Program Project Grant (P01) Guidelines

Below are the guidelines that NIEHS has been using for the P01 mechanism.

Should NIEHS reinstate the use of the P01 mechanism at a future date, these guidelines will be reinstated with any appropriate revisions.

Application Guidelines(http://grants.nih.gov/grants/guide/notice-files/NOT-ES-06-013.html)
National Institute of Environmental Health Sciences
National Institutes of Health
Department of Health and Human Services
Revised March 2007

Table of Contents

Introduction

The mission of the National Institute of Environmental Health Sciences (NIEHS) is to support research and research training relating to the etiology, mechanisms, diagnosis, treatment and prevention of human diseases and disorders caused by physical, chemical, biological, social and psychosocial factors, such as socioeconomic status, education, and cultural variables, in the environment. To achieve this mission, the NIEHS, through the Division of Extramural Research and Training (DERT), employs a number of support mechanisms that are available to investigators. Among these are various types of research grants, including traditional Research Project Grants (R01), Research Program Project Grants (P01), Center Core Grants (P30), and individual and institutional National Research Service Awards (training grants). Research and training areas of interest to the NIEHS may be accessed at http://www.niehs.nih.gov/research/supported/(http://www.niehs.nih.gov/research/supported/index.cfm).

This information bulletin is intended to provide:

• a definition of and criteria for the NIEHS research program project grants;
• instructions for the preparation of new, competing continuation and revised research program project grant applications;
• a brief description of the peer review process and the review criteria upon which research program project grant applications will be evaluated;
• a contact at NIEHS for more information about research program project grants and
• details of new guidelines including the Request for Acceptance letter, budget restrictions and the submission of face page at least 6 weeks prior to submission.

It is important to note that these Program Project Grant (P01) application guidelines are intended as a supplement to the instruction in the PHS 398 and, therefore, the latter instructions will not be repeated extensively in this document. The structure provided in these instructions is not intended to preclude the consideration of deviations on a case-by-case basis after discussions with and concurrence by appropriate institute staff.

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General Description

The Program Project Grant (P01) is a mechanism for the support of a broadly based research program involving a number of established investigators who share knowledge and common resources. This type of grant has a well-defined objective involving either several disciplines or several aspects of one discipline.

The program project mechanism is used by the NIEHS to encourage multidisciplinary talents to converge on complex biological problems and to affect an economy of effort and investment in people, space, and costly items of equipment. A program project is a grant mechanism for the long-term support of an investigator-initiated research program of interrelated projects, whose total research effort is facilitated by sharing specialized equipment, laboratory or clinical facilities and data obtained from the various scientific research and core resources of the grant. Each project within the program must contribute to, and be directly related to, a common programmatic theme. This approach is intended to accelerate the acquisition of knowledge through a unified approach that could not be accomplished as a simple aggregate of research projects operating in isolation without programmatic integration.

Essential Characteristics

Overview

The program project grant supports a broadly based multidisciplinary research program that has a well-defined central research focus or objective. Key factors in a successful research program project are as follows:

• There must be a unifying, well-defined goal or problem area of research to which each project relates and contributes, thereby producing a synergistic research environment that allows each research effort to share the creative strengths of the others. There is the expectation that support of interrelated projects and collaborating investigators would yield results beyond those achievable were each project pursued separately and without formal interaction among the participating investigators. The demonstration of synergy among the projects and the multidisciplinary nature of the work are critical components of a P01.
• Program project grants usually require the participation of established investigators in several disciplines or investigators with special expertise in several areas of one discipline. All investigators must contribute to, and share in, the responsibilities of fulfilling the program objective. The project should be large enough to make a collaborative effort clearly advantageous, yet not so diverse in scope as to make frequent communication and collaboration among participants ineffective.
• The Principal Investigator (PI) must possess recognized scientific and administrative competence. Additionally, the PI must show a substantial commitment of time and effort to the program and exercise leadership in the maintenance of its quality. It is expected that approximately 25% time of the PI should be dedicated to the program project in order to reflect the scientific and management effort necessary for its success.
• A program project grant must contain a minimum of three component research projects that are judged to have significant and substantial scientific merit on their own as well as being complementary or contributory to the central theme of the P01. All component projects must be exceptionally well designed and presented, and each must be of the quality to be competitive in the NIH peer review system as individual research project grants.
• The research proposed must utilize state-of-the-art approaches to achieve the research goals.
• The individual project leaders must be recognized to be sufficiently senior and experienced to organize, manage and administer their scientific project.
• The program project grant must have appropriate and adequate organization and facilities for the conduct of its research activities. Additionally, the facilities and organizational arrangements should stimulate collaboration among constituent programs.
• The grant may also include support for common supporting or shared resources (Cores) required for the conduct of the component research projects. The core components of a program project must provide services to more than one of the research components.
• There must be a demonstrated commitment of the home institution to the support and encouragement of the program project grant. Such support usually involves release time of faculty, capital improvements that will facilitate the research and assistance in the purchase of scientific equipment.

Leadership And Administrative Structure

There must be a strong leader who is substantially committed to the project, is capable of scientific leadership and willing to accept responsibility for the administration and integration of the program. Assessment of the ability of the program project PI to develop a tightly integrated program of collaborative research will be a significant consideration in the final evaluation of the application. Additionally, the individual projects included in the program should be under the direction of experienced scientists with a variety of disciplinary and specialty backgrounds who must be willing and able to relate to each other in a meaningful fashion. Thus, any leads or new scientific information discovered by one of them should be brought to the attention of the PI and to other members of the team. Regularly scheduled meetings of participants (where recent results and new ideas can be shared and evaluated) should be held to facilitate the exchange of new findings relevant to the overall progress of the program project.

A committee formed of the individual project leaders (sub-project Principal Investigators) should be selected to assist the program project PI in making scientific and administrative decisions in the operation of the program. In addition to this committee, the program project PI may wish, and is encouraged, to designate external advisors to provide overall guidance and advice on program direction.

Research Projects

The research projects proposed as part of a program project grant application are crucial to its success. Applicants must carefully consider the essential characteristics of a program project listed in the beginning of this section. It is of paramount importance that each research project be of sufficient scientific merit to warrant independent support, that each project is an integral part of the overall theme of the program project application, and that they are multidisciplinary in nature.

Core Facilities

A core unit is defined as a resource for the program project that provides centralized services to several of the research projects.

Administrative and scientific service core facilities may be proposed as long as they meet the criteria indicated below:

• The core must provide service, on a continuing basis, to two or more component research projects. This support may be directed to different component research projects as the scientific program advances. For example, a chemical synthesis core may be providing service to two or more research projects on a sequential pattern. If it is found that the proposed service core supports one research program predominantly, that core support should be included within the individual project.
• Scientific cores should utilize state-of-the-art techniques and equipment in order to maximize the efficiency of the entire program project grant.
• Core support funded by this grant should provide service for only research projects within the program project grant. Service provided to other projects must be done on a fee-for-service-basis or there must be some reciprocal service provided to the P01 that is substantially of the same value.
• An administrative core must provide the administrative infrastructure for the entire program project grant and should not be duplicated within any other component.

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Budget Guidelines

New P01s submitted to the NIEHS are capped at $1 million direct cost. All budgets must be well justified. A competitive renewal budget may be up to 20% larger than the previous years direct budget excluding third party Facilities and Administrative (F&A) costs. The proposed budget should be discussed early in the planning process with the NIEHS health science administrator of record.

Allowable budget items for program project applications are consistent with those for individual project grants (See http://grants.nih.gov/grants/policy/nihgps_2003/index.htm(http://grants.nih.gov/grants/policy/nihgps_2003/index.htm) )

Pre-application Procedures

Pre-Application Consultation With Program Staff

Note that NIEHS will only accept P01 applications at the September 25 Application Receipt Deadline. NIEHS will not accept P01 applications at the February NIH Application Receipt Date.

