EXPIRED
National Institutes of Health (NIH)
NIH Blueprint for Neuroscience Research
National Institute of Mental Health (NIMH)
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 of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH)
Lifespan Human Connectome Project: Baby Connectome (U01)
U01 Research Project Cooperative Agreements
New
None
RFA-MH-16-160
RFA-AG-16-004, U01 Research Project Cooperative Agreements
RFA-MH-16-150, U01 Research Project Cooperative Agreements
93.242, 93.867, 93.866, 93.273, 93.286, 93.865, 93.173, 93.121, 93.279, 93.113, 93.853, 93.361, 93.213
This Funding Opportunity Announcement (FOA) is issued as an initiative of the NIH Blueprint for Neuroscience Research. The Neuroscience Blueprint is a collaborative framework through which 15 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/). The Neuroscience Blueprint is supporting a Lifespan Human Connectome Project (L-HCP) to extend the Human Connectome Project (HCP) (http://www.neuroscienceblueprint.nih.gov/connectome) to map connectivity in the developing, adult, and aging human brain. The goal of this FOA is to solicit grant applications that propose to extend the experimental protocols developed through the HCP to children in the 0-5 year old age range to investigate the structural and functional changes that occur in the brain during typical development. Related FOAs solicit applications that apply the HCP protocols to the 5-21 year old age range and to middle age and elderly adults to explore changes that occur during normal aging.
April 3, 2015
August 3, 2015
August 3, 2015
September 3, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
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.
Not Applicable
February, 2016
May, 2016
June, 2016
September 4, 2015
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. 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
The National Institutes of Health (NIH) working in part with funds contributed by Wyeth Nutrition in conjunction with the Foundation for NIH (http://www.fnih.org) invites applications to obtain a macro-connectome for children in the 0-5 year old age range. This Funding Opportunity Announcement (FOA) is issued as an initiative of the NIH Blueprint for Neuroscience Research. The Neuroscience Blueprint is a collaborative framework through which 15 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov). The Neuroscience Blueprint is supporting a Lifespan Human Connectome Project (L-HCP) to extend the Human Connectome Project (HCP) (http://www.neuroscienceblueprint.nih.gov/connectome) to map connectivity in the developing, adult, and aging human brain. The goal of this FOA is to solicit grant applications that propose to extend the experimental protocols developed through the HCP to children younger than 5 years of age. Other FOAs solicit applications to collect HCP data in the 5-21 year old age range (RFA-MH-16-150) and to adults in middle age and older (RFA-AG-16-004) . When combined with the data from the original human connectome program (individuals 22-35 year old) a complete set of data will be available to explore the changes in the macro-connectome during normal development and aging. The goal of these complementary FOAs is to enhance and extend the HCP dataset to capture change in early and later lifespan brain connectivity, to expand our understanding of the fundamental organization and operation of the brain and its manifestation in behavior, and to provide valuable reference data to support research examining the role of neurodevelopment and aging in brain disorders.
Background
Over the course of the last decade, there has been an explosion of interest in the organization of structural and functional brain networks, as characterized by connectivity patterns. Mapping brain connectivity will help us understand how the brain is organized, how it develops and changes over time, and how it is altered in diseases and disorders. Connectivity is critical in understanding, diagnosing, and treating certain neurological and psychiatric disorders. Increasingly, disrupted or aberrant connectivity is being implicated or suspected in the etiology of disorders not previously considered from this perspective. For example, it is very likely that quantifiable changes in connectivity accompany the variations in cortical thickness (as demonstrated with structural magnetic resonance imaging) that are seen in diseased brains (e.g., Alzheimer s), and that are seen in brains through the course of early development, adolescence and aging. Similarly, it is likely that qualitative or quantitative changes in connectivity contribute to morphometric differences observed in brains of those with particular disorders, such as schizophrenia. Less clear and ill-defined is the normative trajectory of brain connectivity across the lifespan.
