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Reviewers will provide an overall impact 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.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. Does the project address an important problem or a critical barrier to progress in the field?
Is the prior research that serves as the key support for the proposed project rigorous? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Reviewers should specifically address and consider if the application is significant in one or more of the following criteria:. If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field s?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Reviewers should specifically address and consider if the application is innovative in its plan to use the combination of datasets obtained from two or more multi-site clinical studies. Reviewers should consider if the application is innovative in at least one of the following aspects:. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?
Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Will the scientific environment in which the work will be done contribute to the probability of success?
Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the 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 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 the Guidelines for the Review of Human Subjects.
For additional information on review of the Inclusion section, please refer to 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.
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. As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
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. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group s , in accordance with NIH peer review policy and procedures , using the stated review criteria. As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit generally the top half of applications under review will be discussed and assigned an overall impact score. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date. A formal notification in the form of a Notice of Award NoA will be provided to the applicant organization for successful applications.
The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official. Recipients must comply with any funding restrictions described in Section IV. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
This includes any recent legislation and policy applicable to awards that is highlighted on this website. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols. If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients of federal financial assistance FFA from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.
This includes ensuring programs are accessible to persons with limited English proficiency. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.
The Federal Funding Accountability and Transparency Act of Transparency Act , includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY or later.
In accordance with the regulatory requirements provided at 45 CFR The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system currently FAPIIS. This is a statutory requirement under section of Public Law , as amended 41 U. As required by section of Public Law , all information posted in the designated integrity and performance system on or after April 15, , except past performance reviews required for Federal procurement contracts, will be publicly available.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Recently issued trans-NIH policy notices may affect your application submission. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. Department of Health and Human Services. Part 1. Overview Information. Participating Organization s.
Components of Participating Organizations. Funding Opportunity Title. Activity Code. Announcement Type. Related Notices. Companion Funding Opportunity. Number of Applications. Assistance Listing Number s. Funding Opportunity Purpose. Key Dates.
Posted Date. Open Date Earliest Submission Date. Letter of Intent Due Date s. Expiration Date. Due Dates for E. Required Application Instructions. Use an institutional system-to-system S2S solution to prepare and submit your application to Grants. Check with your institutional officials regarding availability. Use Grants. Table of Contents. Section I. Funding Opportunity Description. Section II. Award Information.
Eligibility Information. Section IV. Application and Submission Information. Section V. Application Review Information. Section VI. Award Administration Information. Section VII. Agency Contacts. Section VIII. Other Information. Part 2. Full Text of Announcement.
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