Definitions of Criteria and Considerations for R13/U13 Critiques

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Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood that the proposed conference/meeting 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. Does the conference/scientific meeting address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the conference/scientific meeting change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

2. Investigator(s). Are the PDs/PIs, collaborators, and other researchers well suited for organizing and fulfilling the goals of this conference/scientific meeting? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? 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?

Are the key personnel and selected speakers appropriate and well suited for their described roles in the conference/scientific meeting?

3. Innovation. Does the conference/scientific meeting content challenge and seek to shift current research or clinical practice paradigms, or employ novel approaches or methods to fulfill its purpose? Will the conference/scientific meeting cover concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Will the conference/scientific meeting address a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the conference/scientific meeting draw together appropriate experts who may otherwise not have an opportunity to meet?

4. Approach. Are the format and agenda for the conference/meeting well-reasoned and appropriate to accomplish the specific aims of the conference/scientific meeting? Are potential problems, alternative strategies, and benchmarks for success presented? If the field is in the early stages of development, will the conference/scientific meeting establish feasibility and will particularly risky aspects be addressed?

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?  Is the conference/meeting timely for the subject matter?

5. Environment. Will the conference/scientific meeting site contribute to the probability of success? Are the institutional support, equipment and other physical resources available adequate for the conference/meeting proposed? Will the conference/scientific meeting benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Appropriate Representation. How well do the plans for inclusion of women, racial/ethnic minorities, persons with disabilities, and other individuals who traditionally have been underrepresented in science provide for their appropriate representation in the planning, organization, and execution of the proposed conference/scientific meeting? See Inclusion of Women, Minorities and Persons with Disabilities in NIH-Supported Conference Grants: (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-066.html.

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. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission. When reviewing a Resubmission application (formerly called an amended application), 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. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision. When reviewing a Revision application (formerly called a competing supplement application), 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.

Provision of Family Care Facilities. Are the plans to inform attendees about family care resources adequate?

Applications from Foreign Organizations. As applicable for the FOA or submitted application, 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. (Not Applicable)

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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