Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Funding Opportunity Announcement.

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose:

The purpose of the FIRST Coordination and Evaluation Center (CEC) will be to coordinate with FIRST Cohort awardees and facilitate the development of strategies to conduct a comprehensive evaluation of the FIRST program. The FIRST CEC will collaborate with FIRST Cohort institutions to identify and harmonize a set of common data elements to be used by each institution to facilitate an objective evaluation of the FIRST program goals.

Background:

NIH institutes and centers remain committed to increasing and sustaining the diversity of the biomedical research workforce. NIH’s commitment has been informed by an extensive body of research supporting the argument that scientific workforce diversity is essential to accomplish the NIH’s mission of discovery and innovation toward improving human health (Nielsen et al., 2017; Valantine and Collins, 2015). Despite recognizing the pressing need to enhance diversity in NIH-funded institutions across the U.S., progress in accomplishing this goal has been seen mostly with trainee populations, leaving biomedical research faculty diversity as an ongoing, recalcitrant challenge (Gibbs et al., 2016). Starkly, extrapolation of current trends suggests that without new and effective strategies, it will take nearly 50 years for women to reach parity among full professors (Valantine et al., 2014; National Science Foundation, 2019) and centuries for underrepresented racial/ethnic groups to reach parity among medical school faculty with the current recruitment pool (U.S. Medical School Faculty Trends: Percentages). This representation gap is driven in large part by institutional cultures lacking necessary elements of inclusion and equity and sending a message to certain groups that they do not belong in science (Price EG et al., 2009; Pololi LH et al., 2013). Because U.S. biomedical research is largely driven by NIH-funded faculty in academic institutions, there is an urgency for NIH to encourage institutions to develop and implement broadly effective strategies to cultivate institutional culture change (Krupat E et al., 2013), with the goal of enhancing scientific workforce diversity at the faculty level. The ultimate goal of the FIRST program is to employ a faculty cohort model to foster cultures of inclusive excellence (scientific environments that can cultivate and benefit from a full range of talents) at NIH-funded institutions with a sustained commitment to diversity and inclusion in biomedical research.

The program will test the primary hypothesis that a cohort model of faculty hiring, sponsorship, continual mentoring, and support for professional development, embedded within an institution implementing evidence-based practices to create academic cultures of inclusive excellence, will achieve significant improvements in metrics of institutional culture and scientific workforce diversity. Evidence supports that diversity positively impacts scientific discovery through improved problem-solving, innovation, prediction, evaluation, verification, and strategization (Page SE, 2017; Page SE, 2007). In addition, the program will test the impact of the cohort on institutional culture change. Implementing and sustaining cultures of inclusive excellence at a range of academic institutions has the potential to be transformational for the biomedical research workforce.

Needs, Gaps, Opportunities:

Establishing and maintaining scientific environments that can cultivate and benefit from a full range of talents is not only essential for the quality and impact of science, but it is also a matter of good stewardship of federal funds to ensure that the most talented of researchers are recruited, supported, and advanced to become competitive research investigators. This initiative defines inclusive excellence consistent with the work of Williams et al., (2005) as the act of establishing hallmarks of excellence and organizational effectiveness; operationalizing inclusion across organizational functions; and creating education and professional development processes that have diversity, equity, and inclusion at their core. Achieving inclusive excellence at the national level must be preceded by transformation at the institutional level, through broad adoption of enhanced diversity of faculty and culture change, creating a welcoming environment to recruit and retain scientific talent. Although achieving inclusive excellence at a national level must be accompanied by enhanced diversity of faculty, culture change at the institutional level is essential for creating the welcoming environment to recruit and retain scientific talent. Thus, inclusive excellence hinges on both enhancing diversity and inclusion, as well as institutional culture change. Thus, inclusive excellence hinges on both enhancing diversity and inclusion, as well as institutional culture change.

 Underrepresented racial/ethnic groups comprise 34% of the US population, but publicly available data indicate that only 15% of the PhD recipient pool (NSF SED, 2018; Doctorate Recipients from U.S. Universities 2018 | NSF - National Science Foundation), 12% of medical school graduates (AAMC Data and Reports), 9% of current assistant professors, and 4% of tenured faculty (Faculty Roster: U.S. Medical School Faculty | AAMC). Recent 10-year trend data, 2010-2020, shows a dismal 0.2% increase in the percentage of URM faculty at US medical schools. Reaching parity in the number of URM faculty with the PhD recipient pool is estimated to require centuries assuming that institutions do not transform their current recruitment practices and work environments to attract and sustain diverse cohorts of faculty. The low diversity of faculty compared to the available talent pool is attributed in part to the disproportionately high attrition of academic researchers from historically underrepresented racial and ethnic groups during the transition from training status into faculty-level research careers Gibbs et al., 2016; and, Valantine, Lund & Gammie, CBE-Life Sciences Education, 2016). By contrast, women in science and medicine have made substantial progress in workforce participation.

Women comprise more than 50% of PhD graduates in NIH research-relevant disciplines, over 50% of U.S. medical school graduates, but only 40.6% of U.S. biomedical tenure-track faculty, 27% of tenured faculty (AAMC faculty roster, 2018), and about one-third of principal investigators (PIs) on NIH-funded research (R01-equivalent) grants (Plank-Bazinet, et al., 2017, Hechtman et al., 2018). Furthermore, there is a lack of representation of women in leadership positions that also needs to be addressed. In addition, literature shows that women from underrepresented backgrounds face particular challenges at the graduate level and beyond in scientific fields (Ong M, et al., 2011).

Because progress has been seen mostly with trainee populations, diversifying the professoriate is the next logical, and achievable, step for an NIH-funded extramural investment. The FIRST program aims to not only provide support for diverse cohorts of new faculty, but to create systemic change at institutions. Reports on faculty cluster hiring at academic institutions suggest that the cohort model might be an effective strategy for enhancing diversity (Sgoutas-Emch S et al., 2016; Lord S, et al., 2015; Faculty Cluster Hiring for Diversity And Institutional Climate Change, 2015). The approach has been tested in undergraduate environments such as the successful Meyerhoff Scholars Program at the University of Maryland, Baltimore County (for example, Sto Domingo, et al., 2019). However, little is known about the multi-level barriers and challenges encountered and overcome by institutions and faculty cohorts where efforts toward inclusive excellence have already been initiated. There is, therefore, a profound knowledge gap regarding integrated strategies to address diversity and inclusion, the impact of faculty cohort hiring in higher education, and institutional change models that achieve the goal of inclusive excellence.

The Faculty Institutional Recruitment for Sustainable Transformation (FIRST) program (consisting of two components: the FIRST Cohort and the FIRST Coordination and Evaluation Center (CEC)) has been developed to determine if a systematic approach that integrates multiple evidence-based strategies, including the hiring of faculty cohorts with demonstrated commitments to inclusion and diversity, will accelerate inclusive excellence, as measured by clearly defined metrics of institutional culture change, diversity, and inclusion. The FIRST program goals are to: (1) foster sustainable institutional culture change; (2) promote institutional inclusive excellence by hiring a diverse cohort of new faculty; and (3) support faculty development, mentoring, sponsorship, and promotion.

Funding for the FIRST program will come from the NIH Common Fund, which supports cross-cutting programs expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

 Objectives:

The FIRST CEC will analyze data provided by FIRST Cohort awardees to test the primary hypothesis that a cohort model of faculty hiring, sponsorship, mentoring, and professional development, embedded within an institution implementing evidence-based practices to create academic cultures of inclusive excellence, will achieve significant improvements in metrics of institutional culture and scientific workforce diversity.

The FIRST CEC will not be evaluating individual FIRST Cohort awardees. Rather, the FIRST CEC working collaboratively with the FIRST Cohort awardees will develop common data elements that FIRST Cohort awardee institutions will collect and provide to the FIRST CEC for an objective evaluation of the program. In addition, the FIRST CEC will not be expected to develop a comparison group for the evaluation. The FIRST CEC will determine appropriate evaluation designs and methods, such as pre-post evaluations, among other approaches.

The FIRST CEC will enable effective communication and coordination across FIRST Cohort awardees and across award cycles. Working with the FIRST Cohort awardees, the FIRST CEC will conduct a comprehensive evaluation and assess progress made toward the FIRST program goals. To accomplish this, the FIRST CEC, in collaboration with FIRST Cohort awardees, will establish common data elements, standardize data collection and submission procedures, receive data from FIRST Cohort awardees, check data quality, harmonize data, conduct objective analyses of the data and generate summary reports. The FIRST CEC will be engaged in writing source code, planning analyses, and providing statistical oversight for both qualitative and quantitative data. The FIRST CEC is also expected to ensure the integrity, privacy, and security of data received from the FIRST Cohorts. The FIRST CEC will be expected to obtain IRB approval before human subjects research or analyses of personally identifiable data are initiated. Also, the FIRST CEC will summarize lessons learned across the FIRST Cohort sites and disseminate the information.

The functions of the FIRST CEC are directly linked to the FIRST program goals. The common data elements may include the following, organized by program goals:

• For Fostering Sustainable Institutional Culture Change: the FIRST CEC in collaboration with FIRST cohort awardees will identify, acquire, or if necessary, develop, measures for institutional climate and culture changes informed by multiple dimensions of culture (Krupat E et al., 2013) or other theories or frameworks as appropriate. Measures within the following dimensions might include but are not limited to: self-efficacy in career advancement; relationships/inclusion/trust; values alignment; ethical/moral distress; leadership aspirations; work-life integration; gender equity; and racial/ethnic equity. These measures coupled with measures at the institutional level are critical to assess whether institutional cultural changes translate to measurable improvements at the individual/cohort and institutional levels.

• For Promoting Institutional Inclusive Excellence by Hiring a Diverse Cohort of New Faculty: The FIRST CEC will facilitate collection of common data to indicate the change from baseline on type and number and diversity of cohort recruitment, retention, promotion, tenure, attainment of research grants, research productivity, development of new research programs, increased collaborations, and impact of cluster characteristics. Data collection on the demographics of the new faculty hires needs to include at a minimum race, ethnicity, sex, disability status, and socioeconomic background.

• For Supporting Faculty Development, Mentoring, Sponsorship, and Promotion: Data collected from the FIRST Cohort awardees might include types and number of faculty-centered supports provided by the institution in the following areas: professional development, academic advancement, managing career challenges and expectations, mentorship team, interventions to prevent or mitigate isolation, discrimination (based on race/ethnicity, gender, sexual orientation, gender identity, ability, geographic origin), or other types of discrimination or injustices such as disproportionate assignment of committee work or other administrative tasks to URM faculty members, or inequitable processes for considering tenure clock extension requests due to childbirth, adoption, severe illness, disability, or caregiving of a family member.

The FIRST CEC will conduct the following activities including, but not limited to:

• Establishing evaluation approaches, logic models, and short/intermediate/long-term common data elements for different levels (institutional, departmental, faculty), as deemed appropriate for FIRST program goals.
• Conducting process and outcome evaluations to assess the strategies implemented by the FIRST Cohort awardees.
•  Identifying measures for assessing the impact of inclusive excellence on scientific discovery and quality of research conducted by FIRST faculty cohorts.
• Collaborating with all FIRST Cohort awardees to iteratively assess the impact of key institutional culture change strategies and other innovative approaches implemented at FIRST Cohort sites to promote inclusive excellence.
• Establishing and coordinating approaches for data collection, data storage, data harmonization, quality control standards, data cleaning, data management, data analyses, and other data related functions.
• Developing novel and innovative quantitative and qualitative data analytic approaches to assess the strategies employed by FIRST Cohort awardees for completing the FIRST program goals.
• Receiving quantitative and qualitative data from FIRST Cohort awardees, checking data quality, analyzing the data, providing statistical oversight, and generating reports.
• Leading the development of a data use and data sharing agreement plan for the FIRST Cohort sites.
• Facilitating and coordinating collection of the minimum set of common data elements from
  FIRST Cohort awardees to conduct a comprehensive evaluation, including assessment of measurable changes in metrics from baseline for all three FIRST program goals.
• Planning and coordinating annual meetings (in person or as appropriate) with all FIRST Cohort awardees to facilitate communication about program progress, preliminary findings, and the sharing of successes and challenges.
• Disseminating successful evidence-based practices, and lessons learned for transforming institutions across FIRST Cohort sites.
• Managing and disseminating all FIRST program-related peer-reviewed research publications, non-peer reviewed publications, and invited presentations.
• Coordinating and facilitating communication among FIRST Cohort awardee institutions through regular meetings, committees, and workgroups as needed.

Applicants are expected to demonstrate appropriate professional expertise and experience in the areas defined above. The applicant institutions must have the necessary facilities to meet the special requirements mentioned in the FOA.

The leadership and key personnel of the FIRST CEC are expected to have broad experience working collaboratively to assess and evaluate the range of activities critical for accomplishing FIRST program goals. The ability to work collaboratively with multiple academic communities while providing strong leadership in evaluative activities is a requirement. The FIRST CEC must also include individuals with expertise in multi-site evaluation as well as in coordination, communication, and consensus-building among diverse groups of stakeholders. The FIRST CEC should also include individuals with knowledge and expertise regarding factors that contribute to inclusive excellence, diversity training, institutional culture change, and the current evidence base related to training and mentoring practices and approaches to evaluate them. Expertise in evaluation methods, psychometric properties of measures, statistics and qualitative methods is also needed.

In developing and implementing the FIRST program evaluation plan, it is expected that the FIRST CEC may also refine evaluation questions and selection of metrics based on the empirical literature, as appropriate, to assess FIRST Cohort program processes, impacts, and outcomes. The evaluation questions developed, and data collected in collaboration with the FIRST Cohort awardees, are expected to apply at the individual, department, and institutional level, as appropriate. The FIRST CEC will also consider the institution types (highly resourced, limited-resourced) and types of partnerships and their impact on the overall program goals.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution, normally identified by having a unique DUNS number or NIH IPF number, is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Section IV. Application and Submission Information

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

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Dr. Rina Das
National Institute on Minority Health and Health Disparities (NIMHD)
Email: FIRSTNIH@nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Application budgets are limited to $840K in direct costs in the first year and $1.5 M in direct costs per year in years 2-5 and need to reflect the actual needs of the proposed project. The PD/PIs are expected to commit 20% effort or 2.4 person months per year for the program. Travel costs for attending any in-person meetings and FIRST Executive Steering Committee (FESC) meetings should be included in the 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, with the following additional instructions:

Research strategy:

Describe how the FIRST CEC will work in close collaboration with FIRST Cohort awardees to facilitate and coordinate FIRST program activities across sites and award cycles. Include plans for fostering communication such as through arranging and hosting monthly PD/PI conference calls as well as similar calls to support various activities across the FIRST Cohort awardees. Provide details on planning and coordinating annual meetings (in person or as appropriate) with all FIRST Cohort awardees to facilitate communication about program progress, preliminary findings, and the sharing of successes and challenges.

Describe the approaches for the coordination of data collection, data standardization, and data harmonization activities across FIRST Cohort awardees. Describe the approach, technical platform and infrastructure available to successfully collect, code, store, track, clean, and manage common data elements received from the FIRST Cohort awards.

Describe approaches for developing data use agreements (DUA) and data sharing agreements (DSA) across FIRST Cohort sites as part of the FIRST Data Sharing Plan. Describe monitoring or oversight strategies to maximize data quality and minimize missing data. Describe plans to address protection of intellectual property, data ownership and rights.

Describe the theoretical models and conceptual frameworks that will guide evaluation activities and the overall evaluation plan. Describe approaches for conducting process and outcome evaluations of the FIRST program goals. Note: the FIRST CEC will not be expected to develop a comparison group for the evaluation. The FIRST CEC will determine appropriate evaluation designs and methods, such as pre-post evaluations, among other approaches.

Describe approaches for conducting a comprehensive evaluation of the FIRST program, using logic models, and short/intermediate/long-term common metrics deemed appropriate for FIRST program goals and the overarching hypothesis. Describe strategies for how FIRST CEC in collaboration with FIRST Cohort awardees will identify and harmonize a minimum set of common data elements to be used by each of the FIRST Cohort awardees to evaluate the faculty and the institutional culture, as well as develop program-specific metrics and milestones which will include appropriate performance measures, program outputs, and outcomes.

Include a description of the potential factors that may contribute to inclusive excellence, and how approaches that seek to promote culture change towards diversity and inclusiveness will be evaluated at various levels (faculty, department, institution). Describe innovative quantitative/qualitative approaches that will be appropriate to evaluate institutional culture change.

Describe how ongoing assessments of measurable changes in metrics from baseline for all three FIRST program goals will be conducted to generate summary interim and final reports.

Describe strategies to keep various stakeholders (within and outside the FIRST program) informed about program-wide practices, lessons learned, and results from intervention projects developed by FIRST Cohort awardees. Describe plans to disseminate the knowledge, data sets, evaluation tools, and other resources generated by the FIRST awardees within and outside the FIRST program.

Describe strengths, expertise, and relevant experience of leadership and key personnel who will be involved in FIRST CEC activities. Especially provide details on experiences in working collaboratively, building consensus with diverse stakeholder groups, and in coordinating and evaluating data. Describe expertise in multilevel processes, impact and outcome evaluation activities, and in developing measures and evaluating strategies for institutional climate and culture change such as inclusive excellence.

Describe the composition and roles of any committees that will help manage or oversee FIRST CEC activities, including the required FIRST Executive Steering Committee (FESC) (roles and composition defined by the NIH in Section VI).
Describe the plan to address any conflict, or appearance of conflict, if awarded both the FIRST CEC and a FIRST Cohort grant.

In addition, a timeline (or Gantt chart) including milestones is required for all applications. Milestones are intermediate steps towards the completion of concrete goals. They must include clear and quantitative criteria for success. Yearly quantitative milestones are required in order to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years. The application should include clearly specified, well-defined milestones, quantitative go/no go decision points, and timelines for assessing progress.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
  
  To achieve the goals of this funding initiative, the collection of certain data is critical. The FIRST program requires sharing of data, resources, and tools to facilitate collaboration with FIRST Cohort awardees. Applicants are required to provide an overarching data sharing plan. The FIRST CEC will lead the development of the final FIRST Data Sharing Plan to be developed in conjunction with FIRST Cohort awardees post award.

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.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

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.

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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, specific to this FOA: To what extent will the proposed comprehensive evaluation contribute to the understanding of factors critical for enhancing inclusive excellence and for increasing and sustaining diversity using a cohort model? To what extent are the proposed activities of the FIRST CEC likely to advance our understanding of evaluating strategies for cohort and inclusive excellence program?To what extent will increasing the faculty diversity enhance institutional biomedical research capability and innovation?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, specific to this FOA: Have the PD(s)/PI(s) demonstrated the ability to coordinate complex programs to establish and implement joint goals? Are the PD(s)/PI(s) experienced with programs that focus on diversity and inclusion at the institution level? Have the PD(s)/PI(s) demonstrated sufficient leadership in coordinating data collection and evaluation activities across multiple sites? Do the investigators have the necessary experience and scientific/technical expertise to coordinate, manage, and analyze the types of data that will be collected from the FIRST cohort awardees? Do the investigators have expert facilitation skills to support solution and consensus building in collaborative environments? Do the investigators have experience disseminating evaluation findings to diverse stakeholders?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, specific to the FOA: Does the application include innovative quantitative or qualitative approaches, methodologies, or study designs to evaluate the effectiveness or impact of programs designed to enhance inclusive excellence in the biomedical research workforce?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, specific to this FOA: have the PIs/PDs described appropriate approaches for developing data use agreements (DUA) and data sharing agreements (DSA) across the FIRST Cohort sites, and is there a clear plan to develop the FIRST Data Sharing Plan?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, specific to this FOA: Is the environment of the awardee institution adequate to support the FIRST CEC in accomplishing its goal of coordinating and evaluating the FIRST Cohort activities?

