Definitions of Criteria and Considerations for P30 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 five core review criteria, and additional review criteria (as applicable for the project proposed).

1. Significance. How will the new Core Center contribute to building a community of multidisciplinary researchers focusing on a common research problem and enhance the ability of the institution/organization to conduct research in the specified area(s) of science? Will new faculty members hired under this initiative conduct research projects and receive career development support that will foster independent research careers and lead toward applications for future independent research project grants to further the mission of the Core Center?

2. Investigator(s). Does the PD/PI have the ability and institutional authority to provide scientific and administrative leadership and direction for the Core Center, and to work with Core Center investigators to develop relevant research projects?

3. Innovation. Does the application identify critical research program needs and seek creative ways to incorporate Core Center resources, new tenure-track faculty and new research projects to help address those needs?

4. Approach. Are the plans for recruiting and appointing new investigators within the Core Center adequate and appropriate for furthering the scientific mission of the Center? Will the research activities and resources of the proposed Core Center assist in the development and strengthening of intra- and inter-institutional relationships across the academic health center or university, or with other institutions? Is the plan for evaluation thorough and rigorous? Are the proposed scientific goals of the Core Center, as well as the plans to achieve those goals, feasible, innovative and of high scientific/technical merit? Are potential problems, alternative strategies, and benchmarks for success presented? Are the proposed plans and criteria to select relevant research projects and monitor their long term success of sufficient strength, feasibility and appropriateness, including whether there is an adequate strategy for selecting projects that leverage resources and complement the Core Center's mission and strengths?

5. Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Is the current infrastructure well described and is it conducive to conducting research projects that are relevant to the research mission of the proposed Core Center? Will the research activities within the Core Center help to foster career development for newly-independent investigators, and lead toward applications for future independent research project grants that further the mission of the Core Center? Are the institutional support, equipment and other physical resources available to the investigators adequate for the development and implementation of relevant research projects? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence that new faculty members hired under this initiative will have at least 75% protected research time during the duration of this award? Will new faculty members be given appropriate joint appointment(s) and access to facilities, resources and graduate students from other components in the institution/organization, or collaborating institutions? Are shared institutional resources being made available to investigators within the Core Center?

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.

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.

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.

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

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