National Institutes of Health (NIH)
U01 Research Project Cooperative Agreements
See Notices of Special Interest associated with this funding opportunity
November 6, 2024 - This PAR has been reissued as PAR-24-325.
NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
This Funding Opportunity Announcement (FOA) solicits applications from research partnerships formed by academic and industrial investigators to accelerate the development and adoption of promising bioengineering tools and technologies that can address important biomedical problems. The objectives are to establish these tools and technologies as robust, well-characterized solutions that fulfill an unmet need and are capable of enhancing our understanding of life science processes or the practice of medicine. Awards will focus on supporting multidisciplinary teams that apply an integrative, quantitative bioengineering approach to developing technologies. The goal of the program is to support technological innovations that deliver new capabilities which can realize meaningful solutions within 5 10 years.
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 |
| May 26, 2022 | May 26, 2022 | September 07, 2022 * | November 2022 | January 2023 | April 2023 |
| September 26, 2022 | September 26, 2022 | January 09, 2023 | March 2023 | May 2023 | August 2023 |
| May 26, 2023 | May 26, 2023 | September 07, 2023 * | November 2023 | January 2024 | April 2024 |
| September 26, 2023 | September 26, 2023 | January 08, 2024 | March 2024 | May 2024 | August 2024 |
| May 24, 2024 | May 24, 2024 | September 06, 2024 | November 2024 | January 2025 | April 2025 |
| September 26, 2024 | September 26, 2024 | January 07, 2025 * | March 2025 | May 2025 | August 2025 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
- Use the NIH ASSIST system to prepare, submit and track your application online.
- Use an institutional system-to-system (S2S) solution to prepare and submit your application
to Grants.gov and eRA Commons to track your
application. Check with your institutional officials regarding availability.
- Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
Purpose
This Funding Opportunity Announcement (FOA) solicits applications from research partnerships formed by academic and industrial investigators to drive the development and speed the adoption of promising bioengineering tools and technologies that can address important biomedical problems for which insufficient or no solutions exist. The partners on each application will establish an inter-disciplinary, multi-institutional research team to develop these tools and technologies as robust, well-characterized solutions that fulfill an unmet need. Collaboration with an industrial partner is required. The use of engineering principles is encouraged to establish integrative, quantitative, and innovative bioengineering approaches to developing technologies that are capable of enhancing our understanding of life science processes or the practice of medicine. The intended outcome is technological innovations that deliver new capabilities which can realize meaningful solutions within 5 10 years. Developing a technology is expected to require innovation, but novelty in and of itself is not a primary requirement.
Background
For many years, the NIH has recognized that the application of principles and techniques from physics, mathematics, chemistry, computer sciences, and engineering can be used to solve significant biomedical problems, leading in turn to new understanding of biological processes, novel products, and innovative tools to improve health. Such solutions typically require inter-disciplinary, multi-institutional partnerships to combine strengths unique to each group to accelerate the development and adoption of promising bioengineering technologies. Moreover, it is essential to engage industry for the eventual broader application and adoption of the technologies and tools by end-users in the medical community to realize the full potential and bring the benefits of these technological innovations to patients.
Partnerships expand access to a range of resources and facilitate problem-solving from initiation through validation, a Federally required approval process, to market delivery and clinical use. For example, technology testing and validation often require specialized animal research facilities and/or clinical settings with patients and clinical expertise. These resources are common in many academic settings, but unusual for most industrial environments. Academic investigators may also experience barriers. They often focus on the discovery phase of an invention with the typical priorities set on the demonstration of feasibility (a proof of principle studies) and publication of their findings. The tasks of robust system engineering and validation studies that would eventually lead to a broader application and acceptance of the technologies by end-users in the medical community are usually considered to be part of product development process. Moreover, by establishing the academic-industrial team, combined diverse expertise and points of view of the participants become a unique resource that may considerably facilitate and accelerate solving diverse problems associated with the inception and development of new ideas. The partnership model is expected to more readily overcome various barriers to accelerating the development and adoption of promising tools and technologies faced by either academia or industry working alone.
