previously published in the Terre Haute Tribune-Star, 16 December 2018
On Nov 26 Dr. He Jankui, a Chinese biomedical researcher, became (in)famous. He shocked the world by announcing that he had used a gene splicing technology to edit the genes of two embryos, who he claims have been born, thus ushering in the age of genetically enhanced human beings.
Why is this so controversial? There are many ways to examine this, but with one, I have 20 years of experience. I’ve served on the “Institutional Review Board” (committee that reviews all human subjects work conducted at ISU) including chairing it for nearly a decade.
Dr. He revealed that he had altered the genes of twin baby girls so they would not contract HIV. It is unclear whether his statement is true, but his university as well as the Chinese government have distanced themselves from Dr. He and suspended his work. The two girls have been born, and if the story is true, they can pass their altered genes to their own children.
Eugenics, a movement to improve the human species by selecting superior traits, arose in the West and then found its greatest expression in Nazi Germany. Indeed, the Nazi human experimentations revealed after the war, led to the creation of the Nuremberg Code, which attempted to guide biomedical research, especially in the West and specifically in the US. Nonetheless, research revealed in the later 1960s and early 1970s that violated the “Code” and most people’s basic sensibilities, resulted in the “Belmont Report” and the formal decentralized regulation of human subjects research in the U.S. that we have today. And those documents and practices have influenced the rest of the world.
Three, at times, competing, ethical principles guide (regulated) human subjects research in the United States. They are “beneficence,” “respect for persons,” and “justice.” They are equal in weight, sometimes conflict, but yield a conservative approach to recruiting and conducting research with human subjects. Understandably, many researchers chafe at human subjects review of their research.
In one of a series of videos Dr. He appears in as part of his announcement, Dr. He outlined the ethical principles that guided his work. However, he justified the therapeutic use of the procedure, not the research. Research ethics are different and arguably more conservative. Indeed, the dual role conflict between clinician offering therapy and researcher is a common challenge in biomedical research.
Dr. He appeared to be motivated to perfect a genetic edit of a gene to make the babies resistant to HIV because HIV has devastated much of the Chinese population. That would be his argument for beneficence and that is certainly defensible, but there are many “howevers.” I could not find a copy of the informed consent document and a detailed description of the process to consent the prospective parents. It does not sound like it was vetted by an ethics board and it is not clear from what I can find if the informed consent document contained all necessary elements of informed consent.
Reports about the informed consent document state that the reason for the research was to create an AIDS vaccine, which the research was clearly not. Deception can be used in research but it must be necessary to the research, not to allay concerns on the part of potential subjects.
Another concern is that paternal transmission of HIV to offspring is rare and the process used for the in vitro fertilization essentially eliminated the possibility of that transmission anyway. Thus there was no medical reason to edit the embryos’ genes. Dr. He justified the research by claiming it would protect the children in the future, but HIV, even in China, is avoidable.
Every human subjects researcher must weigh the risks and benefits of the research. If the benefits do not outweigh the risks, then the research does not go forward. As an experienced reviewer of human subjects research, from what I can piece together, it does not appear that the benefits outweigh the risks. This is, in part, because we don’t fully know the risks.
Even the technique Dr. He used, CRISPR, to edit the genes, has been related to causing cancer because of the imprecision of the editing. Did Dr. He present that as a risk to the parents? The procedure might lead to the daughters being resistant to HIV but at greater risk of developing cancer?
Parents, desperate to have a child, are vulnerable. The father of the twins was depicted by Dr. He as being despondent that he could not have children presumably because he was concerned about passing on HIV to his children. My guess is that the cost of having in vitro fertilization was beyond their means (on average about $4,300 USD; average household income, $10,220 USD) thus agreeing to be part of research in order to get the safer procedure than normal sexual reproduction is ethically problematic as well.
This goes to the ethical principle of respect for persons. Researchers must not use undue influence to gain the consent of their subjects. And if the risks were not fully explained to the parents, then the principle of respect for persons is not upheld. Moreover, Dr. He administered the informed consent himself. Normally, the therapist would not consent his research subjects because of “undue influence” over the subjects.
Lastly is the ethical principle of justice. Had Dr. He undertook this research in order to protect the embryos from infection from their father, Dr. He would have adhered to this principle, because the group most likely to benefit, infected fathers and their partners, are the ones shouldering the risk of the research (although it is the embryos who are actually at risk, but embryos cannot consent to the procedure).
However, Dr. He stated that his motivation was to protect the embryos not from their father but in the future. Therefore, the principle of justice is not upheld. The principle of justice holds that those who benefit from the research should bear the risks of the research. Dr. He however, targeted for recruitment an arguably vulnerable population who were, in their eyes, unable to have children because of the threat of parental transmission. They are not the only group who would benefit; anyone who receives the edited genes would benefit.
Parents without HIV should have also been recruited in order to not solely burden the HIV infected group with the risk of the research that can benefit groups beyond the HIV positive group.
Hence, based on what I can piece together about Dr. He’s research, this research should not have gone forward.
Thomas L. Steiger is a professor of sociology and director of the Center for Student Research and Creativity at Indiana State University. Email thomas.steiger@indstate.edu.
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