Frequently Asked Questions about the NIDCR Award for "Enhancing Research Infrastructure and Capacity Building for U.S. Dental Institutions"

Overview

1. What is the primary focus of this initiative?

The objective of this initiative is to enable U.S. dental schools to enhance their research capabilities and competitiveness through the creation of a critical mass of outstanding research personnel and an appropriate milieu for these individuals to perform sustained high quality science. To achieve these goals, the dental school is expected to establish multidisciplinary collaborations with other institutions either at the same health science center, their parent university, or with external institutions. It is essential for applicants to go outside the dental school for research partnerships. The research areas can include basic, translational, clinical, behavioral and applied/community-based topics.

2. Which dental schools are eligible for the Research Infrastructure Awards (U24)?

All U.S. dental schools that received less than $6 million in FY 2001 are eligible to apply for the U24 award, regardless of whether the institution has previously been awarded a grant for developing a research infrastructure plan (R24 award). The dental schools not eligible for the U24 are: University of California at San Francisco, University of Michigan, University of North Carolina, and University of Washington. Schools that have not had a R24 award must provide evidence of a completed critical research needs assessment in their application.

3. What is a cooperative agreement and why is the NIDCR utilizing this approach?

A cooperative agreement is an NIH grant mechanism in which an Institute, in this case the NIDCR, supports and/or stimulates the grantee's activity by being involved in and otherwise working jointly with the awardee in a partner role. Responsibility for directing the project as a whole rests with the Project Director, although specific tasks and activities in carrying out the project will be shared among the awardee and NIDCR. Delineation of responsibilities is described in the RFA under "Cooperative Agreement Terms and Conditions of Award." The NIDCR is using the cooperative agreement mechanism for this program in order to provide expertise that NIDCR and NIH staff can bring to facilitate activities of the individual awards and of the overall effort.

Application

4. Is there a specific template to be followed in preparing an U24 application?

There is no template or "correct" way for preparing an U24 application. Applicants should build upon the critical needs assessment outcome of their planning phase conducted either through the R24 award or independent planning. As a result, it is anticipated that the approach proposed in the Infrastructure Enhancement Plan and its implementation will vary from school to school. NIDCR expects a range of responses to the RFA, with each unique to the needs and structure of the applicant institution.

5. Are the deadlines for the Letter of Intent and application receipt firm?

The date for the letter of intent, March 14, 2004, is firm. The NIDCR will use the information provided in that letter to help identify potential members of the U24 review committee. Letters of intent prior to that date are welcome. The application receipt date is fixed at April 14, 2004, and no substitute pages/sections after that date will be accepted.

6. How should the substitute Table of Contents page be organized?

Given the unique nature of the U24 program, the application is different from that of the usual research grant. Therefore, in lieu of the preprinted Table of Contents outline on Form Page 3 of PHS 398, a table of contents should be prepared listing all of the major sections described in "Guidelines for U24 Applications." The Table of Contents page should look like the table on the following page and paginated to enable reviewers to find specific information readily.

7. Clarify, under "allowable" costs, travel to required meetings at NIDCR (at this time there appear to be mention of two meetings for the same purpose in the RFA).

Under "Supplemental Instructions, Allowable Costs," the fourth and last bullets refer to an annual meeting at the NIDCR. This is a duplication. They both relate to the same function, a 1 ½ - 2 day annual meeting of Project Directors to be organized by NIDCR staff. Travel and per diem costs should be requested in the grant budget for this meeting.

Budget and Use of Funds

8. What is the relation of funds for direct costs versus the Facilities and Administrative (F&A) indirect costs?

The maximum amount of direct costs is $1 million for each of two years. For the F&A, please see specific instructions in the PHS 398 application. All information about the F&A should be included on the Checklist Form Page. Instructions can be accessed at http://grants.nih.gov/grants/funding/phs398/phs398.html#checklist.

9. Can unobligated funds from budget year -01 be used/applied to year -02 if necessary?

Unobligated funds remaining at the end of the –01 budget period may be carried over to the –02 budget period with the approval of the NIDCR. Such requests should be sent to the Grants Management Specialist, NIDCR, and must be countersigned by the institutional official of the grantee organization. Prior to requests being submitted, the Office of Financial Management, NIH, must have approved Financial Status Report (SF- 269) for the –01 budget period. Requests will be reviewed for adequate justification and need, and will ideally be illustrated using the budget form pages from the PHS 2590 or PHS 398 application kits.

