National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Behavioral and Social Sciences Research (OBSSR)
93.242, 93.867, 93.866, 93.273, 93.286, 93.865, 93.173, 93.213, 93.279, 93.853
The BRAIN Initiative and the neuroscience field as a whole are generating massive and diverse research data across different modalities, spatiotemporal scales and species in efforts to advance our understanding of the brain. The data types are being produced through development and application of innovative technologies in high-throughput -omics profiling, optical microscopy, electron microscopy, electrophysiological recording, macroscale neuroimaging, neuromodulation, and others. The BRAIN Initiative has made significant investments in the development of an infrastructure to make data available to the research community in a useful way. This infrastructure includes data archives, data standards, and software for data integration, analysis and machine learning.
This Funding Opportunity Announcement (FOA) encourages secondary analysis of the large amounts of existing data related to the BRAIN Initiative. The data do not need to be held in one of the funded BRAIN Initiative data archives, but the data must be held in a data archive that is readily accessible to the research community. Support will be provided for innovative analysis of relevant existing datasets using conventional or novel analytic methods, data science techniques, and machine learning approaches. Support may also be requested to prepare and submit existing data into any of the BRAIN Initiative data archives. Investigators should not underestimate the time and effort that may be necessary to curate or harmonize data.
Analyzed data, models and analytical tools generated under this FOA are expected to be deposited into an appropriate data archive. Since the BRAIN Initiative data archives are mostly making the data available to the research community through cloud-based storage, depositing the analyzed data, models and tools are expected to enhance opportunities to create a data sandbox where investigators can easily compare the results of their analysis with those from other research groups.
The goal of this FOA is to promote studies that will significantly advance new discoveries and accelerate the pace of research of the BRAIN Initiative through harnessing the big data and machine learning opportunities. Awardees are expected to enhance the value of existing data, improve the overall data integration and analysis capability, and strengthen the statistical power and rigor and reproducibility of BRAIN Initiative related data.
April 10, 2019
30 days prior to the application due dates
New Date September 6, 2019, June 11, 2020, and February 26, 2021 by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
No late applications will be accepted for this Funding Opportunity Announcement.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
New Date February 27, 2021 per issuance of NOT-MH-20-052. (Original Expiration Date: June 12, 2020)
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative® is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, will show how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to treat and prevent brain disorders.
NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN initiative is guided by the long-term scientific plan, “BRAIN 2025: A Scientific Vision,” which details seven high-priority research areas and calls for a sustained federal commitment of $4.5 billion over 12 years. This and other Funding Opportunity Announcements (FOAs) issued as part of the BRAIN initiative are based on careful consideration by the NIH of the recommendations of the BRAIN 2025 Report, and input from the NIH BRAIN Multi-Council Working Group. Videocasts of the NIH BRAIN Multi-Council Working Group are available at http://www.braininitiative.nih.gov/about/mcwg.htm.
To enable rapid progress in development of new technologies as well as in theory and data analysis, the BRAIN Initiative encourages collaborations between neurobiologists and scientists from disciplines such as statistics, physics, mathematics, engineering, and computer and information sciences. NIH welcomes applications from investigators in all of these disciplines.
NIH encourages BRAIN Initiative applications from investigators that are underrepresented in the biomedical, behavioral, or clinical research workforce (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). Such individuals include those from underrepresented racial and ethnic groups, those with disabilities, and those from disadvantaged backgrounds.
NIH also encourages businesses to participate in the BRAIN Initiative. It is possible for companies to submit applications directly to BRAIN Initiative program announcements or to collaborate with academic researchers in joint submissions. Small businesses should consider applying to one of the BRAIN Initiative small business FOAs (http://braininitiative.nih.gov/funding/index.htm).
In addition to the BRAIN Initiative, the NIH continues to have a substantial annual investment in neuroscience research. The Institutes and Centers contributing to the NIH BRAIN Initiative (http://braininitiative.nih.gov/) support those research efforts through investigator-initiated applications as well as through specific FOAs. Potential applicants to this FOA are strongly encouraged to contact Scientific/Review staff if they have any questions about the best FOA for their research.
The BRAIN Initiative will require a high level of coordination and sharing between investigators. It is expected that BRAIN Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings and in other activities.
The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.
This FOA is related to the recommendations in Section III.5 of the BRAIN 2025 Report. Specifically, this FOA solicits applications that will address the recommendations on “Identifying Fundamental Principles”.