The NIH Blueprint for Neuroscience Research is currently funding the Human Connectome Project (HCP), a cooperative agreement to collect and share structural and functional connectivity data from a large sample of healthy young adults, age 22-35. One of the overarching goals of the HCP has been to develop and share knowledge about the structural and functional connectivity of the human brain to further research in this area. This is being achieved through awards to two different multi-institutional research teams centered at Washington University (http://www.humanconnectome.org/) and Massachusetts General Hospital (http://www.humanconnectomeproject.org/). These teams have developed and optimized non-invasive imaging technologies to acquire structural and functional in vivo data about axonal projections and neural connections from brains of hundreds of healthy young adults. Demographic data and data regarding sensory, motor, cognitive, emotional, social function, and genotyping have also been collected for each subject. The data and experimental protocols have been made available to the research community, and both are now being widely used. Both HCP teams have begun pilot studies to explore the issues with extending the HCP to children and to older adults to represent the lifespan and have made strides in overcoming some of the technical and design challenges inherent to imaging younger and older subjects. Data from these pilot studies are available at https://lifespan.humanconnectome.org/.
Research Studies and Objectives
The purpose of this FOA is to extend and build on the methods and findings from the ongoing HCP to comprehensively and systematically map structural and functional connectivity of the brain in healthy children between the ages of 0 and 5 years old using protocols comparable to those developed by the HCP. The cumulative outcomes of the HCP and the three lifespan connectome FOAs include:
This L-HCP FOA aims to collect structural and functional connectome data representative of the healthy young child. Subjects will span the age range of 0-5 years old. It is expected that cross-sectional, multi-cohorts of different ages will be identified and that connectome data will be collected from at least 300 children. Lifespan projects are encouraged to include multiple timepoints, for at least a subset of participants, allowing for longitudinal (within-subject) analysis of developmental trajectories in addition to cross-sectional comparisons.
L-HCP data collection must use neuroimaging and behavioral protocols compatible with the HCP centered at Washington University. The WU-Minn HCP project is using cutting-edge magnetic resonance imaging (MRI) hardware, acquisition and analysis methods and other neuroimaging protocols to collect task-activated functional MRI (t-fMRI), resting-state fMRI (rs-fMRI), advanced diffusion MRI (dMRI), and high resolution structural MRI (s-MRI) data. Demographic data and data regarding sensory, motor, cognitive, emotional, and social function are collected for each subject, as well as blood samples for DNA genotyping or sequencing. Extensive description and details on the HCP protocols can be found at Project Overview | Human Connectome Project and 500 Subjects Data Release Reference | Human Connectome Project. HCP FAQs can be found at HCP FAQ: Disease-related Connectome Research | Human Connectome Project. Lifespan projects must include rs-fMRI, t-fMRI, dMRI, and sMRI. Tasks chosen for t-fMRI should occur for research participants in appropriate age range and should aim to balance compatibility with tasks employed in the HCP, age-appropriate adaptions, and relevance to scientific hypotheses about sensitive periods in development.
HCP teams have developed and optimized cutting-edge MRI techniques which have been used to acquire structural and functional connectomics in healthy young adults. Both of the HCP scanners at Massachusetts General Hospital and at Washington University have high performing gradient systems. Multiband (also known as Simultaneous Multi-Slice) pulse sequences and reconstruction algorithms used in HCP fMRI and dMRI to substantially increase the sampling rate for a given resolution are available on multiple Siemens 3T platforms (Prisma, Skyra, and Trio) and on the Siemens 7T scanner; GE and Phillips platforms are expected to become available soon. Diffusion MRI benefits from high maximal gradient strength, as is available on the Siemens Prisma (80 mT/m) as well as the customized Siemens MAGNETOM Connectom scanners at WashU (100 mT/m) and MGH (300 mT/m). The L-HCP will implement and use imaging hardware, acquisition methods, and protocols to obtain neuroimaging data of optimal quality and maximal compatibility with HCP data.
HCP behavioral measures include many from the NIH Toolbox plus additional measures from domains not covered by the NIH Toolbox. Identical behavioral measures will be collected in this project when those measures have been validated for the age of the subject. Addition of specific age-relevant behavioral tests or measures for a particular population is expected (e.g. temperament). Age-appropriate behavioral tests are likely to be useful to other researchers who are studying similar age groups and further enhance the utility of the L-HCP data. NIH encourages the use of instruments that have already been made broadly available, such as the NIH Toolbox (http://www.nlm.nih.gov/cde/) and the University of Pennsylvania Computerized Neurocognitive Battery (https://penncnp.med.upenn.edu/index.pl).
