National Cancer Institute (NCI)
April 27, 2020 - Pre-Application Webinar for RFA-CA-20-030. See Notice NOT-CA-20-059.
July 26, 2019- Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128
August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) invites applications to support research in new and innovative cohort studies that identify clinical, lifestyle, genomic, and other factors that affect health outcomes (e.g., morbidity, mortality, quality of life, physical, social, and psychological outcomes) in cancer survivors (i.e., from diagnosis to the end of life).
This FOA intends to support research that requires the creation of a new prospective cohort study that addresses a gap in knowledge pertaining to the health of cancer survivors. Applications must identify the scientific gap that the study addresses, which may include emerging treatments, less common cancer sites, and/or understudied populations of cancer survivors with disparities.
Sample size and proposed data collection must be driven by the scientific questions proposed and should include information from all the following five domains in order to cover the full extent of the cancer survivor experience: 1) disease characteristics (e.g., type, stage, tumor biomarkers), 2) individual survivor characteristics (e.g., comorbidities, socioeconomic status [SES], social connections, information seeking, access to care measures), 3) treatment, treatment-related effects, and follow-up care (e.g. dose, adverse events, palliative care), 4) behavioral and lifestyle factors (e.g., diet, physical activity, adherence) and 5) quality of life outcomes (health-related quality of life (HRQOL), patient symptom reports). These domains may represent exposures and/or outcomes, depending on the research questions, and should be measured at multiple timepoints, when appropriate.
The UG3/UH3 mechanism has two phases: the UG3 Planning-Exploratory Phase focused on the recruitment of study participants and data collection/utilization, and the UH3 Implementation Phase focused on completing the research agenda. Milestones to be accomplished in the UG3 phase for transition to the UH3 phase should be proposed by the Principal Investigator(s) (PIs), which will require NCI review and approval before the grant is awarded , and must include a timeline for recruitment and show feasibility for data collection and analysis. Recruitment is not required to be completed in the UG3 phase, but reasonable progress should be demonstrated to ensure that all aims will be completed in the UH3 phase.
April 8, 2020
30 days prior to the application due date
July 7, 2020
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
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.
This Funding Opportunity Announcement (FOA) is intended to support new and innovative prospective longitudinal cancer epidemiologic research that aims to identify clinical, lifestyle, genomics and other factors that affect health outcomes (e.g., morbidity, mortality, quality of life, physical, social, and psychological outcomes) in cancer survivors. Through this FOA, the National Cancer Institute (NCI) invites the submission of UG3/UH3 applications designed to inform future interventions, clinical guidelines, and patient management strategies development to improve outcomes in cancer survivors. A person is considered to be a cancer survivor from the time of diagnosis until the end of life.
This FOA supports research that requires the creation of a new prospective cohort study of cancer survivors that will help to address a gap in knowledge pertaining to the health of cancer survivors. Applications must identify the scientific gap that the study addresses, which may include late-effects from emerging treatments, less common cancer sites, and/or understudied populations of cancer survivors with disparities.
Sample size and proposed data collection must be driven by the scientific questions proposed and include information from all of the following five domains in order to cover the full extent of the cancer survivor experience: 1) disease characteristics (e.g., type, stage, tumor biomarkers), 2) individual survivor characteristics (e.g., comorbidities, socioeconomic status, social connections, information seeking, access to care measures), 3) treatment, treatment-related effects, and follow-up care (e.g. dose, adverse events, palliative care), 4) behavioral and lifestyle factors (e.g., diet, physical activity, adherence) and 5) quality of life outcomes (health-related quality of life (HRQOL), patient symptom reports). These domains may represent exposures and/or outcomes, depending on the research questions, and should be measured at multiple timepoints, when appropriate.
The UG3/UH3 mechanism has two phases: the UG3 Planning-Exploratory Phase focused on the recruitment of study participants and data collection/utilization, and the UH3 Implementation Phase focused on completing the research agenda. Milestones to be accomplished in the UG3 phase for the transition to the UH3 phase should be proposed by the PI in the application, which will require NCI review and approval, and must include a timeline for recruitment and show feasibility for data collection and analysis. Recruitment is not required to be completed in the UG3 phase, but reasonable progress should be demonstrated to ensure that all aims will be completed in the UH3 phase.
Key Terms for This FOA
Cancer Survivor: any individual diagnosed with cancer from the time of diagnosis until the end of life.
Cohort Study: a longitudinal study that follows a group of people over time collecting data. In this case, the cohort exclusively includes cancer survivors.
Prospective Cohort: a cohort study in which all data are collected about the present, whereas a retrospective cohort queries information about events that occurred in the past.
