The Tragic Irony: South Korean Bioethics Committee Finds Hwang and IRBs Violated the Declaration of Helsinki

Dianne N. Irving
Copyright February 2, 2006
Reproduced with Permission

The South Korean National Bioethics Committee's interim report on Hwang and his team's fraudulent research, and the IRBs that approved it, is worthy of some attention in and of itself. [See, Kim Cheong-won, "Hwang's Team in Ethical Minefield Over Ova: Panel", The Korea Times, Feb. 2, 2006; copied in full below.]. Ironically, although their internal struggle would give some cause to be concerned, it could actually be a sign of hope. It was courageous South Korean junior researchers, after all, who finally exposed Hwang's research to be the fraud that it is. It might also be courageous South Korean ethicists who finally expose "bioethics" for its complicity.

Note the contrasting conclusions of this National Bioethics Committee's interim report. The majority's conclusion about "egg" donation is based on the Declaration of Helsinki - which has a priority of protecting the whole person of the participating human subject - not just the participant's "autonomy". By contrast, some "bioethicists" on the committee appeal narrowly to only the human subject's pure "autonomy" rights -- a very real playing out of a philosophical "mind/body" split in contemporary bioethics' grounding "theory". The two conclusions are irreconcilable - as the women who gave their oocytes to Hwang for his research have tragically personally discovered.

It has been crystal clear to many who refused to cave in to the new "bioethics" for decades that the real purpose of bioethics' appeal to "autonomy" in the research setting is primarily to exploit it, i.e., to shift the ethical and legal burden of the damaging consequences of research from the researchers and IRBs (or HECs) to the human subject participants. "They said it was OK, and their autonomy must be respected above everything else."! So in this Hwang scandal we see that defunct and misguided "ethics" playing out empirically, so to speak - in the gross and unjust violation of women's whole personhood and dignity. The fact is that not only were women's autonomy rights violated while donating their oocytes for Hwang's research project (e.g., their being precluded from giving valid informed consent), but their bodies were also violated (e.g., they were at risk for "severe after-effects, including infertility or even death". This is not just a theoretical violation of their "autonomy" and right to give informed consent. It is a real in-the-flesh consequence to their bodies while participating in this research. And for those with a more holistic view of human nature, it is also a violation of the inherent dignity of their soul and spirit.

Another related but more subtle problem involved that has received almost no attention is that, at least until bioethics' formal "birth" (1978), physicians performing research were traditionally trained to put the welfare of their patients first -- rather than that of "society" or the "advancement of science". As stated quite unambiguously in the Declaration of Helsinki, "In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society." In contrast, basic (bench) researchers were traditionally trained to get the most accurate data out of their "biological materials" no-matter-what.

History has already demonstrated over and over again the real damage that can take place when those academically credentialed in one profession are allowed to practice in professions for which they are unprepared and unskilled, and which have totally different methods and goals. In the mid-1970's the two very different professions - medicine and research -- were once again misguidedly merged following the National Research Act (1975) - once again creating ambitious bench research physicians who are not scientists, and who usually have only M.D. degrees (rather than Ph.D.'s), with severely watered down pure science courses if any, almost no laboratory training whatsoever, and massive financial conflict of interests. These physicians very rapidly took on the mantle of the basic bench researcher -- where, as Jay Lifton might put it, they too learned how to "distance" themselves from the welfare of their patients in order to achieve accurate data -- and big bucks. Now once again basic researchers had access to hoards of human "biological materials" to use in their research protocols. About the same time, bioethics "theory" came along to "ethically" justify it all.

This troublesome scenario was brought home to me personally while working at the bench at NIH. A very good and dedicated physician who was doing research there at the time asked me to check his biochemistry for a research article he was preparing - since he had never taken a graduate course in biochemistry. Along with several basic science errors, I noted that the points on his chart (representing patients versus doses of chemotherapy) would yield better accuracy if clustered more around the highest doses where the most changes to the patients were taking place. After all, the better the accuracy, the better the data, the better the anticipated "therapy" for "future groups of patients" - right? As a traditionally trained physician, he was spontaneously horrified at my comment - yet it took me (a traditionally trained bench researcher) a long time to actually understand his concern. To be honest, it had never really occurred to me that the closer to that point in the chart where the dose line curves dramatically the more devastating the overall damage (rather than "cure") to the human subject patients undergoing the protocol.