NIEHS program staff is particularly cognizant of the scope of their programs and of the P01 guidelines and are especially qualified to advise applicants concerning the preparation of a complete and well-developed application.The initial contact with NIEHS program staff is the responsibility of the potential applicants and should be made as early as possible. The Principal Investigator of a proposed P01 should contact the appropriate NIEHS health science administrator (e.g., health science administrator of record with a grants portfolio in the area of the proposed program project) several months prior to the application deadline to start a dialogue on the preparation of a P01. For information on NIEHS program and grants management staff and their area of responsibilities, please refer to http://www.niehs.nih.gov/research/supported/. This dialog may take the form of correspondence, such as a letter or email, telephone conversations, etc. Such communication will enable the staff to discuss issues such as the need for integration of all projects into the theme of the overall program, the established review guidelines, the proper format of the applications, and the necessary relevance of the proposal to the programs supported by the NIEHS. Please refer to the appropriate Web site for a detailed description of application guidelines.

Request for Acceptance for Review of Applications Requesting More Than $500,000 Direct Costs

Per NIH policy(http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html) applications in excess of $500,000 direct costs require prior written approval before being accepted for review. Thus, following discussions with NIEHS program staff as described above, prospective applicants for a Program Project Grant (P01) are required to submit a Request for Acceptance letter to the NIEHS at least 4 months prior to the September 25 Application Receipt Deadline (by May 25). This applies to both new and competing renewal applications.

The Request for Acceptance letter should include the following:

• a descriptive title of the proposed application;
• the names, addresses and affiliation of all key personnel and participating institutions;
• a proposed overall budget by year;
• descriptive titles for each proposed research project and core;
• date of proposed submission.

NIEHS approval in writing is required before the P01 can be submitted. Following receipt of such requests for large grants, the NIEHS staff will meet with the NIEHS Director of Extramural Research and Training to discuss the potential scientific and financial impact of the proposed research applications on the total NIEHS portfolio. The decision on whether or not to accept the proposal will be sent to the potential applicant at least 3 months prior to the requested submission deadline (by July 1). If the NIEHS agrees to accept primary assignment of the application, Institute staff will notify the Center for Scientific Review (CSR) before the application is submitted. The Principal Investigator must include a cover letter with the application, identifying the NIEHS program staff member who has mediated NIEHS agreement to accept assignment of the application.

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Preparation of Applications

General Instructions for All Research Program Project (P01) Applications

This section supplements the information and instructions found in the Application for a Public Health Service Grant (PHS 398 revised 5/2001). Because these application forms are designed primarily for individual research grants, additional information is required when used for program project applications. Except as modified in the following sections, the official instructions for the PHS 398 must be followed for all new, competing, revised or supplemental applications. The PHS 398 application instructions and fillable format are available at http://grants.nih.gov/grants/funding/phs398/phs398.html(http://grants.nih.gov/grants/funding/phs398/phs398.html) .

Typeset Requirements. The typeset limitations described for PHS 398 must be adhered to for all applications.

Page Limitations. The page limitations specified for PHS 398 apply to the individual projects of the application. The component relating to the overall project should be as concise as possible. It is not appropriate for additional information such as research description for individual projects to be included in the overall project description.

For new, amended, and competing continuation applications, defined page limitations are required. Any component of the application that exceeds the following page limitations will be returned to the applicant without review.

Introduction Section: All amended and supplemental applications must include an introduction. For new, amended and competing continuation applications, the introduction must not exceed 10 pages total. For supplemental applications, the introduction must not exceed one page.

Research Project: The research plan of each project must not exceed 25 pages, this includes all tables, graphs, figures, and charts.

Core Components: Core components must not exceed 15 pages each.

Page Numbering. All pages should be numbered consecutively throughout the program project application beginning with the face page as page 1. Renumber the fillable format form pages as necessary. Individual sub-projects should become part of the overall numbering and must not be numbered separately. The components of the application should be in order as suggested in Illustration I.

The Face Page. The title for the application (item 1) should be chosen to correspond to the major theme of the program project.

Complete Table of Contents, page 3. One complete table of contents should be provided and should follow the overall page numbering indicated above. Do not include a separate table of contents for individual subprojects. Bearing in mind that the application will be reviewed project by project, prepare a detailed table of contents that will enable reviewers to find specific information readily. Projects should be identified by number, title, and responsible project investigator (see Illustration I, Table of Contents).

Consolidated Budget for Initial Budget Period. This is the budget in which the entire program project is summarized for the initial budget period. (Use Form page 4 "Detailed Budget for Initial Budget Period.") Continuation pages may be used if needed. In the Personnel Category, do not list personnel by name; simply list the total personnel costs by project and core. If collaborative efforts or "purchased services" involving other institutions or organizations are anticipated, list each third party participant direct and facilities and administrative costs separately in the Consortium/Contractual Category. Information regarding the establishment and administration of consortium can be found in the NIH Grants Policy Statement (March 1, 2001)(http://www.grants.nih.gov/grants/policy/nihgps_2001/) and the PHS 398 (rev 5/2001)(http://grants.nih.gov/grants/funding/phs398/phs398.html) .

Consolidated Budget for Entire Proposed Project Period. This is a budget page in which the entire program project is summarized for the requested additional years of support. (Use Form page 5 "Budget for Entire Proposed Project Period of Support.")

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New applications (Type 1) will be capped at $1 million direct costs; competing renewal applications (Type 2) will be limited to $1.5 million direct costs, or a 10% escalation over the previous non-competing year (Type 5), whichever is lower.

Individual Project Budgets. A separate budget for each individual project and core unit or activity must be included using duplicates of Form pages 4 and 5. ("Detailed Budget for Initial Budget Period" and "Budget for Entire Proposed Project Period of Support.") All proposed costs must be fully justified for both the 12-month and future year budgets as indicated in PHS 398 instructions. In addition the budget justification should specify the proportion of each investigator's salary that is being requested under each of the investigator categories, i.e., individual project leader. Similar justifications should accompany requests for technical personnel.

Other Support. "Other Support" should be in the recommended format provided in the PHS 398 (rev 5/2001) for all key personnel.

Biographical Sketches. Complete the Biographical Sketches as detailed in the PHS 398 (rev 5/2001). The PI should be first, followed by the other investigators, in alphabetical order.

The Main Body of the Application. The introduction should concisely present the proposed research strategy, including background information leading to the request for program project support, a description of the aims and objectives of the program project, benefits to be achieved by funding as a program project grant, special program resources, and overview descriptions of activities and functions of each core unit and subunit, emphasizing areas of coordination.

Organization and Administrative Structure. (No specific instructions in PHS 398). Describe in detail and by diagram, if appropriate, the chain of responsibility for decision-making and administration beginning at the level of PI. Indicate investigators responsible for individual projects and how the projects are planned, coordinated, and evaluated. Describe role(s) of advisory groups of local or outside consultants. Describe relationships between the program project and other research, academic, and administrative units of the institution, such as centers, institutes, departments and central administration. This should be followed by more detailed presentations of the administrative core, the research projects and the service core units, providing the information indicated below.

Instruction for Individual Projects. Individual projects must not exceed the 25-page limitation for items a-d as noted under "Research Plan," PHS 398 instructions. The title page of individual projects should use a continuation page and clearly denote the project number, the title of the project and project leader.

Description, Performance Sites, and Key Personnel Form Page 2. The abstract should be prepared on a duplicate of Form page 2 of the PHS 398. Key personnel on project should be identified. Note: the name of the Principal Investigator of the Program Project Grant (P01) application is placed in the upper right corner, not the name of the responsible investigator of the particular project.

