EXPIRED
National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (https://commonfund.nih.gov/) through the Office of the NIH Director, Office of Strategic Coordination. All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by a trans-NIH team, which will be led by the National Cancer Institute (NCI) on behalf of the NIH.
U54 Specialized Center- Cooperative Agreements
The purpose of the FIRST Cohort is to transform culture at NIH-funded extramural institutions by building a self-reinforcing community of scientists committed to diversity and inclusive excellence (defined below). Implementing and sustaining cultures of inclusive excellence within the program has the potential to be transformational for biomedical research at the recipient institutions and beyond. This community will be built through recruitment of individuals who:
30 days prior to the application due date
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
July 12, 2022 | Not Applicable | Not Applicable | November 2022 | January 2023 | April 2023 |
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.
No late applications will be accepted for this Funding Opportunity Announcement.
Not Applicable
It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the 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 purpose of the FIRST Cohort is to transform culture at NIH-funded extramural institutions by building a self-reinforcing community of scientists committed to diversity and inclusive excellence (defined below). Implementing and sustaining cultures of inclusive excellence within the program has the potential to be transformational for biomedical research at the awardee institutions and beyond. This community will be built through recruitment of a diverse group of individuals who:
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). This commitment is outlined in the Notice of NIH’s Interest in Diversity (NOT-OD-20-031), which strongly encourages the participation of individuals from identified as underrepresented in the biomedical, clinical, behavioral and social sciences. 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 biomedical research workforce diversity at the faculty level. The ultimate goal of the FIRST program is to utilize 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. This effort aligns with the recent NIH UNITE initiative, which aims to address structural racism, establish an equitable and civil culture within the biomedical research enterprise and reduce barriers to racial and ethnic equity in the biomedical research workforce. In addition to addressing long-standing health disparities and promote health equity, UNITE will seek to improve transparency, accountability, and sustainability in support for research on health disparities, minority health, and health equity.
The FIRST 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 biomedical research workforce diversity. Evidence supports the hypothesis that diversity positively impacts scientific discovery through improved problem-solving, innovation, prediction, evaluation, and verification (Page SE, 2017; Page SE, 2007). Implementing and sustaining cultures of inclusive excellence within the program has the potential to be transformational for biomedical research at and beyond the awardee institutions, as well as for the biomedical research workforce overall.
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 researchers are recruited, supported, and provided opportunities 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 educational and professional development processes that have diversity, equity, and inclusion at their core. Achieving inclusive excellence at the societal 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. Thus, inclusive excellence hinges on both enhancing diversity and inclusion, as well as institutional culture change.
Underrepresented racial/ethnic groups comprise 38% of the US population, but only 16% of the PhD recipient pool (NSF SED, 2020; Doctorate Recipients from U.S. Universities 2020 | 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) according to publicly available data. Recent 10-year trend data, 2010-2020, show 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, unless institutions 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). In 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 48% of U.S. medical school graduates (AAMC Faculty Roster, 2019), but only 40.6% of U.S. biomedical tenure-track faculty, 27% of tenured faculty (AAMC faculty roster, 2020), 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).
Diversifying the professoriate is an important, 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 significant 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 whether 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 at the Assistant Professor (or equivalent) level; 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:
Faculty Institutional Recruitment for Sustainable Transformation (FIRST) Cohort Award.
The FIRST Cohort program aims to transform culture at two types of NIH-funded extramural institutions by building a self-reinforcing community of scientists committed to inclusive excellence, through recruitment of a diverse group of individuals who:
Any individual who meets all of these criteria is eligible to be hired for FIRST faculty positions.
The overall goals and specific measurable objectives that the program expects FIRST Cohort awardees to accomplish are:
Goal 1: Demonstrate institutional support and develop or modify a strategic plan with specific goals and strategies, interventions, and organizational policies that will be implemented to achieve significant systemic and sustainable institutional culture change over baseline toward inclusive excellence (at the faculty, department, and institution level). FIRST Cohort awardees are also expected to develop an evaluation plan to assess the impact of actions taken towards these goals at their institution.
Goal 2: Conduct recruitment activities for new faculty, outline institutional commitment, and develop recruitment committees based on past interests and commitments to diversity, equity, and inclusion. FIRST Cohort awardees are also expected to establish a supportive environment for new faculty.
Goal 3: Develop strategies to establish individual research and career development plans and mentorship and sponsorship plans for all new faculty hired under this award. The applicants must describe how the program will reduce isolation, increase community building, foster career development, and ensure retention of the new faculty.
Applicant institutions must be conducting research in any NIH mission area. This funding opportunity will accept applications from eligible Highly Resourced Institutions (HRI), Limited-Resourced Institutions (LRI), or Partnerships (any composition of HRI and/or LRI) to develop faculty cohort models. All eligible institutions are categorized into these two types to encourage inclusion and broaden participation.
For this funding announcement, to qualify as an LRI, institutions must:
These criteria are similar to the Research Centers in Minority Institutions criteria, an independent program.
HRIs are institutions that do not meet the LRI criteria. Both LRIs and HRIs must provide evidence of their commitment to diversity and inclusion.
All institutions supported in the FIRST Cohort program, regardless of their configuration, must also adhere to the program goal of inclusive excellence.
For HRIs, the faculty cohort must be comprised of no fewer than 10 scientists and for LRIs, no fewer than 6 scientists. Both HRI and LRI institutions can apply to form mutually beneficial partnerships. The number of scientists supported in a partnership must be based on prior planning and what was proposed and justified in the application. If a partnership includes an HRI, it must hire no fewer than 10 scientists. If a partnership includes only LRIs, it must hire no fewer than 6 scientists.
The new faculty comprising a FIRST Cohort must be hired at the Assistant Professor (or equivalent) level, and if there is a tenure track at the recipient institution, these individuals must be hired on the tenure track. The new faculty are expected to be organized into research clusters, and for the purposes of this RFA a cluster is defined as no fewer than three new faculty in a related biomedical research area. All biomedical research areas within the NIH mission are included in this funding announcement. For example, an institutional cohort might be comprised of multiple smaller research clusters of scientists within various scientific disciplines that fall under the NIH mission area (see Mission and Goals and List of NIH Institutes, Centers, and Offices). By incentivizing hiring of a co-localized cohort, this initiative offers an added benefit of engaging both university-level and departmental leadership and leveraging departmental faculty to form an extended network for the cohort to access. Although institutional capacity will shape the size of each cohort and the design of any research cluster, each cohort must be large enough to create an interactive group and include collaborations among relevant departments, divisions, and institutions to help achieve this goal. Professional and research development, mentoring, and sponsorship are integral elements of the cohort model design, and the program must include activities and resources to reduce isolation, increase community building and networking, and foster career, research, and professional advancement. Sponsorship refers to a person in a senior position within the institution who serves as an advocate to assist the faculty member with networking, career opportunities, and strategic identification of individualized professional milestones that ensure success. A sponsor provides an in-depth commitment and possesses the power and influence to substantively support the faculty member. The sponsor’s role extends beyond that of a mentor with respect to advocacy, active tracking, and proactive outreach to those who can impact the career success of the faculty member and includes the gravitas that may not necessarily be characteristic of a mentor. Faculty must be appointed with 75% protected research time averaged across the 12 months of the year and for the length of the award for future transition to competitive research awards. In addition to creating a self-reinforcing community of scientists committed to inclusive excellence, hiring a diverse cohort of new faculty could create a critical mass of scientists within the microcultures in which they work.