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.

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

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

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) () Sharing Model Organisms and (2)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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.

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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

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.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. 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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations 45 CFR Part 75), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will continue as a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

All awards will be cooperative agreements in which the FIRST CEC PDs/PIs and their staff will work together with FIRST Cohort recipients with substantial NIH involvement.

The PIs of the FIRST Cohort awards and FIRST CEC award and involved NIH staff acting as Program officials (POs) and Project Scientists (PSs), and others as needed (ex-officio), will form a FIRST Executive Steering Committee (FESC) which will govern the activities of the FIRST program recipients. There will be a yearly rotating chair of the FESC who will be nominated and selected from among the PIs of the awards. The PSs together (all federal staff) will have a single vote. FESC decisions generally will be made by majority vote.

The FIRST CEC recipient will form a separate FIRST CEC Steering Committee comprised of FIRST CEC PIs and NIH staff (PO, PSs). The PSs, POs, Common Fund and multiple NIH ICOs’ staff members will form an NIH FIRST Working Group which will support the activities of the program of FIRST CEC and FIRST cohort awards. The NIMHD staff member serving as Program Official (PO) will provide the normal scientific and programmatic stewardship of the FIRST CEC award and will be named in the award notice. An NIH Project Team consisting of NIH employees only, including the PO and PSs of the FIRST CEC, will support and fulfill their responsibilities as described below for the award. The NIH will receive input from External Program Consultants (EPCs) who may attend recipient face-to-face or virtual meetings or provide guidance as needed. The FIRST CEC will organize virtual and face-to-face meetings of the FESC and FIRST Cohort recipients, but the NIH will organize meetings with EPCs, who will report only to the NIH.

Milestones and metrics will be developed by the FIRST CEC recipient, and the PI will work with the PO and the Office of Grants Administration before the issuance of the Notice of Award (NoA). Milestones will be aligned with a timeframe in the NoA and the recipient will need to meet milestones by the defined deadlines. Progress on milestones will be monitored annually by NIH staff and through regularly scheduled meetings. The PO, in consultation with the PSs and NIH FIRST Working Group, will determine if the recipient has met the milestones required for each year of funding. The NIMHD, in consultation with the NIH FIRST Working Group of NIH staff from different ICs, generally will work with or afford the recipient an opportunity, consistent with the terms and conditions of the Cooperative Agreement, to correct situations prior to restricting, reducing, or an ordered phase-out of the FIRST CEC award.

If metrics and milestones are not met, are inadequate, are not timely in order to meet the needs of the program, or do not conform with the requirements and restrictions specified in the FOA and NoA and with those described in the application, then the NIH will take the appropriate actions. These actions may include expanded reporting requirements, or more serious actions such as delayed or immediate reductions of funds, restrictions on use of funds, or an ordered phase-out of awards. For example, year 2 funds may be delayed or restricted pending satisfactory completion of any unmet year 1 milestones.

The NIH Data sharing agreements must be met. If the NIH data sharing requirements are not met by the FIRST CEC, then the NIMHD will take the appropriate actions, such as delayed or immediate reductions of funds, restrictions on use of funds, or an ordered phase-out of the FIRST CEC award.

