Trop Med Health. 2015 Jun;43(2):117-22. doi: 10.2149/tmh.2014-36. Epub 2015 Jan 31.

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

Koonrungsesomboon N1, Laothavorn J2, Karbwang J3.

Author information

• 1Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan ; Graduate School of Biomedical Science, Nagasaki University, Nagasaki, Japan.
• 2Albany Law School, NY, USA.
• 3Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan.

Abstract

The process of informed consent 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 eight case studies to illustrate basic ethical elements, the study involved 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.