Administrative Supplements for Human Embryonic Stem Cell Research
Participating Institute: National Institute of General Medical Sciences
Receipt Date: April 1, 2004
This announcement contains the following information:
Purpose
The purpose of these supplements is to enable NIGMS grantees with little or no prior experience working with human embryonic stem cell (HESC) to explore the use of HESC as a model system to further research that is directly related to the aims of the parent grant. Supplements should not expand the original scope of parent grant. The source of HESC will be limited to federally approved stem cell lines listed on the NIH Human Embryonic Stem Cell Registry, which can be found at http://escr.nih.gov.
Background
On August 9, 2001, President Bush announced his decision to allow Federal funds to be used for research on existing human embryonic stem cell lines. Subsequently, the NIH Human Embryonic Stem Cell Registry was created to provide a listing of federally approved Human Embryonic Stem Cell Lines (http://escr.nih.gov) that may be used for such research. The availability of HESC for federally funded research affords an unique opportunity for investigators to use these cells to address fundamental research questions. However, most investigators have had little or no prior experience in working with HESC and have not had the opportunity to propose experiments utilizing HESC in their grant applications. A recent report of an NIGMS workshop on the Basic Biology of Mammalian Stem Cells, which can be found at http://www.nigms.nih.gov/news/reports/stemcellworkshop.html, summarizes many fascinating opportunities to use HESC as a model system to study important biological problems. This notice provides the opportunity for NIGMS grantees to incorporate the use of HESC into their experimental plan when the proposed research falls within the original scope of the parent grant and is a logical extension of the goals and objectives.
Mechanism of Support
Awards will be made through administrative supplements to R01, R37, P01 and S06 awards. Applications may request up to $75,000 in direct costs per year, for up to the duration of the funded grant period. NIGMS has set aside $1.5 million to support successful applications. Grantees may request funds for small items of equipment, supplies and personnel to work with HESC. Funds may be requested to support travel to acquire necessary expertise.
Eligibility Requirements
The PI must have an active NIGMS R01, R37, P01 or S06 research grant. The parent grant must have at least 18 months of support remaining at the time of submission. An investigator will be allowed only one supplemental award under this program.
Where to Send Inquiries
Investigators are strongly encouraged to discuss eligibility requirements with NIGMS staff before preparing an application. We welcome the opportunity to clarify any issues or questions from potential applicants.
Please direct inquiries to the program director listed on your award statement, or to:
Marion Zatz, Ph.D.
Program Director
NIGMS
Telephone: (301) 594-0943
E-mail: zatzm@nigms.nih.gov
Inquiries regarding NIH grant policy or fiscal matters should be directed to:
Ms. Marcia Cohn
Grants Management Officer
NIGMS
Telephone: (301) 594-7316
E-mail: cohnm@nigms.nih.gov
Submitting an Application
This is one-time solicitation with a single receipt date of April 1, 2004. Requests for supplemental support must be submitted on the PHS 398 Form (Rev. 5/2001), which may be obtained at http://grants.nih.gov/grants/funding/phs398/phs398.html.
The identifying number(s) of the approved stem cell line(s) to be used MUST be included in the abstract of the application. Applications that do not specify an approved cell line listed on the NIH Human Stem Cell Registry (http://escr.nih.gov) will be returned to the applicant without further review.
The grantee institution, on behalf of the principal investigator of the parent grant, must submit the request for supplemental funds directly to NIGMS. The request is NOT to be submitted to the NIH Center for Scientific Review. Send an original and four copies of your application to the NIGMS address below by April 1, 2004.
Submit requests to:
Marion Zatz, Ph.D.
Program Director
Division of Genetics and Developmental Biology
NIGMS
Building 45, Room 2AS-25E MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
E-mail: zatzm@nigms.nih.gov
Application Contents
Include the following in the application:
- Completed PHS 398 Face Page. Write the number of the parent grant on the top of the page. The name of this announcement, “NIGMS Administrative Supplements for Human Embryonic Stem Cell Research,” should be entered on line 2.
- Abstract Page. It must contain a description of the proposed supplemental activity, how it is related to the parent grant, and the identifying number(s) of the HESC lines to be used.
- Budget Justification Page(s). Up to $75,000 direct costs may be requested for salary and fringe benefits of key personnel, for costs of procuring HESC, for supplies and small items of equipment, and for travel. The term of support may extend to the end of the funded project, but not beyond it.
- A description of plans to obtain HESC, including status of application for required material transfer agreements (MTA).
- Facilities and Administrative Costs Page of PHS 398 Form Checklist.
- A research plan, not to exceed five pages, that includes the following:
a) rationale for the use of HESC as a model system to further the goals of the research grant;
b) description of experimental design and methods of the proposed supplemental research, including plans to grow and maintain HESC;
c) plans of the PI and key personnel to acquire expertise in working with HESC, or documentation of existing expertise;
d) description of facilities and the research environment for research utilizing HESC; and
e) description of any collaborative arrangements; letters of support from collaborators and/or consultants should be appended to the research plan.
Review Process
Requests that are responsive to this administrative supplement announcement will be reviewed by NIGMS staff, in consultation with external reviewers as needed. Upon receipt, requests will be reviewed for completeness and eligibility. Applicants are required to include in the abstract the NIH code number identifying the approved HESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. It is anticipated that successful applications will be awarded within four months of the receipt date.
Review Criteria
- Does the PI provide a convincing rationale for the use of HESC as a model system to advance the aims of the parent grant?
- Are the experimental plans described in sufficient detail? Are they logical extensions of the goals and objectives of the parent grant?
- Are the plans to obtain and utilize HESC adequately described?
- Are the facilities and the research environment appropriate for the use of HESC?
- Does the experience of the PI and key personnel appear adequate for research with HESC? If added expertise is needed, have appropriate plans been presented to acquire additional expertise?
- If collaborative or consulting arrangements are proposed, do they appear to be adequate to support the proposed research?
- Is the proposed budget reasonable?
- Are the administrative arrangements to procure HESC, including necessary MTAs, spelled-out and reasonable?
Award Criteria
All awards are subject to the availability of funds. No awards can be made until adequate arrangements for the procurement of HESC are documented.
Questions and Answers
PIs are encouraged to visit the NIH Stem Cell Information Webpage at http://stemcells.nih.gov/ for additional information on the use of HESC and to look at the questions and answers below.
Q: Do I need Institutional Review Board review for research using human embryonic stem cells?
A: It depends. Applicants and their institutional officials are encouraged to review guidance from the Office of Human Research Protections (OHRP) regarding this issue, Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells and Cell-Derived Test Articles, at http://www.hhs.gov/ohrp/humansubjects/guidance/stemcell.pdf.
Q: I have read a lot about HESC, but I have never used them in an experiment. Can I apply for a supplement, even though I have no experience with these cells?
A: Yes, but you need to demonstrate plans for key personnel to obtain and develop needed expertise. See http://stemcells.nih.gov/rschFunding/trngGrants.asp for available training courses.
Q: I did not propose to use HESC when I wrote my grant? May I apply for a HESC supplement as a new aim of my research?
A: No, but you can apply for a supplement to use HESC as a model system to address your existing aims, as long as the proposed research is a logical extension of work proposed in the parent grant and does not constitute an expansion of the scope.
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