It’s highly unusual for a journal to publish a research paper accompanied by an editorial and a guest commentary expressing grave reservations about its ethics.
But that’s what Human Reproduction did with a study of a more cost-effective version of IVF.
The researchers recruited dozens of young women from the Mexican city of Puerto Vallarta, on the Pacific Coast, and paid them US$1400. They were given fertility drugs to stimulate the production of eggs and artificially inseminated. Then 4 to 6 days later, the embryos were flushed out and examined.
The researchers wanted to see whether the embryos were as genetically healthy as embryos created through standard IVF in a laboratory. It turns out that they are, according to Santiago Munné, a Catalan reproductive geneticist who was the lead author of the study. This could lead to cheaper, simpler IVF.
Ethical complications? Just a few.
For starters, here’s what the editors pointed out:
… fertile women not wishing to become pregnant were exposed to ovarian hyperstimulation and were treated with intrauterine insemination with semen that did not necessarily come from their own partner. Despite uterine flushing, not all embryos were retrieved and some women accidentally became pregnant. For termination of pregnancy, those women were then treated with methotrexate (MTX), some even with a dilation & curettage (D&C). All of the above interventions are potentially harmful to the women who did not benefit directly from participation—other than through financial compensation.
The guest commentary was negative, with question marks hovering over all ethical aspects of the study: autonomy, justice, beneficence, and non-maleficence.
"What this essentially does is use a woman's body as a petri dish," Laurie Zoloth, a bioethicist at the University of Chicago, told NPR. "And there's something about that that seems so profoundly disturbing."
Her conclusion: "I think this research was unethical."
The situation of the research subjects is troubling. “It is questionable whether it is ethically acceptable to offer individuals who participate in a study that offers no benefit to them (and indeed could potentially be harmful), substantial financial compensation,” the editors of Human Reproduction noted. “In Mexico, $1400 is the equivalent to a 71-working-day wage. Under those conditions, were the participants still free enough to make a well-balanced choice?”
The procedures were carried out at Punto de Mita Hospital, a state-of-the-art medical tourism clinic which also handles fertility services like surrogacy. But most of the women must have come from Puerto Vallarta, a city about an hour away where poverty is a significant problem. About 10% of homes there do not have potable water; 8% do not have connections to a sewer system, and 4% do not have electricity.
And none of these criticisms touched upon the controversial moral status of the embryos and the abortions. Bioethics commentator Wesley J. Smith, writing in the National Review was scathing. The headline over his article said it all: “Experimenters Pay Mexican Women to Get Pregnant and Abort”. The embryos created in the wombs of the Mexican women were created purely for purposes of research; “accidents” were aborted.
Is this an experiment which could have been done in the United States? Probably not. As Smith points out, it is a prime example of “ethical outsourcing”.
However, Dr Munné responds that it had been approved by the Ministry of Health of the State of Nayarit, in Mexico, and the Western Institutional Review Board in the United States. The women had been informed of all the risks.
"We passed all the ethical committees and all the ethical checks and balances," he told NPR.
Michael Cook is editor of BioEdge
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