Update: The following update relating to this announcement has been issued:
- January 29, 2013 - See Notice NOT-OD-13-030. Reminders and Updates: NIH Policy on Post-Submission Application Materials.
Release Date: June 11, 2012
NOT-OD-17-066: Additional Change to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials
NOT-OD-16-130 :Changes to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials for Applications Submitted for Due Dates On or After January 25, 2017
NOT-OD-10-136:
Amended Status of Applications and Awards Involving Human Embryonic Stem Cells,
and Submissions of Stem Cell Lines for Eligibility Consideration
NOT-OD-10-056:
Review Considerations for Applications and Awards under the New NIH Guidelines
for Human stem Cell Research
National Institutes of Health (NIH)
Office of Extramural Research (OER)
This Notice is intended to inform potential NIH applicants of impending changes in the PHS 398 and SF424(S&R) instructions for applications involving the use of human embryonic stem cells (hESC).
Background
Earlier the NIH announced that certain hESC lines had been approved for use in NIH-funded research and had been posted on the NIH Human Embryonic Stem cell Registry (https://grants.nih.gov/stem_cells/registry/current.htm) (see NOT-OD-10-056). Because only a few lines were approved at the time, the instructions for applicants stated the following:
If the proposed project involves human embryonic stem cells, in this section list the registration number of the specific cell line(s) from the stem cell registry found at: http://stemcells.nih.gov. Use continuation pages as needed. If a specific line cannot be referenced at the time of application submission, include a statement that one from the registry will be used.
In addition, if an hESC application proposed research for which scientifically appropriate hESC lines had not yet been approved, reviewers were informed:
only restricted awards would be issued until eligible hESC lines were approved, and the choice of hESC line in the research plan should not affect the individual criterion scores, assessments of overall merit, or overall impact scores during initial peer review.
New Policy
The NIH Stem Cell Registry now lists over 160 approved cell lines. Therefore, beginning with applications submitted for the September 25, 2012 due date and thereafter, applications proposing the use of hESC must:
- Specify a cell line(s) from the NIH Stem Cell Registry that will be used in the proposed research, or
- Provide a strong justification for why an appropriate cell line cannot be chosen from the Registry at this time and a certification that one from the Registry will be used. The justification should be included in the Research Strategy section of the application.
Reviewers will be instructed to evaluate the scientific appropriateness of the proposed cell line(s).. If the proposed cell line(s) is approved by the NIH Stem Cell Registry at least 30 days prior to the peer review meeting, the SRO can include this update to the reviewers as part of the post-submission materials (see NOT-OD-10-115). This evaluation will be allowed to affect individual criterion scores, assessments of overall merit, and overall impact scores during initial peer review.
As before, if an hESC application proposes research for which the specified hESC line(s) has not yet been approved, only restricted awards will be issued until the specified hESC line(s) is approved.
Implementation
Applications submitted for the September 25, 2012 due date and thereafter will be expected to comply with the new policy and will be reviewed accordingly. The PHS 398 and SF424 (R&R) instructions for applicants will be revised subsequently.
Please direct all inquiries to:
Sally A. Amero, Ph.D.
NIH Review Policy Officer
Office of Extramural Research
[email protected]
or
Grants Information
[email protected]
and Human Services (HHS)
