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Informed consent and plain language

  • Informed consent 

    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:

    1. voluntarily agree to take part in your project and
    2. understand what your project involves. 

    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:

    1. nature, complexity and level of risk of your project and
    2. personal and cultural circumstances of the person.  

    Some common ways of recording consent are: 

    • written – for example, the person signs a Participant Information and Consent Form
    • verbal – for example, you ask the person whether they agree to take part in your project and record their response in writing or on an audio device
    • implied – for example, the person gives consent by filling out and returning a survey.

    Children and young people 

    Research with children and young people under 18 years of age raises particular issues around informed consent. Usually, you need to get consent from:

    1. the child or young person and
    2. the parent or guardian. 

    When you are seeking consent from a child or young person, you need to think about:

    1. their capacity to understand what the research involves and  
    2. the complexity of the research, and its potential risks and benefit.

    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.

    Consent in paediatric research

    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. 

    Our website

    On our website you’ll find a number of resources to help you meet the National Statement’s requirements around informed consent. These include:

    FAQs

    When should I get consent from the parent/guardian?

    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. 

    Can a young person consent to taking part in research?

    The young person’s capacity to provide informed consent will depend on:

    1. the nature and complexity of the research project, and
    2. the young person themselves. The capacity to understand and consent to taking part in research varies from young person to young person. You should assess this on a case-by-case basis. Remember that a young person’s capacity can change over time.

    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.

    Can I use an assent form?

    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.