Participant Information, Consent and Waiver of Consent
Participation in research is voluntary. If a person does not wish to take part, they do not have to. All participants and prospective participants receive the best possible care whether or not they decide to take part in research.
To help participants decide whether or not to be part of a research study, members of the research team will explain the details of the study to them. The researchers will also provide a document, called a participant information sheet (PIS), which includes details about the study such as its purpose, duration, required procedures, risks and potential benefits. A participant information sheet informs a potential participant about the research project and explains what is expected of them if they do agree to take part in the study.
The participant information sheet will assist the participant in their decision whether or not to take part in the research. The information sheet must be prepared carefully and clearly communicate what the study involves. Information sheets should avoid the use of scientific language and technical jargon. Potential participants should be encouraged to ask questions about anything that assists in their decision making.
Please see the following ACT Health Participate Information sheet templates
- ACT Health HREC Participant Information Sheet template
- ACT Health Low Risk Research Participant Information Sheet Template
Adults taking part in a research must give ‘informed consent’.
Informed consent means that potential participants are given information, verbally and via the participant information sheet, about the facts of a research study before deciding whether or not to participate.
The potential participant will be asked be asked to sign a consent form. By signing the consent form the participant agrees to take part in the research study and that they have understood what the study involves and what is expected of them.
The consent document is not a contract and participants may withdraw from the study at any time. If a participant decides to withdraw from the study, the relationship between participant and the researcher/clinician will not be affected.
If there are any changes to the research study protocol participants will be kept informed and may be asked to give consent again before proceeding with the amended study protocol.
Studies conducted at or by ACT Health must have consent forms updated to include ACT site specific information. Please see the following ACT Health Consent Form templates:
Giving consent to research on behalf of another person
In 2016 the ACT Government amended legislation to enable research participation by people unable to give consent on their own behalf. These amendments allow decision making by another person such as a guardian, health attorney or enduring power of attorney. The amended legislation will support research in important fields including dementia, emergency care, geriatric medicine, and more.
Please see the following paper which outlines the legislative changes and the effect they have had on research in the ACT:
The requirements on researchers to provide information to the person giving consent are reflected in the following Participant Information Sheets and Consent forms:
Consent for participation in Low-Risk Research by Another Person On Behalf Of the Participant
- Low-Risk Research Information Sheet for Participation on Behalf of another Person
- Low-Risk Research Consent Form for Participation on Behalf of Another Person
Consent for participation in Medical Research by another person on behalf of the participant
- Medical Research Information Sheet for Participation on Behalf of Another Person
- Medical Research Consent Form for Participation on Behalf of Another Person
- Medical Research Independent Doctor Assessment Form for Capacity to Consent
Consent for Children and young people
A child or young person (0-17 years) may not legally give informed consent on their own behalf to participate in research however they might have the ability to assent or to dissent from participation. Children and young people should be asked whether or not they wish to participate in the research.
When seeking assent from a child or young person a researcher must consider their level of maturity and the complexity or nature of the research. An assent form must provide information in language appropriate for the age, maturity and experience of the child or young person. A separate and more detailed participant information sheet and consent form for parents or guardians is also required.
Opt out Consent
An Opt-out process may be used to access, examine and link large electronic databases to inform clinical practice and answer research questions.
Potential participants are provided with written information explaining the purpose of the research study and are informed that their personal health information will be provided to the study database registry for the purpose of quality improvement and research.
Opt-out consent means that a person’s health information will be included in a research project by default unless they actively tell someone that they do not wish to participate. To opt-out means that person’s health information will not be included in the database or registry.
Waiver of Consent
A waiver of consent is not required when accessing de-identifiable data.
When neither informed consent nor an opt-out approach is appropriate, the requirement for consent may be justifiably waived. A waiver of consent should only be sought when obtaining consent is strictly unfeasible. Please consult the National Statement Chapter 2.3 on the requirements for waiving consent.
Where a waiver of consent is included with a low risk ethics application the Low Risk Ethics Sub-committee will provide ethical review of the project and will refer the waiver of consent request to be reviewed at the next available meeting of the full HREC.
Please note that ethical approval of the research proposal and waiver of consent does not provide authorisation to release data. Data release is at the discretion of the relevant data custodian.
If a waiver of consent is required, please complete the template form below and submit with your Ethics application: