The Ethical and Regulatory Problems in the Stem Cell Scandal

Abstract

The recent stem cell scandal of fabrication of two papers published in Science by Dr. Hwang Woo Suk shocked the world and devastated the South Korean society. Investigations conducted by the South Korean government have revealed a variety of ethical and regulatory failures. In this paper, I first explain the South Korean regulatory background to research conducted on human subjects in general and on biotechnological research in particular, and then analyze the ethical and regulatory problems affecting the research for the two papers published in 2004 and 2005 by Dr. Hwang's team, respectively. These problems can be summarized as: 1) problems regarding egg donation (lack of informed consent and donation by vulnerable subjects), 2) ambiguous record-keeping of research funding, 3) insufficient reviews by the two local IRBs (an already established IRB and a newly established IRB, both deferred to the principal scientist's heavy-handed influence), 4) too close ties between the research team and government officials, and 5) the National Bioethics Committee's inertia and lack of impartiality.