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

Multilevel Interventions in Cancer Care Delivery: Building from the Problem of Follow-up to Abnormal Screening Tests (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices
  • February 17, 2016 - Notice of Change in Key Dates for PAR-15-108. See Notice NOT-CA-16-023.
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

PAR-15-108

Companion Funding Opportunity

None

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

93.394, 93.395 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications that strengthen the science of multilevel effects of cancer care interventions by addressing the problem of incomplete follow-up to abnormal screening tests for breast, colorectal, cervical and lung cancers.

The goals of this FOA are two-fold. First, this FOA seeks to advance the science of multilevel interventions in three ways: a) by establishing a common conceptualization of levels and the associated level-specific factors that affect practice; b) by standardizing metrics of the levels and their main effects on other levels and the individuals needing follow-up care; and c) by developing and standardizing the analysis of the effect of interventions on the individuals, groups, and organizations responsible for intervention implementation. Second, this FOA encourages applications that test interventions to improve the follow-up of abnormal screening in one or more ways, including: a) measuring multilevel effects of single-level interventions; b) comparing single vs. multilevel interventions; and c) testing multilevel interventions.

Key Dates
Posted Date

January 30, 2015

Open Date (Earliest Submission Date)

March 9, 2015

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

April 9, 2015; November 25, 2015; May 26, 2016; September 21, 2016; May 26, 2017; September 21, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates .

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June/July 2015; March/April 2016; September/October 2016; January/February 2017; September/October 2017; January/February 2018

Advisory Council Review

New Dates October 2015; May 2016; January 2017; May 2017; January 2018; May 2018 per issuance of NOT-CA-16-023.

October 2015; May 2016; October 2016; January 2017; October 2017; May 2018

Earliest Start Date

December  2015; July 2016; April 2017; July 2017; April 2018; July 2018

Expiration Date

September 22, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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

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

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

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


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

This Funding Opportunity Announcement (FOA) seeks applications that strengthen the science of multilevel effects of cancer care interventions by addressing the problem of incomplete follow-up to abnormal screening tests for breast, colorectal, cervical and lung cancers.

The goals of this FOA are two-fold. First, this FOA seeks to advance the science of multilevel interventions in three ways: a) by establishing a common conceptualization of levels and the associated level-specific factors that affect practice; b) by standardizing metrics of the levels and their main effects on other levels and the individuals needing follow-up care; and c) by developing and standardizing the analysis of the effect of interventions on the individuals, groups, and organizations responsible for intervention implementation. Second, this FOA encourages applications that test interventions to improve the follow-up of abnormal screening in one or more ways, including: a) measuring multilevel effects of single-level interventions; b) comparing single vs. multilevel interventions; and c) testing multilevel interventions.

Background

One of the major impediments to health care quality improvement identified by the Institute of Medicine in its 2013 report, "Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis," is the challenge of care at the transitions between types of care, such as between screening and diagnosis, as well as the lack of common quality metrics.

Intervention is defined as a specified strategy or set of strategies designed to change the behavior of individuals, groups, or organizations, to improve cancer care outcomes for patients.  In this case, the intervention is intended  to improve the follow-up of an abnormal screening test, and therefore facilitate treatment.

Multilevel effect of interventions refers to the impact of an intervention on the individuals, groups, and organizations through which and to which it is delivered. The goal of the intervention is to increase the proportion of individuals with completed evaluations among those with abnormal screening tests. Interventions, however, have an effect on the groups and organizations where they are implemented. Individuals in those groups and organizations must adapt roles, teams must distribute new responsibilities, and organizations may need to change their structure or systems to accommodate interventions in practice. Interventions, therefore, have bidirectional effects:  the providers and organizations implementing the intervention have an effect on the individuals seeking care, and the implementation of the intervention has an effect on the providers and organizations.

The challenge is to recognize these bidirectional effects and the interactions among all those who will be affected such as:

1) individuals seeking care;

2) groups of caregivers and family members;

3) health care organizations;

4) communities;

5) states; and,

6) the nation.

Follow-up of an abnormality is the process of additional testing that is needed to clarify whether the screening test was abnormal because of the cancer of interest or a benign condition. The follow-up process offers many opportunities for interventions to improve the likelihood that follow-up will be complete.

Value of evidence-based screening: Regular, evidence-based screening has been associated with decreased mortality in breast, colorectal, and cervical cancers in the general population and lung cancer in high-risk individuals. Through the treatment of cancer precursors, screening is also associated with decreased incidence of cervical and colorectal cancers. As a result of this evidence, the United States Preventive Services Task Force recommends screening for all four cancers in the appropriate populations. Over the past decade, screening rates have risen. In 2010, 72%, 83%, and 58.6% of the eligible population were current with the recommended screening for breast, cervical, and colorectal cancers, respectively. Screening has just begun for lung cancer in people with a 33 pack/ year history.  However, screening is a process that includes follow-up in order to diagnose cancer among the approximately 10% of screened individuals with an abnormality. Achieving screening rates will only reduce mortality if follow-up of abnormal tests also occurs.

Importance of follow-ups: Although there are no national estimates of the proportion of individuals without follow-up after receiving abnormal screening tests, several reviews of studies in specific populations suggest the rates of incomplete follow-up are high and vary substantially. Failure to follow-up after an abnormal screening test is a problem that limits the effectiveness of cancer screening in general but also perpetuates health disparities. Work is needed to increase the completion of additional evaluations after abnormal screenings in order to achieve the potential mortality reduction of cancer screening and optimize the nation's investment in the delivery of screening tests.

Evaluation of screening abnormalities: As the Affordable Care Act (ACA) changes care incentives and care organizations in the United States, the question of how to ensure that screening abnormalities are evaluated is particularly timely. The ACA has been accompanied by incentives to increase the adoption of electronic medical records. As a result of these incentives, electronic medical record use has nearly doubled to 40% since 2009. The development of information technology and the implementation of electronic health records are expected to provide tools that may solve the problem of failure in follow-up of screening. Unfortunately, the studies of practices with electronic health record systems in place revealed that records were not consulted and contained incorrect data. More research is needed to understand how to address the human factors that influence follow-up of screening and take advantage of the electronic medical records now being integrated into medical practice.

Identification of patient barriers: Although research has commonly focused on the identification of patient barriers to follow-up after an abnormal screening, relevant work has extended beyond patient-level barriers. Factors at the patient level that are associated with completion of follow-up include ethnicity, younger age, higher education, raised risk perception, having insurance coverage, reduced fear and higher coping skills, knowledge of the testing, beliefs about cancer, perception of staff trustworthiness, and logistical issues such as transportation and availability of child care. Provider factors at the individual level are also associated with completion of follow-up and include board certification, years in practice, knowledge of guidelines, communication skills, failure to see and respond to results, and gender.  Factors at the organizational level include hours of operation, patient waiting time to have the test, presence of onsite specialists, and information systems.

Multilevel ecological model of health: A complex set of individual, group, and organizational factors interact with each other and have been recognized as a multilevel ecological model of health. Increased knowledge of such a multilevel model may have implications for other points in the care process where critical transitions occur. For example, findings from investigations of care failures during the transition from screening to diagnosis may inform the understanding of transitions from oncologic centers to primary care after cancer treatment is complete, or when individuals with cancer develop advanced cancer states.

Need for policy in screening interventions: Policy makers, researchers and clinicians have recognized the need for multilevel consideration of interventions in screening and follow-up for more than a decade, yet few such studies have been conducted and reported. Follow-up to abnormal screening has been recognized as being affected by the individuals, providers, and organizations involved for more than 20 years. Despite this recognition, a multilevel analytic approach to intervening has not been widely applied. Such an approach is limited by the availability of relevant metrics and the complexity of intervening. There is also a need to recognize the bidirectional effects of levels. Given the science base for multilevel interventions growing, now is the time to conceptualize, analyze and test multilevel effects.

