According to FDA regulations, what type of copy of the informed consent form can subjects receive?

Informed consent is a crucial part of the clinical trial process, and FDA regulations require that subjects be fully informed about the study they are participating in. One important aspect of this is that subjects must be provided with a copy of the informed consent form. This ensures they have a reference for the information they were given, the procedures involved, and any potential risks associated with the study.

The correct answer indicates that participants can receive either signed or unsigned copies of the informed consent form. This flexibility accommodates various circumstances: a signed copy allows participants to have confirmation of their consent, while an unsigned copy could be provided to ensure that subjects have access to the details of the study before they decide to provide their consent.

Offering either version upholds the principle of respect for persons, ensuring that individuals can review the information provided to them at any time. It fosters transparency and understanding, which are essential components of ethical research practices in compliance with FDA regulations.