National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Cancer Institute (NCI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
National Institute on Minority Health and Health Disparities (NIMHD)
Office of Behavioral and Social Sciences Research (OBSSR)
Adolescent Brain Cognitive Development (ABCD) Study - Coordinating Center (U24)
U24 Resource-Related Research Projects – Cooperative Agreements
93.279; 93.399; 93.242; 93.307 ; 93.273; 93.865
The Collaborative Research on Addiction at the NIH (CRAN) – composed of the National Institute on Drug Abuse (NIDA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Cancer Institute (NCI), and – along with the Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD), the National Institute of Mental Health (NIMH), the National Institute on Minority Health and Health Disparities (NIMHD), and the Office of Behavioral and Social Sciences Research (OBSSR) intend to jointly fund the Adolescent Brain Cognitive Development (ABCD) Study Consortium using the cooperative agreement award mechanism.
The objective of the consortium is to establish a national, multisite, longitudinal cohort study to prospectively examine the neurodevelopmental and behavioral effects of substance use from early adolescence (approximately age 9-10) through the period of risk for substance use and substance use disorders.
The structure of the consortium shall consist of three highly integrated components that may be linked at the time of submission: (1) a set of Research Project Sites, (2) a single central Data Analysis and Informatics Center, and (3) a single overall Coordinating Center. Unlinked applications will also be accepted, and if selected for funding, will be linked to other applications to form a consortium after review.
This Funding Opportunity Announcement (FOA) solicits applications for a single overall Coordinating Center.
This FOA runs in parallel with companion FOAs that solicit applications for Research Projects Sites (RFA-DA-15-015) and a single central Data Analysis and Informatics Center (RFA-DA-15-016).
It is expected that investigators upon funding will work jointly with NIH scientific staff to assist, guide, coordinate, or participate in project activities.
February 4, 2015
March 14, 2015
March 14, 2015
April 14, 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. 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.
April 14, 2015, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on this date. 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.
April 15, 2015
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.
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
Epidemiologic evidence indicates that substance use typically begins in adolescence, with alcohol, nicotine, marijuana, and prescription opioids being the most commonly used substances. National surveys indicate that while overall rates of alcohol and tobacco use have been declining for several years or even decades, the rates of marijuana use have been increasing in recent years. Notably, although the rate of binge drinking has decreased among youth, the amount of alcohol consumed in a binge-drinking episode has increased. Also, of concern is the rate of regular (daily or almost daily) marijuana use among adolescents, which has been increasing since 2007. These recent increases in marijuana use are concurrent with increased national acceptance of marijuana use (in adults), as well as major policy and legal shifts that may encourage its use.
Epidemiologic evidence further indicates that substance use disorders often emerge in late adolescence, and are highly correlated with other mental disorders (e.g., anxiety, attention deficit hyperactivity disorder, and conduct disorder). These mental disorders tend to develop early in life, become increasingly prevalent throughout adolescence, and display concurrent and predictive comorbidity with substance use disorders. Findings suggest complexity in the temporal ordering of disorders – with substance use both preceding or following symptom onset of other mental disorders. Other factors such as gender and race/ethnicity can also influence expression and patterns of comorbidity. Although the comorbidity of various mental and substance use disorders has been suggested to reflect a host of individual, family, and broader environmental factors, the consistency of findings underscores the strong linkages between substance use and other mental disorders, and the need for research to better understand their etiology and co-occurrence.
Adolescence is characterized by marked changes in brain structure and function that may be particularly vulnerable to the effects and risks of substance use. Emergent traits such as sensation seeking, impulsivity, and risk-taking are hallmarks of adolescence and may contribute to the curiosity and willingness to engage in the use of alcohol, tobacco, marijuana, and other substances. Hormonal and related changes associated with puberty may contribute to the emergence of sex differences in behavior, affect and mood regulation, and mental disorders that may, in turn, influence substance use. Social forces such as peer influences and reduced parental supervision become increasingly potent during this developmental period and have been robustly associated with substance use and mental health outcomes.
