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NIDCR Small Grant Program (R03) Guide for Written Review

PA Number: PAR-07-418

PURPOSE: The National Institute of Dental and Craniofacial Research (NIDCR) uses the Small Grant (R03) mechanism to support pilot and developmental research that is likely to lead to a subsequent Individual Research Project Grant (R01) application from new investigators who are in the early stages of establishing an independent research career.

The R03 research must be focused on one or more of the areas within the biomedical and behavioral scientific mission of the NIDCR. For details, please see the Program descriptions listed in the Division of Extramural Research.

ELIGIBILITY: ONLY NEW INVESTIGATORS are eligible to apply for NIDCR R03 awards. Individuals who have received NIH support for previous research (e.g., R01 or anyone with R03 support ) are not eligible. Individuals who have received only training or career development support from the NIH (e.g., K01, K08, K12, K16, K22, K23, K25, K99/R00, F30, F32, and T32) are eligible. Any current support by the F32 and T32 mechanisms must be terminated before an R03 grant can be awarded.

REQUIREMENTS:

  • The NIDCR requires that the Principal Investigator (PI) commit a minimum of 20% effort to the R03 project.
  • Letters of support from the Institution (preferably from the Dean or Departmental Chair) are strongly encouraged. The letters should describe the nature of the PI's appointment and commitments to the PI, such as laboratory and office space, technical assistance, or travel funds.
  • Research plan, Items 2-5, may not exceed 10 pages.
  • R03 appendix materials may include only preprinted questionnaires or surveys.  No publications or figures are allowed in the appendix.
  • Up to two revision of a previously reviewed small grant application may be submitted.

Please use the following format to evaluate R03 applications and to write your review. Your comments will be used essentially unedited in the final summary statement sent to the applicant.

CRITIQUE FORMAT

Review of R03 mechanisms should be based upon the five standard review criteria Significance, Approach, Innovation, Investigators, and Environment). R03 applications usually will not have the same level of detail or extensive discussion of experimental methodologies and background information. Appropriate justification for the research may be provided through literature, citations, data from other sources, or investigator generated data. However, it is important to note that preliminary data typically are not required to justify support for these studies.  Therefore, less emphasis should be placed on the traditional indicators that are used in the review of R01 mechanisms. Instead, reviewers should evaluate the conceptual framework and general approach to the problem. If preliminary data are provided, they must be evaluated scientifically.

Please use as little descriptive information as possible; only evaluative statements should be included. For resubmitted applications, also comment briefly on whether the application is improved or not. In addition, provide a one sentence summary of your evaluation at the end of each section.

  1. Significance:  Does this study address an important problem? If the aims of the application 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?  What is the likelihood that the data generated by the proposed project will be sufficient for a subsequent R01 application? 
  2. Approach:  Are the conceptual or clinical framework, design, methods, and analysis adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  For applications designating multiple PDs/PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PDs/PIs?  Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts? 
  3. Innovation:  Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
  4. Investigators:  Are the PD/PIs 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 PD/PI and the investigative team bring complementary and integrated expertise to the project (if applicable)?
  5. Environment:  Do(es) the scientific environment(s) 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?

OVERALL EVALUATION: After considering all of the review criteria, briefly summarize the most important points of the critique, indicating the relative importance of the major strengths and weaknesses of the application in terms of the five review criteria in arriving at your recommended priority score. An application does not need to be strong in all categories to receive a good rating. Provide the key reasons for your recommendation of a level of scientific merit based on the NIH rating scale.

BUDGET:  Evaluate the appropriateness of the proposed budget in relation to the proposed research. Identify any apparent scientific or budgetary overlap with active or pending support. Two years of support may be requested. Budgets up to $150,000 in Direct Costs over the two years of the R03 award may be requested. The PD/PI must commit a minimum of 20% effort to the project.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: Evaluate the application with reference to the following criteria: risk to subjects, adequacy of protection against risks, potential benefit to the subjects and to others, importance of the knowledge to be gained. If the applicant fails to address all of these elements, notify the SRO immediately. If all of the criteria are adequately addressed, and there are no concerns, write "Acceptable Risks and/or Adequate Protections." A brief explanation is advisable. If one or more criteria are inadequately addressed, write "Unacceptable Risks and/or Inadequate Protections" and document the actual or potential issues that create the human subjects concern.

If the application indicates that the proposed human subjects research is exempt from coverage by the regulations, determine if adequate justification is provided. If the claimed exemption is not justified, indicate "Unacceptable" and explain why you reached this conclusion.

Inclusion of Women, Minorities and Children in Research: Public Law 103-43 requires that women and minorities must be included in all NIH-supported clinical research projects involving human subjects unless a clear and compelling rationale establishes that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research.

The adequacy of plans to include subjects from genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section 8-11 on Human Subjects in the SF424). NIH requires that children (individuals under the age of 21) of all ages be involved in all human subjects research supported by the NIH unless there are scientific or ethical reasons for excluding them.

Each project involving human subjects must be assigned a code using the categories "1" to "5" below. Category 5 for minority representation in the project means that only foreign subjects are in the study population (no U.S. subjects). If the study uses both then use codes 1 through 4.

Examine whether the gender, minority, and children characteristics of the sample are scientifically acceptable, consistent with the aims of the project, and comply with NIH policy. For each category, determine if the proposed subject recruitment targets are "A" (acceptable) or "U" (unacceptable). If you rate the sample as "U", consider this feature a weakness in the research design and reflect it in the overall score. Explain the reasons for the recommended codes; this is particularly critical for any item coded "U".

Gender, Minority, and Children Subjects Categories
CategoryGender (G)Minority (M)Children (C)
1Both GendersMinority & non-minorityChildren & adults
2Only WomenOnly minorityOnly children (age 21 and under)
3Only MenOnly non-minorityNo children included
4Gender UnknownMinority representation unknownRepresentation of children unknown
5  Only Foreign Subjects 

NOTE: To the degree that acceptability or unacceptability affects the investigator's approach to the proposed research, such comments should appear under "Research Plan" in the major review criteria above, and should be factored into the score as appropriate.

IRB Approval: NIH does not require certification of Institutional Review Board (IRB) approval of the proposed research prior to NIH peer review of an application. IRB approval is a just-in-time consideration.

Care and Use of Vertebrate Animals in Research: Express any comments or concerns about the appropriateness of the responses to the five required points (See instructions to NIH application SF424) listed below, especially whether the procedures will be limited to those that are unavoidable for the conduct of scientifically sound research.

Concerns with animal subject use have an impact on the priority score

  • If vertebrate animals are involved, are adequate plans proposed for their care and use?
  • Are the applicant's responses to the five required points appropriate?
  • Will the procedures be limited to those that are unavoidable in the conduct of scientifically sound research
  • Is there any animal Use Protocol approved by the Institutional Animal Care and Use Committee or IACUC

Vertebrate Animals heading must have the following five points. In addition, when research involving vertebrate animals will take place at collaborating site(s) or other performance site(s), the applicant should provide information before discussing the five points. Although no specific page limitation applies to this section of the application, the description has to be succinct.

The application should:

  1. Provide a detailed description of the proposed use of the animals in the work outlined in the Research Design and Methods section. Identify the species, strains, ages, sex, and numbers of animals to be used in the proposed work.
  2. Justify the use of animals, the choice of species, and the numbers to be used. If animals are in short supply, costly, or to be used in large numbers, provide an additional rationale for their selection and numbers.
  3. Provide information on the veterinary care of the animals involved.
  4. Describe the procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices, where appropriate, to minimize discomfort, distress, pain, and injury.
  5. Describe any method of euthanasia to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel on Euthanasia of the American Veterinary Medical Association. If not, present a justification for not following the recommendations.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

This page last updated: March 17, 2008