Improving the informed consent process in clinical research is of constant concern to
regulatory authorities in the field and presents a challenge for both the specialists and …

e18577 Background: The eIC platform was developed to reduce administrative time and
effort associated with paper-based consenting, improve the IC audit trail, and augment …

This study was designed to assess the quality of the informed consent process in clinical
research by measuring subjects' understanding of informed consent. A convenience sample …

Abstract Background In line with Good Clinical Practice and the Declaration of Helsinki, it is
the investigator's responsibility to ensure that research participants are sufficiently informed …

Purpose The aim of the present study was to explore (1) informed consent (IC)
representations, level of understanding, needs, and factors that influence the willingness of …

Purpose: Studies have documented that the majority of consent documents for medical
diagnosis and treatment are written at a reading level above that of the majority of the US …

To the Editor: We have studied the quality of informed consent strategies when cancer
patients were recruited in a Swedish setting to a clinical trial regarding the treatment of …

Background Electronic informed consent (eIC) may offer various advantages compared to
paper-based informed consent. However, the regulatory and legal landscape related to eIC …

Objective The activity of sponsors and Ethics Committees for Research with medicines has
increased in recent years. The objective was to design and validate 2 instruments to analyze …

Background: There is growing evidence that the quality of informed consent in clinical
research is often sub-optimal. Aims: To explore the conformity of patient recruitment with …