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National Institutes of Health US Department of Health & Human Services National Center for Research Resources A c c e l e r a t i n g a n d e n h a n c i n g r e s e a r c h f r o m b a s i c d i s c o v e r y t o i m p r o v e d p a t i e n t c a r e The X02: A New Mechanism for the Review of Complex Applications Greg Farber

Interdisciplinary Roadmap Implementation Group of the NIH Roadmap

Health research traditionally has been organized much like a series of cottage industries, lumping researchers into broad areas of scientific interest and then grouping them into distinct, departmentally based specialties. But, as science has advanced over the past decade it has become clear that the traditional divisions within health research may in some instances impede the pace of scientific discovery. To lower these artificial organizational barriers and advance science, this set of NIH Roadmap initiatives will establish a series of awards that make it easier for scientists to conduct interdisciplinary research.

Meetings and Networks for Methodological Development in Interdisciplinary Research R13 and R21 9 awards $950K Training a New Interdisciplinary Research Workforce T90 17 awards $5.2M Supplements for Methodological Innovations in the Behavioral and Social Sciences 15 awards $1.6M Curriculum Development Awards K07 9 awards $1.0M Short Programs for Interdisciplinary Research Training R13 6 awards $1.2M Interdisciplinary Health Research Training: Behavioral, Environment, and Biology T32 3 awards $600K Exploratory Centers P20 21 awards $12.3M Interdisciplinary Research FY2004 $23M

Exploratory Centers Program The applicant community was ready to propose interdisciplinary approaches to science page applications for the first Interdisciplinary Roadmap RFA

Interdisciplinary Consortium Timeline The Exploratory Centers (RFA-RM ) had a receipt date on Feb 24, awards, 3 years in length, were made beginning September 2004 using FY04 funds. The P20 centers were to be followed by a program to fund large Interdisciplinary Consortia ($3M direct costs per year for a total of five years starting in FY07). Site visits and the results of a meeting at NIH suggested the form that applicants wanted for these consortia.

Structure of a Consortium Giving appropriate credit to all of the members of the interdisciplinary team is the driving idea behind the adopted interdisciplinary consortium structure. Desire was expressed for the following mechanisms as part of a series of tethered awards: R01, R21, R25, T90/R90, P30, K01, competitive supplements, as well as a central U54 for project management.

U54 from NCRR R01 from NIGMS R21 from NIMH Comp Supplement from NHGRI T90/R90 from NIDDK K01 from NINR R25 from NCRR P30 from NCRR R01 from NIMH R01 from NINDS R01 from NIDA

Problem $3M in direct costs can fund ~10 components per consortium. If we received 150 full applications, this would be 1500 R01 sized components to review in one batch. Phone calls prior to the release of program announcements suggested that 150 might be an underestimate of the number of applications. There are only enough funds in the program for 8 consortia.

Potential Solutions 1.Restrict applicants to P20 awardees (limited competition). 2.Require potential applicants to submit an R03 (or other placeholder award). These would be reviewed and would go to council with nominal awards. Only awardees would be allowed to submit full applications. 3.Invent a pre-application mechanism that allows peer-review but does not require an award.

Blame it on the NIH Roadmap, Again The NIH Roadmap process deserves credit for creating new mechanisms that allow non- traditional programs. Examples include: T90/R90 – Training for a New Interdisciplinary Research Workforce (RFA-RM ) DP1 – NIH Directors Pioneer Awards Program (RFA-RM ) PN1 – Nanomedicine Center Concept Development Awards (RFA-RM ) PN2 – Nanomedicine Development Centers Awards (RFA- RM ) X01 – Submit Assays for HTS in the Molecular Centers Network (PAR )

Features of an X02 X02s are used for preapplications. The first round of X02s were peer reviewed. NIH policy would have to change to allow program or administrative review. Preapplications should generally require far less than 25 pages. Preapplications need not go to an advisory council since no awards are being made.

First Use of the X02 The X02 mechanism is being used in PAR , the NIH Roadmap Preapplication for Interdisciplinary Research Consortium This mechanism uses electronic submission

Components Selected for the Interdisciplinary Consortia There are an average of 10.1 components in each consortium. R01 – range from 0 to 13 with an average of 5.6 R21 – range from 0 to 7 with an average of 1.1 R25 – range from 0 to 1 with an average of 0.5 T90/R90 – range from 0 to 2 with an average of 0.5 K01 – range from 0 to 4 with an average of 0.35 Competitive Supplement – range from 0 to 2 with an average of 0.12 P30 – range from 0 to 2 with an average of 1.0 U54 – one was required for each consortium

First Use of the X02 The review of the X02s was managed by NCRR using IAR without a face to face review meeting. Scores were released on August 21. The first summary statements are being released today. Applicants have two weeks after the release of their summary statements to send concerns about the review to program staff.

Post Review Process The Project Team (composed of representatives of all NIH ICs including CSR) will meet on September 13 to construct the first draft of the invitation list. NCRR Council will also receive an update on September 21 since all awards under the Consortium program will initially be made by NCRR.

Post Review Process - 2 The invitation list will be presented to the Interdisciplinary Roadmap Implementation Group (chaired by Drs. Tabak, Grady, and Schwartz) on September 22. The Implementation Group can modify the list and then will vote on the final list. After approval of a list by the Implementation Group, the list will be forwarded to the RICC for final approval. Invitations to Consortium PIs will be made on September 27.

Post Invitation Process Applicants will not have flexibility to change components that are part of an invited Consortium. Those components were specified in the X02 applications. The due date for these applications is December 19, Consortia will be reviewed in a single SEP convened by NCRR.

Other Potential Uses of the X02 In addition to dealing with the situation where a large number of complex applications are expected, the X02 may be useful in portfolio management.

Uses of the X02

Summary The X02 may turn out to be useful in a number of situations where asking for full applications would be a burden on the review and applicant communities.