Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Mental Health (NIMH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA

Funding Opportunity Title

Longitudinal Studies on the Impact of Adolescent Drinking on the Adolescent Brain (Phase II) (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-AA-12-006

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.273, 93.242, 93.865, 93.279

FOA Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to conduct a multisite longitudinal study using a cooperative agreement (U01) mechanism to address the following questions:  1) what are the effects of both long and shorter-term child and adolescent alcohol exposure on the developing human brain; 2) what is the effect of timing, dose, and duration of alcohol exposure on brain development;  3) to what extent do these effects resolve or persist; 4) understand how key covariates factor into alcohol's effects on the brain; and 5) potentially identify early neural, cognitive, and affective markers that may predict alcohol abuse and dependence and onset or worsening of mental illness during adolescence and/or adulthood.

Key Dates
Posted Date

October 3, 2011

Open Date (Earliest Submission Date)

December 18, 2011

Letter of Intent Due Date

December 18, 2011

Application Due Date(s)

January 18, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March-April 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

September 1, 2012, dependent on the availability of funds.

Expiration Date

January 19, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The purpose of this Funding Opportunity Announcement (FOA) is to conduct a multisite longitudinal study using a cooperative agreement (U01) mechanism to address the following questions:  1) what are the effects of both long and shorter-term child and adolescent alcohol exposure on the developing human brain; 2) what is the effect of timing, dose, and duration of alcohol exposure on brain development; 3) to what extent do these effects resolve or persist; 4) understand how key covariates factor into alcohol's effects on the brain; and 5) potentially identify early neural, cognitive, and affective markers that may predict alcohol abuse and dependence and onset or worsening of mental illness during adolescence and/or adulthood. 

BACKGROUND

As part of a two-phase initiative, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) issued an FOA entitled “Impact of Adolescent Drinking on the Developing Brain (R21)" (RFA-AA-07-006) to further our understanding of the effects of child and adolescent alcohol use (particularly episodic binge drinking) on the developing human brain. Phase I called for applications to design and test feasibility studies for undertaking a much larger longitudinal study using neuroimaging and neuropsychological techniques to: 1) assess the short and long-term consequences of alcohol exposure on brain, cognitive, and emotional/regulatory development during preadolescence and adolescence;  2) determine the effects of timing, dose and duration of alcohol on brain and cognitive development; 3) assess recovery of neural and behavioral function to determine if the plasticity of the adolescent brain makes it more or less vulnerable to alcohol’s acute and chronic effects; 4) understand how other key covariates (e.g., existing or emerging psychopathology, family history of alcoholism, environmental factors, pubertal development) factor into alcohol’s effects on the brain; and 5) potentially identify early neural, cognitive, and affective markers that may predict alcohol abuse and dependence during adolescence and/or adulthood.  Based on information from the feasibility studies using diverse designs (standard longitudinal follow-up, co-twin control design, follow-up during recovery) and a variety of neuroimaging techniques (MRI, DTI, fMRI, MRS, ERP, sleep EEG) and neuropsychological tests, the practicability of moving forward with a large scale study was demonstrated.  Therefore, this FOA, which initiates Phase II, seeks support to conduct a full scale multisite longitudinal study using a cooperative agreement mechanism (U01) to address the stated questions about alcohol’s effects on the developing adolescent brain.

Alcohol is the most commonly used substance among adolescents. Epidemiological surveys have shown that 72% of high school seniors have used alcohol in their lifetime and past month alcohol use increases from 15% to 43% between 8th and 12th grade.  Of greater concern is the prevalence of drunkenness and binge drinking.  By their senior year, 27% of those surveyed report having been drunk in the past month and 25% have had an episode of binge drinking (5 or more drinks in a row in the past two weeks).  At the same time that alcohol use is escalating, substantial changes are occurring in brain biology, physiology, and architecture during the transitions from pre-adolescence through adolescence and into young adulthood. Furthermore, emotional responses particularly sensation-seeking and risk-taking are the hallmark of adolescence, and may contribute to the high incidence of drinking in this group. Finally, hormonal changes associated with the onset of puberty may contribute to the emergence of sex differences in behavior as well as alcohol and substance use, affect and mood regulation, and/or trajectories of brain development. Thus, given that adolescence is characterized by dramatic increases in rates of alcohol use concurrent with extensive neuromaturation, studies are needed to identify neural and behavioral risk markers associated with adolescent alcohol use and to determine the impact of early and chronic exposure on brain maturational changes and associated neurocognitive, affective, and behavioral processes. Impaired brain, cognitive, and affective functioning resulting from early alcohol exposure may have potentially harmful effects on future academic, occupational, and social functioning in adulthood.  Therefore, it is crucial that we understand the neurodevelopmental and neurocognitive sequelae of heavy drinking in late childhood and adolescence. 

