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.

Key elements of explicit consent

Informed

Patients must be provided with comprehensive information about the procedure or treatment. This includes:

• The nature and purpose of the treatment.
• The potential benefits and risks involved.
• Alternative options, including the option to refuse treatment.
• The consequences of opting out of the proposed treatment.
  
  

Voluntary

Consent must be given voluntarily, without any form of coercion or undue influence. Patients should feel free to make their own decisions without feeling pressured.

Competent

The patient must be legally and mentally capable of making the decision. This includes:

• Understanding the information provided.
• Appreciating the consequences of their decision.
• Being able to communicate their decision.
  
  

Explicit

The consent must be clearly and explicitly given. This often involves:

• A written and signed consent form, although in some cases verbal consent may be acceptable if documented properly.
• Detailed records of the discussion and the information provided to the patient.

See also: HIPAA Compliant Email: The Definitive Guide

Steps to obtain explicit consent

1. Disclosure: Provide detailed and understandable information about the procedure, its benefits, risks, and alternatives.
2. Assessment of understanding: Ensure the patient understands the information by asking them to explain it back in their own words.
3. Discussion: Allow the patient to ask questions and discuss any concerns they might have.
4. Documentation: Have the patient sign a consent form and document the process of obtaining consent in their medical record.

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

Special considerations

• Language and cultural barriers: Use interpreters and culturally appropriate communication methods to ensure understanding.
• Children and adolescents: Obtain consent from parents or legal guardians, and assent from the child when appropriate.
• Emergency situations: In cases where immediate action is required to save a life or prevent serious harm, implied consent may be assumed if the patient is unable to give explicit consent.
• Research: Informed consent for participation in research must include details about the study’s purpose, procedures, risks, benefits, and the right to withdraw at any time.

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 grounded in 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.