National Institutes of Health (NIH)
National Cancer Institute (NCI)
U01 Research Project Cooperative Agreements
- NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
- September 28, 2022 - Notice of Change to PAR-22-161, "Cancer Epidemiology Cohorts: Building the Next Generation of Research Cohorts (U01 Clinical Trial Not Allowed) . See Notice NOT-CA-22-133
- NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
- April 19, 2022 - Notice of Pre-application Webinar for NCI Funding Opportunity Announcements for Cancer Epidemiology Cohorts (PAR-22-161, PAR-22-162). See Notice NOT-CA-22-081.
Through this funding opportunity announcement, the National Cancer Institute (NCI) solicits applications to Cancer Epidemiology Cohorts: Building the Next Generation of Research Cohorts PAR. This funding opportunity announcement seeks to support initiating and building the next generation of population-based cancer epidemiology cohorts to address specific knowledge gaps in cancer etiology and survivorship. Specifically, it will support methodological work necessary to initiate and build cancer epidemiology cohorts that can address critical scientific gaps concerning (i) new or unique exposures in relation to cancer risks and outcomes and (ii) achievement of diverse populations in cohorts with the inclusion of understudied populations (e.g., racial/ethnic groups, rural populations, individuals living in persistent poverty areas, and others) with substantial community engagement.
Optional
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| July 29, 2022 | Not Applicable | Not Applicable | November 2022 | January 2023 | April 2023 |
| February 28, 2023 | February 28, 2023 | Not Applicable | July 2023 | October 2023 | December 2023 |
| July 28, 2023 | July 28, 2023 | Not Applicable | November 2023 | January 2024 | April 2024 |
| February 28, 2024 | February 28, 2024 | Not Applicable | July 2024 | October 2024 | December 2024 |
| July 29, 2024 | July 29, 2024 | Not Applicable | November 2024 | January 2025 | April 2025 |
| February 28, 2025 | February 28, 2025 | Not Applicable | July 2025 | October 2025 | December 2025 |
All applications are due by 5:00 PM local time of applicant organization.
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.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
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.
- Use the NIH ASSIST system to prepare, submit and track your application online.
- 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.
- Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
Purpose
This funding opportunity announcement (FOA) aims to support the initiation and building of the next generation of population-based cancer epidemiology cohorts to address scientific knowledge gaps in cancer etiology and cancer survivorship across various populations, including underserved and understudied populations. It aims to enable prospective cancer epidemiologic research that can identify environmental, genomic, lifestyle, clinical, socio-cultural determinants, and other factors that affect cancer risk (e.g., incidence) and survivor-related outcomes (e.g., morbidity, mortality, recurrence, secondary cancer, and quality of life). Proposed research cohorts should: (i) complement current existing cohorts and address resource and scientific gaps; (ii) enable prospective investigations of new scientific questions; and (iii) foster incorporation and adaptation of new technologies and approaches to achieve goals and objectives. Specifically, applicants should propose aims that lay the foundation and structure for new sustainable cancer epidemiology cohorts and outline science-driven goals, propose methodological work relevant to the goals, and incorporate hypothesis-driven short-term research question(s) with specific milestones achievable within the 5-year grant period.
Key Definitions for this FOA
Cancer Epidemiology Cohort: An observational population study in which a group of people with a set of characteristics or exposures are prospectively followed over time. Etiology cohorts are followed for the incidence of new cancers. Survivor cohorts follow cancer survivors for cancer-related outcomes. Prospective cohort studies recruit participants and assess exposures before the development of the outcomes of interest (i.e., cancer outcomes).
Understudied populations: Understudied populations are defined as a specific group who may or may not be medically underserved or socially disadvantaged but whose data on cancer health risks and outcomes are currently limited and thus insufficient to inform evidence-based cancer control, prevention, and intervention guidelines. The dearth of research and information for these groups underscores the urgency to improve our available data and knowledge regarding cancer risks and outcomes within these understudied populations.
Underserved: NIH-designated health disparity populations and/or other groups known to experience barriers to accessing health coverage and basic health care services. A full description can be found at https://www.nimhd.nih.gov/about/overview/.
Community partners: Community partners should represent the population being recruited for the study. Partners may be representatives of advocacy groups, community centers, support, or research organizations; community or religious leaders; liaisons to racial/ethnic groups (e.g., Latino, Asian American, Native American, or African American populations); community health workers, etc.