Health Outcomes: Any physical, social, or psychological effect that impacts one's well-being. For cancer survivors, these effects may result from disease as well as from anti-cancer treatments.
It is estimated that more than 16.9 million cancer survivors are living in the United States. The goals of cancer treatment are to eradicate, control, and prevent recurrence of cancer. However, cancer, as well as its treatment, have early and late adverse physical, psychological, social, and financial health consequences. These disease- and treatment-related adverse outcomes (e.g., neuropathy) can significantly impair the quality of survival. Therefore, identification of the key factors that may be modified or intervened upon to prevent or mitigate these adverse consequences and improve overall health outcomes and quality of life for cancer survivors is vital.
Prospective cohort studies of cancer survivors provide important information about the short- and long-term health outcomes of cancer and its treatment, allowing for the identification of key factors that may inform interventions, clinical guidelines, and patient management to mitigate adverse health outcomes. Cohort studies allow for a more representative population than clinical trials, as the cancer patients enrolled in clinical trials tend to be healthier than the general population of cancer patients as a result of restrictive eligibility criteria. For example, patients with comorbid health conditions may be excluded from clinical trials, yet once a treatment is approved, all patients are eligible to be treated. Although much has been learned about the health of cancer survivors from cohort studies, little information is available for longer-term consequences in survivors with less common cancers; racially, ethnically, and geographically diverse populations; and those exposed to new treatments (e.g., immunotherapy and molecularly targeted therapy).
Research Objectives and Requirements
Through this FOA, the NCI supports research that requires the creation of a new prospective cohort study of cancer survivors that addresses a gap in knowledge pertaining to the health of cancer survivors. Applications should identify the scientific gap(s) that the study addresses, which may include emerging treatments, less common cancer sites, and/or understudied populations of cancer survivors with disparities.
Sample size and proposed data collection must be driven by the scientific questions proposed and should include information from the following five domains in order to cover the full extent of the cancer survivor experience: 1) disease characteristics (e.g., type, stage, tumor biomarkers), 2) individual survivor characteristics (e.g., comorbidities, socioeconomic status, social connections, information seeking, access to care measures), 3) treatment, treatment-related effects, and follow-up care (e.g. dose, adverse events, palliative care), 4) behavioral and lifestyle factors (e.g., diet, physical activity, adherence) and 5) quality of life outcomes (health-related quality of life (HRQOL), patient symptom reports). These domains represent exposures and/or outcomes, depending on the research questions, and should be measured at multiple timepoints, when appropriate. Additional data collection (e.g., biospecimen collection, family history), as dictated by the proposed research, is acceptable. Study participants may be enrolled at any point after cancer diagnosis (e.g., during active treatment or long-term survival) as justified by the proposed scientific research question. Cohorts may be defined by cancer type, treatment pattern (e.g., treated with agents that increase the risk of specific toxicities), time since diagnosis (e.g., > 5-year overall survival), demographics (e.g., Native Americans or adolescents/young adults (AYA)), or a unique group relevant to the research questions proposed.
Studies must include:
The use of population-based cancer registries for recruitment is strongly encouraged to promote a broad representation of cancer survivors and as a comparison to assess the representativeness of the study population. If other recruitment sources are used, the applicant must be able to describe the base population used for recruitment and how it compares to the relevant cancer survivor population being studied. Studies submitted in response to this FOA must demonstrate novelty and be designed to inform future clinical guidelines, interventions, and patient management. Applicants are also encouraged to address important racial, ethnic, geographic, or socioeconomic disparities in health outcomes among survivors.
Sample Research Questions:
Research questions of interest may include, but are not limited to, the following:
The UG3/UH3 mechanism has two phases: the UG3 Planning-Exploratory Phase focused on recruitment of study participants and data collection/utilization, and the UH3 Implementation Phase focused on completing the research agenda. Milestones to be accomplished in the UG3 phase for transition to the UH3 phase will be proposed by the PI in the application and will require NCI review and approval before the grant is awarded, and must include a timeline for recruitment and show feasibility for data collection and analysis (e.g., accessing and using electronic medical records (EMRs)). Recruitment is not required to be completed in the UG3 phase, but reasonable progress should be demonstrated to ensure that all aims will be completed in the UH3 phase. Although studies may differ, the UG3 phase is expected to be approximately 2 years, whereas the UH3 phase will be 3 to 4 years (for a total of up to 6 years). The UG3/UH3 mechanism allows NCI the ability to evaluate and ensure adequate recruitment and feasibility of data collection methods before releasing large research funds.
