Really out there

NIH’s new T-R01 program seeks to fund projects that go outside the box

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BETHESDA, Md.—If there is one phrase you don't expect to hear in connection with the protocol-heavy world of pharmaceutical research, especially with relation to project funders, it would likely be: "That's so crazy it just might work." But in fact, as odd as it seems, that's just the path that the National Institutes of Health (NIH) will be taking with its new Transformative R01 (T-R01) program.

The traditional and well-established R01 grant program supports the bulk of mainstream NIH investigator-initiated efforts, but there has been increasing concern that the structure and review of R01 proposals can discourage submission of "the most bold, creative, and risky research proposals," according to an NIH news release. So, the NIH has created the T-R01 program, through which it intends to invest more than $250 million over the next five years to foster "bold and creative investigator-initiated research."

The basic idea for the T-R01 program has been percolating for some time at NIH, according to Dr. Betsy Wilder, director of the Division of Strategic Coordination in NIH's Office of Portfolio Analysis and Strategic Initiatives (OPASI).

"The realization we needed a designated amount of money to fund really 'out there' and outside-the-box ideas came out of the first iteration of the NIH Roadmap for Medical Research four or five years ago," she notes. "Out of that recognition we developed the NIH director's Pioneer and New Innovator Awards programs to locate really intriguing investigators. But there was still a need to identify and fund truly transformative projects, too, and we heard repeated calls for that from the field."

Hence the T-R01 program, which is intended to support exceptionally innovative, original or unconventional research that will, according to NIH, "allow investigators to seize unexpected opportunities and cultivate bold ideas regardless of the anticipated risk. T-R01 funding will support inventive and innovative studies intended to transform current paradigms in biomedical or behavioral sciences."

NIH Director Dr. Elias A. Zerhouni adds the program will pilot novel approaches to peer review to facilitate identification and support of the most ground-breaking, high impact research and augment the existing Pioneer and New Innovator Awards programs.

Dr. Alan Krensky, director of OPASI, notes, "This new mechanism is designed to encourage the generation of new scientific paradigms or the disruption of old ones."
The obvious question, of course, is how "out there" might the projects be? Wilder admits that it's really a matter of opinion what constitutes "crazy" versus "transformative," so the NIH will be relying heavily on its peer reviewers to help make that call.

"We'll also be calling on expert opinions from people outside our usual peer review pool who are closer to the relevant fields so that they can give us a better idea of which ideas are at all feasible and which ones may be fundamentally impossible," she explains.

The NIH is encouraging submission of T-R01 applications from scientists in all disciplines relevant to the NIH mission, including the biological, behavioral, clinical, social, physical, chemical, computational, engineering and mathematical sciences. Areas of highlighted need that have been identified through an NIH strategic planning process include: pharmacogenomics, protein capture, functional variation in mitochondria, complex three-dimensional tissue models, acute to chronic pain transition, and science of behavior change.

Applications for new five-year grants are now being accepted. Review criteria will focus on a project's transformative potential. The NIH plans to fund the first cohort of T-R01 awards in fiscal 2009.

Wilder notes NIH has neither set a cap on award levels for T-R01-funded projects nor tried to set a maximum number—or even a range for that matter—of projects that would be funded. One thing that is certain is NIH will commit a minimum of $25 million for 2009, the first year of the T-R01 program.

"It isn't likely, but for all we know, we could fund a single great project for $25 million next year," Wilder says. "This a very open program, designed to provide to maximum flexibility we need to develop projects and ideas that will have a profound impact on science and the way we conduct science." DDN

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