10. Will there be funds available beyond year -02?

No new funds will be awarded after year –02. However, under the current terms and conditions for NIH awards (see the 09/21/2001 release of the NIH Guide for Grants and Contracts, available online at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-070.html ), grantees have authority to extend the project period of a cooperative agreement one time, for a duration of up to 12 months, without the prior approval of the NIDCR. However, the grantee should notify by e-mail the NIDCR Office of Grants Management and the NIDCR Program Director about the planned extension. Information about the process for e-mail submission of an initial no-cost extension is available online at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-00-037.html . Subsequent extensions will require the prior approval of the NIDCR. Requests for second no-cost extensions must be countersigned by a duly-authorized official of the grantee organization, and submitted to the NIDCR Grants Management Specialist.

11. Is there a maximum amount of money that can be spent on equipment?

There is no limit on the total budget for equipment in any year of the U24 award. The type and costs of equipment may be estimates since the recruitment of research personnel has not occurred and will likely affect the resource needs. The proposal may project anticipated needs for the agreed upon area(s)/investigator(s). Any proposed expenditure for a single piece of equipment that is greater than $50,000 per year requires detailed justification. However, all equipment requested, regardless of cost, must at least be named or identified in some way. For example, an equipment budget of $499,000 for ten unidentified or undefined items at $49,900 each would not be acceptable.

12. How should funds be distributed among the various allowable costs?

Requested funds can be used for and distributed among three major purposes: human resources, equipment/supplies, and administration. The first two will be the largest expenditures. Human resources include costs for recruiting junior and senior research faculty, such as "magnet" investigators, and establishing and conducting pilot programs for research training and faculty development. The second category encompasses the purchase of equipment, materials, supplies and support for laboratory, clinical and community-based research. This also includes the establishment of intra- and interinstitutional research links, such as shared research cores with collaborating institutions. Administrative costs include salaries for key personnel and equipment to support the program, travel costs, conducting regular meetings, data management and statistical analysis, and performance of ongoing evaluation. Applicants should describe and justify the distribution of direct costs among these three main categories. All costs should not be entirely in any one of the categories. If that is proposed, a strong justification must be provided.

Biographical Sketches

13. For whom should Biographical Sketches be submitted?

Biographical sketches are required for (a) Key Personnel and (b) Support Personnel.
(a) Key Personnel : Biographical sketches of no more than four pages are required for all key personnel participating in the program, as listed on PHS 398 Form Page 2. Key personnel are defined as "all individuals who contribute in a substantive way to the scientific development or execution of the project, whether or not salaries are requested." Typically, these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level should be included if their involvement meets the definition of key personnel. Consultants should also be included if they meet the definition of "key personnel." Examples of "Key Personnel" include the Project Director/PI, co-Director(s), members of the Internal Advisory Committee and any other people who will participate on a regular basis in implementing the Institutional Infrastructure Enhancement Plan. All of these individuals should be listed in the Biographical Sketch section as "Active Professional Staff." Instructions on preparing these sketches are found at http://grants.nih.gov/grants/funding/phs398/phs398.html#biosketch. If members of the External Scientific and Program Advisory Committee have been identified, they should be listed under Key Personnel and a Biographical Sketch also should be included for these individuals.
(b) Support Personnel : A Biographical Sketch of no more than 2 pages should be submitted for "Support Staff," which include individuals who may be involved in selected parts of the implementation process but who will not play a major role in the ongoing conduct of the activity. These may include departmental chairs or other faculty in the dental school, other components of the home institution, or particular staff in institutions with whom a partnership will be established.

Program Plan and Implementation

14. What is meant by the statement under Part 1, Critical Needs Assessment Summary, that "where more than one research area is identified, … there should not be any overlap among the specific areas."?

This addresses the need to avoid fiscal overlap among research areas. If multiple research areas are identified in the needs assessment, funds to support infrastructure (e.g., equipment, supplies, human resources, etc.) in those areas should complement but not overlap each other. Costs are not to be paid more than once to prepare for similar scientific work. There cannot be any duplication in costs. Funds cannot be used to pay for the same equipment twice. Any potential or actual fiscal overlap must be explained and justified.

