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Program Project (P01) Policies and Guidelines

Policies

N.B. These revised guidelines are provided at this time to assist applicants preparing P01 submissions for the January 25, 2010 submission deadline. They will be updated following publication of the new PHS 398 forms package.

Review of P01 Applications

Please visit the following links for new policies on Enhancing Peer Review:
Enhancing Peer Review: The NIH Announces Updated Implementation Timeline (12-02-2008)
New Scoring Procedures for Evaluation of Research Applications Received for Potential FY2010 Funding (12-02-2008)
Enhanced Review Criteria for Evaluation of Research Applications Received for Potential FY2010 Funding (12-02-2008)
Restructured Application Forms and Instructions for Submission for FY2011 Funding (09-16-2009)

These instructions have been substantially revised to accommodate the restructured application format that NIH is introducing for the January 25, 2010 deadline. Applications intended for submission for that deadline and future deadlines, whether new, competing renewal, revision (competing supplement) or resubmission applications, must use this new format.

Cost Limits on P01 Applications

The National Institute on Aging (NIA) limits costs on Program Project (P01) applications (See: http://grants1.nih.gov/grants/guide/notice-files/NOT-AG-07-008.html). NIA accepts for review and funding consideration only new (Type 1) and competing renewal (Type 2) P01 applications with requested costs limited to no more than $1.5 million in direct costs in the first year (exclusive of facilities and administrative (F&A) costs on subcontracts). Budget increases in non-competing years will reflect NIH policy in effect for the year of the non-competing continuation and may be requested to reflect an anticipated inflationary 3% annual increase only.

As with all applications requesting $500,000 or more in direct costs in any one year these requests should be submitted to NIA at least 6 weeks prior to the intended submission date NOT-OD-02-004).

General Guidelines and Policies

Program Project Grants are more complex in scope and budget than individual basic research (R01) grants. While R01s are awarded to support the work of (usually) one principal investigator who, with supporting staff, is addressing a scientific problem, program project grants are available to a group of several investigators with differing areas of expertise who wish to collaborate in research by pooling their talents and resources. Program project grants represent synergistic research programs that are designed to achieve results not attainable by investigators working independently. They must consist of at least three subprojects supported through all years of the program project and an administrative core. (Additional subprojects and cores may be proposed as appropriate to the focus of the program project.) The principal investigator of the program project must also be project leader of one of the subprojects.

These instructions supplement but do not replace the Public Health Service Grant Application (revised PHS Form 398) instructions. The revised PHS 398 form with guidance on restructured applications is due to be published by December 1, 2009 and will be available from this site: http://grants1.nih.gov/grants/forms.htm. Applicants are encouraged to refer to the PHS Form 398 periodically because the instructions are updated frequently. In addition to the instructions below, a sample format (see below and at the bottom of this page) is available that shows ways to organize and present the required information.

As NIH no longer mails out reminders of changes in status of applications, following submission of the application investigators need to visit the eRA commons website (https://commons.era.nih.gov/commons/) on a regular basis to obtain information regarding: the status/image of the grant application; meeting roster; review date; review outcome (score); Summary Statements and other related matters.

Eligibility

Applications from domestic institutions are eligible to apply. Applications from foreign institutions are not eligible, but individual foreign subprojects within the P01 are acceptable.

To be eligible for an award, a P01 must have at least three scored subprojects (Note: Cores are NOT subprojects) each grant year, including one for the principal investigator (PI).

Cores must be justified in terms of the P01's needs. A core must serve more than one subproject. Each P01 must have an Administrative Core.

Renewal applications must include progress reports that discuss research and core component accomplishments during the previous award period, regardless of whether the components are included in the renewal application.

Once a P01 has been awarded, revisions (competing supplements) to expand the scope of awarded grants will be considered, but may not extend beyond the timeframe of the parent P01. A revision application will not be accepted until after the parent P01 application has been awarded. A revision must contain at least one subproject. (The subproject may be an expansion of an existing subproject or a new subproject.)