Consistent with this adolescence-vulnerability concept, neuroimaging and neuropsychological research in adolescents has shown that adolescent substance use is associated with abnormalities in the volume of specific brain structures, the integrity of networks connecting them, brain activation related to cognitive tasks, and neuropsychological function. However, prior studies of the impact of substance use on brain development using neuroimaging and neurocognitive techniques have been largely performed in cross-sectional samples of adolescents who engage in heavy episodes of substance use, including binge drinking, or those in substance abuse treatment. Therefore, it is not known whether observed structural and functional deficits predate the onset of substance use, are a consequence of regular use, or a combination of both. Few adolescent neuroimaging studies to date have taken a prospective approach, and those studies that have used a longitudinal design are preliminary in nature by virtue of limited number of subjects and/or length and extent of follow-up. A more robust research strategy to understand the genetic, neural, cognitive, and affective risk markers for substance use, as well as the vulnerability of the adolescent brain to the effects of substances, is through a large longitudinal cohort study that comprehensively assesses individuals before, during, and after the peak periods of substance use to determine the progression or reversibility of the effects of substance use. This study design is also well suited to transform our understanding of the genetic and environmental influences on brain development, structure and function, and their roles in substance use.
The primary objective of this initiative is to design and implement a study that can address the following overarching research questions, which are inherently interdependent and mutually informative: (1) Within the context of normative developmental variation, what is the impact of diverse patterns of substance use on the structure and function of the developing brain? (2) What are the consequences of substance use on physical health and development, psychosocial development, cognition (e.g., information processing, learning, memory, decision making), academic achievement, motivation, emotional regulation, and other behaviors? (3) How does substance use affect the expression (e.g., onset, course, severity) of psychopathology, including substance use disorders, and how does the emergence of psychopathology influence substance use? (4) What factors (e.g., prenatal exposure, genetic, epigenetic, neurobiological, demographic, psychosocial, familial, ecological) influence the trajectories of substance use and its consequences? (5) In what ways does the use of specific substances contribute to the use of other substances (so-called gateway interactions)?
To accomplish this objective, the Collaborative Research on Addiction at the NIH (CRAN) initiative and other NIH ICs intends to establish the Adolescent Brain Cognitive Development (ABCD) Study Consortium that consists of three highly integrated components that may be linked at the time of submission: (1) a set of research project sites, (2) a single central data analysis and informatics center, and (3) a single overall coordinating center. Unlinked applications will also be accepted, and if selected for funding, will be linked to other applications to form a consortium after review.For a graphical representation of the proposed consortium structure, please see http://addictionresearch.nih.gov/adolescent-brain-cognitive-development-study/abcd-study-organizational-structure.
Consortium Coordinating Center: This Funding Opportunity Announcement solicits a single Coordinating Center, led by the Consortium Coordinator. The Consortium Coordinator is the investigator who assembles, integrates, and leads the consortium, and is directly responsible for the overall performance of the project, including the development, tracking, and reporting of performance metrics by research project sites and for the overall project.
Data Analysis and Informatics Center: A separate FOA (RFA-DA-15-016) solicits a single data analysis and informatics center to coordinate, standardize, and integrate all core data-collection, processing, storage, and analytic activities of the consortium.
Research Project Sites: Similarly, a separate FOA (RFA-DA-15-015) solicits applications for research project sites from investigators whose scientific and technical expertise will allow them to address the objective and research questions described above. In addition to addressing the primary objective of the consortium, each research project site will be allowed to pursue additional aims and objectives provided they remain secondary to the overall consortium objective. Each research project site could be a single institution or it could be formed as a central hub institution with other institutions as spokes to the hub (See http://addictionresearch.nih.gov/adolescent-brain-cognitive-development-study/abcd-study-organizational-structure). In either organizational setup, the PDs/PIs will have overall responsibility.
For a list of the Minimal Requirements for all Research Project Sites refer to RFA-DA-15-015. The core areas that are addressed include:
For additional background information regarding study-design issues related to this initiative, applicants can review the Summary of the Expert Panel Meeting (held May 27-28, 2014) on the Development of a National Longitudinal Study of Neurodevelopmental Consequences of Substance Use (http://addictionresearch.nih.gov/summary-expert-panel-meeting).
