NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 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

This Funding Opportunity Announcement (FOA) invites P20 grant applications for the implementation of partnership between institutions serving underserved health disparity populations and underrepresented students (ISUPS) and NCI-designated Cancer Centers (or Cancer Centers with highly integrated cancer research programs). This FOA is designed to facilitate planning and implementation of focused collaborations in cancer-related research, cancer research experience and cancer education. A major goal of the NCI P20 partnership programs is to provide support for investigators at ISUPS and NCI-designated Cancer Centers to conduct joint cancer research pilot projects and education programs, which should allow awardees to obtain preliminary data that will lead to their submission of competitive grant applications to the NIH/NCI. In addition, outreach education efforts at Cancer Centers may result in increased participation of underserved patients in cancer and/or cancer health disparities-related clinical trials. Notably, the P20 grant application must be submitted as a clearly documented partnership between ISUPS and Cancer Center. For each partnership, two separate, but matched applications must be submitted: one from the ISUPS and one from the Cancer Center. (i.e., high school, undergraduate, graduate)

The NCI Feasibility Studies to Build Collaborative Partnerships in Cancer Research (P20) initiative is part of the NCI Partnerships to Advance Cancer Health Equity (PACHE) Program. The P20 partnerships will accomplish their goals by conducting the following:

1) Collaborative pilot research project(s) in any area of cancer-related basic, clinical, translational, prevention, control, behavioral and/or population research; and

2) Collaborative cancer research education program (CREP) that has to integrate all three following activities:

• Research Experiences: For students (i.e., high school, undergraduate, graduate), post-doctoral fellows, and faculty members; new programs may be created to provide graduate students in the ISUPS opportunities to fulfill their research requirements in Cancer Center laboratories using state-of-the-art equipment in the centers; and,
• Curriculum or Methods Development: Augment existing or create new curricula in ISUPS and/or Cancer Center; the development of curricula on emerging technologies (e.g., genomics, proteomics, and nanotechnology) and their use in cancer research are encouraged; curricula may be developed on bioethics or cancer prevention or cancer control and become institutionalized by partnering ISUPS or Cancer Center; other education programs may be geared towards all participants to deal with cancer health disparities and cultural issues; Masters programs in the ISUPS may be formally linked to doctoral programs in Cancer Centers; and,
• Outreach: Enhance outreach education efforts of Cancer Centers into the underserved populations in their geographic catchment areas. Combined efforts of ISUPS and Cancer Center by working with leaders and organizations in an underrepresented/underserved community to develop educational outreach activities to encourage physicians and community-based organizations (CBO) to increase the recruitment and retention of health disparity populations (e.g., racial, ethnic, disabled, rural, medically underserved, etc.) into clinical trials and prevention protocols (weight reduction, tobacco cessation).

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.

An overarching objective for the P20 partnership planning grants should be gathering preliminary data and other preparations that will allow the submission of grant applications to the NIH/NCI.

As appropriate for a given partnership proposed, such grants may be envisaged in various areas:

• research projects (e.g., R03, R21, R01, projects on P01, projects on P50 applications);
• training/career development grants (e.g., K01, K07, K08, K23, K22, T32, and K12 applications);
• individual predoctoral or postdoctoral fellowships (e.g., F31, F32, F33); and/or
• stand-alone NIH/NCI cancer education grants (R25).

The disparities in cancer incidence, morbidity, and mortality in underserved populations, including racial and ethnic populations and socio-economically, disadvantaged populations have continued to rise over several decades, despite the significant progress in other aspects of cancer research. For example, the incidences of colon and lung cancers in Alaska Native and African American men and women are higher than that of other ethnic groups. The 5-year cancer survival rates (e.g., for persons with lung, ovarian, prostate, colon, or breast cancers) in the Native American, African American, Hawaiian, and Hispanic American populations are lower than for those cancer patients in the Japanese and White American populations. Increasing disparity is seen in patterns of prostate cancer among African American males compared with White males in the southeastern United States (U.S.), particularly in rural areas (http://statecancerprofiles.cancer.gov/). Clearly, more research is needed to better understand and overcome these and other cancer health disparities.

ISUPS support a cadre of faculty and investigators who are culturally competent, and have unique expertise to conduct research on cancer health disparities. In addition, this pool of faculty and investigators have the expertise to establish high quality educational programs for persons interested in working with racial/ethnic and the underserved populations. However, investigators at these institutions have to overcome barriers (e.g., limited infrastructure and resources) in developing and sustaining independent programs in cancer and/or cancer health disparities research.

The NCI-designated Cancer Centers are geographically dispersed, research-intensive institutions with well-organized programs for training cancer scientists. They are the major organized units supported by the NCI to: conduct cancer research; support cancer-related research training in the basic, clinical, translational, and population sciences; provide informational services; and develop and sustain educational and/or outreach programs that benefit their communities. Yet, Cancer Centers or other institutions with organized cancer research programs can (and should) play a greater role in facilitating the following activities: 1) conducting research pertinent to cancer in underserved, isolated, and socio-economically disadvantaged groups; 2) training scientists in the care and treatment of individuals from populations with health disparities; 3) reaching out to and partnering with different underserved populations in their communities; and 4) bringing the benefits of advances in cancer research to their underserved communities and populations.

The NCI Partnerships to Advance Cancer Health Equity (PACHE) Program aims to build and sustain excellence. As part of the PACHE Program , the P20 Program serves as a nurturing environment to allow for the development of new pilot projects and programs, and to obtain preliminary data that will lead to the submission of competitively grant applications. The P20 linked award applications must be focused on cancer research and appropriate supporting activities on research education and outreach education are also required.

Area of Focus: Cancer Research

A joint pilot research project may be in any area of cancer-related basic, clinical, translational, prevention, control, behavioral and/or population research. Partnership investigators are encouraged to develop research applications in translational research as defined by the NCI, emerging technologies, such as nanotechnology, proteomics, genomics, and imaging, and research focusing on pediatric, adolescent, and young adult cancers. The NCI encourages the development of research projects leading to increased biospecimen collection from members of underserved populations, which is a critical endeavor to potentially elucidate the biological and genetic factors associated with cancer health disparities. Joint research projects conducted primarily at the ISUPS may be in any area of cancer research. These projects may focus, for example, on general areas of environmental carcinogenesis, cancer biology, molecular epidemiology, and/or behavioral issues related to cancer prevention, treatment, and control. Joint research projects conducted primarily at the Cancer Center must specifically address areas of cancer disparity in underserved populations.

The Program Directors/Principal Investigators (PD(s)/PI(s)), should plan to evaluate their partnership in preparation for NIH requests for information essential to an assessment of the effectiveness of this P20 program.

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

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

Each partnership must include both types of institutions: 1) an Institution serving underserved health disparity populations and underrepresented students (ISUPS); and 2) an NCI-designated Cancer Center (or Cancer Centers with highly integrated cancer research programs

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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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 underrepresented racial and ethnic groups as well as individuals with disabilities 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.

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 groups, persons with disabilities, and women are encouraged to apply. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.

Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents. Participants supported through the CREP may include students (i.e., high school, undergraduate, graduate), post-doctoral fellows, early stage investigators and other less experienced investigators.

Number of concurrent applications/awards. The NCI PACHE Program includes the P20 grant mechanism and the U54 cooperative agreement mechanism (PAR-15-103, Comprehensive Partnerships to Advance Cancer Health Equity [CPACHE]). Each ISUPS and Cancer Center may not have more than one P20 award and one U54 award simultaneously within the same partnering institutions. However, the partnering institutions can establish and apply for P20 partnerships with different partner institutions and new PDs/PIs.

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

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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:

Behrous Davani, Ph.D.
Center to Reduce Cancer Health Disparities (CRCHD)
National Cancer Institute (NCI)
Telephone: 301-276-6098
Email: behrous.davani@nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (use for Administrative Core)	12
Project (use for Pilot Research Projects)	12 (per Pilot Project)
Can Res Edu Prog (use for Cancer Research Education Program (CREP) [RL5])	12 (per Can Res Edu Prog)

Additional page limits 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 a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Pilot Research Projects: required; maximum of 2
• Cancer Research Education Program: required; maximum of 1

Special Requirement: As stated in Section I of this FOA, each P20 application must be submitted as a clearly documented partnership between the ISUPS and Cancer Center. For each partnership, two separate applications must be submitted: one from the ISUPS and one from the Cancer Center.

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Descriptive Title of Applicant's Project: To allow NIH to identify the set of two collaborative P20 applications, the titles for each application in the set must have the following format: a 1/2 or "2/2" indicator + identical title. Titles may not exceed 80 characters in length, including the tag (i.e., 1/2 or 2/2) at the beginning of the title.

Cover Letter: The Cover Letter is one pdf file only. Therefore, it must include the information requested below on the collaborative applications from the ISUPS and Cancer Centers. The following collaborative information is required in the Cover Letter: a listing of BOTH applications that are a part of the set of collaborative P20 applications being submitted, including for each: 1) the PD/PI(s) name(s), 2) the Title (including the tag (i.e., 1/2 or "2/2"), and 3) the Applicant Institution. Each partnering institution should submit an identical list.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions with the following additional instruction.

Other Attachments: The following "Other Attachment" should be included with the overall component. Name this attachment "Certification Letter". Any institution applying as ISUPS must include a letter signed by the designated institutional officials certifying it is eligible as ISUPS in the application.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Introduction to Application: For Resubmission an Introduction to the Application is required. The Introduction to the Application should be identical for both the Institution and Cancer Center applications

Specific Aims: State the objectives of the collaboration. Outline the overall goals relevant to providing support for investigators at both the ISUPS and Cancer Center to conduct cancer pilot projects, research experience and education programs. Specific Aims must be identical for both partnered applications.

Research Strategy: The Overall research strategy should be identical for both the ISUPS and the Cancer Center partnership applications. Although the overall objectives of the two applications must be the same, the actual activities proposed for the two applications should demonstrate how the ISUPS and the Cancer Center efforts both differ and complement each other in achieving their common objectives.

The research strategy should clearly denote the nature of the interactions and deliberations that occurred between the ISUPS and the Cancer Center during the preparation of these applications (and identify the individuals involved).

The Research Strategy for the overall component is limited to a brief description on the following areas of the P20 that bring synergy to the ISUPS and Cancer Center partnership:

• Overall Objectives and Partnership Integration;
• Scientific and Administrative Leadership, and Administrative Core;
• Each pilot research project;
• Cancer Research Education Program; and
• Planning and Evaluation.

The Pilot Research Project and Education Program sections of this FOA require a more detailed description of project and program area listed above.

Letters of Support: Each application must include written "Letters-of-Commitment" from the respective leadership of both institutions to show support of the partnership and commitment to additional resources necessary to ensure that these partnerships will have the maximum sustainability. In addition, if members of federally or state recognized tribes are involved, a Letter of Commitment from the Tribal Nation Leader is also required.

Complete and specific descriptions of these additional resources in the Letters of Support should include the following items:

• A statement detailing the effort of commitment of the designated PD(s)/PI(s) -- The expected effort commitment for the contact PD(s)/PI(s) at the ISUPS is a minimum of 3 months per year and the Cancer Center PD(s)/PI(s) is expected to commit at least 1.2 months effort per year;
• Statement of the activities that each faculty listed as Key Personnel is being released from (e.g., teaching, clinical, administrative duties), including a statement as to whether the costs of this released time are shared or not between the institutions;
• Provisions for recruitment of new faculty members (if applicable);
• Statement about space and facility availability for new projects/programs.

If the PD/PI from the ISUPS or Cancer Center is an individual with no prior experience as a PD/PI on a peer reviewed grant, there must be a written "Letter-of-Support" from a senior member (e.g., Department Chair, Dean, Cancer Center Director) of the ISUPS or Cancer Center. In the letter, the senior member is expected to indicate his/her qualifications and the willingness to provide guidance to the less experienced PD/PI.

