National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Funding Opportunity Title
Research Education Grants for Statistical and Computational Training in the Genetics of Addiction (R25)
R25 Education Projects
Reissue of PAR-08-081
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
Funding Opportunity Purpose
The purpose of this opportunity is to encourage applications focused on research education in statistical and computational models to address genetics-based problems in addiction. Eligible participants may include undergraduate, graduate, and/or postdoctoral level students and may include both US and non-US citizens.
June 8, 2012
Open Date (Earliest Submission Date)
August 14, 2012
Letter of Intent Due Date
Application Due Date(s)
September 14, 2012, August 21, 2013, August 21, 2014, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review
October/November 2012, October/November 2013, October/November 2014
Advisory Council Review
January 2013, January 2014, January 2015
Earliest Start Date(s)
April 2013, April 2014, April 2015
August 22, 2014
Due Dates for E.O. 12372
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.
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
This FOA encourages applications from organizations that propose creative and innovative research education programs in the mission area(s) of the NIH. The NIH Research Education (R25) grant mechanism is designed to support the development of creative and innovative research education programs for the development of biomedical, behavioral, and clinical researchers, or for public education and outreach on health-related research to a variety of audiences. Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine their effectiveness. As such, each application must include a plan to evaluate the activities proposed (see Section IV, Evaluation Plan). For some types of projects, a plan for disseminating results may also be appropriate and may be required as well (see Section IV, Dissemination Plan).
The proposed research education program may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional research training program (T32) and cannot be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.
Nature of the Research Education Opportunity
This FOA invites applications focused on research education
for the development, testing, and application of new, innovative statistical and
computational models to address genetics-based research problems in addiction.
Applications must be focused on substance abuse research questions. For the
purposes of this announcement, substance abuse refers to use, abuse, and
dependence on addictive substances, including alcohol, illicit drugs, and
nicotine; applications which focus on alcohol alone will not be considered
responsive. Applicants are expected to propose a well-integrated research
education and training program in statistical genetics and computational
methods for undergraduate, graduate, and/or postdoctoral level students.
Furthermore, it is expected that during the course of the education program,
new statistical methods and computational models relevant to the genetics of
addiction will be developed. Applicants should propose curriculum development
and core didactic instruction appropriate to participant level. Instruction on
developing innovative statistical methodologies and computational models will
be critical to the success of the Program. Applicants may be drawn from
multiple departments. Team-building must be a clear objective of any programs
proposed. For this FOA, critical research workforce educational development
needs may include: recruiting, supporting and mentoring research investigators
in tenure-track (or equivalent) positions; recruiting outstanding experienced
scientists for tenured positions; retraining senior scientists as necessary;
and providing a well-organized biomedical research environment that includes
technical support personnel, appropriate equipment, supplies, shared resources,
and inter- and intra-institutional linkages.Since institutions may have
particular needs and circumstances, this FOA provides general rather than
specific guidance on the types of activities needed for the development of
courses, curricula, faculty, a program committee and other mentoring
capabilities that are appropriate, and the type of program may influence
choices as well. For example, transdisciplinary statistics programs, such as melding
statistical and computational training in genetics with statistical and
computational training in brain image analysis, will require the respective,
complimentary expertise among the instructional team.
This FOA will use the NIH Research Education (R25) grant mechanism.
Background information and Scientific Knowledge to be Achieved
Genetics research has tremendously increased our understanding of biological processes and the mechanisms underlying disease. This sudden expansion of information has created a critical need for interdisciplinary research education in statistical genetics and computational methods. The capacity of U.S. schools to conduct statistical and computational research and particularly to train statisticians to develop new, useful, and innovative statistical and computational methods to analyze the vast and ever increasing body of genetic data is key to the future of research in public health.
