The maximum project period is 5 years; however, applicants are strongly encouraged to limit the proposed project period to years. Non-domestic non-U. Entities Foreign Institutions are eligible to apply. Organizations are eligible to apply. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Obtaining an eRA Commons account can take up to 2 weeks. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:.
Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information:. Email: NIMHreferral mail. Other Attachments: Applicants should upload a single attachment that includes the following information relevant to the proposed project. Applicants should use the headers below in their description. This attachment must be no more than 4 pages.
Applications that exceed this limit will not be reviewed. Applications lacking the following information will not be reviewed :. Applications should not duplicate information provided in the attachment described in Section IV. Foreign non-U. See Part 1. Section III. Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
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When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants. NIH and Grants. Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
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This initiative is not subject to intergovernmental review. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. See more tips for avoiding common errors. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations , NIH. NIMH encourages the use of common data elements CDEs in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.
CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects. Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD 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 provide a compelling argument for the public health benefit of the proposed strategy, in terms of the implications of improved metrics for monitoring quality e. Do the study results have potential to contribute to a body of generalizable knowledge regarding best-practices for the assessment of quality of psychosocial intervention delivery e.
If Early Stage Investigators or New Investigators, or 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? Are innovative data collection methods e. 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? Does the application describe the empirical basis and provide a compelling rationale for the proposed method for assessing therapy quality, including the rationale for the proposed focus or unit of analysis e.
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Does the application specify a sound research strategy that will be used for the initial development and operationalization of the quality metric e. Does the application describe well-reasoned plans for examining the psychometric properties of the assessment strategy and for prospectively testing whether the candidate measure of quality is associated with patient outcomes and other established metrics of quality, e. Is a compelling power analysis provided for analyses that will be used to examine validity of the assessment approach i. 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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Are the research and clinical resources appropriate for supporting the proposed research? Does the application describe existing infrastructure e. 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. 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.
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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. 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. For example, applying SE methods can be accomplished on simple subsystems or systems and so perhaps belong in a lower proficiency level such as supervised practitioner. Applying SE methods to complex enterprise or systems of systems, may belong in the practitioner or even the expert level. The determination of what proficiency level is desired for each KSAA is determined by the organization, and may vary among different organizations.
When using application as a measure of competency, it is important to have a measure of goodness.
If someone is applying a competency in an exceptionally complex situation, they may not necessarily be successful in this application. An individual may be managing and guiding , but this is only helpful to the organization if it is being done well. In addition, an individual might be fully proficient in a particular competency, but not be given an opportunity to use that competency; for this reason, it is important to understand the context in which these competencies are being assessed.
Even when an individual is highly proficient in an SE competency, context may preclude exemplary performance of that competency. For example, an individual with high competency in risk management may be embedded in a team or an organization which ignores that talent, whether because of flawed procedures or some other reason.
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