Abstract

In 2006 the National Institutes of Health (NIH), guided by the leadership of Elias Zerhouni, launched the Clinical and Translational Science Award (CTSA) program to jump-start transformative change in the nation’s research agenda to emphasize translating discovery from the bench to implementation in the community (1–5). Much of the Funding for the CTSAs was garnered by rolling NIH funding of General Clinical Research Centers (GCRCs), and educational K and T awards. Successful applicants were then asked to utilize these funds to (as stated in the Request for Applications [RFA]) “transform the local, regional and national environments for clinical and translational science and to increase the safety, efficiency and speed of clinical and translational research”(4). Each of the 60 CTSA institutions has approached addressing this transformation in slightly different ways; however, it has become clear over the last 5 years that substantive changes, as a result of CTSA funding at academic institutions, are transforming medical research and the infrastructure that supports it. Each of the CTSA’s is required to address specific Key Functions to advance the consortium goals. These required Key Functions are: (i) expertise in Biomedical Informatics, (ii) a program in Research Education, Training and Career Development, (iii) a program in Community Engagement and Research, (iv) an Evaluation component, (v) Pilot Projects in Translational and Clinical Studies, and (vi) a Regulatory Knowledge and Support component. Optional CTSA Key Functions include: (vii) support of the Development of Novel Clinical and Translational Methodologies, (viii) components or cores to support Research Design, Epidemiology, Biostatistics and Clinical Research Ethics, (ix) Clinical Research Resources and Facilities, and (x) components or cores that develop Translational Technologies and Resources. It is also encouraged for institutions to support research in Child Health. Addressing these Key Functions at the University of Michigan, for example, has led to transformational change in the structure and culture of the institution.

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