Protecting the Unprotected: Ethical Issues of Clinical Trials/Studies on Assisted Reproductive Technology beyond the Belmont Report Framework

Abstract

    Innovative assisted reproductive technology (ART) has traditionally been introduced to clinical practice as an “individual treatment” or “clinical service” without sufficient verification through basic research, animal experimentations, or clinical trials/studies involving human subjects. This unique ART clinical application process, which significantly differs from the regular development process of medicinal substances or devises in general, is attributable to the paucity of arguments on the ethics of clinical trials/studies related to ART from the research ethics perspective of protecting human subjects. However, developers of recent innovative ARTs are now tending to follow the regular steps of clinical trials/studies with human subjects. This article first examines the unique ethical features of ART clinical trials/studies, followed by an argument that ethical issues of ART clinical trials/studies cannot be fully captured within the framework of traditional ethics on clinical human research, which is based on the ethical principles provided by the Belmont Report.