What is informed consent?

As a patient, you have the right to understand and agree to any treatment or medical procedure before it takes place. This is called informed consent.

Informed consent is the communication between you and your healthcare provider that leads to an agreement or permission for medical care, services, or treatment.

This process ensures your doctor or other healthcare providers give you information about your condition and treatment options before you proceed with care.

As a patient, you are entitled to get details and ask questions before receiving medical treatment or undergoing a procedure. In fact, if you are mentally capable of making your own decisions, medical care cannot be provided unless you give informed consent.

While there are many reasons for informed consent, some of the more critical aspects of this process are to

• Establish patient-doctor trust

• Prevent misunderstandings

• Allow healthcare professionals to provide honest opinions

• Avoid legal issues, since consent protects patients against assault and battery in the form of unwanted medical interventions

• Improve patient rights, since the informed consent documents are a systems-level check to ensure the consent process has occurred

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The informed consent process often begins with communication between the medical professional and the patient. This results in the patient’s authorization or agreement to go through a specific medical treatment or procedure.

When a healthcare professional seeks a patient’s informed consent, they need to make sure they

• Provide an explanation of informed consent: what it is, how it works, and what it involves

• Disclose all information about the treatment, such as a description of the procedure, the risks and benefits, and alternative options

• Verify that the patient has the capacity to understand and make decisions about their medical care (if not, the patient should appoint someone to make a decision in their place)

• Ensure the patient understands the information and voluntarily authorizes the treatment plan

Obtaining informed consent is critical to a patient’s care, but getting it isn’t always straightforward. In reality, there are many barriers that can contribute to a lack of understanding about consent, including the following:

• Patient-centered barriers: age, education, cultural factors, illness, and others

• Process-centered barriers: for example, a lack of information on the consent forms, poor readability, and the discussion timing and duration

Although patients want to take part in making their own medical decisions, they often believe these decisions should be the doctor’s task. In other cases, healthcare professionals might not understand the rationale for the patient’s role in making these types of decisions.

Although there are many ways for healthcare professionals to obtain informed consent, the tactics below are considered best practices.

Develop a practice of involving patients in medical decisions

This technique can be a great way to establish trust and understanding. The healthcare professional should apply it to all patients consistently and ensure it’s sensitive to their preferences for information and decision-making.

The practice should be designed to

• Address the treatment’s risks, alternatives, and benefits, and what the patient should anticipate before and after the procedure

• Allow patients or their representatives to make a voluntary choice that’s free from undue influence

• Be easy to understand

Recognize that informed consent serves more than one purpose

Healthcare workers should ensure their informed consent process is flexible enough to fulfill its primary purposes, which are:

• Protecting a patient’s rights

• Allowing autonomous self-determination and decision-making

• Promoting efficiency in the treatments and healthcare provided

• Building trust between medical professionals and patients

Document the informed consent process

Medical professionals should document the process using electronic medical records whenever possible to ensure everything is appropriately and permanently stored.

Depending on the jurisdiction and the compliance standards, the techniques involved with this process may include:

• Specific procedure consent forms

• Having written and electronic patient materials that explain the informed consent process

• Providing narrative notes that discuss the informed consent process and the objectives of the treatments and care involved

• Offering decision aids for treatments that involve complex decisions

The main purpose of informed consent is to protect a patient and their rights. Not only do these legal documents help ensure ongoing communication between the healthcare provider and patient, but they also help them understand the treatments involved.

You can still change your mind about starting a specific treatment procedure, even if you have already signed the consent form. Let your medical team know if you are having second thoughts.

You are allowed to decline any treatments being offered to you. You also have the right to choose an alternative treatment presented to you by your doctor, even if they don’t recommend it.

You can also refuse certain elements of a treatment without rejecting it all. For instance, you can decline surgery but request pain relief. However, it may be up to the medical care provider treating you to decide if they are comfortable with this approach.

Additionally, if you refuse a treatment or diagnostic test, your doctor can discuss the risks and likely outcomes with you. This enables you to make an informed refusal. In this case, you might be asked to sign a form to confirm you have received all of the information but still decline the treatment.

In shared decision-making, the healthcare provider and patient work together to decide on procedures, tests, and treatments. Then, they devise a care plan.

During this process, the doctor will offer information about your condition and the benefits and disadvantages of the treatment options. From there, you can ask questions about each option and get the answers you need.

You can also ask the doctor whether they prefer one choice over another. This type of decision-making is helpful when there isn’t a single best treatment option.

To obtain medical treatment, you first need to offer your consent—unless the treatment needs to be provided immediately because of an emergency.

However, you can ask a doctor for minimal information about your condition and the treatment involved and trust them to make decisions for you.

Even so, under no circumstances can a medical practitioner keep a diagnosis from a patient—even if their family requests to keep it private.

Consent can only be provided by individuals who have reached the legal age of consent. In the US, this generally means 18 years old.

In comparison, assent refers to the agreement of someone who cannot give legal consent to participate in an activity. By definition, these people are too young or unable to provide informed consent—but they are old enough to understand the possible benefits, risks, and activities expected of them.

For instance, while children or adults who are unable to give consent require the consent of a parent or legal guardian, they can give assent to taking part in a procedure or treatment.