Objectives
The primary objective of this FOA is to support Bioengineering Partnerships with Industry (BPI) to: 1) establish a robust engineering solution to a problem in biomedical research or the practice of medicine; 2) develop a strategic alliance of multi-disciplinary partners, one of which must be an industrial partner, based on a well-defined leadership plan; and 3) realize a specific endpoint and deliverables within 5-10 years based on a detailed plan with a timeline and quantitative milestones.
A distinguishing feature of this FOA will be the requirement of an appropriate academic-industrial partnership: a strategic alliance of academic and industrial investigators who work together as partners to identify and translate a technological solution to advance human health. These partnerships are expected to solidify pre-existing collaborations or spur the creation of new collaborations to drive the fields of bioengineering and biomedical imaging further than if they had not been formed.
Achieving the goal of the BPI program will likely require leveraging the expertise of engineering and the life, physical, or computational sciences. Engaging clinical researchers or clinician scientists in the relevant biomedical fields, when appropriate, is strongly encouraged, although not required.
Scope of the Program
Projects proposed in response to this FOA must propose to accelerate the development and adoption of promising, integrative, and quantitative bioengineering tools and technologies as robust, well-characterized solutions that can address an important and unmet biomedical need. Projects may span the development in the research settings, validation, translation into clinical settings as needed, and incorporation of these solutions as endpoints into research protocols to enhance our understanding of life science processes or the practice of medicine to benefit patients.
Funding may be requested to develop, adapt, enhance, optimize, validate, or otherwise accelerate the adoption of promising biomedical engineering solutions, but not for support of commercial production or later stage (Phase II or Phase III) clinical trials.
A project may bring together new or existing technologies to form creative and practical solutions that have the potential to be widely adopted and improve human health. To deliver practical solutions within the timeframe of 5-10 years, applicants are encouraged to use a design-directed research strategy with well-defined end goals and intermediate, quantitative milestones. Goals may include, but are not limited to, establishing proof of concept, pre-commercial prototype production, licensure, release of software packages, designs, or models, demonstrating the biological effectiveness of engineered constructs, elucidating the structural and functional relevance of biomolecules or tissues, first-in-human testing, or starting the investigational device exemption or investigational new drug process.
A Partnership typically consists of partners from multiple institutions or multiple departments from the same institution and industrial partners, with each partner bringing critical strengths to the project, and collaboration with an industrial partner is required. The team may require experience in technology development, appropriate model systems for validation, human factors research, regulatory approval, project management or commercialization to realize and disseminate a robust solution. Potential beneficiaries should be active participants in the partnership from the beginning, to provide assurance that proposed solutions will meet community needs. Partnerships with companies and industrial partners that have relevant expertise or may eventually engage in future commercialization or with organizations that can test and disseminate technologies are required under the Bioengineering Partnerships with Industry program. Each PD/PI or collaborator is expected to provide substantive contributions to the intellectual or technical aspects of the project as well as industrial manufacturing or commercialization expertise and should be clearly differentiated from team members who supply necessary but not unique components or services.
To be responsive to this FOA, application must include an academic-industrial partnership. Applications that do not include an academic-industrial partnership will not go forward to peer review. Additionally, projects must be consistent with the mission of one or more of the NIH Institutes or Centers (ICs) participating in this FOA. Investigators are strongly encouraged to contact the Scientific/Research contacts identified in this FOA to discuss the scope and relevance of their proposed project and guidance on the development of appropriate goals and milestones.
Institute statements of interest:
National Institute of Biomedical Imaging and Bioengineering
The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating engineering with the physical and life sciences to advance basic research and medical care. One way that this is achieved is through the support of research and development of new biomedical imaging and bioengineering tools and technologies to improve the prevention, detection, treatment, and monitoring of disease. NIBIB scientific program areas can be found at http://www.nibib.nih.gov/Research/ProgramAreas. NIBIB supports research from early-stage technology development through first in human demonstrations and early feasibility clinical studies.
