NOT-OD-10-056: Review Considerations for Applications and Awards under the New NIH Guidelines for Human Stem Cell Research

Review Considerations for Applications and Awards under the New NIH Guidelines for Human Stem Cell Research

Notice Number: NOT-OD-10-056

Key Dates
Release Date: February 19, 2010

Other Relevant Notices

June 11, 2012 - See Notice NOT-OD-12-111. Notice of Impending Change in Peer Review Criteria and Submission Requirements for NIH Applications Involving Human Embryonic Stem Cells.
September 10, 2010 – See NOT-OD-10-136 Amended Status of Applications and Awards Involving Human Embryonic Stem Cells, and Submissions of Stem Cell Lines for Eligibility Consideration
August 30, 2010 - See NOT-OD-10-126 Status of Applications and Awards Involving Human Embryonic Stem Cells, and Submissions of Stem Cell Lines for Eligibility Consideration.
February 19, 2010 – See NOT-OD-10-063 Status of Certain Human Embryonic Stem Cell Lines
December 2, 2009 - See NOT-OD-10-020 First Human Embryonic Stem Cells Approved for use under the NIH Guidelines for Human Stem Cell Research
July 15, 2009 See NOT-OD-09-123: Status of Applications and Awards under the New NIH Guidelines for Human Stem Cell Research
July 6, 2009 – NIH Guidelines for Human Stem Cell Research
April 24, 2009 - See NOT-OD-09-086 Public Comment Period Open for Draft Stem Cell Guidelines through May 26, 2009
April 17, 2009 - See NOT-OD-09-085 Implementation of Executive Order on Removing Barriers to Responsible Scientific Research Involving Human Stem Cells

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

Earlier, the NIH issued Guide Notice NOT-OD-09-123 stating that additional information would not be accepted for the initial peer review of hESC applications that propose the use of human embryonic stem cells (hESC) and were going to second-level review in September/October 2009 and January/February 2010 Councils. At the time no hESC lines had been approved for use in NIH funded research, and these restrictions on additional materials served to maintain consistency in the peer review process.

In the interim, certain hESC lines have been approved for use in NIH funded research and posted on the NIH Human Embryonic Stem Cell Registry (http://grants.nih.gov/stem_cells/registry/current.htm). Therefore, the restriction on additional materials for applications proposing the use of hESC will be lifted for applications going to review in May/June 2010 Councils and thereafter.
If an hESC application proposes research for which approved hESC lines have not yet been approved:

Reviewers will be informed that only restricted awards will be issued until eligible hESC lines are approved.
Reviewers will be instructed that the choice of hESC line in the research plan should not affect the individual criterion scores, assessments of overall merit, or overall impact/priority scores.

Inquiries

Inquiries should be directed to:

Sally A. Amero, Ph.D.
NIH Review Policy Officer
Office of Extramural Research
Email: ameros@od.nih.gov

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