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IC Directors' Meeting Highlights

November 7, 2005

To:	IC Directors
From:	Director, Executive Secretariat
Subject:	IC Directors Meeting Highlights — August 25, 2005

Discussion Items

I. RICC Recommendations for Roadmap Initiative Life-cycle and Mid-course Progress Review

Dr. Kleinman updated the group on the activities of the RICC and presented its recommendations on how to manage Roadmap initiative life cycles and multi-phase initiatives. She explained where we have been:

• FY02-FY03 Roadmap planning, concept development and launching,
• FY04/FY09 funding estimated, and
• FY04/FY 05 reality of implementation.

Then she summarized discussions at the 2005 Roadmap and NIH Leadership Budget retreats that:

• clarified Roadmap “rules of the road” and supported an ongoing Roadmap-like process,
• proposed a prototype for funding initiatives selected to transition to NIH home(s), and
• called for steps to be taken to “re-open” Roadmap by clarifying exit strategy for current initiatives.

After discussing the IC Directors' pre-meeting responses to the RICC recommendations, she presented a summary table of initiatives that propose phases and extend beyond FY 2009. IC Directors’ pre-meeting responses included:

• support of initiatives to be completed by FY2009/10 and the transfer of the Clinical Research Policy and Analysis Coordination to OSP,
• interest in continuing the NIH Director’s Pioneer Award program beyond FY2009, not necessarily with Roadmap funds,
• interest in discussing the opportunity to use the NIH intramural research program as a model for interdisciplinary research as an agenda item for a future IC Directors Meeting, and
• need for clarification regarding the proposed transfer of Roadmap initiatives to the Clinical and Translational Science Award program.

IC Directors then discussed the proposed general approach for managing initiatives with multiple phases and supported RICC’s recommendations that:

• Roadmap funds be used to support one planning/pilot phase and one formal funding phase,
• movement from one phase to another depends upon a positive mid-course progress review, and
• when more than one formal funding period is proposed, the second phase will be funded only if used to transition the initiative out of Roadmap funding.

A productive discussion followed. Dr. Collins raised a question about the implications of setting a funding time frame for large, cross-cutting initiatives that benefit all ICs. Dr. Nabel expressed her opinion that a limit should be set for such initiatives.

Several IC Directors who are RICC members then gave their perspectives on the recommendations. Dr. Tabak noted the important issues that the above discussion raises but stressed that RICC members are committed to ensuring that the Roadmap cultural changes persist through the transition. He emphasized that the concept of trans-NIH accountability is critical to a successful transition. Dr. Katz agreed that these RICC mid-year planning recommendations were made early in the cycle meaning formal transition plans were not yet doable. He also raised the need to ensure that the academic health centers know and understand that this is a trans-NIH cultural change.

Dr. Landis addressed the future issue that when the ICs do take on funding, the ICs must clearly communicate and be accountable to disease specific advocacy groups so they understand that these trans-NIH activities are beneficial to all and cost effective.

Dr. Zerhouni concluded the group discussion by noting that this activity required all to be nimble in maintaining the critical balance between specific disease focus and mission and the basic ability of NIH to synergistically conduct and support the best transformational science.

Dr. Kleinman ended her presentation by saying that the RICC will move ahead with caution and will regularly bring key issues and updates to the IC Directors.

II. A Vision for Change: Integrating NIH Clinical Research Resources to Foster the Discipline of Clinical and Translational Science

Dr. Alving discussed the ongoing reengineering of the early Roadmap effort in this area. In accord with the agreement that this effort should be truly transformative, the goals are to —

• provide the academic home [center, department, or institute (C/D/I)] and infrastructure needed to advance the new intellectual discipline,
• create and nurture a cadre of well-trained investigators, and
• advance the health of the Nation by transforming patient observations and basic discovery research into clinical practice.

The C/D/Is are envisioned as encompassing the following functions:

• research services and methodology development
• education core for training and career development
• clinical informatics unit
• clinical research platforms
• instrumentation and other core technologies
• governance — Director or outside advisory board

RFAs, which will be published annually for the next several years, will first be published early this fall. Academic institutions may apply for either a planning grant ($150,000 direct costs) or a full Clinical Translational Science Award (CTSA). Applications will be due in late March 2006 and, after review, grants will be funded in September 2006. The length of the awards will be 5 years. The funding plan for 2006 will be about $327 million covering both the GCRCs and the CTSAs. It is anticipated that the funding sources/plans for the CTSAs, which are anticipated at $488 million in the 2012 round, will come from converted GCRCs, base building, Roadmap, and other NCRR programs.

The group then addressed future funding plans. Dr. Straus applauded the transforming vision but warns that we must find ways of folding GCRCs into this new plan. Dr. von Eschenbach noted that while this is part of the Roadmap effort and thus Roadmap funds will be available, it is important to consider the implications for the future NCRR budget.

Dr Zerhouni noted that NCRR will work with GCRCs that don't apply for CTSAs immediately so that they have assistance in working toward CTSA funding. He thanked the group for this bold effort to transform the conduct of science.

III. Conflict of Interest Update

Dr. Zerhouni announced that later this morning the Conflict of Interest final regulations will be released and that they will be effective next Tuesday. He emphasized the three principles that had been paramount in adjusting the interim final rule:

• The public must be assured that research decisions made at the NIH are based on scientific evidence and not influenced by industry or other outside factors.
• Senior management and people who play an important role in research decisions must meet a higher standard of disclosure and divestiture than people who are not decision-makers.
• To advance science and stay on the cutting edge of research, NIH employees must be allowed interaction with professional associations, participation in public health activities, and genuine teaching opportunities.

Stressing that communication is critical and that he is committed to ensuring that employees and ICs have access to learning resources, he encouraged the Directors to suggest ways that we could most effectively serve employees in understanding the final rule.

Dale Johnson

cc:
OD Senior Staff

This page was last reviewed on September 27, 2006 .

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