NIBIB Guidance for Support of Clinical Trial Applications
NOTE: For this Funding Opportunity Announcement, NIBIB will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.
Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this FOA for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies (https://grants.nih.gov/policy/clinical-trials.htm) and consistent with the types of clinical trial applications that NIBIB supports.
Prior to funding an application, NIBIB program staff will contact the applicant to discuss the proposed timeline and go-no go milestones and any changes suggested by the review panel or program staff. A final timeline and approved milestones will be specified in the Notice of Award. Progress toward achieving the milestones will be evaluated by NIBIB program staff. Program staff may involve independent consultants or subject matter experts with relevant expertise. If justified, future milestones may be revised based on data and information obtained during the previous project period. If a funded project does not meet the milestones, funding for the project may be discontinued.
National Institute on Aging (NIA)
NIA is interested in applying bioengineering approaches to studies of brain aging and Alzheimer's Disease and AD-Related Dementias (AD/ADRD). As described in the AD/ADRD Research Implementation Milestones based on recommendations from the NIH AD/ADRD Research Summits, NIA is interested in supporting research aimed at enabling technologies and AD/ADRD monitoring. This includes studies of wearable technologies, high frequency data capture platforms to enable continuous monitoring of research participants, and technologies for monitoring individuals at all stages of AD/ADRD progression. NIA is also interested in supporting research on standardized diagnostic screening of MCI and dementia, practical applications of innovative technologies to support people living with AD/ADRD (telemedicine GPS, robotics, and social networking), biosensors and prosthetic devices to aid age-related cognitive decline, new technologies for sleep disorders in older persons, improved imaging technology to visualize neural activity during cognitive behavior in older adults, and development of high-throughput measuring and monitoring of neural function in 3D or organoid cultures of human brain cells.
NIA is also interested in potential applications of imaging technologies and associated computational and display tools to the biology of aging. Specifically, NIA seeks to promote imaging of any of the pillars or hallmarks of aging which include protein homeostasis, nuclear and DNA integrity, metabolism and mitochondrial quality control, cellular senescence, autophagy and cell death, and other proposed hallmarks as described in the literature. More specifically, NIA is interested in applications that compare unperturbed to altered aging, where the comparison is between whether there is an intervention that may include any of the numerous pharmacological, genetic, dietary and/or exercise interventions or other experimental paradigms that alter the apparent rate of aging. This may also be considered in the context of human populations, where possible, with a special interest in health disparities, comparisons among groups within the human population covering a range of multi-morbidities, the known progeroid syndromes or existing well-controlled study cohorts where there are rigorous data on health and behaviors. NIA is also interested in the application of imaging of aging to test whether short-term manipulations can be effective surrogates for longer-term studies of aging (e.g., acute versus chronic low-level stressors).
NIA also encourages small businesses developing technologies for the development and testing of innovative technologies that address aging and/or AD/ADRD.
National Eye Institute (NEI)
The National Eye Institute (NEI) supports a broad range of basic, translational and clinical research related to the health and disease of the eye and visual system. Research proposed should focus on the development of tools, novel therapies, or diagnostics for the treatment of visual system diseases and disorders. NEI will only support clinical trial applications for this FOA that fulfill the NIH requirements for either a mechanistic or minimal risk trials. A mechanistic trial is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. A minimal risk trial is one in which the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
National Cancer Institute (NCI)
NCI is interested in the translation of scientific discoveries and engineering developments into methods or tools that address problems in basic cancer research for the purpose of advance the understanding of cancer biology; or in applied cancer research for assessment of cancer risk, cancer prevention, diagnosis, treatment and/or disease management.
Examples of focused research areas include, but are not limited to:
- In vitro and in vivo imaging technologies
- Liquid biopsy technologies that are focused on known and emerging molecular and cellular entities in liquid biopsy for improving cancer detection, diagnosis and treatment, monitoring treatment response, assessing cancer risk, risk of recurrence, prognosis, and minimal residual disease
- Technologies for the detection and evaluation of cancers of unknown primary
- Technologies for neoantigen identification, including circulating dendritic cell-displayed antigens and neoantigens.