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

• All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan.

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

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

When preparing your application in ASSIST, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Administrative costs (which may be higher in the early stage of development and lower in the late stages) can be included for managing the planning effort, such as salaries for key personnel, travel for key personnel (e.g., costs related to attendance at a biennial PACHE workshop), equipment, and supplies to support an administrative structure.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Identify the specific goals of the Administrative Core.

Research Strategy: Succinctly address the following items:

Leadership:

Detail the plans for the organizational, administrative, and scientific management (both basic and clinical research) of the partnership. Describe and/or diagram the chain of authority for decision-making and administration within the program. Leadership with respect to initiating, facilitating, and implementing successful research collaborations should be discussed in the Administrative Core.

Administrative Management:

Describe the plans for the fiscal management, clerical support, manuscript preparation and compliance to NIH public access policy (PMCID), and meeting organizations. Quality control and communication aspects of the grant should be discussed. A succession plan should be included which describes the process by which new leadership will be selected in the event that the PACHE PD(s)/PI(s) is no longer willing or able to lead the partnership. A statement of commitment to attend PACHE-related, NCI sponsored meetings/workshops and other activities should also be included.

Internal Advisory Committee (IAC):

The PD(s)/PI(s) from both partnering components should convene a common Internal Advisory Committee (IAC). The IAC must have equal numerical representation of members from the ISUPS and Cancer Center. A co-chair representing the ISUPS and a co-chair representing the Cancer Center must be selected among the key personnel. PD(s)/PI(s) may not hold the positions of co-chair. The IAC may include community stakeholders with relevant interest and expertise of the partnership objectives. Each proposed pilot project should be evaluated for scientific merit, relevance to the partnership objectives, potential to generate publishable data for peer-reviewed journals, and potential to develop into a competitive grant application to be submitted to NIH/NCI or other equivalent funding agencies. When a pilot project or CREP co-leader is an early stage investigator, the application of both the ISUPS and Cancer Center must be evaluated for the appropriateness of the institutional support and commitment to the individual. In addition to reviewing and prioritizing proposed pilot projects/ CREP, the IAC will also evaluate ongoing pilot projects/ CREP and advise the PD(s)/PI(s) from both partnering components as to the general activities of the partnership and how they may contribute effectively to achieving high priority goals and objectives.

Specific additional items to provide in this section (under indicated headings):

• (i) Estimated Timeline for Initial Planning, Priority-Setting, Implementation, and Evaluation Stages. This section should be identical for both the ISUPS and the Cancer Center applications. Based on prior experience, interactions, and progress in planning, the two applications must clearly describe a collaborative planning process that includes the Planning, Priority-Setting, Implementation, and Evaluation Stages. PD(s)/PI(s) should include a chronological narrative or table listing the specific first year, second year, third year, and fourth year objectives that are expected to be achieved. For each objective, a brief statement should be made about the separate contributions of the ISUPS and the Cancer Center in order to achieve success. The intent of these P20 partnership awards is to provide support for cancer pilot projects and CREP for up to 4 years to perform feasibility studies and obtain preliminary data that will lead to the submission of competitively funded grant applications to NCI and/or other Federal/Non-Federal agencies.
• (ii) Initial Planning Stage. This section should be identical for both the ISUPS and the Cancer Center applications. The applicants should clearly describe each planning activity proposed by the ISUPS and the Cancer Center to ensure a highly interactive and integrated effort between their faculty and scientists. The roles and activities of the Internal Advisory Committee (IAC) should be clearly described (see IAC above). The applicants should also relate each planning activity (e.g., workshop, retreat, executive meeting) to specific objectives and name the specific faculty and interests (e.g., training, clinical oncology researchers, research in prostate cancer, establishing new curriculum in cancer health disparities, nutrition) involved in each activity.
• (iii) Priority-Setting Stage. This section should be identical for both the ISUPS and the Cancer Center applications. In the Priority-Setting Stage, the participants must select the areas of greatest promise for implementation targeting specific pilot projects or pilot programs based on merit and potential to result in a successful grant application (the PD(s)/PI(s) from both partnering institutions. Clearly describe how the specific pilot projects/programs will be prioritized and selected for implementation based on their merit and greatest potential for success. The Initial Planning and Priority Setting Stage should be completed in the first year of the grant.
• (iv) Implementation Stage. This section should be identical for both the ISUPS and the Cancer Center applications. The applicants must provide a brief description of one (required) or up to two pilot cancer research project(s) and a joint cancer research education program to acquire preliminary data for submitting specific competitive grant applications.

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

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

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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
All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Project.

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

SF424 (R&R) Cover (Pilot Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title: Pilot Research Project start with "Pilot Project 1:", 'Pilot Project 2."
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Pilot Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Research Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Provide a short description of the proposed research goals.

Project /Performance Site Location(s) (Pilot Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Pilot Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Pilot Research Project)

Individual research projects should have a detailed budget for the entire proposed project period.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Pilot Research Project)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed.

Specific Aims: State the hypothesis of the proposed pilot research project and its specific aims.

Research Strategy: Describe how this pilot research project relates to the overall priorities of the partnership and the target area(s). Include any preliminary data (if available).

Describe, as appropriate for the nature of the pilot research project, the study design and experimental methods. Identify students, post-doctoral fellows, ESIs or other less experienced investigators involved in the project.

Describe the roles played by the ISUPS and Cancer Center collaborators/mentors. Identify which aspects of the pilot project will be conducted primarily at the ISUPS and which will be conducted at the Cancer Center.

Letters of Support: Letters indicating institutional commitment as well as any letter of support for the proposed research project should be included. For Project Lead from the ISUPS or CC with no prior experience as a PD/PI on a peer reviewed grant or Early Stage Investigators (ESI) with no prior independent funding; the application must include a written "Letter of Support" from institutional leadership or a senior member (e.g., Department Chair, Dean, Cancer Center Director) of the ISUPS or CC. In the letter, the senior member is expected to indicate his/her qualifications and the willingness to provide guidance to the ESI or other less experienced investigators involved as Project Lead on the application components. The letter must also provide detailed statements of the long-term commitment and list specific resources, space and protected time that will be made available to the ESI.

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

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

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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
All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application in ASSIST, use Component Type Can Res Edu Prog'.

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

SF424 (R&R) Cover (Cancer Research Education Program)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title: Cancer Research Education Program
• Proposed Training and Education Program Start/Ending Dates

PHS 398 Cover Page Supplement (Cancer Research Education Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Cancer Research Education Program)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Provide a short description of the proposed research goals.

Other Attachments: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project/Performance Site Location(s) (Cancer Research Education Program)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Cancer Research Education Program)

• In the Project Director/Principal Investigator section, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Cancer Research Education Program)

Prepare a detailed budget and justification for the Entire Proposed Period of Support.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Cancer Research Education Program)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed.

Specific Aims: State the hypothesis of the proposed Research Education Program and its specific aims. Describe the contribution of Research Education Program to the Partnership's overall goal.

Research Strategy:

The Research Strategy must include the following subsections:

Proposed Cancer Research Education Program. A Cancer Research Education Program (CREP) must represent true collaborations that function seamlessly across the ISUPS and the Cancer Center. When research training programs are on going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program. The description should include the educational and/or career level(s) of the planned participants.

Applicants must include plans for tracking of participants .

The partnership applications are to focus on specific project goals relevant to building research capacity at the ISUPS. The research strategy must describe, as appropriate, the nature of the education program, experimental methods/study design, or the education plans and objectives. For example, include the identification of the target pool (students (i.e., high school, undergraduate, graduate), post-doctoral fellows, Early Stage Investigators (ESIs) or other less experienced investigators, and the method of the program evaluation plan and tracking procedures. Describe the role played by the ISUPS and Cancer Center collaborators/mentors. Identify which aspects of the program will be conducted primarily at the ISUPS and which will be conducted at the Cancer Center. Education Programs conducted primarily at the ISUPS may be in any area of cancer research, but Education Programs conducted primarily at the Cancer Center must specifically address cancer health disparities research.

Efforts invested in the CREP should yield institutional commitments to integrate these curricula into their educational systems. Educational outreach activities must include appropriate research questions, tracking, and an evaluation plan.

Successful programs should lead to the submission of competitive grant applications (e.g., T32, K12, stand-alone research education grant) as well as applications for individual pre-doctoral fellowships (F31), career development awards (e.g., K01, K07, K08, K23, K22) and research supplements for participants.

Program Leader(s). Describe arrangements for administration of the program. Provide evidence that the Program Leader(s) are actively engaged in research and/or teaching in an area related to the overall goal of partnership and can organize, administer, monitor, and evaluate the research education program.

Program Participants. Students (i.e., high school, undergraduate, graduate), post-doctoral fellows, early stage investigators and other less experienced investigators will be supported through this program. Joint research education programs are required to include ESIs or other less experienced investigators from both the ISUPS and Cancer Center. The CREP should describe the plan for recruiting, selecting, mentoring, and monitoring the progress of individuals who participate in the program and describe the abilities that participants will be expected to acquire.

Recruitment Plan to Enhance Diversity. Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-15-053). Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise

to address complex scientific problems. There are many benefits that flow from a diverse NIH supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

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

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf.

C. Individuals from disadvantaged backgrounds, defined as:

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

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

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

Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., Inside the Double Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and Mathematics).

New applications must include a plan to enhance recruitment of a diverse participant pool and may wish to include data in support of past accomplishments. The plan should be appropriate and reasonable for the nature and duration of the proposed program.

Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

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

For those individuals who participated in the research education program, the report should include information about the duration of education and aggregate information on the number of individuals who finished the program in good standing. Additional information on the required Recruitment 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 research education program. 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 program in achieving its objectives. For example, the evaluation plan must assess various aspects of participating high school, undergraduate, and graduate students' rates of graduation, entry into academic biomedical and behavioral science programs, publications and presentations, post-doctoral fellows and new/early stage investigators' employment histories, publications support from research grants or contracts, etc. In addition, an evaluation plan to assess pilot programs in cancer research education (including curriculum development and/or outreach activities should be included.

Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements. Specified evaluation metrics should be tied to the goals of the partnership.

Letters of Support: Letters indicating institutional commitment and any letter of support for the proposed cancer research education program should be included. For Program Lead from the ISUPS or CC with no prior experience as a PD/PI on a peer reviewed grant or Early Stage Investigators (ESI) with no prior independent funding; the application must include a written "Letter-of-Support" from institutional leadership or a senior member (e.g., Department Chair, Dean, Cancer Center Director) of the ISUPS or CC. In the letter, the senior member is expected to indicate his/her qualifications and the willingness to provide guidance to the ESI or other less experienced investigators involved as Project Lead on the application components. . The letter must also provide detailed statements of the long-term commitment and list specific resources, space and protected time that will be made available to the ESI.

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

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

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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
All instructions in the SF424 (R&R) Application Guide must be followed.

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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.

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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: https://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the program 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. For example, a program that by its nature is not innovative may be essential to advance a field.

Does the program address an important problem or a critical barrier to progress in the field? If the aims of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, specific to this FOA: Do the proposed partnership and research project address cancer research including cancer health disparities research? Will the proposed partnership, project have a significant effect on the broader field of health disparities?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the program? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? 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?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, specific to this FOA: Does the application use a creative study design? Is the study design being proposed already in existence but being applied to new underserved populations? Will the proposed design be culturally tailored for the population of interest? Will plans be made available and flexible enough for modification, if found to be beneficial?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the program? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the program involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

In addition, specific to this FOA: Are the methods for the Initial Planning Stage proposed by the ISUPS and the Cancer Center to explore areas of research opportunities adequate to ensure highly interactive and integrated efforts between individual scientists and/or between faculty and scientists? Is the duration of the initial planning stage needed to identify areas of potential collaboration adequate?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, specific to this FOA: What is the strength of the evidence that the researchers and faculty of the ISUPS and the Cancer Center worked closely together in the preparation of the application? To what degree do the letters-of-support from senior faculty and/or ISUPS/Center leaders address the need for mentoring of less experienced PDs/PIs or for specific ISUPS/Center commitments to ensure the success of the collaboration?

