Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Cancer Institute (NCI)
U01 Research Project Cooperative Agreements
This Funding Opportunity Announcement (FOA) supports the development of cancer-relevant technologies suitable for use in low- and middle-income countries (LMICs). Specifically, the FOA solicits applications for projects to adapt, apply, and validate existing or emerging technologies into a new generation of user-friendly, low-cost technologies for preventing, detecting, diagnosing, and/or treating cancers in people living in LMICs.
Applicants should have a working assay or device prototype (not necessarily already capable of cancer applications). The U01 project includes studies to both adapt this technology as well as demonstrate technical functionality and clinical performance for use of the device or assay in specific LMIC settings by meeting objective performance milestones followed by improvements and validations of the technologies in the LMIC settings. Projects proposed in response to this FOA will require multidisciplinary efforts to succeed; therefore, all applicant teams must include expertise in engineering/assay/treatment development, oncology, global healthcare delivery, and business development. Investigators responding to this FOA must consider affordability and cost-effectiveness as well as usability at the point-of-need as part of their design criteria.
This funding opportunity is part of a broader NCI-sponsored Affordable Cancer Technologies (ACTs) Program.
30 days prior to the application due date
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| June 02, 2021 | Not Applicable | Not Applicable | November 2021 | January 2022 | April 2022 |
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. No late applications will be accepted for this FOA.
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.
Purpose
This Funding Opportunity Announcement (FOA) supports the development of cancer-relevant technologies suitable for use in low- and middle-income countries (LMICs). Specifically, the FOA solicits applications for projects to adapt, apply, and validate existing or emerging technologies into a new generation of user-friendly, low-cost technologies for preventing, detecting, diagnosing, and/or treating cancers in people living in LMICs.
Applicants should have a working assay or device prototype (not necessarily already capable of cancer applications). The U01 project includes studies to both adapt this technology as well as demonstrate technical functionality and clinical performance for use of the device or assay in specific LMIC settings by meeting objective performance milestones followed by improvements and validations of the technologies in the LMIC settings. Projects proposed in response to this FOA will require multidisciplinary efforts to succeed; therefore, all applicant teams must include expertise in engineering/assay/treatment development, oncology, and global healthcare delivery. Investigators responding to this FOA must consider affordability and cost-effectiveness as well as usability at the point-of-need as part of their design criteria.
This funding opportunity is part of a broader NCI-sponsored Affordable Cancer Technologies (ACTs) Program.
Note: Throughout the following text, references to either the LMIC setting or the global health setting refer specifically to a target LMIC for a proposed technology. LMIC is defined according to the World Bank Country and Lending Groups and is inclusive of low- and middle-income countries, not including upper-middle income countries, for the purposes of this FOA.
Background
It is estimated that more than two-thirds of the 9.5 million annual cancer deaths in the world occur in LMICs. Furthermore, the incidence rate of cancer is on the rise in populations of many LMICs, with substantial inequalities in cancer survival rates across the world. Access to cancer prevention, screening, detection, diagnosis, and treatment is a significant challenge in many LMICs, especially in areas with limited infrastructure.
Prevention, early detection, and treatment are vital to successful cancer control. Unfortunately, many established cancer control technologies are not suitable for use in low-resource settings, either globally or in the U.S., due to expense, dependency on extensive medical infrastructure, or both.
Many leading edge, innovative technologies, such as lab-on-a-chip, portable ablative devices, portable imaging modalities, and liquid biopsies have potential for use in LMICs. Recent developments in consumer electronics, microfabrication, cellular phone communications, and hand-held computers have further improved prospects for adaptation into sensitive, low-cost versions suitable for use in low-resource settings. Additionally, various existing portable technologies and minimally invasive diagnostic/treatment methods might be suitable for low-resource settings.
The ACTs program supports resource-appropriate translational technology research for cancer where affordability and potential impact in low-resource settings are essential design components. Furthermore, technologies supported through the ACTs program are validated in real-world health settings in LMICs, leading to the promise of additional innovations (e.g., enable use by minimally trained health workers, appropriate for use at the clinical point-of-need, and allow robust adaptability to diverse environmental conditions and health systems). Lastly, the technologies advanced through the ACTs program may not only be relevant for LMICs but may additionally provide invaluable insights and tools appropriate for addressing cancer disparities domestically (i.e. urban and/or rural disparities).