Submission Dates

All P01 -- new, renewal, and resubmitted applications:

January 25

May 25

Revisions (Competing supplements) to active P01s may be submitted for any of the regular submission and review cycles in:

January 25

May 25

September 25

P01 applications that do not follow the required format (Font, Page margins, Page limits, etc.) will not be reviewed.

When submitting the application or revision (Competing supplement), send the original and three copies to the Center for Scientific Review (see PHS Form 398 for address). Send two copies of the application and all five copies of the appendix materials on CD to:

Chief, Scientific Review Branch
National Institute on Aging
National Institutes of Health
7201 Wisconsin Avenue, Suite 2C-212
Bethesda, MD 20892 (For Fedex use, MD 20814)

NIH now requires that all appendix material be submitted on CDs. See: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Organization of the Application

Follow the instructions of the PHS Form 398, with the following additions:

Section 1: Information for the Entire Application

Use the sample format in Attachment 1 (MS Word, 33K), (N.B. Look for revised attachment after December 1, 2009) rather than Form Page 3, "Table of Contents" from PHS Form 398, which applies only to applications for single projects.
Number all pages consecutively. Because the first page of the application is the Title Page, begin the next page with the numeral "2." Do not use lettered numbers (e.g., 2A, 2B, etc.).

Appendices (To be submitted on CDs)

Identify appendix material by the PI's name, core or project name and number, and core or project leader's name.
Refer to restrictions on any material that may be included in appendices as outlined in the PHS Form 398 instructions. For example, do not include manuscripts that have been submitted for publication, video clips etc..
Send appendix on 5 identical CDs to the Chief, SRB, NIA.

Budgets

Insert a table describing the "Consolidated Direct Costs for First Year of Requested Support," as shown in Attachment 3 (MS Excel, 16K)(Accessible CSV file, 0.5K).
Insert budgets for the first 12 months and for the entire proposed period for the overall program. List detailed budgets for individual research projects and cores with the corresponding project or core.
Justify all items carefully according to the PHS Form 398 form instructions. A complete budget for a consortium project is to be developed and identified as such. The period of support may not exceed 5 years.

Biographical Sketches

NIA staff will use the information in the biosketch to identify all personnel involved in the program project and their institutional appointments. (That information is necessary to identify which possible reviewers may be in conflict with the application.) Also reviewers will use the biosketch to assess the qualifications of key personnel for their roles in the program project (the “Investigators” criterion in the central review criteria). These two functions determine how the biosketches should be presented in the application.

Information for staff assessment of possible reviewer conflicts

Include for all Key Personnel and Other Significant Contributors a biographical sketch with the educational block at the top of the format page completed and Section B, Positions and Honors completed. List the principal investigator/program director first and then other personnel biosketches in alphabetical order. Do not include Sections A (Personal Statement) C (Selected peer-reviewed publications or manuscripts in press) or D (Research Support) in this part of the application. (See 2. below for where to place this information.) Do include reference to the part(s) (Cores and/or Subprojects) of the application and page numbers where complete biographical sketches for the personnel are located.

Also insert a completed Table II to aid in review of the application. See Attachment 4 “Distribution of Professional Effort (Percent effort) on this application.”

These biosketches and Table II should immediately precede the Introduction to the Entire Application.

Information for reviewer assessment of personnel qualifications for roles on project.

Following the instructions in the most recent PHS 398 form, complete full biosketches for Key Personnel and Other Significant Contributors in the part(s) of the application (Cores and/or subprojects) where each individual contributes. When someone has a role in more than one part of the application then a complete biosketch for that person should be placed in each section where the individual has a role. As the particular qualifications for roles may differ between cores and subprojects or between different subprojects, the selected publications and the description of qualifications for the individual may differ in the several biosketches listed.

Resources

Reviewers will use information from the Resources page to evaluate the quality of the scientific environment for the research proposed. Applicants should complete separate Resources pages for all subprojects and cores. Reviewers will use information from the Resources page of the Administrative Core to evaluate the quality of the overall environment for the program project.

Section 2: Introduction to the Entire Application

Introduction (Resubmission or Revision (competing supplement) Applications only) (1 page)

Resubmissions: Provide an overview of major changes in the application. If subprojects or cores have been deleted or added indicate that here and explain the changes under Significance (below).

