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 goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

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

• Courses for Skills Development: For example, advanced courses in a specific discipline or research area, clinical procedures for research, or specialized research techniques.

This RFA is to support courses for skills development in cross-cutting methodologies and analytics that are needed to advance behavioral and social sciences research (BSSR) but are not well-addressed by existing educational programs widely available to the BSSR community. A definition of BSSR can be found at (https://obssr.od.nih.gov/about/bssr-definition/). Short courses supported by this RFA should develop, implement, evaluate and disseminate education and training focused on innovative methods for BSSR. Methodological domains of focus include but are not limited to innovative data collection methodologies and analytic techniques, analysis and linking of big data, or needed but underutilized designs to advance research across the translational spectrum.

Proposed educational programs should be integrative, both in the transdisciplinary nature of the skills and approaches taught and in applicability across a wide range of BSSR areas. The content of the course should focus on knowledge and skills necessary for the advancement of behavioral and social sciences and/or the integration of BSSR with other areas of science and technology. Content should not be limited to specific disease applications but rather focus on generally applicable research methodologies and analytics crucial for more advanced BSSR.

Applicants are expected to describe the learning objectives for the proposed short course, how the proposed course will enhance existing skills and capabilities of the target participants and how the impact of the learning will be measured. In addition, applicants must describe how this training fills a unique and important skills gap in BSSR that is not already well covered by existing training courses or curricula. Applicants are strongly encouraged to review and document existing courses similar to the short course being proposed and specify why any similar coursesare insufficient to address the training need. Over the period of support, it is expected that the course will be refined, improved, and sufficiently well documented developed and implemented to extend beyond in-person attendance, and beyond the end of the project period (e.g. videos, slides, course materials). The course should be able to benefit more than the limited number that can attend in person. The development and implementation of fully or predominantly remote training programs is encouraged.

Priority will be given to courses that address an important and cross-cutting educational need, that fill a gap in the field not already well addressed by other opportunities, and include a plan for dissemination and sustainability of the training both during and beyond the funding period.

The goal is for the short courses supported by this RFA to build the capacity of the field. In achieving that goal, applicants are encouraged to incorporate methods and models that have the potential to reach an audience that is broader than the attendees. For example, a "Train the Trainers" model is highly encouraged. With this model, participants are not only taught the research skills but also but taught how to teach the material themselves, provided with the tools and resources needed to deliver these trainings in their own institutions (e.g., curricula, selected readings, slide sets, etc.), and receive ongoing technical and evaluation support. Another example is developing remote learning courses or taking the course to the participants at different institutions, thereby reducing travel costs as well as expanding the reach of the program. Training courses can be of varying lengths but the duration of the training and the format (online, in-person, or some combination) must be justified based on the learning objectives. Even if the training is primarily in-person, online adjuncts to the courses are encouraged (i.e., pre-meeting preparation materials and/or post-meeting support materials) and should be made available broadly. Opportunities for attendees to sustain and continue learning beyond the course are strongly encouraged. Such opportunities might take the form of ongoing mentorship, online discussion forums, listservs, or other formats.

Educational opportunities can either recur (the same course is repeated) or can be single-time opportunities (different courses occur over the course of the award period), depending on the needs of the scientific area. The format for course delivery may be in-person, online (e.g., massive open online course [MOOC], interactive online teaching platform), or a hybrid of the two. Skills development courses that are Open Educational Resources (OERs) are strongly encouraged. OERs generally adhere to FAIR principles (findable, accessible, interoperable, and reproducible) and are freely available online.

Target participants can include those just starting their careers (e.g., graduate students, medical students, medical residents, postdoctoral fellows, early-stage investigators) as well as established investigators (e.g., mid- and late-career researchers) who need skills in new methods that can be applied to their research area. The NIH expects all programs to foster the participation of individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, women, and persons from disadvantaged backgrounds. See,Notice of NIH's Interest in Diversity, NOT-OD-20-031. Therefore, all applicants are strongly encouraged to involve a diverse group of faculty and mentors, and their applications must include a plan for recruiting prospective participants from underrepresented groups. In addition, applicants are strongly encouraged to consider how the methodologies and approaches being taught in the proposed course can be reliably and validly applied across diverse groups, as well as how to address potential structural influences and/or consequences for communities/subpopulations that are disproportionally impacted by disease burden.

