What does FDA regulation state about subjects receiving a copy of the consent form?

The regulation set by the FDA emphasizes that participants in clinical trials must receive a copy of the informed consent form. It is essential for the subjects to have documentation that outlines their rights, the nature of the clinical trial, potential risks, benefits, and their ability to withdraw from the study. The key aspect is that this copy should be signed by both the subject and the investigator, ensuring that both parties have a mutual understanding of the consent.

While it is common practice for subjects to receive a signed copy of the consent form, the regulations do allow for the possibility of providing an unsigned copy specific to instances where written consent is not mandated. Nonetheless, participants should ideally have access to a signed version for their records, which supports informed decision-making and good research ethics. Incomplete options that do not emphasize the importance of signed consent could lead to misunderstandings about participant rights and the obligations of the researchers.

Therefore, the ideal situation aligns with the regulation's intent — to ensure informed consent is not only obtained but also documented and understood by participants.