September 14, 2000 Meeting Minutes

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.

Members Present:

  • 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.

Members Absent:

  • 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

Others Present:

  • 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


William R. Brody, M.D., Ph.D.
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.
Physics Department
Stanford University
Stanford, CA 94305-4060
Yank D. Coble, Jr., M.D.
Jacksonville, FL 32205
Victor J. Dzau, M.D.
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.
Smith College
Northampton, MA 01063
Larry L. Smarr, Ph.D.
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

This page last reviewed on February 12, 2011