Cabrini Institute - Human Research Ethics - Guide To Application Form
The application is divided into ten sections as follows:
Section 1 Administrative information
Complete in full and attach copies of supporting documents to this section, including:
- letters of approval from other human research ethics committees;
- letters of support from clinicians expected to recruit patients;
- letters of support from managers of hospital departments expected to provide support to the project.
Where one or more of the researchers is not connected with Cabrini Health and/or the research is being carried out in conjunction with agencies outside of Cabrini Health, the connection to Cabrini of all researchers must be listed, as must the names of all agencies participating in the project.
Please note that, where Cabrini staff are involved, there is a cost to Cabrini associated with the project, or use of Cabrini facilities is proposed, permission to proceed must be obtained prior to submission of the proposal. This must be confirmed in writing by the person in authority and included with the application.
Please ensure that all attachments have appropriate footers as outlined above.
Section 2 Project summary
The project summary should be written in simple language suitable for lay people. This sheet should include the rationale, background from the literature, aims, methodology and method of analysis and should be no longer than an A4 sheet.
Section 3 Resource information
This section should contain sufficient information to assure the Committee that the resources necessary to carry out the project to completion will be made available in line with paragraph 3.3.5 of the 2007 National Statement.
Section 4 Project information
Please ensure that all questions are answered, either on the form, or as part of an attachment. Please ensure all attachments have the appropriate footers.
Please ensure that you outline the potential risks arising from the project (paragraphs 3.3.7 to 3.3.10 of the 2007 National Statement apply), the potential consequences of those risks and the measures to be taken to deal with those consequences. Explain the monitoring, reporting and other procedures to be put in place to manage serious adverse and other unforeseen events. This includes adverse events of a physical or emotional nature, as well as adverse events relating to project information e.g. de-identified information becoming identified.
Section 5 Drugs and therapeutic devices
Please read chapter 3.3 of the 2007 National Statement and complete this section only if the project involves trials of drugs or therapeutic devices. If this section is not relevant to your research, please answer “not applicable” at the start of the section and remove the page break so that the next section may begin immediately.
Section 6 Human tissues
Please read chapter 3.4 of the 2007 National Statement and complete this section only if the project involves use of human tissue such as blood. If this section is not relevant to your research, please answer “not applicable” at the start of the section and remove the page break so that the next section may begin immediately.
Section 7 Human genetic research
Please read section 3.5 of the 2007 National Statement and complete this section only if the project involves genetic analysis of human tissue. If this section is not relevant to your research, please answer “not applicable” at the start of the section and remove the page break so that the next section may begin immediately.
Section 8 Ionising radiation
Complete this section only if the project involves ionising radiation. Please note that the project will require the approval of the Victorian Radiation Advisory Committee if it involves radiation that is not part of normal treatment. For further information please consult the Department of Human Services website at www.health.vic.gov.au/environment/radiation/index.htm.
Please use the Radiation Safety form (attachment 5) and please note that Cabrini’s radiation safety officer is Dr Chris Wriedt.
If this section is not relevant to your research, please answer “not applicable” at the start of the section and remove the page break so that the next section may begin immediately.
Section 9 Human research ethics committee issues
Please ensure that you note items f, h, i and k of this document prior to completing this section.
Section 10 Declaration
The application requires original signatures of all members of the research team.