NIDA supports a wide variety of genetic studies of addiction in humans and other organisms. See NOT-DA-12-012, Notice of NIDA’s Priorities for Human Genetics Research regarding current research priority areas. Addiction, substance abuse and dependence are complex disorders with genetic components. Candidate genes/variants that play a role in addictive processes have been identified using methods such as human genome-wide association scans, gene expression profiling, animal models, QTL characterization, proteomics, and reverse genetic functional screening. NIDA has shown its interest in this area through related announcements that include PA-11-026, Molecular Genetics of Drug Addiction and Related Co-Morbidities (R01) and PA-07-166, Functional Genetics, Epigenetics, and Non-coding RNAs in Drug Addiction (R01, R21, R03). Other candidate genes/variants include genes relevant to co-occurring psychiatric disorders and social behaviors relevant to drug addiction, and genes relevant to other issues within NIDAs mission, including pain and HIV/AIDS susceptibility and progression. Multiple genes each with relatively small effects are likely to influence vulnerability to addiction, and genetic, environmental and developmental interactions appear to play significant roles in mediating outcomes.
Genetic epidemiologic studies support the hypothesis that substance use disorders are in part heritable developmental disorders. A great deal of data has been collected on gene-environment interplay, phenotypes, and methodologic challenges to the field. Recent announcements in this area of research include PA-11-235, PA-11-236, and PA-11-237, Gene-Environment Interplay in Substance Use Disorders (R01, R21, R03).
Molecular genetic studies of addiction in human beings have identified some chromosomal loci and genetic variation in genes that are hypothesized to be associated with abuse and/or initiation of addictions to or dependence on stimulants such as cocaine and amphetamine, narcotics such as cocaine or heroin, and other drugs incuding nicotine, benzodiazepines, barbiturates, cannabis, hallucinogens, and/or multiple drugs of addiction and/or abuse. There also remains an interest in chromosomal loci and/or genetic variation in genes and haplotypes that may be associated with differences in responses to treatment for addiction to drugs of abuse, and treatments for co-morbid disorders.
Integration of genetics with neuroimaging, where genes are related to aspects of brain activation or brain structure, has generated a large but controversial literature. New analytic approaches are needed to resolve numerous issues in this area. Among these issues are: 1) means of comparing two high dimension datasets, ie. multiple-comparisons problem of thousands of genes/SNPs with the multiple comparisons problem of numerous data elements (e.g. voxels) of the brain; and 2) adjustment for the limited sample sizes of imaging studies relative to traditional population genetic studies and the implications for power and replication. For these approaches to be credible, novel statistical and computational approaches will need to be developed and disseminated that combine best practices of statistical and computational genetics with sound data-reduction strategies and multiple-comparison corrections of neuroimage analysis. Such novel approaches not only need to take into consideration means to combine the genetics and imaging datasets, but also how pre-processing of imaging data (e.g. selection of spatial and temporal smoothing kernels) may influence subsequent analysis. Furthermore, the issue of adopting methods beyond traditional General Linear Modeling (GLM) approaches to address high order interactions is particularly acute for the integration of genetics information with brain imaging.
The significantly increasing amounts and complexity of genetic and phenotypic data require more sophisticated statistical methods and computational models for data analyses. Furthermore, as genetic data are being integrated with imaging and developmental data, the challenges of analyzing such large and complex datasets have grown exponentially. Currently, there is a paucity of individuals adequately trained to generate innovative approaches in statistical genetics and computational models of addiction.
Effective advancements in science will require continued developments in technology, computational approaches, and analytic methods. New large databases and mathematical methods will be necessary to catalogue, organize and understand the vast amounts of information generated from the accumulated sequences of genes, proteins and associated phenotypes. This new workforce must be trained in methods to develop new algorithms to analyze and interpret the data and ways to visualize and present genomic information to researchers.
In addition to addressing these scientific gaps, this FOA has a goal of fostering the development of innovative research approaches, which must be:
Examples of Research Education Topics
Research education topics may be directed toward: gene-environment interplay (interactions, correlations, heritability, phenotyping, epigenetics); genetic epistasis; integration of genetic and imaging data; novel methods for analyzing gene variants and copy number variants associated with addiction, neurological, and psychiatric disorders; and modeling population structure and application of the model to the analysis of complex genetic brain disorders. Analyses that include gender differences are encouraged where possible and applicable. Applicants/grantees are encouraged to utilize common measures and increase data harmonization for substance abuse and addiction via the PhenX Toolkit (NOT-DA-12-008). Example topics include, but are not limited to education for devising or extending statistical and computational methods for:
Application Types Allowed
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
The direct costs are limited to $500,000 annually. All personnel costs (including administrative and clerical costs, as well as salaries of the PD/PI and other investigators/faculty) associated with directing, coordinating, and administering the program should be justified and reasonable.