Priority will be given to novel projects that meet identified gaps in the NCI portfolio, particularly those for rare cancers, understudied populations, and understudied treatment groups (See a list of currently funded cohorts at: https://maps.cancer.gov/overview/DCCPSGrants/grantlist.jsp?method=portfolio&owner=rogerssc&portfolio=Cancer%20Epidemiology%20Cohorts). The multifaceted research solicited by this FOA benefits from multidisciplinary teams with expertise driven by the proposed research. Successful applicants will work together with the NCI and other awardees to identify key core data elements that should be collected in all cohort studies of cancer survivors. Feasibility of meeting the proposed recruitment and/or data collection milestones stated in the application is critical for the UG3/UH3 transition phase. All proposed milestones will be included in the terms of awards and will be monitored closely by the NCI. To initiate the transition from UG3 to UH3, the applicant will submit a detailed transition request to progress to the UH3 implementation phase. UH3 transition requests will undergo administrative review by NCI staff to determine whether the study will be awarded the implementation phase (UH3). Transition decisions will be based on achievement of study milestones, readiness to conduct the UH3 study, feasibility of completing the UH3 study, availability of funds, and program priorities. Prospective applicants should note that initial funding of the UG3/UH3 cooperative agreement does not guarantee support of the UH3 implementation phase. Successful completion of UG3 milestones is required to transition to the UH3 award.
Minimum Criteria for Transition to UH3
To meet the research goals of this program, the research applicants/awardees will be expected to:
Awardees are required to provide annual progress reports and descriptive data to NCI, including counts of participants (including current age, vital status, and response rates). Awardees are required to contribute cohort information for a cross-CEC database (https://cedcd.nci.nih.gov). If applicable, investigators are expected to evaluate and document compliance with NCI’s Best Practices for Biospecimen Resources for collection, processing, and storage of biospecimens. Applicants will be required to budget for two in-person meetings at NCI during the grant period where all grantees will discuss their progress, measures, and methodologic work. Additional webinar meetings will take place throughout the grant period. At the first meeting, grantees will work together as a consortium of investigators to develop a core set of questions that will be required to be included within data collection tools for all studies funded by this FOA.
Applications that are based on secondary use of existing cohort data, use a study design that is not a prospective cohort, or exclude data collection from any of the five domains above are not responsive to this FOA and should seek other research-based funding (e.g., PA-19-056). Studies that are based in foreign countries are eligible for this FOA; however, priority will be given to studies with direct relevance to the U.S. cancer survivor population.
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.
NCI intends to commit $3.9 million in FY 2021 to fund up to 3awards.
The proposed project period for the initial development phase (UG3) must not exceed 2 years and the total duration of the UG3/UH3 phases combined may not exceed 6 years.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
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 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.
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.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The multifaceted research solicited by this FOA requires multidisciplinary teams with expertise driven by the proposed research.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
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:
The letter of intent should be sent to:
Joanne Elena, Ph.D., M.P.H.,
National Cancer Institute (NCI)
All instructions in the SF424 (R&R) Application Guide must be followed.
Applicants are required to budget funds for PI(s) for travel to attend two meetings in Bethesda or Rockville, Maryland within the grant period. The purpose of these meetings will be to bring together investigators to share knowledge, progress and findings, and allow for rapid translation of results. In addition, the budget of the UG3 phase cannot exceed $750,000 in direct costs per year. There is no specified budget cap for the UH3 phase; however, budgets must reflect only the work necessary to complete the aims and are subject to available NCI funds.
Specific Aims: Provide the overall goals for the entire application and indicate Specific Aims to be accomplished in the UG3 Phase and the UH3 Implementation Phase.
Research Strategy: Applicants are requested to organize the Research Strategy into the subsections identified below. Applicants may include other sections as needed but must include the information requested below.
Sub-section A. Background and Significance
Sub-section B. Preliminary Data
Sub-section C. Cohort Description
Sub-section D. Approach (may be divided into the UG3 Phase and the UH3 Phase)
Sub-section E. Milestones and Timelines
Letters of Support: Applicants must include letters of support from collaborating entities that are essential to the mission of the work proposed.
The following modifications also apply:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan that is compliant with NIH data sharing policies, including the NIH Genomic Data Sharing Policy (https://datascience.cancer.gov/data-sharing/genomic-data-sharing) with:
Applicants are required to maintain a website that details the procedure for external investigators requesting and obtaining data; procedures and criteria for access must be compliant with NIH data sharing policies. Applicants are encouraged to consider NIH data repositories for sharing data with external investigators. A summary of the number of data requests, acceptances, and rejections should be provided in annual progress reports to NCI.
