Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Implementation Science for Cancer Control: Developing Centers (P50 Clinical Trial Optional)

Activity Code

P50 Specialized Center

Announcement Type

New

Related Notices
  • November 21, 2018 - Notice of a Pre-Application Webinar for RFA-CA-19-005 and RFA-CA-19-006. See Notice NOT-CA-19-013.
Funding Opportunity Announcement (FOA) Number

RFA-CA-19-005

Companion Funding Opportunity

RFA-CA-19-006, P50 Specialized Center

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

 93.353, 93.399 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSM Initiative that is intended to accelerate cancer research. The purpose of this FOA is to support P50 Developing Centers that will build research capacity to study high priority areas of cancer control implementation science, build implementation laboratories, improve the state of measurement and methods, and improve the adoption, implementation, and sustainment of evidence-based cancer control interventions. Specifically, this FOA targets the following areas designated as scientific priorities by the Blue Ribbon Panel (BRP): Prevention and Screening: Implementation of Evidence-based Approaches; Symptom Management, Prevention and Screening: High-Risk Cancers and other cross-cutting Moonshot priorities.

The Implementation Science Centers in Cancer Control (ISCCC) Program will support the rapid development, testing and refinement of innovative approaches to: implement a range of evidence-based cancer control interventions; establish implementation laboratories from existing clinical and community sites providing services across the cancer control continuum; advance methods in studying implementation; develop and validate reliable measures of key implementation science constructs; and together form a large consortium of implementation scientists across this and other Moonshot initiatives.

The ISCCC Program will support P50 Developing Centers (under this FOA) and P50 Advanced Centers (companion RFA-CA-19-006).

Key Dates

 

Posted Date

November 15, 2018

Open Date (Earliest Submission Date)

January 11, 2019

Letter of Intent Due Date(s)

January 11, 2019

Application Due Date(s)

February 11, 2019), by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this Funding Opportunity Announcement.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

April-May 2019

Advisory Council Review

August 2019

Earliest Start Date

September 2019

Expiration Date

February 12, 2019

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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 using ASSIST or an institutional system-to-system solution; paper applications will not be accepted.

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) 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 may be delayed or not accepted for review.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


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

    This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer Moonshot SM Initiative that is intended to accelerate cancer research. The purpose of this FOA is to promote the development of research centers that can build capacity to study high priority, emerging areas of cancer control implementation science, build implementation laboratories, improve the state of measurement and methods, and improve the adoption, implementation, and sustainment of evidence-based cancer control interventions. Specifically, this FOA targets the following areas designated as scientific priorities by the Blue Ribbon Panel (BRP): Prevention and Screening: Implementation of Evidence-based Approaches; Symptom Management, Prevention and Screening: High-Risk Cancers and other cross-cutting Moonshot priorities.

    The Implementation Science Centers in Cancer Control (ISCCC) Program will support the rapid development, testing, and refinement of innovative approaches to implement a range of evidence-based cancer control interventions.  Centers will establish "implementation laboratories" involving existing clinical and community sites providing services across the cancer control continuum, advance methods and valid and reliable measures of key implementation science constructs, and collectively form a large consortium of implementation scientists across this and other Moonshot initiatives.

    The ISCCC Program will support P50 Developing Centers (under this FOA) and P50 Advanced Centers (under companion RFA CA-19-006). The roles of these Centers are outlined below.

    • Advanced Centers: These centers will focus on more established areas of implementation science, for which scale, refinement and expansion of existing scientific and methodologic areas for implementation science in cancer control are achievable. Proposed research activities are organized around a cohesive, overarching “grand challenge” implementation science theme that will frame the activities of each required center component and the research agenda that the center will complete. These centers should leverage existing efforts and clinical and community sites where implementation science can be rapidly tested and advanced. 
    • Developing Centers: These centers will have greater focus on emergent and less well-developed concepts related to implementation science in cancer control. Proposed research activities should be organized around a cohesive, overarching “emerging” implementation science theme that will frame the activities of each required center component and the research agenda that the center will complete. Pilots developed in these centers should be considered more high-risk/high-reward studies. The implementation laboratory in these centers will be scaled appropriately for the work proposed.
    • Organization of Centers: Each center will include the following components: Administrative Core, Research Program and Implementation Laboratory.

    Key Definitions for this FOA:

    Implementation Science: the study of methods to promote the integration of research findings and evidence into public health, clinical practice and community settings. It seeks to understand the behavior of healthcare professionals and other stakeholders as a key variable in the sustainable uptake, adoption, and implementation of evidence-based interventions.

    ISCCC Program: Refers to the combined activities of the Developing Centers (under this FOA), the Advanced Centers (under companion RFA CA-19-006), and the NCI to advance the science of implementation in cancer control through innovative pilots, additional field capacity development, implementation laboratories, improved methods and measurement, and consortium activities. 

    Implementation Laboratory: A collaborative research concept specific to the ISCCC. The "Implementation Laboratory" should reflect a collaboration between the Center awardee institution and an appropriate set of community and/or clinical sites. The collaborating sites may reflect diverse settings (e.g., oncology care, primary care, community services) but all are expected to share interest in and capacity to conduct research consistent with the implementation science theme of the Center.  Each Implementation Laboratory should enable a range of studies focused on the adoption, implementation, sustainment, and de-implementation of various cancer control interventions. As appropriate, studies to be conducted may be observational, experimental, and/or quasi-experimental.

    Clinical Trials: The NIH definition of a clinical trial stated in NOT-OD-15-015 applies to this FOA. A clinical trial is defined as 'research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes'.

    Background:

    Existence of Evidence-Based Practices for Cancer Control. NCI-funded research has resulted in the development of hundreds of evidence-based practices that, if implemented, can demonstrably improve cancer outcomes at every stage of the care continuum. Within one specific repository, NCI’s Research-Tested Intervention Programs (RTIPs) website, 187 programs are available for local implementation. However, as stated in an article published in the New England Journal of Medicine (2017), “as a nation…we fail to adopt strategies to ensure that all population groups benefit equally from our knowledge of cancer prevention.” The gap between what is known and what is standard care requires significant advancement in the science of implementation.