15. What is the role of the External Scientific and Program Advisory Committee (ESPAC)?

The ESPAC serves mainly in an advisory role for implementation of the infrastructure enhancement plan, while the Project Director maintains management responsibility for implementation of the plan. The Committee should consist of at least six outstanding scientists and research administrators from outside the parent institution. The Committee provides an objective and multidisciplinary perspective to assist the grantee institution during implementation of the Research Infrastructure Enhancement Plan. The ESPAC also assesses the institution's progress in accomplishing the implementation of the Plan. The Committee prepares a semi-annual report with recommendations for the Project Director and NIDCR. If the Project Director feels that the ESPAC recommendations are not feasible to implement, he/she must provide an explanation and rationale to the ESPAC and NIDCR.

Magnet Investigators

16. From what types of institutions can the magnet investigator be recruited?

Magnet investigators may be recruited from a component of the same academic health center and parent university as the dental school as well as from other dental, medical, public health, graduate, engineering schools or other research institutions. Funds for travel of "magnet investigators" for purposes of recruitment may be included in the budget.

17. Where should the magnet investigator be located? Do they need to be in the dental school?

Ideally the magnet investigator will be full-time in the dental school. If not, a justification must be provided. In any case, the magnet investigator must demonstrate greater than 50 percent effort devoted to the dental school for purposes of conducting research and mentoring students and faculty in performing their own scientific studies. The magnet investigator should have a joint appointment at the dental school and at least one other component of the collaborating institutions.

18. What are the expectations for the magnet investigator's role?

A justification must be submitted as to why a scientist is a magnet investigator and how he/she will proportion his/her time. The investigator must spend a majority of time while at the dental school involved in research and working with/mentoring dental school faculty, students and other types of oral health trainees or professionals. When not full-time at the dental school, the magnet investigator is expected to channel graduate students or faculty from outside the dental school to collaborate with those at the dental institution. Individuals trained or mentored by the magnet investigator should be strongly encouraged to remain at and become full-time members of the dental school faculty with joint appointment at other institutional partners. It is expected that research grants to the dental school will be obtained by the magnet investigator or the scientists trained through the efforts of the magnet individual.

19. Should names of potential magnet investigators be provided?

If recruitment has progressed sufficiently, then names of "magnet investigators" being recruited should be provided and a biographical sketch of the individuals should be included in the application. However, it is anticipated that in most cases these investigators will not have been recruited. If so, describe the level and type of individual scientists to be recruited.

Evaluation

20. How will implementation of the Research Infrastructure initiative be evaluated?

It is essential that all Research Infrastructure programs have an evaluation of both ongoing processes as well as outcome after the award has finished. Proposed approaches for process and outcome evaluations of each program must be included in the application. It is expected that both the Internal Advisory Committee and External Scientific and Program Advisory Committees will be involved in the evaluation processes. Grantees also may include a consultant to develop an evaluation plan as part of the award. Specific variables to be evaluated should include progress made in attaining at least those factors described in the Research Resources and Research Capacity and Personnel sections of the Institutional Research Enhancement Plan. In addition, increased success by the faculty is expected in receiving research awards from such funding sources as the NIH, NSF, other federal agencies, and foundations. Other variables to be considered include interest developed among students and junior faculty to pursue research careers, degree of understanding and appreciation among faculty and students for the importance of research and the transfer of scientific findings to clinical practice among graduates of the dental school.

Institutional Commitment

21. What should be the commitment from the school/university?

Although no non-Federal matching funds are required for this application, clear evidence of institutional commitment must be included with the application. The level of institutional commitment will differ among applicant institutions because of the variability of resources available among institutions. If any cost-sharing is proposed, remember that there is no predetermined amount or level. Only non-Federal funds can be used for any type of cost-sharing. Other forms of institutional commitment include space, tenured positions, FTEs and resource allocation. Specific types of resources that the parent institution can provide are detailed in the RFA under "Application Requirements, Part 4 - Letters of Commitment and Support." Letters of support should be submitted from senior institutional officials that outline the commitment of resources and facilities to sustain and support the Research Infrastructure award throughout the period of funding and to maintain these resources beyond the period of grant support.

22. Does the school/university have any responsibilities after the Research Infrastructure award is finished?

Institutional commitment should be provided both during the U24 award as well as after it has expired. The school/university should indicate how dental research investigators, facilities and programs will be supported after the two-year U24 award period ends. Of special importance is the situation when equipment costing more than $50,000 has been purchased. The applicant must have a plan to sustain, maintain, repair and replace, as necessary, relevant equipment with similar or updated hardware.

Review

23. If a dental school applied for but did not receive a research infrastructure planning award (R24), will that affect review of the school's application for a U24 award?