Each application must include a plan to evaluate the activities proposed, as well as a plan for disseminating user-friendly course materials to the broader scientific community (see Section IV, Evaluation Plan and Dissemination Plan).

Possible educational topics include but are not limited to the following:

• Recent advances in quantitative, temporally fine-grained laboratory and naturalistic measurement of attention, learning, memory and other cognitive and emotional processes;
• Neuroimaging and other neuroscience measurement approaches specifically applicable to behavioral and social sciences research such as methods for use in dyads or groups;
• Methods and research designs to facilitate early phase/stage intervention development and testing such as N-of-1 or single case designs, dosage designs, adaptive, or optimization designs to determine which combinations of components need to be delivered in which context and target population;
• Methods and measures to increase reach, temporal density and ecological validity of data collection such as mobile and wireless health approaches to assessment and intervention;
• Methods and approaches to encourage linking and merging of different types of data or to improve analytic approaches for combined or multilevel data, such as combining quantitative and qualitative data or integration of community level data such as spatial/geographic and biological (e.g., gene or biomarker), behavioral, or social science data;
• Analytic approaches to better use big data mining, pattern recognition, AI (e.g. machine learning, natural language processing), integration, visualization, and analysis to hypothesis test important research questions in the behavioral and social sciences. Big data in this FOA refers to large, , complex, longitudinal, and/or distributed data sets generated from instruments, sensors, internet transactions, email, video, click streams, and/or all other digital sources available today and in the future;
• Innovative survey methods (such as mixed mode surveys; use of social media and crowd-sourced platforms) and other objective methods (e.g. sensors, GIS) and analysis including, but not limited to, approaches to test trends over time or assess hard to reach populations;
• Methods and research designs to facilitate later stage behavioral intervention testing such as pragmatic trials for effectiveness research, or methods to study dissemination or implementation into community or health care settings;
• Methods to improve the bidirectional translation of knowledge of behavioral and social processes in humans and animal models (e.g., comparable behavioral testing paradigms in humans and model organisms);
• Methods and approaches to facilitate innovative and rigorous evaluations of natural experiments in order to capitalize on existing policy and practice implementation, particularly methods to study the social determinants of health and how health outcomes among NIH identified populations experiencing health disparities
  are impacted by public policies, institutional practices and/or systems (including those outside of the health system such as education, housing, social services, and justice).
• Methods and approaches to advance dissemination and implementation science including integration with other disciplines of research such as community engagement, health communication, health services, and public health research;
• Methods for integrating research on basic behavioral and/or social processes into individual and multi-level behavior change intervention development and testing;
• Computational approaches for integrating multi-level data to understanding complex and multi-level contributors to health and health behaviors;
• Methods to improve the development and implementation of culturally appropriate community engagement in research and translation of knowledge/research findings in verbal or nonverbal modalities and/or other languages;
• Measurement and methods to capture critical developmentally specific experiences (e.g. early childhood, transition to adolescence or early adulthood, transition to parenthood, or transition to retirement) and link those to future health outcomes including intergenerational impact of historical trauma;
• Methods and research designs for partially nested efficacy and effectiveness studies in which participants are randomized to an arm but are also nested in some higher level unit such as group, school, or clinic; particularly in the areas of design, analysis, and sample size estimation;
• Methods for regression discontinuity designs including appropriate uses, design, analysis, and sample size estimation;
• Methods for stepped wedge designs with particular attention to appropriate uses, data analytic and sample size estimation methods, to address issues such as heterogeneity of intervention effects across time and clusters;
• Incorporating data science-related methods into behavioral and social science research including machine learning, natural language processing and data mining;
• Performing behavioral and social science research using an open-science paradigm; use of FAIR principles; use of common data elements; transparency and reproducibility; and ontologies;
• Resources to support research in behavioral and social science: data, measure repositories, analytic help and other research tools.

