What is required when working with individuals who cannot give legal consent to participate in research?

When working with individuals who cannot give legal consent, obtaining informed assent from the subject is crucial. Informed assent refers to the process of seeking agreement from participants who may not have the legal capacity to provide consent, such as children or individuals with certain cognitive impairments. This process involves explaining to the individual, in a way that is understandable to them, what the research entails and ensuring they agree to participate to the best of their ability. It's important to respect their autonomy and to engage them in the decision-making process, even if they cannot provide formal consent.

This approach acknowledges the individual's rights and dignity while also adhering to ethical standards in research. Informed assent is often accompanied by informed consent from a legal guardian or caregiver, further safeguarding the rights of those who cannot fully engage in the consent process.