Getting started

Human research is governed by Australian law that establishes rights for participants and imposes general and specific responsibilities on researchers and institutions.

With the separation over two decades ago, of ethical approval and site governance authorisation, research conducted at the Hospital must hold both HREC approval and governance authorisation. We are also assessed for compliance against the Eye and Ear Clinical Trials Governance Framework under hospital accreditation.

All research involving the Eye and Ear hospital must be conducted in compliance with the National Statement on Ethical Conduct in Human Research and the Australian Code for the Responsible Conduct of Research, and requires:

1. Ethical approval from a Human Research Ethics Committee (HREC); and
2. Research Governance Authorisation from the Eye and Ear

There are several options and combinations for ethical approval and research governance authorisation at the Eye and Ear contingent upon the involvement of the hospital.

The Australian Code for the Responsible Conduct of Research (the Code) has an essential role in promoting good research governance. The Code sets down the broad principles of responsible and accountable research practice and identifies the responsibilities of institutions and researchers in areas such as data and record management, publication of findings, authorship, conflict of interest, supervision of students and research trainees, and the handling of allegations of research misconduct.

It is recommended that contact be made with the Eye and Ear Research Office early to discuss potential new projects and whether the project is research or quality assurance to facilitate identifying the options for HREC review and Research Governance Authorisation for the specific project.

You are also welcome to attend a Research Office Drop In Session on a Tuesday 12-1 in the Level 4 meeting room.

Application requirements vary depending on the level of risk involved to the participants and participating institutions, and the Eye and Ear’s involvement within the project.

As per the National Statement, Chapter 2.1, low risk research describes research, in which the only foreseeable risk is no greater than discomfort. Accordingly, research in which the risk for participants or others is greater than discomfort is not low risk research. Research in this category is considered higher risk research and carries risk of harm. Higher risk research requires review by an HREC.

Risk profiles of research

Lower Risk		Higher risk (individual, group, community, societal or global)
Minimal	Low	Greater than low	High
No risk of harm or discomfort; potential for minor burden or inconvenience*	No risk of harm; risk of discomfort (+/- foreseeable burden)	Risk of harm (+/- foreseeable burden)	Risk of significant harm (+/- foreseeable burden)

* Neither burden nor inconvenience should be considered a type of harm or discomfort and therefore should not be viewed as a risk.

The Eye and Ear has established review pathways corresponding to the level of risk involved in a project. The review pathways are:

1. Quality Assurance/Case Reports – review by the HREC Chair and Research Manager
2. Lower Risk Research – review by the Eye and Ear Lower Risk Research SubCommittee
3. Higher Risk Research – review by the Eye and Ear Human Research Ethics Committee

In addition to the levels of review above, the Eye and Ear is a participating organisation in state and national systems for review of multi-site research projects. The Eye and Ear will accept the approval of a National Mutual Acceptance (NMA) reviewing HREC and will undertake research governance/site specific assessment to determine whether a project is feasible and appropriate to be conducted at the Eye and Ear as a research site.

Discuss your proposal with all members of the research team. A detailed protocol is required which includes but not limited to:

• Literature review
• Research questions defined including hypotheses
• Study design aligned with questions and likely to answer them
• Potential to contribute to field or add to body of knowledge
• Statistical analysis/power
• All documentation provided to participants
• All data collection instruments

Refer to the Protocol Template for non-commercially sponsored studies for more details.

It is important to understand the different parties involved in the research, and whether there is a need for a research agreement (i.e., for the transfer of materials and/or data between parties).

Victorian based applicants will need to submit the application form to the reviewing HREC. The application is submitted via the ERM platform. There are also many different supporting documents that may be required to support your application. To find out what documents you need, refer to the New Applications section.

If you are submitting your application to the Eye and Ear HREC, the Research Office will review the application for governance assessment in parallel to determine whether a project is feasible and appropriate to be conducted at the Eye and Ear hospital. To find out what documents you need, refer to the New Applications section.

If your application has been submitted to an external Reviewing HREC and the Eye and Ear is a research site, you will need to submit an application to the Eye and Ear for governance review. To find out what documents you need, refer to the New Applications section.

Once the above or minimum requirements are ready, submit your application as per details listed in the New Applications section.