Background
The United States (U.S.) is rapidly evolving with a changing environmental and demographic landscape that will differ from the one of previous decades. Climate change, air and light pollution, chemicals, novel behavioral factors (e.g., screen-time, cannabis use), new treatment/medications, and sociocultural-related factors present a few examples selected to illustrate a different environmental landscape from previous decades. Likewise, cancer survivors are living longer, due in part to advances in detection and treatment, but may face physical, mental, social, and financial toxicities resulting from their care. Moreover, the U.S. is becoming more demographically diverse. The 2020 US Census results showed escalating growth for non-white groups such as Asians and Hispanics when compared to the previous decade. Collectively, this changing landscape will impact cancer-related burden which, in turn, will have significant future implications and challenges on cancer control and prevention. The ensuing challenges will require innovative research buttressed by appropriate resources to meet the changing needs of an evolving multi-racial/ethnic nation.
Prospective cohort study design is an optimal scientific method for assessing the effects of suspected risk factors in human populations. It serves a critical role in illuminating the etiologic role of environmental, lifestyle, and genetic determinants for cancer-related risk and outcomes. As such, cancer epidemiology cohorts are fundamental to cancer control and prevention, as they can provide insights that inform interventions to decrease cancer incidence, morbidity, and mortality in humans. Future prospective epidemiology cohort studies, therefore, need to be able to examine the unique cancer burden associated with emerging/novel exposures, incorporate genomic factors, and examine the intersectionality of multiple factors to assess cancer risk and survivorship outcomes, and translate findings to improve the health outcomes for all population groups, with deliberate inclusion of understudied populations.
Research Objectives and Requirements for this FOA
This proposed FOA will provide funding to assemble the framework, structure, and operational foundation to enable the creation of a new prospective cohort study that would advance our understanding of cancer-related risk and survivorship of healthy populations and cancer survivors, respectively. Applicants should address scientific gaps and expand the heterogeneity of population-based research studies such as (i) representation of study populations (racial/ethnic, geographical, and beyond); (ii) relevant individual-level data, e.g., heritage, country of origin, unique environmental exposures (e.g., persistent organic pollutants and other chemicals, pesticides, infectious agents, water quality), genomic, and lifestyle/behavioral factors (e.g., cultural dietary patterns, sleep factors, use of emerging tobacco products); (iii) data on sociocultural measures (e.g., socioeconomic position, acculturation, assimilation, stress markers) critical to a deeper understanding of their multilevel impact on cancer risk and survivorship; (iv) information on survivor-related factors (e.g., clinical factors and treatment-associated outcomes); and (v) access to and quality of healthcare with cancer prevention, screening, and treatment (e.g., cancer-care delivery systems, financial burden and resources, and employment).
Expectations and Requirements for this FOA
Applicants responding to this FOA are expected to include the following elements:
- Scientific justification of the research gap to be addressed in both exposures and outcomes (See Cancer outcomes below).For survivor cohorts, the exposures could be the cancer site or specific survivor-related exposures and endpoints must be justified.
- This FOA intends to fund new cancer epidemiology cohorts. Applicants are encouraged to review existing cohorts (e.g. those listed in the Cancer Epidemiology Descriptive Cohort Database (CEDCD) to avoid overlap.
- Justification of the study population and sample size (including, if applicable, appropriate considerations of statistical precision for future subgroup analyses) as driven by the proposed science.
- Accrual of study population must be completed by year 5 of a 5-year grant period.
- Demonstration of innovation and novelty in addressing proposed research questions.
- Description of the sustainability and preservation of cohort resources that extend beyond the life of the award.
- Detailed data/resource sharing plans that are consistent with NIH policy and follow Findable, Accessible, Interoperable, Reusable (FAIR) principles for Resource Sharing Plans as provided in SF 424 Application Guide. Data collected under support from this FOA are required to be submitted to an NIH designated repository. The NCI-approved data sharing plan will become a term and condition of award. The data sharing plan must include details as outlined below:
- The repository where the data generated under support from this FOA will be deposited, details how to access the data, and limitations (if any) for use of the data;
- Timely data and resource sharing after each wave of data collection;
- Informed consent for the sharing and deposition of data into NIH-designated repository when applicable; and
- A mutually agreed upon letter of agreement for the data/resource sharing plan from the parent institution must be provided prior to award.
