Freedom of Information Act Office
IC Directors' Meeting Highlights
October 23, 2006
|From:||Director, Executive Secretariat|
|Subject:||IC Directors Meeting Highlights—June 22, 2006|
I. Roadmap Trans-NIH Strategic Initiatives Process
Dr. Hodes explained that the OPASI Division of Strategic Coordination (DSC) will soon conduct a pilot process for getting input from NIH and stakeholder communities and that up to $50 million per year from the existing Roadmap (RM) budget will be allocated to fund the selected initiatives. He then discussed the assumptions that underlie the FY08 funding model:
Funds available for new initiatives will ramp up from $30 million in year one to $50 million in years 2-5 for each annual cohort.
Two current RM initiatives did not grow into initially projected budget needs and most of the allocated budgets for these (NECTAR and NCRA) were put back into the Common Fund and proposals for second phase funding will be considered along with new initiative proposals.
NCRR will pay an increasing share of CTSAs as that program grows, freeing up RM funds. Funding and transition options for current initiatives will provide additional flexibility for new RM initiatives.
After summarizing initiative inclusion criteria and noting that all criteria must be met, he outlined the overall plan as follows:
- Phase 1 — Solicit initiative ideas from extramural scientists in 5 consultation meetings (20 to 30 participants total on July 24, 25, 26, and September 21 and 26).
- Phase 1b — Solicit idea nominations from IC Directors and OD Program Offices by way of one-page outline submission (July-August).
- Phase 2 — October 27 IC Directors retreat to discuss and validate Phase 1 input and recommendations and budget corrections.
- Phase 3 — October RFI for Public Comment on Proposed Topics and/or nomination of new ideas.
These activities will be followed by another IC Directors Retreat in November to summarize comprehensively ideas from all sources and to prioritize and recommend ideas to develop into full concepts to Dr. Zerhouni. (Note: This retreat is now scheduled for November 27.) In December, there will be selection/approval of initiatives/ideas, and ICs will be named for each. The concept will be further developed through Pre-FRA activities and budget and FTE estimates and outcome expectations during the early part of 2007; and in May, IC Directors and the ACD will review, and the FY 2008 RM Initiative Finalists will be identified later in May.
Finally, Dr. Hodes noted the many NIH groups that contributed to the planning, governance/process approval, scientific/ priority-setting approval, and implementation processes.
II. Clinical Research Policy Analysis and Coordination (CRpac) Program Update
Reminding the group that OSP serves as the official NIH liaison to both the FDA and the OHRP, Drs. Skirboll and Patterson presented an overview of this program and one of its initiatives in particular: adverse event reporting. Dr. Patterson, who chairs the Federal Adverse Event Task Force (FAET) (comprising members from NIH, VA, DoD, FDA, OHRP, CDC, and AHRQ), noted that the issues it faces are:
- Divergent Federal reporting requirements;
- Resultant confusion, non-compliance, increased costs;
- Poor information quality;
- Deluge of adverse event reports (AERS) difficult to interpret in multi-site trials; and
- Potential negative effects on protection of human subjects.
The Task Force is charged with proposing specific means for promoting harmonized and streamlined Federal requirements for reporting, analyzing, and communicating adverse events in clinical research. The goals include: the development and use of a common lexicon for safety reporting; one core AER format which PIs can use to report to multiple agencies; and unified policies and threshold for reporting AEs. Also, the FAET hopes to develop an AE best practices blueprint for reporting, analysis, and application of safety information. Working with agency focus groups and stakeholder focus groups, the FAET developed a draft Basal Adverse Event Report (BAER) that permits a single baseline set of core medical information that can be used with any legacy IT system. To make sure that the proposed BAER is responsive to IC needs, the FAET will consult with ICs on refinements. This consultation will include a survey of all ICs on what safety data is collected, how it is analyzed, and how it is used. The preliminary findings were presented at the Secretary’s Advisory Committee on Human Research Protections, July 31-August 1, 2006, with target implementation of such a baseline report during 2007.
III. Scientific Presentation—Mainstreaming Environmental Heath Sciences: Progress and Challenges
Dr. Schwartz began by highlighting aspects of the NIEHS 2006-2011 Strategic Plan and recent activities in furtherance of his vision for the Institute, specifically addressing fundamental priority shifts and programmatic developments. Pointing to a number of scientific advances related to basic biological processes such as endocrine disruption, cell signaling, and DNA mutagenesis, he stressed his and NIEHS’s commitment to integrate these discoveries, to move them through clinical research applications, and then to bring to fruition findings and therapies that will improve the public health.
He summarized the recent work of several scientists in epigenetics, among them Andy Fineberg, Bob Waterman and Randy Jirtle, and Matt Anway. Highlighting the opportunities offered by studying the biology of exposure and genetic susceptibility, he stressed the resultant possibilities for individualized medicine.
Dr. Schwartz has positioned NIEHS programs to capitalize on the current scientific synergy in exposure sciences, complex human diseases, and global environmental health by focusing on integrative research and training and recruiting new scientists. He concluded his presentation by recognizing and thanking his intramural, extramural, clinical, translational, and leadership staff for all their efforts toward this vision.
After a discussion in which a number of IC Directors noted specific interplay among genetics, environmental factors, and their own ICs’ missions and areas of interest, Dr. Zerhouni complimented Dr. Schwartz and NIEHS on the exciting and challenging plans, saying that this dynamic scientific area represents the next frontier in medicine.
cc: OD Senior Staff