Part 1. Overview Information

Key Dates

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The overarching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.

The overarching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.

NIDA's mission is to advance science on the causes and consequences of substance use and addiction and to apply that knowledge to improve individual and public health. This funding opportunity seeks to facilitate the research education of undergraduate students, postbaccalaureate students, predoctoral students, postdoctoral fellows, and/or early-stage faculty from diverse backgrounds (including those from underrepresented groups) who are knowledgeable about substance use and addiction research, and plan to study this research area later in their careers.

NIAAA's mission is to generate and disseminate fundamental knowledge about the effects of alcohol on health and well-being, and apply that knowledge to improve diagnosis, prevention, and treatment of alcohol-related problems, including alcohol use disorder, across the lifespan.

To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

• Courses for Skills Development: Providing innovative, state-of-the-art, evidence-based education that relates to the mission of NIDA and/or NIAAA, and is derived from biomedical, behavioral, or clinical research findings. For example, advanced courses in a specific discipline or research area, clinical procedures for research, specialized research techniques, or research methodology. The courses may include elements that promote research skills, career development skills, and/or transitioning to the next career stage. For example, short courses, boot camps, or seminars on NIH grant application development and submission, manuscript preparation and publication, survival skills for early-career scientists, and statistical methods. The format of the courses may involve a traditional in-person approach, online activities, a hybrid of both approaches, and/or other methods.

• Research Experiences: Activities include hands-on exposure and research experiences for undergraduate students, postbaccalaureate students, predoctoral students, postdoctoral fellows, and/or early-stage faculty. The nature of research experiences should be tailored to the needs and career level of participants. It is expected that mentoring will be provided in conjunction with planned research experiences. Research experiences must also be designed to address some area of NIDA and/or NIAAA extramurally supported research and must include a hypothesis driven research project. Programs are also expected to include complementary activities that support the participants' scientific development, such as scientific writing and presentation skills and training in rigor and reproducibility. Programs should consider the needs of the intended participants and the likelihood of improving their knowledge and/or skills when designing the research program. Programs should have clear goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome(s).

  • • For example:
      • Providing details about how this research experience will reinforce the goal to graduate with a STEM degree and support the transition of participants to the subsequent career stage
      • Demonstrating hands-on authentic research experiences that reflect ownership of a project and provide an opportunity for meaningful contribution to the research in question
      • Examples of the participant’s interest in further education and training for future research related to the NIDA and/or NIAAA mission
      • Explaining how this research program would extend the participant’s skills, experiences, and knowledge base and prepare them to successfully transition to an independent research career

Background

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires intellect, creativity, and a wide range of skill sets and viewpoints. . NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that result from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, and advancing the likelihood that underserved populations participate in research. In spite of tremendous advancements in scientific research- information, education, and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences.

In spite of tremendous advancements in scientific research - information, education, and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences.

Need for the Program

This R25 Education Program will provide the resources needed to assist with the preparation of individuals from diverse backgrounds to successfully transition to the subsequent professional career stage. This FOA invites applications from established researchers with a record of NIH funding, who can demonstrate that they have successfully guided previous early career scientists to independent research careers and are able to direct an educational research capacity building program. This R25 program intends to strengthen the pipeline of individuals in biomedical, behavioral, and clinical substance use and addiction research across various stages of the research pipeline to enhance the number of independently funded investigators from diverse backgrounds.

Evidence from several reports demonstrate that an intervention designed to facilitate successful transitions along this pathway would benefit the research community (Expanding Underrepresented Minority Participation: America's Science and Technology Talent at the Crossroads, National Academy of Sciences, National Academy of Engineering, and Institute of Medicine 2011 and Advancing the Nation’s Health Needs: NIH Research Training Programs).

Currently these groups are not only underrepresented in science, technology and engineering (NSF, 2016), their underrepresentation in these fields also increases throughout the training stages. For example, students from certain racial and ethnic groups, including Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders currently comprise ~39 percent of the college age population (Census Bureau), but earn only ~17 percent of bachelor's degrees and ~11 percent of the Ph.D.s in the biological sciences (NSF, 2016).