The HCP has undertaken a Lifespan Connectome Pilot Project that includes scanning protocols similar to those for the WU-Minn HCP except shorter in duration and amenable to children. Detailed information about these modified behavioral and imaging protocols is available on the HCP website HCP Lifespan Pilot Project | Human Connectome Project. Applicants are urged to consider results from this pilot project in the preparation of an application to this FOA.
A successful, complementary extension of the HCP to children must overcome multiple technical challenges such as increased susceptibility of children to head motion and reduced tolerance for lengthy scan time. The L-HCP will optimize data acquisition protocols to allow collection of comparable connectome data from children. This effort will require quality control and quality assurance in data acquisition and various performance characteristics such as signal-to-noise ratio, contrast-to-noise ratio, and spatial or temporal resolution of different imaging methods (e.g. s-MRI, rs-fMRI, dMRI, and t-fMRI). The use of improved hardware (such as variable size head coils) and advanced motion correction techniques are strongly encouraged.
It is expected that L-HCP imaging data and behavioral assessments will be deposited with and made available from a new Connectome Coordination Facility (CCF) to be established at Washington University. That centralized database will work with the L-HCP awardee to provide a single location for the community to find connectome data and will help the awardee ensure that the new imaging data can be easily compared with the existing data. Long-term maintenance of the data following deposition is the responsibility of the CCF.
This complex effort will require robust administrative structures and processes, objective and independent advice by appropriate experts, and strong professional project management by the awardee. It is anticipated that a dedicated project manager will be needed for the aging component of the L-HCP. In addition, the use of a cooperative agreement mechanism will allow significant involvement of NIH staff in the conduct of this award.
The Lifespan Human Connectome projects will consist of two progressive sets of activities. Year 1 of the award, with milestones, will entail the optimization and integration of HCP imaging and behavioral technologies, including pilot data collection, and IRB approval and initiation of subject recruitment. Years 2-4 of the award, with milestones, will entail acquisition of connectome data and deposition of data with the Connectome Coordination Facility on a regular basis.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.
New
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 1 award.
Application budgets are limited to $2,700,000 direct costs over all years of the award.
The maximum project period is four years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
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
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.
Applicant Organizations
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.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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.
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:
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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:
Gregory Farber, Ph.D.
Telephone: 301-435-0778
Email: farberg@mail.nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
NIH expects awardees to come to the Washington area every 12-18 months to describe their research activities. Such travel expenses should be part of the requested annual budget. Applicants should budget funds for Steering Committee meetings. Applicants should budget funds to transfer the data to the Connectome Coordination Facility which will have the responsibility to preserve the data and make it available to the research community.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: The Research Strategy section must address the following elements:
1) Definition of the population that will be included
2) Data acquisition methods and protocols
3) Data quality control and quality assurance
4) Data analysis and data release
5) Administration, operation, and project management.
1) Definition of the population that will be included
The population to be studied must be clearly defined and described. Applicants must describe plans to collect connectome data representative of the typically developing child from at least 300 children in the age range of 0 to 5 years old. Researchers are encouraged to propose cross-sectional, multi-cohorts of different age bands for at least a subset of the sample in order to collect data about neurodevelopmental trajectories. Plans should be described for collecting connectome data on typically developing children who are representative for sex, racial and ethnic make-up of the United States. Applicants should describe plans for subject recruitment: Subjects recruited from existing well-defined and -characterized (e.g., by clinical, biomarker, genetic, and/or behavioral data) developmental cohorts or from proposed new cohorts or a mix of both would be appropriate as long as they are defined as typically developing individuals.
