Informed consent is a process that’s required for most medical procedures. However, there’s often confusion about what informed consent is, what it means, and when it’s needed.
In a healthcare setting, informed consent allows you to participate in your own medical care. It enables you to decide which treatments you do or do not want to receive.
Also, informed consent allows you to make decisions with your healthcare provider. This collaborative decision-making process is an ethical and legal obligation of healthcare providers.
In this article, we’ll help explain what informed consent is, when it’s needed, what it should include, and why it’s important.
Informed consent is when a healthcare provider — like a doctor, nurse, or other healthcare professional — explains a medical treatment to a patient before the patient agrees to it. This type of communication lets the patient ask questions and accept or deny treatment.
In a healthcare setting, the process of informed consent includes:
- your ability to make a decision
- explanation of information needed to make the decision
- your understanding of the medical information
- your voluntary decision to get treatment
These components are essential elements of the shared decision-making process between you and your healthcare provider. Most importantly, it empowers you to make educated and informed decisions about your health and medical care.
The following scenarios require informed consent:
An informed consent agreement should include the following information:
- diagnosis of your condition
- name and purpose of treatment
- benefits, risks, and alternative procedures
- benefits and risks of each alternative
With this information, you can make an educated choice about the procedures you receive.
When your healthcare provider recommends specific medical care, you can agree to all of it, or only some of it.
Before the procedure, you’ll have to complete and sign a consent form. This form is a legal document that shows your participation in the decision and your agreement to have the procedure done.
When you sign the form, it means:
- You received all the relevant information about your procedure from your healthcare provider.
- You understand this information.
- You used this information to determine whether or not you want the procedure.
- You agree, or consent, to get some or all of the treatment options.
Once you sign the form, your healthcare provider can move forward with the procedure.
If you don’t want a procedure or treatment, you can choose to not sign the form. Your healthcare provider won’t be able to provide specific types of treatment if you don’t agree to it.
In some cases, another person can sign a consent form for you. This is appropriate in the following scenarios:
- You aren’t of legal age. In most states, if you’re younger than 18, a parent or guardian will need to give consent on your behalf. But some states allow teens who are emancipated, married, parents, or in the military to provide their own consent.
- You want someone else to make the decisions. If you’d like to let another person make your future medical decisions, you can fill out a form called an advance directive. This allows someone else to give consent on your behalf if you’re unable to.
- You can’t give consent. Another person can make your medical decisions if you can’t provide consent. This may happen if you’re in a coma, or have a condition like advanced Alzheimer’s disease.
Implied consent is a type of informed consent. This consent is suggested, or implied, by the patient’s actions. It isn’t explicitly stated or written down.
For example, if you have a fever and see a healthcare provider, your visit implies that you want treatment. Another example is if you break an ankle and visit a healthcare provider for crutches.
Compared to informed consent, implied consent is less formal. It doesn’t need to be legally recorded.
Informed consent for research or clinical trials is also required. It informs the participants about the trial and lets them make educated decisions about taking part in the study.
The process is similar to informed consent in healthcare. In a research setting, it involves discussing the following:
- purpose and procedure of the study
- relevant information about the study, including risks and benefits
- your ability to understand this information
- your voluntary decision to participate
Informed consent continues until the study is completed.
Informed consent isn’t always required in emergencies.
In an emergency, your provider may look for your closest blood relatives for consent. But if your relatives aren’t available, or if you’re in a life-threatening situation, a healthcare provider can perform the necessary life-saving procedures without consent.
When a healthcare provider recommends a specific procedure, you have the right to accept or refuse it. If you decide to move forward, you’ll need to give informed consent first.
Informed consent means that you made a voluntary and educated decision. It also means that your healthcare provider has fully explained the medical procedure, including its risks and benefits.
Talk to your healthcare provider if you have questions or concerns about this process. As the patient, you have the right to make informed choices about your medical care and what works best for you.