All future FIRST faculty candidates will be required to submit a statement to the grantee institution describing their commitment to promoting diversity and inclusive excellence. Institutions will decide how to evaluate this commitment, but some tangible examples include active participation in diversity efforts, mentoring individuals from groups underrepresented backgrounds in the biomedical research enterprise, volunteer activities in an underserved community, outreach activities, teaching diversity-related courses, the area of a candidate’s research e.g., research in topic areas such as health disparities and workforce diversity, other inclusive excellence activities, etc. This statement would also describe the candidate’s personal trajectory to a scientific research career and philosophy and/or approach to inclusive excellence and diversity.
In addition, NIH will encourage FIRST Cohort awardees to enhance the diversity of the FIRST Cohort by actively recruiting candidates from groups identified as underrepresented in the biomedical, clinical, behavioral, and social sciences, some of which are described in NOT-OD-20-031, such as racial and ethnic minority persons, those from socioeconomically disadvantaged backgrounds, individuals with disabilities, and women. Institutional search processes must mitigate implicit bias in hiring through education modules, tools, and assessments.
Faculty in the FIRST Cohort must participate in multilevel mentoring, sponsorship, and professional and research development trainings embedded within institutions that are actively implementing integrated, systems-level approaches for sustainable culture change.
Each FIRST Cohort awardee will be responsible for evaluating its own FIRST program. Each FIRST Cohort awardee will be responsible for collecting quantitative and qualitative data (e.g., focus group data, observations of processes data, and survey data) and sharing the required data with the FIRST Coordination and Evaluation Center (CEC). The FIRST CEC will conduct a comprehensive evaluation of the program and coordinate with FIRST Cohort awardees to collect the necessary data. The FIRST CEC, in collaboration with the 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. While FIRST Cohort awardees must implement the set of common data elements identified by the FIRST CEC, they may also add measures of interest to their research team and institution. 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.
All FIRST Cohort programs will operationalize activities through three cores Administrative, Faculty Development, and Evaluation.
Applications Not Responsive to this FOA
Applications nonresponsive to terms of this FOA will not be reviewed. The following components must be included to be deemed responsive:
Prospective applicants are encouraged to visit the Common Fund website (https://commonfund.nih.gov/first) to access additional information, including the Technical Assistance Webinar recording and the helpful and continually updated Frequently Asked Questions.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
The NIH intends to commit up to a total of $70.5M total costs over five years to fund up to four awards starting in fiscal year 2023.
These awards are contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.
Application budgets per award are limited to $300,000 direct costs for all cores combined in year one; $3,275,000 direct costs each year in years 2-4; and $120,000 direct costs for all cores combined in year 5 and need to reflect the actual needs of the proposed project.
These awards are contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.
Application budgets are limited and need to reflect the actual needs of the proposed project. Budgets should only reflect the costs the applicant institution(s) are requesting from NIH.
See Budget (Overall) section for full budget details.
The maximum project period may not exceed five 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
Federal Governments
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, e.g., 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
Only one application per institution, normally identified by having a Unique Entity Identifier (UEI) or NIH IPF number, is allowed. This funding opportunity will accept applications from eligible Highly Resourced Institutions (HRI), Limited-Resourced Institutions (LRI), or Partnerships (any composition of HRI and/or LRI) to develop faculty cohort models. All eligible institutions are categorized into these two types to encourage inclusion and broaden participation. If an institution is applying as an LRI, the institution must include a statement demonstrating that it meets the LRI criteria. See Institutional Support section.
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 or an institutional system-to-system solution. A button to apply using ASSIST is 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Jessica M. Calzola, Ph.D.
National Cancer Institute (NCI)
Email: FIRSTNIH@nih.gov
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Component | Component Type for Submission | Page Limit | Required/Optional | Minimum | Maximum |
---|---|---|---|---|---|
Overall | Overall | 12 | Required | 1 | 1 |
Administrative Core | Admin Core | 12 | Required | 1 | 1 |
Faculty Development Core | Faculty Development | 12 | Required | 1 | 1 |
Evaluation Core | Evaluation | 12 | Required | 1 | 1 |
Instructions for the Submission of Multi-Component Applications
The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.
Overall Component
When preparing your application, use Component Type Overall .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424(R&R) Cover (Overall)
Complete entire form.
PHS 398 Cover Page Supplement (Overall)
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Research & Related Other Project Information (Overall)
Follow standard instructions.
Project/Performance Site Locations (Overall)
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Research and Related Senior/Key Person Profile (Overall)
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
Budget (Overall)
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
Budgets should only reflect the costs the applicant institution(s) are requesting from NIH. Application budgets for all cores combined are limited to the following and need to reflect the actual needs of the proposed project:
Year 1: Budget limit $300,000 direct costs for all cores combined.
Years 2-4: Budget limit $3,275,000 direct costs each year (more details on years 2-4 below).
Year 5: Budget limit $120,000 direct costs for all cores combined.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
PHS 398 Research Plan (Overall)
Specific Aims: Outline the rationale for and specific aims of the program and explain how it strategically fits into the organizing framework and will achieve the goals of the FIRST Cohort program.
Research Strategy: Describe how the program will plan, implement, and sustain the overall goals and specific measurable objectives that the FIRST Cohort program expects in the areas of:
Goal 1: Fostering Sustainable Institutional Culture Change:
Goal 2: Hiring a Diverse Cohort of New Faculty:
Goal 3: Faculty Development, Retention, Progression, and Promotion:
Specifically describe and address the following:
Leadership and Key Personnel
Management
Institutional Culture and Environment
Strategy and Methodology
Professional Development and Progression
Institutional Support: An Institutional Letter of Commitment must be included in the Appendix (see below).
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.
All applications, regardless of the amount of direct costs requested for any one year, must address a 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 recipients post award.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
Applications must include a written "Institutional Commitment Letter" in the Appendix. This letter should be from the institution leadership and, if a partnership application, from the leaderships of each of the partnering institutions (e.g., President, Dean) to show institutional commitment to the FIRST Cohort program. This is likely to include commitment of additional resources necessary to ensure that the program will have the maximum success and sustainability. Specifically, institutional leaders must provide detailed statements of both short- and long-term commitment and list the specific resources being provided, including supplemental funding to start-up packages and professional development, laboratory and administrative space, protected time for research independent of grant funding, and access to core resources within the institution. These statements must also identify the specific number of faculty hires expected and commitment to sustainable institutional culture change. The letter must clearly explain how the institution(s) would monitor these efforts and specific steps and procedures to ensure the institution(s) achieve the planned goals and objectives. If an institution is applying as an LRI, a statement demonstrating that the institution meets the LRI criteria must be included.
The letter must include:
Statement detailing the effort of commitment of the designated PD(s)/PI(s).
Statement of the activities that each faculty listed as Key Personnel is being released from (e.g., teaching, mentor, sponsor, clinical, administrative duties), including a statement as to whether the costs of this released time are shared or not between partnering institutions.
Statement that details provisions for recruitment of new faculty, including supplemental funds for startup and professional development and expected number of faculty to be hired.
Statement that identifies the potential research clusters of scientists in various scientific disciplines within the NIH mission.
Statement that details provisions to leverage funds for long-term sustainability of FIRST Cohort-supported activities.
Statement indicating the application type: HRI, LRI, or Partnership.
If this is a Partnership application, statement listing the partnering institutions.
Letters of Support: "Other Letters of Support" should be included in the Appendix.
PHS Human Subjects and Clinical Trials Information (Overall)
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
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.
If the applicant institution envisions hiring faculty that may conduct research with Human Subjects or may conduct Clinical Trials, but the details are unknown at the time of application, a Delayed Onset Study applies.
Vertebrate Animals: If the applicant institution envisions hiring faculty with this award, and those faculty may use vertebrate animals, but the details are unknown at the time of application, a Delayed Onset Study applies.
