Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Library of Medicine (NLM)
U24 Resource-Related Research Projects – Cooperative Agreements
None
This Funding Opportunity Announcement (FOA) invites cooperative agreement (U24) applications for the Network of the National Library of Medicine (NNLM) All of Us Program Center (NAPC). The mission of the NNLM is to provide U.S. health professionals, researchers, public health workforce, educators, and the public with equal access to biomedical and health information resources and data. NNLM’s main goals are to work through libraries and other members to support a highly-trained workforce for biomedical and health information resources and data, improve health literacy, and increase health equity through information. The NNLM All of Us National Program Center (NAPC) will serve as the coordinating center and be responsible for the engagement, programs, partnerships, activities, and training offered by NNLM in support of the NIH All of Us Research Program. All of Us is working to improve health care through research by building a diverse database that can inform thousands of studies on a variety of health conditions. The NACP will continue to improve and innovate in two main functional areas: Training and Education, and Community Engagement. These two functional areas collaborate, coordinate, and cooperate to design, deliver, evaluate, and report on the innovativeness, responsiveness, and effectiveness of these programs and services. They also work together to increase awareness about the NIH All of Us Research Program and to improve the health, digital, and related literacy skills that allow the general public to participate in long-term clinical research programs.
August 17, 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| September 17, 2021 | Not Applicable | Not Applicable | December 2021 | January 2022 | May 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.
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.
The National Library of Medicine (NLM) is the world’s largest biomedical library and one of twenty-seven institutes and centers that form the National Institutes of Health (NIH). Each day, more than four million people use NLM resources such as PubMed, ClinicalTrials.gov, and MedlinePlus. In addition to disseminating the world’s biomedical research and providing trusted health information, NLM has a strong commitment to engaging with its diverse audiences. One of NLM’s innovative approaches to meeting the needs of its scholarly, clinical, and community stakeholders is the Network of the National Library of Medicine (NNLM).
The NNLM consists of seven Regional Medical Libraries (RMLs) and approximately 8,000 member organizations located throughout the US. The NNLM is supported by four Offices—Web Services, Training, Data Science, and Public Health Coordination— and several specialized Centers. Within their focus areas, the NNLM Offices and Centers serve critical roles, including: coordinators of national programs; communication; consensus-builders for NNLM-wide standards; and monitors of contents and outputs for quality and accuracy. The NLM Office of Engagement and Training partners with the NNLM to coordinate and serve as a liaison with NLM and other NIH Institutes. See the NNLM website and the NNLM Workbook for more information about the structure and functions of the NNLM.
The NNLM is a key partner in helping NLM achieve the vision outlined in the NLM Strategic Plan 2017-2027 “to reach more people in more ways through enhanced dissemination and engagement pathways.” The NNLM program supports NLM’s goal to enhance its research, development, training, and information services to make more biomedical data findable, accessible, interoperable, and reusable (FAIR), to invent the tools and services to turn data and information into knowledge and insight, and to develop the workforce for this work. To implement this vision, NNLM will require new partnerships and ways to engage with stakeholders in the public and private sectors, including researchers, librarians, health professionals, entrepreneurs and innovators, and the public, especially persons who experience health disparities and underrepresented populations.
The All of Us Research Program is part of an effort to advance individualized health care by enrolling one million or more participants to contribute their health data over many years. The program aims to reflect the diversity of the United States and to include participants from groups that have been underrepresented in health research in the past. The program is developing custom tools and software to help researchers analyze participant data while keeping information secure. Working together, All of Us researchers, partners, and participants aim to build a better future for health care.
The All of Us Research Program is guided by a set of core values:
Diversity and inclusion are core values of the All of Us Research Program. To meet the diverse needs of the U.S., All of Us is a multi-lingual program that offers engagements and information in languages other than English, at literacy levels that are understandable, and using inclusive and accessible design to meet the needs of all users. All of Us has program partners, including an Engagement Ecosystem, to reach participants across the U.S., in the communities they live. To ensure all of the U.S. is represented in biomedical and health research, All of Us seeks participation by populations Underrepresented in Biomedical Research (UBR). Participation by UBR populations can provide researchers with information about them that can reduce health disparities and improve health equity by broadening access. UBR populations are defined by: Race and Ethnicity; Age; Sex assignment at birth; Sexual and Gender Minorities; Income relative to the Federal poverty level; Educational attainment; Geography; Access to care; and Physical or mental disability. By studying data from a diverse group of people, researchers can learn more about what makes people sick or keeps them healthy. What researchers learn could lead to better treatment and disease prevention for All of Us.
