Consent
The requirement for consent
Participation in research is voluntary and based on informed consent. Under the National Statement the requirements for consent include:
- consent must be freely given
- consent must be based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it
- consent is valid only for the purpose for which the person agreed to
- the person giving consent must have the capacity and legal authority to do so.
Participation in research
To help potential participants decide whether or not to be part of a research study members of the research team will provide a written description of their research. This description is known as a Participant Information Sheet (PIS) and includes details about the study including:
- purpose
- duration
- required procedures
- risks and benefit profile
- alternative to research participation.
The PIS is to be complimented by a discussion with the potential participant. All questions can be answered during this discussion.
The PIS must be prepared carefully and clearly and not use technical language.
You can use the following template forms:
- ACT Health HREC Participant Information Sheet
- ACT Health Low Risk Research Participant Information Sheet
Consent for adult participation in research
After the PIS is completed and a discussion has taken place with a potential participant, those who wish to continue will sign a consent form.
The consent form is different to the PIS but must include high level indications of what the research will include. Indications could include radiation exposure, use of data and other relevant information.
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 or clinician will not be affected.
If there are any changes to the research study protocol participants must be kept informed through updates to the PIS. Participants may be asked to sign a new consent form before proceeding with the amended study protocol.
You can use and adapt these templates to suit your study:
Giving consent for research participation 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 and geriatric medicine.
For full details go to the Powers of Attorney Act 2006.
The requirements of researchers in providing information to the person giving consent on behalf of another are available in the participant information sheets and consent forms below:
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 the participation of children and young people in research
In ordinary circumstances research that involves children and young people (0-17 years) will be done with the consent of a parent or legal guardian. Depending on the age of the child and the nature of the research, the research team may wish to seek assent from the child or young person in addition to consent from the parent or legal guardian.
The requirement for assent is to be determined by the research team. Information provided to the child or young person should be tailored to their age and level of maturity. Researchers may use Gillick principles for guidance in determining appropriate assent processes and information.
You can use this template:
Opt-out processes
Under the National Statement not all research requires active consent. In some cases, researchers may employ opt-in or opt-out processes.
Find out more in the National Statement or contact a member of the REGO team on 02 5124 5659 or ethics@act.gov.au.
Waiver of the requirement for consent
Under chapter 2.3 of the National Statement the requirement for active consent may be waived in specified circumstances.
When neither informed consent nor an opt-out approach is appropriate, the HREC may justifiably waive the requirement for consent. A waiver of consent must be requested in accordance with chapter 2.3 of the National Statement and use this template:
A waiver of consent is not required when accessing de-identifiable data.