Continuation Pages. Subsequent pages (following Description, Performance Sites, and Key Personnel) should use continuation pages and follow PHS 398 instructions. If collaborative or consortium arrangements are included in the application, follow PHS 398 instructions. Discussion should be included as to how the collaborative arrangements will be of value in achieving the specific objectives of the project. In addition, each individual project should clearly state its relevance to the overall program project and its primary theme, its contribution to the other projects and the extent of its dependence on the cores. Please note the following items:

Form Pages 1 and 2 of the application, as well as the pages for "Biographical Sketches" Format page and "Other Support", are omitted from the individual projects and core components. These pages are included elsewhere in the application.

Applicants should carefully read and adhere to the PHS 398 instructions concerning women and minority inclusion and inclusion of children in human study populations.

Appendix material is not a part of the application, and such material is used in the same manner as for a regular R01 grant application. Please note that additional copies of appendix material (up to10) may be requested by the Scientific Review Administrator.

Core Components. The core component(s) must not exceed 15 pages. The core component(s) of a program project may include funds for laboratory and clinical facilities, equipment and services that will be shared by multiple projects and staff members of the program project. The format for describing the core component is as follows:

• Describe the function of the core unit as a resource to the program project. This section must present clearly the facilities, techniques, and professional skills that the core unit would provide. As justification for the core unit, indicate briefly the specific research projects that would use the resources of the core unit. A core unit is principally designed as a service or resource component; it would be highly unusual to include research in a core unit (a possible exception would be methodology development). Please contact the Institute staff if you require guidance on this issue.
• Describe the facilities to be used by EACH core unit. This is to be accomplished by completing the "Resources and Environment" page included in the PHS 398 grant application packet.
• Present the budget for each unit in the format indicated above and according to the instruction indicated for PHS 398. Include explicit and detailed budget justification for all years.
• To facilitate the review process, it is suggested that a table be included that indicates the research projects each core unit would serve and the proportion of the cost of the core units associated with each research project involved. The format suggested is presented in Illustration II.
• If this is a competing continuation or supplemental application, summarize activities carried out during the preceding performance period by this core.
• Using a form continuation page, denote "Core Component" and the Principal Investigator's name. If there is to be more than one core component, there should be separate descriptions for each component (i.e., Core Component A, Core Component B, etc.).
• Describe the role of the core component as a resource to the program project as a whole. Discuss ways in which these centralized services will produce an economy of effort and/or savings in overall costs compared to their inclusion as part of each project in the program, or as part of individually funded grants.
• This section should present a clear understanding of the facilities, resources, services, and professional skills that the core component will provide. To justify the request for the core component, thoroughly discuss the specific projects that will draw upon each element of this resource. Indicate what proportional part of each element applies to each research project. If this is a competing continuation or supplemental application, summarize activities during the preceding project period.

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Additional Instructions for Revised Applications

• Only one revision (A1) will be permitted. Therefore, any applications currently being considered for resubmission that have already been reviewed twice, will not be accepted as revised (A2) applications.
• Prepare a revised (amended) application according to instructions provided in the PHS 398 instructions and as described in this document. A revised application will be returned if substantive changes are not clearly apparent and identified. Simple deletion of projects may not constitute substantive revision. Also, before the research plan for each component, provide an Introduction that responds to the comments of the previous summary statement and which summarizes changes made in the research plan. Incorporate in the Progress Report/Preliminary Results a discussion of any work done since the previous submission. In both the overall and individual project research plans, revised portions or passages MUST BE CLEARLY IDENTIFIED to facilitate the review of the revised aspects of the application. The preferred method is to use a vertical line in the left margin to mark revised areas of the application.
• Discussions with the health science administrator will take the place of the Request for Acceptance letter for a revised application. However, it is mandatory that the PI submit the face page (final signatures not needed) and an abstract to the health science administrator of record at least six weeks before submission.
• Acceptance of a revised application automatically withdraws the prior version.

Supplemental Applications

Supplemental applications are accepted only under special circumstances and will be accepted ONLY with prior written concurrence of NIEHS health science administrator of record.