The total project period for an application submitted in response to this funding opportunity may not exceed five years.
Award Project Period
The maximum period is 5 years.
Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with students/participants are not allowable costs from grant funds).
Participants/trainees may be paid if specifically required
for the proposed research education program and sufficiently justified. Participant
costs must be itemized in the proposed budget. Allowable participant costs
depend on the educational level/career status of the individuals to be
selected to participate in the program.
Other Program-Related Expenses
Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Directors/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
All registrations must be completed by the application due date.
The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.
Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations must complete 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
All Program Directors/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
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from diverse backgrounds, including underrepresented
racial and ethnic groups, individuals with disabilities, and women 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 SF 424 (R&R) Application Guide.
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.
In many cases, it is anticipated that the proposed research education program will complement other ongoing research training occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participants may gain relevant experiences consistent with their research interests and goals. Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. Moreover, the R25 mechanism may not be used to circumvent or supplement Ruth L. Kirschstein NRSA research training mechanisms.
If multiple sites are involved in the research education program, the applicant institution must be the primary site for the Program. The need for and use of multiple sites must be justified. Care must be taken to ensure that a multiple site application does not result in longer time in development of the new program.
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.
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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
Mentors should have research expertise and experience relevant to the proposed program.
Applications must describe the intended participants, and the eligibility and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels essential for participation in the planned program.
Participants may be US or non-US citizens. In the fields of statistics and computational modeling, foreign-trained individuals are believed to bring enriching experiences and to have different kinds of training that serve to engender greater synergy and innovation, both of which are critical objectives of this FOA. It is for this reason that non-US citizens are eligible as participants along with U.S. citizens.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.
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 the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed. with the following changes:
Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:
Facilities & Other Resources
Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.
Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:
All instructions in the SF424 (R&R) Application Guide must be followed, with the additional instructions described below:
The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below: Proposed Research Education Program, Institutional Environment and Commitment, Program Director/Principal Investigator, Program Faculty/Staff, Program Participants, Diversity Recruitment and Retention Plan, Plan for Instruction in the Responsible Conduct of Research, Evaluation Plan, Dissemination Plan.
Proposed Research Education Program (Component of Research Education Program Plan)
While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly describe the distinction between the intended participants in the proposed research education program and the research training supported by the training program. The information should include a description of the education and/or career levels of the planned participants. Provide programmatic detail on the special activities proposed (e.g., courses, curricula, seminars, workshops).
NIDA requires a multidisciplinary Program Committee for the overall administration of this program. A primary responsibility of this committee is the recruitment and selection of participants, procedures for the selection of research education activities and mentors for participants, and evaluation of participant progress. The committee should consist of experts representing statistical /computational and genetic disciplines and addiction/ substance abuse and its treatment and prevention. Schools, departments, and clinical sites participating in joint applications should be represented on the committee. Applicants should provide a description of the committee's structure, composition, and the frequency of meetings. Describe the composition of the Program Committee, identifying the role and the desired expertise of members. A plan for Program Committee approval and the selection of participants should be included. Describe how the Program Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program. Note that proposed Program Committee members should not be named in the application. However, renewal applications with existing Program Committees should include names of existing advisors.
Progress reports for renewal applications (competing continuations) should be contained in the Research Education Program Plan. Applications should contain information on steps that have led to the proposed research education program. A progress report must be included in renewal applications and must address both substance abuse as a focus and provisions to ensure sustainability including progress in development of the provisions of this FOA beyond the R25 mechanism to integrate it into the curriculum at the institution.
Institutional Environment and Commitment (Component of Research Education Program Plan)
Describe the institutional environment, reiterating the availability of facilities and educational resources (described separately under “Facilities & Other Resources”), that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached as part of Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. Describe commitment to the goals of the program under this FOA and any specific accomodations to ensure its success in meeting those goals.