Big Data and Machine Learning Approaches to the BRAIN Initiative
The rapid expansion in the amount of data generated related to the BRAIN Initiative, along with the high dimensionality and complexity of the data, challenge our ability to analyze or interpret the data for scientific discovery. This FOA is meant to provide the necessary funds to:
Often, measured data, especially from high-throughput studies, can be used by researchers to examine hypotheses and questions beyond the interest of those who initially derived the data. An opportunity for secondary data analysis particularly occurs when advanced or new analytic methods, computational tools or theoretic frameworks become available after the initial data were measured. Another opportunity is a joint analysis with the such data as those available from the Human Connectome Projects and the Adolescent Brain Cognitive Development Study.
Data generated from multiple laboratories or across different modalities or scales are also attractive targets for further analysis. In these cases, substantial effort may be needed to harmonize or link the data that are in existing data archives. Harmonization activities to link specific data sets may be generalizable, which is why the NIH expects that such workflows will be deposited in an appropriate data archive.
Machine learning or artificial intelligence is expected to contribute greatly to understanding the data that are relevant to the BRAIN Initiative. Unsupervised learning by methods such as clustering, dimensionality reduction or decomposition, and graph theory could be used on large data sets to better understand brain circuits. Applications involving supervised learning using technologies such as artificial neuronal network, random forest and support vector machines are also welcome under this FOA. Finally, mathematical modeling or simulation by methods such as partial differential equations, agent-based models, Markov chains and Bayesian networks are welcome under this FOA as well.
BRAIN Initiative Informatics Infrastructure
The BRAIN Initiative has made significant investments in the development of informatics infrastructure for a) data archives (awards from RFA-MH-17-255, RFA-MH-19-145); b) data standards (awards from RFA-MH-17-256, RFA-MH-19-146); and c) software tools for data integration, analysis and machine learning (awards from RFA-MH-17-257, RFA-MH-19-147). The infrastructure is mostly implemented in a cloud environment. The three components of the infrastructure also interact with each other: the data archives implement the software tools, which enables users to analyze the archived data on a cloud environment without downloading the data out of the archive; the data archives and the software tools moreover adopt the data standards, which facilitates data sharing and the rigor and reproducibility of research. A complete list of funded projects on the informatics infrastructure can be found at https://www.braininitiative.nih.gov/funding/funded-awards by entering informatics in the Program field..
Wherever possible, the BRAIN Initiative informatics infrastructure should be leveraged in applications submitted to this FOA. Applicants should investigate the computational resources and data processing pipelines that are available from the BRAIN Initiative data archives. Currently the BRAIN Initiative supports and maintains the following five data archives:
Additionally, archives such as the Collaborative Research in Computational Neuroscience, dbGaP and the NIMH Data Archive may have data relevant to the BRAIN Initiative. The NLM maintains a list of data repositories that may also have relevant data (https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html). Applicants should check those or other information to find many of the potential data sources. Applications will be responsive to this FOA as long as the data to be analyzed is readily available to the research community in a data archive. The preceding list of data archives is not exhaustive. Applicants are encouraged to contact program staff if they have questions about whether the data they plan to analyze is in an appropriate data archive.
Investigators who are primarily interested in developing new software tools should consider applying to either RFA-EB-17-005 (BRAIN Initiative: Theories, Models, and Methods for Analysis of Complex Data from the BRAIN), or RFA-MH-19-147 (BRAIN Initiative: Integration and Analysis of BRAIN Initiative Data) depending on their specific interests. While tool development is not prohibited, the real goal of this FOA is to support the application of tools to analyze existing data rather than the development of new tools. Applicants are strongly encouraged to contact program staff if they have questions about the best FOA for their applications.
This FOA invites applications that will conduct secondary analysis or data mining of existing data relevant to the BRAIN Initiative goal of understanding brain circuits. The FOA also invites applications that seek to prepare and submit existing data that are highly relevant to the BRAIN Initiative into one of the BRAIN Initiative data archives.
Applications can propose to generate or test new hypotheses which would not be possible in studies of single experiments, single technologies or single laboratories, or were beyond the scope of the original studies. Applications that propose to reanalyze existing data sets using new tools or approaches are also welcome. The proposed research may involve innovative analyses of existing data or novel combination or integration of existing data sets to address new aims or explore new questions.
Applicants may want to consider the neuroethical implications of proposals involving data from human subjects.
Examples of potential research topics include, but are not limited to:
This FOA encourages use of the BRAIN Initiative informatics infrastructure, including data archives, data standards and analytic software in the proposed research. Applicants should request an appropriate staff time as well as computational time for the proposed analysis. Preference will be given to approaches that compute on the data without moving it rather than approaches that require the data to be downloaded from the archive.