Research Objectives
Applications in response to this FOA must propose to adapt, apply, engineer, and validate existing or emerging technologies or assays into a new generation of technologies and assays for preventing, detecting, diagnosing, or treating of preventable or treatable cancers in specific LMIC healthcare settings.
Projects is response to this solicitation may include, but are not limited to:
Scope
The project must focus on a specific cancer type that is preventable or treatable in the proposed LMIC setting and must show promise to deliver medical utility for improved health outcomes. Suitable technologies/devices/assays to be proposed for development/adaptation must be based on a working prototype or an existing device (which will serve as a basis for adaptation), demonstrating general feasibility of the proposed approaches. After program implementation, the proposed technologies/devices are expected to provide clear clinical utility to the specific LMIC healthcare delivery system. The technology must comply with the applicable regulations and international standards/guidelines [such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), WHO guidelines, FDA Investigational New Drug (IND), FDA Investigational Device Exemption (IDE)or local regulations in LMICs].
Note:
Cancers preventable/treatable in an LMIC Setting:
Because the focus of this FOA is translation, it is important that proposed technologies be targeted towards preventable or treatable cancers within the technical capabilities and resource restrictions of the LMIC. Where possible, investigators should consider how their proposed intervention fits within local cancer prevention and control needs and priorities.
Local Context:
The device design and application should consider local cultural sensitivities that may impede adoption of the technology if not properly accounted for and addressed. Investigators should consider cultural, environmental, societal and demographic issues, including, but not limited to, distance to care, aging in place, and urban versus rural contexts. Local health care delivery models, availability of other companion technologies needed as part of the proposed intervention, and issues around patient contact and follow-up also should be considered. Potential barriers to uptake related to previous community interactions with foreign researchers, including possible mistrust, should be considered as well.
Additionally, investigators should consider the broader health setting and other health priorities in the local context. Possible intersections of the proposed work with key communicable diseases or other co-morbidities should be considered where appropriate.
Community Engagement:
Building trust with research participants is an essential feature of ethical biomedical research involving human subjects, and NIH encourages ongoing community engagement to help establish and maintain this trust. ACTs awardees are expected to incorporate relevant community engagement into their research activities. Community engagement can include approaches to empower communities to contribute to and become partners in the research and activities that engage diverse stakeholders to learn about and contribute to the projects.
Relevant technologies include but are not limited to:
In Vitro diagnostic assays or technologies: Point-of-Care analytics for complex samples such as blood, saliva, or urine (e.g., lab-on-a-chip and biosensors that allow the performance of relevant chemical and/or biological assays outside of laboratory environments);
Imaging technologies: Portable, sustainable modalities for cancer detection, diagnosis, and treatment monitoring at the point-of-need (e.g., optical imaging, spectroscopy, and ultrasound). Further possibilities include leveraging machine learning algorithms to aid in image analysis, segmentation, integration of large data sets or other to evolve the clinical utility of artificial intelligence for cancer imaging. This can include the integration of modern computational or informatics methods (e.g., machine learning/vision, deep learning, neural networks, Machine Intelligence , integrated bioinformatics, predictive analytics, etc.) into preclinical and clinical imaging methods to enhance/optimize utility to detection, diagnosis, workflow, or treatment monitoring.
Treatment-related technologies: any type of treatment modality as well as technologies/devices that may aid/facilitate standard treatment modalities. In particular, tools for various, potentially portable, minimally invasive treatment methods are appropriate, including, but not limited to surgical devices, technologies related to drugs/vaccines/chemotherapy/immunotherapy, and tools for cryotherapy and laser therapy, radiofrequency ablation, low-power-density sonication, high-intensity focused ultrasound, and photodynamictherapy.
Note: The proposed technology may be lab-based, where appropriate. In this case, it is incumbent upon the applicant to address the availability of the lab equipment required, affordability and stability of reagents, and the technical expertise of local staff.
General Technology Characteristics:
The proposed technology should represent the state-of-the-art in terms of comparable technologies available in the local health setting.
Investigators must explicitly consider potential for adoption and scale-up in the local LMIC context as design criteria for technologies proposed in applications responding to this FOA:
Additionally, design-thinking around usability at the point-of-need should be explicitly addressed for all proposed technologies. Such device characteristics may include the following:
Specific Desirable Attributes
Device Pre-requisites and Preliminary Data:
The applicants must have a working prototype or an existing assay/device (not necessarily already used for cancer applications) and preliminary data to demonstrate its potential for preventing, detecting, diagnosing, and/or treating cancer in people in LMIC settings.
