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Embryo research creates heated ethics debates
At issue: Do embryos have rights?
A debate that has become more heated in the 21st century is whether all embryonic research should be subject to human subject research protection and IRB review.
Taken to an extreme, the standard might require the evaluation of whether there is a benefit to the embryo itself and whether the research can be conducted in the absence of such a benefit, says Nancy L. Jones, PhD, MA, associate professor of pathology at Wake Forest University School of Medicine in Winston-Salem, NC, and a fellow for the Center for Bioethics and Human Dignity, affiliated with Trinity International University in Deerfield, IL. She also was appointed to U.S. Secretary of Health and Human Services Secretary’s Advisory Committee on Human Research Protection in December 2002.
"Is this entity before it’s 14 days old something different?" Jones asks. "Is it a tissue culture?"
Historically, animal embryonic research has treated animal embryos as a tissue culture system rather than a whole animal system, she reports.
"So when you apply some of the same things to human embryos, the question is, "Where should it fall?’" Jones asks. "The most important question is what is the morality of the human embryo, and that’s where a lot of the debate is."
Prior to 1994 when the National Institutes of Health (NIH) had a panel look at embryo research, most embryonic research was limited to studies that directly assisted procreation, Jones says.
"In other words, we would improve in vitro fertilization [IVF], help people have children," Jones explains. "So there were restrictions on what you could do with human embryos."
Even now, the research ethics community distinguishes between using embryos for constructive purposes of fertility and procreation and using embryos for destructive purposes in which there is no benefit to the embryo, she adds.
"There was a thought that it was wrong to create an embryo for purposes other than procreation," Jones says. "So if you had some leftover embryos from fertility treatment or research, then it was one thing to use those leftovers, but it was considered taboo to create an embryo specifically for a purpose other than procreative research."
Cloning research pushed the envelope even further, although the research ethics community now has a consensus that human cloning is not right. However, ethicists are divided between those who believe it will always be wrong and those who believe it is wrong now because there are too many health uncertainties for cloned humans, she notes.
"To me, the essential question our culture has to work out is, What is the human embryo?’" Jones says.
There are three basic points of view about this ethical issue:
NIH’s 1994 report on embryonic research issued an intermediate moral view that states embryos are not people and do not have the full moral status of a baby, but the embryo’s moral rights increase the further developed it becomes, she says. "It’s a form of life, but it doesn’t have the full moral status that a baby would have," Jones adds. "But it would have increasingly more weight as it moves along the developmental line and becomes more and more like a baby."
Based on this view, embryonic research would have the condition of being allowed for destructive purposes before the 14th day of life and only if it is not implanted, Jones says.
"Then Congress reacted negatively, and that’s where we got things in an appropriations bill that said researchers couldn’t allow embryos to be created for research or destroyed," Jones says. This applied to research conducted with federal funds.
Private money, different standard
Research involving private funding is less regulated, she adds.
With private money, researchers can take an embryo, let it grow to blastocyst stage, and then take out the inner cell mass and establish a cell line, which is different from creating or destroying an embryo. Cell lines can use federal money for this reason, although one of the first things President George W. Bush did in office was rule that research could continue on existing cell lines, but researchers could not create new cell lines.
So this brings researchers and ethicists to the question of how embryonic research should be reviewed, Jones says. "If you’re going to start soliciting people to donate eggs or leftover embryos, then that would have to go through an IRB review."
While women were not permitted to donate eggs or embryos unless they were undergoing IVF, this restriction changed when Jones Institute for Reproductive Medicine in Virginia Beach, VA, recruited people to give sperm and eggs for embryonic research, she reports.
"A local body reviewed the study," Jones says. "The institute did this specifically for creating an embryo for destructive research and to make embryonic stem cells."
In 2001, after investigators published their work in creating embryonic cells for the purpose of curing chronic illnesses, there was a public outcry that led to Bush’s stem cell decision, and the institute was forced to stop this type of recruitment, Jones adds.
When the ethical issues of research stir up political and scientific issues, it shows that the scientific community needs further scrutiny of human subjects protections, she points out.
"Maybe some research needs to be classified as experimental and there is a need for a different classification, or maybe a new category," Jones says. "But I think it’s too much to ask local IRBs to be competent on all of these novelties, so we need some kind of regional or national group of people who have the expertise to guide this area in an ethical manner."