A plan is also required for continuous assessment and improvement of the curricula and other aspects of the research education program. The plan should be formulated to address statistical methods and computational models with an emphasis on challenges in the genetics of addiction. Plans for the development of skills for new methods development for working on current questions and databases must be addressed. Since institutions may have particular needs and circumstances, this FOA provides general rather than specific guidance on the types of research education activities that are appropriate. Nevertheless, the plan should provide flexibility to remain responsive to evolving and emerging opportunities in the area(s) of research education chosen.
Program Director/Principal Investigator (Component of Research Education Program Plan)
Describe arrangements for administration of the program, provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program. Show how the Program Director is developing and using statistical methods and computational approaches to conduct genetics research. The Program Director must also teach in an area related to the mission of NIDA, and must show they can organize, administer, monitor, and evaluate the research education program, as well as give evidence of institutional and community commitment and support for the proposed program. All of these types of expertise must be held by the Program Director or if there are multiple PIs, then combined they should have all of these types of expertise.
Program Faculty/Staff (Component of Research Education Program Plan)
Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of NIH and particularly NIDA. Describe the teaching, research and other scholarly activities they are engaged in concerning statistics/computation and/or genetics.
Program Participants (Component of Research Education Program Plan)
Where the proposed program involves participants, provide details about the pool of expected participants, their qualifications, recruitment strategies and sources of applicant pool, etc. Indicate the screening process to determine a potential participant's willingness to pursue substance abuse research and an emphasis on innovation in the development of new and improved statistical and/or computational approaches.
Diversity Recruitment and Retention Plan (Component of Research Education Program Plan)
The NIH recognizes a unique and compelling need to
promote diversity in the biomedical, behavioral, clinical and social sciences
research workforce. The NIH expects efforts to diversify the workforce to lead
to the recruitment of the most talented researchers from all groups; to improve
the quality of the educational and training environment; to balance and broaden
the perspective in setting research priorities; to improve the ability to
recruit subjects from diverse backgrounds into clinical research protocols; and
to improve the Nation's capacity to address and eliminate health disparities.
Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.
The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, Hawaiian Natives, and natives of the U.S. Pacific Islands. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.
C. Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
Recruitment and retention plans related to a
disadvantaged background (C1 and C2) are most applicable to undergraduate
candidates, but would be more difficult to justify for individuals beyond that
level of academic achievement. Under extraordinary circumstances the PHS may,
at its discretion, consider an individual beyond the undergraduate level to be
from a disadvantaged background. Such decisions will be made on a case-by-case
basis, based on appropriate documentation.
New applications must include a description of plans to enhance recruitment of a diverse participant pool and may include data in support of past accomplishments.
Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:
For those individuals who were enrolled in the
program, the report should include information about the duration of education and
whether those individuals finished the program in good standing. Additional
information on the required Recruitment and Retention Plan to Enhance Diversity
is available at Frequently Asked Questions: Recruitment and Retention Plan to
Enhance Diversity (Diversity FAQs).
Applications lacking a diversity recruitment and retention plan may be delayed or not accepted for review. An award cannot be made if an application lacks this component.
Plan for Instruction in the Responsible Conduct of Research (Component of Research Education Program Plan)
Every participant supported by this Research Education grant must receive instruction in the responsible conduct of research. All applications must include a plan to provide such instruction. The plan must address five components (format; subject matter; faculty participation; duration of instruction; and frequency of instruction) as detailed in NOT-OD-10-019. Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan.
Applications lacking a plan for instruction in responsible conduct of research will not be reviewed. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019. If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.
Evaluation Plan (Component of Research Education Program Plan)
Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements. This will be a reviewable element of annual non-competing progress reports.
Dissemination Plan (Component of Research Education Program Plan)
A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sample curricula, web postings, presentations at scientific meetings, workshops, etc. Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee.
Resource Sharing Plans
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
Applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
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.
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
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 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.
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, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact/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).
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.