Training in research approaches and methodologies should be relevant to a broad range of behavioral and social scientists. However, the short course must also be directly relevant to the priorities and mission of one or more of the participating Institutes and Centers. If the methods and approaches in the proposed course advance the behavioral and social science more broadly (not just applicable to one disease or age group), short courses may focus on educating researchers with a disease or life stage emphasis. Applicants are encouraged to discuss the focus of their proposed short course with the relevant scientific contact before submitting to be sure the focus is consistent with the FOA and aligned with the mission and priorities of the Institute or Center. Please see below for additional Institute and Center priorities:

NIDA Specific Language

The mission of NIDA is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. NIDA is interested in supporting short courses to build a capacity in the field of observational/etiologic, prevention, treatment, and health services research to address substance use, substance misuse, and substance use disorder, and comorbid conditions including HIV, psychiatric disorders, and suicide. Examples of educational topics of interest to NIDA include, but are not limited to:

• Application of data science to accelerate the pace of sociobehavioral innovation in substance use research, with an emphasis on engaging end-users in the research continuum. Methods of data science might include artificial intelligence and machine learning
• Re-use of data accessible via the National Addiction & HIV Data Archive Program or other NIDA-funded initiatives with data repositories such as the Adolescent Brain Cognitive Development (ABCD) Study, NIDA Clinical Trials Network, or HEAL Data Ecosystem
• Methods and research design that facilitate the generation of actionable findings from epidemiologic research, administrative data, or other existing data resources that can be translated into public health strategies and interventions to prevent and treat substance use and addiction
• Recent advances in role of policy in preventing substance use initiation and enhancing the capacity of systems to deliver prevention programs
• Innovative interventions that address social factors that play a role in substance use initiation
• Innovative methods to improve substance use services research, including but not limited to adaptation of existing services into more patient-centered models of care, understanding and improving capacity and impact of the substance use disorder services workforce, and improving measurement of substance use treatment outcomes
• Methods to improve culturally centered engagement and program related to substance use prevention and treatment, with emphasis on high-risk groups such as the American Indian/Alaska Native and justice-involved populations

NCCIH Specific Language

• NCCIH is interested in applications for educational programs on research methods with relevance to mind and body behavioral interventions, including various meditation approaches (e.g., mindfulness), hypnosis or guided imagery, meditative movement approaches (e.g., yoga, tai chi, qi-gong), body-based approaches (e.g., spinal manipulation, massage, mobilization, acupuncture), a combination of these approaches (e.g., meditation and yoga, such as in mindfulness-based stress reduction MBSR), or complex interventions including music and art therapy. Computational and data science methods for studying complex systems to advance research on Whole Person Health including machine learning and artificial intelligence algorithms, mathematical and computational modeling, predictive multisystem models, problem-driven multi-models, mechanistic multisystem models, or simulation modeling are of interest. Investigators are strongly encouraged to discuss their plans with NCCIH program staff prior to applying.

NIDDK Specific Language

• NIDDK is interested in applications for short courses that advance innovative methods for behavioral and social science training related to the development, progression and/or management of diseases and conditions within its mission (https://www.niddk.nih.gov/about-niddk/research-areas). Applications should align with NIDDK’s Strategic Plan for Research (https://www.niddk.nih.gov/about-niddk/strategic-plans-reports/niddk-strategic-plan-for-research), including proposals for educational activities focused on: multilevel methodologies to analyze links among behavior, biology, and the environment; data science applications to improve behavioral and social science studies and trials; dissemination and implementation science to promote the use of evidence-based prevention strategies and treatments in clinics and community based settings; and/or mixed methodology research engaging stakeholders. NIDDK is particularly interested in applications advancing methods related to health equity research and patient and community engagement, as well as methods that would help to advance research on differences in health status across biological and social constructs of identity including race/ethnicity, sex/gender differences, , and sexual and gender minority-related research (see NOT-DK-22-003). Applicants are strongly encouraged to contact NIDDK staff prior to applying.

NIAMS Specific Language

• The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases.

NEI Specific Language

• NEI is interested in applications for education programs (including summer and online or in-person course development) on behavioral and social science methods relevant to enhancing basic, clinical, and translational vision research. Relevant topics include but are not limited to: incorporating new technologies, data science-related methods (e.g., data harmonization and linkages to contextual data), implementation and dissemination science, telemedicine, and artificial Intelligence/machine learning approaches aimed at advancing the mission of the Institute. Educational programs or innovative courses on research methods aimed at addressing NIH-designated populations that experience health disparities and improving eye and vision health in rural, inner-city and other underserved and at-risk populations are high priority and of particular interest.

ODP Specific Language

• The ODP encourages applications for innovative courses that show promise for skill development in cross-cutting methodologies, especially those focused on integrating research on basic behavioral and/or social processes into multi-level behavior change intervention development. Applications should demonstrate that courses address educational needs and include topics on innovative design, measurement, and analytic methods relevant to disease prevention and meet the overall objectives of this funding opportunity announcement. Applications must also be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed above. ODP does not award grants. Please contact one of the IC program contacts listed for questions related to funding

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.

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

• Local 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)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

• Eligible Agencies of the Federal Government

• 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

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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.

• 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.
• Unique Entity Identifier (UEI) A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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 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. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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.

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 per 2.3.7.4 Submission of Resubmission Application. 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.

Program Faculty

Researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, 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

Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents.

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:

Erica L. Spotts, Ph.D.
Telephone: 301-594-2105
Email: [email protected]

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.

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 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.

• Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.

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
• Recruitment Plan to Enhance Diversity
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan
• Dissemination 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 value added of the proposed, R25-supported short course should be described. If existing training is widely available, applicants should clearly distinguish between the activities in the proposed research education short course and the existing training opportunities, and justify how the proposed training fills an important gap.

Describe the scientific need for and timeliness of the educational program, the potential impact for advancing behavioral and social science research (both in advancing the science and the breadth of science being advanced), how it complements existing training or didactic opportunities (as appropriate), and the rationale for the career stage(s) of the participants in the proposed course. Provide programmatic detail on the course objectives, specific activities proposed (e.g., curricula, seminars, on-line, mentoring), and how the course objectives will be measured.

Describe expected processes for: (a) planning and implementing the proposed educational activities, (b) if applicable, coordinating among existing training or research activities available at a site or across multiple sites, (c) dissemination and sustainability of course material after completion of the period of support.

Describe how the course may be modified over time based on early course evaluation, participant feedback, and/or new developments in the field. The goal of these modifications should be to ensure that the research education continues to provide cutting-edge opportunities that are responsive to the participants needs and continues to meet the overall learning objectives.

Describe the proposed structure of the research education. It is expected that a combination of learning approaches be considered to achieve the educational aim (e.g., online courses, chat rooms, regularly occurring webinars, one-on-one and small group discussions, in-person training). As appropriate to the goals of the course, applicants are encouraged to take advantage of contemporary communication strategies, such as distance learning and social networking. Training-the-trainer approaches should include strategies for providing ongoing support and assistance to the newly trained trainers, and for providing checks on training fidelity in this distributive training model.

In addition, for renewal applications, the progress report should describe the results of the course evaluation (e.g. knowledge/skills acquired, progress of education in the field), the number and characteristics of participants in the past period of support, materials disseminated, and any changes in administration, design/objectives, or targeted participant groups during the prior funding period. The description of the proposed research skills training for the next funding period should highlight how the program continues to offer research education at the scientific cutting-edge as well as any changes in activities that are planned to maintain the currency of the research education offered.

Renewal applications should describe the continuing need for the research education to develop a well-trained pool of researchers, and a clear plan for sustainability or dissemination of the course by the end of the period of support.

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.

Program Faculty. Researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.

Program Participants. Applications must identify the career levels for which the proposed program is planned.

Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program.

Institutional Environment and Commitment. Describe any additional aspects of the Institutional Environment and Commitment not addressed under Facilities & Other Resources or the required Institutional Commitment Letter of Support, described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. This section should not duplicate information provided elsewhere.

If multiple sites are proposed, they must be justified in terms of the research education experiences that will be provided, and adequate plans must be provided for coordination and communication between multiple sites. Describe approaches to minimize barriers for participants nationwide to attend, whether in person or remotely.