    Emergence of Implementation Science. Since 2005, the NCI has been a leader in NIH efforts to grow implementation science, through specific funding opportunity announcements (e.g., PAR-18-007), leadership of an annual conference and conduct of training programs. Simultaneously, leading professional societies in the cancer space (American Society for Clinical Oncology, American Society for Preventive Oncology, American Association for Cancer Research) have spotlighted implementation science in annual meetings to raise the profile and interest in this growing field. The presence of implementation science as a key theme in the Cancer Moonshot has further increased awareness and demand for knowledge that can improve clinical and community practice.

    Current Gaps in the Field. While progress has been made through a set of trans-NIH funding opportunity announcements, there remains limited capacity at research institutions to conduct the range of implementation science investigations needed to close this gap between research and practice. Implementation science trials, such as those solicited through the recent Moonshot RFAs on colorectal cancer screening (ACCSIS), symptom management (IMPACT), and cascade screening for hereditary cancers, will help to develop and test discrete approaches to specific implementation gaps, but may not result in a broad-based effort to improve measurement or research designs, nor will they optimally build knowledge from ongoing efforts to implement and sustain evidence-based cancer control interventions in clinical and community settings. Furthermore, several high priority areas in implementation science (e.g., local adaptation of evidence-based interventions, long-term sustainment of effective interventions, de-implementation of harmful or sub-optimal practices) require additional research investment.

    Need for a Targeted Approach to Build Scientific Capacity. To continue progress, implementation science can be rapidly advanced through a targeted set of activities. First, developing implementation laboratories where ongoing investigations of a range of scientific questions can occur “in vivo” will permit far more rapid knowledge acquisition and hypothesis testing than a typical R01. Second, methods and measurement development will fill clear gaps in assessment of key implementation constructs, outcomes and processes. Third, pooling data across studies will improve statistical power for outcomes in which sample size of any one study is likely to be insufficient (e.g., hospital/system or community-level outcomes). Fourth, building a consortium of investigators working in implementation will likely bridge the gap between initial implementation science training programs (e.g. NCI’s Training Institute for Dissemination and Implementation Research in Cancer, NIH's Training Institute for Dissemination and Implementation Research in Health) and the need for ongoing support, advanced training, and further capacity building.

    Recommendations of the Cancer Moonshot Blue Ribbon Panel: To address the population impact of suboptimal rates for cancer control intervention uptake, the Cancer Moonshot SM Blue Ribbon Panel Implementation Science Working Group recommended a strategic investment in the development and testing of implementation strategies to significantly improve uptake and sustainment of interventions, particularly among traditionally underserved populations. While the working group highlighted tobacco cessation, HPV vaccination and colorectal cancer screening as initial areas of focus, they noted that advances in implementation science could help to accelerate the uptake of additional population-level, cancer prevention and control recommendations. In addition, the symptom management, hereditary cancers and patient engagement recommendations all reflect the need to not just develop interventions, but ensure that they can be adopted, implemented and sustained within clinical and community practices. Thus, this concept reflects an intent to leverage the work across multiple Blue Ribbon Panel recommendations.  

    Research Objectives

    This FOA supports efforts to explore emerging areas in cancer control implementation science that may be considered "high-risk/high-reward" through the development of multiple research centers.  The proposed Developing Centers should be based on an overall unifying scientific theme.

    Potential theme areas for a Developing Center to focus on include but are not limited to:

    • Developing and testing strategies to facilitate evidence-based de-implementation of ineffective, sub-optimal or harmful cancer control or cancer care interventions;
    • Advancing implementation of precision medicine across the cancer control continuum;
    • Optimizing scale-up of cancer control policies and interventions;
    • Examination of the role of policies or changing policies (organizational, regulatory) on implementation processes, outcomes and adaptations;
    • Improving the implementation of evidence-based survivorship care, secondary prevention and quality of life;
    • Use of technologies to support rapid cycle and real time deployment and testing of implementation processes and adaptations within cancer control service systems.

    Required Capabilities. The proposed Developing Center should be capable of addressing all the following aspects:

    • Leveraging existing clinical and community sites where cancer control interventions are delivered to form an “implementation laboratory,” capable of using a range of study designs (e.g., observational, experimental, quasi-experimental, natural experiments) to conduct implementation studies.
    • Development and execution of rapid-cycle testing of innovative approaches to implementing evidence-based interventions or de-implementing interventions.
    • Development and testing of valid, reliable and pragmatic measures of implementation constructs, outcomes and processes to highlight range of measures that are needed but are not currently available to the scientific community. This work may include new theoretical constructs and development of new rapid and real time data collection to inform implementation processes.
    • Generation of pilot studies in emergent, less developed, high-risk/high reward areas of implementation science under-represented in the current NCI portfolio (e.g., implementation of precision medicine, de-implementation, local adaptation of interventions, policy implementation)
    • Contribute and build capacity for nationwide support for implementation scientists in cancer control, including participation in annual meetings, training and mentoring support, technical assistance on proposals and collaborative workspace for innovative study concepts.
    • Supporting transdisciplinary research that brings together diverse teams of cancer control and population scientists, implementation scientists, and experts from allied disciplines that bring new perspectives and tools relevant to enhancing the adoption, implementation, sustainment, adaptation or de-implementation of the range of interventions to improve outcomes along the cancer continuum. Developing Center should consider inclusion of members with experience within the target clinical/community practice settings, including service users, industry, family members, health care providers, community service providers, administrators and payers to advance a pragmatic approach and design for implementation. Research team should be transdisciplinary to expand the capacity of the team to advance emerging implementation science perspectives, tools, and new methods to enhance the adoption, implementation, sustainment, or de-implementation of the range of interventions to improve outcomes along the cancer continuum.

