On 12 February 2004, a team of South Korean researchers, led by Woo-Suk Hwang of Seoul National University, reported in the online edition of Science that they had successfully derived an embryonic stem cell line from a cloned human blastocyst. The publication of these experimental results had several consequences. In the first place, it raised hopes and expectations concerning the treatment through therapeutic cloning of various intractable diseases. Secondly, it sparked renewed interest, both within and beyond Korea, in the debates on the ethics of human embryonic cloning and stem cell research. Thirdly, it thrust Korea into the international spotlight and led to increased scrutiny of the science and ethics of the cloning and stem cell research currently being carried out in Korea.
The following discussion, which details the three ethical shortcomings of the ground-breaking research carried out by Woo-Suk Hwang and his team of researchers is intended as a contribution toward the development of better research ethics within and beyond Korea.
1. The egg collection procedures involved in this research
How were the eggs obtained? Who donated the eggs? Why were the donors not paid?
Hwang et al. (2004) claim that in order to derive a single line of embryonic stem cells they used 242 eggs donated by 16 volunteers. However, 242 eggs from 16 women amounts to an average of 15.13 eggs per woman--an astonishingly high number. One naturally wonders how these women could have produced so many eggs and also why the women volunteered to undergo these painful procedures in the first place. According to a news report in Nature, "Korea's Stem-cell Stars Dogged by Suspicions of Ethical Breach" (6 May 2004, 3), Jose B. Cibelli, a zoology professor at Michigan State University and a co-author of Hwang et al. (2004) admitted that the egg collection procedures involved in this research could never have been carried out in the United States. Indeed, in the U.S. egg donors are often paid considerable amounts of money for the risks and inconveniences they undergo in making their donations.
2. Did female researchers on the team donate their own eggs for this research?
According to the aforementioned news article in Nature, one of Hwang's Ph.D. students and a co-author of Hwang et al. (2004) said in an interview with Nature that she and another woman, who also worked in Hwang's lab, had donated their own eggs for this research (6 May 2004, 13). She explained that she had made the donation out of a "desire to help sick children" and because of her "love for Korea." However if this true, then the research team in this case violated what is, or at least ought to be, a fundamental principle of research ethics that researchers should not associate with donors. Without this principle, it is easy to see how junior researchers, lab assistants, or other people closely associated with members of a research team could be pressured or coerced by senior researchers into making donations against their own will.
3. Did the researchers obtain voluntary informed consent from the donors?
The procedures that eggs donors undergo are burdensome and often painful. Donors should be given hormone injections for at least ten days in order to induce superovulation. Accordingly, it is extremely important to inform donors of the risks associated with egg donation.
Did the researchers in this case fully inform the 16 donors (and the other women who may have refused donation) of these risks? Did the volunteers consent to their donation based on a thorough understanding of the risks? Were the donors aware of their rights to withdraw their approval whenever they wanted to, even after consenting to donate? Did the chief researcher keep the original consent forms signed by the donors? If so, the chief researcher should be willing to comply with an investigation into whether informed consent was obtained in this research.
Hwang said (in private conversation) that he rejected showing the consent forms to the reporter from Nature out of concern for the donors' privacy. However, the reporter requested to see the blank, not the signed, consent forms. Showing the blank forms would obviously not infringe upon the donors' privacy in any way. Thus, Hwang's behavior reinforces, rather than removes, suspicions that the researchers did not obtain the informed consent of the women who donated their eggs for this research. If this is indeed the case, then Hwang and his colleagues violated one of the most important principles of research ethics and bioethics that no medical intervention may take place without the informed consent of the donor/patient.
Koo Young-mo email@example.com
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