Appendix: List all appendix material to accompany the application on the Table of Contents and follow the instructions for the PHS 398 form. Up to three publications per project or core of the types listed in the PHS 398 instructions are allowed.
Send all appendices (five CDs) to Chief, Review Branch, NIDDK, with two copies of the application.
The PHS 398 instructions should be followed with the following clarifications. The overall research strategy within its 12 page limit should include a progress report that includes:
- A brief summary of major accomplishments that can be attributed to the program project grant, a brief explanation of how these accomplishments have contributed to the achievement of the stated objectives of the grant, and a demonstration that synergy has occurred.
- Evidence that the previous specific aims have been accomplished and that the new research goals are logical extensions of those aims.
- The previous performance of the core(s).
- The rationale for adding new projects or cores, deleting a project or core, or changing the key personnel.
After the overall research strategy include a table of publications that directly resulted from the program project since it was last reviewed using the format of Illustration 5 (PDF, 36 kb).
The individual projects should include a progress report in the research strategy section and the Progress Report Publication List as described in the PHS 398 Form instructions.
Preparation of a resubmission application should follow the PHS 398 instructions with the following additional guidelines:
- The Overall Research Strategy should include a one-page introduction that summarizes the changes that have been made from the previous submission.
- Preceding the Research Strategy for each project or core, provide a one-page Introduction that responds to the criticisms raised in the previous review and summarizes changes made in the research plan.
- Substantial scientific changes must be marked in the text of the application by bracketing, indenting, or changing typography. Do not underline or shade the changes. Deleted sections should be described but not marked as deletions. If the changes are so extensive that essentially all of the text would be marked, explain this in the Introduction.
The standard receipt dates for program project applications are used. The continuous submission process does not apply to P01 applications.
The original and three copies of the completed application should be mailed to the Center for Scientific Review; an address label is included in the PHS Form 398 application information. In addition, two paper copies of the application and five CD copies of the appendices should be sent directly to the Chief, Review Branch, NIDDK.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 752
6707 Democracy Boulevard, MSC 5452
Bethesda, MD 20892-5452. For courier/express delivery, please use 20817 Zip code
Phone: (301) 594-8897
Fax: (301) 480-3505 or (301) 480-4126
A non-competing continuation application should be submitted on the PHS 2590 form. Each project should submit a complete PHS 2590 and the forms from all projects submitted as a single packet.
Annual progress reports, submitted as part of the annual, noncompeting, renewal application, are used by the NIDDK to review the progress of the program project. These reports serve to verify, in detail, the achievements of the objectives outlined in the initial application. The NIDDK staff may, as necessary, assemble consultants to review the progress of the program project or to discuss major changes in the program that may require budget adjustments and/or review by the NDDK Advisory Council.
A. General Review Considerations
For a program project application to be assigned an overall impact score, at least three component projects that extend for the duration of the program project must have been judged to have sufficient scientific merit and received impact scores. The NIDDK is interested in supporting only the best research; individual research projects that are relatively lower in merit may not be funded under the "umbrella" of the program project mechanism. Therefore, each project will be assigned a separate impact score, taking into consideration only its merit as an individual research project. Each project must fit and contribute to the theme of the overall program project, but these factors are judged separately and have no bearing on a project's individual impact score. Instead, these considerations will be addressed later with respect to the merit of the overall program project.
It is expected that individual components, in order to receive funding, should in general receive impact scores similar to those for funded R01 grants. However, a project whose score is somewhat poorer than currently funded R01 grants may contribute significantly to the overall program project, whereby synergism with other components and use of core facilities significantly enhance its own value and the value of the other projects. Such considerations would be expected to have an impact on the overall impact score assigned by the reviewers to the program project.
Both the applicant and the reviewers should address the contribution of requested cores to each project in both scientific and budget terms.
Questions on the review process for program projects should be addressed to the Chief of the NIDDK Review Branch.
B. Review Criteria for Individual Research Projects
Reviewers will provide an overall impact score for each project to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the five core review criteria below in the determination of scientific 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 project that by its nature is not innovative may be essential to advance a field.
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?
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, 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 project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
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?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the 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?
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?
Additional Review Criteria. As applicable for the project 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines (PDF, 127 kb).
Inclusion of Women, Minorities, and Children. When the proposed project 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. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines (PDF, 127 kb).
Vertebrate Animals. The reviewers (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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
Resubmissions.If Resubmissions are not allowed for this FOA (i.e., are not included in Section II. Award Information – Application Types Allowed), replace the text with “Not Applicable”. Otherwise, do not change. For Resubmissions, the reviewers will evaluate the projects as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made.
Renewals.If Renewals are not allowed for this FOA (i.e., are not included in Section II. Award Information – Application Types Allowed), replace the text with “Not Applicable”. Otherwise, do not change. For Renewals, the committee will consider the progress made in the last funding period.
Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in arriving the overall impact score.
Applications from Foreign Organizations. Reviewers will assess whether the project 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.
Select Agent 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).
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.
C. Review of Individual Cores
The review criteria for the individual cores are given below (cores receive merit descriptors rather than numeric scores, and individual criterion scores are not provided):
D. Review of Overall Program Project
- Utility of the core to the program project; each core must provide essential facilities or service for two or more projects judged to have substantial scientific merit;
- Quality of the facilities or services provided by this core (including procedures, techniques, and quality control) and criteria for prioritization of usage;
- Qualifications, experience, and commitment of the personnel involved in the core; and
- Appropriateness of the timetable in relation to the scope of the proposed research support.
- For renewals, the reviewers will consider the progress made in the last funding period.
- If human subjects, vertebrate animals, or biohazards are to be used in the core, the adequacy of these sections must be assessed and will be considered in determining the score of the individual core.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
The relationship and contributions of each research component and core to the overall theme of the program project will be discussed and evaluated. These points must be clearly and specifically outlined in the critique of the overall program project. This should be a separate consideration which is not determined exclusively by the impact scores of the individual projects and cores.
1. Specific factors to be evaluated in the consideration of the overall program project are:
a. Scientific merit of the program as a whole, as well as that of individual projects, and its potential impact on the field;
b. The evaluation of the overall program in terms of significance, innovation, investigators, approach, and environment;
c. Scientific gain of combining the component parts into a program project (beyond that achievable if each project were to be pursued separately);
d. Cohesiveness and multidisciplinary scope of the program and the coordination and interrelationship of all individual research projects and cores to the common theme;
e. Leadership and scientific ability of the principal investigator/program director and his or her commitment and ability to develop a well-defined central research focus (request of support for sufficient effort to provide effective oversight and administration of the program should be considered); and
f. Past accomplishments of the program or a demonstrated ability in mounting similar programs.
2. Additional criteria for renewal (competing continuation) applications include:
a. Progress and achievements specific to this program project since the previous review and the evidence through publications, conferences, etc., that collaboration has occurred;
b. Evidence that the previous specific aims have been accomplished and that the new research goals are logical extensions of ongoing work;
c. Previous performance and estimated use of the core(s); and
d. Justification for adding new projects or cores or for deleting components previously supported.
3. Additional Review Considerations: Reviewers will consider the Resource Sharing Plans, but will not give a score for it and should not consider it in providing an overall impact score. They 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; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS)