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Definitions of Criteria and Considerations for Coordinating/Administrative Centers/Cores
Updated March 21, 2016
Standard criteria and considerations are shown below. Individual Funding Opportunity Announcements (FOAs) may have additional criteria and considerations.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the [Center/Core] 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 [Center/Core] proposed).
Scored Review Criteria
Does the proposed [Center/Core] address the needs of the research [programs/projects/network/consortium/resource] that it will [coordinate/administer/serve]? Is the scope of activities proposed for the [Center/Core] appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research [program/projects/network/consortium/resource]?
Are the PD(s)/PI(s)/Directors and other personnel well suited to their roles in the [Center/Core]? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing [adjective] research? Do the investigators demonstrate significant experience with coordinating collaborative [basic or clinical] research? [If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their [leadership approach, governance, plans for conflict resolution, and organizational structure] appropriate for the Center?] Does the applicant have experience overseeing selection and management of subawards, if needed?
Does the application propose novel [organizational concepts, management strategies, or instrumentation] in coordinating the research [program/projects/network/consortium/resource] the [Center/Core] will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of [organizational concepts, management strategies or instrumentation] proposed?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research [program/projects/network/consortium/resource] the [Center/Core] will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the [program/projects/network/consortium/resource], as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the [program/projects/network/consortium/resource] is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the [program/projects/network/consortium/resource]? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of biological variables, such as sex, for studies of vertebrate animals or human subjects?
Will the institutional environment in which the [Center/Core] will operate contribute to the probability of success in facilitating the research [program/projects/network/consortium/resource] it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the [Center/Core] proposed? Will the [Center/Core] benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
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, see the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children.
When the proposed [Center/Core] 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 Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
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 [Center/Core].
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the [Center/Core]. 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.
Applications from Foreign Organizations.
Reviewers will assess whether the [Center/Core] 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).
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) Genomic Data Sharing Plan.
Authentication of Key Biological and/or Chemical Resources.
For [Centers/Cores] involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources. Key biological and/or chemical resources are those that: 1) may differ from laboratory to laboratory or over time; and 2) could influence the research data. These include, but are not limited to, cell lines, antibodies and specialty chemicals.
Budget and Period of Support.
Additional Comments to the Applicant.
Reviewers may provide guidance to the applicant or recommend against resubmission without fundamental revision.