PHS Assignment Request Form (Overall)
All instructions in the SF424 (R&R) Application Guide must be followed.
Administrative Core
When preparing your application, use Component Type Admin Core .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
The Administrative Core includes the faculty start-up (salary and research project start-up) and all administrative management funds. Administrative management costs may be higher in the early years of the program and lower in the later stages for managing the planning efforts, such as salaries for Administrative Core key personnel, travel for key personnel, publications, equipment, and supplies to support the administrative structure. In years 2-4, administrative management costs are limited to $140,000 direct costs per year. Travel costs for attending any in-person meetings and FIRST Executive Steering Committee (FESC) meetings must be included.
Effort Commitments: For effective leadership, individuals designated as PD(s)/PI(s) must be meaningfully committed to the program. Specifically, for a single-PI application, a minimum of 20% or 2.4 person months of effort per year is expected for the PD/PI. For a multi-PI application, at least one PI must commit a minimum of 10% or 1.2 person months of effort per year. In all cases (i.e., single-PI or multi-PI) the total PI salary costs supported by this award cannot exceed 25% of the Administrative Core budget (excluding start up package cost of the Administrative Core budget).
Budget Justification: Justification for all costs associated with this core must be provided. The faculty start-up funds will support both salary and research project start-up costs. Administrative management funds support the salaries for PD(s)/PI(s) and for key personnel such as Program Managers (i.e., key personnel that assist the PD(s)/PI(s) in coordinating and organizing day-to-day activities of the program; travel for key personnel; publications; equipment; and supplies to support the administrative structure).
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Specific Aims: Succinctly list and describe the aims for achieving the specific goals and objectives of the Administrative Core, which will support and manage the FIRST Cohort program.
Research Strategy: For each of the below areas, describe the role the core plays and how the core will plan, implement, and/or sustain its objectives through the activities described.
Leadership and Key Personnel
Management
Culture and Environment
Strategy and Methodology
Professional Development and Progression
Partnership applications must also address the following (Administrative Core):
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, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, must address a 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.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.
Faculty Development Core
When preparing your application, use Component Type Faculty Development .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Faculty Development Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Faculty Development Core)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Faculty Development Core)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Faculty Development Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Faculty Development Core)
Budget (Faculty Development Core)
Budget forms appropriate for the specific component will be included in the application package.
Faculty development costs may be higher in the early years of the program and lower in the later stages for managing the efforts, such as salaries for Faculty Development Core key personnel, travel for key personnel, equipment, and supplies to support the faculty success and retention.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Faculty Development Core)
Specific Aims: Succinctly list and describe the aims for achieving the specific goals and objectives of the Faculty Development Core, which will support and manage faculty development activities in the FIRST Cohort program.
Research Strategy: For each of the below areas, describe the role the core plays and how the core will plan, implement, and/or sustain its objectives through the activities described.
Leadership and Key Personnel
Management
Culture and Environment
Strategy and Methodology
Professional Development and Progression
Partnership applications must also address the following (Faculty Development Core):
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, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, must address a 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.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
Evaluation Core
When preparing your application, use Component Type Evaluation .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Evaluation Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Evaluation Core)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Evaluation Core)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Evaluation Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Evaluation Core)
Budget (Evaluation Core)
Budget forms appropriate for the specific component will be included in the application package.
Evaluation costs may be higher in the early years of the program and lower in the later stages for managing the planning efforts, such as salaries for Evaluation Core key personnel, travel for key personnel, equipment, and supplies to support the evaluation structure.
Budget costs for the Evaluation Core may include costs for internal evaluation activities.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Evaluation Core)
Specific Aims: Succinctly list and describe the aims for achieving the specific goals and objectives of the Evaluation Core, which will support and evaluate the FIRST Cohort program at the applicant institution and collaboratively with the FIRST CEC. Applicants must incorporate aims that are appropriate to the strategies to ensure that planning, monitoring, evaluation, and tracking of program activities will be continuously ongoing, shared as negotiated, and reported to the FIRST CEC.
Research Strategy:
For each of the below areas, describe the role the core plays and how the core will plan, implement, and/or sustain its objectives through the activities described.
Leadership and Key Personnel
Management
Strategy and Methodology
Partnership applications must also address the following (Evaluation Core):
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, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, must address a 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.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
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) using ASSIST or other electronic submission systems. 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.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
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) and component Project Leads must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Scoring. Reviewers will provide an overall impact score for the entire U54 application (Overall). In addition, assigned reviewers will provide individual "criterion scores" for the Overall application but not for the other components.
Other components of the U54 application will be evaluated but each will receive only one overall impact score (not numerical) rating.
In addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific for this FOA:
Leadership and Key Personnel
Management
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
Specific for this FOA:
Are the Resource Sharing Plans, or the rationale for not sharing the following types of resources, appropriate and well justified: Data Sharing Plan?
Strategy and Methodology
Professional Development and Progression
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, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific for this FOA:
Culture and Environment
In addition, for partnership applications:
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Study Timeline
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
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.
Overall Impact Cores
For each of the Cores below (i.e., Administrative, Faculty Development, and Evaluation), reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Core 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). Criterion scores will not be provided for the Cores.
Review Criteria - Administrative Core
Leadership and Key Personnel
Management
Strategy and Methodology
Professional Development and Progression
Culture and Environment
In addition, for partnership applications:
Review Criteria - Faculty Development Core
Leadership and Key Personnel
Management
Strategy and Methodology
Professional Development and Progression
Culture and Environment
In addition, for partnership applications:
Review Criteria - Evaluation Core
Leadership and Key Personnel
Management
Strategy and Methodology
Institutional Commitment Letter
Is the level of authority of the officials committing to this effort adequate? Does the written Institutional Commitment Letter from the appropriate leadership (e.g., President, Dean) detail adequate support of the following:
In addition, does the written Institutional Commitment Letter from the appropriate leadership (e.g., President, Dean):
In addition, for partnership applications:
Additional Review Criteria - Cores
As applicable for the Cores, 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
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not applicable
Renewals
Not applicable
Revisions
Not applicable
Additional Review Considerations - Cores
As applicable for the collaborative partnership 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).
Authentication of Key Biological and/or Chemical Resources
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
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:
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.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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: Generaland 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 must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html. Federal award recipients must comply with 45 CFR 75.300 and the NIH GPS, Chapter 4.1.2 (and the civil rights laws and regulations referenced therein), which prohibit discrimination.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
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 2 CFR Part 200, 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The 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. NCI staff serving as POs will provide the normal scientific and programmatic stewardship of the FIRST Cohort awards and will be named in the award notices. 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 FESC and recipient virtual or face-to-face meetings, but the NIH will organize meetings with EPCs, who will report only to the NIH.
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 recipients. An NIH Project Team, consisting of NIH employees only, including the NCI POs and NIH PSs, will assist the POs with the normal scientific and programmatic stewardship of the awards. PSs may be named after awards are made and the scientific foci of any cohorts and research clusters are known.
The NIH Data sharing agreements must be met. If the NIH data sharing requirements are not met, then the NIH will take the appropriate actions, such as delayed or immediate reductions of funds, restrictions on use of funds, or an ordered phase-out of awards.
Unspent funds from the award will be used to offset funds in the following year.
PI and Program Roles and Responsibilities are described under the terms of the Cooperative Agreement in the FOA.
The PD(s)/PI(s) will have the primary responsibility for:
Minimal PD(s)/PI(s) Commitments. Recipients must be committed to making diversity of the research community a priority. The recipients must ensure a significant effort commitment of the program leadership. Specifically, for a single-PI application, a minimum of 20% or 2.4 person-months of effort per year to the program activities is expected for the PD/PI. For a multi-PI application, at least one PI must commit a minimum of 10% or 1.2 person-months of effort per year. In all cases, the total PI salary costs supported by this award cannot exceed 25% of the Administrative Core budget (excluding start-up package cost of the Administrative Core budget).
