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Frequently Asked Questions About RFA-NS-05-005, "Centers of Excellence in Translational Human Stem Cell Research"

National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)

December 2004

Objectives/Theme

  1. What is a Center of Excellence in Translational Human Stem Cell Research?
    A Center of Excellence in Translational Human Stem Cell Research (hereafter "Center") is a multi-project grant to accelerate the application of the latest advances in human stem cell biology to clinical use. These centers will bring together basic stem cell biologists, researchers and clinicians with disease-specific expertise, physicians and surgeons skilled in novel modes of cell delivery, and investigators experienced in developing and assessing animal models of human diseases to create new research teams. This initiative targets critical gaps in research that are delaying the conversion of new discoveries to new therapies, and particularly encourages the formation of new, multidisciplinary teams involving scientists that may not have worked in the human stem cell field and those that incorporate the full spectrum of expertise and experience in translational medical research. The P50 mechanism will be used.

  2. Where can I read about the program?
    The RFA can be found in the NIH Guide for Grants and Contracts.

  3. What is the scientific scope of the RFA?
    Projects relevant to the mission of all NIH Institutes and Centers are welcome; that is to say, applications are not restricted to the categorical interests of NINDS, NIDDK or NHLBI and no specific scientific or medical areas are required or favored. Per standard NIH policy for multi-institute RFAs, applications will be initially assigned to one institute (NINDS) for the purposes of receipt and technical merit review but upon award will be assigned to the appropriate Institute for management.

  4. What should be the scientific scope of an application?
    To be considered responsive to this announcement, all applications must include both preclinical (translational) and basic research. Each awarded Center must consist of two or more projects, all of which are directly related to the overall translational focus of the program. Each component project, whether preclinical or basic, requires a well-described clinically relevant hypothesis, preliminary data, and a time-table for conducting the proposed investigations.

  5. What is Translational Human Stem Cell Research?
    This initiative will accelerate the conversion of new discoveries to new therapies by targeting critical gaps in current research. Such "gaps" are located at different points within the discovery process relevant to different diseases; accordingly, translational research in some disease areas will require more extensive basic research on stem cell biology than other areas; therefore, it is expected that applications will vary in the timelines proposed for the progression of translational studies to clinical application. Nonetheless, responsive applications should clearly lead to innovative approaches for the prevention, treatment, and cure of disease, and accelerate the translation of basic scientific discoveries in the laboratory to new treatments for patients. A key element in therapy development and translational research is the testing and comparison of the behavior of specific stem cells or their derivatives in animal models of diseases. Note that this element is neither necessary nor sufficient to be responsive to this RFA.

    The NIH recognizes that in some cases "gaps" might include the lack of suitable human stem cell lines. This is an instance where the study of animal stem cells would be appropriate; other instances will be considered on a case by case basis and NIH Program staff will make the final decision whether such applications are responsive to this initiative. Note that human stem cells should be the ultimate focus of the center. When animal stem cells are to be included, the strategy for a transition (within the four years of the Center) to a human stem cell centric program should be clearly described.

  6. Should a Center focus on single a medical condition? If multiple, what level of programmatic interaction/common theme is necessary?
    The breadth of the center is entirely up to the expertise and experience of the group. Interactions between the projects should be mutually reinforcing but they need not be based on a common interest in a specific clinical condition.

  7. Need for Clinical Grade Manufacturing Processes: Are cGMP facilities necessary or appropriate?
    The RFA is focused on translational/preclinical questions and use of cGMP facilities is not necessary. However, the use of GMP facilities for the preparation of cells for preclinical testing may facilitate future clinical applications and contribute to long-term scientific and medical strategies.

  8. Do programs need projects responsive to multiple NIH Institutes? If so, what level of programmatic interaction/theme will be required?
    No. However, Specialized Centers are encouraged to include projects addressing more than one therapeutic area as scientifically justified. Projects should be related to one another and overall the Specialized Center should demonstrate an integrated program of research.

  9. Can the focus of the application be genetically engineered cells?
    Studies that exclusively focus on gene therapy or gene transfer, rather than cellular therapy, are outside of the scope of this announcement. However, projects that focused on a cell-based therapy and that include genetically engineered cells can be submitted. Early in planning process and well before the application receipt deadline, applicants are strongly encouraged to contact NIH program staff to discuss proposed projects.

  10. Would it be appropriate to link other grants (particularly program project grants or PPGs) to the Center proposal?
    It is important to link to other existing programs where possible. Cost savings and benefits to the Center program should be described in the application to demonstrate opportunities for leveraging scientific and budget resources.

  11. Would the Center support more than one disease targets in the same center?
    A Center is encouraged to be appropriately multidisciplinary and may include projects involving more than one disease area.

  12. Do you seek highly interdisciplinary centers or more highly focused-single disease-type centers?
    Either. The RFA allows investigators to submit applications including more than one disease area, but this is not a requirement.

  13. Must the Center Director lead a research project?
    The Center Director must have a clear and substantial role in the Center but need not direct a specific research project.