Delivery of screening interventions: Most intervention studies to date have addressed the individual in need of follow-up to a test; but such interventions have implications for the providers delivering the intervention and the organizations in which the intervention needs to be implemented. Individually directed patient educational interventions, including navigation, use of specifically designed materials, counseling and motivational interviewing by telephone or in-person, transportation assistance, and case management, have all been shown to improve follow-up. Navigation by a nurse, social worker or lay personnel has been the most widely tested approach and has gained some success. However, navigation studies continue to be focused on addressing the individual in need of follow-up, and there is one recent randomized trial showing no effect with such an approach.

Scope of the FOA and Specific Requirements

The scope of this FOA is to support the development and testing of multilevel interventions that strive to improve completion of diagnostic evaluation and reporting of results to the patient after an abnormal breast, colorectal, cervical cancer or lung cancer screening test. Special emphasis is placed on multilevel interventions that anticipate the need to understand and change the context of an intervention during the efficacy phase of testing, in order to facilitate subsequent dissemination of proven interventions. Interventions need to be considered and effects must therefore be measured at multiple levels, even if they are primarily directed at one.   In addition, interventions should be designed to maximize the likelihood that they can be implemented broadly, if demonstrated to be beneficial in improving follow-up to abnormal screening.  The collection of pilot information on how the intervention can be implemented (e.g. training protocols, quality assurance, outcomes assessment procedures) is encouraged.  NCI will work with investigators to establish standardized and/or complementary measures of effect at the organizational, provider team, and patient levels. As new projects are funded, NCI will coordinate efforts among the sites to identify common measures or metrics for outcomes and to identify potential moderators and mediators of these outcomes.

Randomized trials are preferred, but other designs (e.g., factorial, quasi-experiments, natural experiments, interrupted time-series designs) that assess intervention effects with comparable individuals, teams, organizations, and across settings that do not receive the intervention will also be considered. Because interventions have cost consequences, we also emphasize consideration of comparative studies that assess the effectiveness and cost-effectiveness of alternative approaches.

Examples of individual research projects that compare intervention effects and would be considered appropriate to this FOA include but are not limited to the following:

  • A single-level intervention (e.g.?) directed at the provider team but measuring effects of the intervention at the patient, provider, and organizational levels;
  • A multilevel intervention (e.g.) directed at the patient and provider but measuring effects and influences at all three levels; or
  • A multilevel intervention to test behavioral interventions that improve follow-up to abnormal screening tests for breast, colorectal, and cervical cancers. Of particular interest are studies that focus on the three critical levels of the context of care over which health providers and their organizations have some immediate influence: 1) the individual in need of follow-up, 2) the provider team, and 3) the organization.
  • A comparison of the effectiveness of navigators to the incorporation of navigation functions into the practice team. Such a study might consider the effects of navigation on the referring provider team vs the effects of the navigator roles and functions within the provider team and might also consider a cost-effectiveness component.
  • Assessment of electronic medical record systems that facilitate follow-up and link providers referring and/or conducting screening to organizations with providers doing the diagnostic work. Such studies would also consider how to optimize electronic medical records to support the needed functions of the referring and receiving teams, and how to measure the organizational and provider factors affecting the linkage as well as its effects on follow-up completion.
  • Team training and facilitation that would encourage practice reorganization and the development of the communication between the referring organization and the organization doing the diagnostic evaluation. This work would evaluate team functioning and the relationship between that functioning and individual-level patient outcomes.

Any of the above studies are encouraged to compare interventions and effects in low vs. high settings to explore differences due to resources available. Elaboration of the details that make the settings and implementation different are also encouraged.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Resubmission

Revision

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are expected to differ, reflecting the actual needs of the proposed projects. It is anticipated and encouraged, however, that most requests be in the range of $450,000 to $500,000 direct costs per year commensurate with the scope and complexity of the proposed projects. Larger budgets may be requested but no request may exceed $750,000 in direct costs per year.

