Protocol / Research design and data collection tools

The Eye and Ear offers various services to staff and student to assist with research projects. Please review the information below and contact the Research Office for any further queries.

Eye and Ear policies and procedures

Policy Research Policy (P18.0) Human Research Ethics Committee Procedures Procedure Date Next Review RS 1.8 Administration of Ethical Review 2019 RS 1.2 Authorised Prescriber Approval Procedure 2018 2019 RS 1.0 Handling Conflicts of Interest in Ethical...

Ethical standards

Research conducted at the Eye and Ear is reviewed and approved by a registered Human Research Ethics Ethics Committee to ensure it complies with the National Statement on Ethical Conduct in Human Research; NHMRC Further information The Royal Victorian Eye...

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

Expert Reviews and Independent reviews

If you are intending to conduct a First Time in Humans study, the Principal Investigator must submit the Protocol and any safety reports to the Research Office for the Chair of the Human Research Ethics Committee to review and identify which Expert /...

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...

Clinical Trials and TGA requirements

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....

Ethical Review Manager

Ethical Review Manager (ERM) is the current online platform for submission of the Human Research Ethics Application (HREA). Accessing ERM To login and submit applications to ERM, please review the information at Conducting Research at the Eye and Ear...

Signatures

Members of the Research team All members of the research team must be listed as part of the 'Project Team' in the HREA and all members of the research team must sign the HREA. All staff who have patient contact and / or are consenting patients /...

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...

Streamlining Review Pathways

The Eye and Ear is committed to minimising duplicate scientific and ethical review of research projects and participating in streamlining initiatives. The Eye and Ear HREC must review single-site research projects if the Eye and Ear is the investigation...

Human Research Ethics Committee meeting schedule

2020 Human Research Ethics Committee meeting dates and deadlines HREC Submission Deadline HREC Meeting Date Tuesday, 28th January 13th February Monday, 23rd March 16th April Monday, 25th May 11th June Monday, 27th July 13th August Monday, 28th September...

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...

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...

Publications

Publications should identify the hospital as 'The Royal Victorian Eye and Ear Hospital'.

Responsible Conduct of Research

The Royal Victorian Eye and Ear Hospital complies with all relevant research regulations. The Eye and Ear expects research teams to be knowledgeable with the following regulations relating to research: Australian Code for the Responsible Conduct of...

Payments to research participants

The National Health and Medical Research Council (NHMRC) has released an information document that provides information on ethical issues related to payment of participants in research, and is available on the NHMRC website: Payment of Participants in...