Informed consent is the act of obtaining consent after informing the individual of all the possible outcomes and consequences of granting consent, while explicit consent, known as direct or express consent, is when an individual is presented with a decision on whether they authorize the collection, use, and/or disclosure of their personal information before data is collected.
Whether you're a healthcare provider, researcher, or business owner, ensuring that you obtain proper consent is fundamental to maintaining trust and upholding ethical standards.
Explicit consent
Definition
Explicit consent involves a clear and definite agreement by an individual to a proposed course of action or use of their information. This consent is given through affirmative action, such as signing a document, ticking a checkbox, or verbally agreeing to a request.
Characteristics
- Clear agreement: The individual must actively and clearly indicate their consent.
- Affirmative action: Involves a specific action taken by the individual to provide consent.
- Documentation: Often documented to provide proof that consent was obtained.
Examples
- A patient signs a consent form before undergoing a surgical procedure.
- A user ticks a checkbox to agree to the terms and conditions before using an online service.
- Providing a verbal agreement during a recorded conversation for participation in a study.
Informed consent
Definition
Informed consent goes beyond a mere agreement. It ensures that the individual fully understands the implications, risks, benefits, and alternatives related to the action they are consenting to. It is a process that involves communication and comprehension.
Characteristics
Disclosure: The individual must be provided with all relevant information regarding the action or decision.
Comprehension: The individual must understand the information provided.
Voluntariness: The consent must be given voluntarily, without coercion or undue influence.
Competence: The individual must have the capacity to make the decision.
Examples
- A patient is thoroughly informed about the potential risks and benefits of medical treatment and then decides to proceed.
- Participants in a research study are provided with detailed information about the study’s purpose, procedures, risks, and rights before agreeing to participate.
- A person is educated about the use of their data, how it will be stored and shared, and then agrees to the data usage policy.
Related: 9 elements of informed consent
In the news: HHS releases letter with new guidance on informed consent
Comparison and relationship
- Explicit vs. Informed: While explicit consent focuses on a clear, affirmative action to agree, informed consent emphasizes understanding and awareness. Explicit consent can be given without full information (e.g., quickly ticking a checkbox without reading the terms), whereas informed consent requires that the person knows what they are agreeing to.
- Overlap: Explicit consent can be a part of informed consent. For instance, after being fully informed (informed consent), an individual may sign a form (explicit consent) to confirm their agreement.
- Importance in practice: In many ethical and legal frameworks, especially in healthcare and research, both explicit and informed consent are required to ensure that individuals' rights and autonomy are protected.
Application in different fields
Healthcare
- Explicit consent: Signing a surgical consent form.
- Informed consent: Discussing with the doctor about the surgery’s risks, benefits, and alternatives before signing the form.
Research
- Explicit consent: Agreeing to participate in a study by signing a consent form.
- Informed consent: Receiving comprehensive information about the study, including its purpose, procedures, risks, and rights, before signing the form.
Data Privacy
- Explicit consent: Clicking “I agree” on a website’s terms and conditions.
- Informed consent: Understanding how personal data will be used, stored, and shared, and then agreeing to the data policy.
See also: HIPAA Compliant Email: The Definitive Guide
Importance of consent: In the news
The doctor of an Ohio resident performed a vacuum extraction on her baby without informing her before the procedure, despite there being no emergency and only 30 minutes of pushing. This resulted in the patient suffering from a third-degree tear in her perineum that caused excruciating pain even after receiving medical attention for it. This is an example of a consent violation.
The importance of consent lies in its ability to honor an individual's autonomy and safeguard their rights. It guarantees that people have a say when it comes to choosing what affects them, including matters relating to the state of their bodies, data privacy, and general well-being. Consent grants individuals power by protecting them against coercion or exploitation, hence preserving principles like fairness for all parties involved and bringing mutual respect throughout society.
Learn more: Patient consent: What you need to know
FAQs
Can a patient revoke their consent?
Yes, patients can revoke their consent at any time, granting them control over their PHI. However, this revocation might not apply to information already used or disclosed based on the prior authorization.
Is consent a HIPAA requirement?
Yes, consent is a HIPAA requirement, specifically for the use and disclosure of protected health information for treatment, payment, and healthcare operations. HIPAA mandates that healthcare providers obtain explicit consent from patients before sharing their health information with other entities
What happens if consent is not obtained in a situation where it is required?
If consent is not obtained where required, it can lead to legal consequences, including fines and penalties for the organization, and can compromise ethical standards, resulting in a loss of trust and potential harm to the individual involved.
Tshedimoso Makhene
