Definitions of Criteria and Considerations for F Critiques

Overall Impact/Merit. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood that the fellowship will enhance the candidate’s potential for, and commitment to, a productive independent scientific research career in a health-related field, in consideration of the scored and additional review criteria.

Remember that the F programs are training awards and not research awards. Major considerations in the review are the candidate's potential for a productive career, the candidate's need for the proposed training, and the degree to which the research training proposal, the sponsor, and the environment will satisfy those needs.

Additional Guidance for F33. Assess the appropriateness of the years requested for accomplishing the research training and fully justifying any proposed change.

1. Fellowship Applicant.

F30. Are the applicant’s academic record and research experience of high quality? Does the applicant have the potential for, and commitment to, becoming an important contributor to biomedical, behavioral or clinical science as a physician-scientist or clinician-scientist?

F31. Are the applicant’s academic record and research experience of high quality? Does the applicant have the potential to develop as an independent and productive researcher?

F31. Diversity. Are the applicant’s academic record and research experience of high quality? The latter is especially important for advanced graduate students. Does the applicant have the potential to develop as an independent and productive researcher?

F32 and F33. Are the applicant’s academic record and research experience of high quality? Does the applicant have the potential to develop as an independent and productive researcher in biomedical, behavioral or clinical science?

2. Sponsors, Collaborators, and Consultants.

F30. Are the sponsor’s research qualifications (including successful competition for research support) and track record of mentoring appropriate for the proposed fellowship? Are there (1) evidence of a match between the research interests of the applicant and the sponsor (including an understanding of the applicant’s research training needs) and (2) a demonstrated ability and commitment of the sponsor to assist in meeting these needs? Are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, appropriate for the proposed research project?

F31, F31 Diversity, F32, and F33. Are the sponsor’s research qualifications (including successful competition for research support) and track record of mentoring appropriate for the proposed fellowship? Are there (1) evidence of a match between the research interests of the applicant and the sponsor (including an understanding of the applicant’s research training needs) and (2) a demonstrated ability and commitment of the sponsor to assist in meeting these needs? Are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, appropriate for the proposed research project?

3. Research Training Plan.

F30. Is the proposed research plan of high scientific quality, and does it relate to the applicant’s training plan? Is the training plan consistent with the candidate’s stage of research development? Will the research training plan provide the applicant with individualized and supervised experiences that will develop research skills needed for an independent researcher and physician-scientist or clinician-scientist?

F31 and F32. Is the proposed research plan of high scientific quality, and does it relate to the applicant’s training plan? Is the training plan consistent with the candidate’s stage of research development? Does the research plan address scientific significance, originality, and feasibility? Will the research training plan provide the applicant with individualized and supervised experiences that will develop research skills needed for his/her research career?

F31 Diversity. Is the proposed research plan of high scientific quality, and does it relate to the applicant’s training plan? Is the training plan consistent with the candidate’s stage of research development? Will the research training plan provide the applicant with individualized and supervised experiences that will develop research skills needed in preparation for his/her research career? For advanced graduate students, does the research plan address scientific significance, originality, and feasibility? For beginning graduate students, is the research plan of high quality and clarity?

F32. See F31 and F32 above.

F33. Is the proposed research plan of high scientific quality, and does it relate to the applicant’s career plan? Will the research training plan provide the applicant with proper experience to develop research skills needed in preparation for his/her research career?

4. Training Potential.

F30. Does the proposed research training have the potential to serve as a sound foundation that will lead the fellow to a productive research career as a physician or clinician scientist? Does the proposed research training plan have the potential to provide the fellow with the requisite individualized and supervised experiences that will develop his/her research skills?

F31, F31 Diversity, and F32. Does the proposed research training have the potential to serve as a sound foundation that will lead the fellow to a productive career? Does the proposed research training plan have the potential to provide the fellow with the requisite individualized and supervised experiences that will develop his/her research skills?

F33. Does the proposed research experience have the potential to enhance of applicant's capabilities as an independent researcher?

5. Institutional Environment & Commitment to Training.

F30. Is the institutional environment for the scientific development of the applicant of high quality, and is there appropriate institutional commitment to fostering the fellows’ training as a physician-scientist or clinician-scientist? Are the research facilities, resources (e.g. equipment, laboratory space, computer time, subject populations), and training opportunities adequate and appropriate?

