Why is this FIRST program funded through the NIH Common Fund?

• The Common Fund supports programs that are intended to have a transformative impact on biomedical research conducted across all NIH Institutes and Centers. Common Fund programs encourage highly innovative approaches to broadly relevant challenges, coordination among awardees, and rapid dissemination of results and lessons learned. These programs represent NIH-wide priorities, and program areas are selected with input from all Institute and Center Directors and from extramural scientists. Common Fund support of the FIRST program is indicative of the recognition by NIH Leadership that talent from all sectors of the population is necessary to accomplish the NIH mission.
• This program is a high priority for NIH as a whole.

Is there a particular scientific focus for this program?

All biomedical research areas within the NIH mission are included in this funding announcement. (see Mission and Goals and List of NIH Institutes, Centers, and Offices).

What types of institutions are encouraged to apply to this funding announcement?

Applications are encouraged from a diversity of institutions that conduct research in any NIH mission area. Applications may be from Limited-Resourced Institutions (LRI), Highly Resourced Institutions (HRI), or propose Partnerships (any composition of HRI and/or LRI). Additionally, the following types of Higher Education Institutions are always encouraged to apply for NIH support as Public of Private Institutions of Higher Education:

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

Where does funding for this FIRST program come from?

Funding for FIRST comes from the NIH Common Fund. The FOAs will be administered by a trans-NIH team, led by the National Cancer Institute (NCI) and National Institute on Minority Health Disparities (NIMHD) together with a group of NIH staff from multiple institutes, centers, and offices across the NIH.

Can you share who the successful applicants were in the previous rounds of the FIRST cohort RFA?

NIH has announced awardees for RFA-RM20-022 and RFA-RM21-019. Those awardees can be found here.

ELIGIBILITY

What is a Limited-Resourced Institution? What is a Highly Resourced Institution (HRI)?

For this funding announcement, to qualify as an LRI, institutions must:

• have received less than $50 million average in annual NIH funds within the three years prior to the time of application, and
• offer doctorate degrees in the health professions or in a health-related science, and
• have a historical and current commitment to educating underrepresented students, and,
• if institutions provide clinical health care services, those services must be provided to medically underserved communities.

HRI: HRIs are institutions that do not meet the LRI criteria.

Both LRIs and HRIs must provide evidence of their commitment to diversity and inclusion.

Institutions are either LRIs or HRIs; if you are unsure about whether your institution is an LRI or HRI, please reach out to the NIH program staff or consult this flow chart.

Are independent research institutions eligible?

Yes.

Is being an accredited medical school required?

This is not one of the criteria for the RFA.

Will being an institution with no direct NIH funding impact the application?

The applicant institution must be doing research in an NIH mission area. This is often signified by a track record in NIH funding, but if an institution is too new to have established this track record, they must justify why their institution will be an appropriate environment to foster research faculty to successful careers.

If an institution does not qualify as an LRI, is it automatically an HRI, even if it does not meet the $50 million threshold?

Yes. If an institution doesn’t meet one or more of the criteria to apply as an LRI, it is still eligible to apply as an HRI even if it doesn’t meet the $50 million + threshold. Please note that for these institutions, the requirements stipulated in the RFA for HRIs would apply if awarded, for example the requirement to hire a cohort of no fewer than 10.

Are intra-university partnerships, e.g., partnerships between university campuses, permissible?

Yes.

Does an institution need to have been an RCMI awardee to be eligible as an LRI for the FIRST program?

No.

COHORTS AND CLUSTERS

What is the expected size of a cohort that applicant institutions are expected to propose?

• A Highly Resourced Institution (HRI) must hire no fewer than 10 new faculty in its cohort.
• A Limited-Resourced Institution (LRI) must hire no fewer than 6 new faculty in its cohort.
• The number of faculty supported in a partnership cohort 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 new faculty. If a partnership includes two LRIs, it must hire no fewer than 6 new faculty.
• In any negotiation of the terms and conditions of award, NIH will work with awardees to ensure that the Notice of Award reflects the expectation of the appropriate number of faculty hires.

What is the difference between a cohort and a cluster?

• The cohort is the entire group of new faculty hired by an institution via this award.
• A cluster is made up of faculty in related scientific fields and with whom closer collaboration and interaction is expected. There should be no fewer than three scientists per cluster.

NEW FACULTY

What is the timeline for the hiring of the new faculty?

All faculty should be hired by the end of year 3 of an awarded grant.

In a Partnership award, how many new faculty would an awardee be expected to hire?

Please refer to the RFA: “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.”

Do Partnership awardees have the discretion to determine the ratio of the faculty recruitment split between the organizations, e.g., 50/50, 60/40, 70/30 etc.?

Yes, this must be justified as appropriate in application.

What activities will the FIRST Cohort award support in year one?

The launch year is a planning year. Launch-year activities are described in the FOA. FIRST Cohort awardees may begin hiring in year one if they have the funds to do so. NIH faculty start-up funding begins in year two of the award.

How will faculty start-up funds be allocated?

The faculty start-up will be allocated to the Administrative Core. Per the RFA: "In years 2-4, the Administrative Core, which contains the faculty start-up costs, is limited to $2,995,000 direct costs per year, consisting of a limit of $140,000 direct costs for administrative management and a limit of $2,855,000 direct costs for faculty start-up. These faculty start-up funds should be budgeted in three annual allocations (again, maximum $2,855,000/year). These funds can support both faculty salary and research project start-up costs. All faculty should be hired by the end of year 3 of an awarded grant. Each FIRST Cohort awardee institution will determine how to allocate the faculty start-up funds."

Who is eligible for FIRST faculty positions?

• Recruitment is limited to new faculty at the Assistant Professor level. The cohort will be built through recruitment of a diverse group of individuals who:
  • are competitive for an advertised research tenure-track or equivalent faculty position (must be at the Assistant Professor (or equivalent) level),
  • meet the criteria for NIH-defined Early Stage Investigators, and
  • have demonstrated a strong commitment to promoting diversity and inclusive excellence.
• Any individual who meets all of these criteria is eligible to be hired for FIRST faculty positions.
• FIRST Cohort awardees will decide their additional criteria for the new hires.

Can institutions recruit individuals from underrepresented groups?

Yes. Awardees are encouraged to conduct outreach efforts to grow and diversify the pool of qualified, prospective candidates seeking to participate in the program, to include outreach to individuals and groups underrepresented in biomedical research, such as racial and ethnic minorities, those from socioeconomically disadvantaged backgrounds, individuals with disabilities, and women who are competitive for an advertised research tenure-track or equivalent faculty position and who have demonstrated strong commitment to promoting diversity and inclusive excellence. Any individual who is competitive for a research tenure-track or equivalent faculty position and who has demonstrated a strong commitment to promoting diversity and inclusive excellence is eligible for FIRST faculty positions.

Can institutions select faculty based on race, ethnicity, or sex?

Consistent with NIH practice and U.S. federal law, funded programs may not use the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of a prospective candidate as an eligibility or selection criteria. The race, ethnicity, or sex of candidates or prospective candidates will not be considered by NIH in the application review process or when making funding decisions.

What do the new faculty need to demonstrate?

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 underrepresented backgrounds, 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.

Do faculty cohort candidates need to be named/identified at the time of the application?

No

Are faculty hires expected to compete successfully for R01 funding only? What about NSF, foundation or other grant mechanisms if hires don’t achieve R01 funding? Is the only metric of grant making success R01 funding?

The goal is independent funding, not exclusively NIH funding, though faculty hires are expected to be in research areas that address the NIH mission.

Can institutions focus their faculty hiring on individuals from one under represented group?

No. As stated in the RFA, “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.” Additionally refer to 45 CFR §75.300 Statutory and national policy requirements.

Can institutions focus their cohort on research interests that pertain to a single under represented group?

Yes. Applicants may select faculty with research interests that pertain to a single group. However, they may not discriminate against any group in the hiring process.

APPLICATION SPECIFICS

Can I revise and resubmit my application if it is not funded by previous RFA-RM-21-025 or RFA-RM-20-022?

Resubmission applications (A1) are not allowed. You may submit substantially the same idea or a refinement of the idea as a "new" application to RFA-RM-21-025. Do not reference previous applications or reviews in your new submission. Any reference to previous applications or reviews may result in your application being withdrawn.

Are institutions allowed to submit more than one application for this RFA?

Only one application per institution, normally identified by having a Unique Entity Identifier (UEI) number or NIH IPF number, is allowed.

What percent commitment is required of the PI? What percent commitment is required of multi-PI(s)?

• Per the RFA: "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, with a maximum of three person months effort per year. For a multi-PI application, at least one PI must commit a minimum of 10%, and the total PI salary costs supported by this award cannot exceed 25%."
• The effort commitment of each multi-PD(s)/PI(s) must be justified and appropriate.

Does the RFA limit the amount that can be requested for total PI salary?

Yes - PI salary in excess of 25% effort may not be requested and will not be funded

What is the minimum effort acceptable for other Core Leaders (Faculty and Evaluation Core leaders)? Do they need to have a minimal effort level committed?

No minimal effort is specified; however applicant institutions need to justify the effort level they propose.

What needs to be included in the Institutional Commitment Letter?

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, statement demonstrating that the institution meets the LRI criteria. This “Institutional Commitment Letter " must be included in the Letters of Support of the application appendix.

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 members, including supplemental funds for startup and professional development and expected number of faculty to be hired.
• Statement that details provisions to leverage funds for long-term sustainability of FIRST Cohort-supported activities.
• Statement that identifies the potential research clusters of scientists in various scientific disciplines within the NIH mission.
• Statement indicating the application type: HRI, LRI or Partnership.
• If this is a Partnership application, statement listing the partnering institutions.

Can an application include letters of support in addition to the Institutional Commitment Letter?