The Consortium Coordinating Center will provide the organizational framework for the management, direction, and overall coordination of the national multi-site consortium. It will coordinate the interactions of the individual Research Project Sites and the Data Analysis and Informatics Center. The Coordinating Center will also be responsible for the standardization of protocols, training of staff, and testing of inter-rater reliability of the core neuropsychological, clinical, and other phenotypic assessments to make sure administration of these measures is consistent across research sites. The Coordinating Center will work with the Data Analysis and Informatics Center to insure standardization of neuroimaging data acquisition, protocols, and data analysis pipelines. Because the neuroimaging field undergoes rapid technical advances, the Coordinating Center and the Data Analysis and Informatics Center will need to plan for integrating technological advances into the longitudinal study and determine how changes in hardware and analytic approaches will be coordinated across multiple research sites. The Coordinating Center will include Administrative and Project Management Plans (see below), and will also be responsible for collaborative responsibilities such as the functions of an external Scientific Advisory Board and the overseeing of an internal Steering Committee to help develop protocols, evaluate progress and results, recommend changes to the study, if necessary, and suggest future directions. The Steering Committee is also responsible for scientific enrichment activities for the benefit of the consortium and the scientific research community. In addition, the Steering Committee will be responsible for organizing an annual meeting of the consortia investigators.
Central Institutional Review Board (IRB): In order to reduce the burden on local IRB's, to streamline the protocol approval process, and to standardize the oversight of human subjects protection in the ABCD Study, the use of a single IRB is strongly encouraged.
Opportunity Fund: Starting in year 3 of the project, an opportunity fund will be made available to support new collaborative projects in response to initiatives developed by members of the consortium or NIH staff, and to which all consortium investigators can apply. This fund could be used to strengthen ongoing efforts or to pursue new and interesting directions based on the results obtained to date. The Consortium Coordinating Center will manage this fund and with the Steering Committee will decide on the procedures for allocation of these funds. The NIH Project Scientist and the NIH Program Officer must be informed in writing in advance of any decisions for use of these funds. Functions of the Consortium Coordinating Center include but are not limited to:
Provide scientific leadership, overall management, and primary oversight of the activities of the consortium
Provide operational support for the consortium – public relations and media interviews in coordination with the participating NIH Institutes, dissemination and education priorities, communications within the consortium such as listserv e-mail, formation of subcommittees (on topics such as ascertainment and sampling, publications, clinical issues), and conference calls;
Provide logistical and administrative assistance for arrangement of meetings of the Steering Committee and the Scientific Advisory Board;
Provide assistance in arranging workshops for members of the consortium and for the larger scientific community;
Provide for site visits to ensure reliability and consistency of data collected across research sites;
Provide for mechanisms to monitor subject recruitment, retention, and dropout, and develop procedures for adjustment if enrollment targets are not being met;
Provide for mechanisms to monitor the acquisition of neuroimaging, clinical, and neuropsychological data and procedures for remediation if a research site consistently lags in data acquisition benchmarks;
Provide for a detailed system for regular tracking and reporting of study progress, including a description of performance metrics, milestones, timelines, and quality-control measures to keep the study on track and on budget; this system must also include strategies to identify and mitigate problems as they arise;
A timeline should be included that lists milestones that indicate progress at critical junctures of the longitudinal study. The timeline and milestones should be concrete enough to evaluate what has been achieved during the course of the project;
Develop and ensure that the ascertainment and sampling strategies are appropriate for the stated goals of the research project, solicit appropriate epidemiological expertise as needed;
Develop policies for presentation (e.g., at scientific conferences) and publication of findings in peer-review journals from the consortium’s research activities;
Produce and maintain documentation of consortium standard operating procedures and training manuals; and
Develop and maintain a web site to publicize consortium activities and provide a venue for public access to available consortium resources.
