This information relates to where the Eye and Ear is involved in the research project and ethics approval has been/or will be granted from a Human Research Ethics Committee (HREC) (either the Eye and Ear HREC or a Reviewing HREC).
Research Governance Authorisation is a complex mix of which organisations are involved and the role of each organisation and how ethical approval is obtained.
Examples of the Eye and Ear being involved in a research project include, but is not limited to:
- Recruitment of Eye and Ear patients
- Recruitment of Eye and Ear staff
- Eye and Ear staff are the Principal Investigator or Associate Investigator in a research project (specifically related to their employment/role at Eye and Ear)
- Research procedures are conducted at Eye and Ear premises (not including conducted in premises that are leased from Eye and Ear and the procedures are being conducted under the auspices of that organisation)
- Eye and Ear are involved in providing services for research projects (ie Pharmacy, Diagnostic Eye Services)
- Use of Eye and Ear data (health information)
Is the Eye and Ear a Research Site?
The Eye and Ear would be considered a research site if
- Eye and Ear staff are the Principal Investigator or Associate Investigator in a research project (specifically related to their employment/role at Eye and Ear) and procedures are occurring on site, or
- Eye and Ear operating theatre is involved, or
- The research participants are Eye and Ear patients for the purposes of the research project.
Each project has specific requirements and variability so if it is not clear, please contact the Research Office to discuss your project.
The following Research Governance Authorisation pathways are available:
Involvement of Eye and Ear | Research Governance Authorisation Pathway |
---|---|
Eye and Ear is a research site Eye and Ear HREC is the Reviewing HREC |
Research Governance Authorisation will be activated by the HREC review and Research Governance Authorisation will be combined with the letter of ethical approval |
Eye and Ear is a research site Eye and Ear is not the reviewing HREC. The approving HREC must be on the list of NMA Certified Reviewing HREC |
Site Specific Assessment pathway |
Recruitment of Eye and Ear staff and/ or Eye and Ear patients only | Recruitment Authorisation pathway |
Material and/or Data transfer only | Data Transfer Authorisation pathway |
Research Services only | Research Services Authorisation pathway |
Early notification:
To minimise delays, Principal Investigators are encouraged to communicate with the Eye and Ear Research Office as early as possible, such as, when the Eye and Ear Hospital has been selected as a site and advise the name and contact details of the Eye and Ear Hospital site Principal Investigator.
Documents that can be reviewed early:
- Cover Sheet for new Research Project
- Protocol
- Investigator’s Brochure/Device Information
- Research Agreement
- Form of Indemnity
- Insurance Certificate of Currency
If you would like these documents reviewed prior to submission of the SSA application then please send by email to the Research Office.