In September 2017, the NLM initiated a pilot partnership with the NIH All of Us Research Program for the program’s community engagement and training platform through the NNLM. The pilot created the NNLM All of Us National Program consisting of two Centers: the Training and Education Center and the Community Engagement Center. Based on the results and impact of NNLM pilot activities, the partnership continues. More information on the background, history, and accomplishments of the NNLM All of Us National Program is available on the NNLM Workbook. The NAPC represents the next phase of that partnership.
Purpose
This Funding Opportunity Announcement (FOA) invites cooperative agreement (U24) applications for the NNLM All of Us Program Center (NAPC). NAPC will combine two main functions of training and education, and community engagement into one integrated, organizational structure. These two functional areas will collaborate and coordinate resources to design, deliver, report, and evaluate innovative, responsive, and effective programs and services. Robust community engagement and training structures are needed to build and maintain partnerships, administer subawards, provide technical assistance to subawardees, and serve as leaders in the All of Us Engagement Ecosystem consortia. Both functional areas will provide engagement programs and activities that (1) contribute to an individual’s or community’s awareness about All of Us and (2) increase ability to participate in research.
To support the All of Us mission and core value of diversity, the NAPC must engage effectively with populations that are underrepresented in biomedical research (UBR), working through libraries and community-based organizations across the U.S. In addition to partnering with All of Us consortia members, working with Minority Serving Institutions (MSIs) and community-based health programs to accomplish program goals is strongly recommended. All programs and projects must meet the needs of the partners and communities, as well as focus on the needs of UBR communities.
NAPC Community Engagement
The NLM seeks a dynamic program that delivers national and regional results by responding to the evolving All of Us and All of Us consortia partners’ user needs, the latest research on health information implementation and engagement, and effective partnership development and maintenance. The NAPC Community Engagement will focus on partnerships, diversity, equity, inclusion, and accessibility, and community-driven needs, using community-based participatory research approaches and other evidence-based methods. Each Community Engagement project, program, event, or activity must focus on All of Us in one or more of the following areas:
Responsibilities of the Community Engagement functional area include:
NAPC Training and Education
The NAPC will continue to offer a robust, responsive, and innovative training and education program for the All of Us consortia, libraries, and other community-based partners using a wide range of formal and informal learning approaches and methods. As the repository for All of Us educational content, the NAPC provides All of Us with a Training and Education Platform (TEP) which currently has over 1,200+ users, with 3,500+ course completions, and 11 courses. This functional area leverages existing infrastructure provided by NNLM Offices and Centers for the TEP and other programs and services: (1) the Moodle Learning Management System (LMS) maintained by the NNLM Web Services Office (NWSO); (2) instructional design and support resources of the NNLM Training Office (NTO); and (3) evidence, evaluation, and analysis support from the NNLM Evaluation Center (NEC).
A critical component of the training and education functional area is work in cooperation with the All of Us Consortium Training (ACT) Board to develop, maintain, and host national training for the Program. The ACT Board is a governance board which implements the Program's policy governing oversight of internal All of Us Consortium Training Resources. The ACT Board is responsible for assessing the training needs of AoU Consortium members and to ensure that appropriate training content is developed, deployed, and maintained to meet those needs. Annually, the ACT Board develops a project plan, as the result of All of Us priorities, needs assessments, and requests received. Quarterly, the Board prioritizes the training requests so that the NAPC can develop and deploy the most responsive training content to Consortium needs.
The NAPC will use a systematic process for program development (including pilot-testing) and implementation for the development, distribution, and evaluation of training. NAPC will provide leadership and management in the development of programs, activities, and other materials that must meet the needs of the partners and communities, as well as focus on the needs of UBR communities.