Additional Instructions for Competing Renewal Applications

Competing continuation applications must contain the following information in addition to all the requirements described under the new application section.

Summary Report of Progress. Competing continuation and supplemental applications must include a general progress report that describes achievements under the grant since the last competitive review. The sections of the individual projects will provide the details as requested in the PHS 398 instructions for competing/new applications. The PI should carefully prepare this section and it should not be a copy of the material included for the individual projects. This is the section where the benefits of the program project can be expressed/demonstrated. Items to be included are:

• A brief summary of major accomplishments that can be attributed to the program project grant, and a brief explanation of how they have contributed to the goals of the grant.
• Detailed reports on projects that are not being continued, and the reason for deleting them from the program project.
• A list of projects and core components in tabular form (by project title and investigator) that denotes which projects have been discontinued or completed in the latest year of funding (labeled Section 1). Projects that are continuing, are new, or are substantially modified (labeled Section 2), will also be listed. Therefore, Section 2 is a listing of projects proposed in the application. These lists should be in the same order and numbered as in the application.
• A list of all publications and completed manuscripts that are a direct result of the support provided by the program project grant. With an asterisk, denote each publication that is a result of formal collaborations between different projects within the program.

NOTE: The PI submitting a competing continuation application must also submit the face page (final signatures not needed) and a copy of the overall abstract to the health science administrator of record at least six weeks prior to submission.

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Submission Procedures

Submission

It is essential to note that the application submitted is the document of record. No substitutions of pages will be allowed. However, if the PI wishes, he/she must contact the Scientific Review Administrator (SRA), responsible for the scientific review, to discuss the possibility of submitting errata documents.

Submit a signed single-sided, typewritten, original application, including the Checklist, and three signed, photocopies in one package to the Center for Scientific Review (CSR) as stated in the PHS 398 instructions. In addition to those copies submitted to the CSR, please send two informational copies, under separate cover, to the SRA at the address listed in the section entitled Staff Consultation. These copies are useful to the NIEHS staff for planning purposes.

Appendix material should be mailed directly to the SRA. Prior to submission of these materials, please contact the SRA for exact requirements as to the number of collated copies necessary.

The CSR has the responsibility of assigning an application to the appropriate NIH Institute. The Institute assignment is based on the scientific goals of the entire program and the CSR, in consultation with the Institute, makes the decision as to whether or not a given application fits established criteria for a Research Program Project Grant (P01).

Research, Review, and Start Dates

Applications for all types of program project grants--new, competing continuation, and supplemental--competing for funds in a given fiscal year are submitted on one of two possible receipt dates that have been announced through a solicitation in the NIH Guide to Grants and Contracts http://grants.nih.gov/grants/guide/index.html(http://grants.nih.gov/grants/guide/index.html) . Please refer to the schedule shown below.

RECEIPT, REVIEW AND START DATES

Review Procedures

The Center for Scientific Review (CSR), NIH, serves as a central point for receipt of applications for most discretionary PHS grant programs. Upon receipt, applications and supporting material will be examined for completeness by CSR. Incomplete applications will be returned to the applicant without further consideration. Extramural staff will administratively review applications assigned to the NIEHS. The specific points of consideration are: (1) the appropriateness of the science proposed for the mission of the NIEHS; and (2) the general completeness of the application and organizational adequacy for review (this includes both scientific and budgetary considerations). Applications that do not meet the referral guidelines for NIEHS programs may be assigned to another institute or returned to the applicant.

Initial Scientific Review

The NIEHS will not conduct site visits as part of the review of these applications. Applicants for P01 support should submit complete stand-alone applications addressing all of the review criteria as stated in the NIEHS Guidelines for submission of P01 applications.

All P01 (new, competing, and amended) applications will be reviewed by a Special Emphasis Panel (SEP) selected by the NIEHS Scientific Review Administrator (SRA), which will be composed of scientists and administrators with appropriate expertise to evaluate the application and its various components in accord with the review criteria listed under REVIEW CRITERIA.

