Sponsor:  National Institutes of Health (NIH)

Sponsor Program Solicitation: RFA-TR-14-009
Funding Amount: $110 million in FY2015 to fund up to 21 awards
Duration: Up to 5 years


Status of this Limited Submission Opportunity

Closed


Deadlines

NU Pre-Proposal Deadline: 10/15/2014
Sponsor Deadline: 01/15/2015
Letter of Intent Deadline: 12/15/2014


Eligibility and Nomination Requirements

Only one application per institution is allowed. This opportunity is still open. If you are interested in applying, please contact Karen Drew (x4824) as early as possible.

 


Funding Areas

The purpose of this funding opportunity announcement (FOA) is to invite applications to participate in the Clinical and Translational Science Award (CTSA) program which supports high quality translational and clinical research locally, regionally, and nationally, and fosters innovation in methods, training, and career development. Currently awarded CTSAs with project period end dates in 2016, 2017, or 2018 are not eligible to apply to this FOA.

 

Specific Objectives

The NCATS CTSA program as a whole actively supports the full spectrum of clinical and translational research while encouraging flexibility for each hub to build on its own unique strengths.  To reach and maintain this goal, defined sets of capacities and resources should be present at each hub so that it can act as a qualified partner in the CTSA program, promoting an environment of quality, safety and efficiency for translational and clinical research.  CTSA hubs should be agents of continuous improvement as they identify gaps and opportunities in the research process and develop innovative solutions.  CTSA hubs should promote team science, and the development of a well-trained and skilled translational workforce.

An additional important objective for each CTSA hub is the support of collaboration among CTSA hubs towards building a national CTSA network.  This national network will allow for the efficient planning and implementation of high-quality multi-center research, will harmonize standards and best practices, and will enhance translational research training through shared innovative curricula, mentorship programs, online courses, or “externships” to take advantage of unique learning opportunities outside of the CTSA hub.  In response to the IOM report, an enhanced CTSA program will have an increased focus on the network as a whole, and its goal to realize the promise of translational science.  Synergy within the CTSA program is likely to yield greater impact than any sum of unique, individual efforts.  Strengthening synergy will add to the justification of the nation’s investment into the CTSA program.

Enhancing the CTSA program’s capacity as a network will require changes at the local hubs.  It is, however, expected that these changes will in the long run improve the local hubs’ ability to compete nationally and internationally, and will increase scientific and economic opportunities.  As the rising tide lifts all boats, it is anticipated that the evolution of the CTSA program into a synergistic network will benefit all participants, and most importantly result in improved health with the community enjoying more effective prevention, diagnosis and treatment of diseases sooner.

In the future, NCATS plans to strengthen the CTSA program’s capacity as a network by creating new centers that will focus on supporting multi-site clinical studies through centralized infrastructure (such as IRB and contracting) and through centralized recruitment efforts. These new centers will work with all CTSA hubs that elect to participate in a given study.

This FOA calls for applications from medical research institutions to participate as hubs in the CTSA program.  This program includes three parts which are linked at the time of application, but will be separated at the time of award:

  • UL1 award for a translational science hub that provides an Administrative Core and four additional components: (1) Translational Science Base; (2) Research Expertise and Methods; (3) Research Implementation and Participation; and (4) Network Resources and Optional Modules;
  • KL2 award for mentored career development programs;
  • TL1 award (optional) to support research training for pre- and post-doctorates.

The K and T components will be reviewed by training experts and will receive separate scores. The overall impact score for the U54 will include all components.  When NCATS issues the separate yet linked K and/or T awards, it will formally designate as PD/PIs those individuals identified with the Project Role of “Other-Project Lead” for those programs in the application.  Meritorious K and T awards will only be made when the associated UL1 is funded. The U, K, and T awards each will maintain their own, separate budgets.

The CTSA hubs are charged with the continuing education of translational and clinical research personnel so that they have mastered core competencies in their own discipline, and the capacity to effectively communicate and collaborate as members of multidisciplinary teams.  CTSA hubs should foster innovation in research education.  This research education may include non-degree opportunities tailored to the specific needs of the workforce at the CTSA hub, and for those involved with human subjects, lead to Good Clinical Practice (GCP) certification as a minimum standard.  CTSA hubs should foster team science and develop academic promotion criteria that help create a viable career path for translational scientists. The CTSA T and K programs are complementary and focus on the education of pre- and postdoctoral trainees, and on the career development of early-career translational researchers, respectively.