The PD(s)/PI(s) will have the primary responsibility for:

• Conducting a comprehensive evaluation of the FIRST program in collaboration with FIRST Cohort recipients (process, impact, and outcome evaluations, as appropriate).
• Establishing common data elements, metrics, milestones, data acquisition procedures, and data harmonization across FIRST Cohort recipients in collaboration with the FIRST Cohort recipient PIs.
• Collaborating with FIRST Cohort recipients, to identify and harmonize a minimum set of common data elements to be used by each of the FIRST Cohort recipients to evaluate the faculty and the institutional culture, as well as develop program-specific metrics and milestones which will include appropriate performance measures, program outputs, and outcomes.
• Disseminating data, protocols, and methods developed for or derived from the FIRST CEC program within and outside the FIRST program.
• Establishing data collection and reporting timelines in collaboration with FIRST Cohort recipients and providing periodic reports and data to the NIH in a timely fashion and in standard format, as agreed upon by the FESC and NIMHD.
• Submitting periodic progress reports in a standard format, in addition to the RPPR, as agreed upon by the FESC and NIMHD.
• Facilitating collection of data from FIRST Cohort recipients and analyzing data submitted to the FIRST CEC.
• Establishing and participating in group activities, including FESC, working groups, and subcommittees, as needed.
• Coordinating the FIRST program meetings throughout the duration of the FIRST program, and other meetings (in-person and teleconference meetings) as needed and as recommended by the FESC.
• Preparing abstracts, presentations, and publications and collaborating with FIRST Cohort recipients in making the public and professionals aware of the program.
• Assessing quantitative and qualitative data received from the FIRST Cohort recipients for measuring the impact of the program.
• Adhering to policies regarding data sharing and publication established by the FESC to the extent consistent with the applicable NIH policies, laws, and regulations.
• Abiding by common definitions, timelines, and procedures established by the FESC, as appropriate.
• Attending and participating in FESC meetings and accepting and implementing its decisions, as appropriate.
• Complying with governance processes of the FESC for issues affecting the program.
• Ensuring that resources (e.g. data sets; procedure manuals) developed during this program are made publicly available to the extent consistent with applicable NIH policies, laws, and regulations, and that results are published in a timely manner.
• Adhering to applicable NIH policies, laws, and regulations regarding intellectual property and data release, and to other FESC policies to the extent consistent with applicable NIH policies, laws, and regulations.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

The FIRST CEC is required to participate in all FIRST program activities. These requirements include attendance at virtual or face to face FIRST program meetings, regularly scheduled FESC and workgroup calls and collaborative development of program resources such as protocols, tools, metrics, surveys.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIH Project Scientist(s) (PSs) will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. However, the role of NIH staff will be to facilitate and not to direct the activities. The FIRST Cohort and FIRST CEC awards’ PS(s) and POs will participate as members of the FESC.

The PS(s) will have the following substantial involvement:

• Participating with the other FESC members and the FIRST CEC Steering Committee in addressing issues that arise with FIRST CEC planning, operation, assessment, and data analysis. The PS(s) will assist and facilitate group process and not direct it.
• Serving as a liaison, helping to coordinate activities, including acting as a liaison to other NIH Institutes/Centers, and as an information resource for the recipients. The PS(s) will also help coordinate the efforts of the FIRST program with other groups conducting similar efforts.
• Attending FESC meetings as a voting member, assisting in developing standard operating procedures, and consistent policies for dealing with situations that require coordinated action. The PS(s) will be responsible for working with the recipients, as needed, to help manage the logistic aspects of the FIRST CEC program.
• Reporting periodically on FIRST CEC progress to the NIH Project Team, NIH FIRST Working Group and the NIH Common Fund.
• Serving on subcommittees of the FESC as appropriate.
• Assisting recipients in the development, if needed, of policies for dealing with situations that require coordinated action.
• Providing advice in the management and technical performance of the award.
• Assisting in promoting the availability of the data and related resources developed in the course of this program to the scientific community at large.
• Participating in data analyses, interpretations and, where warranted, co-authorship of the publication of results of studies conducted through the program.
• Other NIMHD and NIH FIRST Working Group staff may assist the recipient as designated by NIMHD.