Training and education functional responsibilities include:
Technical Assistance Webinar and Support Materials
Thursday, August 5, 2021, 3:00 - 4:00 PM, Eastern Daylight Time (New York, GMT-04:00)
NLM will conduct a technical assistance webinar regarding RFA-LM-21-002 "Network of the National Library of Medicine All of Us Program Center (U24)." You can access the webinar via the URL listed above from a computer or mobile device. You can also listen in to the webinar via phone using the dial in number and passcode listed above. The meeting will review the purpose and objectives of the FOA, review application instructions, and address questions from the community concerning the FOA. All prospective applicants are invited to participate. Following the meeting questions and answers will be posted at http://www.nlm.nih.gov/ep/NAPCWebinar.html .
Additional information about the NNLM and the existing RMLs can be found at the NNLM website (https://nnlm.gov). Current operational procedures, evaluation methods, and reporting plans of the NNLM and the RMLs are found in the NNLM Organizational Workbook (https://nnlm.gov/workbook).
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?
NLM intends to commit $4,470,000 in FY 2022 to fund 1 award.
Applicants may request up to $3,200,000 in direct costs per year. Application budgets need to reflect the actual needs of the proposed project.
The proposed project period is 4 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 not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not 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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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:
Zoe Huang, MD
National Library of Medicine (NLM)
Telephone: 301-594-4937
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.
The following additional instructions must be followed:
Milestone Plan: The filename "Milestone Plan.pdf" should be used.
The applicant is required to provide detailed information and timelines for completing all necessary planned activities. Milestones should be easily measurable and realistic. These milestones will be negotiated at the time of the award, as appropriate. Applications that lack the Milestone Plan are considered incomplete and will not be peer reviewed.
Organization Plan: The filename "Organization Plan.pdf" should be used.
The application must describe how the NAPC will be organized and managed. This should include information on the leadership of the NAPC, the proposed work sites, and the ability of the PD/PI to bring together the necessary resources to support the operation of the NAPC. Provide a description of the NAPC organization and administration, including, but not limited to: a description of organizational structure needed to manage the complexity of the NAPC; the role of any internal or external advisory committees; and the oversight, responsibilities, and coordination of any organizational units proposed for the NAPC. If an advisory committee is planned, applicants should not contact or name potential advisory committee members. Applications that lack the Organization Plan are considered incomplete and will not be peer reviewed.
Stakeholder Engagement Plan: The Filename "Stakeholder Engagement Plan.pdf" should be used.
The application must describe stakeholder engagement activities already conducted and how these activities influenced development of the plan for the NAPC. Also, provide a summary of the stakeholder engagement activities planned for the development, implementation and evaluation of the NAPC. Applications that lack the Stakeholder Engagement Plan are considered incomplete and will not be peer reviewed.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R 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:
The NAPC should address the engagement, programs and activities, and training needs of public libraries, NNLM members, and community-based organizations, to raise awareness and participation in the NIH All of Us Research Program. The application should demonstrate a broad understanding of how to implement engagement, education, and training with populations underrepresented in biomedical research. Theories and practices that support evidence-based and evidence-informed community engagement should be discussed as methods for community-driven and community co-developed activities and programming. Theories and practices that are associated with education, training, and human centered design should be discussed as development, testing, and validation methods for community-focused design. All approaches should detail community partnership, including memorandums of understandings, with clear role of partners. For new methods of community engagement and training, a standardized process should be described for systematically documenting and validating the methods.
Describe plans for the NAPC to:
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.
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 the National Library of Medicine, 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.
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?
Does the proposed Center foster a robust program that delivers engagement, programs and activities, and trainings to diverse stakeholders across the U.S.?
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?
Does the project team have experience in coordinating complex engagement and training programs involving multiple sites and working with partners to establish and implement joint goals? Does the project team have experience with programs that focus on diverse participant populations and communities affected by health disparities, including those underrepresented in biomedical research (UBR)?
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?
Does the application propose evidence-based, evidence-informed, novel, or cutting-edge methods, techniques, or approaches to community-based participatory research and engagement and elements of human centered design?
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?
