Ethics applications

Overview

Most research involving humans will require ethical review, and the level of review will be commensurate with the level of risk to which participants are exposed.

Risks include physical, emotional, psychological, social, legal and reputational risks to participants, their families and communities, researchers, and/or institutions involved in the research. ‘Discomfort’ should be interpreted broadly to mean ‘minor adverse impact on those directly or indirectly involved'.

Applications from other organisations are not automatically accepted for review and may need to be assessed for suitability.

Before embarking on an application, researchers should be familiar with applicable:

• Alfred Health and The Alfred Ethics Committee policies and guidelines
• Site requirements relevant to Alfred Health applications
• The multi-site streamlined review scheme or seek further information or training

Low risk applications

Research is ‘low risk' where the only foreseeable risk is one of discomfort. Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk. Refer to the low risk guideline to check whether the research fits into this category at Alfred Health.

If still in doubt about which category the research falls into, researchers are encouraged to seek guidance from the Office of Ethics and Research Governance.

Low risk projects only taking place at Alfred Health, or Epworth Health or a single Alfred Research Alliance affiliated site are reviewed out-of-session by Ethics Committee delegates. Researchers may use the application documents for single site low risk applications.

For applications involving or potentially involving more than one site and/or sites external to the Alliance, researchers should use the greater-than-low-risk process and application documents on this page. Multi-site low risk projects are reviewed by the full Ethics Committee and are subject to the Ethics Committee's meeting dates and deadlines.

Multi-site streamlined applications

Streamlined ethical review means that an eligible multi-site research project is only required to have one ethical review by a certified (and in Victoria accredited) Ethics Committee.

Find out more about multi-site streamlined before embarking upon an application.

Application Documents

The Ethics Submission checklist supports researchers in compiling and completing ethics submissions. Parts A and B need to be completed and the checklist submitted for project registration. The checklist also contains site specific authorisation requirements (PART C) if Alfred Health is a participating site and Tele-trials requirements (PART D) if applicable.

The checklist is intended as a guide only and submissions requirements will vary with each application.

Documents for greater-than-low-risk research applications are created or downloaded from several sources:

• Ethics Review Manager (ERM) system (Department of Health)
• Clinical Trials and Research website (Department of Health) 
• Ethics and Research Governance pages of the Alfred Health website

Documents:

• Human Research Ethics Application (HREA) created in the ERM website
• ​Victorian Specific Module (VSM) created in the ERM website

• Protocol or project proposal (see Project Description for basic protocol outline)
• State and/or Territory legal opinion (for multi-site projects involving interstate sites and participants unable to provide consent)
• Detailed budget (draft is acceptable)
• Participant Information and Consent Forms (PICFs), participant explanatory statements, participant brochures
• Advertisements
• Letters/emails to participants, phone script
• Questionnaires, interview guides
• Data collection sheets
• ​Medical Physicist Report for each site included in the application (for projects involving exposure to ionising radiation)
• Data custodian approval for projects involving use of established databases 
• State specific documents (WA Specific module)
• Site Specific Assessment Form (SSA) created in the ERM website and Use of Alfred Health services form

• Fully signed Resource Centre Declarations (for projects involving Alfred Health services such as Pathology or Medical Records)
• Nursing Research approval (for nursing research or research involving nurses)
• Research Agreement (Clinical Trial Research Agreement, Research Collaboration Agreement or Material Transfer Agreement) 
• Insurance, indemnity, Clinical Trial Notification to the TGA 
• ​Fee payment form
• Head of Department sign-off for external projects with no Alfred SSA