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Participant Information and Consent Forms

Templates for the following Participant Information & Consent Forms (PICFs) for self and parent/guardian and medical treatment decision maker and can be found on the Department of Health and Human Services website:

  • non-interventional
  • health and social science
  • genetic
  • participant partner pregnancy

Templates for PICFs for Clinical Trials for self and parent/guardian and medical treatment decision maker can be found on the Department of Health and Human Services Clinical Trials website :

  • interventional 
  • genetic
  • participant partner pregnancy

Please select the appropriate template for your research.


The Eye and Ear Hospital site specific requirements for PICFs:

Page 1. Use The Royal Victorian Eye and Ear Hospital logo

Do not use the Eye and Ear letterhead - just use the logo.

Please contact the Research Office for the logo.

 

Page 1. Associate Researchers

The Eye and Ear prefers to list only 

  • Coordinating Principal Investigator (if relevant)
  • Site Principal investigator

 

Complaints section

Use the following details for the complaints section

If you have any complaints about any aspect of the project, the way it is being conducted or any questions about your rights as a research participant, then you may contact:

Position : HREC Secretary
Telephone : (03) 9929 8525

You will need to tell the Secretary the name of one of the researchers given above.

 


Eye and Ear HREC PICF requirements:

These elements must be included if the Eye and Ear is the reviewing HREC for the project:

 

Reviewing HREC / Local HREC Office

Use the following details for the Reviewing HREC information section:

The reviewing HREC approving this research and contact details of the Executive Officer are:

Reviewing HREC name : The Royal Victorian Eye and Ear Hospital Human Research Ethics Committee
HREC Executive Officer : Kerryn Baker
Telephone : (03) 9929 8525

Email:  ethics@eyeandear.org.au

 

4. Memo regarding use of witness on the PICF

Memo regarding use of witness on the PICF

 

5. If genomic research

For all research projects involving genetic testing, attach the Key Facts sheet issued by the Financial Services Council.

 

Clinical Trials involving Eye and Ear 

For all clinical trials, attach the Australian Charter of Healthcare Rights (2nd edition) with the Participant Information and Consent Form 

There are many additional options including translated versions, animated version and AUSLAN version.  Please use these additional resources based on the needs of each potential research participant and research partcipant. 

This is a requirement to comply with the National Clinical Trials Governance Framework and Eye and Ear Patient Rights & Responsibilities Procedure (available on the Eye and Ear intranet)

 

Further information 

https://www.fsc.org.au/resources/standards

 

Last updated 24 November 2020

 

 

Last updated on 30 October 2019