Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences  (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Library of Medicine (NLM)
Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH) National Center for Advancing Translational Sciences (NCATS)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Division of Program Coordination, Planning and Strategic Initiatives
Office of Research Infrastructure Programs (ORIP)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women’s Health (ORWH)
Office of Strategic Coordination (Common Fund)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Funding Opportunity Title

BD2K Open Educational Resources for Skills Development in Biomedical Big Data Science (R25)

Activity Code

R25 Education Projects

Announcement Type

Reissue of RFA-HG-14-008

Related Notices
  • May 27, 2016 -Notice of NIBIB's Participation in RFA-HG-16-016 . See Notice NOT-EB-16-007.
  • Funding Opportunity Announcement (FOA) Number

    RFA-HG-16-016

    Companion Funding Opportunity

    RFA-ES-16-002, BD2K Mentored Career Development Award in Biomedical Big Data Science for Clinicians and Doctorally Prepared Scientists (K01)

    RFA-ES-16-003, BD2K Career Transition Award in Biomedical Data Science for Intramural Investigators (K22)

    RFA-LM-16-002, Predoctoral Training in Biomedical Big Data Science (T32)

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

    93.172; 93.989; 93.350; 93.242; 93.173; 93.853; 93.398; 93.279; 93.865; 93.867; 93.846; 93.847; 93.866; 93.313; 93.879; 93.213; 93.121; 93.856; 93.855; 93.310; 93.351; 93.113 93.286  

    Funding Opportunity Purpose

    The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH.  The over-arching goal of this Big Data to Knowledge (BD2K) 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 biomedical researchers who need the requisite knowledge and skills to extract knowledge from biomedical Big Data.  To extend the reach of the course, each educational activity is required to develop open educational resources (OERs) that adhere to FAIR (findable, accessible, interoperable, and reusable) principles. Ideally, OERs should be useful to individuals at all career levels, from predoctoral students to established investigators.    

    Key Dates

     

    Posted Date

    May 18, 2016

    Open Date (Earliest Submission Date)

    July 2, 2016

    Letter of Intent Due Date(s)

    30 days prior to the application due date

    Application Due Date(s)

    August 2, 2016; August 2, 2017, by 5:00 PM local time of applicant organization. All types of applications allowed for this funding opportunity announcement are due on these dates.

    Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

    AIDS Application Due Date(s)

    Not Applicable

    Scientific Merit Review

    November 2016, November 2017

    Advisory Council Review

    January 2017, January 2018

    Earliest Start Date

    April 2017, April 2018

    Expiration Date

    August 3, 2017

    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

    It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

    Applications that do not comply with these instructions will not be reviewed


    There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.

    Problems accessing or using ASSIST should be directed to the eRA Service Desk.
    Problems downloading forms should be directed to Grants.gov Customer Support.
    Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement
    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    The 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 over-arching 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) enhance the diversity of the biomedical, behavioral and clinical research workforce; (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 over-arching goal of this BD2K 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 biomedical researchers who need the requisite knowledge and skills to extract knowledge from biomedical Big Data.  To extend the reach of the course, each educational activity is required to develop open educational resources (OERs) that adhere to FAIR (findable, accessible, interoperable, and reusable) principles.    

    Training for the BD2K Initiative

    Extracting useful knowledge from biomedical Big Data is a major limiting factor to understanding health and disease.  The focus of the Big Data to Knowledge (BD2K) Initiative is to support the research and development of innovative and transformative approaches and tools with the goal of maximizing and accelerating the utility of Big Data and data science in biomedical research.  For the purposes of this FOA, biomedical is broadly defined to include biomedical, behavioral, or social science research focused on health.  To address the growing need for skilled researchers to fully utilize the vast amount of heterogeneous biomedical Big Data there must be an increase in the number of individuals: (1) trained in developing tools, methods, and analyses to make Big Data useful, and (2) knowledgeable about how to use the tools, methods, and analyses.   Thus, the primary goals of training and education efforts for the BD2K Initiative are 1) to increase the number of expert biomedical data scientists, and 2) to elevate general data science competencies of all biomedical scientists. 

    Data Science training and education needs in the biomedical workforce vary greatly based on an individual’s prior knowledge and their intended use of data.  Thus, BD2K programs to support training, education, and career development reflect a variety of needs within the workforce:

    • For biomedical scientists to become conversant in data science and learn to utilize existing tools, courses and open educational resources are available.
    • To address the growing need for specialists in biomedical data science, predoctoral students and early career scientists are supported.
    • To foster the development of new interdisciplinary teams consisting of biomedical scientists and data scientists, BD2K is collaborating with the National Science Foundation.
    • To train a diverse workforce, under-resourced institutions serving diverse populations are developing data science curriculum and providing short-term research experiences for students and faculty.

