Definitions of Criteria and Considerations for R25 Critiques

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Overall Impact. Reviewers will provide an overall impact/priority score 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).

1. Significance. Does the proposed research education program address an important problem or critical question in research education or other critical issues? How will implementation of the proposed program advance the objectives of the proposed program?

2. Investigator(s). Are the PD(s)/PI(s), collaborators, and other researchers appropriately trained and well suited to the proposed research education program? Is the PD/PI an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program? If Early Stage Investigator or New Investigator, or in the early stages of an independent career, does the PD/PI have appropriate experience to lead the program? 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? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives?

3. Innovation. Is the proposed research education program characterized by innovation and scholarship? Does the proposed program challenge and seek to shift current research education paradigms or clinical practice, or address an innovative hypothesis or critical barrier to progress in the field? Are the proposed concepts, approaches, methodologies, tools, or technologies novel for this area? Does this proposed program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere? Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program.

4. Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If called for, is the proposed plan for evaluation and/or dissemination of the education program sound and likely to provide data on the effectiveness of the education program? Is there evidence that the program is based on sound research concepts and educational principles? Is the approach feasible and appropriate to achieve the stated research education goals? If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of children, justified in terms of the scientific goals and research strategy proposed?

5. Environment. Will the scientific/educational environment in which the proposed research education program will be conducted contribute to the probability of success? Are the institutional commitment and support, equipment and other physical resources available to the investigators adequate for the program proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, and institutions? If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)?

Protections for Human Subjects. Generally not applicable. 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, see the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children. Generally not applicable. When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information, see the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals. Generally not applicable. 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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards. Generally not applicable. 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.
Resubmission. For Resubmissions, the committee will evalua
te 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, and the success of the program in attracting and retaining individuals from diverse populations, including populations underrepresented in biomedical and behavior.

Revision. For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Recruitment & Retention Plan to Enhance Diversity. Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel's evaluation will be included in an administrative note in the summary statement. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research. Taking into account the specific characteristics of the research education program, level of participant experience, and the particular circumstances of the participants, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures 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 how faculty will participate in the instruction? Do the plans ensure participants will receive instruction (or in the case of more senior level participants, provide instruction) for an appropriate amount of time given the length of the research education experience? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

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 (Optional). Reviewers may provide guidance to the applicant

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