Definitions of Criteria and Considerations for K Critiques

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Overall Impact. Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact/priority score.

1. Candidate.

K01

K02

K05

K07 (Development)

K07 (Leadership)

K08

K22 (Mentored)

K23

K24

K25

K99/R00

2. Career Development Plan/Career Goals & Objectives/Plan to Provide Mentoring.

K01

K02

K05

K07 (Development)

K07 (Leadership)

K08

K22 (Mentored)

K23

K25

K24 [Plan to Provide Mentoring]

K99/R00

3. Research Plan.

K01

K02

K05

K07 (Development and Leadership)

K08

K22 (Mentored and Independent)

K23

K24

K99/R00

4. Mentor(s), Co-mentor(s), Consultant(s), Collaborator(s).

K0

K02 [Consultants and Collaborators]

K05 [Consultants and Collaborators]

K07 (Development)

K07 (Leadership) [Consultants and Collaborators]

K08

K22 (Mentored)

K22 Independent [Consultants and Collaborators]

K23

K24 [Consultants and Collaborators]

K25

K99/R00

5. Environment and Institutional Commitment to the Candidate.

K01

K02

K05

K07 (Development and Leadership)

K08

K22 (Mentored and Independent)

K23

K25

K24

K99/R00

Additional Review Criteria

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 Guidelines.

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.

Renewals. For Renewals, the committee will consider the progress made in the last funding period.

Revisions. 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.

Training in the Responsible Conduct of Research

K01, K07 (Development Award), K08, K18, K22, K23, K25 and K99/R00. Taking into account the circumstances of the candidate, 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 candidate'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.

K02, K05, K07 (Leadership), K24 and K26. Taking into account the circumstances of the candidate, including the more senior level of experience of candidates for this award, 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 that the candidate will participate in? 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 candidate's role in the participation in instruction in RCR? 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.

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).

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.

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

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