This document discusses the process of informed consent for clinical research studies. It defines informed consent as a voluntary confirmation by a research subject of their willingness to participate after being informed of all relevant study details. The goal is to provide sufficient information for subjects to make an informed choice about participation. Key aspects of the informed consent process include guidelines from regulatory bodies, ensuring subjects' comprehension and voluntariness, obtaining consent at the right time and place, addressing any questions, and documenting consent with a signed form. The form should include essential elements like the study purpose, risks, benefits, and subjects' rights, as well as additional details like withdrawal criteria and contact information.