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Program Project (P01) Guidelines

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Table of Contents

Introduction
General Considerations
Essential Features of a Program Project Grant
Budget Limits and Length of Projects
Before Applying for a Program Project Grant
Other Considerations

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) uses the program project grant (P01) mechanism to promote innovative, multidisciplinary, interactive and synergistic research on reproductive, developmental, behavioral/social, and rehabilitative processes that determine the health of or that optimize the functioning of newborns, infants, children, adults, families, and populations.

The P01 mechanism supports complex programs involving multiple related projects while facilitating economy of effort, space, and equipment.  Under appropriate circumstances, the collaborative research effort of a P01 can accelerate the acquisition of knowledge more effectively than a simple aggregate of research projects without thematic integration.

General Considerations

The program project grant provides support for a research program that has a well-defined central theme, research focus, or objective. P01s must have at least three interrelated, well thought-out research projects along with the core resources necessary to support these projects at all times. It is expected that interrelationship and synergism among component research projects will often be multidisciplinary in nature, and will result in greater scientific contributions than if each research project were supported individually. The P01 is based on the concept that projects closely related to a central theme can be conducted more effectively and efficiently through a coordinated, collaborative, multidisciplinary approach.

The P01 research effort is facilitated by the sharing of ideas, data, and specialized resources, such as equipment, services, and clinical facilities. Although the component projects must be scientific meritorious they must also complement one another, be interdependent, and support the program's overall theme. Thus, the program's overall scientific merit is expected to be greater than the sum of its parts.

Research projects should be led by experienced scientists with a variety of disciplinary and specialty backgrounds. They should be able to collaborate productively so that new scientific information may be freely exchanged and effectively applied by others in the program. The program director/principal investigator (PD/PI) of the overall P01 should be an established investigator with demonstrated administrative capabilities.

Regular meetings of participating investigators who share and evaluate results and new ideas are essential to the consolidation of the research projects into a cohesive program.  The participating investigators are expected to assist the PD/PI in making administrative as well as scientific decisions.  The judicious use of an external advisory committee, composed of consultants from outside the program, can be helpful in providing independent program evaluation and guidance.

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Essential Features of a Program Project Grant:

  • There must be a unifying, well-defined goal or central research theme to which each component research project relates and contributes scientifically, thereby producing a synergistic environment that allows each research effort to share the creative strengths of the other projects.

  • The program must involve interrelated research projects and collaborating investigators, yielding results beyond those achievable if each project were carried out separately.

  • The PD/PI must possess recognized scientific and administrative competence, devote substantial commitment of effort to the program, and demonstrate leadership in maintaining program quality.

  • There must be at least three research project components at all times during the grant period; the research projects should be comparable to R01 research project grants in terms of size, scope, and scientific rigor.

  • Each research project must independently have significant and substantial scientific merit, as assessed by peer review, and must complement the other research projects in the program.

  • In addition to the required R01-type research projects, smaller developmental/pilot research projects similar to R21s/R03s may also be included.

  • Research projects should be supported by technically competent and efficient Core components to enhance the research efforts.

  • Program projects require the participation of established investigators in several disciplines or investigators with special expertise in several areas of one discipline. All key investigators (Project Leads, Core Directors) must contribute to, and share in, the responsibilities of fulfilling the program objectives.

The program project should be planned carefully. The program must comprise a sufficient number of scientifically meritorious R01-type research projects (at least three) to permit an effective collaborative effort among the participating investigators. On the other hand, research efforts should not be so diverse and diffuse in scope as to hinder productive collaboration. In such instances, consideration should be given to submitting individual R01 research project grant applications. P01s that are too large may inhibit communication and interaction among collaborators and, as a result, become less effective.

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Budget Limits and Length of Projects

Scope and size of program project grants:

  • A five-year total project period for P01 programs is encouraged, but is not mandatory. The minimum total project period is three years.
  • Research Project components and Core components should have a duration of at least three years.
  • There must be at least three Research Project components at all times during the grant period.

Application budgets need to reflect the actual needs of the proposed program project. 

Effective with the September 25, 2013 receipt date and thereafter, new P01 applications may request up to $1 million in direct costs per year (or up to $5 million in direct costs over 5 years), but applications may not request inflationary increases for the non-competing years or for renewals.  NICHD will rarely, if ever, accept an application requesting more than $1 million in direct costs per year ($5 million over 5 years).

