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Informed consent and plain language

  • PICF and plain language resources

    We have a number of templates and resources to help you write your PICF and other participant-facing materials in 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. They should: 

    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

    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 - see Chapter 4.2 of the National Statement. 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.

    If the child cannot consent, you should still involve them in appropriate discussions about the research. A Child Information Sheet could help you do this. See our resources for guidance.

    Think about your participant's needs

    You may be seeking informed consent from an individual whose needs do not suit the templates on our website, for example, the parent of a deceased child. If this is the case, please contact our office for advice. We will help you make sure that your written materials, and your recruitment processes, are appropriate for that individual. 

    Opt out approach

    The National Statement says that you should respect people's capacity to make their own decisions. This normally means that people should give express consent to take part in your project. Sometimes it may be justifiable to use an alternative approach. This might be appropriate if you are running a large scale, low risk project and it is not feasible to get express consent from each person.

    Using an opt out approach means that participants are included in the research unless they give their express decision to be excluded. Their decision must be informed. Therefore, you still need to give them information about your project. Once you have done this, you can assume that they are willing to take part in your project unless they say they do not want to. 

    If you want to use an opt out approach, you must get permission from a Human Research Ethics Committee. You need to make a strong argument that:

    1. your project poses little or no risk to participants and
    2. the risk of not seeking express consent is outweighed by the public benefit or interest of the research.

    This is only appropriate if people can make an informed choice about participation. This requires that:

    • you give people written information about the project
    • people receive this information, and are able to read and understand it
    • people are able to act on the information to decline participation.

    It may be appropriate for you to use different types of consent for different parts of your project. For example, you might seek explicit written consent for participation in clinical research. You might then use an opt out approach if you are seeking to use people’s information as part of a registry.

    The opt out approach is unlikely to constitute consent if you are applying Commonwealth privacy legislation to the handling of sensitive information, including health information. In some cases, it may not be feasible for you to get a participant’s explicit consent to use their information, but you cannot achieve the purpose of your research by using non-identifiable information. In these cases, you must comply with the guidelines under section 95 or section 95a of the Privacy Act 1988. If you are seeking to use an opt out approach to which sections 95 or 95a apply, only a HREC can grant this approval.

    For more information about an opt out approach, see Chapter 2.3, 2.3.5 - 2.3.6 of the National Statement.

    Waiver of consent

    In some cases, you may be able to use tissue or data without getting express consent from the individuals involved. In order to do so you will need to seek a waiver of consent. The National Statement on Ethical Conduct in Human Research states that a waiver of consent can only be granted by a fully constituted Human Research Ethics Committee (HREC). The HREC can only grant a waiver if sufficient justification is provided, and the necessary criteria are met. For more information about this, see Chapter 2.3 of the National Statement.

    You can find a list of projects that the RCH HREC has granted a waiver of consent for on our website.

    Withdrawing from research

    You should make your withdrawal processes as simple as possible. When designing your research, consider how your participants prefer to communicate. For example, they may like to communicate verbally or by text message. If so, your withdrawal processes should reflect this.

    At the time of consent, you should tell people about the consequences of withdrawing from the research. You should also outline this in your Participant Information and Consent Form (PICF). See sections 2.2.6(g) and 2.2.20 of the National Statement.

    If a participant does want to withdraw from the research project, engage them in a conversation so they understand the implications of withdrawal. This should be in line with your consent discussion and PICF. You can clarify exactly what they are withdrawing from. For example:

    • Are they willing for you to you continue using their already collected data or do they wish for it to be securely destroyed if possible?

    • Do they want to know what the study found? 

    • Would they mind being contacted about future research projects?

    • If they were on an investigational product, do they understand it may be in their best interests to be followed for safety?

    In some cases, it may be appropriate to explore the reasons they want to withdraw. While they  are not obliged to give you this information (see section 2.2.19 of the National Statement) if they are willing to share then it may help improve the current project or help you design future research projects.

    Make sure you record the participant’s withdrawal. If they withdraw verbally, keep a file note of your conversation including the date and the people involved in the discussion, in addition to the information above.

    Communicating your research results

    The National Statement advises that you should communicate your research results to participants in a timely manner, and in clear and accessible language. See section 3.1.72 of the National Statement. The RCH HREC expects that in most cases you should do this by sending participants a final letter. Our office needs to approve this letter before you send it to participants. You can email the letter to us at rch.ethics@rch.org.au

    Please:

    • include your study number in the subject heading of the email
    • let us know whether your study is single site or multi-site. If your study is multi-site, clearly list the full names of all the sites in the email
    • make sure you send a clean copy of the letter in Word format. We cannot provide advice on PDF letters.

    Once we have approved the letter, you can send it to participants. 

    For more information, refer to the Final letter guidelines

    Plain Language Adviser

    If you need help extra help writing in plain language, you can contact the Plain Language Adviser (PLA), who is based in Research Ethics and Governance. The PLA will be of particular assistance to new researchers. However, experienced researchers may also wish to seek assistance from the PLA. 

    The PLA can review documents for participants, including PICFs, newsletters and letters, and provide advice on how to make them clearer. Before you arrange for your documents to be reviewed, please:

    • review the resources on our website, particularly the Example PICF
    • proofread your documents
    • obtain an ERM number, and quote this in the subject-line of your emails to us
    • make sure your documents are clean copies in Word - please, no PDFs or track changes
    • provide the PLA the protocol for your project - the PLA will use this for background information. They will not provide feedback on your protocol.

    Please contact our office to request or arrange a review or make a time to discuss the resources and education materials available:  rch.ethics@rch.org.au

    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.