NIH Rushes to Hand Out Stem Cell Grants During Temporary Stay

The National Institutes of Health (NIH) is scrambling to push out research grants for work on human embryonic stem cells (hESCs) and has given a cautious all-clear to in-house stem cell researchers after an appeals court yesterday temporarily lifted a ban on federal funding for hESC research.

The stay allows NIH to return to business as usual until at least 20 September, which is the deadline for the parties to file briefs so the appeals court can decide whether to continue a lower court's 23 August preliminary injunction.

In an e-mail sent yesterday afternoon, extramural research chief Sally Rockey told the heads of NIH institutes that during the 11-day window, "hESC awards should be given priority including non-competing continuations, and new and renewing competing awards." Applications due for final approval or renewal in September or October should be given expedited treatment, she said. That should allow NIH to disburse funds for 24 ongoing grants up for annual renewal in September. Rockey's e-mail also suggests that NIH can fund about 20 grant proposals that had passed the first stage of peer review and were awaiting review by institute councils. However, hESC grants just beginning the peer-review process probably can't be paid until next fiscal year, which begins 1 October.

As reported on Nature's blog yesterday, Michael Gottesman, NIH's deputy director for intramural research, also told intramural labs working with hESCs that they could resume work. But given the short duration of the all-clear, he warned, "To assure appropriate stewardship of NIH resources, prudence in resuming experiments is advised."

And in the latest legal development, the plaintiffs in the case, as expected, requested yesterday that Washington, D.C., Circuit Judge Royce Lamberth decide the case quickly. In light of the 23 August ruling, their lawyers write, "the time is right for this Court to grant summary judgment in favor of the Plaintiffs' claim" that the current NIH guidelines governing hESC research "are invalid as a matter of law." In their 68-page motion for summary judgment filed yesterday, the lawyers reiterate their claims that the guidelines violate the Dickey-Wicker Amendment prohibiting research that harms embryos and charges that NIH improperly ignored public comments submitted regarding the draft guidelines. (A majority of the comments submitted opposed NIH funding the research.)

Although Lamberth hasn't yet set a schedule for both sides to file documents in the case, the expectation is that he would not move ahead before the appeals court has made a decision about the Department of Justice's (DOJ's) request to stay the preliminary injunction.

So what happens after 20 September? The appeals court will probably rule on DOJ's emergency motion for a stay within a few days, says John Robertson, a professor at the University of Texas School of Law in Austin. If the court grants a more permanent stay, NIH could keep funding hESC work while the same court hears the government's appeal of the preliminary injunction. Lamberth, meanwhile, could grant the plaintiffs' motion for summary judgment and decide the full case. Although based on Lamberth's previous rulings in the case, he seems likely to rule in favor of the plaintiffs and issue a permanent injunction, Robertson predicts that stay or a new version of it would remain in place while the decision is appealed. "My sense is that NIH will be able to continue to operate," probably for many months, he says.

However, if the appeals court does not continue the stay, hESC research will again be shut down—potentially for a long time.

Rockey's full e-mail:

From: Rockey, Sally (NIH/OD) [E]

Sent: Thursday, September 09, 2010 4:45 PM

In light of the Order issued by the US Court of Appeals for the D.C. Circuit (No. 10 5287, Filed on September 9, 2010) which provides a temporary administrative stay until at least September 20, 2010 of the district court's August 23, 2010 preliminary injunction (PI), NIH may proceed with awarding pending hESC grants as necessary to meet end of year deadlines. The Court of Appeals has requested quick briefing of the motion for a permanent stay pending appeal of the PI and could decide as early as September 20th as to whether to grant or deny a permanent stay. We will provide additional guidance at that time.

The following applies to pending hESC awards.

* The suspension of all pending grants and contracts, and applications and proposals that involve the use of hESCs, is hereby temporarily lifted.

* Given the delay in their issuance, hESC awards should be given priority including non competing continuations, and new and renewing competing awards.

* Competing applications must have Council concurrence before issuing the award. If the application was deferred before Council review happened, ICs must secure Council concurrence before issuing the award. Expedited Electronic Council approval can be used.

* If there are any applications pending 10/2010 Council that you expect to fund this Fiscal Year and Council is meeting after 9/20, you are encouraged to use expedited Council concurrence for those as well.

* Competing applications should move forward based on the peer reviewed and approved scope.

* There is no need to issue special hESC specific restrictions (except for standard hESC footnotes).

* Do not modify the hESC indicator in IMPACII unless the indicator is erroneous and should be corrected.

* Any other pending actions placed on hold (i.e., revised awards for CAN changes, administrative supplement actions, no cost extension requests, prior approval actions, etc.) may also be processed at this time.

* These instructions apply to pending all hESC ARRA and non ARRA awards.

With regard to applications placed on hold:

* Those on hold for Council Review may proceed to September/October 2010 Council. hESC applications that were submitted originally for August 2010 Council or October 2010 Council and were deferred to January 2011 Council will be reinstated for October 2010 Council. IC Staff will be responsible for re instating those applications.

* Those on hold for SRG Review (January 2011 Council) may proceed to initial peer review. Staff may re assign the applications from the IRG designation (CSR) or ZIC designation (IC staff) to the appropriate study section designation. If review in the originally scheduled meeting is not feasible, an application(s) can be reviewed in another appropriate meeting, as long as the reviews are completed in time for January Council.

As everything regarding hESC continues to change from moment to moment, we will send out additional information as it is received and please continue to monitor the situation from your end.

*This item has been corrected on 15 September. Aspects of the next steps in the legal process have been clarified and/or corrected.

See our complete coverage of this issue.