It is expected that efforts and resources from this program will foster a greater understanding of the implications of substance use and addiction nationwide and contribute to the biomedical research workforce which will help to develop solutions to reduce the burden of substance use, addiction, and their health-related consequences across all populations. The specific NIH Institute and Center scientific areas supported through this FOA include the following:

NIDA encourages research experiences to include, but not limited to: cellular and molecular neuroscience, neuroimaging, genetics, medication and treatment development, development of new and improved strategies to prevent substance use and its consequences, pain and analgesia, neuroimmune signaling, neuropathology in brain systems, cognitive processes, population neuroscience, delivery of HIV and substance use prevention and treatment services, medication development, epidemiology of substance use, identifying the biological, environmental, behavioral, and social causes and consequences of substance use and addiction across the lifespan, and implementation science, including secondary data analysis. In addition, American Indians and Alaska Natives experience tremendous disparities in substance abuse and addiction, having the highest rates of abuse and addiction relative to other racial/ethnic groups, and experience high rates of negative consequences from substance abuse. Research addressing American Indian and Alaska Native substance abuse and addiction health related disparities is particularly encouraged.

NIAAA encourages research experiences across a broad spectrum of inquiry related to alcohol use and alcohol use disorder. The areas of interest include but are not limited to genetics/epigenetics, neuroscience, including cellular and molecular and clinical, neuroimaging, development of novel medications and behavioral treatments, psychiatric comorbidities, pain; basic and translational research on the health consequences of alcohol consumption; applied, translational, and methodological research on the epidemiology and prevention of hazardous alcohol consumption and related behaviors, alcohol use disorder, alcohol-related morbidity and mortality; health services, stigma, fetal alcohol exposure and fetal alcohol spectrum disorder, dissemination and implementation, and health disparities. NIAAA also encourages research aimed at reducing alcohol-related health disparities within American Indians and Alaska Natives.

A milestone plan with concrete goals for participants, timelines for proposed research and professional development activities, and evaluation metrics is required for all applications. The milestone plan will be used to evaluate: participant research experiences, technical skill development opportunities; formal mentoring plans, professional career development activities, NIH application and manuscript submissions plans, courses and seminars for skills development, participant feedback, and the successful graduation or transition of participants to the subsequent career stage.

Applicants can focus on a single career stage or encompass multiple career stages (undergraduate students, postbaccalaureate students, predoctoral students, postdoctoral fellows, and/or early-stage faculty) within their approach, but must include research experiences and courses for skills development to prepare participants to successfully transition to the subsequent professional career stage as key components of the program. Partnerships between institutions are allowed and encouraged. Institutions with a historical or demonstrated track record of educating and promoting minorties are encouraged to apply.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs. Because the R25 program is not intended as a substitute for an NRSA institutional training program (e.g. T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Other Award Budget Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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 federal 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

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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 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 SF424 (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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Program Faculty

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Participants

Participants supported by this research education program should be U.S. citizens and permanent residents.

This program is designed to prepare individuals from diverse backgrounds to conduct research and to prepare for research careers, including those from groups underrepresented in the biomedical, behavioral, clinical and social sciences research workforce. The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders (see https://ncses.nsf.gov/pubs/nsf19304/). It is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this program. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at https://www.nsf.gov/statistics/women/). 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 data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in NIH programs to enhance diversity. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity (https://www.govinfo.gov/content/pkg/FR-1997-10-30/html/97-28653.htm).

Participants may be undergraduates, postbaccalaureate students, predoctoral students, postdoctoral researchers, and/or early career faculties.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) 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 will not be reviewed.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to: NIDALetterofIntent@mail.nih.gov.

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

Office of Extramural Policy and Review
National Institute on Drug Abuse
DER/OEPR
3WFN 9^th Floor, MSC 6021
301 North Stonestreet Ave
Bethesda, MD 20892

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.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional 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.

Other Attachments.

Enhancing Biomedical Workforce Statement: Fostering workforce diversity is a key strategy to uphold the quality of scientific innovation and discovery. NIH encourages institutions to diversify their trainee and faculty workforce to enhance the participation of individuals from groups identified as underrepresented in the biomedical sciences (e.g., see the Notice of NIH's of Interest in Diversity). For the purposes of this announcement, the applicant must include an Enhancing Biomedical Workforce Statement. The statement should include a description of the applicant’s commitment to workforce diversity in the biomedical sciences. In addition, applicants should include a description of past and present leadership, mentoring, and outreach activities to enhance workforce diversity - especially involving groups identified as underrepresented in the U.S. biomedical research enterprise. The applicant should include a description of former and present demographic distribution and career trajectories of underrepresented populations in the applicant’s laboratory, institution, and/or research program. Describe ongoing and planned outreach, mentoring activities, and actionable milestones to enhance workforce diversity in the applicant’s laboratory, institution, and/or research program. Describe planned activities during the grant period designed to develop or enhance skills of talented scientists from a wide variety of demographic groups and any actions planned to promote inclusive and equitable scientific biomedical research environments. Future goals, activities, and milestones should include a description of how the effectiveness and impact of these activities will be monitored and evaluated. The interventions identified should be evidence-based and designed to lead to improved quality of research and/or foster scientific innovation in the laboratory, institution, and research program.

