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When can ICH allow subjects to be enrolled that cannot consent for themselves?

1 Answer

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Final answer:

When subjects cannot consent for themselves, their parents or legal guardians can provide consent on their behalf. The Institutional Review Board (IRB) ensures that all participants, including those who cannot consent, are protected through informed consent forms. Informed consent provides participants with information about the study.

Step-by-step explanation:

When subjects cannot provide consent for themselves, their parents or legal guardians can provide consent on their behalf. This is often the case with children under the age of 18, who are not considered competent to provide consent. In medical studies, the Institutional Review Board (IRB) ensures that all participants, including those who cannot consent, are protected through informed consent forms signed by their parents or legal guardians. Informed consent provides participants with information about the study, including potential risks and benefits, and guarantees that their involvement is voluntary and confidential.

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