The telephone conference call meeting of the Advisory Committee to the Director (ACD), National Institutes of Health, was convened on Thursday, September 14, 2000, in Room 151, Building 1, National Institutes of Health (NIH), Bethesda, Maryland. The entire meeting was open to the public beginning at approximately 4:20 p.m. Dr. Ruth L. Kirschstein presided as Acting Chair.
William R. Brody, M.D., Ph.D.
Christine K. Cassel, M.D.
Thomas R. Cech, Ph.D.
Steven Chu, Ph.D.
Yank D. Coble, Jr., M.D.
Victor J. Dzau, M.D.
Rebecca Eisenberg, J.D.
Elaine V. Fuchs, Ph.D.
Ting-Kai Li, M.D.
Jane A. Menken, Ph.D.
Shirley M. Tilghman, Ph.D.
Phillip L. Williams
Donald E. Wilson, M.D.
Eric S. Lander, Ph.D.
Philip Needleman, Ph.D.
Ruth J. Simmons, Ph.D.
Larry L. Smarr, Ph.D.
Arthur D. Ullian
NIH Employees Present:
Vida Beaven, Ph.D., OD/NIH
John Burklow, OCLP
Sarah Carr, OBA
Donna J. Dean, Ph.D., OD/NIH
Robert Lanman, OGC
Janice C. Ramsden, OD/NIH
P. Pearl O'Rourke, M.D., OSP
Amy Patterson, M.D., OBA
Lana Skirboll, Ph.D., OSP
Stuart Orkin, M.D.
I. Call to Order
Dr. Ruth L. Kirschstein, Acting Chair, called the meeting to order and welcomed the members participating in the conference call.
II. Second Part of Interim Report of the Working Group on NIH Oversight of Clinical Gene Transfer Research
Dr. Christine K. Cassel, Chair of the Working Group on NIH Oversight of Clinical Gene Transfer Research, summarized the July 14, 2000 meeting, reminding the ACD members that this meeting was to address the second and last portion of the interim report dealing with reporting of adverse events. She said that the process for such reporting needs to be clarified for institutions and initial review boards (IRBs). The Working Group recommended that an NIH employee should be designated to receive reports on adverse events. In addition, there is need to protect the privacy of the subjects, basic scientists, clinicians, and staff involved. The Working Group felt that a data analysis on trends should be performed.
Information on adverse events would be provided by the Office of Biotechnology Activities (OBA) or some other group, to the Director, NIH, and made available to the public on a regular basis. Specific criteria should be developed by this group and Dr. Cassel emphasized the need for the data to be analyzed carefully.
Dr. Cassel pointed out that, in the recommendations made by the Working Group, a report on adverse events should be made during the public RAC meetings and thus be available to the public. There should be a structured time period established for reporting by either OBA or another designated group. Dr. Amy Patterson pointed out that a requirement of the Federal regulations is that pre-clinical findings must be reported within 15 days to the Food and Drug Administration.
There was agreement that the report was well done and a motion was made, which passed unanimously, to approve the second part of the interim report.
Recommendations will be provided to Dr. Kirschstein and a report will be presented at the December 7, 2000 meeting of the Advisory Committee to the Director.
The meeting ended at approximately 4:50 p.m. on September 14, 2000.
I hereby certify that the foregoing minutes are accurate and complete.
Ruth L. Kirschstein, M.D. Acting Chairperson Advisory Committee to the Director National Institutes of Health
Second Part of the Interim Report of the Working Group on NIH Oversight of Clinical Gene Transfer Research
ROSTER OF ACD MEMBERS
William R. Brody, M.D., Ph.D. President Johns Hopkins University Baltimore, MD 21218-2688
Christine K. Cassel, M.D. Professor and Chairperson Department of Geriatrics and Adult Development The Mount Sinai School of Medicine New York, NY 10029-6574
Thomas R. Cech, Ph.D. Distinguished Professor Department of Chemistry and Biochemistry University of Colorado Boulder, CO 80309-0215
Steven Chu, Ph.D. Professor Physics Department Stanford University Stanford, CA 94305-4060
Yank D. Coble, Jr., M.D. Physician Jacksonville, FL 32205
Victor J. Dzau, M.D. Chairman Department of Medicine Brigham and Women's Hospital Boston, MA 02115
Rebecca S. Eisenberg Professor of Law Stanford Law School Crown Quadrangle Stanford, CA 94305-8610
Elaine V. Fuchs, Ph.D. Amgen Professor of Basic Sciences The University of Chicago Department of Molecular Genetics and Cell Biology Chicago, IL 60637
Eric S. Lander, Ph.D. Professor of Biology Massachusetts Institute of Technology Director, Whitehead Institute/MIT Center for Genome Research Cambridge, MA 02139-1561
Ting-Kai Li, M.D. Distinguished Professor Indiana University School of Medicine Indianapolis, IN 46202-5124
Jane A. Menken, Ph.D. Population Program Institute of Behavioral Science University of Colorado at Boulder Boulder, CO 80309-0484
Philip Needleman, Ph.D. Chief Scientist Monsanto Company St. Louis, MO 63167
Ruth Simmons, Ph.D. President Smith College Northampton, MA 01063
Larry L. Smarr, Ph.D. Director National Center for Supercomputing Applications University of Illinois Champaign, IL 61820
Shirley M. Tilghman, Ph.D. Lewis Thomas Laboratory Department of Molecular Biology Princeton University Princeton, NJ 08544
Arthur D. Ullian Chairman, Task Force on Science, Health Care and The Economy Boston, MA 02110
Phillip L. Williams Vice Chairman (Retired) The Times Mirror Company Pacific Palisades, CA 90272
Donald E. Wilson, M.D. Vice President for Medical Affairs Dean, School of Medicine University of Maryland, Baltimore Baltimore, MD 21201-1559
Executive Secretary Ruth L. Kirschstein, M.D. National Institutes of Health Bethesda, MD 20892