Research consent

Few topics are as important (or as interesting) as that of free, informed consent during research projects.

The research ethics and governance processes will ensure that for projects involving human participation (either directly or indirectly, e.g. via use of data arising from humans) has appropriate consent processes in place.

However, this page provides information on two common consent approaches: using a consent form, and applying to HREC for a waiver for the requirement to obtain consent.

For adults giving their own consent, we encourage you to use the ‘CT:IQ InFORMEd PICF Template’, developed through CT:IQ’s project, and aiming for a simplified, consumer-centred PICF template that adheres to national and international guidelines.

This template is available here

It is supported by this user guide.
 
For all other PICF types (e.g. ‘PICF interventional for parent or guardian’) please use the templates available via the Department of Health here (see 'Templates' section).

All PICFs must:

1. Be clear, non-coercive, and understandable to members of the cohort from which you’re hoping to recruit
2. Have version control (e.g. specifying version number and version date, in the footer of the document, as well as the file name)
3. Provide details for who to contact at this site when wishing to make a complaint related to the research project – which should be as follows:

Contact for complaints

Manager, Research Ethics and Governance

Telephone

(03) 5320 8661

Email

ResearchEthics@gh.org.au 

Where you are requesting a waiver of the requirement to obtain consent (for example, from individuals whose data was collected for care purposes, but you want to access and use it for research purposes), HREC requires that a waiver of consent be officially requested, in line with National Statement guideline 2.3.10. That is, requesting a waiver, and stating how the project meets the nine criteria set out in NS2.3.10, which are:

a) involvement in the research carries no more than low risk to participants (see Chapter 2.1)

b) the benefits from the research justify any risks of harm associated with not seeking consent

c) it is impracticable to obtain consent (for example, due to the quantity, age or accessibility of records)

d) there is no known or likely reason for thinking that participants would not have consented if they had been asked

e) there is sufficient protection of their privacy 

f) there is an adequate plan to protect the confidentiality of data

g) in case the results have significance for the participants’ welfare there is, where practicable, a plan for making information arising from the research available to them (for example, via a disease-specific website or regional news media)

h) the possibility of commercial exploitation of derivatives of the data or tissue will not deprive the participants of any financial benefits to which they would be entitled

i) the waiver is not prohibited by State, federal, or international law.

Your statement describing how the project meets these nine criteria should be inserted into the Consent section of your protocol, and into the relevant part of the ethics application form.