    To ensure that BD2K’s training and education efforts have maximum impact in generating knowledge, educational resources should be findable, accessible, interoperable, and reusable (FAIR).  The FAIR principles are applied in the development of an Educational Resource Discovery Index that will help biomedical scientists find and access the most appropriate data science educational resources to meet their training and educational needs.  The BD2K Training Coordination Center (TCC) is developing this Educational Resource Discovery Index and is providing coordination and communication among those interested in Big Data training and education (the BD2K Training Consortium). 

    Taken together, the BD2K training and educational programs will improve the ability of the entire biomedical science community to utilize the growing volume and complexity of data. Additional information about BD2K’s portfolio of training and education awards is available online.

    Courses for Skills Development

    This FOA will support creative educational activities with a primary focus on courses to provide opportunities for individuals at all career levels to acquire new skills and knowledge in biomedical Big Data Science.  For the purposes of this FOA, a course is a resource that provides knowledge to a participant.  Courses may serve different purposes, including the following:

    • to instruct students and scientists in the use of specific big data science methods and tools,
    • to train instructors in new big data science methods/tools or the foundations on which they are built,
    • to raise the big data science skills and knowledge of students of varied backgrounds to a sufficient starting level by providing tailored, in-depth instruction,
    • to recruit the next generation of biomedical big data scientists,
    • to showcase interesting and collaborative case studies that led to the development of new or tailored big data science analysis methods,
    • to focus individuals with varied expertise on solving a big data driven problem, and/or
    • the development of infrastructure that enables virtual tutoring with an expert, and/or
    • one-on-one interaction between a participant and a machine that enables a participant to query through an existing knowledge base for instruction.

    All proposed courses must produce an open educational resource (OER).  OERs generally have the following characteristics:

    • adhere to FAIR principles – findable, accessible, interoperable and reproducible, and
    • are freely available online and indexable following best practices in metadata usage.

    Examples of OERs are:

    • freely accessible, openly licensed educational materials (e.g. curricular and other course materials),
    • educational events (e.g. Innovation Lab, hackathon, challenge) that produces open resources, and/or
    • infrastructure that is freely available for educational use.

    Where appropriate, OERs are encouraged to use technology to tailor learning for the student, e.g. to create personalized learning paths.

    The format for course delivery may be in-person, online (massive open online course - MOOC), or a hybrid of both.  The development of creative formats to achieve the proposed objectives is highly encouraged.  If an in-person course is a component of the educational program, the course:

    • should emphasize hands-on immersive experiences over didactic ones,
    • should require constructive team-based interactions between participants,
    • is encouraged to draw participants together from different disciplines to learn from each other (computer science, mathematics, biological sciences, etc),
    • must draw from a national audience, potentially by co-locating with scientific meetings,
    • must make course materials freely available online, and
    • must adapt in-person course materials to an online format that will enable individual learning.

    In-person courses, if included, can be of varying lengths that should be appropriate for the learning objectives (e.g. from one-day workshops, to one-week Innovation Labs, to summer boot camps).  Courses will be limited in time, but PDs/PIs are encouraged to create opportunities for continual learning, both for participants and for scientists who were not able to participate during the time that the course was offered.  A hybrid approach could contain two phases with an online component followed by an in-person component with the instructor(s). 

    Innovation in approaches to content delivery is highly encouraged.  Examples of a course that would be considered responsive to this FOA include:

    • challenges/competitions for solving a biomedical, behavioral, and/or clinical research problem,
    • hackathons and the data and instructional material to reproduce them,
    • Innovation Labs designed to build diverse interdisciplinary teams to address complex biomedical data questions (for more information see: https://datascience.nih.gov/enhancing-training/InnovationLab),
    • development of curriculum for and hosting of workshops in conjunction with professional society meetings, and
    • innovative technology that facilitates personalized learning and its evaluation in biomedical data science.

    The content of the course should focus on specific areas necessary for the utilization and extraction of knowledge from Big Data, and may include the computational and statistical sciences in a biomedical context.  Content should not target specific diseases, but rather methods/tools that are generally applicable to big data biomedical research. Examples of content that could include one or more of the following topics are the following:

    • concepts necessary for analysis of large-scale, multi-element patient data sets [electronic medical records (EMRs), etc],
    • using, analyzing and/or integrating clinical or mobile health data (quantifiable behaviors, wearable sensors, motion detection),
    • integrating different types of data to extract novel knowledge that would not be identified using a single type of data (clinical, genetic, proteomic, imaging, behavioral, phenotypic, mobile health, wearable sensors, motion detection, etc),
    • tools that promote open science, the open sharing of all aspects of scientific research, data and dissemination accessible to all (amateur to professional),
    • management of the data lifecycle (biological and/or clinical), and/or
    • using the Commons to access data, use data, and compute within the Commons space (for more information see: https://datascience.nih.gov/commons/).
    • Examples of activities that would not be considered responsive to this FOA:
    • applications for the development of institutional programs/curricula that primarily benefit students from the applicant institution, and/or
    • applications for programs that solely support research experiences.

    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

     

    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New

    Resubmission

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Funds Available and Anticipated Number of Awards

    NIH intends to commit $1.5 million in FY 2017 to fund 7-8 awards.

    Award Budget

    Application budgets may not exceed $200,000 in direct costs annually and need to reflect the actual needs of the proposed project.

    Award Project Period

    The scope of the proposed project should determine the project period.  The maximum project period is 3 years.

    Other Award Budget Information

     

    Personnel Costs

    Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds).  

    Participant Costs

    Participants may be paid if specifically required for the proposed research education program and sufficiently justified. Participant costs must be itemized in the proposed budget

    Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.

    While generally not an allowable cost, with strong justification, participants in the research education program may receive per diem unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition and other education-related expenses.

    Expenses for foreign travel must be exceptionally well justified.

    Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by an R25 program, as participants, but may not receive salary or stipend supplementation from a research education program.

    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.

    Other Program-Related Expenses

    Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution. Reasonable costs associated with the evaluation of the project, including fees and expenses for beta-testers and/or focus group participants must be justified based on the project.  Costs for the PDs/PIs to attend an annual BD2K Consortium meeting in Bethesda, MD should be included, not to exceed $1500 per trip. 

    Indirect Costs

    Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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:

    o    Hispanic-Serving Institutions

    o     Historically Black Colleges and Universities (HBCUs)

    o     Tribally Controlled Colleges and Universities (TCCUs)

    o    Alaska Native and Native Hawaiian Serving Institutions

    o    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.

    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

    Required Registrations

    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) (formerly CCR) – 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

    Eligible Individuals (Program Director/Principal Investigator)

    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

    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

    Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

    2. Content and Form of Application Submission

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

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

     
    Letter of Intent

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

    By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

    • 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 Rosemond, Ph.D.
    National Center for Advancing Translational Sciences (NCATS)
    Email: bd2k_training@mail.nih.gov

    Page Limitations

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

    Instructions for Application Submission

    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.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424 (R&R) Other Project Information Component

    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.   

    SF424(R&R) Senior/Key Person Profile Expanded

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

    R&R Budget

    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.
    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan Component

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

    Research Strategy

    The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:

    • ·    Proposed Research Education Program
    • ·    Needs Assessment
    • ·    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. Applications that propose in-person or hybrid courses should address the necessity and benefits of travel to a central location.  Applications that propose online or hybrid courses should address how interaction with and among the participants will be facilitated.

    Needs Assessment.  Applications must demonstrate the demand for the educational content and evaluate the number of participants/learners who would benefit from the education. 

    The needs assessment should demonstrate the demand for the course and evaluate the number of learners who would benefit from the proposed education, compared to the number who can be accommodated          

    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 racial and ethnic minorities, 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 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. Identify the career levels  for which the proposed program is planned.        

    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.       

    Recruitment Plan to Enhance Diversity: Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-15-053). 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 researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

    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 identified as underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

    A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see 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, and Native Hawaiians and other Pacific Islanders.

    B. 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, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf.

    C. Individuals from disadvantaged backgrounds, defined as:

    1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.

    2. Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.    

    The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.

    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., Inside the Double

    Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and mathematics   http://her.hepg.org/content/t022245n7x4752v2/fulltext.pdf).

    New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of 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. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

    • ·    Individuals who applied for admission to the research education program,
    • ·    Individuals who were offered admission to the research education program,
    • ·    Individuals who participated in the research education program. 

    For those individuals who participated in the research education program, the report should include information about the duration of education and aggregate information on the number of individuals who finished the program in good standing. Additional information on the required Recruitment and Retention Plan to Enhance Diversity is available at Frequently Asked Questions: Recruitment and Retention Plan to Enhance Diversity (Diversity FAQs).

    Applications lacking a diversity recruitment and retention plan 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. The plan should be appropriate and reasonable for the nature and duration of the proposed program.
    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.  The evaluation plan should detail how the program will be evaluated for course content, educational effectiveness, participant recruitment, and overall effectiveness as an educational tool and should be linked to a developed model.