F31, F31 Diversity, F32, and F33. Is the institutional environment for the scientific development of the applicant of high quality, and is there appropriate institutional commitment to fostering the fellows’ training? Are the research facilities, resources (e.g. equipment, laboratory space, computer time, subject populations), and training opportunities adequate and appropriate?

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

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 (as described in Human Subjects Protection and Inclusion), reviewers are asked to 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. 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. Also, if a clinical trial is proposed, evaluate the Data and Safety Monitoring Plan. (If the plan is absent, notify the SRO immediately to determine if the application should be withdrawn.) Indicate if the plan is "Acceptable" or "Unacceptable", and, if unacceptable, explain why it is unacceptable.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt, evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. If the claimed exemption is not justified, indicate “Unacceptable”, and, if unacceptable, explain why it is unacceptable.

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

For additional information to assist you in making these determinations, please refer to the Human Subjects Protection and Inclusion and Human Subjects Worksheet for Comments.

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.

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. 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 thru 4. Examine whether the minority and gender 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 Inclusion Code	Minority Inclusion Code	Children Inclusion Code
G1 = Both genders	M1 = Minority and nonminority	C1 = Children and adults
G2 = Only women	M2 = Only minority	C2 = Only children
G3 = Only men	M3 = Only nonminority	C3 = No children included
G4 = Gender composition unknown	M4 = Minority composition unknown	C4 = Representation of children unknown
	M5 = 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 "Approach" in the five major review criteria above, and should be factored into the score as appropriate.

For additional information to assist you in making these determinations, please refer to the Human Subjects Protection and Inclusion and Human Subjects Worksheet for Comments.

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.

For additional information to assist you in determining if the Vertebrate Animals section is “Acceptable” or “Unacceptable”, please refer to Vertebrate Animals checklist.

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.

Select Agents. 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). For more details, please see Select Agents.

Responsible Conduct of Research. Every NRSA fellow must receive instruction in the responsible conduct of research (http://grants.nih.gov/grants/guide/notice-files/not92-236.html). Applications must include the sponsoring institution’s plans to provide and the candidate's plans for obtaining instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction. The amount and nature of faculty participation must be described. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the overall impact/priority score. The plan will be judged as acceptable or unacceptable. If unacceptable, it will be noted and described in an administrative note of the summary statement. Regardless of the overall impact/priority score, an application with an unacceptable plan will not be funded until the applicant provides a revised, acceptable plan. Staff in the NIH awarding component will judge the acceptability of the revised plan.

Budget and Period Support.

F30, F31. Fellowship budgets are fixed, and, therefore, no comment is needed. Consider instead whether or not the requested duration of the proposed training program is appropriate. Individuals may receive up to five years of aggregated Kirschstein-NRSA support at the predoctoral level. Training beyond this time limit may be possible by obtaining a waiver through the NIH awarding component.

F32. Fellowship budgets are fixed, and, therefore, no comment is needed. Consider instead whether or not the requested duration of the proposed training program is appropriate. Individuals may receive up to three years of aggregated Kirschstein-NRSA support at the postdoctoral level. Training beyond this time limit may be possible by obtaining a waiver through the NIH awarding component.

F33. The amount of the award for a senior fellowship will be determined individually at the time of award, based on the salary at the home institution.

For more details, please see Budget Information.

Resource Sharing Plans.
Reviewers will comment on whether the Resource Sharing Plan for Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html) is reasonable.

Sharing Model Organisms. For many individual fellowships it is anticipated that plans for sharing model organisms would have already been reported to the NIH by the sponsor in his/her research application. When this has occurred, applicants will indicate so and include the appropriate grant number. However, if the development of a new model organism is anticipated, applicants will include a description of a specific plan for sharing and distributing unique model organism research resources or state appropriate reasons why such sharing is restricted or not possible (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html). Unlike the NIH Data Sharing Policy, the submission of a model organism sharing plan is NOT subject to a cost threshold of $500,000 or more in direct costs in any one year, and is expected to be included in all applications where the development of model organisms is anticipated.

Additional Comments to the Applicant.
Reviewers may provide guidance to the applicant or recommend against resubmission without fundamental revision.

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