Program Meetings. Each recipient must plan regular meetings (no less frequently than monthly) to discuss the progress and direction of its activities and to ensure that the necessary interactions are taking place. Recipients will be expected to participate in FIRST program-wide meetings. These meetings may be in the form of phone teleconferencing, videoconferencing, and/or web conferencing as well as face-to-face meetings. Unwillingness or a consistent inability of a PD/PI to attend may be the basis for administrative action including termination of the award.
Face-to-Face PI Meetings. The contact PD/PI and senior administrators for the program (e.g., Program Managers) must attend FIRST Program PI meetings for the purpose of sharing information and strategies.
Reports. Each recipient will submit annual progress reports to the NIH/NCI that describe activities and accomplishments during the previous funding period as part of the Research Performance Progress Report (RPPR).
Approval of Changes. If the institutional leadership changes during the award, new letters of commitment must be sent to NIH/NCI no later than 90 days after the change. Documentation should include Institutional Commitment Letter and rationale for replacement.
Sharing Experiences. Successful programs are expected to participate in sharing their approaches and experiences with other FIRST recipients and the broader community.
Participation in External Program Evaluation Through FIRST CEC. All PD(s)/PI(s) of the FIRST Cohort awards are expected to participate and facilitate an evaluation of the program through the FIRST CEC. Conducting the national evaluation ensures objectivity and credibility of the evaluation findings and recommendations. However, NCI POs will remain responsible for the normal scientific and programmatic stewardship, annual progress report review of each FIRST Cohort award, and evaluation of the partnership program. The FIRST CEC, in collaboration with FIRST Cohort recipients, will 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 which will be used to identify the core data elements required for monitoring and evaluating the program overall.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Additionally, NIH Program Official(s) will be responsible for the normal scientific and programmatic stewardship of the FIRST Cohort awards and the FIRST CEC award and will be named in the award notice. Prior to funding an application, the PO will contact the applicant to discuss the proposed milestones and any changes suggested by NIH staff or the NIH review panel. Milestones and metrics will be developed by each FIRST Cohort recipient, and each PI will work with 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 NCI, in consultation with the NIH FIRST Working Group of NIH staff from different ICs, generally will work with or afford the recipients an opportunity, consistent with the terms of the Cooperative Agreement, to correct situations prior to restricting, reducing, or an ordered phase-out of FIRST Cohort awards. The NCI Program Official(s), 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 dominant role and prime responsibility for the activity resides with the recipients for the program, although specific tasks and activities in carrying out the programs will be shared among the recipients and the NIH PO/PS and/or NIH FIRST Working Group.
The NIH FIRST Working Group will participate and select program staff to review supplemental requests, extensions, and/or bridge funding requests.
In this case, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NCI PO and PS may not be the same person.
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 program. The recipients and the Project Scientist(s) will meet virtually or in person with the FESC at least once a year throughout the duration of the FIRST programs, and will meet on conference calls, as needed, to share information on methodologies, analytical tools, and preliminary results. PDs/PIs, key co-investigators and 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 interact with the FIRST Cohort and FIRST CEC investigators. The FESC membership will include PD(s)/PI(s) of each FIRST Cohort award and the FIRST CEC 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 from the PIs of the awarded sites. 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 Program Scientists (all Federal staff together) will have one vote. FESC decisions generally will be made by majority 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 Cohort recipient agrees to work collaboratively to:
External Program Consultants
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 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.
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 75.113and 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 75and 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: 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: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Jessica M. Calzola, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7474
Email: FIRSTNIH@nih.gov
Center for Scientific Review
Email:FOAReviewContact@csr.nih.gov
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.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 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.