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.
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.
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.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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 and responsiveness by the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
Applications in response to this FOA (UG3/UH3) will include two phases: the UG3 Planning-Exploratory Phase focused on study participant recruitment and data collection/utilization, and the UH3 Implementation Phase focused on completing the research agenda. Milestones to be accomplished in the UG3 phase for transition to the UH3 phase should be proposed by the PI and will require NCI review and approval before the grant is awarded, and must include a timeline for recruitment and show feasibility for data collection and analysis (e.g., accessing and using EMRs). Successful projects will be new longitudinal cohorts of cancer survivors that identify a pressing gap in knowledge among cancer survivors, address important research questions that directly affect the health of cancer survivors. Applications are expected to have a data sharing plan that describes the investigator’s intent to share relevant resources and data through NIH supported repositories.
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 do the findings of the project directly inform future interventions, clinical guidelines, and patient management strategies to improve health outcomes in cancer survivors? How well does the project advance the health of cancer survivors?
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?
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 project provide novel information about an understudied group of cancer survivors, based on demographics, race, geography, or socioeconomic status (e.g., AYA , Hispanics, Native Americans, long-term survivors), or the cancer site (e.g., rare/rarer cancers, molecularly and stage defined cancer subgroups)?
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?
Specific for this FOA:
Have the investigators presented adequate plans in the study to address disease characteristics (e.g., type, stage, tumor biomarkers), individual survivor characteristics (e.g., comorbidities, SES, social connections, information seeking, access to care measures), treatment, treatment-related effects, and follow-up care (e.g. dose, adverse events, palliative care), behavioral and lifestyle factors (e.g., diet, physical activity, adherence) as well as quality of life outcomes (health related quality of life (HRQOL), patient symptom reports)? How appropriate are the measures of relevant exposures and outcomes to ensure high-quality data using validated methods and instruments and evidence-based approaches? Have the investigators presented adequate plans to address cancer recurrence as a disease endpoint and if not, have the investigators presented adequate justifications in this regard? How well does the study address treatment data collection including specific therapies and cumulative doses? Have the investigators presented acceptable plans to use a population-based cancer registry/registries for recruitment? How well does the study present a plan for using cancer registry data to compare how the proposed cohort differs from the US population of relevant cancer survivors?
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?
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?
How appropriate are the milestones and are the related criteria quantitative, appropriate, sufficient, and rigorous enough to ensure successful recruitment and the collection and use of critical data within the allowed project period?
For research that involves human subjects but does not involve one of thecategories 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.
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.
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.
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.
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.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
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.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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.
Information regarding the disposition of applications is available 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.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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.
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 “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) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (45 CFR Part 75), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
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, as described below. The NCI Project Scientist will be the main NCI contact for all facets of the scientific interaction with the awardees and will provide advice to the awardee on specific scientific and/or analytic issues in addition to programmatic issues. As needed, additional NCI scientific staff members with relevant expertise may also become substantially involved as Projects Scientists/Coordinators. The responsibilities of substantially involved NCI Program Staff members will include the following aspects.
Additionally, an NCI 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 Responsibilities:
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 activities and for establishing inter-project collaborations. In addition to the interactions defined above, the NCI Project Scientist and awardees shall share responsibility for the following activities via a Program Steering Committee, which will serve as a non-voting organizational body for the NCI and awardees.
The Program Steering Committee will consist of:
Two representatives of each awardee (the contact PD/PI and designated backup senior investigator); and
Two NCI Project Scientists.
The Program Steering Committee will be organized and administratively managed by the NCI program staff and will meet for two in-person meetings at NCI during the grant period where all grantees will discuss their progress, measures, and methodologic work. Additional webinar meetings will also be organized by the NCI program staff throughout the grant period. At the first meeting, grantees will work together under the guidance of NCI program staff as a consortium of investigators to develop a core set of questions that will be required to be included within data collection tools for all studies funded by this FOA.
The NCI Project Scientist will serve on the steering committee. In addition, the Project Scientist, or other NCI Program Officials, may serve on the committee 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 Steering Committee may establish working groups/sub-committees as needed, e.g., to address specific scientific or administrative issues.
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: one NIH designee and two designees with expertise in the relevant area, chosen by the NCI Cohort Consortium Steering Committee. 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.
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 agreementsare 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.
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Contact Center Telephone: 800-518-4726
Joanne Elena, Ph.D., M.P.H.,
National Cancer Institute (NCI)
National Cancer Institute
National Cancer Institute (NCI)
Office of Grants Administration
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