An Advisory Committee is not a required component of a Research Education program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application only if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file Advisory_Committee.pdf .

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

• Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

Follow all instructions provided in the SF424 (R&R) Application Guide.

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

Research Strategy

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
• Program Director/Principal Investigator
• Program Faculty
• Program Participants
• Institutional Environment and Commitment
• Diversity Recruitment Plan
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan
• Dissemination Plan

Research Education Program Plan

Proposed Research Education Program. 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 distinguish between the activities in the proposed research education program and the research training supported by the training program.

The description should include the educational and/or career stages(s) of the participants. It should also provide details on the proposed research areas of study and on courses or seminars for skills development. The application should also detail plans for providing strong mentoring. A milestone plan with a timeline is highly encouraged, including for example, didactic courses, professional development workshops/seminars, research goals, and mentoring activities. In addition, since the intent of this program is to assist in the transition of participants to the subsequent research career stage, plans to do so must be included in the application. The proposed research education program should include benchmarks and metrics used to meet the overall program goals. Provide support for the feasibility of the proposed activities and how they relate to the strengths of the institution. The description should also discuss any perceived impediments to implementing the proposed activities and alternative strategies to achieve the measurable objectives. Importantly, the description should detail how the progress of the participants and mentorship activities will be monitored and documented, and what steps will be in place for mediation should problems occur. As a component of the oversight of the participant's progress, it is highly encouraged that an individual development plan (IDP) (NOT-OD-14-113) is developed with the PD/PI and/or their mentor. Describe innovative strategies that could serve as a model for other institutions.

Program Director/Principal Investigator. Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator 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. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project. Provide evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished.

The responsibilities of the PD(s)/PI(s) include recruitment, selection, placement, and retention of participants in research laboratories; ensuring the research experience is advancing the skills and development of the participants, as well as coordination and implementation of developmental and mentoring activities. For example: publishing manuscripts, submitting NIH grant applications, participating in professional development workshops, attending scientific conferences to present research findings, and preparing participants to successfully transition to the subsequent career stage.

Program Faculty : Faculty with a track record of mentoring, advising, and guiding participants to the subsequent career stage should be included in the program faculty. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research and mentoring expertise and experience relevant to the proposed program and career stage and demonstrate a history of, or the potential for, their intended roles. It is essential that trainees have exposure and access to a broad range of appropriate mentors. This includes individuals with different perspectives, senior faculty who have the benefit of long experience, and junior faculty who have more recent experience in transitioning to independent positions. Programs should describe efforts to achieve diverse representation in program leadership, participating faculty and mentors, and invited speakers. List the Program Faculty whose role is to develop, direct, mentor, and evaluate the proposed research experiences program as Key Personnel and provide their biographical sketches. Describe the experience of the participating faculty in mentoring students and/or investigators, as well as their ability to serve as good role models for the participants by virtue of their own scientific accomplishments.

Program Participants. Applications must describe the intended participants. They must also identify and justify the career levels for which the proposed program is planned. Participants may be from a single career stage, or programs may propose to bridge several career stages of participants. Describe the process for selection of the program-supported participants. Examples of accepted indicators include, but are not limited to, previous academic success, academic area of specialty, previous research experience, written statements that express interest and commitment to a long-term career in substance abuse, and addiction research. Include the candidate qualification process, final selection process, and mentor matching. Describe the retention strategies and follow-up activities across the program that would ensure participants remain engaged and are receiving high quality experiences , mentorship, and guidance within the program and assistance as they transition to the subsequent career stage.

Institutional Environment and Commitment. 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 (see below). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

The scientific environment and institutional commitment should clearly contribute to the probability of success for each supported participant. The institutional support, equipment, and other physical resources available to the participants should be clearly described and detailed relative to the implementation of quality research experiences for the participants. Research activities provided through the institution should foster career development for lead the participants to applying for independent grants.

Where appropriate, describe any unique features of the scientific environment, subject populations, or collaborative arrangements that may be leveraged to the advantage of the proposed research experiences program. Describe efforts to enhance diversity and promote inclusion through an environment that promotes the success of individuals with a wide variety of backgrounds and perspectives (i.e. institutional and departmental environments in which scholars from all backgrounds feel integrated into and supported by the biomedical community).

Recruitment Plan to Enhance Diversity (NOT-OD-20-031):

Diversity Statement
Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires intellect, creativity and a wide range of skill sets and viewpoints. Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

Underrepresented Populations in the U.S. Biomedical, Clinical, Behavioral and Social Sciences Research Enterprise
In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

1. 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 data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in NIH programs to enhance diversity. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity (https://www.govinfo.gov/content/pkg/FR-1997-10-30/html/97-28653.htm).


2. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, https://www.nsf.gov/statistics/2017/nsf17310/static/data/tab7-5.pdf.


3. Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria:

   Students from low socioeconomic (SES) status backgrounds have been shown to obtain bachelor’s and advanced degrees at significantly lower rates than students from middle and high SES groups (see https://nces.ed.gov/programs/coe/indicator_tva.asp), and are subsequently less likely to be represented in biomedical research. For background see Department of Education data at, https://nces.ed.gov/; https://nces.ed.gov/programs/coe/indicator_tva.asp; https://www2.ed.gov/rschstat/research/pubs/advancing-diversity-inclusion.pdf.

   1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche.ed.gov/mckinney-vento/);
   2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www.acf.hhs.gov/cb/focus-areas/foster-care);
   3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.fns.usda.gov/school-meals/income-eligibility-guidelines);
   4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces.ed.gov/pubs2018/2018009.pdf);
   5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.ed.gov/programs/fpg/eligibility.html);
   6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.fns.usda.gov/wic/wic-eligibility-requirements).
   7. Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer (https://data.hrsa.gov/tools/rural-health), or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas (qualifying zip codes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.
4. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008902/).

Women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines, and may also be underrepresented at other faculty levels in some scientific disciplines (See data from the National Science Foundation National Center for Science and Engineering Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available at https://www.nsf.gov/statistics/2017/nsf17310/, especially Table 9-23, describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank).

Upon review of NSF data, and scientific discipline or field related data, NIH encourages institutions to consider women for faculty-level, diversity-targeted programs to address faculty recruitment, appointment, retention or advancement.

New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of prospective trainees from underrepresented backgrounds and may wish to 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, including successful and unsuccessful recruitment strategies. Information should be included on how the proposed plan reflects the program’s past experiences in recruiting individuals from underrepresented groups.

Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

Evaluation Plan. A milestone plan with timelines and metrics is required for all applications. The detailed milestone plan will be used to evaluate the application during peer review and in consideration of the awarded project for funding of non-competing award years. The milestone plan will be used to evaluate the research experiences and technical training of participants; formal mentoring plans and professional career development activities completed by participants; NIH application and manuscript submissions from participants; courses for skills development offered, participant participation, and feedback; and when appropriate, the successful graduation or transition of participants to the subsequent career stage. Applications must include a plan for evaluating the milestone plan supported by the award. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

Dissemination 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., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above: Institutional Environment and Commitment").

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

When relevant, 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:

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

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.

3. Unique Entity Identifier and System for Award Management (SAM)

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.

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

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.

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 (SAM). 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Section V. Application Review Information

1. Criteria

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.

The goal of this R25 program is to support educational activities that enhance the training of a diverse workforce to meet the nation’s biomedical, behavioral and clinical substance abuse and addiction research needs. Applicants can focus on a single career stage or encompass multiple career stages (undergraduate students, postbaccalaureate students, predoctoral students, postdoctoral researchers, and/or early-stage investigators) within their approach, but must provide comprehensive research experiences to prepare participants to successfully transition to the subsequent professional career stage as a key component of the program.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this R25 Education Program, 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.

Significance

Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?

Does the program identify a novel and creative approach to enhancing diversity in substance abuse and addiction research? Does the proposed program identify and address gaps, challenges, or other barriers in recruiting diverse groups in the substance abuse and addiction research workforce and propose a sustainable plan to address these challenges?

Investigator(s)

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? 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 diverse representation in program leadership, participating faculty and mentors, and invited speakers?

Does the PD/PI have the experience needed to coordinate and implement a research capacity program including: managing mentor-mentee relationships, guiding participants in their professional/career development, ensuring they are attending scientific conferences where they will present their research studies, and having a proven and demonstrated track record of preparing participants to successfully transition to the subsequent career stage? Also, does the PD/PI have experience ensuring that participants at the undergraduate, postbaccalaureate, predoctoral, postdoctoral, and early career faculty stages are publishing manuscripts and submitting NIH grant applications?

Innovation

Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?

Does the applicant clearly distinguish what is novel in this diversity enriching research educational program and why their approach will lead to program success? Does the applicant incorporate truly innovative strategies that could serve as a model for other institutions?

Retention approaches, and successful transitioning steps to assist early career scientists from diverse groups to successfully transition to the subsequent career stage?

Approach

Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?