2) Data Acquisition Methods and Protocols
Both HCP teams have developed and optimized cutting-edge MRI techniques which have been used to acquire structural and functional connectomic data in healthy young adults. Applicants must describe how they will implement and use imaging hardware, acquisition methods, and protocols to obtain neuroimaging data of optimal quality and maximal compatibility with HCP data. L-HCP imaging data acquisition should match the nominal spatial resolution reported by the HCP pilot for children. Applicants should detail the relevant data acquisition methods and protocols such as pulse sequences and reconstruction algorithms, experimental parameters including the number of head coil channels, spatial and temporal resolution, number of slices and brain coverage, number of directions for dMRI, and scan time for each imaging session.
HCP behavioral measures include many from the NIH Toolbox plus additional measures from domains not covered by the NIH Toolbox. Plans should be described for the L-HCP collection of identical behavioral measures, with justifications provided for adaptations of behavioral assays due to age of cohort. Addition of specific age-relevant behavioral tests or measures for a particular population is expected (e.g. measures of temperament) and should be described in terms of how they will facilitate understanding of brain connectivity-behavior relationships in children. Exclusion of behavioral tests that are available in the HCP data set should be justified based on the population to be studied.
Applicants must describe how they will harmonize their proposed imaging and behavioral data with the data that are currently available from the HCP.
Applicants should describe plans to collect blood, or other tissue samples, for biochemical analysis and DNA genotyping or sequencing, and plans to deposit biosamples in an NIH approved facility such as the NIMH Center for Collaborative Genomic Studies on Mental Disorders (http://www.nimhgenetics.org/).
3) Data quality control and quality assurance:
Applicants should describe how the L-HCP data acquisition protocols will be optimized to allow collection of comparable connectome data from children. The development and implementation of appropriate quality control and quality assurance procedures used in the acquisition of data are important requirements and should be delineated.
4) Data Analysis and Data Release
L-HCP imaging data and behavioral assessments will be deposited with and made available from a new Connectome Coordination Facility (CCF) to be established at Washington University. Applicants should describe their plans to use the CCF to aggregate and store data collected in the project supported by this FOA. Applicants also should describe any data analysis workflows they plan to use that are beyond the ones made available by the HCP. Modified data processing and analysis pipelines should be described and made available to the research community through the CCF. Applicants will be expected to deposit their imaging and behavioral data in the Connectome Coordination Facility at least every 12 months during the course of the award.
5) Administration, Operation, and Project Management
The L-HCP may include a number of diverse units and activities, with collaborators and research expertise being located across disparate locations. Applicants should describe plans for project administration, coordination and oversight in order to achieve the specified goals within the project period. Such plans should address the need for robust administrative structures and processes, objective and independent advice by appropriate experts, and strong project management by the grantee and/or a dedicated project manager.
A detailed timetable with clear milestones is expected as part of the application. Year 1 of the award, with milestones, will entail the optimization and integration of HCP imaging and behavioral technologies, including pilot data collection, and IRB approval and initiation of subject recruitment. Years 2-4 of the award, with milestones, will entail acquisition of connectome data and deposition of data with the Connectome Coordination Facility.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
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.
Part I. Overview Information contains information about Key Dates. 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.
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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
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 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.
Important reminders:
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.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
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? 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? If the aims of the application are achieved, will scientific knowledge of human brain connectivity be advanced? If the aims of the application are achieved, will scientific knowledge of the age group that is being studied be advanced?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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)? 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 project manager have appropriate qualifications and experience to operationally coordinate a project of this size and complexity? Is there evidence that the PD/PI and key personnel can work together effectively to achieve the goals of the project? Does the overall research team have sufficient expertise in all of the critical aspects of this undertaking, e.g., knowledge about the age group being studied, neuroimaging, behavior, informatics, and recruitment?
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? 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? Will the project acquire data of optimal quality and maximal comparability to the HCP neuroimaging and behavioral data acquisition protocols? Will any changes to the HCP data collection protocol, either imaging or behavioral measures, degrade the ability of the new data to be aggregated with the existing HCP dataset? If additional age-relevant imaging and/or behavioral measures are proposed, are they scientifically justified? Will it be possible to aggregate and harmonize the L-HCP data with the existing HCP data? Will the data be deposited in a timely fashion to allow rapid access to the data by the research community? Will the proposed administration, operation and project management, including plans for leading, managing, governing, coordinating, and integrating the efforts of the various components, allow the proposed goals and objectives to be achieved?
