EXPIRED
National Institutes of Health (NIH)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. ORWH may co-fund applications assigned to those Institutes/Centers.
U24 Resource-Related Research Projects Cooperative Agreements
January 3, 2024 - Notice of Early Expiration of RFA-OD-23-004 Advancing Gender Inclusive Excellence (AGIE) Coordinating Center (U24 Clinical Trial Not Allowed)". See Notice NOT-OD-24-052
NOT-OD-22-195 New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023
NOT-OD-22-189 Implementation Details for the NIH Data Management and Sharing Policy
NOT-OD-22-198 Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023
NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
The National Institutes of Health (NIH) Office of Research on Women’s Health (ORWH), in collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), intends to promote a new initiative by reissuing RFA-OD-21-010, "Advancing Gender Inclusive Excellence (AGIE) Coordinating Center (U54 Clinical Trial Not Allowed)" to invite applications for an Advancing Gender Inclusive Excellence (AGIE) Coordinating Center (U24 Clinical Trial Not Allowed).
The purpose of the AGIE Coordinating Center will be to provide the organizational framework for the management, direction, and overall coordination of all common activities aimed at investigating strategies, approaches, and interventions promoting gender equity or addressing barriers to gender equity, including for women, at the faculty and leadership levels in many areas of science, technology, and engineering.
April 28, 2023
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
May 31, 2023 | May 31, 2023 | Not Applicable | November 2023 | January 2024 | April 2024 |
January 31, 2024 | January 31, 2024 | Not Applicable | July 2024 | August 2024 | September 2024 |
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.
Purpose
The Office of Research on Women's Health (ORWH) in collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to promote a new initiative by reissuing RFA-OD-21-010, "Advancing Gender Inclusive Excellence (AGIE) Coordinating Center (U54 Clinical Trial Not Allowed)" to solicit applications for an Advancing Gender Inclusive Excellence (AGIE) Coordinating Center (U24 Clinical Trial Not Allowed).
The purpose of the AGIE Coordinating Center will be to provide the organizational framework for the management, direction, and overall coordination of all common activities aimed at investigating strategies, approaches, and interventions promoting gender equity or addressing barriers to gender equity, including for women, at the faculty and leadership levels in many areas of science, technology, and engineering.
Background
Though parity is being reached between men and women at the graduate level in the biomedical sciences and in medical schools, women remain underrepresented in Science, Technology, Engineering, Mathematics, and Medicine (STEMM) faculty and leadership ranks. Underrepresentation of women faculty is particularly severe in the mid- to senior-level and leadership ranks, but women may also be underrepresented at other faculty ranks in some scientific disciplines. For example, a reported 22% of U.S. medical school department chairs were women in 2021. This compares with almost 48% of U.S. medical school graduates reporting they are female in 2018/19 and female having been 30% or more of medical school graduates since 1984/85.
Advancing scientific progress requires a well-trained, diverse, and robust STEMM workforce. The NIH recognizes the important role of organizational change strategies to enhance diversity and gender equity in STEMM academic and research careers. Through NIH funding, our understanding has increased about the systemic and organizational factors that impact gender equity. For example, the NIH funded a 2009-2013 grant program, Research on Causal Factors and Interventions that Promote and Support the Careers of Women in Biomedical and Behavioral Science and Engineering. A summary of this research can be found on the ORWH website at: https://orwh.od.nih.gov/about/director/messages/research-shows-us-how-address-underrepresentation-women-academic-medicine. On behalf of the NIH Working Group on Women in Biomedical Careers (WgWBC) and in collaboration with NIH Institutes, Centers, and Offices (ICOs), ORWH is working to end systemic gender-based inequities impacting the academic and research workforce in STEMM.
The research conducted under the AGIE Coordinating Center will aim at providing a more inclusive environment to enhance gender equity in retention and advancement at the faculty and leadership levels in the STEMM academic and research workforce. The primary vision for the AGIE Coordinating Center is to ensure collaborative coordination of data collection and the AGIE Coordinating Center will serve as a means for developing and operating as a centralized resource hub to collect, store, and disseminate resources for and results of current and future programs. The research is anticipated to include diverse research designs, approaches, and multidisciplinary and interdisciplinary academic disciplines and target different or multiple organizational levels (from interpersonal to departmental to institutional). NIH encourages applications that include diverse groups that can aid in understanding and investigating the intersectionality issues faced in these research areas.
The AGIE Coordinating Center will also serve as a hub to house evidence-based and evidence-informed strategies aimed at various levels of an institution that promote gender equity including in recruitment, retention, and advancement of women in the biomedical research workforce, particularly at the faculty and leadership levels. The AGIE Coordinating Center will establish effective collaboration methods for partnering with stakeholders and institutions to effect change.
Research Objectives and Scope
The AGIE Coordinating Center will be responsible for the administration and management of a Pilot and Feasibility Studies program (expected to start in year two (2) of the agreement). The AGIE Coordinating Center will lead, coordinate, manage, and harmonize the research work conducted under the Pilot and Feasibility Studies program among the Pilot and Feasibility Studies program implementers and with its own research work. The AGIE Coordinating Center will support the provision of quality assurance and monitoring, and function as a central repository for data and other tools and resources across NIH programs. Specifically, the AGIE Coordinating Center will:
Expected outcomes from the project period will be:
Project Organization
The efforts of the AGIE Coordinating Center will be governed by an External Steering Committee (ESC) composed of the PD(s)/PI(s) of the awarded cooperative agreement and at least five total outside experts convened to provide unbiased scientific and programmatic oversight (see under Section VI, Cooperative Terms and Conditions). The ESC will collaborate to share best practices; develop relevant common programming; provide networking and other opportunities; and to develop an evaluation for the overall and program-specific components of the consortium. The ESC will meet at least two times per year; one of these meetings should be held in-person in the Bethesda, MD area if possible given pandemic conditions, while the other meeting(s) can be virtual. The ESC will also establish defined metrics to permit evaluation of the program components. It is expected that the ESC will disseminate best practices, recommendations, and lessons learned from the program to the broader research community or to inform NIH of potential future directions and the field. NIH anticipates that the ESC will participate in the evaluation of the Pilot and Feasibility Program. The ORWH Advisory Council will provide oversight, which will act as an advisory to the ORWH.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
The following NIH components intend to commit the following amounts in FY 2024:
ORWH, $500,000 and
NIDDK, $100,000
Application budgets should not exceed $400,000 in direct costs per year for five years, and need to reflect the actual needs of the proposed project.
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
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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
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.
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:
Benjamin Johns, Ph.D.
Office of Research on Women’s Health
Email: benjamin.johns@nih.gov
Tel: 301-435-1681
Page Limitations
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.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide 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.
SF424(R&R) Project/Performance Site Locations
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.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Statement of Willingness:
This statement should be provided as an PDF attachment and should be entitled Willingness . It is expected that the PD(s)/PI(s), as well as the applicant institution, have a commitment to serve the AGIE Coordinating Center objectives as outlined in this FOA. Thus, applicant(s) should provide a statement counter signed by the Department Chair indicating their willingness to:
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
The Center Director(s) (PD/PI) should be an established investigator in biomedical workforce development with relevant publications. Interdisciplinary teams are encouraged to apply.
The PD/PI is responsible for ensuring that AGIE Coordinating Center goals are met, for developing and managing a decision-making structure, and for allocation of resources to achieve stated goals. If named, the Associate Director will partner with the PD/PI to facilitate and advance the goals of the Center.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working for the AGIE Coordinating Center.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
The PD(s)/PI(s) will be required to declare a minimum effort of 1.95 person-months (15 percent) effort per year. Applications proposing Multiple PD(s)/PIs(s) must have a minimum combined PD/PI effort of 1.95 person months, and the role of each PD/PI should be clearly defined. Applications that do not propose this minimum effort will be withdrawn and will not be reviewed. The AGIE Coordinating Center may also include administrative assistant(s) and specialized support personnel (e.g., central repository developer) and be clearly justified.
