What to Do If Your Award or Application Involves Stem Cells

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If you are conducting ongoing NIH-funded research involving previously approved uses of human stem cells, please know that your research may continue as NIH works to finalize the Guidelines for Human Stem Cell Research. While no new uses of human embryonic stem cells may be initiated in NIH-funded studies at this time, NIH will continue to accept competing applications proposing the use of human embryonic stem cells during the period of Guideline development.

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. The “Yes or No” checkboxes for human embryonic stem cell use should be marked appropriately. This is item 4 on the PHS 398 cover page supplement for electronic submissions using the SF 424 (R&R). For paper submissions, it can be found at the end of PHS 398 Form Page 2. Additionally, applicants should indicate in the appropriate checkbox that the specific stem cell line to be used cannot be referenced at this time.

As indicated in Guide Notice NOT-OD-09-085, once the Guidelines have been issued in final, applicants will have the opportunity to revise their applications as necessary to comply with the Guidelines, including utilization of eligible cells. The modified applications will then be peer reviewed and considered for funding.

Guide Notice NOT-OD-09-085 further states that NIH will not consider administrative supplement requests to any grants that involve or include costs for the study of human embryonic stem cells until the Guidelines are finalized.

Per President Obama’s Executive Order 13505, NIH will issue final Guidelines by July 7, 2009. After the Guidelines are issued in their final form, all subsequent requests for funding will be expected to comply with the new Guidelines.