    General characteristics of research agenda expected for Developing Center:

    • Size and scope of science should comprise at least one initial exploratory research study. This study should involve an innovative, high-risk/high-reward approach to implementation science questions that address ISCCC goals of improving adoption, implementation, sustainment and/or de-implementation of interventions across the cancer control continuum and are intended to be located within the Center's defined Implementation Laboratory. Developing Centers are intended to facilitate emerging opportunities for measurement and methods pilot research by developing at least one initial measurement and/or methods pilot studies that can be launched within the study period.
    • Data and measures to be developed and used within and across sites as common data elements may be multi-level and contextual by including two or more of the following levels: individual, family, school, workplace, social network, community, as well as characteristics of the social and built environments, payment structures, policy, institutional and public health and health care settings. These data are integrated and captured across observational, self-report, objective and/or real time data capture towards the research theme of the center(s) to identify synergistic, complementary and interacting elements across levels.
    • In addition, the Developing Centers should take advantage of emerging opportunities for additional pilot research through a defined process for soliciting, reviewing and selecting promising studies to be completed over the grant period. 
    • Developing Centers are intended to move the field of implementation science in new directions through research studies, activities and implementation laboratories at a single institution or across multiple institutions. Collaborations among cancer research programs, implementation science programs, and a range of different service providers are encouraged, even if this means that investigators are geographically distributed.
    • Developing Centers are expected to provide opportunities for graduate students, postdoctoral researchers, and new investigators to participate in cancer control implementation science.
    • Each Center should be prepared to host one of the annual ISCCC consortium meetings over the course of the study period which the network unit will be engaged in planning.

    Center Organization

    The proposed Developing Center should consist of three components.  The scope of each component is defined below:

    Administrative Core to manage and coordinate all Center research and activities, within a cohesive organizing framework, including training, evaluation, networking and dissemination.

    • Network Unit to connect the center with the consortia of ISCCCs centers to build the research capacity, collaboration on data measures, and dissemination of tools and findings across and within centers and for the broader research field.

    Research Program to cover both implementation studies and methods and measurement studies related to the Center's focus through corresponding functional units.

    • Implementation Studies Unit is intended to foster a set of innovative investigations, related to the Developing Center's theme, that will move the cancer implementation science field in exciting new directions. Applications are expected to detail at least one initial study that the Unit will conduct, which can include observational, experimental and quasi-experimental studies, and are intended to be executed within the Implementation Laboratory. These studies should be closely integrated into the organizing framework and suggest a multifaceted approach to advancing implementation science, as well as processes through which additional pilot studies will be developed in future funding years. Applicants are encouraged to develop studies that break new ground in implementation science, consistent with the Center's thematic focus around an understudied area in the field.
    • Methods Unit to oversee measurement development and methods studies related to the Developing Center's focus. Each center should include at least one initial measurement and/or methods studies that fill gaps in methods and measurement in implementation science, promote common data elements across studies, as well as processes through which additional studies will be developed in future funding years. There are many areas of methodological investigation that could be included in this component, both as initial studies and long-term foci for the Unit to address. The following are examples that are not meant to be comprehensive or exclusive of other topics:
    • Develop and evaluate innovative process, context and outcome measures relevant to implementation, including new measures to broaden assessment of the effect of implementation strategies at multiple levels (e.g. individual, community, clinic, health system).
    • Improve the methods for assessing the mechanisms of action of implementation strategies in clinical and community settings.
    • Utilize mixed methods to study the effectiveness, acceptability, adaptation, and sustainability of interventions implemented in clinical and community settings.
    • Improve methods that increase the relevance of research findings for community stakeholders (e.g., economic analyses, policy evaluation, policy implementation, impact analyses).
    • Development, application, and implementation of technology for rapid cycle and real time deployment and testing of implementation processes and adaptations within cancer control topics.

    Implementation Laboratory to enable a range of observational, experimental and/or quasi-experimental pilot implementation studies to be tested within a set of clinical and/or community service settings that have shared interest in the Center theme, capacity for study participation, and engagement in improving cancer control across the continuum. The sites that are part of Developing Center laboratories can be existing networks with existing research studies, an expansion of an existing network or a laboratory that is defined by a natural experiment.

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

    Section II. Award Information
    Funding Instrument

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

    Application Types Allowed

    New

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

    Clinical Trial?

    Optional: Accepting applications that either propose or do not propose clinical trial(s)

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The NCI intends to commit $3,000,000 in FY 2019 to fund up to three awards, depending on the submission of a sufficient number of meritorious applications.

    Award Budget

    Budget is limited to $600,000 in direct costs per year.

    Award Project Period

     The maximum project period is 5 years.  

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

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

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

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

    Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

    Required Registrations

    Applicant Organizations

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

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from 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.

    An individual designated as a PD/PI on an application for Advanced Center (under RFA-CA-19-006) is not eligible for serving as a PD/PI on the application for Developing Center submitted in response to this FOA  

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

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

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

    The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution

    2. Content and Form of Application Submission

    It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, 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.

    Letter of Intent

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

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

    • Descriptive title of proposed activity
    • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
    • Names of other key personnel
    • Participating institution(s)
    • Number and title of this funding opportunity

    The letter of intent should be sent to:

    April Oh, Ph.D., M.P.H.
    Telephone: 240-276-6709
    Fax: 240-276-7907
    Email: ohay@mail.nih.gov

    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    6

    Admin Core (use for Administrative Core)

    12

    Program (use for Research Program)

    12

    Core (use for Implementation Laboratory)

    6

    Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

    Instructions for the Submission of Multi-Component Applications

    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: one required (one allowed)
    • Research Program: one required (one allowed)
    • Implementation Laboratory: one required (one allowed)
    Overall Component

    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.

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

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

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Facilities and Other Resources: Document the environment, characteristics and/or commitments of participating institutions. As applicable, explain how multi-institutional collaborations will broaden the range of expertise required for a comprehensive, transdisciplinary approach to the implementation science theme proposed by the center.    

    Project/Performance Site Location(s) (Overall)

    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.

    Research & Related Senior/Key Person Profile (Overall)

    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.

    Budget (Overall)

    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.

    PHS 398 Research Plan (Overall)

    Specific Aims:  Specific Aims should outline the overall vision and goals for the Developing Center. These Aims should be overarching and at a high level and distinct from the aims of the individual cores.

    Research Strategy:  The Research Strategy must consist of the sub-sections A-E defined below:

    Subsection A. Center Overview: The Overview should provide an overall description of the Developing Center rationale, mission, and goals. It should include a clear statement about the value added of this Center to the field and to advancing Implementation Science in Cancer Control. An essential part of the application is to explain how the proposed research activities are organized around a cohesive, overarching “emerging” implementation science theme that will frame the activities of each required center component and the research agenda that the center will complete.  The application should also state how the implementation science field will likely benefit from the center activities above and beyond what can be accomplished in stand-alone grant applications.  Thus, applicants must clearly define the value added that center support will provide and demonstrate how the center will be more than a collection of studies to advance implementation science. For this P50, it is expected that applicants will have a substantial amount of relevant expertise in implementation science and choose a theme for which less progress has been made in the field that can benefit from the support requested under this FOA. Identify clearly any innovative directions in implementation science that are proposed to be explored as a potential basis for larger implementation studies down the road. The Developing Center may consist of several collaborating sites that are not all located in a single institution or geographic region. The collaboration of multiple institutions and settings to create a virtual center must be specified and explained in this section so the feasibility of such arrangements can be evaluated.

