What is the main purpose of informed consent?

September 27, 2025 •

3 min read

According to a study on informed consent, a patient's right to self-determination is paramount. Therefore, understanding what is the main purpose of informed consent is crucial for anyone engaging with the healthcare system, ensuring personal autonomy is protected.

Quick Summary

Informed consent's core purpose is to uphold patient autonomy, ensuring individuals have the necessary information about treatments, risks, and alternatives to make voluntary, educated decisions about their own healthcare. It is a legal and ethical cornerstone of modern medicine that protects both the patient and the provider.

Key Points

Respecting Autonomy: The primary purpose is to empower patients to make voluntary decisions about their own medical care, based on personal values and beliefs.
Ensuring Comprehension: The process ensures patients understand the nature of a procedure, its potential risks and benefits, and available alternatives before agreeing to treatment.
Building Trust: Informed consent fosters a transparent, honest relationship between patients and healthcare providers, which improves patient satisfaction and outcomes.
Minimizing Coercion: It protects patients from being unduly influenced or pressured into making medical decisions they are not comfortable with.
Protecting Providers: By documenting that a patient was fully informed, it provides a legal defense for healthcare providers in the event of an adverse outcome.
Continuous Communication: It is an ongoing dialogue, not just a signed form, that continues throughout the course of treatment, especially if new information arises.

Understanding the Ethical and Legal Foundation

Informed consent is a fundamental aspect of modern healthcare, built upon the ethical principle of respecting patient autonomy. Historically, medical decisions were often made paternalistically by clinicians. This began to change with legal precedents like the 1914 Schloendorff v. Society of New York Hospital case, which affirmed an individual's right to control their own body. This legal principle supports the ethical duty of healthcare professionals to fully inform patients. It's a communication process, not just a document, ensuring patients understand proposed procedures or treatments. The legal document serves as proof that the process occurred and the patient's decision was voluntary and informed.

The Three Core Elements of Informed Consent

Effective informed consent requires three essential components: disclosure, comprehension, and voluntariness.

Disclosure of Information

Providers must disclose all relevant information a reasonable person would need for a decision. This includes the procedure's nature and purpose, foreseeable risks and discomforts, potential benefits, alternative treatments (including no treatment), and the risks and benefits of these options.

Comprehension

Patients must understand the information presented. Providers should use clear language, avoiding jargon. Factors like literacy, language barriers (requiring professional translators if needed), and emotional state are important considerations. Assessing understanding is ongoing to ensure accurate processing of information.

Voluntariness

Consent must be given freely, without coercion or undue influence from staff, family, or others. Patients should feel free to ask questions without fear that their decision will negatively impact their future care.

Informed Consent in Practice: Clinical Treatment vs. Medical Research

While principles are similar, application differs in clinical practice and research.


Feature	Clinical Treatment	Medical Research
Primary Goal	Provide best care for an individual patient.	Generate generalizable knowledge and test interventions.
Information	Focuses on specific treatment details, risks, benefits, and standard alternatives.	Includes more detail on the experimental nature, study procedures, and potential unforeseen risks.
Regulation	Governed by state laws, ethics, and institutional policies.	Heavily regulated by federal agencies (e.g., FDA, HHS) and IRBs.
Key Protection	Empowers patient to make decisions for their health.	Protects human subjects from harm and exploitation.
Flexibility	Requires explicit consent for major procedures.	Has strict rules, with limited waivers (e.g., emergency research).

Exceptions and Special Circumstances

Limited situations allow for altered or waived informed consent, under strict regulation:

Emergency Situations: In life-threatening emergencies where a patient is incapacitated and a representative isn't available, treatment may occur without explicit consent to save a life.
Minimal Risk Research: IRBs may waive consent for some research with minimal risk.
Advance Directives: Patients can use advance directives or healthcare proxies to make decisions if they lose capacity.

The Critical Role of Communication

Informed consent is an ongoing discussion, not just a signature. If new information arises during treatment or research, providers must discuss it with the patient and reconfirm consent. This continuous dialogue builds trust and keeps patients involved in their care. Patients should feel empowered to ask questions until they are confident in their decision. A strong informed consent process indicates a patient-centered healthcare system.

A Foundation of Trust and Empowerment

The process builds trust between patients and providers. By being transparent, providers show respect for patient autonomy. For patients, it's about controlling their health journey and ensuring interventions align with their values. This collaboration improves patient satisfaction and health outcomes through shared decision-making. Informed consent is a vital ethical practice that empowers individuals and strengthens the patient-provider relationship.

For more detailed information on informed consent and its ethical principles, you can consult resources from the National Institutes of Health (NIH).

Frequently Asked Questions

In cases where a patient is unconscious or lacks the capacity to decide, a legally authorized representative, such as a healthcare proxy or family member, may provide consent. Exceptions also exist for life-threatening emergencies where immediate treatment is necessary.

Yes, you have the right to withdraw your consent at any time, even after a procedure has begun. You must notify your healthcare team of your decision and understand the potential consequences of stopping treatment.

The disclosure must include the nature and purpose of the procedure, its risks and benefits, alternative treatment options, the risks and benefits of those alternatives, and the option to refuse treatment.

No, there are limited exceptions. These typically involve emergency situations where a delay would cause serious harm, or specific, low-risk research scenarios approved by an Institutional Review Board (IRB).

For a clinical trial, the informed consent process is often more extensive and detailed, covering the experimental nature of the treatment, the study protocol, and potential unforeseen risks more rigorously.

The healthcare provider who will perform the procedure is ultimately responsible for obtaining informed consent. While parts of the process can be delegated, the provider must ensure the patient understands and consents.

Informed consent requires a thorough, documented process of disclosure, comprehension, and voluntariness. Simply giving permission, or assent, does not involve the same level of detail and mutual understanding required by law and ethics.

You can ask your healthcare provider to use simpler language, provide printed materials, bring a family member to help, and take time to consider your decision before signing. It's important to ask as many questions as needed until you feel confident.