POPULATION RESEARCH INFRASTRUCTURE PROGRAM

Summary Table: R21 and R24 Differences
Application Guidelines: Infrastructure Awards (R24)
Application Guidelines: Developmental Awards (R21)
Sample Research Support Summary Table

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APPLICATION GUIDELINES: INFRASTRUCTURE AWARDS (R24)

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 below and paginated to enable reviewers to find specific information readily. The Table of Contents should contain the types of information suggested below in three sections: Section I - General Information, Section II - Research Plan, and Section III - Appendix. The following guidelines will provide directions and descriptions for preparing each section. Major areas to be listed and paginated in the Table of Contents appear in capital letters.

SECTION I. GENERAL INFORMATION

A. FACE PAGE

Complete all items on the application face page. This is page 1; number succeeding pages consecutively.

The RFA title ("Population Research Infrastructure Program") and number (HD-03-026) must be typed on line 2 of the face page and the YES box must be marked.

B. DESCRIPTION AND PERSONNEL

Abstract of Research Plan. On page 2, describe briefly the objectives of the proposed infrastructure grant and the proposed infrastructure components. The abstract should fit in the space provided.

List key scientific and technical personnel participating in the grant. Do not list all researchers affiliated with the applicant program. List only those individuals who contribute significantly to the leadership and guidance of the proposed program and infrastructure components. Use continuation pages as necessary, numbering consecutively.

C. TABLE OF CONTENTS

Prepare the Table of Contents as noted above. The major areas to be listed are enumerated in these instructions.

D. BUDGET ESTIMATES

Prepare composite budget tables for the Infrastructure Grant as requested below. Separate detailed budget tables also are required for each component.

1. Composite Budget

Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," of the PHS 398 to present the total budget for all requested support for the first year. For each category, such as "PERSONNEL," "EQUIPMENT," etc., list the amount requested for each component.

If consortium arrangements have been made involving other institutions or organizations, include total costs [direct plus Facilities and Administrative (F & A) costs] associated with such third party participation in the "CONSORTIUM/CONTRACTUAL COSTS" category. Costs for purchased services should be itemized under "OTHER EXPENSES."

Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," to prepare a budget, by category, that provides totals for each year of requested support.

2. Infrastructure Component Budgets

Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," to present the total budget for each component for which support is requested for the first year. For each category, such as "PERSONNEL," "EQUIPMENT," etc., list the amount requested for each component.

Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," to prepare a budget, by category, that provides totals for each year of requested support for each component.

Consortium Budgets (if applicable) should be presented as described in Item 1 (Composite Budget). Total Direct and F & A Costs of sub-awardee are to be shown under "CONSORTIUM/CONTRACTUAL COSTS" on individual component budgets and a detailed consortium budget is to be inserted following the appropriate core budget, using Form Pages 4 and 5.

3. Budget Justifications

Describe the specific functions of key scientific and technical personnel (named on Form Page 2), consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For additional years of support requested, justify any significant increases in any category over the first 12-month budget period. Identify such significant increases with asterisks against the appropriate amounts. If a recurring annual increase in "PERSONNEL" or "OTHER EXPENSES" is anticipated, give the percentage. However, current NIH practice limits this annual increase to three percent.

E. BIOGRAPHICAL SKETCH

Biographical sketches are required for all key scientific and technical personnel named on Form Page 2, as well as for all active program researchers, as defined in the RFA under "FUNDS AVAILABLE."

1. Active Program Researchers

Beginning with the Principal Investigator, and following in alphabetical order, submit biographical sketches as described in the instructions for Form PHS 398. Do not exceed two pages for each person.

2. Technical Staff

List all technical personnel involved in infrastructure components of the application. In alphabetical order, submit biographical sketches as described in the instructions for Form PHS 398. Do not exceed two pages for each person.

F. OTHER SUPPORT

Information regarding active and pending research support of all key scientific and technical personnel named on Form Page 2 (except consultants) should be presented following the instructions for "Other Support" in Form PHS 398.

G. SUMMARY TABLE OF RESEARCH SUPPORT

Present a summary table of the levels of infrastructure and research support received by the unit, by source. This table should show, for the applicant unit as a whole, the total funds supporting research and infrastructure in the unit for the most recent budget year available. Show sources of funds in major categories (e.g., NICHD R24, P30 or P50 grant, if applicable, other NICHD, other NIH, NSF, Foundations, parent institution, etc.). This table should be presented in a format such as that presented in the Sample Research Support Summary Table.

H. RESOURCES AND ENVIRONMENT

Complete the "RESOURCES" section on Form Page 8 for the overall unit. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical, laboratory, and computer facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources. Provide a floor plan for the space(s) available to the applicant unit, indicating the location of space(s). Use continuation pages as needed.

SECTION II - RESEARCH PLAN

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II. Identify each section by title, and assign each a capital letter (A,B,C) that reflects the order in which they are presented in the application research plan.

Page limitations: The length of the sections devoted to the overall description of the program, progress report, research activity, and proposed infrastructure components must not exceed those specified below. Be concise.

Assurances and Collaborative Agreements. Any arrangements for collaborative and cooperative endeavors or subcontracting should be highlighted in the appropriate section below. Letters of Intent to Collaborate and Letters of Agreement from consultants should be referenced here and included at the end of the appropriate component.

A. PROGRAM OVERVIEW

Summarize the unit's research program, identifying signature population-related themes that exemplify the unit's most significant current and/or anticipated contributions to population research. Address the scientific and practical significance of each research theme. Describe the current and recent research activity in the unit that has contributed to the theme, identifying relevant scientific accomplishments and describing their impact. Highlight activities that have produced significant innovation and/or interdisciplinary collaboration. Describe the vision of program scientists for advancing research related to the theme.

Also describe other major contributions the unit's active researchers have made to population research within the last five years. Examples of such contributions include large-scale projects that benefit the field broadly, creation of interdisciplinary collaborations, training and mentoring of junior scientists, scientific leadership of program personnel, and translational activities to improve clinical practice, public intervention programs, and public policy formulation. Do not repeat contributions discussed in the context of signature population-related themes.

Summarize the vision of unit researchers for the unit's future scientific advances and contributions. Describe strategies the unit employs for advancing the quality and innovation of its population research program over the short and long run. Describe how the unit fosters the development of an intellectual community that bridges investigators from different disciplines and different projects and promotes innovation in population research. Describe how the unit develops and implements its goals. Describe how the unit assures the development and success of junior scientists.

Describe the configuration and governance of the unit and provide an organizational chart. Include information on administrative position of the unit within the larger institution, the authority of the Director, and the role of advisory or user committees. Outline the principles and procedures the unit uses to determine membership in or affiliation with the unit and to allocate resources and grant access to core services. If the unit employs more than one category of membership or affiliation, explain the privileges and responsibilities associated with each. Describe how the NICHD support would leverage and interact with all other forms of support contributing to the research activities of the program.

Summarize the key features of the proposed infrastructure program and explain how each element will advance the quality, productivity, and innovation of the unit's research activities. For Public Infrastructure activities, explain the value and significance of the activities.

B. PROGRESS REPORT

Applicants currently funded under the P30 or P50 Population Research Center Grant program or under the Population Research Infrastructure Program should prepare a progress report as required in PHS 398.

Do not exceed five pages.

C. RESEARCH ACTIVITY OF PROGRAM SCIENTISTS

Briefly summarize the recent and current research activity of each active program scientist with respect to each of the five points listed below. Use one page per active researcher. Describe the Principal Investigator's research activity first and that of all other researchers subsequently in alphabetical order.

• Summarize the most important scientific accomplishments of the researcher during the 36 months prior to the receipt date for this RFA. Discuss these accomplishments with respect to their significance, innovation, and actual or potential impact on population research.
  
  
• Identify externally funded research projects in which the researcher participated as key personnel during the 36 months prior to the receipt date for this RFA, the amount, source, and period of funding, and the role and time commitment of the individual on the project.
  
  
• Briefly summarize relevant working papers and future research plans (e.g., pending and planned research grant applications).
  
  
• Describe how the researcher contributes to the unit's research program: how his or her expertise, disciplinary training, substantive interests, technical skills help to advance the central scientific objectives and signature population-related themes of the unit. Identify recent, active, or planned collaborations involving this researcher. If the researcher holds an appointment in another institution or center, describe the degree to which the researcher is involved in the applicant unit's program, providing specific and quantitative measures of involvement.
  
  
• Describe how the researcher uses (or would use) the proposed infrastructure cores or activities.
  
  

D. INFRASTRUCTURE COMPONENT DESCRIPTIONS

Describe proposed infrastructure components, as applicable, in the order listed below. If more than one component is proposed under a given category, assign letters to distinguish the components (e.g., 1.a; 2.c). For each component, provide the name of the Director and describe procedures used to assure cost-efficiency and high quality administrative and research activities.

Do not exceed five pages in describing each component (core or activity). If any component is described as a collaborative activity (i.e., involving partnership with another institution), applicants may use one additional page to describe how each partner will contribute (e.g., in terms of administration, staffing, and other resources); how each partner will benefit (e.g., in terms of access to services or research productivity); and how decision-making will be shared.

1. Research Support Cores - Describe the objectives, administrative organization (use organizational chart), staffing (including a Core Director and any professional or technical personnel and their duties), space and physical resources, current and projected services, eligibility for and allocation of services, and cost-sharing arrangements. Briefly describe current or planned research activities that will utilize the core services.

Explain how the proposed research support cores will contribute to advancing the research program and its signature population-related themes and to fostering innovation in the program's research. Describe strategies for assuring that research support services effectively respond to and anticipate the evolving needs of science conducted in the unit. Justify the core in terms of scientific impact and cost-effectiveness. Explain what the proposed core services will provide over and above research support that the applicant's institution and specific research projects already provide and why they are essential to meet the needs and goals of the research program.

2. Developmental Infrastructure - Describe the objectives and administrative organization of each type of developmental infrastructure. Describe the impact of the infrastructure on population research within the unit. In describing seed grant programs, provide details on program procedures and policies, including review procedures; priorities for allocating funds; requirements for leveraging funds or preparing research proposals to extend or continue the project; size of awards; length of award periods; number of awards permitted to an individual researcher; mentorship arrangements; and cost-sharing arrangements with the parent institution.

Faculty development may include salary and/or research support for new faculty. Describe the probable use of faculty development funds and the ways in which the plan will advance the unit's research objectives.

3. Research Projects - For each component research project, provide a full description of the project following the format presented in Form PHS 398. Begin the presentation of each component research project on a separate page.

Indicate: Project Title, Principal Investigator, title, location, other investigators, consultants, and collaborators, titles (associate professor, postdoctoral fellow, student), and location.

Present an Abstract of Research Plan (use Form Page 2 of PHS 398).

Present the Research Project Plan (do not exceed 25 pages for Sections A-D). Discuss the purpose and nature of the project and its relevance to the program's signature theme(s). Address the following: Specific Aims, Significance, Preliminary Studies and/or progress to date (for competing continuations), if applicable. Discuss the Research Design and Methods. For research involving human subjects, this section must address the inclusion of women, minorities and their subgroups, and children as research subjects, following relevant policy announcements (see INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS and INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS). Discuss Human Subjects, Vertebrate Animals, Consultants, Collaborative arrangements, including pertinent letters of assurance and intent. Present a section on Literature Cited.

4. Public Infrastructure - Describe the objective of each activity and the target audience (e.g., population researchers, program managers, policy makers). Explain the significance of the activity. Discuss the potential of the activity for advancing population research, stimulating innovative or interdisciplinary research, and/or enhancing the effective dissemination and translation of research findings. Describe the unique contribution of the activity compared with other similar activities that may already exist. Describe the administrative organization (use organizational chart), staffing, space and physical resources and current or projected services and activities. Describe the plan for disseminating the resources, services, or products to the target audience. Justify the core in terms of cost-effectiveness and describe short- and long-range plans for supporting the activity.

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APPLICATION GUIDELINES: DEVELOPMENTAL AWARDS (R21)

Applications for the R21 must be prepared according to Modular Grant instructions. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 5/01) is to be used in applying for these grants, with the modifications noted below.

For responses to this RFA, Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $150,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below:

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 below and paginated to enable reviewers to find specific information readily. The Table of Contents should contain the types of information suggested below in three sections: Section I - General Information, Section II - Research Plan, and Section III - Appendix. The following guidelines will provide directions and descriptions for preparing each section. Major areas to be listed and paginated in the Table of Contents appear in capital letters.

SECTION I. GENERAL INFORMATION

A. FACE PAGE

This is page 1; number succeeding pages consecutively.

Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $150,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period.

Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support (up to five years).

The RFA title ("Population Research Infrastructure Program") and number (HD-03-026) must be typed on line 2 of the face page and the YES box must be marked.

B. DESCRIPTION AND PERSONNEL

Abstract of Research Plan. On page 2, describe briefly the objectives of the proposed developmental grant and the proposed infrastructure components. The abstract should fit in the space provided. Applicants seeking R21 Developmental Grant funding should indicate this in the abstract.

List key scientific and technical personnel participating in the grant. Do not list all researchers affiliated with the applicant program. List only those individuals who contribute significantly to the leadership and guidance of the proposed program and infrastructure components. Use continuation pages as necessary, numbering consecutively.

C. TABLE OF CONTENTS

Prepare the Table of Contents as noted above. The major areas to be listed are enumerated in these instructions.

D. BUDGET ESTIMATES

• DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application.
  
  
• BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application.
  
  
• NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form Page.
  
  Provide an estimate of direct costs associated with each proposed infrastructure component. Provide requested information on personnel separately for each infrastructure component.
  
  
• Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. Describe the specific functions of key scientific and technical personnel (named on Form Page 2), consultants, collaborators, and support staff. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request.
  
  
• For Consortium/Contractual costs, provide an estimate of total costs (direct plus F & A) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project.
  
  Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium.
  
  
• Provide an additional narrative budget justification for any variation in the number of modules requested.
  
  

E. BIOGRAPHICAL SKETCH

The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key scientific and technical personnel named on Form Page 2, as well as for all active program researchers, as defined in the RFA under "FUNDS AVAILABLE." Follow the instructions below. List active program researchers first, beginning with the Principal Investigator, and following in alphabetical order. Then list all technical personnel involved in infrastructure components of the application in alphabetical order. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm

• Complete the educational block at the top of the form page.
• List position(s) and any honors.
• Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years.
• List selected peer-reviewed publications, with full citations.

F. OTHER SUPPORT

Not required for modular grant application.

G. SUMMARY TABLE OF RESEARCH SUPPORT

Present a summary table of the levels of infrastructure and research support received by the unit, by source. This table should show, for the applicant unit as a whole, the total funds supporting research and infrastructure in the unit for the most recent budget year available. Show sources of funds in major categories (e.g., NICHD R24, P30 or P50 grant, if applicable, other NICHD, other NIH, NSF, Foundations, parent institution, etc.). This table should be presented in a format such as that presented in the Sample Research Support Summary Table.

H. RESOURCES AND ENVIRONMENT

Complete the "RESOURCES" section on Form Page 8 for the overall unit. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical, laboratory, and computer facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources. Provide a floor plan for the space available to the applicant unit, indicating the locations of any spaces that are not physically contiguous. Use continuation pages as needed.

CHECKLIST: This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years.

The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review.

SECTION II - RESEARCH PLAN

Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II. Identify each section by title, and assign each a capital letter (A,B,C) that reflects the order in which they are presented in the application research plan.

Page limitations: The length of the sections devoted to the overall description of the program, progress report, research activity, and proposed infrastructure components must not exceed those specified below. Applicants should be concise.

Assurances and Collaborative Agreements. Any arrangements for collaborative and cooperative endeavors or subcontracting should be highlighted in the appropriate section below. Letters of Intent to Collaborate and Letters of Agreement from consultants should be referenced here and included at the end of the appropriate component.

A. PROGRAM OVERVIEW

Summarize the unit's research program, identifying signature population-related themes that exemplify the unit's most significant current and/or anticipated contributions to population research. Address the scientific and practical significance of each research theme. Describe the current and recent research activity in the unit that has contributed to the theme, identifying relevant scientific accomplishments and describing their impact. Highlight activities that have produced significant innovation and/or interdisciplinary collaboration. Describe the vision of program scientists for advancing research related to the theme.

Also describe other major contributions the unit's active researchers has made to population research within the last 5 years. Examples of such contributions include large-scale projects that benefit the field broadly, creation of interdisciplinary collaborations, training and mentoring of junior scientists, scientific leadership of program personnel, and translational activities to improve clinical practice, public intervention programs, and public policy formulation. Do not repeat contributions discussed in the context of signature population-related themes.

Summarize the vision of program researchers for the unit's future scientific advances and contributions. Describe strategies the unit employs for advancing the quality and innovation of its population research program over the short and long run. Describe how the unit fosters the development of an intellectual community that bridges investigators from different disciplines and different projects and promotes innovation in population research. Describe how the unit develops and implements its goals. Describe how the unit assures the development and success of junior scientists.

Describe the configuration and governance of the unit and provide an organizational chart. Include information on administrative position of the unit within the larger institution, the authority of the Director, and the role of advisory or user committees. Outline the principles and procedures the unit uses to determine membership in or affiliation with the unit and to allocate resources and grant access to core services. If the unit employs more than one category of membership or affiliation, explain the privileges and responsibilities associated with each. Describe how the NICHD support would leverage and interact with all other forms of support contributing to the research activities of the program.

Summarize the key features of the proposed infrastructure program and explain how each element will advance the quality, productivity, and innovation of the unit's research activities.

Do not exceed 20 pages for this section.

B. PROGRESS REPORT

Not required.

C. RESEARCH ACTIVITY OF PROGRAM SCIENTISTS

Briefly summarize the recent and current research activity of each active program scientist with respect to each of the five points listed below. Use one page per active researcher. Describe the Principal Investigator's research activity first and that of all other researchers subsequently in alphabetical order.

1. Summarize the most important scientific accomplishments of the researcher during the 36 months prior to the receipt date for this RFA. Discuss these accomplishments with respect to their significance, innovation, and actual or potential impact on population research.

2. Identify externally funded research projects in which the researcher participated as key personnel during the 36 months prior to the receipt date for this RFA, the amount, source, and period of funding, and the role and time commitment of the individual on the project. Information provided in the BIOGRAPHICAL SKETCH may be referenced as appropriate to avoid repetition.

3. Briefly summarize relevant working papers and future research plans (e.g., pending and planned research grant applications).

4. Describe how the researcher contributes to the unit's research program: how his or her expertise, disciplinary training, substantive interests, technical skills help to advance the central scientific objectives and signature population-related themes of the unit. Identify recent, active, or planned collaborations involving this researcher.

5. Describe how the researcher uses (or would use) the proposed infrastructure cores or activities.

D. INFRASTRUCTURE COMPONENT DESCRIPTIONS

Describe proposed infrastructure components, as applicable, in the order listed below. If more than one component is proposed under a given category, assign letters to distinguish the components (e.g., 1.a; 2.c). For each component, provide the name of the Director and describe procedures used to assure cost-efficiency and high quality administrative and research activities.

Do not exceed five pages in describing each component (core or activity). If any component is described as a collaborative activity (i.e., involving partnership with another institution), applicants may use one additional page to describe how each partner will contribute (e.g., in terms of administration, staffing, and other resources); how each partner will benefit (e.g., in terms of access to services or research productivity); and how decision-making will be shared.

1. Research Support Cores - Describe the objectives, administrative organization (use organizational chart), staffing (including a Core Director and any professional or technical personnel and their duties, space and physical resources, current and projected services, eligibility for and allocation of services, and cost-sharing arrangements. Briefly describe current or planned research activities that will utilize the core services.

Explain how the proposed research support cores will contribute to advancing the research program and its signature population-related themes of the and to fostering innovation in the program's research. Describe strategies for assuring that research support services effectively respond to and anticipate the evolving needs of science conducted in the unit. Justify the core in terms of scientific impact and cost-effectiveness. Explain what the proposed core services will provide over and above research support that the applicant's institution and specific research projects already provide and why they are essential to meet the needs and goals of the research program.

2. Developmental Infrastructure - Describe the objectives and administrative organization of each type of developmental infrastructure. Describe the impact of the infrastructure on population research within the unit. In describing seed grant programs, provide details on program procedures and policies, including review procedures; priorities for allocating funds; requirements for leveraging funds or preparing research proposals to extend or continue the project; size of awards; length of award periods; number of awards permitted to an individual researcher; mentorship arrangements; and cost-sharing arrangements with the parent institution.

Faculty development may include salary and/or research support for new faculty. Describe the probable use of faculty development funds and the ways in which the plan will advance the unit's research objectives.

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