    Subsection B. Investigator Team. Without repeating information in individual biosketches, explain how the collective expertise and experience of the investigators will include the necessary expertise and experience to support the team science environment needed to complete the proposed multidisciplinary work. The application should also describe how the Developing Center will expand opportunities for junior investigators, particularly for underrepresented racial and ethnic groups, individuals with disabilities and individuals from disadvantaged backgrounds. Established investigators, including clinicians, data scientists, economists, social scientists, and organizational researchers, willing to refocus their efforts on implementation science in cancer can also be included in these opportunities. The direct support of training efforts (e.g., stipends), however, should be sought through other NIH training and career development grant mechanisms.

    Subsection C. Center Organization and Integration: Include a concise description of the structure of the Center including the organizing framework. Explain how the components of the Center (administrative core, research program, and implementation laboratory) will interact and why each component is essential for addressing the organizing framework of the Center. Applicants should demonstrate that use of the research Center mechanism is essential to accomplishing studies that would not occur without the climate, facilities, and research resources that a research Center can uniquely provide. Briefly describe the initial set of proposed pilot studies, including those located in the research program, including their scientific integration, staffing plan and a rationale for how each study will help, within the funded period, to generate sufficient results to drive the development of new knowledge on implementation science in cancer control.

    Subsection D. Implementation Laboratory: Briefly describe the intended composition of clinical and/or community sites within the proposed Implementation Laboratory and the activities to be conducted over the study period to test whether the Laboratory can successfully house the types of implementation studies relevant to the P50 Center theme.  Specify organizational characteristics of the sites (e.g. if clinic-academic/physician owned, if community site-types of partners and leadership, urban/rural, common reporting systems or EHRs) number and type of providers, practitioners or public health workers, features of the population they serve (e.g. number of patients/community members, diversity, cancer burden, screening rates, access to services and resources).

    Subsection E. Health Disparities: The BRP recommendations outline a set of opportunities that, if implemented, will transform our understanding of cancer and result in new opportunities to more effectively prevent and treat the disease, which can reduce the burden of cancer in all Americans and the health disparities that currently exist. Racial/ethnically diverse populations and those from urban and rural areas who are poor and medically underserved continue to suffer disproportionately from certain cancers and have higher morbidity and mortality rates. If applicable to the type of research studies being proposed, explain how populations experiencing health disparities and data from these communities will be integrated into the proposed studies.

    Letters of Support:  Letters of support for the entire application should be provided under Overall.  Letters of support should be submitted by all institutions participating in a multi-institution collaboration and should specify institutional, expertise and commitment and if appropriate the population that the institution serves.

    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 address a Data Sharing Plan.
    • The Data Sharing Plan should be provided only under the Overall component but it should cover all the activities of the Center.
    • Addressing the Cancer Moonshot Public Access and Data Sharing Policy: Utilizing the provision outlined in the 21st Century Cures Act, NCI has established a data sharing policy for projects that are funded as part of the Beau Biden Cancer MoonshotSM Initiative that requires applicants to submit a Public Access and Data Sharing Plan that: (1) describes their proposed process for making resulting Publications and to the extent possible, the Underlying Primary Data immediately and broadly available to the public upon publication; and (2) if applicable, provides a justification to NCI if such sharing is not possible. NCI will give competitive preference and funding priority to applications that comply with the strategy described here. The data sharing plan will become a term and condition of award.

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.    

    PHS Human Subjects and Clinical Trials Information (Overall)

    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

    Note for applications proposing clinical trials: do NOT enter study record here (all study records are to be included under Research Program component).

    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

    PHS Assignment Request Form (Overall)

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

    Administrative Core

    When preparing your application, 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
    PHS 398 Cover Page Supplement (Administrative Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Administrative Core)

    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.

    Project /Performance Site Location(s) (Administrative Core)

    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 (Administrative Core)
    • 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.
    • Research Program is expected to be led by an individual(s) designated as PD(s)/PI(s) on the application.
    Budget (Administrative Core)

    Budget forms appropriate for the specific component will be included in the application package.

    Applicants may propose and budget for a Center Administrator to manage day-to-day operations.

    Applicants must budget for travel and per diem expenses for Annual Consortium meetings. In the first year, applicants should plan for at least two senior investigators (all PDs/PIs, if desirable, or the PD/PI and a senior investigator if multi-PD(s)/PI(s) option is not used), to attend a Consortium Meeting. In the second and subsequent years, applicants should plan for at least two senior investigators (all PDs/PIs, if desirable, or the PD/PI and a senior investigator if multi-PD(s)/PI(s) option is not used) to attend one Consortium meeting per year.

    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 (Administrative Core)

    Specific Aims:   Succinctly describe the strategies and goals for managing the Developing Center and connecting the Center to the broader field of Implementation Science in Cancer Control. 

    Research Strategy:  Describe the proposed Administrative Core explaining how it will serve to integrate the scientific and research capacity aims. Address the following: administrative functions, leadership for the center, clinical trials operations (where applicable), data management and statistical analysis, and dissemination activities.

    Describe plans for the Administrative Core to foster an environment of research excellence, support methodological innovation, facilitate multidisciplinary collaborations, build research capacity/investigators skills, coordinate efforts for the innovative pilot research studies, and monitor progress according to an overall focused research agenda across the center components.

    The Research Strategy must consist of the sub-sections A-E defined below:

    Subsection A: Operational Structure. Describe the plans for management and integration of Center activities and communication and evaluation of progress across the Center. Describe the leadership and communication strategies to manage and track progress of the multiple studies and sites that make up the Center. Include a description of the Center leadership structure and concisely describe oversight mechanisms that will be used by the Center PD(s)/PI(s). The application should describe an administrative structure that maximizes efficiency through program planning and monitoring, a capacity development and maintenance plan, opportunities for investigators to do integrative work, and plans for accountability for the entire center as well as accountability and collaboration across the network of ISCCCs.  If internal/external advisory groups are proposed, describe the expected/required expertise but do NOT list any names of potential members and do not contact potential members before the review.