Cancer Outcomes: Cancer outcomes must be validated through linkage to population-based cancer registries and/or medical records or pathology reports.
Applicants should propose specific aims to align with the following:
Methodological Studies
Methodological efforts are practical and important to determine the cohort operational structure, obtain critical baseline data, and develop key infrastructure critical to establishing and sustaining a new cohort. As such, methodologic work focused on logistical and practical details such as (i) approaches to engage, recruit, and retain study participants; (ii) optimal and novel methods to collect accurate exposure and individual-level data; and (iii) methods for biospecimen collection and plan for assessment of stability of long-term storage when appropriate.
Types of feasibility study that would be considered appropriate for this FOA include, but not limited to:
- ascertain the most appropriate and efficient methods to engage, recruit, and retain a specific population group (e.g. understudied and/or underserved populations);
- assess innovative approach to enhance participant engagement or optimize data access and sharing;
- test novel methods and strategies for data and/or specimen measurement, collection, and/or storage;
- assess effective strategies for biospecimen ascertainment across different facilities (e.g., biobanks, hospitals, commercial labs);
- integrate or link to existing databases to obtain and/or augment non-traditional information (e.g., administrative, socioeconomic position) relevant to cancer control and prevention; and/or
- test measures, data abstraction, or data linkage strategies related to healthcare delivery including, but not limited to, cancer caregiving, financial hardship, telehealth, coordination of care, and access to preventive cancer care and post-diagnosis follow-up care, utilization, and health outcomes;
- assess or test innovate approaches to collect information related to sociocultural, behavioral, lifestyle, disparities and equity, and/or health outcomes across the cancer continuum; or
- test methods to capture cancer recurrences and/or subsequent primary cancers in cancer survivors.
Research Outcomes
Exposures have variable associated latency periods, which will influence the short- and long-term goals of the proposed studies. Applicants should consider research questions that could be addressed in the short-term including assessing validated biomarkers of intermediate risk, behavioral outcomes, or healthcare utilization outcomes. A variety of relevant research may be addressed in the short term related to topics such as exposure assessments, mechanisms of carcinogenesis, association of exposures with intermediate cancer outcomes, genomic studies of diverse populations and cancer risk, exposures, or progression (e.g., using survivor cohorts for cancer cases and other cohorts for controls; using a case-cohort or case-control design leveraging cancer registries for identifying and recruiting cancer cases), socio-cultural and behavioral outcomes, and barriers to the delivery of optimum healthcare.
Community Engagement
The bi-directional partnership between the research scientists and the community partners is critical to incorporate and integrate respective unique strengths and perspectives to inform research priorities. There are also needs for awareness of local culture and belief systems. As such, community engagement activities designed to inform research, enhance recruitment and retention efforts, and disseminate results must be incorporated into the proposed application. Moreover, applicants are strongly encouraged to take advantage of available resources, whenever feasible and applicable, such as those supported by the NCI Center to Reduce Health Disparities (CRCHD):
Applicants must provide detailed plans for direct community engagement, in which community partners are incorporated throughout the process. Applicants should provide details for community engagement including:
- Plans to establish a community advisory board with a broad and diverse representation of community-based organizations and key racial/ethnic minority community leaders as relevant to the study population, and multidisciplinary members
- Plans to leverage and/or establish new partnerships with community-based organizations and community partners
- Plans of engaging with the community and study participants using current state-of-the-art approaches, including such aspects as:
- how planned methods of engagement will be culturally sensitive and appropriate for the population of focus; and
- community-based participatory research approaches, as applicable for specific research proposal and populations, in which communities are treated as partners with research institutions.
- Plans to communicate to the community and study population information about relevant resources, progress and outcomes such as:
- summary of health information and resources used in the study;
- ongoing study updates;
- aggregated results when available; and/or
- lay abstracts of study results and publications as appropriate.
Additional Requirements
- Create and maintain an active cohort’s website with relevant study population’s details (current age and vital status) and information on data sharing/access;
- Deposit data to an NIH data repository or a NIH-approved public controlled access data repository, when appropriate;
- Submit descriptive cohort data to the Cancer Epidemiology Descriptive Cohort Database (CEDCD) when requested;
- Evaluate and document compliance with NCI’s Best Practices for Biospecimen Resources for the collection, processing, and storage of biospecimens, if applicable and appropriate;
- Include common use data elements and share protocols for the collection of data and/or biological specimens, as appropriate scientifically; and
- Attend annual meeting(s) at NIH/NCI during the award period design to facilitate exchange of knowledge and foster interactions with other cancer epidemiology cohorts. Additional attendance to webinar meetings may be required throughout the award period.