- Advanced technologies for circulating neoantigen-specific immune repertoire profiling
- Technologies to evaluate metastatic potential of circulating hybrid cells
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.
Renewal
Resubmission
Revision
New, resubmission, renewal, revision
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).
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
Federal Government
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
- Non-domestic (non-U.S.) Entities (Foreign Institutions)
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
- Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Attachments: Applicants are required to include a Leadership Plan. For applications that do not utilize Multiple PDs/PIs, this item must be uploaded as a separate attachment in pdf format with a filename that corresponds to the item (Leadership Plan). For Multiple PD/PI applications, the Leadership Plan should be uploaded using the Multiple PD/PI Leadership Plan attachment on the PHS 398 Research Plan form. Applications lacking this required item will be deemed incomplete and will not be reviewed.
The Leadership Plan is limited to 6 pages.
Leadership Plan: All applications are required to develop a strategic alliance of multi-disciplinary partners, one of which must be an industrial partner, based on a well-defined Leadership Plan. As part of the Leadership Plan, applicants are encouraged to build collaborations and partnerships among allied quantitative and biomedical disciplines. An organizational structure that clearly defines the partnership and relationships among the various components must be described in the Leadership Plan and illustrated in an organizational chart. This plan should also describe the governance and organizational structure of the leadership team and the research project, including communication plans, processes for making decisions on scientific direction, intellectual property, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators, including clear descriptions regarding the roles of the industrial partner(s). For publications, policies to address the ordering and recognition of authors, and decisions about what material to publish, consistent with the interests of commercial partners (where applicable) should be presented. Under terms and procedures to be defined in the Leadership Plan, the partnership has the responsibility and authority to use BPI funds in the most productive way to achieve the goals defined at the time that the award is made. To accomplish these tasks, the PDs/PIs can adjust funding among BPI participants to support new partners or to reduce support to existing partners as needed. Plans for enhancing the abilities and opportunities for investigators to work across disciplinary boundaries should also be included.
All instructions in the SF424 (R&R) Application Guide must be followed.
Biographical Sketch. Indicate experience in project management as well as assessing and meeting stakeholder needs.
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.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: The problems to be addressed and the timeliness and appropriateness of the solution must be stated concisely. Key milestones, uniqueness of the team, and the expected outcomes of the project, if successful, should be described succinctly.
Research Strategy: As part of the Research Strategy, applicants are asked to address the following points:
Note for Applications Proposing the involvement of Human Subjects and/or Clinical Trials: Use the Research Strategy section to discuss the overall strategy, methodology, and analyses of your proposed research, but do not duplicate information collected in the PHS Human Subjects and Clinical Trial Information form. The PHS Human Subjects and Clinical Trial Information form will capture detailed study information, including eligibility criteria; inclusion of women, minorities, and children; protection and monitoring plans; and statistical design and power. You are encouraged to refer to information in the PHS Human Subjects and Clinical Trial Information form as appropriate in your discussion of the Research Strategy (e.g., see Section 2.4 Inclusion of Women, Minorities, and Children).
Significance: Briefly describe the area of bioengineering research that is the focus of the BPI. Explain why a multidisciplinary multi-institutional approach with both academic and industrial participations is needed to realize a solution. Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice by providing new capabilities to users. Critically evaluate existing knowledge and approaches that have been or are being applied in the area and specifically describe how the proposed BPI approach will advance the field.
Innovation: Describe the innovative features of the proposed project, based on a coherent plan that applies integrative, quantitative bioengineering approaches to accelerating the development and delivery of new capabilities to fulfill an unmet biomedical need, including through the integration of proven approaches. Describe how the project develops new or brings together existing technologies to form creative and practical solutions that have the potential to be widely adopted and improve human health. For this announcement, innovation is defined as the likelihood to deliver robust, well-characterized tools that can be used in the research or clinical settings to enhance our understanding of life science processes or the practice of medicine.
