True or False: The investigator's signature is required on the informed consent form.

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The correct response highlights an important aspect of the informed consent process in clinical research. While the investigator plays a crucial role in ensuring that informed consent is properly obtained, the signature of the investigator is not universally required on the informed consent form itself.

The primary focus of the informed consent process is to ensure that potential study participants understand the nature of the research, the procedures involved, potential risks and benefits, and their rights as subjects. While it is essential for an investigator to communicate this information and document that consent has been obtained, the actual signature may not be legally mandated depending on regulatory requirements or institutional policies.

In many cases, what is required is the participant's signature on the consent form, which acknowledges that they have been informed and agree to participate. Although the investigator may need to sign documents related to the study, such as protocols or reports, their signature does not need to be on every informed consent form unless specifically required by local regulations or study protocols.

This understanding emphasizes the main purpose of the consent process: to empower participants with knowledge and affirm their autonomy, rather than focusing solely on the completion of paperwork.

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