Provide for plans for including scientists from diverse backgrounds, and junior investigators at various levels (e.g., pre-doctoral, post-doctoral, junior faculty) of their research career to ensure the long-term sustainability of the consortium;
Provide for dedicated expertise and plans to address the various bio-ethical issues and concerns (e.g., handling of sensitive data, participatory risk, involvement of vulnerable populations, incidental findings, early substance use or substance use problems in study participants) that are likely to arise during the conduct of the research;
Provide a data sharing policy with explicit plans, procedures, milestones, and timelines to make the data and biospecimens available for access and analysis by the research community; the timeline should be as aggressive as possible to permit prompt access without compromising data quality, confidentiality, and security.
HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.
National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Web site at http://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.
Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community. Please see http://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding- for details.
Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org). Please see NOT-DA-12-008 (http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.
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.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
NIH intends to fund 1 award, corresponding to a total of $2M for fiscal year 2015.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
The maximum project period is 5 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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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.
Consortium Coordinator: The Consortium Coordinator is the PD/PI of the of the Coordinating Center and is responsible for assembling, integrating, and leading the consortium, and is directly responsible for the overall performance of the project, including the development, tracking, and reporting of performance metrics by research project sites and for the overall project. The Consortium Coordinator should have multidisciplinary expertise and a working knowledge of the resources, methods, and logistics required in support of the objective and research questions described above. Because a substantial level of effort will be necessary to lead and manage a project of this magnitude and complexity, the Consortium Coordinator is expected to dedicate a major commitment to directing, managing, and executing the goals and collaborative requirements of this project. Minimum effort for a single PD/PI is 4.2 calendar months per year, and when there are multiple PDs/PIs, each multi-PD/PI must commit at least 2.4 calendar months per year. The Consortium Coordinator(s) cannot be a PD/PI on another component of the consortium.
This FOA supports but does not require linked applications. Multiple PDs/PIs are allowed on any single application. PD(s)/PI(s) from each linked application should not be designated as multiple PDs/PIs on each application of a collaborative set.
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:
In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:
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: NIDALetterofIntent@mail.nih.gov
Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
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.
The following additional instructions apply only to linked applications.
Descriptive Title of Applicant's Project: To allow NIH to identify a group of applications as a related set of collaborative applications, the titles for each application in the set must have the following format: a “1/N” indicator + Title (e.g., “1/3”, where the 1/3 means this is site 1 of 3 sites in the set. The other sites will be labeled 2/3, etc.). A set of applications is defined as all applications for a single consortium submitted in response to this FOA as well as the other two associated FOAs (RFA-DA-15-015 and RFA-DA-15-016). Titles of all collaborative applications must be identical except as follows. Applications submitted in response to this FOA must include "Coordinating Center" at the end of the title; applications submitted in response to RFA-DA-15-015 must include "Research Project" at the end of the title; and applications submitted in response to RFA-DA-15-016 must include "Data Analysis Center" at the end of the title. The numbering order of the collaborative applications in a consortium is at the discretion of the applicant. Titles of all may not exceed 200 characters in length, including the tag, e.g., 1/3, at the beginning of the title.
Cover Letter Attachment: The Cover Letter is one pdf file only. The following collaborative information is required in the Cover Letter: a listing of all the applications that are a part of the set of collaborative applications being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag, e.g., “1/3”), and 3) the Applicant Institution.
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.
Additional instructions include:
The application should include costs for post-award kick-off meeting(s) at a location of convenience for Consortium and NIH staff.
Opportunity Fund: Provide budget details about this fund starting in Year 3 of the project. This fund could be used to strengthen ongoing efforts or to pursue new and interesting directions based on the results obtained to date
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:
The Consortium Coordinating Center application will be the lead application of the consortium and should include an Administrative Section, listing all the research project site components and the data analysis and informatics center, together with the Administrative and Project Management Plans and Plan for Data Sharing and Intellectual Property. This application should discuss the theme, goals, and specific aims of the consortium, and should include a scientific rationale for the various research project sites as well as the data analysis and informatics center that make up the overall consortium. This application should describe the Administrative and Project Management Plans, oversee training and administration of a common protocol across research project sites, and work with an internal Steering Committee and an external Scientific Advisory Board. It should also describe the design, method, and core set of measures that will be used within each of the research project sites.
