Guest Editorial

Opening the Doors of the Clinical Center

BY JOHN I. GALLIN, DIRECTOR OF THE NIH CLINICAL CENTER

This year the Clinical Center (CC) is celebrating its 60th anniversary, and the NIH is launching an exciting experiment using CC resources. We are opening our doors to investigators from academia and industry and providing them access to our special resources. The experiment provides, for the first time, a formal funding opportunity for new partnerships between outside and intramural investigators at the CC. The result should bring new intellectual excitement to the intramural program while enabling clinical research projects that might not otherwise occur.

This initiative came about as a result of the Congressionally mandated Scientific Management Review Board’s review in 2010. It recommended the CC’s vision be expanded to “serve as a state-of-the-art national resource, with resources optimally managed to enable both internal and external investigator use.” In response, NIH released a new Funding Opportunity Announcement called “Opportunities for Collaborative Research at the NIH Clinical Center” (http://grants.nih.gov/grants/guide/pa-files/PAR-13-029.html).

The new program, which will use the NIH U-01 grant mechanism, will support collaborative research that is aligned with NIH’s efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. The program will provide renewable three-year awards and a stipend of up to $500,000 per year in direct costs. Research teams must have at least one extramural and one intramural co-principal investigator. Twelve institutes and centers (ICs) and two NIH offices have signed up to sponsor the new awards (NCI, NEI, NHGRI, NHLBI, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NLM, ORWH, and ODS). Institutes that have not signed on can participate next year.

The application process and key dates are described in detail on the Web site above. The applications will be batched annually with a single closing and due date (March 20) for each year. It’s strongly recommended, but not required, that applicants submit a letter of intent 30 days before the application is due so the CC and the proposed sponsoring IC can review it to determine resource availability and programmatic alignment.

Applications must be accompanied by letters from the CC and the sponsoring IC acknowledging the availability of resources and program alignment. Scientific reviews will be conducted by either institute-based or special study sections established by the NIH Center for Scientific Review. IC advisory councils will evaluate reviews in October.

Review criteria will include an assessment of whether the proposal has a well-defined collaborative plan with clearly identifiable responsibilities for the intramural and extramural investigators, a plan for management of the collaboration, descriptions of what each participant will provide, a clear statement of the advantage to bringing intramural and extramural investigators together, and a description of what unique CC research opportunities will be used. Award announcements are expected in November or December each year.

Grant funds will flow from the pool of extramural dollars to outside principal investigators; ICs will program intramural dollars to support the intramural investigators and CC costs. The funds needed for CC activities will be determined from resource templates submitted by investigators to the CC.

How will we measure success of this experiment? The intent is to enrich and not compromise the intramural environment. Investigator demographics, the portfolio of institutions applying for and receiving grants, the research studies associated with the grant, and the type of collaborations will be evaluated. The program will be reviewed for its ability to implement grants, develop new tools, and overcome barriers to the grant process. In addition, outcome measures such as the number and impact of resulting publications and the number of new drugs and devices will be monitored.

As the German writer and scientist Johann Wolfgang Von Goethe said in 1813, “Science and art belong to the whole world, and the barriers of nationality vanish before them.” If the NIH experiment works, we hope the barriers to intramural-extramural collaborations will vanish. What better way to celebrate the 60th anniversary of the CC than with the new vision of opening our doors?

For more information on the CC’s resources and potential partners as well as answers to frequently asked questions, visit http://www.cc.nih.gov/translational-research-resources. For other questions, e-mail ClinicalCtrPartner@mail.nih.gov or contact the Call Center at 301-496-4121.