    Subsection B: Implementation Science Outreach. Applications should address potential opportunities for growing the field of implementation science within their institutions and in collaboration with other Developing and Advanced Centers. The center should include established investigators in the areas chosen for research and provide opportunities for professional development for new and mid-level investigators. Centers that consist of multiple research sites should describe how they would take advantage of the professional development opportunities offered by such an arrangement. This could include having early stage investigators spend time at various settings or institutions. The direct support of training efforts (e.g., stipends) should be sought through NIH training and career development mechanisms. In addition, applicants should address the ways in which training opportunities will seek to reduce disparities in cancer prevention and control of traditionally underserved populations.

    Subsection C. Network Unit. The Network Unit is intended to work to connect between both Developing and Advanced Centers, to the broader implementation science field of researchers, and other core stakeholders. Using the headers indicated below, address the following aspects.

    Subsection D. Evaluation Unit: The Administrative Core should include a plan with dedicated personnel that describes how the activities of the center will be evaluated, including metrics for each of the core center functions, upon which center progress will be judged. Evaluation plans should reflect evaluation targets for the various activities within the center, and data collection and analysis methods across the project period.

    Subsection E. Timeline, Milestones, and Advisory Board:  A graphic Timeline and a descriptive Milestones section must be included in the Research Strategy section for the Administrative Core. Milestones should be identified along the timeline. Milestones should be well described, quantifiable, and scientifically justified benchmarks at critical junctures as well as annual indicators of progress. This section should also include alternative strategies should any component efforts fail to perform as expected. The timeline should include the establishment of a to-be-named advisory board to be convened annually to assess progress and accomplishments, and to advise the Center.  Advisory board members should only be identified and convened after an application is funded.  During the project period, the Center Director will be expected to refer to these milestones in annual progress reports

    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 address a Data Sharing Plan. Resource Sharing Plans should only be provided in the Overall component of the application.

    Appendix:

    Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Administrative Core)

    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, with the following additional instructions:

    Note for applications proposing clinical trials: do NOT enter study record here (all study records are to be included under Research Program component).

    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

    Research Program

    When preparing your application, use Component Type ‘Program.’

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

    SF424 (R&R) Cover (Research Program)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Research Program)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Research 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:  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) (Research 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 (Research Program)
    • 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.
    • Research Program is expected to be led by an individual(s) designated as PD(s)/PI(s) on the application.
    • 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 (Research Program)

    Budget forms appropriate for the specific component will be included in the application package.

    Outline requested budget for research studies and pilots planned over the course of the ISCCC. This budget request may include funding for equipment, software, and computing resources. It is expected that the Research Program should be the largest proportion of the budget for the Center. Funds for research supplies and equipment should not be duplicated in other parts of the budget.

    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 (Research Program)

    Specific Aims: Succinctly describe the goals of the Research Program. Explain how the Research Program will, through the Implementation Studies and Methods Units, contribute to the development and oversight of the implementation science pilot studies, methods and measurement studies, and other research activities of the ISCCC.

    Research Strategy:

    The Research Strategy must consist of Subsections A-C below:

    Subsection A. Research Program Overview.  This subsection should describe how the Research Program will develop and manage a set of scientific activities that will enhance knowledge on the center's emergent implementation science theme through studies conducted within the Center's Implementation Laboratory.  This description should summarize the initial research pilot studies, each of which should offer potential for future NIH applications, and how these studies will relate to and support one another as well as studies in other units. Applicants should describe how the Methods Unit and Implementation Studies Unit are integrated in the service of this Research Program and how the Research Program will relate to the Implementation Laboratory.

    Subsection B. Implementation Studies Unit. This subsection should address the following headings:

    • Initial Pilot Study. Describe one initial implementation study, intended to be conducted in the first two years of the study period, that advance the scientific theme of the Center.  This study is intended to be conducted within the Center's developing Implementation Laboratory and should be designed to provide preliminary data to guide the design of future more definitive investigations. The focus of this study should be directly linked to the focus of the Center and should have clear theoretical or conceptual bases and plans for integration of measures across studies. While the study (and subsequent studies over the full study period) is intended to be modest in scope, it should maximize innovative cross-disciplinary linkages within the center and exemplify high-risk /high-pay-off studies designed to advance innovative science are particularly encouraged. This study should be described in n the following sections: Significance, Approach, Innovation, Investigator, and Environment:
    • Significance: Describe overall goals and explain how the science proposed in the study will advance the state-of-the-art of the field. This section should also briefly explain the contribution of the study to the overall goals of the Developing Center, how the study will interact with and benefit from other components of the Center and the appropriateness of the center approach and environment. 
    • Innovation:  Describe the unique and innovative contributions that will be made by the research study. Explain how these contributions will synergize with the rest of the Center to achieve more than what could be achieved through an independent research study. Research study should propose novel, transdisciplinary, convergent solutions to challenging implementation science themes consistent with the overall goals of the Developing Center.
    • Approach: Research study proposed for the Developing Center should be designed to yield preliminary data of sufficient quality to guide the design of future, more definitive investigations centered on advancing implementation science in cancer control. The pilot implementation study might involve 1) observational research aimed at evaluating the impact of natural experiments occurring within the Implementation Laboratory, 2) observational research on the multi-level factors affecting adoption, implementation, adaptation, sustainment, or de-implementation of cancer control interventions, or 3) experimental and quasi-experimental trials testing innovative implementation strategies to optimize uptake of evidence-based interventions across the cancer continuum. To the extent possible, results of these pilots should also inform mechanistic understanding of implementation and other related processes and inform decisions about the next study to be conducted.
    • The content of the Implementation Study should be directly linked to the Center’s primary scientific theme and should show a clear rationale for why the study is innovative and can overcome current limitations in implementation science knowledge. It is expected that these studies will have highly innovative cross-disciplinary linkages and high-risk/high-pay-off components designed to address priority implementation science challenges in cancer control. Describe the feasibility of the proposed research study, the advantages of any new methodologies, potential pitfalls, and alternative approaches for the study and how these might impact on progress in the overall Center.  
    • Additional Innovative Study Ideas. Describe at least two additional innovative study concepts related to the center theme that will be of smaller scope than those included above and may be considered as vehicles for junior investigators with little research experience that may lead to R03, R34, R21, or R01 submissions by these investigators. How these studies will lead to further research and how they contribute to the overall focus of the Developing Center should be described in this application.
    • Process for Developing, Reviewing, Choosing and Managing Additional Studies. While the Implementation Studies Unit will initially focus on conducting the initial pilot studies described within the application, the Unit will be expected to continue to develop additional pilot studies throughout the funding period. This section should describe the process for developing, reviewing, choosing and managing additional pilots of two different scales.   

    Subsection C. Methods Unit. Using the headings provided, address the following aspects:

    • Strategies and Goals. Describe the scientific goals that the methods unit will pursue, who will ensure these goals will be met, and how the Unit will contribute to individual Research Studies and to attaining the Center's objectives. Describe how the Methods Unit will function as an incubator for innovative approaches to studying the implementation science priorities related to the Center's theme (e.g., identify opportunities to rapidly refine/optimize data acquisition methods; apply innovative approaches to study design, participant selection/engagement, ecologically valid assessment, and monitoring of study progress). Describe how the unit’s efforts will accelerate study of implementation efforts in clinical and community settings (e.g., improving analysis of natural experiments, maximizing power in multi-level implementation studies, and other approaches that can be used to seamlessly integrate research-supported strategies into routine practice). Describe how the Methods Unit will facilitate novel and convergent solutions to intractable methodological and measurement issues in implementation science by integrating input from implementation scientists, insights from key clinical and community stakeholders, and contributions from diverse experts in complementary fields, as relevant (e.g., behavioral and social science, health informatics, systems engineering, communications, economics, decision science, and/or data modeling).
    • Measurement and Methods Studies: One initial methodological or measurement development study must be described in this section with enough detail to allow appropriate peer-review of their significance and methodological soundness. For the purposes of this FOA and because of the funding limitations, such studies are not expected to be major research proposals but should be targeted to overcome ongoing measurement gaps and methodological challenges. The focus of this study should be directly linked to the focus of the center and should include plans for integration of measures and methodological advances within the center activities, as well as dissemination to the broader research community.  Innovative cross-disciplinary linkages and high-risk /high-pay-off studies designed to advance innovative science are particularly encouraged. This study should be described addressing: Significance, Innovation, Approach.
    • Significance:  Describe overall goals and the impact of the measurement and/or methods study proposed in relation to the state-of-the-art of the field.  This section should also explain the contribution of the study to the overall goals of the ISCCC, how the study will interact with and benefit from other components of the Center and the appropriateness of the center approach and environment. 
    • Innovation:  Describe the unique and innovative methodological contribution that will be made by the research study. Explain how this contribution will synergize with the rest of the Center to achieve more than what could be achieved through an independent research study. Methods studies should propose novel, transdisciplinary, convergent solutions to research design, measurement gaps, and analytical hurdles in implementation science consistent with the overall goals of the ISCCC.
    • Approach: Methods studies proposed for the ISCCC should be designed to yield valid and reliable measures for key implementation constructs or advances in design and analysis that will guide the design of future studies for implementation science in cancer control.  Describe the scientific approach to the study and how it will ensure the high-quality completion of the methods study. Describe where the methods study will take place and available resources to support its high-quality completion.
    • Development of Additional Methods and Measurement Studies: Detail how the Methods Unit will facilitate the development and design of additional ISCCC measurement and methods studies over the study period that address additional gaps in implementation science methods and measurement. Describe how these studies will lead to further research and how they contribute to the overall focus of the ISCCC.
    • Generate Innovative Research Methods and Chart Future Directions: Describe the Unit’s role in generating new measures and methodological advances that fill clear gaps in the field. Detail the Unit’s role in catalyzing, selecting, and rapidly implementing pilot studies proposed by Center collaborators, including trainees, junior faculty, and new investigators, during the 5-year project period. Describe strategies that will be used to monitor and incorporate emerging scientific, technological, methodological, and analytic innovations and to identify and engage new collaborators working in allied areas, such as adult learning, machine learning, artificial intelligence, bioinformatics, etc.
    • Operational Support to Implementation Pilot Studies: Describe how the Methods Unit will provide expert conceptual, methodological, technical, and analytic statistical support to the Center’s investigators for the proposed pilots as well as additional studies over the project period. Describe the facilities and resources that will be available for methodological support for the research studies of the Center, including (a) computing resources, (b) consultative expertise (e.g., study design, IS theory/framework development, measurement, qualitative and mixed methods approaches), and (c) centralized analysis and data management and integration services.
    • Dissemination of Methodological Advances and other Center-generated Resources: Describe how the Unit will function as a national consultation resource beyond the Center collaborations.  Detail the Unit’s role in facilitating the development and dissemination of measurement and methods resources. Address such aspects as:
    • New data collection/assessment approaches and analytic methods; 
    • Common data elements for use in a range of implementation studies;
    • Data sets that can be shared for re-analysis/meta-analysis; or
    • Other common-source materials (including new methods and analytic strategies for mining and analyzing ‘big data’ from Implementation Laboratory data collection efforts).

    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 address a Data Sharing Plan. Resource Sharing Plans should only be provided in the Overall component of the application.

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Research Program)

    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, with the following additional instructions:

    For any clinical trial proposed (including those involving Implementation Laboratory component) complete appropriate Study Record here.

    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

    Implementation Laboratory

    When preparing your application, use Component Type ‘Core.’

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

    SF424 (R&R) Cover (Implementation Laboratory)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Implementation Laboratory)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Implementation Laboratory)

    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.

    Project /Performance Site Location(s) (Implementation Laboratory)

    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 (Implementation Laboratory)

    ASSIST will default to “Project Lead”. If you would like to use a different category, then replace “Project Lead” below with a different Category (e.g., Core Lead).

    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.

    Implementation Laboratory is expected to be led by an individual(s) designated as PD(s)/PI(s) on the application.

    In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. These personnel may include proposed laboratory site(s) personnel that will be engaged in the proposed laboratory activities.

