Clinical Research: Comprehension of the Patient Information Leaflet and the Consent Form

Informed consent process is an integral component of conducting clinical research ethically. Prior to giving an informed consent to participate in clinical research, it is important that the participant has fully understood all the components of a patient information leaflet and the consent form. The issue of comprehension of informed consent form and patient information leaflet has acquired particular importance in view of research being carried out in developing countries and in vulnerable population. The present review addresss this issue by discussing the need for addressing comprehension of research process by the participant, the tools for assessing the same and various ways in which these tools have been used.