Effective with the September 25, 2013 receipt date and thereafter, the total length of support for P01 grants will be limited to 10 years, i.e., only one renewal will be awarded.  Therefore, current P01 awardees are strongly encouraged to contact the NICHD program official identified on their most recent Notice of Award for further information and to discuss future options which may include transition from support under the P01 mechanism to support under other investigator-initiated grant mechanisms or submission of a new P01 application with significant changes in scope and direction and, when appropriate, changes in individual project leadership.

In addition, all P01 applications must follow the requirements of the NICHD Large Grants Policy, as described at http://www.nichd.nih.gov/grants-funding/policies-strategies/policies/pages/large-grants.aspx.

NOTE: For the purpose of determining budget limits, the calculation of total direct costs may exclude all facilities and administrative (indirect) costs, including those indirect costs associated with subcontracts. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html)

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Before Applying for a Program Project Grant

Investigators should contact the appropriate extramural program officials listed at the following NICHD website: http://www.nichd.nih.gov/about/org/der/branches/Pages/index.aspx.  Early communication with NICHD staff is strongly recommended, so that staff may determine whether the proposed program project grant is responsive to the NICHD research mission and whether it meets P01 criteria.  Applications that do not meet NIH or NICHD guidelines for program project grants, including budget limits, will not be accepted for review.  Communication will also enable the potential applicant to benefit from consultation with NICHD staff.

When contacting NICHD program staff, investigators should address the following:

  • applicant qualifications, including key collaborators;
  • the P01 central theme and objectives;
  • a brief description of each research project and Core unit, including project leaders, and how each project will contribute to the overall P01 goal; and
  • an estimate of the annual budget and the number of years of support requested for the total program project and for each research project and Core.

Most importantly, applicants should contact NICHD staff early in the process.  Since NICHD P01 applications are also subject to the NIH Large Grants policy staff should be contacted at least 6 weeks prior to the receipt date, and earlier for very large or complex applications.  And when preparing the application, it’s important to read the Funding Opportunity Announcement (FOA) carefully and follow the instructions.

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Other Considerations

Changes in Personnel: Institutions must notify NICHD staff immediately if a program director or the leader of a research project or Core plans to leave the institution or can no longer fulfill the day-to-day role prescribed in the grant award. The notification should include a plan for disposition of the funds involved, either by discontinuing the relevant portion or by appointing a new individual.  A change the PD/PI or leader of a research project or Core must be approved by NICHD; a letter of justification, co-signed by the responsible university official, and a curriculum vitae must be submitted to the NICHD grants specialist to initiate this process.

Changes in Projects: An award authorizes expenditure of funds only for research projects and Core components reviewed through the competitive peer-review process. The addition of a new research project or Core component requires scientific peer review of a revision application (formerly called a competing supplement).  If a revision application is submitted for an existing program project grant, then the entire cost of both the existing grant and the additional component must be within the overall budget limits unless a waiver is given beforehand.

Transfers: Program project grants are not transferrable to other institutions. However, administrative actions such as organization name change, successor in interest, or mergers are usually acceptable.

Foreign Institutions: Foreign institutions are not eligible to apply for a program project grant, but foreign components are allowed.

Multiple PD/PI: Program project grants may use the Multiple PD/PI option as described at: http://www.grants.nih.gov/grants/multi_pi/.  Multiple PD/PI applications must include a leadership plan, and only the PI(s) on the overall grant will be considered as PI.  Project directors for individual research projects are to be listed as “Project Lead” when submitting, and more than one investigator may be given this role.

Electronic Submission:  Effective with the September 25, 2013 receipt date at thereafter, program project grant applications are to be submitted electronically, using Grants.gov

Scientific/Administrative Overlap: Potential overlap of P01 subprojects with other current and/or pending applications must be addressed in the Other Support sections of the application, and should include plans for adjustment, as necessary. The simultaneous submission of an R01 and a P01 application for support of the same research project is allowed, but if both applications receive a fundable score the leader of the research project must decline the R01 award and keep the project in the P01.

Last Updated Date: 04/23/2013
Last Reviewed Date: 04/23/2013

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