A guide to obtaining explicit consent

According to the Society of Radiographers, it is the healthcare practitioner's responsibility to ensure that the patient or service user has given genuine consent prior to any procedure being carried out, as “it is they [the healthcare practitioner] who will be held responsible in law if this is later challenged.”

Obtaining explicit consent in healthcare ensures patients are fully informed about and agree to the proposed medical procedures, treatments, or participation in research. This process is central to respecting patient autonomy and maintaining ethical standards in medical practice.

Why is consent required?

According to the article Informed Consent by Parth Shah et al., “The function of informed consent in health care is to ensure that patients are fully informed about the medical procedures or treatments they may undergo, enabling them to make autonomous decisions about their care. The informed consent process serves ethical and legal purposes by safeguarding patient rights, fostering transparency, and promoting trust between healthcare professionals and patients. Informed consent ensures that patients understand the risks, benefits, alternatives, and potential consequences of medical interventions, allowing them to weigh their options and participate actively in their treatment plans. This process is critical for respecting patient autonomy and allowing individuals to make decisions aligned with their values, beliefs, and preferences.” The process of consent benefits both the patient and healthcare providers. As the article notes, “informed consent protects clinicians by documenting that patients were adequately informed, reducing legal liability in case of adverse outcomes. Ultimately, informed consent is a tool to enhance patient-centered care and strengthen the clinician-patient relationship through open, honest communication.”

When is consent required?

According to Cleveland Clinic, patients must give “informed consent any time there’s a risk with a test or treatment. That includes physical risks and even privacy risks.” Healthcare providers must explain what’s involved so the patient can decide if they agree. “That includes risks to your privacy. Specific tests and treatments that are likely to require informed consent include:

• Anesthesia
• Biopsies
• Blood transfusions
• Cancer treatments like chemotherapy and radiation
• Childbirth interventions like forceps delivery or episiotomy
• Clinical trials (research studies)
• Genetic testing
• Medical implants
• Surgery
• Treatment with high-risk medications, like opioids
• Tests or procedures that go inside your body, like an endoscopy.”

Additionally, patients must give informed consent any time their personal medical records are transferred to another person or place.

Key elements of explicit consent

According to AMA ethics guidance, informed consent occurs when “communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention.” This definition stresses that consent is about understanding, choice, and agreement and encompasses:

Assessing the patient’s ability to understand

Before treatment discussions can begin, healthcare providers have the responsibility to determine whether the patient can comprehend the relevant information and make an independent decision. The AMA states that physicians should “assess the patient’s ability to understand relevant medical information and the implications of treatment alternatives and to make an independent, voluntary decision.” This ensures that the consent is both informed and valid, reflecting the patient’s free choice.

Presenting relevant information clearly

Once the healthcare provider has determined capacity, they must present “relevant information accurately and sensitively.” This includes details about:

• Diagnosis, when known
• Purpose and nature of the treatment or intervention
• Risks, benefits, and burdens of all options, including doing nothing

The AMA emphasizes that this information should be tailored to align with the patient's preferences and level of understanding, rather than being presented as a generic message.

Documenting the consent process

Finally, properly recording the conversation and the patient’s decision ensures clarity and accountability. As the AMA states, providers must “Document the informed consent conversation and the patient’s (or surrogate’s) decision in the medical record in some manner. When the patient/surrogate has provided specific written consent, the consent form should be included in the record.” Documentation serves both ethical and legal purposes, making it clear that consent was obtained thoughtfully and with respect for the patient’s autonomy.

See also: HIPAA Compliant Email: The Definitive Guide

Steps to obtain explicit consent

To obtain consent, the AMA notes that “Successful communication in the patient-physician relationship fosters trust and supports shared decision making. Transparency with patients regarding all medically appropriate options of treatment is critical to fostering trust and should extend to any discussions regarding who has access to patients’ health data and how data may be used.” The process “occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention.”

