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Eye and Ear Site Specific Information

You will need to understand the following essential elements to facilitate either obtaining ethical approval or research governance authorisation to conduct research at the Eye and Ear:

• COVID-19 pandemic related updates
• Research Office
• Information for Eye and Ear staff and student for Investigator Initiated projects / Clinical Trials
• Minimum standards for all applications/documents
• Eye and Ear Ethical Review Pathways for Human Research
• Eye and Ear Human Research Ethics Committee
  • Meeting schedule and submission deadlines
• Eye and Ear Low Risk Research Subcommittee
• Eye and Ear Research Governance Authorisation pathways for Human Research
• Research Governance requirements
• Eye and Ear Policies and Procedures
• Safety Monitoring and Reporting
• Research-related Service Fees
• Participant Information and Consent Forms
• Members of the Research Team and Signatures
• Honorary Researcher appointments and credentialing procedures
• Involvement of Eye and Ear Hospital departments in research projects
• Information about specific types of projects
• Research Agreements / indemnity / insurance
• CTN Form details

Refer to the information in the boxes below or return to Conducting research at the Eye and Ear Hospital

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Last updated 14 September 2020

• Minimum standards for all applications / documents

  Minimum standards apply to all applications: Applications must be complete; incomplete applications will be returned to the researcher Handwritten applications will not be accepted Principal Investigators must sign all correspondence Applications must be...

• Site Specific Information - Ethical Review pathways for Human Research

  There are many options and combinations for research ethics and research governance ethics review at the Eye and Ear. It is important to understand the options prior to submitting an application; detailed information is available below: All human research...

• Eye and Ear Human Research Ethics Committee

  This page contains information specifically related to the Eye and Ear Hospital Human Research Ethics Committee. For information about submitting applications for ethical approval from the Eye and Ear Hospital HREC or applying for Research Governance...

• Eye and Ear Low Risk Research Subcommittee

  The Eye and Ear Low Risk Research Subcommittee reports to the Eye and Ear Human Research Ethics Committee. The current membership includes: The Research Manager for research governance related matters; and at least one member who has expertise in the...

• Site Specific Information - Research Governance Authorisation pathways

  Research projects involving the Eye and Ear require Research Governance Authorisation from the Eye and Ear. Examples of the Eye and Ear being involved in a research projects include, but is not limited to, Recruitment of Eye and Ear patients Recruitment...

• Research Governance requirements

  As a world leader of eye, ear, nose and throat research and teaching, we are committed to conducting our research honestly and accurately and at the highest professional standards. Research Governance is a framework that ensures accountability for the...

• Eye and Ear policies and procedures

  Policy Research Policy (P18.0) (version 6 dated 11 July 2019) Eye and Ear Research Procedures Procedure Date Next Review RS 1.1 Handling Research Related Complaints RS 1.2 Authorised Prescriber Approval Procedure 2018 RS 1.4 Monitoring and Safety...

• Safety Monitoring and Reporting (from 23 October 2019)

  The Eye and Ear has adopted the following guidelines from 1 April 2019 NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods (NHMRC; November 2016) NHMRC Guidance: Risk-based management and monitoring of Clinical...

• Fees

  Fees apply for certain categories of applications. Tax invoices for Human Research Ethics Committee or Research Governance Authorisation review fees will be sent by the hospital directly to sponsors/public health bodies following submission of...

• Participant Information and Consent Forms

  Templates for the following Participant Information & Consent Forms (PICFs) for self and parent/guardian and medical treatment decision maker and can be found on the Department of Health and Human Services website: non-interventional health and social...

• Members of the Research Team and Application Form Signatures

  Principal Investigator A copy of a Curriculum Vitae (CV), professional registration and GCP certificate for the Principal Investigator should be uploaded to ERM as part of the submission. Members of the Research team CVs for research team members are to...

• Honorary appointments and credentialing procedures

  To ensure that members of research teams have the qualifications and skills required for their role on the research project, the Eye and Ear has a credentialing procedure. Review the supporting documentation and Verified Scopes of Practice then follow the...

• Involvement of Eye and Ear Hospital departments in research projects

  The Eye and Ear Hospital clinical departments are supportive and encouraging of research projects conducted by Eye and Ear staff and research partners. There are logistical considerations when research is to involve these resources including staff and...

• Types of research

  This information relates to types of research projects. See below for Clinical Trials Research involving biospecimens Genetic/Genomic research

• Research Agreements

  Clinical Trials Agreements must utilise the templates listed in the below sections of this page, unless the project is a type of project that is not specified in the templates. Agreements which do not utilise the templates may require additional review by...

• Indemnity

  For studies conducted by a third party, the third party is requested to indemnify the hospital and provide a current certificate of insurance. When The Royal Victorian Eye and Ear Hospital is not a site and the Eye and Ear's Human Research Ethics...

• Insurance

  The Royal Victorian Eye and Ear Hospital The Eye and Ear is insured by the Victorian Managed Insurance Authority. Please refer to the VMIA Medical Indemnity website for further information. Investigator initiated studies The VMIA provides insurance cover...

• TGA CTN and CTA Form details

  Clinical Trials conducted under the TGA Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) schemes. TGA Clinical Trial Notification (CTN) scheme The CTN scheme transitioned from a paper-based system to electronic system on 1 July 2015....