Does the proposed research education program address an important problem or critical question in research education or other critical issues? How will implementation of the proposed program advance the objectives of the proposed program? If the aims of the education program are achieved, will they (1) lead to the development of highly trained scientists focused on substance abuse research and with advanced skills in innovation in statistical and/or computational methods in genetics in adequate numbers and in appropriate scientific areas as outlined in the FOA, and (2) provide public education and outreach on NIDA-funded research to a variety of audiences?
Are the PD(s)/PI(s), collaborators, and other researchers appropriately trained and well suited to the proposed research education program? Is the PD/PI an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program? If Early Stage Investigator or New Investigator, or in the early stages of an independent career, does the PD/PI have appropriate experience to lead the program? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives?
Is the proposed research education program characterized by innovation and scholarship? Does the proposed program challenge and seek to shift current research education paradigms or clinical practice, or address an innovative hypothesis or critical barrier to progress in the field? Are the proposed concepts, approaches, methodologies, tools, or technologies novel for this area? Does this proposed program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere? Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program.
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If called for, is the proposed plan for evaluation and/or dissemination of the education program sound and likely to provide data on the effectiveness of the education program? Is there evidence that the program is based on sound research concepts and educational principles? Is the approach feasible and appropriate to achieve the stated research education goals? If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool?
Is the proposed research education program focused on substance abuse and addiction? Are there adequate plans to ensure a substance abuse focus?
Is there an appropriate plan for the continuous assessment and improvement of the curricula and other research education activities supporting grant and publication productivity of its education program participants and faculty?
Is there an adequate plan to screen potential participants for their willingness to pursue substance abuse research and an emphasis on innovation in the development of new and improved statistical and/or computational approaches?
Are there adequate plans to ensure sustainability of the provisions of this FOA beyond the R25 mechanism to integrate it into the curriculum at the institution?
Is the proposed Program Committee designed adequately to ensure scientific and administrative oversight of the proposed research education program?
If the program 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?
Will the scientific/educational environment in which the proposed research education program will be conducted contribute to the probability of success? Are the institutional commitment and support, equipment and other physical resources available to the investigators adequate for the program proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, and institutions? If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)? Have appropriate plans and assurances been provided to ensure timely engagement of participants? If multiple sites are participating, has there been adequate accomodation for this extra level of organization in engaging participants? Is the statement of institutional commitment to provide sustained leadership and dedicated faculty time adequate to the development and implementation of the Program as well as a commitment to the development of junior investigators as productive, independent investigators adequate? Is there a satisfactory institutional commitment to the development of new statistical methods and computational models under the Program and to making these available to be used by others in the field?
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.
Protections for Human Subjects
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Inclusion of Women, Minorities, and Children
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
For resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. Both should be summarized in the introduction.
For renewals, the committee will consider the progress made in the last funding period and the success of the program in attracting and retaining individuals from diverse populations, including populations underrepresented in biomedical and behavioral research . Have they adequately addressed both substance abuse as a focus and provisions to ensure sustainability including progress in development of the provisions of this FOA beyond the R25 mechanism to integrate it into the curriculum at the institution?
For revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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.
Recruitment & Retention Plan to Enhance Diversity
Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Training in the Responsible Conduct of Research
Taking into account the specific characteristics of the research education program, level of participant experience, and the particular circumstances of the participants, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe how faculty will participate in the instruction? Do the plans ensure participants will receive instruction (or in the case of more senior level participants, provide instruction) for an appropriate amount of time given the length of the research education experience? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.
Applications from Foreign Organizations
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) , 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. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the
PD(s)/PI(s) will be able to access his or her Summary Statement (written
critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
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.
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.
The Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted.Programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the PHS 2590 Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards.
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.
Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.
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.
In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
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)
Beth Babecki, M.A.
Deputy Training Coordinator
Division of Neuroscience and Behavioral Research
National Institue on Drug Abuse (NIDA)
6001 Executive Boulevard
Bethesda, MD 20892-9555
Mark Swieter, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse (NIDA)
Grants Management Branch
National Institute on Drug Abuse (NIDA)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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