Is the proposed milestone plan well-detailed and does it include benchmarks that will set up each participant for success , education and support so that participants are equipped with the skills needed to have a sustainable research career? Does the approach fully education and prepare participants for the NIH grant submission and review process? Does the approach incorporate manuscript development into their course offerings? Will the plan for evaluation meet program goals and outcomes and is it likely to provide information on the program effectiveness? Does the evaluation plan include the data elements outlined in this FOA including but not limited to: demographics of participants, NIH grant application submissions from participants, successful transition of participants to the subsequent career stage, document formal mentor-mentee interactions, and allocation of resources from the institution? Is there an appropriate plan for dissemination of successful and unsuccessful practices?

Are the overall strategy, methodology, and analyses well-reasoned, feasible, and appropriate to accomplish the specific aims of the proposed research educational program? Are the participants equipped with the skills needed to have a sustainable research career? Does the approach fully educate and prepare participants for the NIH grant submission and review process? Does the approach incorporate manuscript development into their course offerings? Will the plan for evaluation meet program goals and outcomes and is it likely to provide information on the program effectiveness? For applications designating multiple PDs/PIs, is the Leadership Plan approach, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the project/program and the expertise of each of the PD/PIs?

Environment

Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?

Are efforts to enhance diversity and promote inclusion through an environment that promotes the success of individuals with a wide variety of backgrounds and perspectives well-described and likely to succeed?

Are the institutional support, equipment and other physical resources available to the participants adequate for the development and implementation of quality research projects? Does the applicant adequately discuss how the program will benefit from unique features of the scientific environment or collaborative arrangements?

Will the environment(s) within the program help to foster career development and success of the participants, and provide enriching and novel research experiences for participants?

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.

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.

Enhancing Biomedical Workforce

When the proposed project involves enhancing the biomedical research enterprise, the committee will evaluate and assess how the proposed workforce enhancement strategies and future plans will lead to more innovative discoveries and ideas in scientific and research contributions. Reviewers will assess the likelihood that the future plans and strategies will be effective and impactful beyond what currently exists. Reviewers will assess whether the proposed milestones for evaluating the effectiveness of the strategies are adequate and feasible. Reviewers should also assess if the applicant is proposing to use established evidenced-based workforce diversity enhancement and inclusiveness strategies, which should be documented in the Enhancing Biomedical Workforce statement. The committee should also assess if the proposed scholar recruitment and retention plan to enhance the scientific biomedical workforce is justified and feasible. Consider the proposed career stages supported and institutional, regional, and/or national demographics. A well justified recruitment plan is required regardless of the size of the recruitment pool of historically underrepresented minorities.

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

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.

Revisions

Not applicable

Renewals

For renewals, the committee will consider the progress made in the last funding period, and the success of the program in attracting individuals from diverse populations, including populations underrepresented in biomedical, behavioral and clinical research on a national basis.

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.

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans 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 proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Applications from Foreign Organizations

Not applicable

Select Agent Research

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

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.

If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIDA 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:

• 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.
• Will receive a written critique.

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.6. 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.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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 Trainee Diversity Report, in accordance with the RPPR Instruction Guide.

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.

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.

Other Reporting Requirements

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.

A final RPPR 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.

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their R25 research education programs, employing the measures identified below. In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants subsequent educational or employment history and professional activities.

Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.

In evaluating this research education program NIDA expects to use the following evaluation measures:

For Research Experience and Mentoring Programs Involving the Following Groups:

Undergraduate Students:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress, including:

Successful completion of an undergraduate degree in a STEM field
Enrollment in an advanced degree program in a STEM field

Postbaccalaureates:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress, including:

• Successful transition to an advanced degree program in a STEM field
• Hands on exposure and research experience/training in a biomedical laboratory

Graduate Students:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress of participants, including:

Successful completion of a STEM graduate program
Subsequent participation in a formal research training or career development program in a STEM field
Subsequent participation in research
Subsequent employment in a research or research-related field
Subsequent authorship of scientific publications in a STEM field
Subsequent independent research grant support from NIH or another source

Postdoctorates and Early Career Faculty:

• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress of participants, including:

Subsequent participation in research
Subsequent employment in a research or research-related field
Subsequent authorship of scientific publications in a STEM field
Subsequent independent research grant support from NIH or another source

• Formal participant feedback on their research experience while supported by the R25 Education Program

Section VII. Agency Contacts

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: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Angela Holmes, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: (301) 827-2487
Email: angela.holmes2@nih.gov

Laura E. Kwako, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-8507
Email: laura.kwako@nih.gov

Dharmendar Rathore, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email: Dharmendar.Rathore@nih.gov.

Ranga Srinivas, Ph.D.
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-2067
Email: srinivar@mail.nih.gov

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301- 480-1159
Email: pfleming@nida.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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.