Human research ethics

All research projects involving humans are subject to review and prior approval by The University of Melbourne Human Research Ethics Committee (HREC). Research involving human subjects can not and must not proceed until clearance has been obtained. The HREC has established sub-committees and Advisory Groups to review staff and student ethics applications. The Graduate School Human Ethics Advisory Group (GSHEAG) suggests that you read the information on the procedures for submitting an ethics application, taking particular note of the GSHEAG scheduled deadline. The GSHEAG strongly advises you to visit the HREC website to obtain information about the processes and the requirements of successfully completing an ethics application.

Administration is provided by the Research Ethics Officer, Mr Tim Mattingsbrooke [8344 8662], who is happy to provide advice and assistance.

A detailed Human Research Ethics Kit [13MB PDF file] is available for download.

Ethics Applications and Procedure

• Who should complete an application?
• What are 'high risk' and 'low risk projects'?
• On-line application through Themis Where do I log in?
• How can students submit an on-line application through Themis?
• When should I submit an application?
• Who do I submit the application to?
• How long will it take?
• What will the GSHEAG do?
• What do I do if the GSHEAG approves it without amendment?
• What do I do if the GSHEAG suggests changes?
• What happens after the GSHEAG approval?
• What happens at the HESC?

Who should complete an ethics application?

All researchers who are members of staff of the Graduate School, who aim to conduct research which involves humans as participants, must submit an application to the GSHEAG for review and approval. In addition, all postgraduate students in the Graduate School of Education who are enrolled in a thesis subject, and are gathering data from human subjects must submit an application to the Graduate School Human Ethics Advisory Group (GSHEAG) for review and approval. In the case of student projects, the student completes the ethics application in consultation with their supervisor . The application form must be read and signed by the supervisor (as the Principal Investigator) before being submitted. Project applications must also have the approval of the relevant Human Ethics Sub-Committee, of the Human Ethics Committee (HREC) before undertaking any research involving human subjects. In the case of Education projects, this is usually the Humanities and Applied Sciences Sub Committee (HAPS).

What are 'high risk' and 'low risk' projects

For ethics purposes, projects are classified as being either 'high risk' or 'low risk', depending on the nature of the enquiry being undertaken and the nature of the participants. As a general indication, projects involving children, persons undergoing medical treatment or any person likely to be seen as vulnerable will be 'high risk'. Projects involving consenting adults with non-controversial subject matter will be low-risk. The online process through Themis will make these distinctions clearer, and will usually ensure that the appropriate forms are used.

Low-risk projects generally take less time to approve than high-risk.

On-line application through Themis: Where do I log in?

All ethics applications are lodged through the Themis Ethics module, as follows:

1. Log in to www.themis.unimelb.edu.au for the online form
2. Click on UOM Research Service
3. Click on Human Ethics Workbench
4. Follow the instructions

How can students submit an on-line application through Themis?

Student access to the Themis Human Ethics module is now available for "research-active" students [those enrolled in a recognised research degree, such as the PhD]. Students will be assigned the Responsibility of UOM Research Student Self-Service. For the Human Ethics module this will give them access to the same functionality as staff researchers – namely the Human Ethics Workbench, Meeting Schedules and Reporting functionality. Students who are “flagged” in their person record as “research-active” can access Themis.  Students who are not research-active cannot, although it is also possible for individual students to have their status set to "research active", either individually or as a cohort.

Access is only available once the student has activated a Themis account. Students activate their Themis account via ARS (Account Registration System) just as Staff do.  They will need the following information to activate their Themis account:

         Full name
         Student number
         Date of Birth (format is DD-MON-YYYY)
         Postcode of home residence
         Library BarCode
 
Using this information, the student logs in to the Accounts Registration System (ARS): http://accounts.unimelb.edu.au/

When should I submit an application?

As a guide, applications should be submitted at the beginning of a month for consideration at the Humanities and Applied Sciences HESC for the following month. View the current schedule.

Who do I submit the application to?

A hard-copy original application signed by all the investigators and supporting documentation must be forwarded to Mr Tim Mattingsbrooke, Room 428, Alice Hoy Building.

Tim will process your application and send copies of the application to GSHEAG reviewers for comment.

How long will it take for the GSHEAG to review my application?

Approximately two months should be allowed for the processing of a high-risk project, whereas low-risk projects which undergo expedited review application usually take up to one month, depending on the extent of any required changes.

What will the GSHEAG do?

The GSHEAG will review your application and do one of two things. Either it will:

*approve an application without amendment, or

*suggest amendment to the application before forwarding to the HESC for consideration

What do I do if the GSHEAG approves my application without amendment?

If no amendments are required by the GSHEAG, the signed original hard-copy application is forwarded to the GSHEAG Chair and the Associate Dean (Research & Research Training) for approval.

What do I do if the GSHEAG recommends changes?

If the GSHEAG requires amendments, Tim Matingsbrooke will contact the investigators via email or internal mail to the Principal Investigators with details of the GSHEAG comments and suggestions.

The investigators, or the student in consultation with his/her supervisor, will make the recommended amendments or provide appropriate arguments why the change should not be made.

Amended pages can be submitted to Tim either in electronic form or hard-copy.

The amended original is forwarded to the GSHEAG Chairperson and Associate Dean (Research & Research Training) for approval.

What happens after the GSHEAG has approved the application?

The original approved applications are returned to Tim to make the required number of copies. The original and copies are sent to the Humanities and Applied Sciences HESC for consideration on behalf of the HREC.

What happens at the Humanities and Applied Sciences HESC?

The Humanities and Applied Sciences HESC will review the application and make a recommendation. For details of this part of the process please visit the HREC website.

Answers to these questions are available from the HREC website:

• how long it will take for the Humanities and Applied Sciences HESC to review my application?
  
• if the Committee requests further information what do I do?
  
• how do you know whether your application has been successful?
  
• what are the conditions of approval?
  
• what if I decide to amend my project?
  
  

Useful Links for Graduate School of Education Staff and Students

Checklist for completion of normal and 'low risk' ethics applications

Powerpoint presentation on human research and ethics by Dr Michele de Courcy, Chair, Graduate School of Education HEAG

Consent

General Information on the issue of consent can be found at MRO Human Ethics consent page.

Guidelines
Sample Form

Plain Language Statement

General Information on the use of plain language and features of a Good Statement can be found at the MRO Human Ethics website.

Sample Forms

• Required letterhead for consent form and plain language statement
• Letter Model
• Subheadings Model
• Intercultural Model
• Children's Model