What is explicit consent?

As of January 2023, 10.7 million people aged 18 and over had recorded their organ donation choice in the Donor Register, with 4.8 million giving explicit consent, 1.5 million leaving the decision to their next of kin, and 3.3 million having no objection. But what is explicit consent?

Explicit consent goes beyond a simple checkmark or casual verbal agreement on a website. It represents an unmistakable and direct willingness from individuals to grant organizations permission to gather and handle their personal information.

Understanding explicit consent

Explicit consent is a clear and unequivocal agreement to a specific action or arrangement, given by an individual with full awareness and understanding of what they are consenting to. This type of consent is characterized by a definitive and informed decision, often communicated through explicit words or actions. In many contexts, explicit consent is documented in writing or through a clearly affirmative gesture to ensure there is no ambiguity.

Explicit consent requires that individuals actively show their willingness to share their data by taking affirmative steps like pressing a consent button or signing a form. This ensures that consent is freely given, specific, informed, and revocable.

Related: Patient consent: What you need to know

Key elements of explicit consent

• Clear communication: Organizations must communicate the purpose for which consent is sought in plain and understandable language. Individuals should be fully aware of what they are consenting to.
• Unambiguous action: Consent must be obtained through a clear and affirmative action. This could be clicking an “I agree” button, signing a consent form, or another action that leaves no room for ambiguity.
• Specificity: Consent should be specific to the intended data processing activities. Organizations cannot obtain broad, all-encompassing consent and must seek separate consent for different purposes.
• Informed consent: Individuals should be provided with sufficient information about the data processing activities, including who is collecting the data, why it is being collected, and how it will be used.

See also: HIPAA Compliant Email: The Definitive Guide

Best practices

Obtaining explicit consent is crucial in various contexts to ensure clarity, respect, and legal compliance. Here are some tips and best practices to effectively obtain and manage explicit consent:

Clear communication

• Use simple language: Avoid jargon and legalese. Use straightforward language that is easy to understand.
• Be specific: Clearly explain what the consent is for, including any potential risks, benefits, and alternatives.
  
  

Informed Consent

• Provide complete information: Ensure that the individual has all the necessary information to make an informed decision. This includes details on the purpose, scope, and duration of what they are consenting to.
• Allow questions: Encourage individuals to ask questions and provide thorough answers to ensure they fully understand.

Learn more: 9 elements of informed consent

Documentation

• Written consent: Whenever possible, obtain written consent to have a record of the agreement. This can be a signed document or a digital confirmation.
• Record keeping: Maintain accurate records of all consent obtained, including the date, time, and method of consent.
  
  

Voluntariness

• No coercion: Ensure that consent is given voluntarily, without any pressure or coercion.
• Right to withdraw: Inform individuals that they have the right to withdraw their consent at any time and explain how they can do so.
  
  

Regular updates

• Reaffirm consent: Periodically check in to reaffirm consent for ongoing activities or long-term agreements.
• Notify of changes: If the terms or conditions of the consent change, notify the individuals and obtain new consent if necessary.
  
  

Accessibility

• Ensure accessibility: Make sure that the consent process is accessible to all individuals, including those with disabilities. Provide consent forms in multiple formats if needed.
• Language options: Offer consent forms in multiple languages to accommodate non-native speakers.

See also: How to obtain legal digital consent while maintaining HIPAA compliance

Legal compliance

• Understand legal requirements: Familiarize yourself with and adhere to relevant laws and regulations regarding consent, such as GDPR for data privacy or HIPAA for healthcare.
• Consult legal professionals: When in doubt, seek advice from legal professionals to ensure your consent processes comply with all applicable laws.

FAQs

Why is explicit consent important?

Explicit consent is crucial for ensuring that individuals are fully aware of and agree to what they are participating in or allowing. It helps prevent misunderstandings, respects personal autonomy, and ensures legal and ethical compliance.

What should be included in a written consent form?

A written consent form should include:

• A clear description of the activity or agreement.
• Detailed information about any risks, benefits, and alternatives.
• Statements confirming the individual’s understanding and voluntary agreement.
• Space for the individual’s signature and the date.

How should explicit consent be handled with minors?

Obtaining explicit consent from minors involves seeking assent from the minor and consent from a parent or legal guardian. The information should be presented in an age-appropriate manner, ensuring both the minor and guardian understand the implications.