    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 (Implementation Laboratory)

    Budget forms appropriate for the specific component will be included in the application package.

    The budget for the implementation laboratory may include resources for the data management unit including development or amendment of existing technical and data infrastructure across the laboratory sites. With the exception of data analytic support and equipment, the budget should not duplicate other Center expenses.  

    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 (Implementation Laboratory)

    Specific Aims: Succinctly describe the composition and characteristics of the Implementation Laboratory.  Explain how the Implementation Laboratory will be able to host a variety of innovative and priority implementation studies over the course of the study period that will contribute to the advancement of implementation science in cancer control broadly and to attaining ISCCC objectives.

    Research Strategy: The Research Strategy must consist of subsection A-D defined below.

    Subsection A. Implementation Laboratory Overview and Leadership. Describe how the component will develop, facilitate, administer, coordinate, and cultivate an implementation laboratory.  The scope of the laboratory should enable and serve as the context for the research theme and implementation research questions of the research program.  The laboratory is not restricted to a specific geographic area, but the infrastructure, engagement, and partnership must demonstrate the resources and capacity to be a sustainable laboratory that is a part of the center research during the duration of the grant and at minimum 1 year after the grant’s completion.  Describe the leadership structure for the laboratory, including personnel from both academic and laboratory member sites that will oversee and support the laboratory activities.

    Subsection B. Implementation Laboratory Membership. Describe how the implementation laboratory will be established as a partnership with laboratory partners and components which could include, but are not limited to oncology, primary care or community settings (e.g., public health departments, churches, schools) or some combination of them, and will feature use of common data to study implementation, experience in conducting health care and public health practice research, priority areas for implementation science, and buy-in from clinical or community leaders. However, given the natural evolution of organization change that may occur, if components of the laboratory, including participating organizations, are required to change due to unforeseen circumstances, the centers should have an articulated plan for how to address these changes and maintain the capacity to continue the work expected as part of the Research Program. Experience, capacity, and staffing within the implementation laboratory sites in implementing and or delivering evidence-based interventions should also be described, as well as articulated priorities by the participating organizations/entities within the laboratory for specific implementation science topics linked to the ISCCC theme.

    Subsection C. Data Management Unit. Describe processes for coordination with the ISCCC core investigators to support data collection, IRB activities, and data safety and monitoring.  Areas to be addressed within this subsection may include:

    • Formation of a data management unit that would coordinate the data sharing and analysis activities across the laboratory
    • Systems for data sharing across the laboratory, which could include, but are not limited to common EHR systems (or interoperable systems), history of secure data exchange across laboratory sites and stakeholders.
    • Communication plan for continuous feedback between Laboratory membership and Center investigators on issues related to data privacy, security, and monitoring.

    Subsection D. Practice Surveillance Unit.  Describe plan for how ongoing implementation activities will be monitored to inform ISCCC studies.  This requires the use of available data to identify baseline cancer control intervention implementation, priorities for implementation studies, and progress made over time. Describe existing data resources within laboratory sites to capture contextual information critical to implementation science, as well as gaps with plans for how improved capacity for data collection will occur over time.

    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 address a Data Sharing Plan. Resource Sharing Plans should only be provided in the Overall component of the application.

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

    PHS Human Subjects and Clinical Trials Information (Implementation Laboratory)

    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, with the following additional instructions:

    Note for applications proposing clinical trials: do NOT enter study record here (all study records are to be included under Research Program component).

    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

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

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

    For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    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 and responsiveness by the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    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.

    Section V. Application Review Information
    1. Criteria

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

    For this FOA, note the following:

    Reviewers will provide an overall impact score for the entire Developing Center application. In addition, assigned reviewers will provide individual "criterion scores" for the Overall criteria but not for the other components.

    All other components of the Developing Center (i.e., Administrative Core, Research Program, and Implementation laboratory) will be evaluated but each will receive only one overall adjectival (not numerical) rating.

    In addition, for applications involving clinical trials:

    A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Developing Center 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 Developing Center proposed).

    Scored Review Criteria - Overall

    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 center that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the center address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the center 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?   

    How compelling is the justification for the Center’s focus and the overall significance of the program of research in terms of:

    • the potential benefits of the Center's research for cancer control through implementation science (e.g., the number of affected individuals, the associated severity of inadequate access or quality to evidence-based cancer control interventions, and/or overall burden associated with unmet cancer needs);
    • the implementation science questions that will be studied, including the potential for substantial knowledge gain on adoption, implementation, sustainment, adaptation, or de-implementation of cancer control interventions beyond existing approaches;
    • the potential reach and overall benefits of embedding research in the target clinical and/or community practice settings that comprise the Implementation Laboratory; 
    • the anticipated dissemination, adoption and sustained use of new methods and measurement and their impact on the broader field; and

    In addition, for applications involving clinical trials

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Developing Center? 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? 

    How well does the proposed PD/PI(s) record of leadership in the area of science and the Director's record of scientific achievements support their ability to lead the Center?  To what extent does the PD/PI(s) have a proven record that demonstrates his/her ability to organize, direct, and administer complex studies, as well as past participation in collaborative scientific activities? 

    Is (are) the proposed Center Investigator(s) at the forefront in the proposed scientific area; to what extent do the Research Project Leaders bring complementary and integrated expertise to the overall Center? 

    To what extent do the Center Investigators have demonstrated competence in the area of science and do they have a record of interacting and working well with other investigators at their institution and elsewhere? 

    In addition, for applications involving clinical trials

    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

    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, for applications involving clinical trials

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?  Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the Center 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?   

    How compelling is the justification for an interdisciplinary Center approach as necessary and suitable for the proposed work?  How likely is it that an integrated Center approach will add significantly to what could be accomplished through other modes of research support?  To what extent will synergy between Center components contribute to the overall Center objectives? 

    How will the proposed research designs maximize the reliability and replicability of the findings? 

    What is the quality level of the plans for managing the Center's research and administration, fostering synergy, ensuring appropriate prioritization of research, needed course corrections and problem identification and resolution, and effective sharing of resources?  How likely are these plans to contribute to the effective, productive management of the Center as a whole? How will the organizational structure facilitate coordination and integration of Center activities and progress?

    To what extent does the overall approach where relevant take into account the perspective of relevant stakeholders/end-users and key characteristics of the settings that will implement cancer control interventions in order to ensure that the implementation strategies are feasible and scalable and to ensure that the research results will have utility for end users? 

