Governance Review
Work Health and Safety
As per the ECU Work Health and Safety (WHS) Hazard Identification and Risk Management Guidelines it is mandatory to complete a Health and Hazard risk assessment which can be found here. The WHS hazard risk assessment must be submitted for approval to the Research Supervisor/Line Manager in the first instance. If the level of risk is outside their scope of approval they will redirect it for approval in accordance with the ECU risk acceptance criteria. Further approvals may be required after completing the WHS Hazard Risk Assessment, such as approval to use radiation, biosafety and hazardous substances (RBHS) or to undertake fieldwork, events or travel (FET).
For information regarding any of the Riskware modules please contact the Safety and Employment Relations (SER) Team – osh@ecu.edu.au , Radiation, Biosafety and Hazardous Substances Committee (RBHSC) – RBHSC@ads.ecu.edu.au or call (61 8) 6304 2302.
Enterprise Risk
Enterprise Risk assessment mandatory clinical trials using an unapproved drug or medical device as well as any research projects deemed controversial. In this context, a controversial activity is defined as research which may result in increased reputational, contractual or compliance risk to the University, such as political and geopolitical commentary; defence, immigration or similar government programs; or association with contentious industries (e.g. tobacco; alcohol; gambling; drugs).
Further information or queries regarding Enterprise risk assessments contact enterprise.risk@ecu.edu.au.
Insurance
ECU has a duty to its insurance provider to notify them of ECU's involvement in any clinical trials prior to the clinical trial commencing.
Early notification of clinical trials ensures that insurance protection is afforded to both the University and the researchers during the clinical trial period. Whilst ECU insurance coverage provides Medical Malpractice Protection (Medical Treatment Liability) to the University, this cover does not automatically extend to clinical trials. As such, a separate protection must be applied for all “clinical” trials.
The Research Ethics Team will liaise with ECU Risk and Enterprise to notify the insurer of the clinical trial. Confirmation of insurance coverage may be a condition of ethics approval.
For more information or queries regarding ECU Insurance, please contact insurance@ecu.edu.au.
Site Governance Approval
If the project is being conducted externally, governance approval should be obtained from each participating site prior to the trial commencing (at their site).
For WA public hospitals, governance approvals can be sought via the WA Department of Health online Research Governance Service. Governance approvals can be requested in parallel to requests for Hospital HREC approvals.
Clinical Trial Research Agreement
Depending on the nature of the clinical trial the trial may require one or more different research agreements. For projects being conducted at hospitals or other medical sites a Clinical Trial Research Agreement (CTRA) is generally required and forms part of the governance approval process in hospitals. Other research agreements may provide for facilities access, data access, drug or device supply agreements and/or research collaboration agreements.
ECU’s Research Contracts and Funding Team can assist you with preparing a CTRA or research agreement for your project. Please see the Research Services webpages for more information on research agreements or contact research.grants@ecu.edu.au.
Governance Review
To ensure all considerations are made and requirements met for each individual project a Research Governance review will be undertaken in conjunction with the Ethics review. The governance review process collates the specific requirements overseen by various areas of the university (other than ethics ie: risk/contracts/legal/etc) and ensures that these areas are informed and involved in the governance review of all clinical research being undertaken at ECU as well as ensuring that the project complies with the requirements of GCP and the TGA (if necessary).
The governance review will consider specifics of the research project and assess which aspect of the review and compliance are required on a project by project basis. The table below outlines different governance requirements and who is involved in completing individual requirements:
Requirement | Responsibility | All CT’s | CTN/CTA |
|---|---|---|---|
Ethics Protocol and associated essential documentation | Chief Investigator |
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Risk assessment and management plan | Chief Investigator |
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Scientific Review | Chief Investigator |
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Ethical approval | Chief Investigator/Human Research Ethics Committee |
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Site-specific assessment if the research is not conducted at ECU | Chief Investigator |
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Registration on a publicly accessible register complying with international standards (eg: ANZCTR/ClinicalTrials.gov) | Chief Investigator |
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Insurance cover | Research Ethics Team/ ECU Risk and Assurance |
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Contracts and agreements | Research Administration |
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Good Clinical Practice Training Certification | Chief Investigator/Researchers |
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Monitoring and Progress reporting (including Adverse Events) | Chief Investigator/HREC |
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Identification of trial sponsor | Chief Investigator | - |
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Therapeutic Goods Association - Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) | Manager Research Governance /Director Research Services/Deputy Vice Chancellor Research | - |
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Therapeutic Goods Association - Safety monitoring and reporting | Chief Investigator/HREC | - |
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Therapeutic Goods Association - Reporting of Serious Breaches of GCP or the Protocol | Chief Investigator/HREC | - |
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