Freedom of Information Act Office
IC Directors' Meeting Highlights
September 20, 2002
| To: | IC Directors |
| From: | Senior Policy Analyst, Executive Secretariat |
| Subject: | IC Directors' Meeting Highlights — August 22, 2002 |
I. Analysis of Clinical Research Reporting — Follow-up to Discussion at June 27 IC Directors' Meeting
Dr. Katz summarized the discussion at the June 27 IC Directors' meeting that led to today's presentation. To follow up on that discussion, Drs. Katz and Straus and Mr. Poppke led a small group in a statistical experiment to test the impact of the four different approaches ICs have been using to code and report funding of clinical research. Dr. Straus described the experiment and results. Based on the study's findings, the small group recommended that each IC code every one of its grants and subprojects and report the best estimate of costs attributable to clinical research in quartile increments of either 0, 25, 50, 75, or 100 percent of the total award amount. Adopting this reporting method NIH-wide will respond to recommendations of the GAO, will be transparent and rational to all NIH's constituencies, and will provide accurate (as determined by the experiment) and consistent data while making effective use of resources and staff. The group recommended beginning use of this reporting methodology for all awards that are new in FY03.
The other question the small group addressed was whether NIH should attribute any of its core costs as clinical research costs. The group recommended not doing so.
After discussion, the IC Directors and Dr. Zerhouni agreed to these recommendations.
Summarizing the decisions regarding reporting of clinical research funding made at this meeting and at the June 27 meeting, beginning in FY03 NIH will report clinical research funding as follows:
- Every IC will use the Nathan Panel's definition of clinical research.
- NIH will use the total funding amount reported by OB, based on data from the ICs and including intramural research.
- For the intramural program, each IC will report its costs for intramural clinical research projects but will not report any of its CC assessment; the CC's funding (the total of the IC assessments) will be reported as a whole.
- Each IC will code every one of its grants and subprojects and report the best estimate of costs attributable to clinical research in quartile increments of either 0, 25, 50, 75, or 100 percent of the total award amount.
II. Information Items
Mr. Poppke informed the group that there is a small amount available in the Director's Discretionary Fund for FY02 and invited IC Directors to submit proposals for use of the DDF to him by August 30. The proposed projects must be ready for immediate funding because of the short time left to commit FY02 funds.
Dr. Zerhouni announced that he is establishing an NIH stem cell research task force, which Dr. Battey has agreed to lead. This group will help guide scientifically driven decisionmaking regarding stem cell research. Dr. Battey said the task force will include both intramural and extramural NIH staff, and will call on workgroups of people from outside NIH to provide input. Dr. Zerhouni asked all the IC Directors to support Dr. Battey in this activity.
Dr. Zerhouni thanked everyone for their participation in the NIH Roadmap meetings. He credits OSP with setting up an efficient process and believes the meetings went very well. Some strong, consistent themes arose from the separate groups.
Dr. Kirschstein mentioned that a task force is planning a scientific workshop on hormone therapy, following up on the halting of the Women's Health Initiative study of estrogen/progestin therapy for post-menopausal women. The workshop will take place October 23-24 at the Natcher Conference Center. After discussion among the group, Dr. Zerhouni said he wants to be sure NIH leads the scientific agenda. He asked Dr. Kirschstein to make a thorough presentation on the planned workshop at the next IC Directors meeting (September 12, following the Leadership Forum).
Tom Gill
cc: OD Staff
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