At a White House ceremony attended by scientific leaders, President Obama on Monday ordered the National Institutes of Health to issue guidelines removing the Bush administration's limits on human embryonic stem cell research funding within 120 days.
Obama also ordered the White House Office of Science and Technology Policy — in a "Scientific Integrity" memorandum — to create a plan to fill federal science positions solely based on merit and to insulate them from political interference. "Political officials should not suppress or alter scientific or technological findings," says the memorandum.
"The two (orders) are a nice pairing: One is a very concrete step on stem cells, and the other sets a much wider tone on how science will be conducted," says attorney Robert Kenney of Hogan & Hartson in Washington, D.C., who specializes in federal research funds.
Here are answers to common questions, based on interviews with researchers and policy experts.
Q: What does this mean for research?
A: Federal funding "to the extent permitted by law" will become available for hundreds of human embryonic stem cells derived from colonies created since Aug. 9, 2001, many of them genetically marked for diseases such as diabetes or cancer. Under the Bush administration rules, only 21 stem cell "lines" had been eligible for research funding.
Q: What are embryonic stem cells?
A: They are cells isolated from the early stages of embryo growth, which turn into almost all of the tissues of the body. At their early stage, however, they are unspecialized, with the potential to grow into any type of cell and to reproduce in large numbers.
Q: How are they collected?
A: Typically, couples donate excess embryos from fertility procedures to researchers. Researchers pull the 150 or so cells from inside one of these roughly 6-day-old embryos, destroying it, and grow the cells in a lab.
Q: Why is this controversial?
A: Some religious groups, such as the U.S. Council of Catholic Bishops, and political leaders, such as former president George W. Bush, have decried the death of the embryos. Bush called it the "taking of innocent human life of the hope of finding medical benefits for others" in a 2006 veto of a bill that would have made the same research funding available then that Obama made available on Monday.
Q: What dangers do opponents see in Obama's action?
A: The National Right to Life Committee says the order "opens door to human embryo farms," charging that researchers will start mass-harvesting embryos to create cell lines. Rep. Joe Pitts, R-Pa., echoed these concerns and, in a statement, called the moves "divisive" amid larger concerns about the economy.
Q: What limits did Obama place, if any, on the stem cell lines that can now receive federal dollars for study?
A: Obama called for "appropriate safeguards," allowing research "only when it is both scientifically worthy and responsibly conducted. We will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse."
The NIH will take its cue from science organization guidelines that preclude cell lines gathered without informed consent or inappropriate compensation of embryo donors.
Although the Bush administration funded some human embryonic stem cell research, a 1996 law precludes federal funding of "research in which a human embryo or embryos are destroyed," which opponents such as Richard Doerflinger of the U.S. Conference of Catholic Bishops have argued makes it illegal.
Over 12 years, this law forced both political leaders and scientists to walk a fine line. Neither the Bush nor Clinton administration interpreted this to mean that funds couldn't be granted to stem cell lines already created.
A bipartisan stem cell research bill vetoed by Bush in 2006 and 2007, likely up for vote again soon, would override this law.
Q: How much federal money are we talking about?
A: The National Institutes of Health estimates it provided $938 million in research grants to stem cells in 2008, with $88 million of it going to human embryonic stem cell research. An extra $10 billion of the recent stimulus bill funds went to the NIH as well, and some portion will go to stem cells research.
"We just want a fair shot at funding; we aren't asking for special treatment," says stem cell researcher George Daley of Children's Hospital Boston.
Q: How will researchers apply for this money?
A: Through the NIH, which receives applications three times yearly and makes awards based on expert evaluation of proposals. Science policy expert Aaron Levine of Georgia Tech University in Atlanta says top-rated cell labs will likely make advances more quickly, particularly those looking at cells that bear genetic markers for inherited diseases.
Q: Will there be benefits to researchers besides money?
A: Some stem cell labs have been literally split into private and federally supported halves, forcing researchers to duplicate equipment and personnel to do disease research, in some cases putting "hands off" stickers on equipment purchased with private money.
"I will immediately be able to have my NIH-funded graduate students get to work on important disease research they were barred from undertaking," says Harvard's Kevin Eggan.
Also, the NIH will become the effective coordinator of basic stem cell research, playing its traditional role in U.S. research.
Q: How long will it take for the impact to be seen?
A: Results usually appear a few years after funds are provided for experiments, says Harvard's Kevin Casey. "We're going to have to work to catch up to the rest of the world." The United Kingdom and Singpore have become centers of embryonic stem cell research since the 2001 funding restrictions on U.S. research.
Q: What about the embryonic stem cell look-alikes generated from adult cells, the so-called induced pluripotent stem cells?
A: These cells, which look very promising for stem cell research, were already eligible for funding under the old policy, although they were isolated from human tissues only in 2007. Researchers such as Eggan say that combined with embryonic research, advances in iPS cells should come even faster, the two cell types providing reinforcing insight into the biology of cell specialization.
Q: What benefits do researchers expect from studying more cell lines?
A: First, the opportunity to study disease-specific cell lines should give researchers insight into how these diseases originate in the body on a cellular level, shining light on the exact genetic defects behind diseases.
Second, cells can be cultured to screen for their response to drugs designed to address these defects, speeding pharmaceutical discoveries.
Third, an era of "regenerative medicine," in which patients get immune-system-friendly transplant organs might spring from stem cells. Geron Corp. in January received Food and Drug Administration clearance to begin testing of nerve stem cell injections of patients with spinal cord injuries.
Q: What's behind the scientific integrity memorandum?
A: The Bush administration was accused in a number of highly publicized cases of interfering with actions by federal agencies in such areas as global warming and endangered species. The Obama memorandum echoes a 2008 Union of Concerned Scientists call for transparency in how federal agencies make science decisions and for insulation from political interference.