Definitions of Criteria and Considerations for F Critiques
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.
For this particular announcement, note the following:
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.
F31, F31 Diversity, F32 and F33. Are the applicant fellow's academic record and research experience of high quality? Does the applicant fellow have the potential to develop as an independent and productive researcher in biomedical, behavioral or clinical science?
F30. Are the applicant fellow's academic record and research experience of high quality? Does the applicant fellow have the potential for, and commitment to, becoming an important contributor to biomedical, behavioral or clinical science as a physician-scientist or clinician-scientist?
2. Sponsors, Collaborators, and Consultants.
All Fs. 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 fellow 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.
F31, F31 Diversity, F32 and F33. Is the proposed research plan of high scientific quality, and does it relate to the applicant fellow's training plan? Is the training plan consistent with the applicant fellow's stage of research development? Will the research training plan provide the applicant fellow with individualized and supervised experiences that will develop research skills needed for his/her independent and productive research career?
F30. Is the proposed research plan of high scientific quality, and does it relate to the applicant fellow's training plan? Is the training plan consistent with the applicant fellow's stage of research development? Will the research training plan provide the applicant fellow with individualized and supervised experiences that will develop research skills needed as a physician-scientist or clinician-scientist?
4. Training Potential.
F31, F31 Diversity, F32 and F33. Does the proposed research training plan have the potential to provide the applicant fellow with the requisite individualized and supervised experiences that will develop his/her research skills? Does the proposed research training have the potential to serve as a sound foundation that will lead the applicant fellow to an independent and productive career?
F30. Does the proposed research training plan have the potential to provide the applicant fellow with the requisite individualized and supervised experiences that will develop his/her research skills? Does the proposed research training have the potential to serve as a sound foundation that will lead the applicant fellow to a productive research careers as a physician or clinician scientist?
5. Institutional Environment & Commitment to Training.
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 Human Subjects Protection and Inclusion.
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 Human Subjects Protection and Inclusion Guidelines.
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 on review of the Vertebrate Animals section, please refer to 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. For Resubmissions, the committee will 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.
Renewal. For Renewals, the committee will consider the progress made in the last funding period.
Revisions. Not Allowed.
Training in the Responsible Conduct of Research. Taking into account the circumstances of the fellow, including level of experience, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework, and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of the sponsor/mentor or other faculty involvement in the fellow's instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus rating of the review committee. Applications rated UNACCEPTABLE will not be funded until the applicant provides an acceptable, revised plan.
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). For more details, please see Select Agents.
Resource Sharing Plans. Reviewers 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).
Budget and Period of Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. For more details please see Budget Information.
Additional Comments to the Applicant. Reviewers may provide guidance to the applicant or recommend against resubmission without fundamental revision.
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