The dominant role and prime responsibility for the activity resides with the recipients for the project as a whole, although specific tasks and activities in carrying out the programs may be shared among the recipients, the NIH PS(s) and/or NIH FIRST Working Group members.

Additionally, an NIMHD PO will be responsible for the normal scientific and programmatic stewardship of the FIRST CEC award and will be named in the award notice. The assigned PO may also serve in the NIH FIRST Working Group to assist the recipient.

Areas of joint responsibility include:

Close interaction among the participating investigators will be required, as well as significant involvement from the NIH, to manage, assess, and disseminate the FIRST CEC program. The recipients and the PS(s) will meet virtually or in person with the FESC at least once a year throughout the duration of the programs. In addition, the FIRST CEC recipient and PS(s) as part of the FIRST CEC Steering Committee and as FESC members, will meet on conference calls, as needed, to share information on metrics, approaches, tools, and preliminary results. PDs/PIs, key co-investigators, faculty hires and mentors, are eligible to attend these meetings.

The FESC will serve as the main governance body of the program. The FESC will be responsible for coordinating the activities being conducted by the program and is the committee through which the NIH FIRST Working Group formally interacts with the FIRST Cohort and FIRST CEC investigators. The FESC membership will include all PD(s)/PI(s) of the FIRST CEC and each FIRST Cohort award, other staff as needed (ex-officio), and the FIRST Cohort and FIRST CEC awards’ PSs and POs. There will be a yearly rotating chair of the FESC who will be nominated and selected from among the PIs of the awards. The FESC may add additional members, and other government staff may attend the FESC meetings as desired. Each award will have one vote, and the FIRST Cohort and FIRST CEC awards’ PSs (all Federal staff together) will have one vote.

The FESC may establish subcommittees, as needed, to address issues. These subcommittees will include representatives from the program and the NIH and possibly other experts. The FESC will have the overall responsibility of assessing and prioritizing the progress of the various subcommittees.

The FIRST CEC recipient agrees to work collaboratively to:

• Provide for secure, accurate, and timely data submission in collaboration with FIRST Cohort recipients.
• Participate in presenting and publishing new processes and substantive findings.
• Assess and disseminate FIRST CEC data and resources.
• Participate in the governance of the FIRST program as a member of the FESC.
• Interact with other relevant NIH activities or programs, as needed, to promote synergy and consistency among similar projects.

External Program Consultants (EPCs):

The NIH will consult with experts, External Program Consultants (EPCs), to receive input as it supports and stimulates the recipient’s activities in the program. These individual consultants may provide input with respect to all aspects of the program. All EPC opinions and advice will be given to the NIH as individual opinions; consensus opinions will not be requested or obtained; the group will never vote on issues. The NIH may use this consultant feedback in its review and evaluation of the program. The EPCs will consist of four to eight senior, non-federal experts who are not directly involved in the activities of the FIRST CEC program and who have relevant expertise. The FIRST Cohort and FIRST CEC awards’ POs, PSs, NIH FIRST Working Group, and other NIH staff may attend the EPC meetings.

NIH will seek input from individual EPCs on an as-needed basis. They will generally be asked to attend any face-to-face PI meetings of the FIRST Cohort recipients to gather information and meet with the NIH FIRST Working Group. EPCs may be consulted by phone or email at other times, as needed.

Annually, the EPCs will provide their individual assessments (no consensus will be requested or obtained) to the NIH of the progress of the program and, as necessary, will present recommendations regarding any changes. The assessments and recommendations will be provided, through the NIH FIRST Working Group, to the Director of the Office of Strategic Coordination, NIH.

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. The three members will be a designee of the FESC 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. Reporting

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.

Section VII. Agency Contacts

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: GrantsInfo@nih.gov (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: support@grants.gov

Dr. Rina Das
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-496-3996
Email: FIRSTNIH@nih.gov

Weijia Ni, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-594-3239
Email: weijia.ni@nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov

Section VIII. Other Information

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.