See more tips for avoiding common errors. Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
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Only the review criteria described below will be considered in the review process. As part of the NIH mission , all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
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 there a strong scientific premise for the project? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Does the application address a critical minority health or health disparities issue with potential to make a significant contribution to the field? 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 investigative team have multidisciplinary expertise including disparities research and simulation modeling?
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? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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? Is the selected SMSS methodology appropriate for the minority health or health disparities questions to be addressed?
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?
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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 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 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 convened by Center for Scientific Review, in accordance with NIH peer review policy and procedures , using the stated review criteria. Applications will compete for available funds with all other recommended applications.
Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:. 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. Awardees 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.
Recipients of federal financial assistance FFA from HHS must administer their programs in compliance with federal civil rights law. This includes ensuring your programs are accessible to persons with limited English proficiency.
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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.
HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. 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 awardees 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. Gregory Bloss, M. Bloss nih. Howard Hoffman, M. Elizabeth Neilson, Ph. Jane L. Bostick is a graduate of the U.
He currently serves as the Chief Operating Officer at Intrexon, a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet. As Chief Operating Officer, Lt. Ret Bostick oversees operations across the Company's multiple technology divisions, driving efficiency and effectiveness in the application of the Company's assets toward its development projects. Ret Bostick has been one of the leading advocates in the federal government on resilience and developing a systems approach to watersheds. He led the U.