    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 (such as OERCommons.org, MERLOT.org, AMSER.org, CNX.org, and FREE.ed.gov), presentations at scientific meetings, workshops.  A goal for this R25 is to release educational materials into the public domain. Use of a public domain license such as Creative Commons http://creativecommons.org/is strongly encouraged.  The dissemination plan should describe how widely and freely the course materials are shared, including whether they are in a form that adhere to the FAIR principles (findable, accessible, interoperable and reproducible

    All open educational resources, including course components, tests, and e-publications developed under this FOA should be produced to maximize interoperability, exchange, and reuse.

    1.  Attribution and License:  Although proper attribution through citation is expected as a community norm, licensing for use is also important.  Prior to release, all OERs must be licensed for free, attributed public use and distribution.  In general, such licenses should comply with the Open Knowledge Definition of an open license. Examples of open licenses are listed below:

    Creative Commons Zero Public Domain Dedication (CC0), e.g. https://creativecommons.org/publicdomain/zero/1.0/

    Creative Commons Attribution (CC BY), e.g. https://creativecommons.org/licenses/by/4.0/

    2.  Metadata:  Applicants must identify, in the application, the industry standard they intend to use for metadata to describe the resource. Metadata are "tags" attached to digital resources that make it easier to publish, discover and reuse educational content. These tags allow learning systems to accurately generate data on how resources are used by educators in diverse learning environments across the Web. BD2K grantees should tag their resources using a widely-used metadata standard for educational resources such as the Learning Resource Metadata Initiative (LRMI) standard.  For details about the current state of metadata for educational resources, visit http://www.bigdatau.org.

    3.  Repositories:  As early as possible, but no later than the end of the grant period, all OERs must be placed in a public repository for educational materials.  Examples of such repositories are https://www.skillscommons.org, http://cnx.org, https://www.oercommons.org, and https://www.merlot.org.

    4.  Reusability and machine-readability:  To enable others to easily access and work with all BD2K-funded OER content, content should be made available in file formats that allow anyone to natively and directly edit the content, to the extent possible. Content should also be made available in a machine-readable format.  

    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, with the following Guide, with the following modification:

    Plans to share open educational resources should be described under the Research Strategy Section (Dissemination Plan).

    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

    Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide .

    PHS Inclusion Enrollment Report

    When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.  

    PHS Assignment Request Form

    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. Add 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.  

    Post Submission Materials

    Applicants are required to follow our Post Submission Application Materials policy.        

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical, behavioral, and clinical research 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 via courses that complement and/or enhance the training of biomedical researchers who want to acquire the skills necessary to extract knowledge from biomedical Big Data.  Courses are required to develop open educational resources that have the ability to reach a large number of biomedical researchers who need to utilize biomedical Big Data.  Educational resources must be widely disseminated and made openly available, so that access is not restricted by either lack of funds or lack of time flexibility.  Ideally, open educational resources should be useful to individuals at all career levels, from predoctoral students to established investigators.

    Overall Impact

    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.

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

    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?

    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?   

    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?

    Evaluation Plan: Are the proposed plan and timeline for evaluation of the education program sound and likely to provide data on the effectiveness of the education program?  Is the program evaluation linked to an adequately developed model?

    Dissemination Plan: Is the proposed plan for dissemination of the education program strong and of high quality?  Are the developed resources openly accessible in the public domain?  Does the dissemination plan address communication of the availability of the developed resources?   

    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?  

    Additional Review Criteria

    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact 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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Children 

    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 children 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.

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations

    As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact 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 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:

    • 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.

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

    Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research. The following will be considered in making funding decisions:

    • 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.
    • Compliance with resource sharing policies.
    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 grantee’s business official.

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

    Any application awarded in response to this FOA will be subject to 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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general 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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. 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. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. 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 http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    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 Training 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.

    A final progress report 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 the NIH BD2K Initiative expects to use the following evaluation measures:

    For Courses for Skills Development:

    • Aggregate number and demographic characteristics of participants exposed to the new curricula or methods
    • Educational level of participants
    • Content
    • Participants’ feedback on the program
    • New knowledge or skills acquired
    • Use of innovative technology
    • Dissemination and sharing of open educational resources and other curricular materials
    • Aggregate number of learners not enrolled in the course who accessed the materials
    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
    Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Scientific/Research Contact(s)

    Erica Rosemond, Ph.D.
    National Center for Advancing Translational Sciences (NCATS)
    Telephone: 301-594-8927
    Email: bd2k_training@mail.nih.gov

    Richard Baird, Ph.D.
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)
    Telephone: 301-496-7671
    Email: bd2k_training@mail.nih.gov

    Peer Review Contact(s)

    Mark Caprara, Ph.D.
    Center for Scientific Review (CSR)
    Telephone: 301-613-5228
    Email: capraramg@mail.nih.gov

    Financial/Grants Management Contact(s)

    Angela M. Eldridge
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)
    Telephone: 301-451-4793
    Email: bd2k_training@mail.nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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