title: Ethical considerations and challenges in first-in-human research.
abstract: First-in-human (FIH) research is a translational process to move a new potential therapy from bench to bedside. Major ethical challenges of an FIH trial arise because of the indeterminate nature of the risks involved and the controversial risk-benefit justification. Severe adverse events and death of subjects who participated in FIH research in the past have led to an increased attention on ethical considerations in the design and conduct of such research. Furthermore, novel therapies in the current decade, such as molecular-targeted, gene transfer, and pluripotent stem cells therapies, have led to numerous emerging ethical challenges or different ethical assessment and justification frameworks for FIH research. This article presents, discusses, and interlinks ethical considerations and challenges in FIH research through a review of related ethical principles and their application to each ethical issue with given examples. Possible solutions to address each ethical challenge are presented. The scope of this article focuses on 4 major ethical issues in FIH research: risk-benefit assessment and justification for the conduct of research, selection of a suitable target population, informed consent, and conflict of interest.
authors.affiliation: Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan; Leading Program, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
authors.forename: Nut
authors.initials: N
authors.lastname: Koonrungsesomboon
authors.affiliation: Chulabhon International College of Medicine, Thammasat University, Pathum Thani, Thailand.
authors.forename: Junjira
authors.initials: J
authors.lastname: Laothavorn
authors.affiliation: Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan. Electronic address: karbwangj@nagasaki-u.ac.jp.
authors.forename: Juntra
authors.initials: J
authors.lastname: Karbwang
mesh_terms: D016265:Conflict of Interest; D032984:Ethics, Research; D064368:Healthy Volunteers; D006801:Humans; D007258:Informed Consent; D018570:Risk Assessment; D014930:Women