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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 contact person (if Eye and Ear is a research site) 

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 : Research Office
Telephone : (03) 9929 8525

 

Reviewing HREC approving this research and HREC Executive Officer details

Obtain details from the reviewing HREC.

If Eye and Ear is the Reviewing HREC:

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

Local HREC Office contact (Single Site - Research Governance Officer)

 

If Eye and Ear is the research site:

 

Name: Research Governance Officer

Position: Research Governance Officer

Telephone: (03) 9929 8525

Email:  ethics@eyeandear.org.au

 

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)

 


Eye and Ear HREC PICF requirements:

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

Memo regarding use of witness on the PICF

Memo regarding use of witness on the PICF

 

Genomic research

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

Further information 

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

 

Guidance for Principal Investigators

Many studies include a component of genetic research – that is characterising the genome of the participants.  Genomic research may be targeted – testing genes known or having the potential to cause or influence certain diseases. Alternatively, it may use methods that sequence large parts of the genome or the whole genome, with the potential to discover mutations well outside the scope of the research. Genomic research can be carried out on a sample from an individual, or on pooled samples in population-based research that does not have the potential to discover genetic mutations of interest to an individual participant. 

All genomic studies must conform to the principles in the NHMRC National Statement on Ethical Conduct in Human Research (Chapter 3.3) and all applicable privacy laws and regulations.  An important consideration is the potential for unreliable and unverified results to do harm to the participant.

The RVEEH HREC considers projects involving genomic research on a case by case basis.  Guidance on certain important aspects of a research plan for genomic studies is provided below. Researchers are advised to contact the Research Office before submission of research for further guidance.

There are five elements listed in Chapter 3.3 of the National Statement, which the project must provide for:

  • Element 1: Research Scope, Aims, Themes, Questions and Methods
  • Element 2: Recruitment
  • Element 3: Consent
  • Element 4: Data Collection and Management
  • Element 5: Communication of research findings or results to participants

Specific discussion of the financial and legal implications for the participant must form a part of the consent process. This is to assess and disclose the potential economic harm including the imposition of direct or indirect costs on participants – (refer to Good Clinical Practice (GCP) 4.8.10 and National Statement Chapter 2.1).

If researchers intend to provide research findings to participants, researchers must justify the communication of the findings. When considering whether research findings should be returned to participants, researchers should consult the National Statement’s Decision tree for the management of findings in genomic research and health care and Guidance for the Development and Evaluation of an Ethically Defensible Plan for the Potential Return of Findings and Individual Results from Genomic Research. In particular, if the research may result in inadvertent (also known as incidental) findings that are of potential clinical relevance to the participant, the research team must justify whether or not these findings are to be reported to the participant.

If any research findings that are clinically significance or potentially clinically significant (whether those findings are ‘primary’ or inadvertent) are to be returned to a participant, those findings must first be verified to a clinically acceptable standard (see National Statement, 3.3.29). If individual research results are to be returned to participants, the research plan should address access to clinical services and genetic counselling (National Statement, 3.3.31).

 

 

 

Last updated 20 May 2021