Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
U24 Resource-Related Research Projects – Cooperative Agreements
None
This limited competition Funding Opportunity Announcement (FOA) is to support the continuation of the Administrative Resource for the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA). Only the current NCANDA Administrative Resource awardee is eligible to apply in response to this FOA. The NCANDA Administrative Resource coordinates the activities of the nation-wide consortium to study the impact of alcohol drinking on brain structure and function during adolescence and into early adulthood. RFA-AA-21-007 will support the continuation of the Research Projects Sites within the consortium and RFA-AA-21-009 will support continuation of the NCANDA Data Analysis Resource.
July 18, 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| Not Applicable | August 18, 2021 | Not Applicable | March 2022 | May 2022 | June 2022 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
No late applications will be accepted for this Funding Opportunity Announcement
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.
Purpose
The purpose of this limited competition Funding Opportunity Announcement (FOA) is to support the continuation of the Administrative Resource for the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA).The NCANDA Administrative Resource coordinates the activities of the nation-wide consortium to study the impact of alcohol drinking on brain structure and function during adolescence and into adulthood.
Background
Adolescent or underage drinking is a serious public health issue not only in terms of increased risk for alcohol-related problems (e.g., driving under the influence, physical and sexual assaults) but also for the untoward effects that drinking may have on the still-developing central nervous system with concomitant effects on behavior and cognition. Recent statistics showed that young people ages 12 to 20 drank alcohol in the past month. Alcohol misuse often begins during adolescence and becomes more likely as adolescents age. Based on the National Survey on Drug Use and Health, a large majority of all alcoholic drinks consumed by underage young people (age 12-20) are consumed through binge drinking (4+ drinks for females and 5+ drinks for males on the same occasion) that brings the blood alcohol concentration at least up to the legal intoxication level. In 2012, the NIAAA, with support from NIMH, NICHD and NIDA, funded a nation-wide research consortium to investigate adolescent brain and behavior development with a particular emphasis on the effects of drinking alcohol during this critical period of maturation.
The funded consortium named the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) consists of an overall Administrative Resource, a central Data Analysis Resource, and five research projects sites where the adolescent participants are enrolled and participate in the standardized study protocol. The study protocol includes structural and functional imaging of the brain along with detailed neuropsychological and clinical assessments over the course of follow-ups after entry into the study. The enrolled adolescents (N = 831) are followed with an accelerated longitudinal design with the baseline enrollment age at 12 to 21 and the current cohort reaching ages 19 to 30 by the end of the funding period. While one of the advantages of accelerated longitudinal designs is that it allows for a wide sampling of ages to model a developmental trajectory within a limited time frame, these designs usually have the drawback of short longitudinal trajectories (few time points) for each of the different age cohorts. To characterize more fully and accurately the changes in brain and behavior development across the adolescent years and into early adulthood (up to age 30), a longer period of follow-up assessments for each of the different age cohorts is needed The NCANDA consortium has successfully met their target enrollment goal and has a retention rate of over 94% of the original adolescent participants (N = 831) who have completed the baseline protocol and are on schedule with the longitudinal follow-up assessments. The detailed information that has already been acquired on these participants and that will be acquired over a longer term follow-up will advance our understanding not only of adolescent brain and behavior development but also of the potential long-lasting effects in adulthood from adolescent alcohol misuse.
Objective and Organization of the NCANDA Consortium
The primary objective of NCANDA is to address the following research questions: 1) what are the effects of both long and shorter-term 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 into adulthood. To achieve these objectives, NCANDA will continue the annual surveys and interviews of the enrolled participants and acquire neuroimaging data at age 24 and 27 after the participants research age 22.
The COVID-19 pandemic continues to affect families and individuals of a wide range of ages across the United States and globally. It is likely to have long-lasting impact on public health and well-being. There is emerging evidence that effects of the COVID-19 pandemic on social, environmental, life stress, and other affective changes are associated with a substantial increase of alcohol consumption with dramatic increases in hospital visits and alcohol related deaths in the United States. Alcohol misuse also has the potential to further complicate the COVID-19 pandemic outcomes. To better understand the impact of the pandemic on social environmental and behavioral changes and their associated effects on alcohol misuse should be included as an additional research objective of NCANDA.
The organization of the NCANDA consortium consists of an overall Administrative Resource, a central Data Analysis Resource, and research project sites as described below.
The NCANDA Administrative Resource (this FOA) coordinates the activities of the nation-wide consortium and is responsible for the development, tracking, and reporting of performance metrics from the research project sites and the overall consortium, and for laying out a plan on how the next generation of scientists from diverse backgrounds would be elevated to leadership positions.
The NCANDA Data Analysis Resource (RFA-AA-21-009) has responsibility for the standardization, storage, and analysis of the data acquired by the research project sites of the consortium.
The NCANDA Research Project Sites (RFA-AA-21-007) have responsibility for the acquisition of data according to the standard protocol for the nation-wide consortium and for the development of special research projects related to their expertise and interests that complement and support the overall objectives of the consortium.
