Fraud and Misconduct

2. Examples of Fraud in Clinical Research

2.1. Example 1: Korean Stem-Cell Case, Woo-Suk Hwang

Between 2004 and 2005, Professor Woo-Suk Hwang, a highly regarded, highly funded South Korean researcher at Seoul National University, achieved international fame for his work on embryonic stem cells and the promises his findings offered. Considered a national hero, he had surprised the world with his report of creating 11 patient specific stem cell lines. His reputation was quickly destroyed, however, and his research activities were halted when his success in somatic cell nuclear transfer (SCNT – a method of ‘cloning’) became mired in scandal, particularly when it emerged that many of his data on SCNT were made up. He lost his university position and his two important papers on embryonic stem cell research had to be retracted from the journal ‘Science’.

Read more about the case here: Wikipedia and here.
Ethics violations

Several ethics violations were committed by his team members during the course of their research. In 2009, Hwang was convicted of misusing research funds and illegally buying human eggs for his research. Among many transgressions was the dubious manner in which the team persuaded women to donate their eggs for their SCNT research. Investigations revealed that many of the women who provided eggs had not given valid, informed consent, and nearly 75% of them reported that they were given cash or offered various financial incentives.

Some of the women who provided eggs were infertile patients who had agreed to donate any excess eggs following their fertility treatment. What they weren’t told, however, was that their eggs were initially assigned a quality grade, and the higher marked eggs were set aside for research while the lower graded ones were used for their treatment. Others who agreed to donate for the cause of research alone were not fully informed of the potential risks and harms involved in the egg donation process or the nature of the research for which their eggs would be used.

Concerns about probable coercion later surfaced when it became clear that at least two of the egg donors were junior members of Hwang’s research team. One, a PhD student, was listed as a co¬author of the 2004 Science paper. The other, apparently reluctant, was escorted to the donor clinic by Hwang himself. Given the precarious position in which they presumably found themselves, the reported pressure to donate seems obvious.

The other chief concern raised by the method of gaining eggs was the payment that many of the women received. Some eggs were purchased directly, while in other cases women received compensation in the form of discounted fertility treatment. Though the concerns of egg trafficking – i.e. that women will be unduly pressured to donate despite the inherent risks are well agreed upon, there is no international consensus on the acceptability of selling eggs. There were no legal restrictions in place at the time of Hwang’s actions.

The large number of eggs Hwang used in his SCNT experiments was staggering. The Ministry of Health and Welfare reported that Hwang acquired 2,221 eggs from 119 women while the Prosecutors’ Office reported that 2,236 eggs were acquired from 122 women. Additionally, there were eggs that were retrieved from excised ovaries. The total number of eggs purchased or traded was 1,649, approximately 75% of the total number of eggs the Hwang lab used for research.