In this section
The National Statement on Ethical Conduct in Human
Research says that if you want people to take part in your
research project, you need to get their informed consent. This means that they:
To help people understand your project, you should
give them information in plain language. Our website provides a number
of plain language resources to help you do this.
You also need to record the fact that each person
has consented to take part in your project. You can record consent in a number
of ways, depending on the:
Some common ways of recording consent are:
Research with children and young people under 18
years of age raises particular issues around informed consent. Usually, you
need to get consent from:
When you are seeking consent from a child or young
person, you need to think about:
You should respect the developing capacity of children and young people to be involved in decisions about their participation in research. In some cases, parental consent may not be necessary. For example, a 17 year-old with good literacy skills may be able to consent to low-risk research. For further information about doing research with children and young people, see Chapter 4.2 of the National Statement.
The Australian Paediatric Research Ethics and Governance Network (AGPREG) has produced a guide on consent in paediatric research. It provides information about clinical trials, participants who are children, and consent.
On our website you’ll find a number of resources to
help you meet the National Statement’s requirements around informed consent.
In general, you should get consent from the parent/guardian if the young person is under 18 years of age. Sometimes you should seek the young person’s consent as well. See the next question.
The young person’s capacity to provide informed consent will depend on:
You should offer young people over 12 years of age the opportunity to consent if they are capable and mature enough to do so. This is in addition to their parent/guardian’s consent.
In some cases, you can get consent solely from a young person who is a mature minor, and not their parent/guardian. If you are seeking to do this, you need to provide the ethics committee with justification in line with sections 4.2.8 and 4.2.9 of the National Statement.
If a young person does not have capacity to consent, you should still involve them in discussions about the project. You may also wish to give them an information sheet about the project.
The term 'assent' has no legal standing in Australia and is not recognised in the National Statement. The Australian Paediatric Research Ethics and Governance Network (APREG) guidelines on consent reiterate that assent forms are not appropriate. For this reason the RCH HREC will not approve an assent form.