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Limited Submission: NIH Faculty Institutional Recruitment for Sustainable Transformation (FIRST) Program: FIRST Cohort (U54 Clinical Trial Optional)

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.

Summary

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 early-career faculty 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.

Please read the full program announcement before preparing your internal application.

Award Amount

  • The maximum project period may not exceed five years.

Eligibility

  • 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.

Selection Criteria

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?

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?

In addition, for this FOA:

Leadership and Key Personnel

  • Are the experiences and expertise of the leadership and key personnel relevant to the proposed activities?
  • Are the roles and responsibilities of key leadership, including detailing the experience and expertise needed to lead and guide the FIRST Cohort program, adequate? Are leadership roles with respect to initiating, facilitating, and implementing the successful completion of the program goals adequate?
  • Are the details for succession planning to sustain FIRST Cohort award activities in the event of transitions of FIRST Cohort leadership or FIRST Cohort faculty adequate?
  • Are details demonstrating institutional support adequate?

Management

  • Is the overall governance structure with leadership, administration, fiscal, and scientific functions outlined with levels of authority for each appropriate?
  • Are the core interactions and integration plans adequate?

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

  • the protection of human subjects from research risks; and
  • 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?

Limitation Details

An Institution may submit one proposal.

If you are interested in submitting for this program, you must first submit an internal application to limsub@uga.edu according to the required instructions below.

Internal Applications must include the following:

  • A cover page listing
    • The name of this funding opportunity and title of your proposal
    • Your name, UGA position, home department, email, and UGA contact information
    • Collaborator names, positions, and institutions (if any)
    • Indicate whether or not you have submitted to this program in the past. If so, please provide a copy of the review at the end of the internal application.
  • A (maximum two-page) proposal summary that addresses the program’s specific selection criteria.
  • One paragraph describing why this proposal should be UGA’s submission (i.e., why it will be the most competitive for this program)
  • Curriculum vitae

Internal Selection

Limited Submission announcements often generate multiple competing proposals.  UGA reviewers judge proposals as they would in any peer review process, so PIs are urged to put their best foot forward.  Along with typical criteria, reviewers will evaluate internal proposals based on their fit with the sponsor’s articulated goals and criteria.

Internal Submission Instructions

The above internal application materials should be submitted via email as a single .PDF file to limsub@uga.edu by the internal deadline listed above.

Questions?

Please submit questions regarding the internal competition to limsub@uga.edu.

For questions directly related to this program, please contact the following program officers:

Sanya A. Springfield, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6170
Email: FIRSTNIH@nih.gov


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