Related: How to obtain legal digital consent while maintaining HIPAA compliance

Special considerations

There are additional factors that can affect a patient’s ability to understand, freely choose, or meaningfully participate in decisions about their care. These specific considerations extend beyond the fundamental aspects of consent and require that clinicians adapt their communication and decision-making strategies accordingly. The article by Parth Shah et al. identifies the following as special considerations:

Impaired decision-making capacity

Patients may struggle to understand medical information due to cognitive impairment, severe illness, or mental health conditions. As the article notes, “Informed consent can be challenging in specific situations, such as with patients who have impaired decision-making capacity due to cognitive impairments, mental health conditions, or severe illness.” This means clinicians must carefully assess capacity and, when necessary, involve surrogates or legal guardians so that consent remains ethically valid.

Children and minors

According to the article, “Children, typically younger than 18, cannot provide informed consent. Instead, parents or legal guardians must permit treatments or interventions,” indicating that for minors, consent comes from guardians. Exceptions exist for emancipated youth, whose legal capacity may differ.

Emergencies and exceptions to consent

In an emergency, when immediate action is needed and no surrogate is available, the usual consent process may be bypassed. As the article explains, “Several exceptions to the requirement for informed consent include … in life-threatening emergencies where there is not enough time to obtain consent.” However, clinicians should still inform the patient or surrogate as soon as possible once the immediate crisis has passed.

Language and communication barriers

The article points out that “Language barriers and the inadequate use of interpreters further complicate the informed consent process, especially in diverse populations where patients may not be fluent in the healthcare provider’s language.” Using interpreter services, translating materials, or offering sign language support helps ensure consent remains meaningful rather than merely procedural.

Cultural considerations

Consent processes can conflict with cultural norms. The article describes how “In certain cultures, decisions are made collectively by a group rather than by individual signatures, and written consent may be perceived as a sign of mistrust.” Being sensitive to cultural decision-making practices, without compromising ethical standards, improves patient understanding and respects diverse values.

Time pressures and quality of consent

Under time constraints, consent discussions can become rushed or incomplete. The article notes that “Time pressures in medical settings often result in rushed consent processes, where healthcare professionals might not dedicate adequate time to thoroughly discuss all aspects of the decision-making process.” Allowing time for reflection and questions is a crucial element of ethical consent.

Technology and electronic consent

Digital tools can enhance the consent process but also raise new challenges. The article notes that electronic informed consent (or eConsent) can improve engagement, noting, “Electronic consent offers several benefits, including enhanced accessibility, the ability to integrate multimedia tools for better patient understanding, and streamlined documentation processes.” However, ensuring equitable access and protecting data privacy remain important considerations.

Legal and ethical framework

The US Centers for Medicare and Medicaid Services (CMS) has updated its guidance on sensitive examinations, requiring patients to have full information about their health status, diagnosis, and prognosis, and the option to refuse treatment. The updated guidance acknowledges that in the past, sensitive exams were allowed under anesthesia, promoting informed consent.

Explicit consent is based on both legal and ethical principles, including:

• Autonomy: Respecting the patient’s right to make informed decisions about their own health.
• Beneficence: Acting in the best interest of the patient.
• Non-maleficence: Avoiding harm to the patient.
• Justice: Ensuring fairness and equity in the provision of healthcare.

FAQs

What is assent?

Assent refers to the affirmative agreement of a person who is not legally able to provide informed consent (such as a child or someone with certain cognitive impairments) to participate in medical treatment or research. Assent is not merely the absence of objection, but an active agreement to the proposed action.

What happens if a patient is unable to give consent?

If a patient is unable to give consent due to incapacity, consent may be obtained from a legally authorized representative, such as a family member or legal guardian. In emergencies where consent cannot be obtained, implied consent may be assumed to perform life-saving treatments.

Can a patient withdraw consent after it has been given?

Yes, patients have the right to withdraw consent at any time before or during the treatment or procedure. Healthcare providers must respect this decision and discuss any potential consequences of withdrawal.