Purpose and Functions of the Administrative Resource
The Administrative Resource provides the scientific leadership, overall management, and primary oversight of the activities of the NCANDA consortium. It will coordinate the interactions of the individual Research Project Sites and the Data Analysis Resource. The Administrative Resource 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 Administrative Resource will work with the Data Analysis Resource to insure standardization of neuroimaging data acquisition, protocols, and data analysis pipelines. Because the neuroimaging field undergoes rapid technical advances, the Administrative Resource and the Data Analysis Resource 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 the multiple research sites. The Administrative Resource must have a plan on how the next generation of scientists from diverse backgrounds would be elevated to leadership positions and to integrate the examination of COVID-19 pandemic impact on alcohol misuse behavior as part of the research objectives. The Administrative Resource 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.
Diversity of Research Teams
Research shows that diverse teams working together outperform homogenous teams. Scientists and trainees from diverse backgrounds and with different life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific workforce. It is expected that the NCANDA consortium will include a diverse group of scientists, including individuals from underrepresented backgrounds as per NOT-OD-20-031 (Notice of NIH's Interest in Diversity). NIAAA is especially interested in enhancing representation from racial, ethnic and gender minorities and early-stage investigators.
See Section VIII. Other Information for award authorities and regulations.
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. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
NIAAA and participating ICs intend to commit an estimated total cost of $5.0 M in FY 2022 to fund one consortium in response to this FOA and companion FOAs (RFA-AA-21-007, RFA-AA-21-009).
The participating ICs intend to make 1 award from this FOA
Applicants may request up to $350,000 in Direct Costs per year.
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 from this FOA.
Only institutions with active NIAAA U24 awards “Longitudinal Studies on the Impact of Adolescent Drinking on the Adolescent Brain (Phase II)” are eligible to apply.
Federal Governments
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
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.
Only PD(s)/PI(s) from institutions with active NIAAA U24 awarded through RFA-AA-17-004, "National Consortium on Alcohol and Neurodevelopment in Adolescence” (NCANDA) are eligible to apply.
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:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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 sent to:
Abraham Bautista, Ph.D.
Telephone: 301-443-9737
Fax: 301-443-6077
Email: bautista@mail.nih.gov
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.
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.
R&R Budget
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, with the following additional instructions:
Research Strategy: This application should discuss the theme, goals, and specific aims of the consortium. This application should describe the Administrative and Project Management Plans, as well as plans to 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. Administrative and Project Management Plans: The 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 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. 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. Finally, applicant should describe leadership succession plans to ensure continued leadership and how the next generation of scientists from diverse background would be elevated to leadership positions.
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.
The following modifications also apply:
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIAAA Referral Office by email at bautista@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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 proposed Resource address the needs of the research within the NDCANDA Consortium that it will administer? Is the scope of activities proposed for the Resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research described in the NCANDA Consortium?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Administrative resource of the NCANDA Consortium? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing the Administrative resource? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the Administrative resource is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Administrative resource of the NCANDA consortium? Does the applicant have experience overseeing selection and management of subawards, if needed?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application propose novel organizational concepts and management strategies, in coordinating the research described in the NCANDA Consortium, the Administrative resource will serve? Are the concepts, or strategies novel to one type of management or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, or management strategies proposed? Is there a plan for the next generation of scientists from diverse backgrounds to be elevated to leadership positions or included in the research team?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research described the NCANDA consortium, the Administrative resource will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the Administrative resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
Specific to this FOA:
How adequate are the leadership succession plans to ensure continued leadership and how the next generation of scientists from diverse background would be elevated to leadership positions?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the institutional environment in which the Resource will operate contribute to the probability of success in facilitating the research within the NCANDA consortium that the administrative resource serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Administrative resource proposed? Will the Administrative resource benefit from unique features of the institutional environment, infrastructure, or personnel?Are resources available within the scientific environment to support electronic information handling?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
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) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIAAA, 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 will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
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 Alcohol Abuse and Alcoholism. The following will be considered in making funding decisions:
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 recipient'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.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (45 CFR Part 75), 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 recipients 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 in those aspects of management of the project as described below. Each U01 research project and U24 support components will receive a separate award, and the Principal Investigator will have control over the project's operating budget. Recipientswill be required to attend consortium Committee meetings and participate in the cooperative nature of the consortium. Recipientswill 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, recipientswill 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. Recipientsshould comply with their institutional intellectual property policies and practices as approved in the award.
Recipientswill 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 NIAAA Extramural staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
NIAAA Project Scientist
The NIAAA Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIH Project Scientist will not attend peer review meetings of renewal or supplemental applications related to the project, and shall not participate in funding decisions.
NIAAA Project Scientist 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 recipientsfor the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the recipients, the NIAAA Program Official, and the NIAAA Project Scientist.
The NIH Project Scientist will have voting membership (one combined vote) on the Steering Committee and, as determined by that committee, its subcommittees. The NIH Project Scientist 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.
The NIH Project Scientist 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
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 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.
An NIAAA Project Scientist and Program Official shall not have dual and concurrent role in the management of the cooperative agreement grant.
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 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 on proposed goals for the next year of support. The panel members are designated by the NIAAA 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 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 Scientist. 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 also reserves the right to augment the scientific expertise of the Steering Committee when necessary, and to appoint additional NIAAA 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 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.
A final RPPR, 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.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Benjamin Xu, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-6545
Email: benxu1@mail.nih.gov
Cheryl Boyce, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1070
Email: cboyce@nida.nih.gov
Ranga Srinivas, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-2067
Email: srinvar@mail.nih.gov
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4707
Email: jfox@mail.nih.gov
Maryellen Connell
National Institute on Drug Abuse (NIDA)
Telephone: 301-774-3803
Email: mconnell@nida.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.