Prior research in adolescents has shown that heavy alcohol consumption is associated with abnormalities in brain structure volume, white matter structure and integrity, brain activation to cognitive tasks, and neuropsychological function.  However, these studies of the impact of drinking on brain development using neuroimaging and neurocognitive techniques have been largely performed in cross-sectional samples of adolescents who engage in heavy episodes of binge drinking or those in treatment for alcohol use disorders.  Therefore, it is not known whether these structural and functional deficits predate the onset of alcohol use or are a consequence of heavy drinking. Few studies to date have taken a prospective approach, and those studies that have used a longitudinal design are preliminary in nature, enrolling a very limited number of subjects. The way to understand the neural,  cognitive, and affective risk markers for alcohol use, as well as the vulnerability of the adolescent brain to the effects of alcohol is through a large longitudinal study which captures children before they begin drinking and then follows them to determine the progression or reversibility of alcohol’s effects.

ORGANIZATION OF THE CONSORTIUM AND SCOPE OF THE STUDY

The NIAAA and NIMH envision a multisite consortium that consists of research project components, an administrative component and a component for centralization of data analysis, integration, and informatics.

The multisite research project components will be formed from a group of investigators and clinicians (within and across institutions) whose scientific and technical expertise will allow them to interactively study the effect of late childhood and adolescent drinking on brain, cognitive, and affective/regulatory development using neuroimaging, neuropsychological, and behavioral techniques. The consortia should have a core set of measurements (neuroimaging, neuropsychological, clinical assessments), that capitalize on the multitude of available techniques, tests, and assessment measures from existing large-scale studies of neurodevelopment. The core set of measures  are required at all sites, but each site will also have the flexibility to add on additional measures, sampling times, or other particular design features of interest to them. In addition, a component for centralization of data analysis, data integration, and informatics will also be a part of the consortium, which will standardize data collection, storage, and analysis procedures for the core measures.  Lastly, an administrative component, lead by the Consortium Coordinator, will include the Administrative Management Plan, and oversee training to ensure that administration of core measures are consistent across sites. 

The Consortium Coordinator is the scientist who assembles and integrates the collaborative research consortium and is responsible for overall performance of the project.  The Consortium Coordinator should have a working knowledge of the multiple measures being undertaken in the consortium. Because a substantial level of effort will be necessary to manage a project of this magnitude, the Consortium leader is expected to make a major commitment to directing, managing and executing the goals and collaborative nature of this project. 

The Consortium Coordinator's application will be the lead application of the consortium and should include an Administrative Section, listing all the components, together with the Administrative Management Plan and Plan for Data Sharing and Intellectual Property, consistent with achieving the goals of the program.  This application should discuss the theme and goals of the consortium and should include a scientific rationale for the various research project components as well as the data analysis/integration/informatics application that make up the consortium. It should also describe the core set of neuroimaging, neuropsychological and clinical assessment measures that will be used within each of the research project components.  The application should also include a comprehensive budget of the whole consortium in addition to its own individual budget.  It is acceptable for the Consortium Coordinator to submit a research component or a resource component in addition to the lead application. 

Each application will originate from the Program Director(s)/Principal Investigator(s) research institution and awards will be made to individual institutions.  More details regarding the individual research components are listed below.