Applicants are encouraged, where appropriate, to incorporate data through linkages to existing databases with relevant exposure, administrative, and health-related data. For example, linkages to state cancer registries through the Virtual Pooled Registry Cancer Linkage System (VPR-CLS) funded by NCI. Other resources such as Human Health Exposure Analysis Resource (HHEAR) co-funded by NCI, can enable cost-effective approaches to both exposure assessment. Population-based cancer registries (Surveillance, Epidemiology, and End Results Program and State Cancer Registries) also provide frameworks for identifying and recruiting cancer cases.
Non-responsive Applications
Applications that propose any of the following will be deemed non-responsive and will not be reviewed, including those that:
- Are not limited to human populations;
- Does not incorporate a longitudinal study design;
- Continue support to or research solely from an established cohort (defined as those with advanced or completed study enrollment);
- Use primarily secondary data from existing cohort data;
- Do not collect validated cancer outcomes;
- Include foreign components (e.g., countries or exposures) that do not reflect direct relevance to U.S. populations;
- Have data and/or resource sharing plans that do not comply with NIH policy and follow FAIR principles (https://www.go-fair.org/fair-principles).
NOTE: Applicants to this FOA are strongly encouraged to attend a planned NCI-sponsored pre-application webinar prior to the first due date. For subsequent due dates, applicants will be able to access the recording of the pre-application webinar on the Epidemiology and Genomics Research Program’s website. Applicants should review relevant due dates on the website and contact NCI staff as soon as possible in the development of the application to discuss the details of their proposed study so that NCI staff can help the applicant understand whether the study is within the goals and mission of the Institute and is appropriate for this FOA.
See Section VIII. Other Information for award authorities and regulations.
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. See Section VI.2 for additional information about the substantial involvement for this FOA.
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
The scope of the proposed project should determine the 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.
1. Eligible Applicants
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local 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)
Federal Government
- 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)
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.
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.
- 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.
- Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
- Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
- eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, e.g., Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
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.
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, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications)
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.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:
Tram Kim Lam, Ph.D., MPH
National Cancer Institute (NCI)
Telephone: 240-276-6970
Email: lamt@mai.nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Biosketches should reflect the PD(s)/PI(s) and key personnel's expertise in community-based participatory research, clinical trial education and outreach, referral-to-care, health services or healthcare delivery research, multilevel interventions, experimental or quasi-experimental designs, and implementation science. Research personnel are also expected to have a track record of conducting studies with multiple stakeholder groups involved in healthcare delivery.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Any individual designated as a PD/PI must commit a minimum of 1.8 person-months effort per year to the project (MPIs must commit a minimum of 1.2 person-months per NCI policy). The PD/PI person-months effort cannot be reduced in later years of the award.
Applications should budget for at least one key personnel to attend the annual Programmatic Meeting for each year of a grant period. The Meeting may take place at an NIH location in Maryland and may overlap the NCI Cohort Consortium's annual meeting.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: All applicants must include the aims that address the main requirements (See Part II.Section 1).
Research Strategy: Applicants must organize the Research Strategy to include the sub-section elements identified below. Applicants may include other sub-sections as needed but must include the information requested below.
Sub-section A. Background and Significance
Define, justify, and explain the rationale for the proposed study population and exposure of interest and the selection of the understudied population(s) focus of the project. Provide the research gaps the proposed cohort will address, including how the proposed project will inform future cancer prevention strategies, interventions, and public health guidelines to decrease the cancer burden of people in the United States?
Sub-section B. Preliminary Data
Though preliminary data (including findings to support proposed approaches) are not required, if limited preliminary data are provided, they will be evaluated. In lieu of preliminary data, applicants may provide the underlying logic or rationale for pursuing the project in the manner proposed. Summarize what is believed to be the major challenges and described alternative approaches that may need to be pursued.
Sub-section C. Short-term and Long-term Research Outcomes
Provide and outline the broad research agenda that the proposed cohort would pursue, including specific long-term research questions. Provide specific short-term research questions and outcomes that are achievable within the grant period.
