The April 17 NIH Guide includes a Notice on Implementation of Executive Order on Removing Barriers to Responsible Scientific Research Involving Human Stem Cells.
This NIH Guide Notice links to Draft National Institutes of Health Guidelines for Human Stem Cell Research. The draft guidelines were published in the April 23 Federal Register; comments must be received by NIH on or before May 26, 2009. NIH plans to issue final Guidelines within the 120 day limit set by the President.
The Notice provides the following implementation guidance:
- Ongoing NIH-supported research: Pending issuance of new Guidelines, all ongoing NIH-funded research involving approved uses for human stem cells, including human embryonic stem cells, may continue. However, until the Guidelines are issued in final, no new uses of human embryonic stem cells may be initiated in NIH funded studies unless previously reviewed and approved by the NIH for the ongoing supported research projects. Further, NIH will not consider requests for either administrative supplements or revisions to any grants that include costs for, or involve the study of, human embryonic stem cells until the Guidelines are finalized.
- Peer reviewed competing applications: Pending issuance of new Guidelines, any applications previously submitted to the NIH and already reviewed, which propose to use human embryonic stem cells, will be held for funding decisions until the final Guidelines are issued. At that time, highly ranked applications can be modified, as necessary, to comply with the Guidelines, to receive full consideration for funding.
- Competing applications pending submission and/or peer review: NIH will accept applications for research proposing to use human embryonic stem cells during the period of Guidelines development, but the review and funding of these applications will be deferred until NIH issues final Guidelines. Such applications should identify illustrative cells for the purposes of the research plan. Once the Guidelines have been issued in final, applicants will have the opportunity to revise their application as necessary to comply with the Guidelines, including utilization of eligible cells. These modified applications will then be peer reviewed and considered for funding.