Applicant(s) should also include:
Support for a Pilot and Feasibility Program of about $250,000 or more per year (inclusive of all F&A costs) over three years that will enable the conduct of research and the formation of new collaborations and partnerships. The AGIE Coordinating Center should not calculate F&A on Pilot and Feasibility Program set aside. Rather, the AGIE Coordinating Center should budget for costs associated with the administration of the Pilot and Feasibility Program (including key personnel). The AGIE Coordinating Center is also entitled to F&A costs on the first $25,000 of each subaward made from the Pilot and Feasibility Program. Please note that the F&A costs for the subaward institution are included in the total costs of each subaward.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: This section should include the overall aims of the AGIE Coordinating Center. These should be overarching and should include a vision for how the Center will enable future institutions that are undertaking studies under the Pilot and Feasibility Program to: (1) Provide data on strategies and approaches to promoting gender equity at the faculty and leadership levels of the biomedical research workforce; (2) Work with experts to assess validity and reliability of the evaluation/assessment and of the data for any newly developed strategies or approaches; (3) Obtain information on the types of evidence-informed or evidence-based programs that exist and information on concerns staff need to address as programs are implemented; environment where the original strategy was implemented; and any other validity or reliability data available; and (4) Obtain training or connect with other experts in the field to provide guidance, recommendations and assist in the development or implementation of strategies.
Research Strategy: The Research Plan should outline strategies 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:
Regardless of the amount of direct costs requested for any one year, applicants are expected to refer to the Implementation Details for the NIH Data Management and Sharing Policy notification (NOT-OD-22-189) and related announcements. Concerns, governances, policies, and procedures set forth in this notice around data collection, integrity, storage, security, etc. should be addressed in the application. NIH has issued a Data Management and Sharing notification (NOT-OD-22-189) and applications in response to this FOA should be responsive to this notification. Specifically, consistent with achieving the objectives of the AGIE Coordinating Center, all resources, tools, technologies, protocols (including analytical methods), and other research resources are to be made publicly available to the larger national research community as soon as QA/QC procedures have been completed, and in accordance with the policies developed by the AGIE Coordinating Center.
The application is expected to include the development and maintenance of an outward facing central repository to disseminate information on existing evidence-informed strategies that may identify and address any barriers to gender equity at the faculty and leadership levels in the biomedical research workforce. The central repository would house information on the cost, methods, outcomes, modality, expertise needed, target population, barriers to implementation, etc. and, where possible, information on obtaining data from studies that implemented these strategies. Where possible:
ORWH and NIDDK will make all final decisions concerning resource sharing and data access policies, and all policies are subject to change by the NIH as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within the project.
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 application forms packages.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
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.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
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
4. Submission Dates and Times
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.
6. Funding Restrictions
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.
7. Other Submission Requirements and Information
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 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 provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
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.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy
1. Criteria
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.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.
For this particular announcement, note the following:
Reviewers are asked to especially consider the justification of the following:
The methodologies and approaches proposed in the application may not be innovative but should address the AGIE Coordinating Center needs in achieving its goals and objectives.
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 proposed Center address the needs of the research programs that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program?
Specific to this FOA: Will the proposed administrative support and project management enable the AGIE Coordinating Center to lead, coordinate, manage, and harmonize the research work investigating the systemic and organizational factors that impact gender equity? Do the plans appropriately involve developing a central repository to provide evidence-based information and resources to interested parties? Is the evaluation plan appropriate and is it likely that the evaluation plan will inform ongoing and future research efforts?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing organizational and institutional research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
Specific to this FOA: How appropriate is the PD(s)/PI(s) experience in managing multi-site evaluation activities? Is the PD(s)/PI(s) experienced with programs that focus on the issue of gender equity in faculty and leadership positions in the STEMM academic and research workforce? Have the PD(s)/PI(s) demonstrated leadership in coordinating data collection activities across multiple sites?