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable?

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

    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 project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

    In addition, for applications involving clinical trials

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

    Additional Review Criteria - Overall

    As applicable for the Center 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.

     Study Timeline

    Specific to applications proposing clinical trials

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Individuals Across the Lifespan  

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

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations - Overall

    As applicable for the center 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.

    Applications from Foreign Organizations

    Not Applicable.

    Select Agent Research

    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).

    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 .


    Authentication of Key Biological and/or Chemical Resources

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    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.

    Review Criteria for Administrative Core

    Reviewers will provide only one overall adjectival impact rating for the Administrative Core (criterion scoring is not used for this component). Reviewers will consider the following aspects while determining scientific and technical merit of this component:

    How strong are the organizational structure, communication and support for early career investigators in terms of their quality and potential effectiveness?  How will the plans for developing new professional development opportunities and integrating them with ongoing opportunities at the participating institution(s) benefit early career investigators?   

    How likely is it that the specific strategies that are proposed will promote cross-fertilization of ideas and facilitate new investigators’ exposure to potential consultants and collaborators (e.g., in-house lecture series, webinars, visiting scholar series, meetings with potential practice partners from new community settings)?

    How strong are the plans for coordinating the evaluation of the Center’s research activities and public health impact?  To what extent will the evaluation plan be useful for iteratively refining the Center’s ongoing activities and informing plans for future collaborative research?

    How strong are the plans for operational structure and the network unit in creating opportunities for collaboration of investigators across the ISCCC?

    How effective are the dissemination plans and the potential to reach a broad and diverse audience and increase science literacy? How adequate are the plans for sharing research resources (e.g., new methods and measures, common data elements, data analytic strategies, de-identified data collected in research studies, etc.) with the scientific community?

    How practical are the timeline and descriptive milestones proposed in achieving the applicants' Center research goals and consistency with the research theme? Does the timeline include an appropriate advisory board and means for coordination of milestone across Research Program and Implementation Laboratory activities?

    Review Criteria - Research Program

    Reviewers will provide only one overall adjectival impact rating for the entire Research Program (criterion scoring is not used for this component). Reviewers will consider the following aspects while determining scientific and technical merit of this component:

    Implementation Studies Unit

    How do the studies detailed in the Unit complement and contribute to the Center as a whole?

    How well are the studies integrated with the scientific objectives and implementation science theme of the Center?

    How qualified are the study leaders; are the study leaders at the forefront of the area of implementation science proposed or if early career investigators do they have the necessary support to maximize project feasibility? 

    To what extent are the studies original and innovative, and break new ground in implementation science? 

    How well does the application articulate a process for developing and executing additional implementation studies? 

    Evaluate the appropriateness and quality of the conceptual design, methods, and analyses to achieve the research objectives as consistent with the center theme.

    How likely is it that the studies will yield preliminary data of sufficient scope and quality to guide the design of future, more definitive studies and/or the development of future research applications consistent with the Center’s research focus? 

    Methods Unit

    To what extent will the qualifications, past performance (if applicable), and time commitments of the Methods Unit Leader(s) contribute to the likely success of the Center?  Evaluate the appropriateness of the expertise for carrying out the functions proposed for the unit.

    To what extent will the Methods Unit:

    Facilitate development and design of the Center’s methods pilots and how will it identify and apply scientific, technological, and methodological innovations and tools to facilitate both the research enterprise and accelerate implementation science in clinical and community settings?

    Provide expert conceptual, methodological, technical, and analytic statistical support to the Center’s investigators?

    Offer facilities and resources that are appropriate and optimal for supporting the pilot implementation studies, given the goals of the Center?

    Help generate research methods and future directions, including pilot feasibility studies of 1-2 years duration proposed by center collaborators?

    Monitor and incorporate emerging scientific, technological, methodological, and analytic innovations and identify and engage new collaborators working in allied areas?

    Function as a national consultation resource beyond the Center collaborations in order to disseminate methodological advances and other Center-generated resources?

    Review Criteria - Implementation Laboratory

    Reviewers will provide only one overall adjectival impact rating for the Implementation Laboratory (criterion scoring is not used for this component). Reviewers will consider the following aspects while determining scientific and technical merit of this component:

    To what extent will the qualifications, past performance (if applicable), and time commitments of the Implementation Laboratory Leader(s) contribute to the likely success of the Center?  Evaluate the appropriateness of the expertise for carrying out the functions proposed for the unit.

    To what extent will the Implementation Laboratory:

    • Facilitate delivery, data collection and participation of laboratory sites in research studies proposed in the Center Research Program?
    • Demonstrate a research partnership between the Center and the Implementation laboratory sites, including an organizational infrastructure of IRB review, organizational communication, decision making and dissemination.
    • Provide infrastructure to support research studies for the duration proposed by center collaborators, including data collection, recruitment, common data elements (and one year after the funding ends)?
    • Detail a plan for membership of implementation laboratory sites and a plan for addressing changes in membership to maintain the capacity of the laboratory to continue work expected as part of the Research Program?
    • Detail a plan and infrastructure for the data management unit across the laboratory sites to coordinate data sharing, analysis and communication of findings across laboratory membership and center investigators.
    • Detail a process and infrastructure of monitoring research studies conducted within the implementation laboratory to inform Center and ISCCC studies.
    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the 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 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.  
    3. Anticipated Announcement and Award Dates

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

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

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

    Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. 

    ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all 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.  Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).    

    Prior Approval of Pilot Studies

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

    2. Administrative and National Policy Requirements

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

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    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.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

    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 RPPR, 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. 

    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.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, 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 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

    Scientific/Research Contact(s)

    For inquiries related to themes in cancer control:

    April Oh, Ph.D., M.P.H.
    National Cancer Institute (NCI)
    Telephone: 240-276-670
    Email: ohay@mail.nih.gov

    For inquiries related to implementation science:

    Cynthia Vinson, Ph.D., M.P.A.
    National Cancer Institute (NCI)
    Telephone: 240-276-6745
    Email: cvinson@mail.nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

    Crystal Wolfrey
    National Cancer Institute (NCI)
    Telephone: 240-276-6277
    Email: wolfreyc@mail.nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

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

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