It is thus more than interesting -- and hopeful -- that at least the majority of the members of this South Korean National Bioethics Committee are appealing to the Declaration of Helsinki, rather than to the pure patient "autonomy" of bioethics. It is also hopeful that all of the other provisions of the Declaration of Helsinki are likewise ruled on by them - rather than pulling out only its provisions on "informed consent". [For a more detailed discussion of Hwang's research and the other relevant and critical provisions of the Declaration of Helsinki and of the Nuremberg Code, see Irving, "When is 'not-self' really 'self'? International Research Ethics Standards Require Hwang's Team to Retest Its Stem Cells" (Dec. 6, 2005).]

The Korea Times
February 2, 2006
By Kim Cheong-won
Staff Reporter

Hwang's Team in Ethical Minefield Over Ova: Panel

The team of now-disgraced cloning expert Hwang Woo-suk gathered 2,221 eggs from 119 females for stem cell research from 2002 until last December, and ran into "serious ethical problems" with ova procurement, Korea's bioethics committee announced Thursday.

The number of eggs used in the research was 160 more than what Seoul National University's (SNU) investigative panel indicated in their report on the stem cell scandal.

The university panel announced last month that Hwang's team had obtained up to 2,061 eggs from 129 females, which contradicts Hwang's assertion that they had used only 427 eggs.

After holding its general meeting at a hotel in downtown Seoul, the National Bioethics Committee revealed its midterm report, saying that Hwang's team failed to sufficiently protect ova donors' rights, such as providing sufficient information on possible side-effects.

"A total of 15 out of 119 donors provided their ova more than twice for the stem cell research. And 66 out of the 119 received money in return for their donation," said Cho Han-ik, vice president of the committee.

The money given to the females ranged from 300,000 won to 1.5 million won, he said, adding that the final report will come out after the prosecutors' investigation into Hwang is completed.

Regarding Hwang's two junior researchers' ova donations, the committee claims it seems Hwang violated the Helsinki Declaration because he was deeply involved in the process of acquiring ova, such as handing out written consent forms for ova donation to his junior researchers.

The declaration was adopted by the World Medical Association in 1964, stating the ethical code of conduct for medical research involving human subjects.

One of its charters states that "when obtaining informed consent for a research project, a physician should be particularly cautious if the subject is in a dependent relationship with the physician or may be under duress." Late last year, professor Hwang admitted that his lab's two female researchers donated their eggs in 2003 "voluntarily for the success of the research by sacrificing themselves."

After Hwang's confession, the Ministry of Health and Welfare claimed the donations were not a violation of ethics guidelines because they were made voluntarily. Experts said that up to 10 percent of women who undergo ovarian stimulation to procure eggs experience severe after-effects, including infertility or even death.

The committee will also take disciplinary measures against the Institutional Review Board (IRB) of Seoul National University's veterinary medicine college, and Hanyang University Medical Center's IRB, which approved Hwang's research.

The panel said that the two IRBs did not pay much attention to the ethical problems of Hwang's team.

If Hwang's team is found to have violated the bioethics law, which came into effect in January last year, the committee plans to file a lawsuit against Hwang.

The law forbids trade in sperm and ova for commercial purposes. It stipulates that those offering ova for a commercial purposes are subject to prison terms of up to three years, and those arranging the illegal trade may face a maximum of two years in jail.

But as the law does not contain clear-cut guidelines on ova donations, such as how many times ova donation is possible, the committee discussed how to revise the law during the meeting.

Possible amendments could include allowing a woman to donate ova only twice during her lifetime, and banning researchers in stem cell studies from donating ova to avoid ethical disputes and to protect donors' health.

But due to different opinions among committee members, the possible amendment needs more discussion and will be finalized later, officials said.

Meanwhile, prosecutors raided Hwang's home again Thursday and the homes of eight of his collaborators, suspecting that there might have been an attempt to cover up the truth behind Hwang's faked data in research papers published in 2004 and 2005 in the U.S. journal Science.

Criminal investigators have so far searched more than 28 places, including a laboratory in SNU's Veterinary College and the fertility clinic Mizmedi Hospital in Seoul. They have also seized computer files as well as daily records of experiments by researchers.

Hwang achieved global stardom by claiming three firsts _ the first cloned human embryonic stem cells (Science, Feb. 2004), the first patient-specific stem cells (Science, May 2005) and the first dog clone (Nature, Aug. 2005).

It was found out later, however, that Hwang falsified data in the 2004 and 2005 papers. The peer-review committee at SNU concluded that Hwang's team has never obtained stem cells from cloned embryos.

The committee did however confirm that Hwang create the world's first cloned dog, Snuppy.