Does the application clearly describe the role of staff and consultants, and technology in designing and delivering engagement, programs and activities, and trainings to the multiple end user groups? Does the plan include a data driven decision strategy to allocate resources and evaluate outcomes to meet the needs of multiple stakeholders/end users, and programmatic needs? Does the application include a clear plan for disseminating program impact and results to multiple stakeholders including the general public?
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?
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.
Are the proposed milestones appropriate for the DAPC? Will they allow meaningful tracking of DAPC performance and are they feasible for the work proposed?
Organizational Plan
Does the Organizational Plan provide information that indicates that the DAPC will be well managed, have sufficient resources, and structured in such a way to facilitate the success of the development, implementation and evaluation of the DAPC?
Stakeholder Engagement
Does the stakeholder engagement plan reflect meaningful interaction with all relevant stakeholders, including a discussion of how information from meetings with stakeholders will be used and how bidirectional discussion and communication will occur?
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
Not Applicable.
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 the National Library of Medicine, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Library of Medicine's Board of Regents. The following will be considered in making funding decisions:
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 (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) primary responsibilities
The PD/PI will agree to accept the close coordination, cooperation, and participation of the NLM staff (Project Scientists (PS), Project Coordinator (PC), Program Official (PO) and other appropriate NLM staff) in those aspects of program and technical management of the project as described below. Specifically, the PD/PI supported by the Cooperative Agreement will:
NIH program staff provides scientific technical assistance and advice to recipients of cooperative agreements during the conduct of an activity, above and beyond the levels required normally for program stewardship of grants, but without dominating the relationship, as described below.
Project Scientist (PS) Responsibilities
One or more designated NLM staff members, acting as Project Scientist (PS), will have substantial programmatic involvement. The role of the PS will be to facilitate and not to direct. This includes facilitating the partnership and collaboration between NAPC, RMLs, Offices and Centers, national partners, and NLM. The PS role includes helping to maintain the overall balance in the program commensurate with the functions and scope of the program’s activities, facilitating communication and coordination, and ensuring that the activities of the awardees are consistent with the mission of the NNLM. Specifically, the NLM Project Scientist(s):
Project Coordinator (PC) Responsibilities
The Project Coordinator will work in partnership with awardees, PSs and the PO to help coordinate activities and resources across the NAPC program to ensure effective and efficient performance of the aims and mission of the NAPC. Specifically, the NLM PC:
Program Official (PO) Responsibilities
The PO is the NIH official responsible for the programmatic, scientific, and/or technical aspects of the award that provides normal program stewardship of the award. The PO will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. The PO may use information obtained from the data for the preparation of internal and external reports on the activities of the project. The PO will work in partnership with the PC and PSs in regards to providing technical assistance to the NAPC. Normal PO stewardship includes:
Enforcement of general statutory, regulatory, or policy requirements;
Areas of Joint Responsibility include:
The PD/PIs of the NNLM RMLs, Offices and Centers, and the PSs and PC will be jointly responsible for the coordination and collaboration of NAPC activities and the integration of individual projects with other appropriate NLM programs. Joint responsibilities include:
Steering Committee(SC)
The Steering Committee (SC) will provide overall integration among NNLM RMLs, Offices and Centers (including NAPC), and network partners. It will also serve as an interface between the individual projects funded under this FOA and appropriate NLM programs. The SC will consist of the PD/PI for each NNLM RML, heads of the Offices and Centers (including NAPC), and the PC. The PSs and the PO will be nonvoting members. When appropriate, the SC may include representatives from outside working groups and NLM staff who will be nonvoting members. The SC Chair will be elected from among the NNLM voting members, but may not be an NLM or NIH staff member. Additional information about the NNSC and current procedures is available in the NNLM Organizational Workbook.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
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]
Alan VanBiervliet, MA, PhD
National Library of Medicine (NLM)
Telephone: 301- 594-4882
Email: [email protected]
Zoe Huang, MD
National Library of Medicine (NLM)
Telephone: 301-594-4937
Email: [email protected]
Samantha J. Tempchin
National Library of Medicine (NLM)
Telephone: 301-496-4221
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.
Awards are made under the authorization of Federal Regulations 42 USC 286b-6 and under Federal Regulations 42 CFR Part 59a.