Technology Development and Validation Studies in LMICs:
This funding opportunity is focused on translational technology research and includes both engineering and design components as well as clinical validation at the point-of-need in an LMIC. Because of the broad scope of this FOA, it is expected that applicants will propose technologies that vary in readiness (beyond the initial prototype requirements stated above). As such, it is up to investigators to clearly delineate the engineering/design components of the project, define clear quantitative milestones for readiness to move into clinical validation studies, and design these studies.
Investigators are to adapt, apply, and/or engineer an existing prototype or existing device/assay/treatment for use in a low-resource setting. Applicants will have to demonstrate the analytical and clinical performance of the assay or technology for cancer, as well as its potential suitability for use in a low-resource setting.
Considerations for this phase of work include:
Note: The goal of this work is translational in nature, rather than being focused on early stages of technology development. Therefore, if a detection application relies on novel biomarkers, these biomarkers should have been previously validated or be currently in use in clinical settings for the cancer in question.
All the projects must include appropriate clinical studies to validate the use and benefits of the technology/device/assay/treatment and establish the device’s potential clinical utility in the targeted low-resource environments. The validation studies must be conducted in LMICs.
Expected outcomes of this phase of work include:
All projects will be routinely assessed by NCI program staff to track the following:
Trans-network Interactions and Program Governance:
The awardees supported under this FOA will be required to be members of a Steering Committee (for details, see Section VI.2. Cooperative Agreement Terms and Conditions of Award).
Researchers uncertain as to whether their intended technology development project meets the requirements of this FOA are strongly encouraged to contact the Scientific/Research Contact listed below.
Non-Responsive Projects
The following aspects/characteristics remain outside the scope of the ACTs Program and this FOA. Applications proposing projects with any of the following characteristics will not be reviewed:
The following aspects/characteristics remain outside the scope of the ACTs Program and this FOA. Applications proposing projects with any of the following characteristics will not be reviewed:
As there are several unique review considerations for this FOA, applicants must address the requested items outlined for the Research Plan in Section IV.2. Application and Submission Information. An application lacking appropriate milestones and timeline, as determined by the NCI program staff, will not be reviewed.
Additionally, NCI will hold a pre-application informational webinar for this FOA. Date, time, and other details will be posted at: http://www.cancer.gov/aboutnci/organization/global-health/events.
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.
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.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
NCI intends to commit $4.0 million to support up to six awards in FY2022.
Applicants may request up to $475,000 in direct costs per year.
The proposed project period must not exceed 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.
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
For-Profit Organizations
Local Governments
Federal Governments
Other
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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
Individuals from both the high-income countries (HIC), such as the U.S., and the LMIC institutions are eligible PDs/PIs. The main collaborating individual(s) from the proposed HIC and LMIC institutions must serve as PDs/PIs or other key personnel. Multi-PI applications are encouraged.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
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:
The letter of intent should be sent to:
Paul C. Pearlman, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5354
Fax: 240-276-5820
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing 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.
All applications must have at least one LMIC researcher and at least one high-income country (HIC) researcher as key personnel. Since the global health technology field is multidisciplinary and cross-sectoral in nature, applicants should consider appropriate collaborations with researchers from diverse disciplines such as engineering, computer science, business, medicine, public health, and/or other relevant fields. In addition, applicants should consider partnering with individuals in public or private organizations, including health system entities, which could enable future research or implementation efforts within the relevant LMIC.
Combined, the multidisciplinary team must have expertise in the following areas:
Additionally, while not required, an industrial partner is encouraged to provide expertise in fabrication, help with governmental regulatory approvals including in-country regulatory expertise, and prepare, disseminate, and sustain the technology for clinical use.
R&R or Modular Budget
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, with the following additional instructions:
Specific Aims: Specific Aims should describe the overall goals of the entire application, including the proposed device adaption/engineering required for fielding in the LMIC setting as well as the proposed clinical validation study in the LMIC setting.
Research Strategy: Organize the Research Strategy in the subsections identified below:
1) Significance - in addition to the SF424 (R&R) Application Guide, include the following:
2) Preliminary Data
3) Shared Leadership of the Investigator Team in an LMIC setting
4) Approach- in addition to the SF424 (R&R) Application Guide, include the following:
Technology Development - address each of the items listed below.
Clinical Validation - address each of the items listed below.
Furthermore, applicants should highlight plans for the translation and delivery of the research findings to appropriate audiences through broad stakeholder engagement and include plans for ongoing and future community engagement activities and their potential benefits to relevant communities.
