www2.health.vic.gov.au/about/clinical-trials-and-research/clinical-trial-research/monitoring-reporting

     

    d) Changing Members of a Research Team (please click on the title)

     

    e) Fee Form (please click on the title)


    St Vincent's Hospital, Melbourne RGU uses Australian Medicine Template and the Medical Technology Association of Australia Template for Clinical Trial Research Agreement and Indemnities 

     

    a) Clinical Trial Research Agreement and Indemnities  (For Study not involving Devices)

    i) Commercial Studies and Collaborative Research Agreement:

    https://medicinesaustralia.com.au/policy/clinical-trials/clinical-trials-research-agreements/

     

    ii) Clinical Trial Agreement - For Investigator Initiated Study:

    https://www2.health.vic.gov.au/about/publications/formsandtemplates/clinical-trial-research-agreement-investigator-initiated

     

    iii) Form of Indemnity:

    https://medicinesaustralia.com.au/policy/clinical-trials/indemity-and-compensation-guidelines/

     

    b) Clinical Trial Research Agreement (For Study involving Devices)

    i) Medical Technology Association of Australia Research Agreement and Indemnity:

    https://www.mtaa.org.au/clinical-investigations

     

    Resources

    Resources / News / Training

    Resources

    St Vincent's Hospital Certificates of Currency 2012-2013

    • Professional Indemnity
    • Public and Products Liability

    News

     

    Training Manuals

    • Site specific requirements for participant information and consent forms at St Vincent's
    • Hints and Tips for writing a great Participant Information and Consent Form (PICF)


    Codes

    SVHM Radiation Safety Licence Number: 300042061

    SVHM TGA Sponsor Reference Number: 28204

    SVHM CTN Code: 30514

    SVHM HREC Code: EC00343


    Contact Us

    For more information visit the Research Governance Unit Contact page