Age, literacy level, and health status shape participants’ understanding of clinical trials. OUCRU researchers observed the consent process in two trials and noted many ways that participants’ understanding of study information can be enhanced.
Informed consent is an essential process when doing clinical trials involving human subjects, according to NIHR Good Clinical Practice. This step ensures that trial participants are aware of the trial information, study purpose, potential risks, and benefits to their health before making an informed decision to participate.
Studies at OUCRU follow international and national guidelines on ethical standards and procedures for biomedical research involving human subjects—however, a new social science study by Nguyen Thi Hong Yen et al. found participants still had many different perceptions and misunderstandings of research and clinical trial information.