Milestones and Timelines
A timeline (Gantt chart) including milestones is required for the project duration. Milestones are goals that create go/no-go decision points in the project and must include clear and quantitative objective criteria for success. Annual milestones should function as indicators of a project's continued progress, thus revealing emergent difficulties, and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years.
Milestones/quantitative performance measures should be well-defined in the application. For examples of appropriate milestones, seehttps://imat.cancer.gov/applicant-resources/specific-application-requirements. At the end of the "Approach" section, milestones and timelines should be provided under separate headings. The following are particularly important:
Letters of Support: A letter of support from the LMIC clinical site(s) is required and should include information about the organization's technical and clinical expertise and capabilities, which populations are served, other funding sources, plans to deploy the technology in the stated setting, and other relevant information.
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:
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.
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 (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.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. 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.
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:
This FOA is focused on new technologies or modifications of existing technologies that can have a significant impact on cancer detection, diagnosis, monitoring, and treatment in limited resource settings, such as those often encountered in low- and middle-income countries. Therefore, the potential of the proposed projects to result in a tool useful for a specific cancer-related clinical need of the targeted LMIC and suitable for an LMIC setting is essential and will be emphasized in assessing the overall merit of the applications. Priority will be given to technologies that are likely to be sustainable and projects with a high potential for fast, low-cost application in low resource settings.
In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
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).
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.
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:
Does the technology proposed address an appropriate cancer problem that is significant in the proposed settings of a given LMIC? What is the potential of the proposed technology to be sufficiently and broadly adopted by local healthcare providers in the proposed setting? How directly will the technology inform potentially actionable strategies to reduce cancer morbidity/mortality in the LMIC setting?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
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?
Specific for this FOA:
Do HIC and LMIC investigators appropriately contribute to the proposed research activities (i.e., is there parity in the collaboration)? Is the team's expertise appropriate and sufficiently diverse to effectively manage the steps necessary to develop and test the technology in the chosen low-resource settings? For example, does the team include appropriate expertise for assay/device/treatment development including engineering, oncology, and site-specific global health expertise? What is the likelihood that all the collaborators and partners will be able to work together to effectively complete translation of the proposed technology for broader application in the global health setting?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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 innovative are the proposed approaches in terms of combining low cost (at the manufacturing and operation levels) with functionality and usability in the selected low-resource setting?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
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 coherent is the plan to develop, test, and validate a technology/ assay/device/treatment that has potential for clinical utility in the chosen LMIC setting?
How appropriate is the design of the clinical validation trial (e.g., in terms of sufficient statistical power to assess the clinical effectiveness of the technology)? Does the application describe appropriate strategies for community engagement with clear objectives of what they expect to achieve?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific for this FOA:
Is the range of proposed collaborations sufficient in terms of including appropriate organizations in the HIC and the LMIC site? How appropriate is the foreign site in the LMIC for the proposed validation trial? Are the commitments of all partnering institutions sufficient for the conduct of the proposed studies?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Milestones
Is the sequence of elements/steps in the project clearly defined, logical, and complete? Are milestones provided properly objective and quantitative whenever appropriate? Are these milestones well aligned with the specific aims? How realistic are these milestones and associated timelines? Are critical go/no go decision points and timelines well defined and appropriate?
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
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.
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.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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. 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) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
Awardees will retain custody of and have primary rights to the data, technologies, and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
The PI(s) will have the primary responsibility for:
NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The main activities of the NCI substantially involved staff members include but are not limited to the following aspects:
Steering Committee:
The awardees funded under this FOA will form a Steering Committee consisting of the following voting members:
Other NIH staff members may participate in the activities of the Committee as needed as non-voting members.
The Steering Committee will be responsible for communication and coordination among funded projects, including sharing ideas, logistics, and solutions to technical issues. When feasible and appropriate, the Steering Committee will seek to establish consensus on platform interoperability in areas such as control software, data analysis, communication protocols, and standard power sources. Other shared advice may include promise of clinical potential, manufacturability, regulatory issues, and deployment into local resource limited settings. The members of the Steering Committee will meet once a year in person and by conference calls as needed.
The Steering Committee, in collaboration with the NCI, will also be responsible for planning the scientific content of the annual investigator meeting.
Dispute Resolution:
Any disagreements that may arise in scientific and/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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Paul C. Pearlman, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5354
Email: [email protected]
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]
Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: [email protected]
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.