To comply with ICH guidelines, what should be included in the consent form?

The inclusion of a statement indicating that subjects will receive a copy of the signed consent in the consent form is essential for ensuring transparency and trust between the investigator and the trial participants. This statement serves to inform participants of their rights and reinforces their understanding that they have access to the documentation of their agreement to participate in the study. By providing a copy of the consent form, the study ensures that participants can refer back to the information provided, including the details of the study, potential risks, and their rights as participants. This supports ethical practices and regulations outlined by the ICH guidelines, promoting informed consent and respecting the autonomy of subjects.

In contrast, other options do not align with the requirements for consent forms under ICH guidelines. For example, a place for the investigator's personal notes does not belong in the consent form as it detracts from the purpose of the document, which is to convey important information to the participants. Similarly, a section for multiple consent signatures could confuse participants and isn’t a standard practice, as each participant should sign their own form for clear accountability and tracking. Finally, limiting the form to only information about the trial's risks neglects the necessity of providing comprehensive information, including the purpose of the trial, procedures, benefits, and alternatives