While some of the BRAIN Initiative data are already stored in one of the BRAIN Initiative data archives or other stable data repositories (e.g., CRCNS.org), others datasets that are ready for additional analysis might only be available in the laboratory that collected the data. Applicants may propose to analyze such privately held data, but such applications must request funds to deposit the data at the beginning of the project. Data analysis will not be permitted until the data have been deposited in a data archive so that the data are available to others in the research community.
This FOA expects deposition of the analysis pipelines or/and analysis results (e.g., processed data, training or gold-standard data, computational models, and statistical models) to a relevant data archive after secondary analysis or data mining. In this way, the FAIR principles for data sharing and the rigor and reproducibility of research will be enhanced.
This FOA encourages either collaborations with or applications from mathematicians, theoreticians, physicists, ethics specialists, computer scientists or artificial intelligence experts for cross-fertilization in the big data and machine learning approaches to the BRAIN Initiative. Collaborations between those who originally acquired the data and those analyzing the data are not required but may be helpful.
Applications will be considered non-responsive to this FOA if they:
Applicants are encouraged to contact the Scientific/Research staff listed below for clarification regarding the scope of this funding opportunity.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Issuing IC and partner components intend to commit an estimated total of $4,000,000 to fund 8 awards in FY2020.
The scope of the proposed project should determine the project period. The maximum project period is 3 years
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. 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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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:
The letter of intent should be sent to:
All instructions in the SF424 (R&R) Application Guide must be followed.
In the Significance section, describe the relevance or importance of the project to the goals of the BRAIN Initiative, found in BRAIN 2025: A Scientific Vision.
In the Approach section, if the data are held in a non-BRAIN Initiative funded archive, describe the archive and explain how researchers can access the data. Describe how the archive will make analysis pipelines and results available to research community to create a data sandbox where other researchers can continue to build on this work.
In the Investigator section, explain how the research team has appropriate expertise from all of the disciplines that are needed to conduct the proposed research.
Location of Data: Applications must clearly state where the data proposed for analysis are located. This statement should include relevant data set identifiers. In cases where the data are currently privately held, the archive that has been selected to hold the raw data must be indicated. In such cases, a letter of support from the manager of the data archive should be included in the application indicating that the archive will accept the data set.
Timeline: A timeline should be included as part of the Research Strategy and should include a distinct final section, entitled “Milestones”, that briefly proposes indicators of progress at critical junctures. These should be tailored to the unique scope of each project and written concretely enough to evaluate what exactly will have been achieved during the project.
The following modifications also apply:
The data sharing expectations for BRAIN Initiative awards can be found at NOT-MH-19-010.
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. There is no prescribed single license for the distribution of software or other analytic tools produced through grants responding to this announcement. However, the data sharing plan is expected to discuss: (1) how the software or tools will be made widely available; (2) transferability, i.e., ability of another individual or team to continue development as appropriate; (3) terms of availability that will enable researchers to enhance the software or tools and share those enhancements with colleagues.
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
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. 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.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
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. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at NIMHReferral@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applications Involving the NIH Intramural Research Program
The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.
If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.
Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.
Use of Common Data Elements in NIH-funded Research
Many NIH ICs encourage 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. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g., genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
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? 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 aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Will the outcome the proposed data analysis be important in achieving the goals of the BRAIN Initiative ? If data archiving is proposed, will the newly available data be widely used or important to the research community? Will the output from a grant award contribute to a creation of a data sandbox where other researchers can continue to build on this work?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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)? 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?
Does the research team have expertise from all of the disciplines that are needed to conduct the proposed research?
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 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?
Is the location of the data set clearly stated? Does the proposed archive make the data easily accessible to the research community? Does the proposed archive have an appropriate infrastructure to make data analysis pipelines and results be easily accessible to the research community? Will the proposed archive allow the research community be able to build on the results of this work?
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) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
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?
Milestones and Timelines
Are the proposed milestones and timeline described in a sufficient detail and are they appropriate for the project? Is the timeline reasonable? Are the milestones feasible, well developed, and quantifiable?
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.
When the proposed project 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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. 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.
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 project.
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.
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 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 (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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 grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. 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.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. 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 means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. 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.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. 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 awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. 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. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. 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. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The Federal Funding Accountability and Transparency Act of 2006 (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 FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. 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 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
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Ming Zhan, Ph.D.
National Institute of Mental Health (NIMH)
Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
National Institute of Mental Health (NIMH)
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