Approach: Describe the preliminary results upon which the technical feasibility for the approach is established so that any risks present can be mitigated using engineering and project management principles. The robustness and reproducibility of preliminary results should be described along with independent validation or replication of results if available. Alternative interpretations of preliminary data, including relevant literature in support or disagreement with the results, should be described. Compare proposed performance specifications with current practice, such as sensitivity, specificity, reproducibility, reliability, portability, throughput, operability by biological researchers or healthcare workers, potential research or clinical utility and cost of acquisition and operation as applicable. Details for making the performance of technologies sufficiently selective, sensitive, or otherwise appropriate for the identified problem should be supported with quantitative benchmarks. Describe the multidisciplinary nature (consisting of both academic and industrial entities) of the approach. An integrative systems approach or a design-driven approach and their appropriateness for the proposed project should be described, including plans for collecting, analyzing, interpreting, and archiving data. Potential technical challenges and possible alternative approaches to achieve the aims of the project should be discussed. If the proposed BPI research is closely related to ongoing research, explain how the research activities of the BPI will complement but not overlap with the existing research. For projects that pursue feasibility in humans, the approach should describe contact with appropriate regulatory bodies and milestones for achieving regulatory approval.
Project Milestones, Timeline and Deliverables: To deliver practical solutions within the timeframe of 5-10 years, applicants must include as part of the Approach Section well-defined end goals and intermediate, quantitative Milestones, a project Timeline and Deliverables. Include quantitative milestones that briefly proposes indicators of progress at critical junctures, a schedule of tasks and events including responsible personnel, and/or other evaluative criteria. For each milestone, provide details on methods, assumptions, experimental designs, and data analysis plans (if applicable) to permit a thoughtful evaluation of precisely what will be achieved throughout the duration of the project. Quantitative criteria for success in the milestones may also be used for making go/no-go decisions and this should be specified. Applicants are encouraged to discuss impediments that could require a revision to the research plan, milestones, or timeline, with a discussion of alternative approaches.
Specific deliverables should be clearly described, which may include, but are not limited to, establishing proof of concept, pre-commercial prototype production, licensure, release of software packages, designs, or models, demonstrating the biological effectiveness of engineered constructs, elucidating the structural and functional relevance of biomolecules or tissues, first-in-human testing, or starting the investigational device exemption or investigational new drug process.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
All applications, regardless of the amount of direct costs requested for any one year, should address a:
Data Sharing Plan.
The plan should include details for sharing raw (unreduced) data with other researchers who may wish to analyze them independently, and include plans for disseminating resources. Investigators are expected to be aware of and abide by all applicable NIH guidance for sharing of research resources and data, consistent with existing laws, regulations, and policies. Please see https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm
There is no prescribed sharing approach for software produced by a project. However, reviewers will be asked to comment on the adequacy and effectiveness of plans based on their likely impact. Program staff may negotiate modifications of software sharing plans with the PD/PI before making recommendations on funding of an application.
All applications should describe plans for disseminating the techniques and technologies to end-users. The plan should complement the research and development strategy, and may involve additional partnership with industry, professional organizations, or community engagement.
Letters of Support: To highlight the clinical applicability and anticipated dissemination of new technologies and methods, it is encouraged to include letter(s) of support from university-based tech transfer office(s); industrial supporters or collaborators in support of the commercialization of the academic Intellectual Property associated with the aims of the research.
Organizational structure and leadership plan:
The arrangements for collaborations must allow administration of the joint effort as a single project. Describe the overall organization, major tasks each partnering organization will complete, and what contributions each partner will bring to the effort. Describe the extent an award under this FOA could advance the product or service far enough to attract sufficient, independent third-party financing and/or strategic partnerships in carrying out full commercialization. Include details on shared leadership, administration, cost sharing (if any), conflict resolution, as well as technical, pre-clinical and clinical responsibilities, as appropriate.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign Institutions
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions.