Revisions (competing supplements): The Introduction should provide an overview of how the revision relates to the funded award. Identify whether new subprojects and cores are being proposed. Revision applications must contain at least one subproject which may be new or expanded in order to be accepted.

Specific Aims (1 page)

Describe the aims of the overall program project and outline how the different subprojects and cores will contribute to these aims.

Research Strategy (6 pages):

Items 1, 2 and 3 below are included in the six page limit.

1. Significance: Focusing on the program project as a whole address (i) the importance of the problem or critical barrier to progress in the field that the proposed project addresses, (ii) how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields, (iii) how the concepts methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved. (One to two pages recommended).

New Applications: Follow the instructions above.

Competing Renewals: Identify and justify any changes in research emphasis and level of funds requested. If the structure of subprojects and cores has changed identify the cores and subprojects consecutively (numbers/subprojects, letters/cores) according to how they are arranged in the current application. Show the correspondence to the prior structure.

Revisions (competing supplements): Explain how the proposed work expands the scope of the funded award and how the expansion benefits the program project as a whole.

Resubmissions: Follow PHS 398 instructions to mark changes in the text from the prior version. If the structure of subprojects and cores has changed identify the cores and subprojects consecutively (numbers/subprojects, letters/cores) according to how they are arranged in the current application. Show the correspondence to the prior structure.

2. Innovation: Considering the program project as a whole, show how the proposed research seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Are these concepts, approaches, methodologies, instrumentation, or interventions novel to the research field or novel in a broad sense? Does the proposed work refine, or improve, or apply in a new way, the concepts, approaches, methodologies, instrumentation, or interventions proposed?(One page recommended)

3. Approach: Include the major approaches and studies involved in the application showing how the approaches of cores and subprojects complement each other or are inter-dependent. Describe the mechanisms that will ensure the coherence of the project and maintain a multidisciplinary focus. (Three to four pages recommended.)

Competing Renewals: Describe findings (with citations) from the prior period of support that are of particular significance to the program project as a whole. If subprojects or cores included in the prior period of support are not part of the current submission describe their progress and explain why they are not included. Identify and justify any substantive differences in approaches from the prior period of support.

Revisions: Describe progress on the funded award that is relevant to the aims of the revision and any overall change in approach or new approach proposed in the revision application.)

4. Discuss the interrelationship of the program to other activities in the applicant's institution (e.g., other relevant research projects) and the extent of institutional, departmental, and interdepartmental cooperation (a chart or diagram to demonstrate the relationship may be used).

Human Subjects

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

See PHS Form 398 instructions.

Women, Minorities and Children

Describe the composition of the human subjects and the proactive plan to recruit women, minorities, and children (if appropriate).
List the page numbers for the relevant Women, Minorities, and Children sections.
For most NIA applications involving human participants, a justifiable exclusion for children is that the topic is not relevant to children.

See PHS Form 398 instructions.

Vertebrate Animals

Describe the general principles and policies that will apply to vertebrate animals.
List the components in the application that involve vertebrate animals and page numbers for the relevant Vertebrate Animal sections.

See PHS Form 398 instructions.

Consortium/Contractual Arrangements

List all performance sites - including the applicant institution and the collaborating institutions - on page 2 of the P01 application.

See Detailed Budget Initial Period (Adobe PDF, 292K) of PHS Form 398 instructions.

Consultants

Summarize this information for all components of the program, and indicate the consultants by name.
Include biographical sketches and signed letters of agreement to serve. For new applications, advisory committee members should not be recruited until after the review is complete, but include criteria used to select advisors.
Identify consultants -- and their respective institutions -- currently employed or with whom prospective employment has already been discussed.

Use of Cores by Subprojects

Insert a completed Table III (see Attachment 5 (MS Excel, 15K) (Accessible CSV file, 0.3K): "Percent use of each core by each project per Year").

