Interventions to improve research human subject's understanding for informed consent in quantitative studies: review of articles

Informed consent and participation of human subjects in clinical studies, even when there is no adverse effects, is important, so, it leads to constructive relationship between the physician and the client. Potentially, this improves the safety of the study and favorable outcomes, and minimizes side effects and feeling of coercion and discomfort in participants. The aim of this research was to identify the effective interventions to improve research participants’ understanding of informed consent trough search in databases from 2003 to 2013. Clinical, longitudinal trials and trials by control group with at least one control group reviewed and compared. From total of 15 studies that has inclusion criteria, we utilized multimedia interventions in 5 studies, enhanced consent forms in 4 studies and educational interventions, debates and corrective feedback in 6 studies. From these studies 4, 2 and 5 studies reported significant improvement in participants’ understanding, respectively. So, the process of informed consent based on ethical principle of respect for Autonomy is valuable, when the researcher conducts human subjects to free and informed choice, compassionately. For this reason, education and face-to-face counseling, regarding more time and interaction, and use of multimedia methods especially in patients with lower capacity is recommended.