Pertanika Journal of Social Sciences & Humanities
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Pertanika · Universiti Putra Malaysia Press

Pertanika Journal of Social Sciences & Humanities

Official journal of Universiti Putra Malaysia for scholarly work across the social sciences, humanities and related interdisciplinary fields.

e-ISSN 2231-8534 ISSN 0128-7702
Research article

Short Communication: An Improved Risks and Benefits Assessment Tool for Institutional Review Boards

Wei-Hong Lai, Tze-Ming Ho and Zainanda Zainal

KeywordsRisks and benefits assessment, bioethics
Article content

Abstract

Ethical oversight is a critical requirement to conduct clinical research involving human participants and Institutional Review Board (IRB) and it is responsible to evaluate the ethical elements of a clinical research. However, there is no consensus on criteria for evaluating risks and benefits to human participants. Therefore, this article reviews the evaluation of risks and the potential benefits of a clinical trial using Multi-Attribute Utility Theory (MAUT) and suggests the incorporation of 5 levels of likelihood that risk event will occur for the standardisation of risk and benefit utility values.