On Monday, Judge Royce Lamberth of the U.S. District Court for the District of Columbia issued a temporary injunction blocking the federal government from implementing the current National Institutes of Health (NIH) guidelines governing research with human embryonic stem cells (hESCs). Here are some frequently asked questions about the ruling, and ScienceInsider’s answers.
1. Will the ruling stand?
It might. Other legal observers have warned that NIH was on shaky legal ground when it argued that funding hESC work was not prohibited by a congressional ban on U.S. funding of “research in which a human embryo or embryos are destroyed,” known as the Dickey-Wicker Amendment. Louis Guenin, a lecturer on ethics in science at Harvard Medical School, warned shortly after Barack Obama was elected president that Congress needed to act on the issue. Guenin, who supports federal funding for hESCs, worried that an Executive Order, like the one Obama issued on 9 March 2009, would be vulnerable to legal challenges.
In 1999, NIH officials made a distinction between derivation of hESCs and research on derived cells. They argued that use of cell lines did not violate the specific language of the Dickey-Wicker Amendment. In his decision, Judge Lamberth said that NIH’s distinction was invalid. Although Guenin says he’s frustrated by the situation, he believes the judge is correct in ruling that funding for hESC work is incompatible with current law. The same would be true for research that involved killing bald eagles, he says. “It’s illegal to kill the birds. Even if someone else shoots the birds for you, you’re still going to go to jail because you’re complicit in an arrangement in which the birds are killed,” he says.
To be on safe legal ground, Guenin and others say, Congress needs to remove the prohibition against embryo research or pass a law explicitly allowing federal funding of research on hESCs.
Other observers point out, however, that there appears to be a contradiction in Lamberth’s ruling. The judge claims that granting the injunction “would simply preserve the status quo and would not interfere with [researchers’] ability to obtain private funding for their research.” However, NIH has been funding some work with hESCs for nearly a decade; halting all federal funding for hESCs is not exactly the status quo.
2. Would this injunction throw out the rules in place under President George W. Bush?
Yes. The Bush Administration allowed NIH to fund work with hESCs derived before 9 August 2001, the day Bush announced his policy. Lamberth argues that as long as the Dickey-Wicker amendment is in place, federal funding for any hESCs, no matter when they were derived, is illegal.
3. Can other researchers sue if their grant applications are denied?
Not exactly. Lamberth initially threw out the lawsuit, saying that the plaintiffs had no standing because they hadn’t shown they would be harmed. An appeals court disagreed, ruling in June that two stem cell researchers, James Sherley and Theresa Deisher could be harmed by the NIH policy: “Because the Guidelines have intensified the competition for a share in a fixed amount of money, the plaintiffs will have to invest more time and resources to craft a successful grant application. That is an actual, here-and-now injury.” Some commentators have worried that the injunction implies that anyone who feels slighted by grant reviewers or elbowed out by competing areas of research could sue the government. However, this lawsuit is very narrow: It challenges the legality of funding hESC research under a specific law. Most areas of research don’t have a Dickey-Wicker Amendment complicating their legal standing.
4. Will researchers have to stop using government-funded stem cells immediately?
No, ongoing grants can continue for now. NIH Director Francis Collins said yesterday that the injunction won't affect 199 grants using hESCs that have already gone out the door this year. (NIH sent grantees an e-mail today saying investigators who have already received an award notice can continue their research for the current award period.) However, NIH will not be able to fund 22 grants that were up for annual renewal at the end of September. NIH has also halted the review process for 62 grants that were awaiting peer review or had gone through the first stage and were to be reviewed soon by NIH advisory councils.
More ongoing grants will come up for annual review in the coming months, so they will also be halted if the injunction stands. In addition, Steven Aden of the Alliance Defense Fund, a co-counsel in the plaintiff's suit, says the plaintiffs haven't ruled out a challenge to the Adminstration's interpretation of the ruling.
5. What comes next?
The Justice Department has said that it will appeal the injunction this week. Aden says the government first must ask Judge Lamberth to stay the ruling; if he declines, the Justice Department can take their appeal to the D.C. Court of Appeals. Aden expects a decision would follow within a few days.
If the injunction stands, the lower court (Lamberth's) will then hold a hearing on the full case. That could take months.
See our complete coverage of this issue.