Informed Consent
Before you decide
Questions to consider
There are strict guidelines in place to protect clinical trial participants. All trials must be reviewed, critiqued and approved by a Human Research Ethics Committee (HREC) before they can commence. During this medical-scientific ethics review period the committees can make changes to a trial in order to optimise patient safety. Patients must also give informed consent.
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Informed Consent
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to particpate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provide an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
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Before you decide
If you are interested in participating in a clinical trial you may want to make contact with the trial researchers and ask any questions that you would like answered before you make your decision.
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Questions to consider
Some questions that may be relevant that you might like to ask include:
- What is the trial’s purpose?
- How long will I have to be involved in the trial?
- How often will I need to attend appointments and where will they be?
- Will it cost me anything to participate in the study?
- What treatments and/or tests will I have during the trial?
- What risks, side effects and benefits do I face in the trial?
- Will I be able to continue my current medicines during the trial?
- Can I talk to other people participating in the trial?
- What happens to my treatment after the trial ends?
You might want to take a friend or relative with you if you decide to meet with the researcher so that you can take notes and discuss your options after the meeting/s.
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