Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members

ABSTRACT

Informed consent process remains a constant challenge in clinical research.  The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations.  Using 8 case studies to illustrate basic ethical elements, the study consisted of 107 participants, mainly from the Asia Pacific and African regions.  The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF. However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively.  This suggests that participants’ understanding of the underlying concepts of the required ICF elements is limited.  Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed.