OLDER AMERICANS INDEPENDENCE CENTERS (OAIC) APPLICATIONS (P30)

OLDER AMERICANS INDEPENDENCE CENTERS (OAIC)APPLICATIONS (P30) in Adobe PDF (46K)

SUPPLEMENTAL INSTRUCTIONS

NATIONAL INSTITUTE ON AGING

2003

.                NATIONAL INSTITUTE ON AGING

SUPPLEMENTAL INSTRUCTIONS FOR COMPLETING PHS FORM 398 (REV. 5/01 FOR AN OAIC APPLICATION

(Note: Be certain to attach the RFA label as described in the PHS Form 398 application kit.)

Follow the instructions in the Form 398 application kit for all items not addressed in these supplemental instructions.

SECTION 1.  INFORMATION FOR THE ENTIRE OAIC APPLICATION

Face Page, PHS 398

Item 2: Check "YES." cite the RFA number and "NIA Older Americans Independence Center" as the title in the appropriate places.

Page 2, PHS FORM 398

Description: The description serves as an overview of the entire application. The description should be brief and summarize the general plan and goals for the entire proposed Center or individual component. It should not be used to justify the application or component or provide an historical perspective. (Insert in the appropriate place, a separate page 2, renumbered according to its sequence in the application, for each core.)

Table of Contents (PHS 398, Form Page 3)

Do not use Form Page 3, "TABLE OF CONTENTS" of Form 398. It applies to grant applications for single projects. In its place, use the sample format provided in Attachment I of these instructions. Number all pages consecutively. Since the first page of the application is the "Title Page," begin the next page with the numeral "2." If necessary, disregard the preprinted page numbers. Do not use lettered numbers (e.g., 2A, 2B, etc.).

Place appendix material at the back of the proposal and identify it, as appropriate, by the principal investigator's name, core name and core leader's name. Send four complete sets of appendix materials, arranged for individual cores, directly to the NIA Scientific Review Office. Do not send any appendix material to the CSR. Also, do not insert appendices in the body of the application. Restrictions on material that may be included in appendices are found in PHS 398, Submitting Your Application, p. 29.

Budgets (PHS 398 Form, Pages 4 and 5) and Tables II and III:

To aid in the review of the application, insert a consolidated budget table, as shown in sample Attachment 3 (see Attachment 3. Table I. "CONSOLIDATED DIRECT COSTS FOR FIRST YEAR OF REQUESTED SUPPORT"). Attach a similar table for the entire proposed period for the overall program. Do not include detailed budgets for individual cores here: instead, place them with the corresponding component (see Section 3 of sample Attachment 1. "Table of Contents"). Justify all items carefully according to the Form 398 instructions: insufficient justification can result in the deletion of items by an initial review group. The period of support may not exceed five years.

Biographical Sketches (PHS 398, Preparing Your Application, p. 15)

Insert biographical sketches next.

Other Grant Support and Tables II and III.

"Other grant supportSupport" for the key personnel is included under Biographical Sketches.

Table II (See sample Attachment 4). "DISTRIBUTION OF PROFESSIONAL EFFORT (%) ON THIS APPLICATION."

Table III (See sample Attachment 5), "DISTRIBUTION OF PROFESSIONAL EFFORT (%) FOR ALL OTHER ACTIVE AND PENDING SUPPORT."

SECTION 2.  SUMMARY RESEARCH PLAN FOR THE ENTIRE APPLICATION

In this section, present a succinct plan for the entire application. These guidelines and instructions supplement those found in PHS 398, Preparing Your Application, beginning on page 15 ‑ Research Plan. Note that Section b (Background and Significance) and Section d (Research Design and Methods)in the Form 398 instructions are omitted from this overall summary.

1.     Introduction to the Application (Specific Aims).  This section is limited to 10 pages.

Describe the goals to be achieved by the OAIC, including:

• the OAIC's  selected area(s) of focus, and basis for selection
• crucial problems or limitations in knowledge, technology, infrastructure, and/or availability of researchers that the OAIC would address in the area(s) selected
• advances in regard to these problems or limitations in knowledge, technology, infrastructure, and/or availability of researchers that the OAIC would achieve over its five‑year award period.

Describe the OAIC's overall strategy for serving as a sustained resource to the research program in its selected area(s). Describe how it will accomplish the innovation, intellectual leadership, translational, interdisciplinary, collaborative, and career development functions expected of an OAIC (see page 4 of these Instructions).

Describe the specific activities that the OAIC will undertake to accomplish the goals and strategy described above, how the different components of the OAIC will interact to help accomplish them, mechanisms to ensure the coherence of the Center and maintain an interdisciplinary focus, and the mechanisms to be used in assessing progress toward the OAIC's goals. (Where appropriate, timelines and organizational charts should be provided.) Note the major OAIC cores and other activities, referencing appropriate subsequent sections of this application that contain more detail.)

Discuss the relation of the Center to other activities in the applicant institution (such as related research projects) and the extent of institutional, departmental, and interdepartmental cooperation. Summarize the major resources available to the Center and the environment in which it will be conducted. In addition, describe the administrative relationships of the proposed Center to the institution. Issues relating to institutional commitment and settings are relevant.

Present the scientific expertise of the Principal Investigator in the proposed OAIC's area(s) of focus and his/her capacity for the leadership of a core center of excellence in aging research.

2.  Preliminary Studies/Progress Report (Form 398, Preparing Your Application, p. 17c).

For all applications: Include a brief summary of aging and other active and recent aging related research, and career development programs, at the applicant institution that are relevant to the proposed Center, including sources of support and selected recent references.

For applications from institutions previously awarded a P60 Older Americans Independence Center: Describe activities conducted by the Center that are relevant to the goals of the proposed new P30 Center.

Information in the above sections should be provided in very brief form. Additional information may be provided as appropriate in description of proposed cores.

3.  Human Subjects.  Approval must be by each individual protocol for, if applicable human research not having human subjects approval elsewhere, e.g. developmental and pilot projects (Form 398, Preparing Your Application, p. 18). 

Describe fully the general principles and policies that will apply to human subjects.  List all components of the application that involve human subjects and page numbers for

the relevant human subjects sections. Include in the appendix all consent forms for human subjects research which apply to development projects and pilot/exploratory studies.

4. Vertebrate Animals, if applicable.  Approval must be by each individual protocol for projects not having approval elsewhere (Form 398, Preparing Your Application, p. 28).

List the components in the application that involve vertebrate animals and page numbers for the relevant vertebrate animal sections.

5. Literature Cited (Form 398, Preparing Your Application, section g, p. 29).

List only those references cited in this section. Include appropriate full citations with each core and project.

6. Consortium/Contractual Arrangements (Form 398, Preparing Your Application,

section h, p. 29.

Before submitting an application that contains a consortium arrangement, the applicant institution and each collaborating institution should reach at least tentative agreement on the scientific, administrative, financial, and reporting requirements for the grant. For consortium arrangements, the application must include the following additional information:

a.     A list of all performance sites, including the applicant institution and the collaborating institutions.

b.   A separate, detailed budget for the initial and future years for each institution and, where appropriate, for each unit of activity at each institution. Request F&A costs for the consortium institution as a direct cost and include them in the "Other" category. Insert the amounts requested in the appropriate budgets for the applicant institution. The detailed consortium/contract budgets follow those for the appropriate applicant institution budgets.

c.   A composite budget for all units of activity at each institution for each year, as shown under section b above, as well as a composite budget for the total proposed funding for each year. Insert these budget pages after the composite budgets for the applicant institution.

d.   An explanation of the programmatic, fiscal, and administrative arrangements made between the grantee institution and the collaborating institutions.

e.   Include the following statement, accompanied by signatures of the appropriate administrative officials, from each of the collaborating institutions:

"The appropriate programmatic and administrative personnel of each institution involved in this grant application are aware of the NIH consortium grant policy and are prepared to establish the necessary inter‑institutional agreement(s) consistent with that policy."

Include this information here or with individual projects, as appropriate.

7.  Consultants (Form 398, Preparing Your Application, section I, p. 29).

Summarize this information for all components of the Center. Indicate the consultants by name. Include biographical sketches and signed letters of agreement to serve. Advisory committee members should not be recruited until after the review is complete. However, include criteria to be used to select advisors. Advisors/ consultants already employed or with whom prospective employment has already been discussed must be named and their institution identified.

8. Table IV (See Attachment 6) "PERCENTAGE DISTRIBUTION OF RESEARCH RESOURCES CORES TO OAIC AND EXTERNALLY FUNDED RESEARCH PROJECTS."

SECTION 3. PLAN OF INDIVIDUAL CORES

Prepare each core as a separate section that begins on a new page of the application.  Begin each with a title page (see Attachment2) and a detailed first year and summary budget for all years.  Continue to number the pages consecutively.

Title Page for Individual Cores

Use the format of sample Attachment 2.  Do not use the face page of Form 398.

PHS Form 398, Page 2

Follow instructions in the Form 398 application kit and the instructions in Section 1 of these guidelines for the “Description.”  “Performance Sites” and “Key Personnel.”  For Key Personnel, include after each name, in parentheses, the page number where the individual Biographical Sketch can be found.  Do Not insert additional copies in this section.

PHS Form 398, Pages 4 and 5

Budgets for the first 12-month budget period and for the entire grant period for individual cores (including a detailed budget justification).

The individual responsible for a component is the “core leader.”  Refer to other scientific staff as “senior investigators” or other titles, as appropriate.  Since only one individual is recognized as the responsible person, “do not use “Co-investigator.”

Budgets and Justification pertaining to Consortium/Contractual Arrangements (See Preparing Your Application, section h, Consortium/Arrangements, p. 29 of the PHS 398).  Provide documentation, if applicable.

Biographical Sketches of Project Leader and Other Key Personnel

State the pages in the application where the appropriate biographical sketches can be found.  Do not insert additional copies here.

Indicate the pages in the application where the appropriate “Other Support” pages can be found.  Do not insert another copy here.

Resources and Environment (self-explanatory)

INDIVIDUAL PLAN FOR EACH CORE

PLAN OF RESEARCH CORES (RC)

Research Cores (RCs) should be identified by titles (Recruitment Core, Biostatistics Core, etc.)  and by consecutive numbers (RC 1, RC 2, etc.).

Each RC should be presented in the following format.

Title page (see Attachment 2.)  Do not use page 1 of PHS Form 398.

Description and Key Personnel – Use page 2 of PHS 398.

Budgets for First 12‑month Budget Period and for Entire Period for Individual Core ‑ Use pp 4, 5 of PHS 398. If other than inflationary increases are requested in future years, detailed budgets should be provided for all years.

Presentation of Proposed Core Activities:

a.      Specific Aims of Core ‑ Explain the purpose and functions of the core. Present a clear statement of how the core will contribute to the goals of the OAIC.

b.      Administration ‑ Describe the administration of the core, and how projects eligible for core support will be selected and prioritized for access to core resources. A discussion of the role and qualifications of the proposed Core Leader should be included here.

c.      Background and Significance ‑ Include brief descriptions of the research projects for which the core is to provide support, and how research quality and efficiency would be enhanced by use of core services, specifying any pertinent uses of cores by junior faculty and how such use will promote research leading to increased independence of older persons.  The core resources requested for each project from the RC and the other cores will be summarized in Table IV (Attachment 6).

d.      Summary of Services, Experimental Design and Methods. Include descriptions of core services and methods/techniques employed and a completed Gender and Minority Inclusion Table, Attachment 8. This table may also be found in PHS‑398 (Rev 5/01).

These items (a‑d) may not exceed 25 pages.

e.      Development Projects.

1)    Present development projects proposed for the 01 year of the OAIC Grant and justify their selection in terms of the overall goals of the OAIC. (These must be prepared on the 5/01 revision of the PHS 398 application package and included in the OAIC proposal as part of an RC.) If human subjects are involved, include plans for the protection of human subjects in accordance with NIH and NIA policies.

2)      Present a general plan for the selection of development activities for subsequent years of the grant period that includes the use of an advisory committee with at least one third of the members external to the OAIC and the grantee institution.  (Plans for the constitution, and function for this committee, along with a budget request for its support, will be more completely presented as part of the Leadership/Administrative Core (see below).

The specific aims, background and significance, preliminary studies, and experimental design and methods sections should not exceed eight pages total for each development project. This is in addition to the 25 pages that may be used for items a‑d above.

A proposed RC may request support of up to $105,000 (first year direct costs) per year for Development Projects. The minimum budget request for each proposed Development Project is $35,000 with the maximum being $105,000 (first year directs costs). Thus, a maximum of three Development Projects can be requested as part of a Research Core.  Specific developmental projects to be conducted by an RC using these funds may last from one to five years.  NIA requires that programs be notified when a developmental grant award is made.  This can be done at the time of the progress report.

PLAN OF RESEARCH CAREER DEVELOPMENT CORE (RCDC)

The Research Career Development Core should be presented in the following format:

Title page (see Attachment 2)   Do not use page 1 of PHS Form 398.
Description and Performance Sites Key Personnel ‑ Use page 2 of PHS 398.

Budgets for‑ First 12‑month Budget Period and for Entire Period ‑ Use pp 4-5 of PHS 398.

Overview:   Describe the purpose, function, leadership and administrative mechanisms planned to achieve the objectives of this core including:

1)  Its contribution to the OAIC's overall goals

2)  A discussion of the role and qualifications of the proposed Core Leader

3)  A general plan for recruiting, selecting, mentoring, and monitoring the progress of individuals who will receive RCDC support. This plan should include the use of an advisory panel with at least one third of the members external to the OAIC and the grantee institution. (Plans for the constitution, and function of this committee, along with a budget request for its support, will be more completely presented as part of the Leadership/Administrative Core.)

4) The abilities that junior faculty who are recipients of this support are expected to acquire during their period of support by the core.

Career Development Plans:  Present the RCDC's career development plans for at least some of the junior faculty and research associates to be supported. The Career Development Plans should:

1)   Identify the individuals selected for at least the first year of RCDC support, and should describe for each:

a)   the candidate's preparation (include a biosketch) proposed research and other career development activities, and the nature of institutional commitments to the individual's development:

b)   the mentor's research activities and past history of research training (include a biosketch) and the commitments to training and supervising the candidate and,

c)   the OAIC's goals for the individual's career progression by the end of the OAIC award period. The description should explain how the proposed use of OAIC funds (including funds for Pilot/Exploratory Studies Core funding, if this is also proposed for the individual) will contribute to OAIC program goals for research career development in its selected research area.

Other Educational Activities:

1)   Describe other educational activities of the RCDC such as regular research meetings, conferences, workshops, availability of formal courses. etc., which will be used to achieve the objectives of this core and for which support is requested.

A maximum of $400,000 in first-year direct costs may be requested for the Research Career Development Core. Budget increments in future years will generally be limited to one percent. 

PLAN OF PILOT/EXPLORATORY STUDIES CORE (P/E C)

The Pilot/Exploratory Studies Core should be presented in the following format:

Title page (see Attachment 2) Do not use page 1 of PHS Form 398.

Description and Performance Sites Key Personnel ‑ Use page 2 of PHS 398.

Budgets for First 12‑month Budget Period and for Entire Period ‑ Use pp 4, 5 of PHS 398.

Overview:  The purpose and function of this core should be fully described.

1)   Describe how the activities of this core will promote progress in the OAIC's area(s) of research focus.

2)   Present the qualifications and experience of the proposed core leader.

3)   Present a general plan for the selection of studies proposed for the Pilot/exploratory Studies Core that includes the use of an advisory committee with at least one third of the members external to the OAIC and the grantee institution.  (Plans for the constitution, and function of this committee, along with a budget request for its support, will be more completely presented as part of the Leadership/Administrative Core.)

4)   Describe how, together with the OAIC PI, the Core Leader will monitor ongoing progress of studies and assist in the planning for the development of pilot/exploratory studies, where appropriate, into independently funded grant applications.

5)   If human subjects are involved, include plans for the protection of human subjects in accordance with NIH and NIA policies.