There is absolutely no relation between an institution's unsuccessful R24 application and review of that school's U24 application. There will be no bias against applications from these institutions since reviewers will not receive copies of R24 summary statements or be informed by NIDCR staff in any other way about previous R24 applications. Whenever possible, reviewers for an institution's R24 application will not be assigned to evaluate the school's U24 application.

24. Will there be any site visits as part of the review?

There will not be any site visits as part of the U24 reviews because of inadequate time between the receipt and review of applications.

Other Related NIH Mechanisms

25. What other NIH funding mechanisms are available to dental schools that can be used to enhance their research infrastructure?

The most relevant mechanisms are those of the National Center for Research Resources, or NCRR. These include the following:

(a) Research Facilities Improvement Program (RFIP). These "grants are provided to public and nonprofit private biomedical institutions to expand, remodel, and renovate or alter existing research facilities or construct new research facilities. Improvements under this program must support basic and clinical biomedical or behavioral research as well as research training. RFIP funding, provided by the NCRR Division of Research Infrastructure (DRI), supports new facilities; additions to existing buildings; completion of "shell" space; and alterations and renovations. RFIP grants do not support construction of "shell" space; instrumentation or moveable equipment, which is usually requested as part of the research project grant; or land acquisition or off-site improvements." Additional information about the RFIP is available at the following internet site: http://www.ncrr.nih.gov/research_infrastructure/research_facilities_improvement/.

(b) Centers of Biomedical Research Excellence (COBRE). These centers are available to dental schools in specific states that participate in the Institutional Development Award Program. The COBREs "build research infrastructure to enhance an institution's research capacity and competitiveness for NIH grants. Supported by the NCRR Division of Research Infrastructure (DRI), these awards provide five years of funding for multidisciplinary teams to develop faculty with biomedical research expertise and competitiveness within a thematic research focus of their choosing." Additional information is available at http://www.ncrr.nih.gov/research_infrastructure/institutional_development_award/centers_of_biomedical_research_excellence/.

(c) The Research Centers in Minority Institutions (RCMI) Program. This "enhances the research capacity and infrastructure at minority colleges and universities that award doctorates in the health sciences or sciences related to health. Institutions eligible to apply for the RCMI grants must have one or more underrepresented minority groups that comprise 50 percent or greater of their student body representation and offer doctorate degrees in the health-related sciences. The Division of Research Infrastructure also funds the RCMI Clinical Research Infrastructure Initiative. This initiative supports clinical research activities at institutions that have RCMIs to encourage minority scientists to participate in clinical investigations through the RCMI Clinical Research Infrastructure Initiative (RCRII). The initiative was established to expand the capacity for clinical research at RCMI institutions with affiliated professional schools by providing resources to develop the appropriate infrastructure. The long-range objectives of this initiative are to 1) assist participating institutions to conduct clinical research to improve the health of the Nation's citizens, especially racial and ethnic minorities; 2) enhance the clinical research capacity of RCMI institutions with affiliated medical schools; 3) position these medical schools to compete successfully for clinical research support; and 4) enhance their probability of success in competing for Federal funds to establish a General Clinical Research Center (GCRC)." Additional information can be obtained at http://www.ncrr.nih.gov/resinfra/ri_rcmi.asp. For more information about the RFIP, COBRE, RCMI and RCRII, you also can contact either Dr. Sidney McNairy, Director, DRI, or other DRI staff at (301) 435-0788.

(d) The General Clinical Research Centers (GCRCs). These "are a national network of 78 centers that provide optimal settings for medical investigators to conduct safe, controlled, state-of-the-art, in-patient and out-patient studies of both children and adults. GCRCs also provide infrastructure and resources that support several career development opportunities. Investigators who have research project funding from NIH and other peer-reviewed sources may use GCRCs. To request access to a GCRC facility, eligible investigators should initially contact a GCRC program director, listed in the Clinical Research Resource Directory. Because the GCRCs support a full spectrum of patient-oriented scientific inquiry, researchers who use these centers can benefit from collaborative, multidisciplinary research opportunities. To ensure research diversity at the GCRCs, no single group of investigators at a center may utilize more than 33 percent of the resources." The internet site http://www.ncrr.nih.gov/clinical_research_resources/resource_directory/general_clinical_research_centers/program_information/ provides additional information about the GCRCs. You also can contact Dr. Anthony Hayward, Director, Division of Clinical Research, or Dr. Geoffrey Cheung (301-435-0790) for more information about the GCRC program.

To find out information about the entire array of NCRR research funding opportunities, you can search http://www.ncrr.nih.gov/research_funding/.