Guidelines for Ethics applications

• Steps
• Contacts

All human research ethics applications must now be submitted through the Themis ethics module.

Steps

New Applications

1. Preparation
2. Submission
3. HEAG Approval
4. Responding to HEAG comments
5. For Minimal Risk applications/Project within Programs
   For Standard Project/Program
   
   Amendments
   

Step 1: Preparation

Contact the School of Physiotherapy Human Ethics Advisory Group (HEAG) Administrator if assistance is required with ethics applications. Applications must be prepared according to the instructions provided on the Melbourne Research Office website and the Themis Ethics Module.

Step 2: Submission

1. Applications must be submitted by the deadline dates as set by the Physiotherapy Human Ethics Advisory Group. As this is a two-stage process requiring approval at departmental and also central level, there are deadline dates at different stages of the process. The initial submission must occur before the first deadline date in the table below. Late applications will be carried over to the next meeting.
2. Applications must be submitted via the Themis Ethics module. A hard copy of the application, all attachments, and the application summary and the School’s Ethics Submission Checklist (Aug08) must also be submitted to the school’s HEAG administrator by the due date.

Dates for 2008

Date applications due with Steve (before midday)	Physio HEAG meeting date THURSDAY 9am	Date applications due at MRO	HESC Meeting date
	Jan 24	Feb 12	Feb 19
Feb 11	Feb 21	March 3	March 18
March 17	March 27	April 7	April 22
April 24	April 24	May 5	May 20
May 12	May 22	May 30	June 17
June 16	June 26
July 14	July 24	August 4	August 19
August 11	August 21	September 1	September 16
September 15	September 25	October 6	October 21
October 13	October 23	November 3	November 18
November 3	November 13	November 24	December 9

 

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Step 3: HEAG Approval
Once submitted, the school's HEAG Administrator, will check the application. If all the requirements that are outlined in the Ethics Submission Checklist (Aug08) are met, the HEAG administrator will distribute it to members of the HEAG for review. The reviewers will submit their comments to the school’s HEAG administrator who will collate them into a master document. Researchers will be invited to attend the HEAG meeting to discuss their application with the HEAG members. The researchers will then receive the HEAG administrator's comments in writing.

Step 4: Responding to HEAG comments
Researchers will receive the written comments regarding their application from the HEAG administrator. They are required to respond to each comment by making track changes in their application as well as responding to each comment in the Master document. When these changes are accepted by the HEAG Chair the researchers must accept the track changes, submit this version of the application via Themis, print out the application and attachments and obtain signatures from all researchers named on the application and submit this to the school’s HEAG administrator.

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Step 5

• For Minimal Risk applications/Project within Programs
  If your application is a minimal risk application or a project within a program, the HEAG can approve the research. You will receive an approval letter through Themis and a paper-based version of this letter. When you have received this notification you may begin your research.
• For Standard Project/Program
  Once your responses to the comments have been approved at HEAG level, your application will be sent to the Health Sciences Human Ethics sub committee for approval. You will then be expected to respond to any comments made at that committee level before approval is granted. Once you receive an approval letter from the Melbourne Research Office you may begin your research.

Amendments
Amendments to previously approved applications undergo the same preparation, submission and review processes as mew applications.

Follow the instructions provided on Themis for the details required for amendments.

For further information please see the Melbourne Research Office.

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Contacts/Support

• For quick reference cards to assist you through the ethics application process see Quick Reference Cards: Themis Human Ethics Application
  
• For enquiries about the HEAG approval process, please contact
  Steve Martin HEAG Administrator
  8344 4172
  
• For policy enquiries, contact the Human Research Ethics staff at the Melbourne Research Office
  
• For Themis ethics module enquiries see the Themis Help Desk Service Centre
  

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