Section 3: Research Strategies for Individual Cores and Subprojects

How to Organize the Layout of the Cores and Subprojects:

Present information for each component subproject and core according to the Table of Contents.
List the cores first, identifying multiple cores by consecutive letters (Core A, Core B, etc.) and titles (Administrative Core, Laboratory Animal Core, etc.).
List individual research subprojects in the application after the cores, and identify them with consecutive Arabic numbers and titles (Subproject 1, Subproject 2, etc.).
For competing renewals, resubmissions and revisions (supplements), List the cores and subprojects as for a new application. In addition in the Introduction to the overall program project show the correspondence between the structure of the competing renewal, resubmission or revision and the original application.
Write the title following the PHS 398 instructions.
Include the project leader's (PL) or Core leader’s (CL) name at the upper right-hand corner of each page under the PI's name.
Prepare each core or subproject as a separate section beginning on a new page of the application, and begin each with a title page (use the format of Attachment 2 (MS Word, 25K), not the face page of PHS Form 398) and a detailed first year and summary budget for all years. Number the pages consecutively.

How to Organize Cores:

Introduction (Resubmission or Revision applications only) (1 page)

Resubmissions: The Introduction should be a summary response to the global concerns expressed about the core.

Revisions: The Introduction should describe the nature of the revision and how it will affect the goals of the program project as a whole and of particular subprojects. If it is an expansion of a currently funded core it should also describe how the Specific Aims and Research Strategy of the currently funded core will change.

Specific Aims (1 page)

Identify which subprojects the core will assist and indicate the overall role of the core in the program project.

Research Strategy (6 pages)

Organize the Research Strategy into sections on: a. Significance; and b. Approach

How to Organize Subprojects:

Introduction (Resubmission or Revision applications only) (1 page)

Resubmissions: The introduction should be a summary response to the global concerns expressed about the subproject.

Revisions: The Introduction should describe the nature of the revision and how it will affect the goals of the program project as a whole. If it is an expansion of a currently funded subproject it should describe how the Specific Aims and Research Strategy of the funded subproject will change.

Specific Aims (1 Page)

Follow instructions in the PHS 398 form

Research Strategy (12 Pages)

Following Instructions in the PHS 398 form the Research Strategy should be organized into sections on: a. Significance; b. Innovation; and c. Approach.

Note on Resubmissions (Subprojects and Cores): All changes in the Specific Aims and in the Research Strategy must be clearly marked by bracketing, indenting, or changing type font, unless the changes are so extensive that they include most of the text. Deleted sections should be described but not marked as deletions. This exception should be explained in the Introduction. Changes should not be underlined or shaded and should meet the 12-page or 6-page limit.

Review Criteria

Program Project as a Whole

Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the program project to exert a sustained, powerful influence on the research field(s) involved, considering the following five core review criteria, and additional review criteria (as applicable for the project proposed).

They will give weight both to the merits of the individual subprojects and cores and to the overall impact of the program project as a whole. The following criteria will guide their assessment of the overall impact of the program project as a whole. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What is the added value to scientific knowledge, technical capability, and/or clinical practice of the program project considered as a whole compared to the separate impact of the individual subprojects? How essential is the program project structure to the prospects for success of the individual subprojects?

Investigator(s): Are the PLs/CLs, collaborators, and other researchers well suited to the program project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the program project? How compelling are the program project’s principal investigator’s skills, research record and prior leadership experience? Has the program project principal investigator devoted sufficient effort to accomplish the goals of the program project? Do the investigators on the separate subprojects and cores show evidence of collaborating to advance the goals of the overall program project?

Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? How much does combining the different cores and subprojects into a single overall program project enhance innovation or increase the originality of the proposed work?

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the program project? Are potential problems, alternative strategies, and benchmarks for success presented? If the program project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Do the different approaches taken in the cores and subprojects create a synergy that itself enables new knowledge and/or clinically relevant findings? Are the approaches of the different subprojects consistent? Do they provide additive value beyond their individual strengths?

Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the environment encourage collaborative work among the project investigators?

Subprojects

Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood that the subproject will exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core (central) review criteria, and additional review criteria (as applicable for the subproject proposed).

