Informed assent

Informed Assent is a process that involves obtaining the agreement of a person, who is not legally capable of giving Informed Consent, to participate in a medical procedure or research. This process is often used with children or adults with cognitive impairments.

Definition

Informed assent is a person's agreement to participate in a medical procedure or research, after receiving a full explanation of the proposed intervention, including its potential benefits and risks. This process is used when the person is not legally capable of giving Informed Consent, such as children or adults with cognitive impairments.

Process

The process of obtaining informed assent involves several steps. First, the person is provided with information about the proposed intervention in a manner that is understandable to them. This includes explaining the nature of the procedure or research, its purpose, the procedures involved, the potential benefits and risks, and any alternatives.

The person is then given the opportunity to ask questions and express their concerns. The healthcare provider or researcher must ensure that the person understands the information provided and that their agreement to participate is voluntary.

Legal and Ethical Considerations

Informed assent is a legal and ethical requirement in many jurisdictions. It is based on the principles of respect for persons and autonomy, which require that individuals be treated as autonomous agents and that those with diminished autonomy be protected.

In the case of children, the assent of the child is usually required in addition to the consent of the parent or guardian. The age at which a child is considered capable of giving assent varies, but it is generally around 7 years old.

For adults with cognitive impairments, the assent process may involve a legally authorized representative, such as a guardian or power of attorney.

Challenges

Obtaining informed assent can be challenging, particularly when dealing with individuals with cognitive impairments or children. It requires a careful balance between respecting the person's autonomy and protecting them from harm.

Healthcare providers and researchers must ensure that the person understands the information provided and that their agreement to participate is voluntary. This can be difficult when the person has limited cognitive abilities or when the information is complex.

See Also

• Informed Consent
• Medical Ethics
• Patient Rights
• Clinical Trials