From our colleagues at the Medical Research Council (MRC):
Informed consent is a fundamental pre-requisite of clinical research. The process ensures that participants entering into clinical research do so freely and with full knowledge and comprehension of the study process, as well as its risks and benefits.
Full disclosure is easy to achieve; ensuring full comprehension however requires careful consideration and a sensitivity to the cultural and societal requirements of individual study settings. In sub-Saharan Africa for example, empirical evidence has consistently shown that participants demonstrated poor comprehension of even fundamental study concepts, such as placebo, randomisation and blinding.
In award winning research, Dr Muhammed Afolabi (MRC CEO Award – Driving Change) of the MRC Unit The Gambia developed a multimedia consent tool for achieving informed consent in low to non-literate settings, where study participants first language is frequently non-written. The tool has been designed to communicate both trial specific and general concepts in a modular format and is suitable for the communication of this information in multiple languages. In a pilot study, the tool was demonstrated to increase comprehension from 40% to 64%, elicited a statistically significant increase in recall and understanding and led to high levels of participant satisfaction.
Find out more by downloading the attached document.