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 children, 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? Does the institution have an appropriate MRI scanner to conduct the proposed Lifespan HCP experiments? What are the nature and level of resource commitments from the home institution and from other participating institutions?
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.
Milestones and Timeline
Are appropriate, evaluative milestones clearly defined for the progressive research stages (Years 1 and 2-4)? Are milestones feasible, well developed and quantifiable with regard to the specific aims? Do milestones include measures for determining the operational feasibility of advancing between progressive research stages? Are success criteria defined in terms of outcomes achieved rather than as tasks completed? Is the timeline for optimization of behavioral and neuroimaging paradigms feasible? Is the timeline for data collection, quality control, and data storage feasible?
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.
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 children 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 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 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.
Not Applicable
Not Applicable
Not Applicable
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 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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.
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 the National Institute of Mental Health, 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.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement. Prior to funding an application, the NIMH Program Officer will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement. The Program Officer and the applicant will negotiate and agree on final sets of milestones. The PD/PI will summarize progress on milestones in the annual progress report. Release of funds for non-competing renewals will be based on successful completion of negotiated scientific milestones.
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.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
The NIH Project Scientist will have the primary responsibility for:
The NIH Program Officer, in consultation with the HCP Blueprint Project Team, will have programmatic stewardship, which encompasses the following:
Areas of Joint Responsibility include:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The Panel will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
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.
Recruitment Reporting and Trial Registration
NIMH requires reporting of recruitment milestones for participants in clinical trials as noted at http://grants.nih.gov/grants/guide/notice-files/NOT-MH-05-013.html. While trials in response to this FOA might not seek 150 subjects or more (the level at which this reporting has been required), all trials funded under this FOA must report recruitment milestones, including those with fewer than 150 subjects. This expectation will be stated in the notice of grant award.
The NIMH expects the registration and results reporting for all NIMH-supported clinical trials, regardless of whether or not they are subject to FDAAA (see http://grants.nih.gov/ClinicalTrials_fdaaa/at-a-glance.htm). This expectation will be stated in the notice of grant award.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov
Grants.gov
Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov
GrantsInfo (Questions regarding
application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267
Gregory K. Farber, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-435-0778
Email: farberg@mail.nih.gov
Cheri Wiggs
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: cheri.wiggs@nih.gov
John Matochik
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-7319
Email: jmatochi@mail.nih.gov
Elizabeth McNeil, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496- 9135
Email: mcneilde@ninds.nih.gov
Lisa Freund
Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD)
Telephone: 301-435-6879
Email: freundl@mail.nih.gov
Lois Tully
National Institute of Nursing Research (NINR)
Telephone: 301-594-5968
Email: lois.tully@nih.gov
Janet Cyr
National Institute on Deafness and Other Communication
Disorders (NIDCD)
Telephone: 301-402-3458
Email: cyrj@nidcd.nih.gov
Annette Kirshner
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0488
Email: kirshner@neihs.nih.gov
Steven Grant
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-8869
Email: sgrant@nida.nih.gov
Bradley Wise
National Institute on Aging (NIA)
Telephone: 301-496-9330
Email: wiseb@nia.nih.gov
Wen Chen
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-451-3989
Email: wen.chen2@nih.gov
David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: armstrda@mail.nih.gov
Rebecca Claycamp
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email: rclaycam@mail.nih.gov
William Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: darby@nei.nih.gov
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov
Tijuanna Decoster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov
Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov
Randi Frendlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: freundlichr@mail.nih.gov
Chris Myers
National Institute on Deafness and Other Communication
Disorders (NIDCD)
Telephone: 301-435-0713
Email: myersc@nidcd.nih.gov
Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: carows@mail.nidcd.nih.gov
Molly Puente
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-1373
Email: puentem@niehs.nih.gov
Maryellen Connell
National Institute on Drug Abuse (NIDA)
Telephone: 301-774-3803
Email: mcconnell@nida.nih.gov
Richard Proper
National Institute on Aging (NIA)
Telephone: 301-402-7735
Email: properr@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.