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 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) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.

The over-arching 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:

• Curriculum Development: Specifically, exportable training modules designed to enhance the rigor, reproducibility, and responsible conduct of biomedical and behavioral data science research, targeted to trainees and researchers at any career level.

Background

Scientific rigor, reproducibility, and responsible conduct of research have major implications for the credibility of science. In most cases, the lack of rigor and reproducibility is not due to intentional lack of good practices or fabrication or falsification of data. Rather, often there is a lack of awareness or adherence to sufficiently high standards in the planning, design, execution, interpretation and reporting of scientific studies. Examples include inherently weak experimental designs; over-interpretation of statistically marginal differences in results; variability of materials, such as differing brands, composition of media or reagents; differing or evolving strains of organisms and cells in culture; lack of adequate controls; issues of interpretation such as confirmation bias. In addition to the data collection step, rigor and reproducibility issues can also stem from how biomedical data is handled and processed, such as poor curation or missing provenance information or lack of appropriate quality controls during data processing. Rigor and reproducibility problems may also arise from unintentional mishandling of the datasets due to lack of standards, open file formats, or interoperability of datasets.

Responsible handling of the biomedical data, particularly the datasets containing personally identifiable information, requires extra privacy and security measures, and ethical considerations. Examples of possible issues include data privacy and security, appropriate use of informed consent, ethics of handling personal data, potential for bias, and data sharing on a need-to-know basis. Proper training of data scientists about issues related to biomedical data handling and sharing is of the utmost importance for the responsible conduct of research and the credibility of science at large.

NIH has voiced its concerns over these matters publicly (http://www.nature.com/news/policy-nih-plans-to-enhance-reproducibility-1.14586) and NIGMS, in collaboration with other NIH Institutes and Centers, has issued FOAs for the development of training modules to help with improving good research practices (RFA-GM-15-006 and RFA-GM-18-002). Links to the training modules developed as part of these efforts can be found at the NIGMS clearinghouse. This new FOA proposes to expand such efforts to address specifically the training needs in areas relevant to the rigor, reproducibility, and responsible conduct of biomedical data science research.

Research Education Objectives

The purpose of this FOA is to develop exportable training modules with the potential to enhance the scientific rigor, reproducibility, and responsible conduct of biomedical data science research, and to provide for communication and coordination of the development and deployment of such modules. The resulting modules will be relatively short units of training of sufficient depth and coverage to empower the trainee with the knowledge and skills to improve the rigor, reproducibility, and responsible conduct of their data science research. Exportable in this case means shareable and accessible, open educational resources, which can be used as standalone modules or combined to form courses. Addressed data types can cover any part of the wide spectrum of subjects, i.e., the range from simple in vitro data involving cells to personally identifiable information from patients. Modules can address issues related to any stage of the data lifecycle (from data acquisition, to organizing, filtering, annotating, mining, visualizing, publishing, and/or preserving data) and data issues related to data stewardship, quality control, ethics, and regulatory policies. It is expected that the proposed training modules will identify deficiencies and teach best practices in one or more data science areas. Examples include, but are not limited to:

• Scientific principles of rigorous and reproducible data science: such as how to ensure that datasets are handled in a FAIR (Findable, Accessible, Interoperable, and Reusable) manner; how to establish best practices and policies to manage, share, and preserve data; how to promote the development of open source tools which enforce the use of data science standards, can interconnect data for use/reuse with proper quality controls, and are capable of adapting to changing research needs.
• Good practices in scientific rigor and reproducible data science: such as how to ensure inclusion of adequate metadata and proper annotation of the biomedical and behavioral datasets, which are increasingly growing in volume and complexity; how to develop standardized scientific workflow systems to capture the provenance of data transformations and associated metadata; how to ensure that software tools are developed with proper documentation and version controls, tested, and validated for reproducibility enforcement; how to promote the development of open source software tools which adopt commonly accepted data science standards and allow for the interoperability of datasets.
• Good practices in the responsible conduct of data science research: such as how to ensure that scientific ethics and the necessary privacy and security measures are in place throughout the lifecycle of data; how to ensure that various types of datasets are collected, stored, handled, and analyzed responsibly; how to eliminate the potential bias in the design and execution of data science studies; how to properly de-identify personal data; how to design and prepare informed consent forms to ensure that participants are adequately informed about the studies they are willing to be part of; how to maintain privacy and security when utilizing electronic health records or mobile health applications; how to ensure patient safety when relying on artificial intelligence to inform healthcare decisions.

The target audience for these modules are trainees and researchers at any career level. The training modules are expected to cover material not typically taught as part of current institutional coursework. For example, modules that simply replicate material found in standard statistics or data science courses are discouraged. However, it is expected that the developed modules could be utilized as learning material in future courses to enhance and standardize the concepts of rigor, reproducibility and responsible conduct of biomedical data science research. Materials should be derived from the training needs experienced by research personnel.

The participating Institutes and Centers are committed to supporting modules that cover a wide range of issues relevant to enhancing the rigor, reproducibility, and responsible conduct of biomedical data science research.

Program Structure for Module Development and Accessibility

This training may take many different types of formats and approaches, but should be timely, informative, engaging, and easily accessible to everyone at no cost. Some general expectations are as follows:

Platforms: examples include, but are not limited to, interactive online modules; videos or case studies with supporting discussion materials, problems, etc.; Massive Online Open Courses (MOOCs); computer-video simulations.

Module length: short but will depend on the area(s) selected.

Length of awards: it is expected that all modules will be developed, piloted, and disseminated within the first two years of the award; budgets may be awarded for up to three years to allow module evaluation and module modification/maintenance in year three.

Awardees will be expected to attend at least one PD/PI meeting held by the NIGMS Division of Training, Workforce Development, and Diversity (TWD) during the term of the award. The intent is to have the grantees share their knowledge and insights into developing engaging and informative educational modules and subsequently present an overview of the modules they have developed, results of pilots, and plans for outreach and evaluation to the wider education community.

Once the modules have been developed and made available, links to these educational resources will be posted and maintained on the NIGMS clearinghouse web site.

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.

Areas of Specific Interests

NIDCR: The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to improve dental, oral, and craniofacial (DOC) health. NIDCR will support applications that contribute to training the DOC data science workforce in areas relevant to the rigor, reproducibility, and responsible conduct of biomedical, behavioral, and clinical DOC research and clinical practice that align with the NIDCR Mission and NIDCR Strategic Plan.

NIBIB: The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical technologies. NIBIB is committed to integrating engineering with the physical and life sciences to advance basic research and medical care. One way that this is achieved is through the support of research and development of new biomedical imaging and bioengineering tools and technologies to improve the prevention, detection, treatment, and monitoring of disease. NIBIB scientific program areas that are appropriate for this funding opportunity can be found at NIBIB website.

Training modules of particular interest to NIBIB include the following educational areas: i) Scientific rigor, reproducibility, and responsible conduct of data science associated activities for biomedical imaging, imaging informatics and bioengineering. ii) Maintaining privacy and security when utilizing electronic health records or mobile health applications. iii) Ensuring patient safety when relying on artificial intelligence to inform healthcare decisions. iv) Strengthening experimental design through theoretical modeling frameworks that incorporate uncertainty quantification.

NIAID: The National Institute for Allergy and Infectious Diseases (NIAID) leads research to understand, treat, and prevent infectious, immunologic, and allergic diseases. Within this context, NIAID will support educational and training activities on topics such as, but not limited to adoption of FAIR principles, data security and privacy of NIAID funded data, and adoption of best practices in robust software development.

NLM: The National Library of Medicine (NLM) is interested in supporting the development of training modules to enhance rigor and reproducibility training for informatics and data science researchers working with data drawn from electronic medical records or other identifiable personal health data, covering topics such as ethics, protecting confidentiality, deidentification, issues in integration of disparate datasets, methods for assessing and ameliorating gaps or bias in the datasets.

NCCIH: The mission of the National Center for complementary and Integrative Health (NCCIH) is to define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health interventions and their roles in improving health and health care. NCCIH will support applications that contribute to training the complementary and integrative health research workforce in areas relevant to the rigor, reproducibility, and responsible conduct of basic, mechanistic and clinical research that aligns with the NCCIH Strategic Plan.

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

Section II. Award Information

Other Award Budget Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

• 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

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

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

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

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 Guideexcept 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.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. 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.

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.

• Applicants should budget travel funds to attend at least one TWD program director meeting in year -02 or -03.
• Budget categories should not include inflationary escalation for recurring costs in out years.
• Program evaluation costs may be requested, not to exceed $3,000 direct costsover the entire project period.

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
• Institutional Environment and Commitment
• 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.

State the goals for education and justify the area of training selected for module development in terms of its relevance and potential impact on improving the development of skills and knowledge important for rigorous, reproducible, and responsible conduct of biomedical data science research. Describe the data science subject material to be covered, and provide details of the evidence-based methods that will be employed to achieve the training goals. Describe the format for the proposed training module and justify it in terms of the education goals. Chosen subject material may address a particular level of technical complexity/expertise, but the proposed research education must target a broad audience, i.e., trainees and investigators at any career level. The length of the proposed training module should be explained in terms of scope and depth of coverage of the subject matter. In addition, how the research education will be utilized by trainees or investigators should be described - for example, a module on how to properly handle biomedical data to be taken by all beginning laboratory workers, or a module on appropriate data provenance to be taken immediately prior to beginning such work. Describe the plans for piloting and evaluating the effectiveness of the training module.

Describe plans for making the proposed training module section 508 compliant with the Rehabilitation Act (29 U.S.C. '794 d), as amended by the Workforce Investment Act of 1998 (P.L. 105 220; see http://www.section508.gov/ for additional information).

Describe the electronic format of the proposed modules and discuss how the used formats are standard, making themodules widely shareable. Provide a timeline for module development, piloting and refinement, dissemination, evaluation, and maintenance. This timeline must propose making the training publicly available within two years of the award date.

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.

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.

Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award in terms of their frequency of use and their usefulness. The use of multiple evaluation approaches is highly encouraged, as is testing several groups with different characteristics. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of test groups) in a structured format, as well as quantifiable measures to gauge the short and long-term success of the research education award in achieving its objectives, including testing for content comprehension and retention. Applicants are expected to obtain feedback from test groups to help identify weaknesses and to provide suggestions for improvements, and make the evaluation and feedback data available to the NIH staff.

Dissemination Plan. Applications must include a specific plan for disseminating the finished training modules online and their digital material nationally, and for making them accessible to everyone at no cost. In addition, links to these modules and their digital material will be posted and maintained on the NIGMS clearinghouse web site.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above: Institutional Environment and Commitment"). Applications that do not include this Letter of Support will be withdrawn prior to review.

Resource Sharing Plans

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

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application.There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

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

Appendix

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

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or 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 with the following additional instructions: 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.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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 the development of exportable training modules designed to enhance the rigor, reproducibility, and responsible conduct of biomedical and behavioral data science. Target audiences of the developed modules are trainees and researchers at any career level.

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 training need in rigor, reproducibility, and responsible conduct of data science research 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?

Are the proposed modules and their digital material in standard and shareable format, and easily available to the public at no cost?

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? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Revisions

Not Applicable

Renewals

Not Applicable

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

Recruitment Plan to Enhance Diversity

Not Applicable

Training in the Responsible Conduct of Research

Not Applicable

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

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 Office of Scientific Review, NIGMS, 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Advisory Councils of participating NIH Institutes or Centers. 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.

It is unlikely that more than one award will be made to develop modules on the same topic.

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.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights 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.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.htmlPlease 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.htmlor 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.

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 agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings.Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters. A final RPPR and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement.

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their R25 research education programs, employing the measures identified below. In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from module users themselves. Where necessary, PD/PIs and module users may be contacted after the completion of a research education experience for periodic updates on module users' 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 NIH expects to use the following evaluation measures:

• Breadth of training module topic areas

• NIGMS clearinghouse web page analytics

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:[email protected](preferred method of contact)
Telephone: 301-945-7573

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

Veerasamy Ravichandran, Ph.D
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Lynn Mertens King, Ph.D
National Institute of Dental and Craniofacial Research (NIDCR)
Email: [email protected]

Zeynep Erim, Ph.D
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Email: z[email protected]

Ishwar Chandramouliswaran, Ph.D
National Institute of Allergy and Infectious Diseases (NIAID)
Email: [email protected]

Hua-Chuan Sim, MD
National Library of Medicine (NLM)
Email: ?[email protected]

Lanay M. Mudd, Ph.D
National Center for Complementary and Integrative Health (NCCIH)
Email:? [email protected]

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences
Email: [email protected]

Kimberly Cornwell
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Email:? [email protected]

Monique Binger, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Email: [email protected]

Kevin Heath
National Institute of Allergy and Infectious Diseases (NIAID)
Email:? [email protected]

Samantha Tempchin?
National Library of Medicine (NLM)
Email: [email protected]

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Email: [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.