Freedom of Information Act Office
IC Directors' Meeting Highlights
April 16, 2003
|From:||Director, Executive Secretariat|
|Subject:||IC Directors Meeting Highlights—April 10, 2003|
l. Intramural Clinical Research Retreat
Dr. Gottesman reported on the March 21, 2003, Intramural Clinical Research Retreat that he and Dr. Spiegel coordinated in order to examine successful examples of innovative clinical research at the Clinical Center (CC),
and develop strategies to overcome barriers to optimal use of the Clinical Research Center (CRC), and
define the CRC's role as an integral part of the overall NIH clinical research effort.
Approximately 180 people, representing the full range of NIH staff involved in clinical research as well the CC Board of Governors, attended the retreat. Dr. Gottesman noted that the group, aware of the impact that the NIH program has on clinical practice at large, was enthusiastic and determined to pursue next steps that will evaluate the role of the intramural research program (IRP) in the overall clinical research effort and how to remove barriers to innovative clinical research. He summarized these next steps: establish a blue ribbon panel with both NIH and non-NIH membership that will address ways NIH can best continue paradigm-shifting clinical research, delineate ways to encourage such research, and suggest ways that we can measure success;
create an internal working group that will address questions regarding the recruitment, training, and retention of clinical researchers;
set up a standing committee to be co-chaired by the Director of the CC and the Deputy Director for Intramural Research that will investigate infrastructure impediments to clinical research and, on the basis of priorities set by the panel and working group, will make recommendations.
Dr. Gottesman concluded the discussion by pointing out that Roadmap activities will also address overall bureaucratic obstacles to the conduct of clinical research and that he will continue to work with existing groups such as Scientific and Clinical Directors to foster innovative clinical research with the highest standards of protection of human subjects.
ll. Transcriptome Trans-IC Consortium
Dr. Battey discussed an innovative sequencing technology, massively parallel signature sequencing (MPSS), that is extremely sensitive and provides comprehensive digital data on gene expression in human cells and tissues. He suggested that ICs may want to join in support of a trans-IC effort to utilize MPSS. Noting that at present the cost is $30,000 per sample, he recommended a first-tier, concerted effort in which ICs combine to contribute $3 million to cover sequencing of 100 samples to be selected by a steering committee. In a second-tier effort, ICs would select samples and pay individually for their sequencing. Dr. Battey stressed that the resulting data would be a valuable resource and would be shared with the research community at large in accord with the Bermuda Principles. The group then discussed various attendant costs beyond the sequencing, including the cost of the database, which Dr. Battey said that NLM's National Center for Biotechnology Information would maintain. Dr. Zerhouni asked if it might not be possible to negotiate the cost in the event that NIH should want to do a large number of sequences. And in response to concerns regarding the rapidly evolving technological environment, he stressed that what should drive the choice of whether to move forward with this effort should be whether this is information that we can use and want and that will remain useful even if technology evolves. If the answer is yes, he supports it. Dr. Battey promised to return to the group with a funding proposal.
lll. Update on NIH Administrative Issues
Mr. Leasure summarized the HHS and OMB administrative efforts related to NIH as ones intended to reduce duplication and overlap to ensure resource redirection toward mission-critical areas. He brought the group up-to-date on the status of FTE reductions, hiring freezes, buy outs, the A-76 time line, and other administrative issues including facilities. He pointed out the need to carefully assess when renovations, which are paid for from the IC budgets, may cross the threshold from what is considered renovation into the construction area, which is a Buildings and Facilities item. He is working with OS on this issue and will notify the group when an agreement is reached.
Mr. Leasure announced the formation of an NIH Administrative Restructuring Advisory Committee (ARAC) that Dr. Kington will chair and that will comprise broad NIH representation. The ARAC will focus on trans-NIH issues that are changing the NIH administrative management functions.
The group then discussed the challenges that the resource redirection presents to the ICs. There was a great deal of support for Dr. Collins' statement that these initiatives have had a profound, negative impact on morale and are already affecting our ability to carry out our mission. Dr. Zerhouni noted that we need more frequent and factual discussions of these management issues; he asked Mr. Leasure and Mr. Hosenfeld to work together to quantify the major challenges so that we can address them most effectively. He agreed with the suggestion that perhaps a third- party look at the situation would bring some good insights as to how we can best move forward.
Dale Johnson cc: