It is critical that applicants follow 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 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

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

The NIH Research Education Cooperative Agreements Program (UE5)supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The overarching goals of the NIH UE5 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 NCI UE5 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:

This UE5 FOA is a part of the NCI’s Informatics Technology for Cancer Research (ITCR) program (https://itcr.cancer.gov/). The UE5 awardee to be supported under this FOA will serve as an ITCR Education Resource for educational activities that will help their participants to enhance the use and usability of the informatics tools and other resources developed and supported by the ITCR program.

Specifically, it is anticipated that the UE5 awardee will provide short courses for both cancer researchers and developers of informatics tools for cancer research

The proposed UE5 Resource must provide focused education courses in each of the following two areas:

• Courses in cancer informatics for cancer researchers to help them use informatic tools and incorporate informatics analyses into their research; and
• Courses for developers of informatics tools to help them optimize informatics tool usability and user support for cancer research.

For the courses supporting education in cancer informatics, the proposed UE5 Resource must offer multiple informatics courses that incorporate ITCR tools (https://itcr.cancer.gov/informatics-tools) as exemplars for applying these informatics methods, including, as appropriate, hands-on training on the associated tools and analysis workflows for participants. The spectrum of courses should cover the variety of cancer research domains supported by the ITCR program and provide sufficient depth to enable participants to incorporate the methods covered by the informatics courses in their research programs. A variety of course structures may be proposed including, but not limited to, approaches such as multi-day in-person courses, single-day workshops, or single day online courses.

For courses in optimizing informatics tool usability and user support, the proposed UE5 Resource must focus on designing educational activities that target the needs of currently funded ITCR development teams (see https://itcr.cancer.gov/about-itcr/funded-projects for a list of currently funded ITCR projects; these educational activities should be open to the full ITCR development team) to enhance the usability and user support of their tools. A variety of course structures may be proposed including, but are not limited to, approaches such as in-person workshops, virtual courses, series of short on-line courses, and hackathons.

The central mission of the ITCR program is to promote informatics technology across the development lifecycle to address priority needs in cancer research. The proposed UE5 Resource is expected to support this mission by providing the educational activities that will enable cancer researchers to better utilize informatics technologies and by improving the usability and user support of the informatics tools and resources developed and supported by the ITCR program.

Whereas understanding of the ITCR initiative is essential, the applicants need not be current ITCR awardees.

Other components of the ITCR Network

The ITCR Education UE5 Resource must be based on close interactions with other ITCR awardees (to be supported under companion FOAs), who are developing informatics tools and resources across the development lifecycle. This includes the development of innovative methods and algorithms; early stage software development; advanced stage software development; and sustainment of high-value resources.

Key Terms for this FOA:

• Cancer informatics: Cancer informatics is the intersection of information science, computer science, medical oncology, communication, and health care. Cancer informatics deals with the resources, devices, and methods required to optimize the acquisition, storage, retrieval, and use of information in cancer.
• Informatics tool usability: Informatics tool usability refers to how useful, usable, and satisfying an informatics tool is for the intended users to accomplish goals in the work domain by performing certain sequences of tasks.
• Informatics tool user support: Informatics tool user support refers to services to assist intended users in operation of informatics tools. It may include assistance in installation, training, troubleshooting, maintenance, or upgrading of tools.
• Informatics Technology for Cancer Research (ITCR) tools: ITCR tools refer to the various informatics tools and resources developed and supported through the ITCR program. A full listing of ITCR tools can be found at: https://itcr.cancer.gov/informatics-tools
• Domains supported by ITCR tools: Areas of cancer research that are supported by tools and resources developed and supported through the ITCR program. Domains supported by ITCR tools may include, but are not limited to, genomics, proteomics, imaging, clinical, and network biology.
• ITCR development team: ITCR development team refers to all PDs/PIs, co-investigators, and personnel with significant effort in the development and/or dissemination of ITCR tools (which may include students, postdoctoral researchers, staff scientists, collaborators, and subawardees).

Growth of biological and biomedical information. Recent major advances in biological sciences, coupled with progress in information technology, have led to an exponential growth of biological and biomedical data. This situation provides opportunities for new discoveries, while simultaneously introducing challenges for researchers, including bench biologists and clinicians, to access data, analyze data, and ultimately transform discovery into new knowledge and clinical practice. These challenges are particularly relevant to the field of cancer research, where complexity and heterogeneity of the disease translate to complex data generation conditions and high data management and analysis overhead, which can create barriers to knowledge discovery and dissemination.

The essential role of and challenges for biomedical informatics. The field of biomedical informatics is critical to creating solutions to meet these challenges. At the intersection of biology, physics, chemistry, medicine, mathematics, statistics, computer science, and information technology, biomedical informatics involves the development and application of computational tools to support the organization and understanding of biomedical information, so that new insight and knowledge can be discerned. There is a growing consensus that biomedical research is an information-intensive science and biomedical informatics is an integral component of all biomedical research.

The emerging use of cloud computing to support big data analysis; innovative computational methods for variant calling and driver mutation detection; the application of machine learning and other artificial intelligence methods to image analysis; and the application of natural language processing to clinical information, for example, have all impacted cancer research. However, the use of informatics in everyday research remains a challenge for several reasons including the low availability of user-focused tools; lack of sufficient support for existing tools; the need for training materials; lack of interoperable tools; and the lack of tools to meet specific scientific needs.

NCI support for cancer-related biomedical informatics tools and technologies. The critical needs in the field of cancer-related biomedical informatics are recognized by NCI and formed the basis of the NCI ITCR Program whose scope serves informatics needs that span the cancer research continuum. Moreover, ITCR provides support for informatics resources across the development lifecycle, including the development of innovative methods and algorithms, early stage software development, advanced stage software development, and sustainment of high-value resources on which the community has come to depend.

NCI also recognizes that development of informatics tools and resources needs to be accompanied by efforts to ensure that these tools are adapted and used by the cancer research community. To foster broader uptake and use of the tools and resources developed by the ITCR program, additional education and guidance components must be added to complement and amplify the outreach and support conducted by individual ITCR development teams. Given the information-intensive nature of cancer research, there is a recognized need to more broadly educate researchers on topics in cancer informatics to enable them to use tools such as those developed by the ITCR development teams. Informatics training is not sufficient to increase uptake and use of informatics tools; there is a complementary need to provide guidance and support to informatics tools developers to make these tools as robust and usable as possible.

The overarching goal for the ITCR Education Resource is to provide educational resources that will enhance the use of the informatics tools and resources developed and supported through the ITCR program. This goal will be addressed by increasing the ability of the broader cancer research community to incorporate informatics analyses into their research programs and by improving the usability of the ITCR tools.

Accordingly, the proposed UE5 Education Resource should provide a multifaceted informatics education program targeting the research needs of end users and focused on enhancing the use of ITCR tools. In addition, the proposed UE5 Resource should develop educational activities to provide guidance for ITCR development teams, focused on improving usability and user support of the ITCR tools. For all of these activities, the proposed UE5 Resource is expected to work in close partnership with the ITCR development teams.

Important Note: Because the UE5 Resource will be required to interact closely with ITCR development teams, it is imperative that all applicants responding to this FOA familiarize themselves with the ITCR program as well as companion FOAs. If desirable, applicant teams may incude ITCR-affiliated investigators.

Required Short Courses

Courses for Skills Development in Cancer Informatics (for cancer researchers, who are end users of informatics tools)

The proposed UE5 Resource must be capable of providing multiple courses in cancer informatics meeting the specific requirements listed below. The proposed courses should incorporate ITCR tools as exemplars for applying these informatics methods, including, as appropriate, hands-on training on the associated tools and analysis workflows for participants. ITCR tools may include both currently funded tools as well as tools which were previously supported by ITCR (https://itcr.cancer.gov/informatics-tools). The goal is to not only provide the community with educational opportunities in cancer informatics, but also to help researchers identify appropriate informatics tools for answering specific scientific questions and to increase awareness of and disseminate further use of ITCR tools.

Some examples of cancer informatics topics include, but are not limited to:

• Multi-omics analysis for cancer driver gene discovery;
• Lineage analysis of cancer cell populations to understand tumor evolution in the development of drug resistance;
• Integrated genomic analysis of racial disparities in cancer development and response to therapy;
• Facilitating analysis and interpretation of impact of genetic variations or mutations on disease risk or outcomes; and
• Accessing and utilizing electronic health record data for epidemiology studies.

Target audience for courses in cancer informatics

Applicants should describe the target audience for each of the proposed cancer informatics courses, with the following considerations:

• Participant scientific background. The cancer informatics courses developed by the proposed UE5 Resource should be targeted to cancer researchers of diverse types (e.g., basic researchers, population scientists, and clinical and translational researchers).
• Participant informatics background. The proposed courses may target different levels of informatics experience. Applicants should state the expected informatics experience of participants and expected proficiency of participants in informatics analyses after completing the courses.
• Participant career stage. The target audience for the proposed cancer informatics courses may include researchers across all career stages who need additional cancer informatics skill development to enhance their ability to incorporate specific informatics analyses into their research program.
• Participant selection. Applicants should describe how participants for the proposed cancer informatics courses will be selected.

Specific attributes and requirements for courses in cancer informatics

Applicants should describe the cancer informatics courses that they propose to develop as part of the UE5 Resource, with the following considerations:

• Number of courses. The applicant should propose a minimum of six unique courses that cover a breadth of cancer informatics topics. These proposed courses should be varied in their complexity (e.g., no more than two single-day online courses or single-day workshops).
• Course topics. While a given course may focus on a specific cancer informatics domain, the full spectrum of courses proposed by the applicant should cover a variety of the cancer research domains supported by ITCR tools (as defined above under Key Terms). At the same time, each course should demonstrate depth in a specific area; the proposed course should enhance the participants ability to incorporate specific informatics analyses into their research programs, including selection and application of appropriate informatics methods to perform desired analyses.
• Course format. Applicants should explore a variety of approaches to providing focused cancer informatics training, and highlight innvoative aspects as appropriate. A mix of courses varying on the complexity of formats is expected. The variety of course structures could include, but is not limited to, approaches such as multi-day in-person courses, single-day workshops, or single-day onine courses. Proposed courses must incorporate ITCR tools to demonstrate how to apply the informatics methods. As appropriate, courses should include a component of hands-on training with selected tools.
• Course development. Applicants should describe the cancer informatics courses that they anticipate developing as part of the UE5 Resource, but actual course development may occur after award. In developing these courses, the proposed UE5 Resource is expected to ensure that appropriate data needed to support the courses are available. The proposed UE5 Resource should collaborate with the ITCR development teams for their input on course content and other participation, as appropriate.
• Timeframe for offering courses. The first course should be offered within the first year of award. Each course should be offered at least three times over the award period, with appropriate revisions and updates to the courses based on evaluation and feedback of each course offering.
• Post-course completion. After the completion of each course, materials such as syllabi and archived video recordings of the course, with closed captioning, should be provided openly and without restriction for use by the broader community.

Courses for Skills Development in Optimizing Informatics Tool Usability and User Support (for informatics tool developers)

The proposed UE5 Resource must also offer educational activities to provide guidance aimed at currently funded ITCR development teams in improving informatics tool usability and user support, including topics such as documentation, dissemination, user engagement, and outreach. The goal is to assist cancer informatics tool developers in creating tools and resources that are useful, usable, robust, maintainable, and sustainable to serve the needs of the cancer research community. Applicants should plan on identifying the needs of currently funded ITCR development teams in determining the topics for these courses.

Some examples of topics may include, but are not limited to:

• Increasing and improving user engagement in support of user-driven design;
• Increasing tool adoption and dissemination;
• Improving user support through tool documentation, tutorials, and example analyses; and
• Approaches to enable researchers to use multiple informatics tools to perform integrative analyses.

Target audience for courses in optimizing informatics tool usability and user support

The target audience is currently funded ITCR development teams (see https://itcr.cancer.gov/about-itcr/funded-projects for a list of currently funded ITCR projects; these educational activities should be open to the full ITCR development team). While the resources developed will likely be of interest to informatics tool developers beyond ITCR, priority topics should be identified based on the needs of the ITCR development teams. Members of the ITCR development teams should also have a priority in course participation.

Specific attributes and requirements for courses in optimizing informatics tool usability and user support

Applicants should describe the proposed educational activities in optimizing informatics tool usability and user support with the following considerations:

• Topics. The proposed educational activities should support increasing the usability, robustness, maintainability, and ultimately utilization of the tools and resources developed by the ITCR program. (Only examples of anticipated topics are needed for application; priority topics will be selected post-award based on the needs of currently funded ITCR development teams).
• Educational activity development. The applicant should describe approaches to working with ITCR development teams to identify priority topics. Actual activity development and may occur after award.
• Educational activity format. Proposed courses may explore a variety of approaches, for example, workshops, virtual courses, series of online courses featuring subject matter experts, or hackathons.
• Timeframe for offering educational activities. The first course should be offered within 18 months after award. Topics should be repeated based on the interest and demand of the ITCR development teams.

Sharing Course-related Resources (applicable to both types of courses).

Any resources developed as part of the proposed educational activities (for example, best practice documents or video recordings of lectures), should be provided openly and without restriction, to allow for propagation of best practices to other informatics tool developers beyond the ITCR community.

Non-Responsive Applications

Applications with any of the characteristics listed below will be considered non-responsive and will not be reviewed:

• Proposed activities do not include both focus areas for courses, i.e., cancer informatics and optimizing informatics tool usability and user support;
• Proposed cancer informatics courses that do not include ITCR tools as exemplars;
• Proposed courses in optimizing informatics tool usability and user support that are not targeted to currently funded ITCR development teams; and/or
• Applications that do not demonstrate collaboration and partnership with ITCR development teams.

Important aspect of the ITCR program are the trans-network activities, including monthly teleconferences, working group meetings in areas of interest across ITCR, and the annual ITCR meeting. UE5 awardees will be required to participate in this annual ITCR meeting.

Engagement in the activities of the ITCR Network will be critical for the proposed UE5 Resource to better understand the scope of informatics topics supported by ITCR as well as the areas in which the proposed UE5 Resource can develop educational activities to further support and amplify the efforts of the ITCR development teams.

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. UE5programs 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.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

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

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

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

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

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).

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as Program Faculty, serving as instructors, advisors, preceptors, or lecturers, etc.

Participants may include cancer researchers at various professional levels ranging from graduate students, and post-doctoral fellows through junior and senior faculty levels. Participants are not required to be United States (U.S.) citizens or permanent residents.

Priority for participation in the courses in optimizing informatics tool usabilty and user support will be given to members of currently funded ITCR development teams. If open positions remain in the optimizing informatics tool usability and user support courses, the UE5 Resource PD(s)/PI(s) may broaden the participation beyond currently funded ITCR development teams to include other developers of bioinformatics tools.

In addition, if slots are available, NIH intramural researchers may participate in any of the proposed courses, but cannot receive any financial support from the UE5 award.

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.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.

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:

Elizabeth Hsu, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-5733
Email: hsuel@mail.nih.gov

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.

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 with the following additional modifications:

• List PD(s)/PI(s) and all Program Faculty whose role will be to develop, implement, and direct the proposed courses as Key Personnel and provide their biographical sketches.
• In the biographic sketches of the PD(s)/PI(s) describe (in addition to standard content):
• Their careers as both educators and researchers, particularly in the relevant informatics domains.
• Their experiences in providing both administrative and scientific leadership to the development and implementation of an education program, particularly in situations that extend beyond the applicant institution and attract participants from a national audience.

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.
• If participant costs or limited scholarships are proposed, use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
• Include the hotel/facility and audiovisual costs required to conduct any proposed in-person courses in the Other Direct Costs section of the budget.
• Include in the Travel section of the budget funds for transportation, housing and per diem costs for all personnel and consultants involved in offering any proposed in-person courses.
• Include in the Travel section of the budget funds for transportation, housing and per diem costs for PD(s)/PI(s) and other senior/key persons to attend the annual 2-3 day ITCR meeting (location varies).

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

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
• 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

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.

Clearly state the overall vision for the UE5 Resource, including the proposed organizational and leadership structure, how the components of the UE5 Resource support the overall goals of the UE5 Resource, and the proposed approach for collaborating with ITCR development teams.

Describe the proposed multifaceted program for educational courses addressing all the aspects indicated below.

Courses for Skills Development in Cancer Informatics:

• Describe the vision of the cancer informatics curriculum as a whole and how it supports the previously articulated goals of the UE5 Resource.
• Course topics
• Clearly state the goals and objectives of the proposed cancer informatics courses.
• Provide the underlying rationale supporting the proposed courses.
• Explain how the courses will enable researchers to incorporate informatics analyses into their research programs.
• Describe the breadth of the cancer informatics courses as a whole.
• Describe the depth of each individual cancer informatics course.
• Course formats
• Describe the approaches of the proposed cancer informatics courses, highlighting any innovative aspects, if applicable.
• Describe the variation in the complexity of the proposed course formats, highlighting any innovative aspecits, if applicable.
• Explain how ITCR tools will be incorporated into the educational courses.
• Course development
• Describe how the courses will be developed.
• Provide a strategy for the partnering with ITCR development team as needed to develop and deliver the educational courses, as well as the ability to supply any data required to conduct the courses.
• Course timeframe
• Provide a timeline for course development and offering of courses.
• Explain how courses will be revised and updated based on evaluation and feedback on prior course offerings.

Courses for Skills Development in Optimizing Informatics Tool Usability and User Support:

• Describe the vision of educational activities for informatics tool developers as a whole and how it supports the previously articulated goals of the UE5 Resource.
• Topics
• Clearly state the goals and objectives of the proposed educational activities in optimizing tool usability and user support.
• Provide the underlying rationale for the proposed activities.
• Explain how the proposed areas will aid ITCR development teams in improving the usability of their tools and their existing user support efforts.
• Explain how priority areas will be selected.
• Describe the approaches of the proposed tool usability courses, highlighting any innovative aspects, if applicable.
• Educational activity timeframe
• Provide a timeline for identification of priority topic areas, educational activity development, and offering of activities.
• Explain how feedback from the ITCR development team will be obtained and used to update or repeat topics.

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.

Explain how the complementary teaching, technical, and administrative skills of the PDs/PIs or investigator teams will foster successful implementation of the proposed UE5 Resource. If a PD/PI team or multiple PDs/PIs are proposed, clearly define and justify the role of each PD/PI and describe how they fit into the proposed leadership structure of the UE5 Resource.

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.

Without repeating biosketches, briefly summarize the characteristics of the participating faculty in terms of expertise in informatics education, informatics analyses and/or tool development, deployment, dissemination, and user support.

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.

Describe any specific scientific background, research interest, or informatics background that may be needed to participate in the proposed courses in cancer informatics, if applicable. Explain how participants will be selected for the proposed cancer informatics courses.

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.

Where appropriate, describe any unique features of the scientific environment or collaborative arrangements that may be leveraged to the advantage of the proposed UE5 Resource. If multiple institutions are participating, describe how this will enhance the quality of the proposed UE5 Resource, as well as how activities will be coordinated, including the approach to effective communication among the sites.

Recruitment Plan to Enhance Diversity (NOT-OD-18-210): 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.

A. Underrepresented Populations in the U.S. Biomedical, Clinical, Behavioral and Social Sciences Research Enterprise
In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as: Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering).

The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders.

In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this program. For more information on racial and ethnic categories and definitions, see NOT-OD-15-089.

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 https://www.nsf.gov/statistics/2017/nsf17310/static/data/tab7-5.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) refers to the financial and educational background of individuals, particularly before graduating from high school, while residing in the United States

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.

Additional information on the required Recruitment Plan to Enhance Diversity is available at Frequently Asked Questions: Recruitment Plan to Enhance Diversity (Diversity FAQs).

Applications lacking a diversity recruitment 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. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

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

Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

Evaluation of courses in cancer informatics should gauge the proficiency of the participants in their ability to incorporate the methods covered by the courses into the research programs. The evaluation plan should include a timeline and specific and detailed plans for obtaining feedback from the participants on the impact and value of the courses. Mechanisms to obtain feedback from program faculty should be described. The evaluation plan should specify how areas of improvement will be identified and incorporated for subsequent course offerings.

Evaluation of courses in optimizing informatics tool usability and user support should gauge how well informatics tool developers are better able to support their user communities and improve their tool usability. The evaluation plan should include a timeline and specific and detailed plans for obtaining feedback from the ITCR development teams on the impact and value of the activities. The evaluation plan should specify how areas of improvement or increased need will be identified and incorporated for future activities.

Letters of Support

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

All proposed Program Faculty should submit letters of support. Letters of support from ITCR development teams willing to support the proposed courses are highly encouraged.

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 modifications:

Educational materials and resources developed for both the courses in cancer informatics and in optimizing informatics tool usability and user support should be openly provided, without restriction for use by the broader community. Materials and resources could include, but are not limited to:

• Course syllabi
• Archived video recordings of the course, with closed captioning
• Informatics tool usability best practice documents
• Software, defined as any code, script, or application developed in the support of a course. Examples could include code used to run example informatics analyses (in support of cancer informatics courses) or a computer program to build user-friendly documentation (in support of courses in optimizing informatics tool usability and user support). Dissemination of such software should be addressed in the software dissemination plan, as outlined below.

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.
• To further enhance the potential impact of their software, applicants may consider proposing a plan to manage and disseminate the improvements or customizations of their tools and resources by others. In support of this goal, awardees are encouraged to manage and disseminate their source code through an open revision control and source code management system such as GitHub.
• Prior to funding, NCI program staff may negotiate modifications of software sharing plans with the applicant. Any software dissemination plans represent a commitment by the institution (and its subcontractors, as applicable), to support and abide by the plan. The final version of any accepted software sharing plans will become a condition of the award.

Appendix

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

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

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

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.

This initiative is not subject to intergovernmental review.

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

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

Applications must be submitted electronically following the instructions described in the 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 for responsiveness by the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

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 emphasis of this UE5 FOA is on ability of the educational activities proposed to enhance the use and usability of the informatics tools and resources developed and supported through the ITCR program by the broader cancer research community

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this UE5 Research Education Cooperative Agreements Program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.

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

Significance

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

Specific to this FOA: How likely are the proposed informatics courses to enable participants to incorporate methods covered by the informatics courses in their research programs? How likely are the proposed courses in optimizing informatics tool usability and user support to increase usability of the tools and resources developed by ITCR development teams? How compelling is the rationale for a need for the proposed courses and activities?

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?

Specicifc to this FOA: Do the PD/PI(s) have sufficient levels of expertise and experience in cancer informatics and informatics tool development and dissemination? How well does the proposed organizational and leadership structure support the vision and goals of the UE5 Resource?

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?

Specific to this FOA: How innovative are the proposed course designs?

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?

Specific to this FOA: How well are the cancer research domains supported by ITCR tools covered by the proposed courses? How well is the content of the courses matched to the anticipated research needs of the targeted participants? How reasonable is the mix of courses in terms of varying complexity and formats? How effective is the approach for identifying ITCR development team's educational needs in optimizing tool usability and user support? How adequate are plans for collaboration with ITCR development teams?

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?

Specific to this FOA: If multiple institutions are participating, how strong are the plans for coordination of activities and effective communication across these sites?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

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

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 education program.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Cancer Institute (NCI), 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 National Cancer Advisory Board. 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.

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.

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.

[RJ([1] [WM([2] Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols."

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 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.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. 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.

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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• All administrative, programmatic, and evaluation aspects of the ITCR Education UE5 Resource
• Determining organizational structure and programmatic approaches to developing a UE5 Resource that encompasses a holistic vision of enhancing the use of ITCR tools through courses in cancer informatics as well as courses in optimizing informatics tool usability and user support
• Defining the overall objectives and directions for the ITCR Education UE5 Resource , including oversight on the developing and implementing the informatics courses and educational activities in optimizing informatics tool usability and user support proposed, involving management of such activities as:
• Recruitment and selection of participants for the informatics courses;
• Logistics of participant registration;
• Logistics of contracting the facilities that will host the courses and provide housing for course faculty, staff, and participants as needed;
• Ensuring that the courses offered represent the breadth of cancer research domains supported by ITCR tools;
• Developing and administering course-specific evaluation instruments to course participants and faculty; and
• Ensuring that the educational activities in informatics tool usability and user support are tailored to the needs of the ITCR development teams.
• Ensuring interactions and collaborations with ITCR development teams
• Participating in ITCR network activities, such as monthly meetings, working group calls, and the annual in-person meeting

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An NCI Program staff member(s) acting as Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Additional NCI staff members may be designated to have substantial involvement (as Project Scientists). This includes a Project Scientist who will provide program-wide coordination among program investigators.

Additionally, an NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The specific roles of the substantially involved NCI staff members include the following activities:

• Coordinating and facilitating interactions and collaborations with awardees of the ITCR Program;
• Serving as a liaison between the UE5 Resource and other components of the ITCR Program;
• Evaluating and making recommendations regarding plans for dissemination of course materials and resources;
• Assisting in avoiding unwarranted duplication of effort with other related NIH or NCI efforts;
• Participating in organizing ITCR annual meetings and special workshops;
• Developing working groups and trans-ITCR efforts as needed;
• Assisting the awardee with the promotion of the courses and reaching the targeted investigators; and
• Working closely with the awardees on optimal implementation of courses.

Whereas the awardee will retain custody of the data and resources developed under these awards, the NCI will have access to aggregate participant information (e.g., scientific background of participants, informatics background of participants, number of attendees for courses), course materials, evaluation data etc., and may periodically review these data.

Areas of Joint Responsibility include:

The NCI Project Scientist(s) and the PD/PI of the Cooperative Agreement award funded under this ITCR initiative will be jointly responsible for participating in initiative-wide activities and for establishing trans-ITCR collaborations.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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.

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.

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their UE5 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 an evaluation of the UE5 research program, NIH and its ICs will determine whether to (a) continue the UE5 research education program as currently configured, (b) continue the UE5 research education program with modifications, or (c) discontinue the UE5 research education program.

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

For Courses for Skills Development:

Courses in cancer informatics

• Aggregate number and demographic characteristics of participants, including career stage.
• Prior informatics experience of participants.
• Content of informatics courses.
• Participants feedback on the program.
• New informatics knowledge or skills acquired.

Courses in optimizing informatics tool usability and user support

• Participation rate of ITCR development teams in informatics tool usability and user support courses.
• Topic areas covered in informatics tool usability and user support.
• Feedback from end users on usability of informatics tools.
• Adoption and use of ITCR informatics tool by the cancer research community.
• Dissemination and/or adoption of the approaches to improving informatics tool usability and user support by ITCR development teams.
• Feedback from ITCR development teams on the activities in informatics tool usability and user support.

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

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

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

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

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

Elizabeth Hsu, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-5733
Email: hsuel@mail.nih.gov

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390.

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: ines@mail.nih.gov

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.