Award Project Period

The total project period may not exceed 4 years. 

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

Multiple PD/PI applications could have different responsibilities with respect to one or more of the following functions: 1) analysis and metrics, 2) medical care interventions and 3) behavioral interventions.

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).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.  The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.
Section IV. Application and Submission Information
1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions 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:

Stephen Hunt Taplin, MD MPH
National Cancer Institute (NCI)
Telephone: 240-276-6947
Email: taplins@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.  Sites should have a history of successful transdisciplinary and multidisciplinary collaboration

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Key personnel should have expertise in measurement and analysis relevant to their multilevel framework and intervention plan (e.g. individuals, groups, organizations and/or communities).  Key personnel should also have a demonstrated successful record of multi-center and multidisciplinary scientific collaboration. Investigators with a record of transdisciplinary collaboration are encouraged.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. In addition, applicants should budget for the full costs of covering expenses of an annual meeting (to be held in the Washington, DC, area). All applicants should also budget funds in the out years for cross-validation studies of targets identified by other funded investigators and NCI scientific staff.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: All proposed approaches should include:

  • A strong multilevel conceptual framework that motivates their intervention and allows the investigators to propose and test how the effects are moderated and mediated
  • Measurement of relevant characteristics of the levels of the proposed multilevel framework at baseline and relevant times over the course of the intervention.
  • Measurement of the bi-directional effects of the intervention and the context in which it is used in at least three levels (the patient, the provider group, and the organization where care is delivered).
  • Documentation of four endpoints: 1) initiation of the diagnostic evaluation, 2) completion of the diagnostic evaluation, 3) report of results to the referring provider, and 4) report of results to the patient with the abnormal screening test. 
  • Plans for how they will work with other investigators to develop a standardized set of measures and analytic approaches for organizational, team, and individual-level effects that can then be the basis for standardizing measures and analyses of multilevel effects.  
  • Acknowledgement that measures and approaches will be expected to be validated, shared and adapted as new investigative groups join this effort.

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 submitted for the January 25, 2015 due date or after are expected to comply with the NIH Genomic Data Sharing Policy as detailed in NOT-OD-14-111, as applicable.

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

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

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.

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project 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?  

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

Specific for this FOA: Do the PD(s)/PI(s) have the expertise to identify useful and valid multilevel measures? Do the investigators have a plan for collaboration and the sharing of metrics? Does the application convey the importance and clarity of the conceptualization of multilevel effects? Will the proposed science contribute to developing the science of multilevel interventions? Do the investigators have a record of successful collaborative work?

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?

Specific for this FOA: Does the application propose new and/or dominant validated approaches to measuring organizational, provider group, family group, or individual factors that influence and are affected by processes that facilitate or inhibit follow-up to abnormal screening tests?  Is the intervention addressing the problem of follow-up to abnormal cancer screening in new ways? Does the application propose new and/or dominant validated approaches to measuring effects of interventions on providers and those responsible for implementation? Will the proposed research provide new insights into multilevel effects and interventions?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

Specific for this FOA: Is there useful and thorough conceptualization of multilevel effects? Do the intervention and analysis apply concepts from the conceptualization? How likely is the intervention to be adopted in practice? 

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

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?    

Specific for this FOA: Does the environment encourage conceptualization and testing of multilevel effects?  Does the environment have a history of considering and analyzing multilevel effects on health care?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
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

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

Section VI. Award Administration Information
1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies. 