The submitted application will be the document reviewed. However, as a part of the scientific review process, the SRA may contact the PI prior to the review meeting. The purpose of this contact will be to alert the PI of the need for additional material or information identified by the reviewers prior to the review. The additional material or information will be made available to the reviewers prior to or during the review meeting. During the review, a maximum of 60 minutes will be allotted for a teleconference between the review committee and the PI and assembled co-investigators. The purpose of this teleconference is to allow the applicants to address the review committee directly and to answer questions or to address concerns that have been raised during the review.

The SEP will report its findings and recommendations, including the priority scores for all applications "recommended for further consideration," to the National Advisory Environmental Health Sciences Council for the final review.

Recommendations Regarding Budgets

The SEP may recommend adjustments, as judged appropriate, in the requested budgets and periods of support for the components of P01s which are deemed to have significant and substantial merit. It is important to note that SEP members will examine proposed budgets closely.

Submission of Additional Information

New applications (Type 1) will be capped at $1 million direct costs; competing renewal applications (Type 2) will be limited to $1.5 million direct costs, or a 10% escalation over the previous non-competing year (Type 5), whichever is lower.

There is a period of several months between the time of submission of the application and the initial review. In the event of substantial new findings during this interval, the applicant must contact the SRA to seek permission to submit supplementary materials. These materials will generally not be accepted within 30 days prior to the initial scientific review. The SRA will make the final determination as to what additional information will be provided to the reviewers.

National Advisory Environmental Health Sciences Council (NAEHSC) Review

The final review and recommendations on all applications that are recommended for further consideration is made by the NAEHSC. The Council has two responsibilities relating to grant applications under review: (1) it evaluates the adequacy and appropriateness of the initial review process, and (2) considers the significance of the application to the overall program goals of the NIEHS. Upon consideration of these issues the Council makes appropriate recommendations to the Director, NIEHS. The Council does not function as a second scientific review body.

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Review Criteria

Peer review for scientific and technical merit emphasizes two major aspects of the program project application: (1) review of the individual research projects and core unit(s), and (2) review of the program as an integrated research effort focused on a central theme.

Review Criteria for the Overall Program Project

The relationship and contributions of each research component and core (excluding those removed through recommendations by the SEP) to the overall theme of the program project are discussed and evaluated. This is a separate consideration that is not influenced by the merit ratings of the individual projects. Although projects not recommended for inclusion in the program automatically are removed from consideration as part of the overall program project, such projects will reflect on the leadership capabilities of the Principal Investigator and shall be considered in the overall merit.

The overall Research Program Project Grant application is evaluated considering the remaining projects, supporting cores, and the administrative structure. For the program project to receive a priority score, it must consist of at least three projects (each found to have significant and substantial merit) for the duration of the project period. Each core must provide essential functions of services for at least two of these projects.

The overall program is assessed based on the following criteria:

• Significance: Does this program address an important problem? If the aims of the program are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
• Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the program? Does the applicant acknowledge potential problem areas and consider alternative tactics?
• Innovation: Is the program original and innovative? For example: Does the program challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the program develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
• Investigator: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
• Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

For competing continuation applications, the following additional criteria will be included:

• Evidence that the previous specific aims, as funded, have been accomplished and that the new research goals are logical extensions of ongoing work.
• Previous performance and estimated use of core(s).
• Justification for adding new research projects or cores or for deleting components previously supported.

Review Criteria for Program as an Integrated Effort

The program as an integrated effort is assessed based on the following criteria:

• The cohesiveness and multidisciplinary scope of the program and the coordination and interrelationship of all the individual research projects and cores to the common theme of the program.
• The scientific gain of combining the component parts into a program project.
• The presence and quality of mechanisms for regular communication and coordination among investigators.
• For new applications, the synergy (degree of interaction, collaborative research opportunities) which will be stimulated by the program and how the research projects and cores relate to the central theme and the ability of the program to meet its long range goals.

