Consent vs. Assent

Summary

The video script discusses the critical distinction between informed consent and informed assent in medical ethics, particularly for minors. It explains how minors, who cannot provide informed consent, must give informed assent for high-risk procedures. The script emphasizes that both legal guardians' consent and the minor's assent are required for participation in trials, and if the minor refuses, the procedure cannot proceed. Additionally, the information provided to minors should be adjusted based on their age to ensure understanding, making this topic highly relevant for ethics exams like USMLE or COMLEX.

Takeaways

• 🧠 Practice ethics questions are crucial for better understanding, especially for exams like USMLE or COMLEX.
• 👧 A 14-year-old with end-stage malignant leukemia needs both parental informed consent and the minor’s informed assent to participate in a clinical trial.
• 💡 Informed assent is required from minors since they cannot give legal consent, but it mirrors the informed consent process, explaining risks, benefits, and alternatives.
• 👶 Minors under 18 who are not emancipated must give informed assent before participating in high-risk procedures or trials.
• 🛑 If a minor does not provide informed assent, they cannot be enrolled in a trial, even if the legal guardians have provided informed consent.
• 🤝 In cases where the legal guardian and the minor disagree, the physician should try to resolve the discrepancy before proceeding.
• 🔍 Informed assent must be directed toward the minor’s age and understanding level, ensuring they comprehend the risks and benefits.
• 📜 The process of explaining informed assent involves simplifying complex medical terms so that minors can make an informed decision.
• ❌ A minor can opt out of high-risk procedures if they don't give informed assent, even with parental consent.
• 📚 Informed assent is a requirement in any situation where minors are involved in high-risk medical trials or treatments, and the explanation must be age-appropriate.

Q & A

What is the difference between informed consent and informed assent?

Informed consent is the legal agreement given by a person who fully understands the procedure's risks, benefits, and alternatives, typically an adult or legal guardian. Informed assent is similar but is given by a minor who is not legally allowed to provide full consent but can still express their understanding and willingness to participate.

Why is informed assent required from minors in high-risk clinical trials?

Informed assent is required because minors cannot legally give informed consent. However, ethically, they should still be involved in the decision-making process for high-risk procedures by expressing their understanding and willingness to participate.

In the case presented, why is both informed consent and informed assent necessary?

Both informed consent from the legal guardians and informed assent from the minor are necessary because the trial is high-risk. The legal guardians must approve, but the minor also needs to agree to the procedure since it directly affects them.

What happens if a minor refuses to give informed assent but the legal guardians provide informed consent?

If the minor refuses to give informed assent, they should not be enrolled in the clinical trial, even if the legal guardians have provided informed consent. The minor's willingness is crucial in such cases.

How should the informed assent process be conducted for a minor?

The informed assent process should be tailored to the age of the minor, ensuring that the explanation of the procedure, risks, benefits, and alternatives is presented in a way they can understand.

What is the best course of action if the legal guardians and the minor disagree about participating in a clinical trial?

The best course of action is to attempt to understand the reasons behind the disagreement, being neutral and understanding. The healthcare provider should try to resolve the discrepancy by discussing the concerns with both parties.

Why is it important to explain procedures in simpler terms when obtaining informed assent from a minor?

It is important to simplify the explanation because minors may not fully understand complex medical terms. The description of the procedure, risks, and benefits should be adapted to their cognitive level so they can make an informed decision.

Can a minor's informed assent override the legal guardian's decision in a clinical trial?

No, a minor's assent does not override the legal guardian's decision. Both assent from the minor and consent from the legal guardian are required for the minor to participate in a high-risk clinical trial.

What ethical principle supports the need for obtaining both informed consent and informed assent?

The ethical principle of autonomy supports the need for both informed consent and informed assent. Even though minors cannot give legal consent, they have the right to participate in decisions affecting their health and autonomy, especially in high-risk situations.

What would be the correct answer in the practice question if the patient does not want to participate but the legal guardians do?

The correct answer is that the patient should not be enrolled in the trial. Even though the legal guardians have given informed consent, the patient has not given informed assent, and their decision must be respected.