Sub-section D. Approach
Describe methods/approaches that will be used to accomplish proposed Specific Aims;
- Describe the epidemiological information and data that will be collected.
- Describe the appropriateness of the proposed study design.
- Describe the recruitment and retention approach(es) that will be used. Include a description of community engagement to optimize recruitment and retention of study participants.
- Describe proposed measures of relevant exposures and the technology/approaches used, when possible highlight the innovation, for data collection and storage as appropriate.
- Describe the analytic plan, including calculations for sample size and power analyses for all aims, and including subgroups, as appropriate.
Sub-section E: Data Sharing and Dissemination
Applicants must provide a detailed plan for the facilitation of data and resource sharing after each wave of data collection. The data/resource sharing plans must be consistent with NIH policy and follow Findable, Accessible, Interoperable, Reusable (FAIR) principles (see https://www.go-fair.org/fair-principles/). Instructions for Resource Sharing Plan is provided in SF424 Application Guide. Describe the management and decision-making process that promotes data sharing and timeline for sharing, the repository where the data will be located, process for accessing data, any limitations, etc. The plan should include steps for creating standard operating procedures, accessibility requirements, and review process for granting access to the research community, and dissemination of that information.
Letters of Support: Applicants must include letters of support from collaborating entities (e.g., community partners, community-based organizations, etc.).
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.
The following modifications also apply:
- All applications, regardless of the amount of direct costs that are requested for any one year, must address a Data Sharing Plan.
- Applicants must propose a detailed data sharing plan that addresses rapid data sharing with the community and describes plans to adhere to the FAIR Guiding Principles (Findable, Accessible, Interoperable, Reusable) for each wave of data collection.
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.
The following modifications also apply:
- All applications, regardless of the amount of direct costs requested for any one year must address a Data Sharing Plan.
- Applicants must propose a detailed data sharing plan that addresses rapid data sharing with the community, includes informed consent to permit data deposition/sharing to an NIH-recommended repository, and describes plans to adhere to the FAIR Guiding Principles (Findable, Accessible, Interoperable, Reusable) for each wave of data collection.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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. 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
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
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.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 8 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. For more information, please see https://epi.grants.cancer.gov/funding/large-grant-applications/.
Furthermore, applicants requesting $700,000 or more in direct costs in any year will be required to participate in a pre-submission consultation meeting with Program Staff at least 12 weeks prior to receipt date to ensure the scope of the application is appropriate to basic maintenance for existing cohorts to serve as a resource for research according to NIH data sharing policies. Additional information, including contact information and materials required, is outlined on https://epi.grants.cancer.gov/funding/large-grant-applications/. Applicants should contact NCI early enough to ensure the meeting will occur at least 12 weeks prior to submission. Failure to comply will result in the application being deemed non-responsive to the intent of the PAR.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided 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 and responsiveness by the NCI. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
1. Criteria
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
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? Is the prior research that serves as the key support for the proposed project rigorous? 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?
Specific for this FOA:
- How well does the application describe how the proposed cancer epidemiology cohort and study population (e.g., inclusion of understudied populations) address specific scientific gaps relevant to cancer etiology and survivorship?
- How well does the application describe how the proposed project will inform future cancer prevention strategies, interventions, and public health guidelines to decrease the cancer burden of people in the United States?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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?
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:
- How well does the application propose novel approaches to improve measurement of exposures and/or representation of populations?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific for this FOA:
- How well does the approach address both the proposed short-term and long-term research outcomes?
- How well are the sample size and proposed data/biospecimens collection support the research aims of the study?
- How appropriate are the plans for data and/or biospecimens collection and storage?
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?
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.
Recruitment and Retention
- How clearly are the steps described to assess recruitment progress and future retention?
- How well described is the proposed plan to assess timely recruitement progress?
Resource/Data Sharing
- How well does the application describe the facilitation of timely and broad access to cohort-related data and resources to the external scientific community?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable
Revisions
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.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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) Sharing Model Organisms; (2) Genomic Data Sharing Plan (GDS); and any applicable NIH Data Sharing Policy.
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.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
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.
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 NCI's 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.
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 recipient's business official.
