What is the best course of action when an eligible subject's legal representative is unavailable during informed consent?

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The best course of action when an eligible subject's legal representative is unavailable during the informed consent process involves ensuring that the consent is obtained through proper protocols. Obtaining consent via facsimile from the representative is deemed acceptable in certain situations because it allows for the prompt continuation of the participation process while still adhering to the legal and ethical requirements for informed consent. This method provides a way to engage the legal representative in the process even if they are not physically present, ensuring that the rights of the subject are protected and that they are not unduly delayed in their potential participation in the study.

The approach of waiting for the representative to return would unnecessarily prolong the consent process and could potentially hinder the subject's timely participation. Documenting the subject's assent without the representative's consent does not fulfill the legal requirements for informed consent, as it lacks the essential endorsement from the legal representative who has the authority in such matters. Lastly, obtaining consent from family members who are not designated representatives does not comply with the necessary legal framework, as only the legally authorized representative has the authority to provide informed consent on behalf of the subject.

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