What should subjects or legally acceptable representatives receive according to ICH guidelines?

According to ICH guidelines, it is essential for subjects or their legally acceptable representatives to receive a signed and dated copy of the informed consent form. This requirement is fundamental for ensuring that participants are fully informed about the study and have agreed to participate voluntarily.

Providing a signed and dated copy serves multiple purposes. Firstly, it reinforces the importance of the informed consent process by documenting that the subject has been informed about the study's purpose, procedures, risks, and benefits. Secondly, it provides a tangible record for the subjects, which can help them to recall the information provided and ensure they have a reference point for any questions or concerns that may arise later during the study.

Receiving only an unsigned copy of the informed consent form would not fulfill the requirement for proper documentation of consent, and simply providing contact information for the investigator or brochures outlining study details does not encompass the legal and ethical obligations of informing participants and securing their consent for participation. Therefore, the signed and dated copy is critical for ethical research practice and participant rights as outlined in the ICH guidelines.