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 Research Education Core, 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 an important problem or a critical barrier to progress in the field? If the aims of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, specific to this FOA: Does the proposed education program address cancer research including cancer health disparities research? If the aims of the research education program are achieved, will they contribute to the skills development of highly trained cancer scientists?

Investigator(s)

Are the Program leaders, collaborators, and other researchers well suited to the proposed program ? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the program is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the program?

In addition, specific to this FOA: Does (Do) the investigator(s) have prior adequate training and experience in designing and implementing new education programs that are culturally appropriate? Do the applicant(s) and other team members have prior experience in recruiting new and early stage investigators or other less experienced investigators and providing them with cancer research experience?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, specific to this FOA: Does the application use a creative study design? Is the study design being proposed already in existence but being applied to new underserved populations? Will the proposed design be culturally tailored for the population of interest? Will plans be made available and flexible enough for modification, if found to be beneficial?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CREP? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the program involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

In addition, specific to this FOA: Are the methods for the Initial Planning Stage proposed by the ISUPS and the Cancer Center to explore areas of education opportunities adequate to ensure highly interactive and integrated efforts between individual scientists and/or between faculty and scientists? Is the duration of the initial planning stage needed to identify areas of potential collaboration adequate?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the program proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, specific to this FOA: What is the strength of the evidence that the researchers and faculty of the ISUPS and the Cancer Center worked closely together in the preparation of the application? To what degree do the letters-of-support from senior faculty and/or ISUPS/Center leaders address the need for mentoring of less experienced PDs/PIs or for specific ISUPS/Center commitments to ensure the success of the collaboration?

As applicable for the Program 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.

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

Not Applicable

Not Applicable

As applicable for the project/program 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.

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

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 .

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

As applicable for the project/program 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 will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s),convened by 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.

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.

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.

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, 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.

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

Upon the completion of a program evaluation, NIH 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 NCI expects to use the following evaluation measures:

• Aggregate number and demographic characteristics of participants in the Research Experiences
• Aggregate number and demographic characteristics of participants exposed to the new curricula
• Aggregate number and demographic characteristics of individuals reached
• Educational level of participants
• Participants feedback on the program
• Content of the research experience
• New knowledge or skills acquired
• Effectiveness of the new curricula assessed by skills/competencies gained compared to existing curricula
• Dissemination and/or adoption of the new curricula
• Number and Topics/ foci of educational outreach activities conducted;
• Number and types of partnerships formed by the Cancer Center (CC) with community-based organizations (CBOs);
• Types and amounts of contributions of partners/ CBOs to each outreach educational activity;
• Number and types of educational materials and tools developed for outreach education purposes; and;
• Types/ cadre of personnel who conducted the educational outreach activities (nurses, physicians, CHEs, cancer survivors, etc.)

For Education Programs Involving the Following Groups:

Undergraduate Students:

• Subsequent educational/career progress, including:
• Successful completion of an undergraduate degree in a STEM field
• Enrollment in an advanced degree program in a STEM field

Graduate Students:

• Subsequent educational/career progress of participants, including:
• Successful completion of a STEM graduate program
• Subsequent participation in a formal research training or career development program in a STEM field
• Subsequent employment in a research or research-related field
• Subsequent authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source

Postdoctorates and Early Career Investigators:

• Subsequent educational/career progress of participants, including:
• Subsequent employment in a research or research-related field
• Subsequent authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source

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

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

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

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

Behrous Davani, Ph.D.
National Cancer Institute (NCI)
Telephone: 301-276-6098
Email: behrous.davani@nih.gov

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Candace M. Cofie
National Cancer Institute (NCI)
Telephone: 240-276-6317
Email: candace.cofie@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.