Administrative and Project Management Plans: The Consortium Coordinating Center application must include an Administrative Plan that discusses overarching issues related to the whole consortium, and outlines the policies and procedures for access of participating investigators to the collaborative project resources. The Administrative Plan should address the flow of information within the consortium, the integration among individual research project sites and the data analysis and informatics center, and plans for how the information will be integrated into the solution of the overall questions being addressed. The application must also include a Project Management Plan (that addresses issues related to evaluating and maintaining progress), including an ongoing evaluation plan, to ensure consistent forward progress of the project. The priorities for the allocation of resources within the consortium should be described. The mechanism for monitoring subject recruitment and retention should also be described. Procedures for adding new participating investigators and managing or removing members whose association with the project has not been productive should be documented in the Project Management Plan. The plan should also include proposed methods for conflict resolution among the participating sites and for information dissemination both within the consortium and to the larger scientific community. A discussion of scientific community views will be part of the agenda for annual meetings of the Steering Committee with the Scientific Advisory Board.
Opportunity Fund: Describe the process whereby projects will be solicited, selected, and monitored for opportunity fund allocations.
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.
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.
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.
NIH intramural scientists may also apply as PDs/PIs of research sites within the consortium. Requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, they 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 project 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.
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?
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 Consortium Coordinating Center have the appropriate expertise and experience to oversee a large-scale multi-site consortium involving a longitudinal design? Is the coordinator's effort appropriate for a project of this magnitude? Do the investigators have a track record of performing the specialized work required for the project (e.g., conducting and managing large, complex, multi-site projects, ensuring cross-site harmonization of methods and data collection procedures, ensuring that milestones are met on time and on budget, etc)?
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? Do the aims of this application indicate that this Center could adequately contribute to the overarching goals of the consortium which are to establish a national, multisite longitudinal cohort study to prospectively examine the neurodevelopmental and behavioral effects of substance use? Are the milestones and timelines adequate and justified to measure progress annually? Is the data sharing plan adequate for achieving the goal in a timely manner for use by qualified investigators? Is there a plan to make study protocols and analytical tools available to the larger research community?
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?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
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.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will 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.
Are the informed consents consistent with the intent of broad sharing of data and biospecimens and achieving the goals of the project?
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 CSR, 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 on the basis of established PHS referral guidelines 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 National Advisory Council on Drug Abuse. 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.
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 project 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:
Coordinating project activities both scientifically and administratively with their respective consortium. The PD(s)/PI(s) will be responsible for the scientific and technical direction of the project and agrees to abide by the policies and rules set up by the consortium. This includes accepting the actions and recommendations approved by the Steering Committee. In addition, each Program Director(s)/Principal Investigator(s) will agree to accept close coordination, cooperation and participation of the CRAN and other involved NIH ICs in those aspects of management of the project as described below. Each U01 research site project, the U24 data analysis and informatics center, and the U24 coordinating center will receive a separate award, and the Principal Investigator will have control over the project's operating budget. Awardees will be required to attend consortium committee meetings and participate in the cooperative nature of the consortium. Awardees will retain custody of, and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. However, awardees will implement the approved data sharing plan (see Submitting an Application), which will be incorporated as an additional term of award, and will be expected to share (make available) these data both within the consortium and with the scientific community. Awardees should comply with their institutional intellectual property policies and practices as approved in the award.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
The NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The NIH Project Collaborators will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIH Project Collaborators will not attend peer review meetings of renewal or supplemental applications related to the project (unless IC waiver is obtained) and may not be involved in the normal programmatic stewardship of the project. If such participation is essential, this individual will seek IC waiver. An NIH Program Official will handle the normal stewardship of the award, as described below.
The NIH Project Collaborators will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees, the NIH Program Official, and the NIH Project Collaborators.
The NIH Project Collaborators will have voting membership (one combined vote) on the Steering Committee and, as determined by that committee, its subcommittees. The NIH Project Collaborators will coordinate and facilitate the Consortium project, will attend and participate as a voting member in all meetings of the Steering Committee, and will provide liaison between the Steering Committee, the Consortium, and CRAN and other involved NIH ICs.
The NIH Project Collaborators will assist the Steering Committee in developing and drafting operating policies and policies for dealing with recurring situations that require coordinated action.
