Before volunteering to take part in a clinical trial, participants need to give their informed consent, which is when a participant gives their permission to take part in a clinical trial after they have been given clear and in-depth information about what is involved and any possible risks that may occur.
What Is Informed Consent?
Informed consent is when a healthcare professional or medical researcher thoroughly explains a medical process, or what is to be expected during a clinical trial, as well as providing the participant with relevant documentation which outlines the clinical trial in great detail. This includes the likelihood of any risks and benefits, the estimated timeline of the clinical trial and the participant’s rights. The participant is then able to give their consent to take part in the clinical trial, feeling confident in their decision to do so.
The process of Informed Consent includes:
- The participant’s ability to make a clear and informed decision with a sound mind.
- The relevant information needed to make an informed decision. (The name and purpose of the clinical trial. What disease or condition is it for? What’s the end goal for the clinical trial? How long is the clinical trial expected to last? What are the potential risks and benefits?)
- The participant’s understanding of the relevant information, and their rights.
- A participant’s willingness to participate in the clinical trial without any coercion.
For Informed Consent to be valid, it needs to consist of the following factors:
- People need to volunteer to participate in a clinical trial on their own terms, not under any coercion.
- Participants need to be of sound mind.
- All participants need to be informed about the likelihood of any benefits or risks before signing the consent forms.
All participants are given a Participant Information and Consent Form with all the relevant information. Once a participant voluntarily agrees to participate in a clinical trial, they sign the consent form to show that they are agreeing to take part in the clinical trial and understand what is involved.
Participants will be asked to sign new consent forms if there are any changes to the clinical trial.
It’s important to remember that a consent form is not a legally binding contract, and a participant has the right to withdraw from the clinical trial at any time without any consequences.
The Three Types of Different Consent include:
Implied Consent: Agreement is given by cooperating or listening to a healthcare professional during routine procedures (blood tests, etc).
Verbal Consent: You verbally agree to a treatment or medical procedure (especially used for procedures that don’t have a high risk).
Written Consent: Your agreement is given by signing a legal document for a treatment or procedure that may present a higher risk (clinical trials).
Why is Informed Consent So Important?
- Participants have a clear understanding of what is expected of them during clinical trials and feel confident about their decision to take part.
- Participants are able to make informed decisions about their health and healthcare.
- It shows that clinical trials are following Good Clinical Practice (GCP) guidelines.
- Participants can ask questions and can say no to the clinical trial.
- Participants are aware of their rights.
- Integral to the right to information in the Australian Charter of Healthcare Rights (describes what a patient can expect when receiving healthcare).
- Recognised in the Professional Codes of Conduct (ethical principles which form the basis for practicing required standards of behaviour for members of a profession).
Participant and Patient Rights
Participants and patients’ rights exist to give people the right to safe healthcare, the right to refuse healthcare or take part in a clinical trial, and the right to privacy. Some rights are enforceable by law, and all healthcare professionals have to abide by these laws.
Understanding your rights means that you’re empowered enough to take an active role in your own healthcare with the knowledge that:
- You can ask questions.
- You can stop treatment or pull out of a clinical trial if you don’t feel comfortable.
- You can ask for more information.
- You can talk about your worries or fears to your healthcare provider.
- You are shown respect at all times.
- You won’t be judged or discriminated against.
- Your private information will be kept confidential.
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