Foreign Institutions
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed. Applications lacking an academic-industrial partnership will not go forward to peer review.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
1. Criteria
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the 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 to this FOA: Does the inter-disciplinary, academic-industrial research team have sufficient complementary expertise to achieve the goals of the proposed project?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA: Does the application apply integrative or novel bioengineering approaches to accelerating the development and delivery of new capabilities to address an important biomedical problem?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 to this FOA: Does it appear that the partners could work together effectively? Does the governance and organizational structure appropriately describe the extent by which the collaboration and the proposed project could be accomplished? Are the roles of each partner clearly described and appropriate?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If 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?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Leadership Plan
Do the organizational structure and leadership plan of the project indicate an ability to meet the proposed goal(s) within 5 10 years? Does the information provided suggest an ability for the academic-industrial partners to effectively collaborate and manage multidisciplinary projects and address sensitive but critical go/no-go decisions in a team-based environment? Are the roles and administrative, technical, and scientific responsibilities for the project or program well delineated for the PDs/PIs and other collaborators, including clear descriptions regarding the roles of both the academic and industrial partner(s)?
Milestones, Timeline, and Deliverables:
Do the milestones describe clear, quantitative criteria for success that allow go/no-go decisions? Are the timelines proposed for achieving the milestones realistic and inclusive of necessary steps? Are specific the deliverables appropriate and would achieving the proposed milestones result in the accomplishment of the deliverables?
Study Timeline
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
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
One Competitive Renewal for an additional five years will be allowed for each awarded U01. For Renewals, the committee will consider the progress made in the last five-year funding period. Applicants for Renewals should be aware that BPI funding will not be extended past the end of the second funding award.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) 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.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific review , 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.
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
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 recipient 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).
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, 2 CFR 200, and other HHS, PHS, and NIH grant administration policies. The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
The Program Director/Principal Investigator will have the primary responsibility for: defining objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. Awardees are responsible for identifying specific, rigorous milestones and objective success criteria, quantitative where appropriate.
Recipientswill retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
Recipients agree to participate at least once a year in progress meetings that may be called and organized by IC staff.
Recpients are responsible for pursuing patent protection.
Recipients are responsible for providing progress reports that include experimental design, including assumptions that underlie the design of the experiments, the results of the investigations, interpretations of the results, and whether or not milestones have been met or exceeded. In cases when IC staff request raw data, awardees agree to provide those data.
Recipientsagree to communicate study reports, meeting minutes, and associated data packages if applicable, letters and other forms of communications with regulatory agencies, and other authorities if applicable.
NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An Institute program officer serving as Project Scientist will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice and coordination above and beyond the normal program stewardship role in grant awards, as described below. The IC Project Scientist will provide input on the milestones and make decisions regarding their finalization. The program officer will be responsible for technical monitoring of the project, such as approval of changes in experimental approaches, objectives, milestones and timelines; assessing progress against specified milestones and stated project timelines, as well as for recommending if further funds should be released to the project. However, the role of the Project Scientist will be to facilitate and not to direct the activities. It is anticipated that decisions on major changes will be reached by consensus between the PD(s)/PI(s) and the Project Scientist, and that Institute staff will be given the opportunity to offer input into this process. The Project Scientist may provide assistance by accessing Institute-supported resources and services.
Additionally, an Institute program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibility include:
Clarifying, negotiating and finalizing the milestones and timelines as well as attending any project-specific meetings called by the Project Scientist to discuss and resolve issues that may arise during the project period, which affect project performance and/or progress.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee for the investigators 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 disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16. Final decisions made by NIH regarding a discontinuation are not appealable.
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Guoying Liu, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone:301-594-5220
Email: [email protected]
Miguel R. Ossandon, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5714
Email: [email protected]
Leonid Tsap, Ph.D.
National Institute on Aging (NIA)
Phone: 301-402-7747
Email: [email protected]
Tony Douglas Gover
National Eye Institute (NEI)
Phone: 301-529-7370
E-mail: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Katie Ellis
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4791
Email: [email protected]
Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: [email protected]
Jessi Perez
National Institute on Aging (NIA)
Phone: (301) 402-7739
Email: [email protected]
Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: [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.
and Human Services (HHS)