For competitive continuation applications, the overall productivity of the program project, placing emphasis on the degree of interaction, and the collaborative research opportunities stimulated by the program will be reviewed.

Principal Investigator (program PI) is assessed based on the following criteria:

• The relevant experience of the PI, particularly in those areas germane to the proposed program. The applicant should include a discussion of his/her ability and commitment to assume scientific and administrative leadership of the program project. Components not recommended for further consideration may impact negatively on the evaluation of the Principal Investigator's skills and scientific judgment.
• The adequacy of the commitment (percent effort) of the PI to the scientific and administrative aspects of the program project.

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Review Criteria for the Administrative Core

The Administrative Core is assessed based on the following criteria:

• The adequacy of the decision-making process within the proposed program for the evaluation of research productivity, allocation of funds, and management of the resources.
• Evidence that the administrative core promotes joint planning and evaluation activities as well as collaborations and interactions among different research cores of the program project.
• Academic environment and resources in which the research will be conducted, including availability of space, equipment, human subjects, animals, or other resources as required, and the potential interaction with scientist(s) from other departments.
• Institutional commitment to the requirements of the program project, including fiscal responsibility and management capability of the institution to assist the Principal Investigator and his/her staff in following DHHS, PHS, and NIH policy.
• The adequacy of the plan for the program project evaluation of how the internal and external advisory groups would be used and the composition and expertise of the advisory committees.
• Appropriateness of the budget in relation to the proposed program project.

Review Criteria for the Research Project(s)

The Research Project(s) is assessed based on the following criteria:

• Significance: Does the study address an important problem? If the aims of the application are achieved, then how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive the field?
• Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
• Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?
• Environment: Does the environment in which the work will be performed contribute to the probability of success? Do the proposed experiments take advantage of the unique features of the scientific environment or employ useful collaborative arrangements?

Additionally, each project will be evaluated on the basis of its contribution to the overall goal of the program project.

• The scientific merit of each individual project in the context of the proposed program, (i.e., assessment of the importance of the ideas or aims, the rationale and originality of the approach, the feasibility of the methods and the value of the result).
• The specific scientific objectives of each project that will benefit significantly from, or depend upon collaborative interactions with other projects in the program (i.e., objectives that can be uniquely accomplished, specific contributions to the accomplishments of objectives in other projects, objectives that can be accomplished with greater effectiveness and/or economy of effort, etc.).
• When human subjects are involved, the adequacy of plans to include women and minorities in the study design and the potential of that design to address the scientific question(s) proposed must be addressed.
• Adequacy for the use of vertebrate animals.
• Adequacy of plans for studies involving the use of children.

Review Criteria for the Facility/Service Core(s)

The Facility/Service Core(s) is assessed based on the following criteria:

• The core's utility to the program. Each core must provide services for two or more research projects judged to have substantial merit.
• The quality of the facility or services provided.
• The cost effectiveness of the service.
• The qualifications of the personnel involved, their experience, and commitment to the core.

For competing continuation applications, the progress made during the past period of funding is also an important consideration in the review of the research projects and cores.

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Policies and Assurances

The award and administration of program projects are subject to the same policies and procedures as other research grants. These policies and cost principles are set forth in the current NIH Grants Policy Statement, and NIEHS issuances, and Federal legislation and regulations.

Staff Consultation

Prior to application and especially while the application is being developed; inquiries about Research Program Project Grants (P01) should be addressed to the health science administrator whose portfolio the application will best fit.

The following URL can be used to determine the appropriate NIEHS health science administrator of record: http://www.niehs.nih.gov/funding/grants/contacts/

Questions of an administrative or fiscal nature not directly related to the scientific aspects of the program project application should be directed to the Grants Management Branch.

Once the application has been submitted to the NIH/NIEHS, the primary point of contact should be:

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Illustration

ILLUSTRATION I - PROGRAM PROJECT GRANT TABLE OF CONTENTS

ILLUSTRATION II - SUGGESTED PRESENTATION OF CORE UTILIZATION

Relation of Core Units to Research Projects

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