RESEARCH PROJECT COMPONENTS

The research project component applications will represent different sites for subject recruitment and follow-up, test administration and collection of data from the core test battery including neuroimaging, neuropsychological, and clinical assessments.  Each research project component will also be responsible for submitting their data to the Data Analysis, Integration, and Informatics component.  In addition to collecting data for the main longitudinal study, each research project component will be allowed to pursue additional designs and measures of particular interest to them, such as supplementary neuroimaging techniques, cognitive activation tasks, sleep measures, or follow-ups during recovery.

REQUIRED FEATURES OF THE STUDY DESIGN

The minimum requirements for the longitudinal study design across sites are as follows:

Administrative Component:   The Administrative Component will provide the organizational framework for the management, direction, and overall coordination of the consortium.  It will coordinate the interactions of the Research Project Components with the Data Analysis, Integration, and Informatics Component. The Administrative Component will also be responsible for the standardization of and training on the core neuropsychological and clinical assessments to make sure administration of these measures is consistent across sites.  The Administrative Component will include an Administrative Management plan (see below) and this component will also be responsible for the collaborative responsibilities such as the functions of the Scientific Advisory Panel and the overseeing of a 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.

Administrative and Project Management Plans:  The Consortium Coordinator must include an Administrative Management Plan that outlines the policies and procedures for access of participating investigators to the collaborative project resources.  The application should address the flow of information within the project, the integration among individual projects and plans for how the information will be integrated into the solution of the overall question being addressed.  The application must include a Project Management Plan, including an ongoing evaluation plan, to ensure consistent forward progress of the project.  The mechanism to add new participating investigators and dealing with members whose association with the project has not been productive should be documented in the application.  The plan should also include proposed methods for conflict resolution among the participating sites and information dissemination both within the collaborative projects and to the scientific community.  Furthermore, the application will include a mechanism to consider and respond to concerns of the scientific community directly affected by the operation and impact of the project.  A discussion of scientific community views will be part of the agenda for annual meetings of the Steering Committee with the Scientific Advisory Panel.

Plan for Data Sharing and Intellectual Property:  NIH expects applicants who respond to this FOA to develop and propose specific plans for sharing the data and materials generated through the large-scale collaborative project, consistent with achieving the goals of the program.  This would entail addressing the interests of the Government in the availability of and access to, the results of publicly funded research.  The initial review group will comment on the proposed plans.  In addition, as one of the criteria for award, NIAAA staff will also consider the adequacy of the plans.  Because advancing research in this field is a critical and important aspect of this FOA and can be achieved through broad dissemination of data and research resources, the proposed sharing and data release plans, after negotiation with the applicants when necessary, will be made a condition of the award.  The members of the consortium should disclose their ties to profit-making organizations to aid the project in avoiding conflict of interest situations.  Applicants are also reminded that the grantee institution is required to disclose each subject invention to NIAAA within two months after the inventor discloses it in writing to grantee institution personnel responsible for patent matters.

Data Analysis, Integration, and Informatics Component:  This component will develop the procedures for collection of neuroimaging, neuropsychological and clinical assessment data in a manner that will maximize comparability across the individual research components, facilitate cross-site pooling of data, and harmonize with existing large-scale neurodevelopmental research efforts. Within this component, the Imaging section will design the image acquisition protocols for the MRI (T1-weighted and T2-weighted), diffusion tensor imaging, and resting state fMRI data. These protocols will require that a common image format be used across the different research components that will facilitate image processing and analysis.  This section will ensure that quality control measures are in place at each site for the acquisition of imaging data. The Imaging section would take the lead in image processing of the pooled data to provide post-processed data for analysis with collaboration across image collection sites to test the broad hypotheses generated by the consortium, and to allow individual investigators to test more detailed specific hypotheses generated as the research projects mature.  An Informatics section will coordinate the combining of data and the analysis of results across and within research components, and will provide input and consultation on statistics and experimental design.  This section will devise methods for integrating data from different levels of analysis from the neuroimaging to the behavioral levels. The Informatics section will also create a database for the collection of data generated from the common neuropsychological and clinical assessments, and provide an interactive user interface for use by all research components.  With the establishment of this database, there will also be a need for additional refinement of bioinformatics tools (such as developing interoperable informatics software packages) to facilitate extraction and efficient dissemination of information from the database.  Consistent with NIH policy (http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm and

http://grants.nih.gov/grants/policy/policy.htm), it is expected that the database developed will be available for use by non-Consortia member investigators.  The applicants will need to develop a plan to be approved by the Institute indicating how they will comply with this policy.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIAAA intends to commit up to $4 million in Total Costs in FY 2012 to fund 1 consortium, dependent on the availability of funds.