Recipients 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.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity , sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
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.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
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 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR 200 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 recipients 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 for the project as a whole resides with the recipients, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The PD(s)/PI(s) will have the following primary responsibilities:
- Define the overall research objectives;
- Determine approaches, design protocols, set project-specific objectives (e.g., milestones), and oversee the conduct of the research;
- Ensure compliance with the applicable mandatory regulations (including protection of human subjects) as required by specific research activities;
- Adhere to the NIH policies regarding intellectual property, data release, and other policies;
- Cooperate with NCI programmatic, technical, and administrative staff;
- Participate in the Cohort Program Steering Committee;
- Attend annual meetings, be held either virtually and/or in-person at the Bethesda, Maryland, area;
- In addition to standard annual Research Performance Progress Report (RPPR) submissions, PD(s)/PI(s) may be expected to supply additional progress-related information to the NCI.
The PD(s)/PI(s) assume(s) 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 in accordance with these terms and conditions of the award.
Recipients are required to provide annual progress reports and descriptive data to NCI, including counts of participants (including current age, vital status, response rates, and losses to follow-up or withdrawals) and a summary of data shared (including the number of requests, approvals, denials, and list of collaborators) when appropriate.
NCI program staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The substantially involved NCI program staff member(s), acting as Project Coordinator(s), will coordinate in a centralized fashion various activities of the recipients. Specific responsibilities of the NCI Project Scientist(s)/Coordinator(s) will include the following aspects:
- Facilitate collaborations between the awardees and other NCI-sponsored programs, investigators, or organizations;
- Assist with the coordination of efforts that may contribute to the projects goals and NCI’s priorities;
- Advise recipients on compliance with NIH policies, such as NIH data sharing policies;
- Attend the cohort’s steering committee/external advisory board meetings and/or other standing/ad hoc meetings as appropriate;
- Organize and conduct annual meetings to discuss progress and longer-term projects or activities.
- Provide input on methodological work or approaches, assist in designing protocols, and consult on updates to project progress;
- Provide advice to the awardees on specific scientific and analytical issues;
- Organize and participate in webinars with PDs/PIs to monitor progress and facilitate cooperation;
- Monitor progress of the projects and adherence to the strategic goals of the program;
- Track accrual of study participants to ensure proper completion of this essential step;
- Provide administrative management to convening the Cohort Program Steering Committee, organize meetings, and monitor implementation of its guidelines and procedures;
- Stimulate interactions among awardees; and
- Contribute to publications and presentations resulting from the project if appropriate.
Additionally, an NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibility include:
The NCI Project Scientist and the PD/PI of the Cooperative Agreement awards funded under this initiative will be jointly responsible for participating in initiative-wide and cohort-related activities and for establishing inter-project collaborations with other awardees of cancer epidemiology cohorts. In addition to the interactions defined above, the NCI Project Scientists and awardees shall share responsibility for the following activities via a Cohort Program Steering Committee, which will serve as a non-voting organizational body for the NCI and awardees.
The Cohort Program Steering Committee will consist of:
- Principal investigator(s) of each award;
- Two NCI Project Scientists (Cohort Co-Coordinators); and
- One NCI Program Director assigned to the awarded grant.
The Cohort Program Steering Committee will be organized and administratively managed by the NCI program staff and will meet for at least one annual meeting (either virtually or in-person) during the grant period where all awardees will discuss award-related and program-related issues, including but not limited to progress on proposed specific aims, data collection measures, methodologic work, recruitment/retention goals, data sharing, data deposition, and community-engagement activities. Additional webinar meetings will also be organized by the NCI program staff throughout the award period as needed. At the meeting(s), awardees will work together under the guidance of NCI program staff as a consortium of investigators to advance the objectives and goals of this initiative.
The NCI Project staff and awarded PIs will serve on the Cohort Program Steering Committee. In addition, other NCI Program Officials may serve on the committee to help with issues regarding recruitment, follow-up, quality control, protocol adherence, assessment of problems affecting the study and potential changes in the protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment. The Cohort Program Steering Committee may establish working groups/sub-committees as needed, e.g., to address specific scientific or administrative issues.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee 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 recipient. This special dispute resolution procedure does not alter the recipient'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.
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
3. Reporting
When multiple years are involved, recipients 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Tram Kim Lam, Ph.D., MPH
National Cancer Institute (NCI)
Telephone: 240-276-6970
Email: lamt@nih.gov
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov
Dawn M. Mitchum, MPH, CRA
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: dmitchum@mail.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
and Human Services (HHS)
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