Yes. Other "Letters of Support" should be included in the Appendix.

Can an application be submitted as a multi-institutional proposal utilizing sub-awards?

Yes.

Are these applications expected to be developed at an institutional level vs. within a specific school at an institution?

This is up to the applicant institution.

The core budgets seem quite limited, why is this?

Please refer to the requirements for the Institutional Commitment Letter in the RFA, which states: "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."

Will this FIRST Cohort RFA be reissued?

No. NIH planned to issue this RFA for a total of three rounds. This is the third round.

What is the relationship between the FIRST Cohort awardees and the FIRST CEC awardee?

Each FIRST Cohort awardee will be responsible for evaluating its own FIRST program. Each FIRST Cohort awardee will be responsible for quantitative and qualitative data (e.g., focus groups, observations of processes, and survey data) and sharing the required data with the FIRST CEC. The FIRST CEC will coordinate with FIRST Cohort awardees to collect the necessary data and conduct a comprehensive evaluation of the program. 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.

How should the Administrative Core budget be constructed for faculty salaries and projected start-up funds?

• Faculty cohort candidates do not need to be named/identified at the time of the competing application. Therefore, put the budget together requesting faculty salary/startup funds in each of the three years (2, 3 and 4) as described in the RFA. It is possible to collectively budget for all personnel on one line of the budget. However, you will need to provide the effort and institutional base salary for newly hired faculty positions and any personnel.
• Per the RFA. “These faculty start-up funds should be budgeted in three annual allocations (again, maximum $2,855,000/year).” How those funds will be awarded each year will depend on meeting milestones in hiring the new faculty and NIH would expect that the RPPRs for each year will reflect the budget according to the faculty proposed/hired.

If an applicant institution does not know whether new faculty hired under its proposed program will be conducting human subjects research, animal research, biohazards, etc., how should the application institution address these items in the application?

The applicant institution should say “Yes” to both Animal Research and Human Subjects Research and put both as Delayed Onset, since there will not be definite plans in the application. If the institution receives a FIRST Cohort award and hires a faculty member(s) who engages in either, the institution must provide a Vertebrate Animal section and/or a Human Subjects section and the appropriate IACUC or IRB certification.

How should applications handle human subjects research or clinical trial designations?

• The Common Rule defines research as a systematic investigation designed to develop or contribute to generalizable knowledge. Evaluation activities are included within this definition. If the comprehensive evaluation is research, an applicant needs to determine if the research involves human subjects. Please also refer to NOT-OD-19-050.
• The Common Rule defines human subjects as: a living individual about whom an investigator
  • obtains information … through intervention or interaction with the individual and uses, studies, analyzes, or generates identifiable private information OR
  • obtains, uses, studies, analyzes, or generates identifiable private information.
• A human subject is the person that the information is about, and not necessarily the person providing the information. If any focus groups or survey data ask any questions about a person (such as opinion of the program, the persons experience in the program), human subjects are involved in the research.
• If there are specific plans for research involving human subjects, applicants should add a study record for each proposed study involving human subjects. See the PHS Human Subject and Clinical Trials Information instructions, section Study Record(s) for additional information. If you anticipate that there will be research conducted that involves human subjects but cannot describe the study at the time of application, and we imagine this might be the case since new faculty hires are not identified at the time of the application, you should enter a Delayed Onset Study Record. See the PHS Human Subject and Clinical Trials Information instructions, section Delayed Onset Study(ies) for additional information. Because the Evaluation Core is responsible for the design and conduct of the program evaluation, human subjects research should be reported in the Evaluation Core.

Is cost sharing required?

• Budgets should only reflect the costs they are requesting from NIH. &The Letter of Institutional Commitment requested in the application should explain the institutional commitment to the program.
• As stated in the FOA and in NIH Grants Policy – NIH does not require nor expect cost sharing on NIH funded grants and cooperative agreements.
• 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, statement demonstrating that the institution meets the LRI criteria.
• This is intended to be commitment to the program as a whole – examples are provided of what could be considered institutional commitment – but it will be up to the applicant to describe that commitment in a way that provides evidence.
• Like all NIH grants and cooperative agreements, these are assistance awards to support what is proposed in the application. We understand that there may be voluntary uncommitted cost sharing to help support other costs not covered by the award. However, voluntary committed cost sharing described in the application would require tracking and would impact F&A rate calculations as described in the regulations.

CONTACT AND ADDITIONAL IMPORTANT INFORMATION

Who is the program contact for the FIRST Cohort RFA?

Jessica Calzola, Ph.D.,P.M.P.
National Cancer Institute
Telephone: 240-276-7474
Email: [email protected]

What is a Cooperative Agreement? What should we expect?

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

Is this Common Fund’s FIRST program directly related to the recent notice NOT-GM-21-008: Support for Research Excellence - First Independent Research Support & Transition (SuRE-FIRST)?

No. The NIH is committed to fostering diversity in the biomedical workforce. As such there are many independent programs and initiatives all related to this goal.