Does the application propose novel management strategies in coordinating the research program the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of management strategies proposed?
Specific to this FOA: How innovative or appropriate are the proposed strategies to evaluate the knowledge generated through the research to inform institutional policies, programs, and practices? Do they detail the types of knowledge that will be generated by looking across the different trials and the literature? Are proposed strategies appropriate for this kind of research?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
Specific to this FOA: Is there a clear and logical organizational and governance structure, including the composition and roles of committees? Are the dissemination plans feasible and likely to be widely available / have a national influence? Is infrastructure to support communication and the central repository activities described? Is the central repository sustainable and easily managed, maintained, and updated? Will the central repository lend itself to ease of use?
How appropriate are the proposed plans for national Pilot and Feasibility Program that include organization of the overall process of solicitation, review, selection, administration, and monitoring of these Programs? How appropriate are the plans to actively monitor and report QA/QC for all resources?
Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
Specific to this FOA: How appropriate is the institutional record of leading, coordinating, managing, and harmonizing a highly collaborative research network? How appropriate is the institutional record of fostering an inclusive research environment?
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.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.
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.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
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.
For Renewals, the committee will consider the progress made in the last funding period.
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.
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.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.
Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For programs involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
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.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
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:
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 will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. 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.
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 the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 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 recipient is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipient's 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 reside with the recipient for the project as a whole, although specific tasks and activities may be shared among the recipient and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
Any third-party collaboration (including but not limited to interactions with organizations from industry, academia, and nonprofit institutions) should be governed by a research collaboration agreement (e.g., Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, and with written approval from NIH Program staff. Any relevant proposed third-party agreements between the grantee and the third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies. Further, at the request of the NIH Program staff, any other network-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions , and Section 8.5.2, titled: Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support , noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.
Any involvement of a third-party (including but not limited to industry, academia, and nonprofit institutions) in the study and Pilot and Feasibility Program activities that includes access to any Pilot and Feasibility Program generated resources (i.e., data and biosamples), or study results that are not publicly available, or using the name of the NIH or NIDDK, is permitted only after written permission by the NIDDK Program staff who will consult with others at NIH and NIDDK Technology Advancement Office.
Support or other involvement of industry or any other third party in the study (e.g., participation by the third party; involvement of project resources or citing the name of the study or NIH support; or special access to project results, data, findings, or resources) may be advantageous and appropriate. However, except for licensing of patents or copyrights, support, or involvement of any third party will occur only following notification of and concurrence by NIH.
Recipient will adhere to the NIH policies regarding intellectual property, data release and other policies. If additional policies are established during the course of this activity, they must be consistent with applicable NIH policies, laws, and regulations.
Resource Management and Sharing Plan:
The NIH-approved plan will become a term and condition of award, be routinely monitored during the award period, and compliance may factor into future funding decisions. By the end of the funding or proprietary period, a recipient or study group may not continue to use or share study-generated resources until those resources are available to the public via an NIH approved repository per the NIH approved sharing plan. The NIDDK has established a Central Repository to support the receipt, storage, and distribution of data, biosamples, and other resources generated in clinical studies funded by the NIH/NIDDK. When the NIDDK Central Repository is to be utilized, prior to enrolling participants, the PI or his/her designee will coordinate with the NIDDK Program and Central Repository staff to prepare for the eventual archiving and distribution of the study generated resources that are to be maintained in the Central Repository. All resources transferred to the Central Repository will be under the custodianship of the NIDDK. The study’s leadership will have proprietary control of and exclusive access to the resources per the NIDDK-approved sharing plan. Subsequently, these resources will be available to the wider scientific community in accordance with the NIH policy on Data Sharing (http://grants.nih.gov/grants/policy/data_sharingand,https://sharing.nih.gov/, andhttps://sharing.nih.gov/faq#/data-sharing.htm) as well as the NIDDK policy for resource sharing,https://www.niddk.nih.gov/-/media/Files/Research-Funding/Process/PublicversionNIDDKdatasharingpolicy2013July2013.pdf.
The NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The NIDDK and ORWH will designate program staff, including a Project Scientist (PS), a Program Officer (PO), and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement. The PO and Grants Management Specialist will be named in the Notice of Grant Award.
The role of the Project Scientist (PS) in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PD(s)/PI(s). The PS will:
The Program Officer is responsible for the normal scientific and programmatic stewardship of the award. The PO will:
Both the Project Scientist and the Program Official will cooperate in carrying out research, and maintenance of high-quality research in each of the individual research project(s) and review the project(s) for compliance with operating policies developed by the External Steering Committee and may recommend to the NIH to continue funding; withhold support or restrict an award for lack of scientific progress or failure to adhere to policies established by the ESC.
Additionally, an agency program official or IC 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:
The PD(s)/PI(s) and NIH PS will be jointly responsible for participating in Consortium-wide activities and for establishing collaborations across the Consortium and with other related activities.
External Steering Committee (ESC)
The ESC will be the primary governing body for all AGIE Coordinating Center activities. The voting membership of the ESC will include: one PD/PI from the AGIE Coordinating Center and the NIH PS(s), plus at least five appointed members, including one member of the ORWH's Advisory Committee on Research on Women's Health (ACRWH). The Chair(s) of the ESC will be selected by the ESC. A portion of the ESC meetings may be open to the public.
If needed, other NIH staff members may also participate in ESC meetings as nonvoting members. All ESC decisions and recommendations that require voting will be based on a majority vote. The ESC will meet at least twice annually or as needed, with intermittent conference calls as needed. The frequency of ESC meetings can be adjusted on a AGIE Coordinating Center need basis. The ESC may, as it deems necessary, invite additional, non-voting scientific consultants to meetings at which research priorities and opportunities are discussed. The NIH reserves the right to augment the expertise of the ESC when necessary. The ESC will schedule the time for and prepare concise (3 to 4 pages) summaries of the ESC meetings, which will be delivered to members of the group within 30 days after each meeting.
The ESC will:
The NIH intends the resource sharing plans for the AGIE Coordinating Center to follow the policy and objectives stated in the original FOAs. Specifically, consistent with achieving the objectives of the AGIE Coordinating Center, all resources, tools, technologies, services, expertise, protocols (including analytical methods), ontologies, biological samples and other research resources are to be made publicly available to the larger national research community as soon as QA/QC procedures have been completed, and in accordance with the policies developed by the ESC. Limited exceptions to the requirement for community dissemination may be identified by the ESC. The NIDDK, in consultation with the ESC for this project, will make all final decisions concerning resource sharing and data access policies, and all policies are subject to change by the NIH as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within the project.
Recipients will comply with and implement the recommendations and decisions of the ESC with respect to the sharing of resources developed by the AGIE Coordinating Center investigators.
Recipients are expected to register resources supported by this FOA with the NIDDK Information Network (dkNET) at https://dknet.org/ and use Research Resource Identifiers (RRID) assigned through dkNET in any publication supported by this FOA.
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 ESC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
3. 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.
4. 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition 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: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Benjamin Johns, Ph.D.
Office of Research on Women's Health (ORWH/OD)
Tel: 301-435-1681
email: benjamin.johns@nih.gov
Robert Rivers, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 443 8415
Email: robert.rivers@nih.gov
Center for Scientific Review (CSR)
Email: FOAReviewContact@csr.nih.gov
Helen Cox, M.H.S.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK))
Telephone: 301-496-7274
Email: helen.cox@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301, and 405, and 486 of the Public Health Service Act as amended (42 USC 241, and 284, and 287d) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.