Does the FDA allow subjects or their legally acceptable representatives to receive either a signed or unsigned copy of the Informed Consent Form (ICF)?

The FDA allows subjects or their legally acceptable representatives to receive either a signed or unsigned copy of the Informed Consent Form (ICF) as a standard practice. This policy emphasizes the importance of transparency and the participants' rights in clinical research. By allowing the distribution of copies, the FDA ensures that subjects have access to the details of the study, including its purpose, procedures, potential risks, and benefits, which fosters informed decision-making.

Providing a copy of the ICF supports ethical principles in research, especially respecting and protecting the rights of participants. It allows them to review the information at their convenience and even discuss it with family or advisors before making their decision to participate. Having access to both signed and unsigned copies enhances the participants' understanding of what they are consenting to, thereby upholding the integrity of the informed consent process.