  14. Will Centers using other NIH resources (e.g., cell or vector production facilities, imaging, biomanufacturing) be favored?
    While applicants are encouraged to utilize available resources at their Specialized Centers, such applications will not be given special consideration.

  15. Can studies with human stem cells other than human embryonic stem cells be included in a Specialized Center?
    Yes. The RFA has no restrictions on the use of human stem or progenitor cells other than that for human embryonic stem cells, i.e. only lines from the NIH Human Embryonic Stem Cell Registry are eligible for federal funding.

  16. Can studies with animal stem cells be included in a Specialized Center?
    Yes, although human stem or progenitor cells should be the ultimate focus of the center. When animal stem cells are to be included, the strategy for a transition (within the four years of the Center) to a human stem cell centric program should be clearly described.

  17. Can support for the operation of an institution's own GMP facility be included to produce stem cells?
    Yes, if the costs are appropriate for the project(s) in the Center application.

  18. Can program personnel help us reviewing broad area of each of the projects before submission?
    Yes. Applicants are strongly encouraged to submit to program staff (at appropriate Institutes) an overview describing the projects and cores, listing the project leaders, and describing the synergy between the projects and cores.

  19. Will there be a uniform procedure for data sharing? What needs to be stated in application regarding data sharing plan?
    As stated in the RFA, there will be a yearly Centers meeting in Bethesda at which time we expect Centers will report their progress. The applicant should state their willingness to share data in the body of the application.

  20. Is there a priority or a disadvantage to be more "clinical" than "basic"?
    There is no predetermined priority. NIH recognizes that the barriers to human stem cell therapies are different in each disease context and further, that applicants will accordingly develop a translational research program appropriate to, and possibly unique to, their therapeutic objectives.

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Budget

  1. Is there a limit to the number, size or duration of Pilot & Feasibility Projects?
    No. The number, size (budget) and duration (years) of P&F projects should be determined by scientific need and opportunity as judged by peer review.

  2. Do indirect costs of institutions under a subcontract count toward the $1 million cost cap? Does the cap apply beyond the first year?
    No, while indirect costs for subcontracts are considered in total costs, the $1 million cost cap will be calculated by the sum of the direct costs of each of the Center's components. The cap applies to all years of the award.

  3. Would leveraged commitment of additional funds from the University to support the program be viewed favorably by the NIH?
    The RFA calls for "a statement of institutional commitment that addresses how the institution will incorporate the Center high within its institutional priorities." Note that institutional commitment can be demonstrated in many ways, including but not limited to financial support.

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Formatting

  1. What is the format of the application?
    Applications should use the standard PHS 398 form. Detailed recommendations as to formatting are specified in the RFA-NS-05-005 posting.

  2. For clinical protocols submitted with initial proposal, must they be in the 25-page "project" or in the appendix?
    The focus of the Center should be on preclinical/translational projects and the 25-page project description will serve as the basis for the review.

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Review

  1. Must an overall Director of a Center be a physician?
    No. However, the PI should be experienced and knowledgeable in translational research

  2. Is there a required level of effort for the Center Director or project PIs? Can an investigator be the PI for more than one projects?
    No specific level of effort is required but the commitment of the investigators will be considered by the review committee. Investigators are encouraged to contact program officers to discuss their qualifications.

  3. Can a project be headed by an individual who is K08 funded? Can junior investigators serve as a project PI? Is prior R01 funding necessary?
    While not a requirement, most project leaders with the appropriate experience are likely to have already received R01 grants or other similar support. Similar to level of effort, no specific level of seniority is required but the experience of the investigators will be considered by the review committee. Investigators are encouraged to contact program officers to discuss their qualifications.

  4. How much emphasis will be placed on a hypothesis?
    The review criteria of Specialized Centers are listed in the RFA. While research projects are expected to be hypothesis-driven, Pilot/Feasibility projects may not be.

  5. Can an institution outside of the United States apply?
    No, but an individual project or parts of a project could be from a non-US institution.

  6. Are Canadian Universities/research centers eligible institutions?
    Canadian institutions are considered to be foreign with respect to submitting an application in response to this solicitation. A foreign institution is defined as "an organization located in a country other than the United States and its territories that is subject to the laws of that country, regardless of the citizenship of the proposed PI." This is defined in the Glossary Section of Part I of the NIH Grants Policy Statement, dated 12/03, and located on the Internet at address: http://grants1.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm#_Toc54600040.

  7. Can an institution collaborate with other institution(s)?
    Yes; the usual subcontracting requirements apply.

  8. Can my institution submit two applications for the same RFA?
    Yes, however per NIH policy, the same project cannot be submitted for multiple considerations; the same core function might be included in more than one application and would not be considered inappropriate.

  9. Is a letter of intent required?
    No, but it helps the Institute staff to plan the review. If you intend to submit an application, check the information in the RFAs for the due dates and addresses.

  10. Is presubmission approval required?
    No, as an RFA, approval to submit has already been given.

  11. Can I personally deliver the application on the due date at NIH?
    No, NIH no longer accepts applications in person; they must be either mailed or sent by one of the overnight delivery services.