Importance of Patient Informed Consent

‍‍Every medical treatment has risks and benefits. Physicians weigh the risks and benefits before recommending a specific treatment to a patient, but they also have a duty to ensure that patients understand how a treatment could help or harm them. This process of educating a patient about a particular treatment so they can decide whether or not to move forward with it is known as patient informed consent.

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Read on to learn why informed consent is crucial for both patients and their physicians.

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Why Is Patient Informed Consent Important?

Informed consent is important for patients because it protects their autonomy and empowers them to make decisions about their own health. It ensures patients understand what to expect with their medical treatment, even if they do not have any medical training.

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For physicians, informed consent is essential for building trust and fostering a strong doctor-patient relationship. It also helps defend physicians from medical malpractice claims for failing to get a patient’s informed consent prior to treatment. According to one study, more than 25% of all medical malpractice claims involve allegations about the lack of informed consent.

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Despite its importance, informed consent is challenging in some situations. For example, patients may not understand medical terms and concepts. Breaking down medical terms and concepts into layman's terms such that they can be easily understood by a patient is an important element of ensuring informed consent.

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Read our blog if you're asking yourself what the difference between "patient informed consent" and "consent to settle" is.

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Ethical Considerations in Informed Consent

Informed consent to medical treatment is one of the cornerstones of medical ethics. The key ethical considerations include:

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• Necessity of consenting to treatment: Patients have the right to make decisions about their own bodies and be free from unwanted medical procedures.
• Impact of informed consent on patient’s trust: Research shows that patients who are more involved in the decision-making process maintain more trust in their physicians.
• Balancing the rights of patients and physicians: The informed consent process aims to find a balance between the physician’s expertise and the patient’s autonomy.

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The Principle of Informed Consent

Patient informed consent supports some of the core ethical practices in medicine, including:

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• Autonomy and respect for persons: Patients have a right to make decisions about their care.
• Beneficence and non-maleficence: Physicians have an obligation to act in their patient’s best interest and minimize the chances of harm.
• Justice in healthcare settings: Patients must be treated fairly and equitably.

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Medical Procedures Requiring Informed Consent?

Informed consent is required for a wide range of medical procedures. It’s needed for most surgeries, even those done in office-based settings. It’s also required for complex medical tests, like endoscopies, and higher-risk medical treatments, such as corticosteroids. Blood HIV testing may require consent, depending on state laws.

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What Are the Two Exceptions to Informed Consent?

While patients generally have the right to informed consent to medical treatment, there are two main exceptions to the rule:

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• Life-threatening emergency: During an emergency situation, there may be no time to obtain consent before taking steps to stabilize a patient.
• Incapacitated patient: Some patients, such as those with dementia, are not able to make an informed decision. Physicians have an ethical responsibility to get informed consent from the patient’s surrogate decision maker.

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Legal Aspects of Informed Consent

Physicians have both a legal and ethical obligation to get informed consent from their patients before providing treatments. Patients have the right to get information about recommended interventions and make their own decision about whether they want to proceed.

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There are three legal standards for informed consent. Physicians are responsible for determining the right approach in each situation:
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• Subjective standard: What the patient in front of you would need to know to make an informed decision.
• Reasonable patient standard: What an average patient would need to know to make an informed decision.
• Reasonable physician standard: What a typical physician would say about the procedure.

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Obtaining Patient Informed Consent

To obtain informed consent, physicians talk to their patient about the treatment and confirm the patient wants to proceed. Here’s a closer look at the process.

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Who Is Responsible for Obtaining Patient Informed Consent?

The treating healthcare provider is responsible for getting informed consent from their patient. There are three types of informed consent in healthcare, and the type a provider needs to get varies based on the situation.
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• Implied consent: Implied consent means a patient cooperates without discussion. For example, putting out an arm to have their blood pressure taken.
• Oral consent: Oral consent means a patient says they want to proceed, but does not sign any forms. It may be appropriate for basic procedures.
• Written consent: Written consent happens when a patient fills out a patient consent form. It’s necessary for many procedures, including surgeries.

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What Are the Four Elements of Informed Consent?

Four elements must be present for a patient to provide meaningful informed consent to medical treatment:
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• Information disclosure: The physician must explain the risks, benefits, and alternatives to treatment.
• Competence: The patient must have the capacity to make an informed decision.
• Comprehension: The patient must understand the relevant information.
• Voluntariness: The patient’s consent must not be coerced.

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Discussing Risks, Benefits, and Alternatives to Treatment

To ensure patients can make an informed decision about a proposed medical treatment, physicians have an obligation to discuss the following five components:
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1. The nature of the procedure: Patients need to know what will happen during the procedure, including the key steps involved.
2. The procedure’s risks and benefits: Physicians must explain why they are recommending the procedure, as well as potential complications.
3. Reasonable alternatives to the procedure: Physicians should discuss other therapies or interventions that may be appropriate.
4. Risks and benefits of alternative options: To make an informed decision, patients must understand the pros and cons of other treatment options.
5. Assessment of patient understanding: Physicians must confirm the patient understands the discussion.

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Strategies for Effective Communication in Medical Procedures

To communicate effectively with patients, physicians should use clear, non-medical language. Patient education materials, such as videos or pamphlets, can be helpful. To confirm understanding, physicians can ask patients to repeat the information in their own words.
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For patients who are not native English speakers, physicians should enlist the help of a professional translator for the informed consent discussion.
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Challenges in Patient Informed Consent

Informed consent for medical treatment is crucial, but it can be challenging for doctors to manage in some situations. Potential issues include:
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• Dealing with limited patient understanding: Some patients are not native English speakers or have limited medical knowledge.
• Informed consent in emergency situations: In life-threatening situations, there may be no time to get informed consent.
• Concerns with informed consent in research: Insufficient information about the risks and benefits of new treatments complicates the informed consent discussion.
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Informed Consent & Indigo

Physicians have a responsibility to obtain informed consent before providing medical treatment, with few exceptions. Getting informed consent protects patients’ autonomy, builds trust with patients, and helps physicians reduce the risk of malpractice claims.

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Ultimately, whether informed consent is challenged in any scenario will depend on whether the physician can demonstrate reasonable due diligence. The more the physician can demonstrate the reasonableness of their efforts, ideally with proper documentation, the more likely any challenge to informed consent will be overcome.

Medical malpractice insurance from Indigo helps protect physicians in the event a patient files a lawsuit for issues related to informed consent.

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Request your quote from Indigo today.

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_{Photo by Kelly Sikkema on Unsplash.}