NIMH intends to commit $500,000 in Total Costs in FY 2012 to fund the consortium, dependent on availability of funds.

Award Budget

Application budgets should be no more than $2.8 million in Direct Costs for the entire consortium.

Award Project Period

The total project period for an application submitted in response to this funding opportunity announcement may not exceed five 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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

Foreign Institutions

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.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.

Letter of Intent

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 emailed to:

Abraham Bautista, Ph.D.
Director, Office of Extramural Activities
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 2089
Rockville, MD 20852
Telephone: (301) 443-9737
Email: bautista@mail.nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

R&R Budget Component

The total budget for all years of the proposed project must be requested in Budget Period 1 Do not complete Budget Periods 2 or 3.  They are not required and will not be accepted with the application.

Complete only Budget Period 1 of the PHS398 R&R Budget component. 

Budget Period 1: Direct Costs

Budget Period 1: Indirect Costs:

Budget Justification: Please attach the Personnel Justification and Consortium Justification.  If the requested budget requires any additional justification, attach an Additional Narrative Justification. 

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:  

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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.

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 SF 424(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.

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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.  

Section V. Application Review Information

1. Criteria

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.

Overall Impact

Reviewers will provide an overall impact/priority 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).

Scored Review Criteria

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.

Significance

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?  

Investigator(s)    

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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

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?   

Approach

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? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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?       

Additional Review Criteria

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/priority score, but will not give separate scores for these items.   

Integration and Collaboration

Do the scientific aims of the application significantly complement other projects within the consortium and advance the overarching goals of the consortium? Is there evidence of significant collaboration with other projects or components in the consortium?

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

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/priority score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Alcohol Abuse and Alcoholism , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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 Alcohol Abuse and Alcoholism. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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: coordinating project activities both scientifically and administratively with their respective consortium. The Program Director(s)/Principal Investigator(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 NIAAA and NIMH in those aspects of management of the project as described below. Each U01 research project and U01 support components 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 NIAAA Program Official will handle the normal stewardship of the award, as described below.

One or two 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 NIAAA 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 programs, 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 NIAAA and NIMH.

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 NIAAA 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 NIAAA Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  The NIAAA 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 NIAAA and NIMH 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 NIAAA and NIMH on proposed goals for the next year of support.  The panel members are designated by the NIAAA and NIMH in consultation with the Steering Committee, and consist of research scientists not actively involved with the consortia. 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 NIAAA and NIMH 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 NIAAA and NIMH also reserves the right to augment the scientific expertise of the Steering Committee when necessary, and to appoint additional NIAAA and NIMH 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 alcohol 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 NIAAA and NIMH 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 occurs 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 NIAAA Program Official and other NIH staff will provide the Steering Committee with advice on appropriate topics and participants for the workshops and symposia.

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. 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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Potential applicants for coordinator of the consortium could contact the NIAAA Scientific/Research contact(s) (listed below) to discuss the composition of the planned consortium.    

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Ellen Witt, Ph.D.
Deputy Director, Division of Neuroscience and Behavior
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: (301) 443-6545
Email: ewitt@mail.nih.gov

Stacia Friedman-Hill, Ph.D.
Chief, Mechanisms of Cognitive Dysfunction Program &
Trajectories of Neurocognitive Functioning Program
Division of Developmental Translational Research
National Institute of Mental Health (NIMH)
Phone: 301-443-8458
Email: friedmans@mail.nih.gov

Peer Review Contact(s)

Ranga Srinivas, Ph.D.
Chief, Extramural Projects Review Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: (301) 451-2067
Email: srinivar@mail.nih.gov

Financial/Grants Management Contact(s)

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4707
Email: jfox@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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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