The Joseph and Rose Kennedy Institute for the Study of Human Reproduction and Bioethics

Institute of Society, Ethics and the HOWARD H. HIATT, M.D.

University of Pennsylvania Law HALSTED R. HOLMAN, M.D.
School

Professor of Medicine

Stanford University School of
Medicine

Biological, Behavioral and Social LAWRENCE HOROWITZ, M.D.

Sloan-Kettering Institute for Can- ROBERT L. SINSHEIMER, Ph. D.

BIOMEDICAL RESEARCH AND THE PUBLIC

AGENDA

3:00 pm 3:30 pm

THURSDAY, APRIL 1

Introduction to Conference. Willard Gaylin-Institute of Society, Ethics and the Life Sciences.

3:30 pm-4:10 pm

The Congress and Biomedical Research: The Changing Relationship. Chairman: Daniel Callahan, Institute of Society, Ethics and the Life Sciences. Speaker: Stephen P. Strickland, University of California, San Francisco School of Medicine. Respondents: Robert Q. Marston, University of Florida; André Hellegers, The Joseph and Rose Kennedy Institute for the Study of Human Reproduction and Bioethics.

4:10 pm-4:40 pm

Open discussion.

4:40 pm-5:05 pm

Decisionmaking:Biomedical Research and the Public. Speaker: Ruth S. Hanft, Institute of Medicine, National Academy of Sciences.

5:05 pm-5:30 pm

Open discussion.

8:00 pm-8:50 pm

Freedom of Scientific Inquiry and the Public. Chairman: Robert S. Morison, Massachusetts Institute of Technology Speaker Hans Jonas, The New School for Social Research. Respondents: Alexander M. Capron, University of Pennsylvania Law School; Gerard Piel, Scientific American; Robert Sinsheimer, California Institute of Technology.

Legislative Perspectives. Chairman: Willard Gaylin. Speaker: Edward M. Kennedy, United States Senate.

10:45 am-11:45 am

Sources of Tension. Chairman: Willard Gaylin. Panelists: Howard H. Hiatt, Harvard School of Public Health; Stanley Jones, United States Senate Health Subcommittee; Jonathan King, Science for the People.

11:45 am-12:30 pm

Open discussion.

12:30 pm-2:00 pm

Luncheon. Speaker: Jacob K. Javits, United States Senate.

2:00 pm-5:00 pm

Mechanisms for Public Participation and Decisionmaking. Chairman: Frederick C. Robbins, Case Western Reserve University Medical School.

2:00 pm-2:45 pm

General Mechanisms. Available Governmental Procedures. Bertram S. Brown, National Institute of Mental Health.

Legislation. Peter Barton Hutt, Covington & Burling.

Litigation. Robert A. Burt, University of Michigan Law School.

2:45 pm-3:15 pm

Open discussion.

3:30 pm-4:30 pm

Other Mechanisms.

Scientific Organizations. William A. Blanpied, American Association for the Advancement of Science.

Asilomar. Maxine F. Singer, National Cancer Institute; David Baltimore, Massachusetts Institute of Technology; Harold P. Green, The National Law Center, George Washington University.

National Commissions. Kenneth J. Ryan, Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

4:30 pm-5:00 pm

Open discussion.

5:00 pm-5:30 pm

Summary and Synthesis. Gerald L. Klerman, Harvard Medical School.

Statements, Declarations and Future Options. Chairman: Frederick C. Robbins.

BIOMEDICAL RESEARCH AND THE PUBLIC

THURSDAY, APRIL 1

INTRODUCTION TO THE CONFERENCE

WILLARD GAYLIN. I want to briefly go over the planning, the format, and the expectations for this meeting.

In every phase of the planning it seems we ran into some trouble. Originally, the title was "Biomedical Research and the Public Interest." With the possible exception of the conjunction "and" we had trouble with every one of those words. Someone wanted to know what we meant by biomedical research. I tried feebly to explain that I didn't think we should invite metallurgists and astrophysicists.

We wanted representatives of Congress; we hoped we would get 25 percent representation from that group. Then people said, "they're not the public," although in a democracy one tends to think of them as at least representing the public. We also wanted people who were associated with public interest in biomedical research, but perhaps from different disciplines, so we thought about having about 25 percent participation from fields like law and sociology. And then we thought there ought to be 25 percent participation from the research community. Since we were limited to about 50 people, it became very difficult, We invited what some people thought was a disproportionately large percentage of people from genetics and molecular biology. That was done purposely, because we felt their experience with Asilomar 1 would be helpful. On the other hand, research did not mean to us just basic laboratory research. Indeed, the problems with the public, the delight of the public, and the anxieties of the public are often most strongly felt at times of application. Because of our work at the Institute, we

1Asilomar is a conference center on California's Monterey Peninsula, where, from February 24 through 27, 1975, approximately 140 molecular biologists met with a handful of lawyers to hammer out draft guidelines governing the safety of a new line of research on which they were embarking. Known popularly as genetic engineering, the work involves the insertion of genetic material from one organism into another, resulting in the creation of a new organism which does not exist in nature, and is called by the scientists recombinant DNA (for deoxyribonucleic acid, the material from which genes are made). Most of the work has been done with viruses and bacteria, particularly a laboratory version of the bacterium Escherichia coli, a normal resident of the human intestinal tract. Exceptional safety precautions were deemed desirable by many molecular biologists because they thought there might be a chance that the new organism (carrying, for instance, a newly inserted tumor virus or a gene for resistance to antibiotics) might infect laboratory workers or even the world outside the lab. The word "Asilomar" has come to refer not to the meeting itself, but to the entire process leading up to the meeting and still going on, in which scientists-for the first time in history-attempted to anticipate a possible ill effect from their work and make provision for it ahead of time. In addition, a voluntary moratorium on this work-whose theoretical and practical ramifications are thought to be of immense importance-was requested by a small group of prestigious molecular biologists and has apparently been largely complied with throughout the world. The process has received wide coverage in both the lay and scientific press. and figured heavily in the discussions at this meeting on biomedical research and the public, at which a number of Asilomar participants were present. For a description of the Asilomar meeting itself. see Stuart Auerbach. And Man Created Risks. The Washington Post, March 9, 1975. p. B1. For a positive view of recombinant DNA research, see Joshua Lederberg, DNA Splicing: Will Fear Rob Us of Its Benefits? Prism, November 1975, p. 33. For a negative view, see Liebe F. Cavalieri. New Strains of Life- or Death. The New York Times Magazine, August 22, 1976, p. 8.