New Submissions

Determining Research Governance Review Pathway

Research Governance Authorisation is a complex mix depending on which research partner organisations are involved and the role of each organisation and how ethical approval is obtained.

If the Eye and Ear is involved in the research project in any way, then the Eye and Ear will need to grant Research Governance Authorisation using one of the Research Governance Review pathways.

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 on 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 is involved in providing services for research projects (i.e., Pharmacy, Diagnostic Eye Services)
• Use of Eye and Ear data (health information)

Involvement of Eye and Ear	Research Governance Review Pathway
Eye and Ear is a research site and Eye and Ear HREC is the reviewing HREC	Research Governance and HREC review occur concurrently.  Research Governance Authorisation will be combined with the letter of HREC 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 Reviewing HRECs	Site Specific Assessment pathway
Recruitment and/or Research Services	Recruitment/Research Services Authorisation
Material and/or Data transfer only	Data Transfer Authorisation pathway

Each project has specific requirements and variability so if it is not clear, please contact the Research Office to discuss your project.

Site Specific Assessment (SSA) pathway

The SSA pathway applies if you intend to apply for/have ethical approval from an NMA Reviewing HREC; and

Eye and Ear is involved as a research site and

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), or

Eye and Ear operating theatre is involved, or

Eye and Ear patients under our ongoing care for the condition under investigation.

Recruitment and or Service Authorisation pathway

For recruitment all the following must apply:

1. The involvement of the Eye and Ear extends only to providing project information to patients / staff
2. Research participants will not become Eye and Ear patients solely for the purposes of the project
3. The project does not require approval from the Eye and Ear Human Research Ethics Committee (HREC)
4. The research project must have ethical approval from a registered NHMRC Human Research Ethics Committee (HREC) and the Eye and Ear must be listed as a recruitment site in the application.

An example of this type of project:

Participants in a clinical trial at another site(s) require a specific eye test; the Eye and Ear provides the test as a service/subcontractor but Eye and Ear is not a research site for the purposes of the clinical trial.

For research services all the following must apply:

For this pathway to be relevant all the following must apply:

1. The involvement of the Eye and Ear extends only to providing research services
2. Participants will not be Eye and Ear patients for the purposes of the project
3. The project does not require approval from the Eye and Ear Human Research Ethics Committee (HREC)
4. The research project must have ethical approval from a registered NHMRC Human Research Ethics Committee (HREC) and the Eye and Ear must be listed as a research site providing services.

Material and/or Data Transfer Authorisation pathway

This information relates to projects that

1. Have ethical approval from a Reviewing HREC (not Eye and Ear HREC)
2. The Eye and Ear is involved in the project only for the purposes of provision of data and/or material

If the Eye and Ear is involved in the project for more than data and/or material only then this pathway does not apply and you should review the Research Governance Pathways information in more detail and/or contact the Research Office.

For this pathway to be relevant all the following must apply:

1.  The involvement of the Eye and Ear extends only to providing data and/or material
2.  Participants will not be Eye and Ear patients for the purposes of the project
3.  The project does not require approval from the Eye and Ear Human Research Ethics Committee (HREC)
4.  If the project is a research project then the project must have ethical approval from a registered NHMRC Human Research Ethics Committee (HREC) and the Eye and Ear must be listed as a site providing data.