1. Do I need to submit my research proposal to the Ethics Committee for approval?

2. I am collecting blood from participants for my research project. Do I need to apply to the Ethics Committee for approval to do this?

3. What do I need to do to submit an application to the Ethics Committee?

4. When I submit my initial application to the Ethics Manager, what should I do about documents that cannot be e-mailed?

5. Are there any other requirements before I can submit my application?

6. Will any fees be payable for review of my application?

7. When should I submit my application?

8. Do I need to include details of the study budget if my research project will be covered by a research grant or institutional funding?

9. I'm planning to do some nursing research. Can I submit my application directly to the Ethics Committee?

10. Are there any special requirements for student research projects?

11. Is there anywhere I can get advice on the statistical design of my research project?

12. My research project involves the use of ionising radiation. Should I present my application to the Radiation Safety Officer?

13. What is the difference between audit/quality assurance and research? Is it necessary to apply to the Ethics Committee for approval of my audit/quality assurance project?

1.  Do I need to submit my research proposal to the Ethics Committee for approval?

If your project involves any aspect of research involving humans, even if you propose to use only a questionnaire or analyse medical records, you will need to submit an application for review by the Ethics Committee.

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2.  I am collecting blood from participants for my research project. Do I need to apply to the Ethics Committee for approval to do this?

Yes, any research involving humans will need to be reviewed by the Ethics Committee. You should read chapter 15 of the National Statement on Ethical Conduct in Human Research (2007) before proceeding with your application. As well as completing module 1 of the ethics application form, you will need to fill out module 3 (Use of human tissue samples). If you are undertaking a genetic study or storing DNA, you will need to complete module 4 (Human Genetic Research) as well.

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3.  What do I need to do to submit an application to the Ethics Committee?

You will need to download and fill out the core module (module 1) and any other applicable module/s of the application form from the 'applications' page. You will also need to fill out the financial details module (module 6). You should then submit one complete copy of your application by e-mail to the Ethics Manager (for complete details see Applications and Submission dates).

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4.  When I submit my initial application to the Ethics Manager what should I do about documents that cannot be e-mailed?

Not all documents can be e-mailed, and reference should be made to these documents in the e-mailed application (on the checklists). You must include them with the full submission.

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5.  Are there any other requirements before I can submit my application?

If you intend to use radiation, pathology services, pharmacy services, Heart Centre resources or any other Alfred resources, you should fill in the appropriate form/s, obtain the signature of the Resource Centre Manager and submit these forms to the Ethics Manager with the rest of your application. Information and Resource Centre Declaration forms are available from the Applications page.

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6.  Will any fees be payable for review of my application?

Fees are payable for commercially sponsored clinical trials and not-for-profit externally coordinated studies, such as those conducted by public health bodies. In addition, studies presented by chief researchers or students not affiliated with The Alfred will incur a fee. For full details, see the Fees page.

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7.  When should I submit my application?

The Alfred Ethics Committee meets on the fourth Thursday of each month. You should submit one complete copy of your application to the Ethics Manager by e-mail (see Applications and Submission dates). You will be allocated a project number and will also be advised of the number of copies of your application which will be required. You should submit these copies of your application by the date for full submission (see Submission dates).

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8.  Do I need to include details of the study budget if my research project will be covered by a research grant or institutional funding?

Yes, The Alfred  requires full financial details for all projects submitted for review by the Ethics Committee.

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9.  I'm planning to do some nursing research. Can I submit my application directly to the Ethics Committee?

It is essential that nursing applications are processed via the Nursing Research and Access Committee (NR&AC) prior to submission to the Ethics Committee. The NR&AC will review the application and, if satisfactory, provide clearance for submission to the Ethics Committee. Any projects involving nursing resources must also be considered by the NR&AC before submission to the Ethics Committee. For full details, see the Nursing research page.

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10.  Are there any special requirements for student research projects?

The student’s supervisor(s) must be a member of the research team and accept overall responsibility for the conduct of the project. A senior staff member of  The Alfred  must also be a member of the research team.

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11.  Is there anywhere I can get advice on the statistical design of my research project?

The Monash University Department of Epidemiology and Preventive Medicine provides the services of a biostatistician for researchers to consult on the statistical aspects of research design and analysis. The biostatistician is available to Alfred staff for statistical consultation by appointment on Tuesdays and Thursdays and can be reached by e-mail at michael.bailey@med.monash.edu.au.

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12.  My research project involves the use of ionising radiation. Should I present my application to the Radiation Safety Officer?

All research projects involving any source of radiation must be referred to the Hospital's Radiation Safety Officer as part of the ethics evaluation process. Researchers must draw this exposure to the attention of the Ethics Committee when they complete the application form (see Applications).

Where normal volunteers are involved or where patients involved in the study are otherwise healthy with normal life expectancy, and the radiation exposure is clinically significant, then the Radiation Safety Officer will also refer this project to the State Government's committee (see Radiation Safety Officer).

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13.  What is the difference between audit/quality assurance and research? Is it necessary for me to apply to the Ethics Committee for approval of my audit/quality assurance project?

Click here for an explanation of the difference between quality assurance and research adapted from information provided by the Department of Human Services Human Research Ethics Committee. Also explained is whether or not a particular audit/QA project will require Ethics Committee review.

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This page was last modified on 13/01/10

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E-mail: research@alfred.org.au