Recruitment Plan to Enhance Diversity :

The applicant must provide a recruitment plan to enhance diversity. Include outreach strategies and activities designed to recruit prospective participants from underrepresented groups, Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups.

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.

Applications lacking a Recruitment Plan to Enhance Diversity will not be reviewed.

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 and NOT-OD-22-055. 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. 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.Depending on the length of the course, applicants may want to consider a strategy for ongoing follow-up evaluation

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.

Applicants must describe how they will make the materials developed under the auspices of the research education program widely available and disseminate the materials to the relevant behavioral and social science research community. Examples of a dissemination plan might include but are not limited to, deploying a train-the-trainer model, sharing course curricula and related materials via web postings, conducting preconference workshops, integrating the curricula into graduate and/or postgraduate training programs, and/or developing MOOCs or other interactive online training resources.

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 Plan

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

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.

Delayed Onset Study

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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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 form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the {IC} Referral Office by email at {[email protected]} when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) name(s), and title of the application.

Requests of $500,000 or more for direct costs in any year

Not Applicable

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

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.

For this particular announcement, note the following:

The goal of this R25 program is to support educational activities that focus on cross-cutting methodologies and analytics that are needed to more rapidly advance behavioral and social sciences research (BSSR) and are not already well-addressed by existing educational programs widely available to the research community.

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?

To what extent will implementation of the proposed program advance skills in innovative methods and approaches relevant to BSSR? Is the program applicable across a range of disciplines, outcomes and age groups? Is the educational opportunity justified and based on addressing important gaps in existing opportunities?

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?

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 proposed program challenge and seek to shift current research education paradigms or clinical, behavioral, or public health practice, or address innovative hypotheses or critical barriers to progress in the field? Does the proposed course provide state-of-the-art educational opportunities?

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?

Does the proposed course integrate different disciplines? Are potential problems, alternate strategies, and benchmarks for success provided? Is there a plan for disseminating the course information to as large an audience as possible? Are learning objectives provided, along with plans for enhancing the targeted skills? Are there clear plans for refinement of the course in response to the changing needs over the period of support?

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?

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.

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., .

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

The applicant must provide a recruitment plan to enhance diversity. Include outreach strategies and activities designed to recruit prospective participants from underrepresented groups. Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups.

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.

Applications lacking a Recruitment Plan to Enhance Diversity will not be reviewed.

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 and NOT-OD-22-055. 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

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s),convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

• 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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 recipient’s business official.

Recipients 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, 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 (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals, 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 information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, 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, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. 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.

• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws 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 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients 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.

NIH FOAs outline intended research goals

and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

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 recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Failure by the recipient 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 45 CFR Part 75 and 2 CFR Part 200 and Appendix XII to 45 CFR Part 75.113 and 2 CFR Part 200.113, 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 and 2 CFR Part 200 Award Term and Condition 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. Recipients 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.

5. 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 OBSSR expects to use the following evaluation measures:

For Courses for Skills Development:

• Aggregate number and demographic characteristics of participants
• Educational level of participants
• Content
• Participants feedback on the program
• New knowledge or skills acquired

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: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

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

Erica L. Spotts, Ph.D

Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-594-2105
Email: [email protected]

Regina Bures, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9485
Email: [email protected]

James Churchill, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3621
Email: [email protected]

Satoko Janet Kuramotocrawford
National Institute on Drug Abuse (NIDA)
Phone: 3014438856
E-mail: [email protected]

Lanay M. Mudd, Ph.D., FACSM
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-9346
Email: [email protected]

Stephanie M George, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
E-mail: [email protected]

Melissa C. Green Parker, Ph.D.
Office of Disease Prevention (ODP)
Phone: 301-480-1161
E-mail: [email protected]

Sergey Radaev, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5630
Email: [email protected]

James Gao
National Eye Institute (NEI)
Phone: 301.594.6074
E-mail: [email protected]

Maureen Monaghan Center, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: none
E-mail: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: [email protected]

Pamela G Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

Sahar Rais-Danai
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: 301-594-5032
E-mail: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: [email protected]

Christina Coriz
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-594-8848
E-mail: [email protected]

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 and 2 CFR Part 200.