According to FDA regulations, what signature is required on the informed consent form?

According to FDA regulations, what signature is required on the informed consent form?

• A. Only the subject's signature and date.
• B. The subject's signature, date, and investigator's signature.
• C. The signature of a legally acceptable representative only.
• D. The signature of a witness is required.

Answer: (A)

The correct answer highlights that only the subject's signature and date are required on the informed consent form according to FDA regulations. This is critical because informed consent is fundamentally about ensuring that the individual participating in a study is fully aware of the potential risks and benefits involved, as well as their right to withdraw from the study at any time without penalty. The subject's signature signifies that they have understood the information provided and have agreed to participate. The inclusion of the date ensures that there is a timestamp for when the consent was granted, establishing a clear timeline for ethical considerations and regulatory compliance. While additional signatures, such as those from an investigator or a legally acceptable representative, may be beneficial in certain contexts, the fundamental requirement as per FDA regulations is for the subject themselves to provide their signature along with the date. This emphasizes the importance of direct engagement between the researcher and the participant in the informed consent process.

The correct answer highlights that only the subject's signature and date are required on the informed consent form according to FDA regulations. This is critical because informed consent is fundamentally about ensuring that the individual participating in a study is fully aware of the potential risks and benefits involved, as well as their right to withdraw from the study at any time without penalty.

The subject's signature signifies that they have understood the information provided and have agreed to participate. The inclusion of the date ensures that there is a timestamp for when the consent was granted, establishing a clear timeline for ethical considerations and regulatory compliance.

While additional signatures, such as those from an investigator or a legally acceptable representative, may be beneficial in certain contexts, the fundamental requirement as per FDA regulations is for the subject themselves to provide their signature along with the date. This emphasizes the importance of direct engagement between the researcher and the participant in the informed consent process.