The NIH Program Official will review the scientific progress of individual components, and review them for compliance with the operating policies developed by the Steering Committee, and may recommend withholding of support, suspension, or termination of an award for lack of scientific progress or failure to adhere to policies established by the Steering Committee.
The NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH Program Official may elect to attend the Steering Committee meetings, but not as a member of the committee.
Areas of Joint Responsibility include:
Consortium Coordinator’s Rights and Responsibilities: The consortium coordinator (the PD(s)/PI(s), see above) is charged with coordinating the scientific and administrative activities of the consortium. The consortium coordinator has the responsibility for the scientific and technical direction of the research projects, and the administration and overall operation of the consortium. Therefore, the consortium coordinator is responsible for ensuring that projects awarded are fully integrated within the scientific scope and mission of that consortium. This includes assuring that all investigators have access to the resources within the resource facilities of the consortium. A Steering Committee serves to assist the consortium coordinator with the governance of the consortium. The consortium coordinator chairs this committee. In addition, the consortium coordinator must abide by the operating rules and guidelines developed by the Steering Committee. Furthermore, the consortium coordinator has agreed to accept participation of NIH staff members in those aspects of management of the project described under "NIH Staff Rights and Responsibilities." Lastly, the consortium coordinator ensures the timely dissemination of information generated by the consortium component projects to both the consortium project members and the scientific public.
Scientific Advisory Board: The consortium includes an external scientific advisory board whose purpose is to meet with the consortium coordinator and the Steering Committee to assess progress and provide feedback to the investigators and CRAN and other NIH ICs on proposed goals for the next year of support. The panel members are designated by CRAN and other NIH ICs in consultation with the Steering Committee, and consist of research scientists not actively involved with the consortia. The Scientific Advisory Board should meet with the consortium investigators after the release of the Notice of Award to review and revise the protocol before formal data collection activities begin. Thereafter, the Scientific Advisory Board should meet at least once a year immediately prior to the submission of the consortium annual progress report.
Steering Committee: The consortium has a Steering Committee, which is the main governing board of the consortia. This committee develops collaborative protocols, and functions to set priorities for model derivation, defines the parameters for model validation, identifies technological impediments to success and strategies to overcome them, and decides when models should be made available to the research community for individual investigator-initiated projects. The members of the Steering Committee for the consortium are selected by the consortium coordinator with input from the NIH program staff. The Steering Committee is primarily composed of the consortium coordinator, several principal investigators of the research project components and resource components, and the NIH Staff Collaborators. The Steering Committee may, when deemed necessary, invite additional, non-voting scientific advisors to the meetings at which research priorities and opportunities are discussed. The CRAN/NIH also reserves the right to augment the scientific expertise of the Steering Committee when necessary, and to appoint additional NIH staff as nonvoting members of the Steering Committee and Subcommittees. Each primary member of the Steering Committee has one vote. The chairperson of the Steering Committee is the consortium coordinator. The Steering Committee may establish subcommittees as it deems appropriate to facilitate the planning and operation of the consortia. The Steering Committee meets at least twice annually to discuss and refine the scientific mission and objectives of the consortia, and to evaluate the scientific progress being made both within the consortium research components and by outside laboratories. The Steering Committee discusses the various experimental approaches that were proposed in the individual components and any relevant new information, and subsequently sets the research priorities for the consortium. In the interest of facilitating research in the substance abuse field, the Steering Committee of the consortium evaluates the progress of any new technology being developed and decides when the technology is sufficiently validated for distribution to the research community. The CRAN/NIH will provide the means to disseminate the technologies and the information related to them.
The Steering Committee will plan one or more meetings a year to which non-consortium participants will also be invited to enable the consortium to explore scientific or technologic advances and innovations that occur during the course of the project. For the second and subsequent years of operation of the consortium, the Steering Committee will plan a symposium or workshop to inform the research community of the progress made. The NIH Program Official and other NIH staff will provide the Steering Committee with advice on appropriate topics and participants for the workshops and symposia.
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. It 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.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding 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
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Center for Scientific Review (CSR)
Center for Scientific Review
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 Parts 74 and 92.
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