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

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

The PD(s)/PI(s) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under this program. The PD(s)/PI(s) assume responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research supported by the U01 award. Specific responsibilities and rights include:

  • The PD(s)/PI(s) for each U01 award will also have the responsibility for working with NCI scientific staff to define measures of levels and collaborate with other investigators to establish core measures, pursue the objective  of developing multilevel science, conduct specific studies, analyze and interpret research data, and prepare publications for their projects while recognizing the need to contribute across projects; Budgets should include appropriate statistical expertise and express willingness to work with other teams, and a plan for how they would do that if they were identified as the statistical lead for the effort.
  • Representatives of each U01 award will be expected to work with the NCI Project Scientist on the coordination of intra-program activities and the scientific integration of individual projects with respect to measures of effects, and standardization of analyses. These actions may involve (but will not be limited to) the participation in the appropriate coordinating meetings and/or working groups, and/or teleconferences as needed; working with other investigators to conceptualize levels and level-specific measures that characterize the levels, and document effects of interventions.
  • In addition to providing standard annual progress reports (see Section VI.3. Reporting), each U01 awardee will be responsible for providing other relevant information to the NCI Project Scientist, and coordinate and cooperate with the NCI Program staff; as new investigators join the project existing investigators will be expected to share and adapt measures as needed and guided by the scientific efforts.
  • Ensuring and overseeing the sharing of results, resources, and methods with NCI Program staff, and with other FOA awardees as appropriate and consistent with achieving the goals of the program.
  • Developing and sharing analytic techniques that advance the science of multilevel interventions

Awardees will be expected to work together within and across the applications to develop and implement common, uniform standard operating procedures and technical formats for depositing data into public databases.

Each U01 awardee will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies, though they will be expected to develop validated core metrics that are standardized across projects.

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

A designated NCI Program Staff member, acting as a Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.

Specifically, the NCI Project Scientists will:

  • Work with a lead PI to coordinate and facilitate the interactions among all the U01 awardees under this initiative;
  • Work closely with investigators and lead PI to coordinate and facilitate interactions/collaborations among the U01 awardees;
  • Serve as liaison between awardees and investigators involved to facilitate interactions and scientific integration among the U01 awardees;
  • Review of all major collaborations that the awardee might propose with research groups outside the awardee institution and advise on their appropriateness before implementation to assure consistency with the goals of this FOA;
  • Provide technical assistance and advice to the awardees as appropriate;
  • Assist in avoiding unwarranted duplication of effort with other NCI efforts;
  • Monitor institutional commitments and resources to the awardees;
  • Suggest reprogramming efforts, including options to modify projects/programs when certain objectives of this FOA are not met -- specifically, the NCI Project Scientist may recommend withholding of support, suspension, or termination of a U01 award for lack of adherence to required policies and/or procedures;
  • Work with a lead PI to develop working groups and trans-project efforts as needed;
  • Monitoring progress and direction of awardees and working groups as needed; and
  • Organize and conduct regular meetings to share progress either by teleconference, videoconference, or face-to-face, as needed between the awardees and between awardees and NCI staff.

Areas of Joint Responsibility include:

The NCI Project Scientist and the PD/PIs of the U01 awards funded under the FOA will be jointly responsible for the coordination of intra-program activities and the scientific integration of individual projects with other appropriate NCI consortia.  A lead PI will be identified from among successful applicants to work with the NCI Project Scientist. That lead PI will rotate on no more than a yearly basis. Choice of the lead PI will be made based on demonstrated leadership, scientific rigor, and the ability to collaborate.  Suggestions will be sought from among the PIs but final choice will rest with the NCI project scientist.

The NCI Project Scientist will initiate the formation of a Coordinating Group, if needed, and will facilitate its activities. A Coordinating Group will include senior representatives of each U01 project, the lead PI, the NCI Project Scientist, and other NCI staff members as appropriate. Meetings of the Coordinating Group may be virtual or by teleconference. One meeting/year will occur in person as noted above, and budgeting for that meeting should be included in the submissions.

Dispute Resolution:

Every effort will be made to air scientific differences in a constructive and open way to achieve consensus on measures, analytic approaches, and science. Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution, when they cannot be resolve satisfactorily within the structure of the cooperative agreement. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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 progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Stephen Hunt Taplin, MD, MPH
National Cancer Institute (NCI)
Telephone: 240-276-6947
Email: taplins@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: hines@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 Parts 74 and 92.

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