Central Review Criteria: Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a subproject that by its nature is not innovative may be essential to advance a field.

Significance: Does the subproject address an important problem or a critical barrier to progress in the field? If the aims are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s): Are the investigators, collaborators, and other researchers well suited to the subproject? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the subproject is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the subproject? Are potential problems, alternative strategies, and benchmarks for success presented? If the subproject is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the subproject involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the subproject proposed? Will the subproject benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the subproject proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects: For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children: When the proposed subproject involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals: The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards: Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the subproject.

Renewal Applications: When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications: When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the subproject. If a new subproject is proposed the committee will consider its merits relative to the scope of the overall program project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Note on resubmitting subprojects that have been administratively cut: NIA may make a reduced award to a program project. In order to be able to resubmit portions of the program budget for additional funding, the institution needs to submit revised reduced aims at the reduced budget level prior to award and the revised aims need to be indicated in the Notice of Award for the parent program project. If revised aims with a reduced budget are not received prior to award of the program project then the investigators may not resubmit parts of the program project for future funding.

Additional Review Considerations

As applicable for the subproject proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Budget and Period Support: Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agents Research: Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Applications from Foreign Organizations: Reviewers will assess whether the subproject presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Resource Sharing Plans: Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Cores

Overall Impact: Reviewers will provide an adjectival rating of high, moderate, or low enthusiasm

Central Review Criteria: Reviewers will consider each of the four review criteria below in the determination of scientific and technical merit. As cores are generally resources to enable or to advance research, “Innovation” is not considered routinely as an independent review criterion for cores. Innovative cores may be valuable and that value will be assessed under Significance or Approach as appropriate.

Significance: Does the core address an important problem or a critical barrier to progress in the field? If the aims are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What is the value of the core to the overall program project and to the individual subprojects? Can the core support at least two subprojects?

Investigator(s): Are the investigators, collaborators, and other researchers well suited to the core? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the core is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the core? Administrative Core: Do the core leader’s administrative, management, and leadership capabilities provide for the following activities: Internal quality control of ongoing research; Management of day-today program activities: Management of contractual agreements; Fair, effective communications and cooperation among program leaders and/or program investigators; Resolution of disputes; Development of scientific meetings; Allocation of funds. Scientific Core: Are the skills of the core leader and key personnel appropriate to manage the core?

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the core? Are potential problems, alternative strategies, and benchmarks for success presented? If the core is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the core involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? Administrative Core: Is the operational plan and organizational structure well justified? Is the core adequate to support and encourage optimal interactions among participants of the overall program? Scientific Cores: Are the methodologies used in the core and the resources of the core most appropriate to the needs of the subprojects? Do they fully address these needs?

Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the proposed core? Will the core benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the environment enhance integration of the cores and subprojects? Does it facilitate interactions between cores and subprojects?

Additional Review Criteria

As applicable for the core proposed, reviewers will consider the following additional items in the determination of scientific and technical merit.

Inclusion of Women, Minorities, and Children: When the proposed core involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Biohazards: Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Renewal Applications: When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications: When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the core. If a new core is proposed the committee will consider its merits relative to the scope of the overall program project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident. N.B. NIA will accept revision applications only if a new subproject or an expansion to an existing subproject is proposed. NIA will not accept stand-alone core revision applications.

Additional Review Considerations

As applicable for the core proposed, reviewers will address each of the following items.

Budget and Period Support: Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications from Foreign Organizations: Reviewers will assess whether the core presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Complete list of Attachments for Program Project Applications

Attachment 1 (MS Word, 41K): Table of Contents

Attachment 2 (MS Word, 25K): Sample Title Page for Individual Core or Component

Attachment 3 (MS Excel, 16K)(Accessible CSV file, 0.5K): Consolidated direct costs for first year of support

Attachment 4 (MS Excel, 16K)(Accessible CSV file, 0.5K): Distribution of professional effort (%) on this application

Attachment 5 (MS Excel, 15K)(Accessible CSV file, 0.3K): Percentage use of each core by each project in the first year.

Page last updated Nov 10, 2009