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Perspectives in Biology and Medicine 44.2 (2001) 170-182

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The First Twenty-Five Years after Asilomar

Donald S. Fredrickson

America's Move Toward the Federal Solution

As the participants milled around the conference center following the last night session on 26 February 1975, David Baltimore bumped into William Gartland, the "official" National Institutes of Health (NIH) observer. "Well," Baltimore said, "Tomorrow it will be all yours." That same week President Ford passed my name to the Senate for confirmation to return to the NIH. I was sworn in as the 11th Director on 1 July 1975.

The Recombinant DNA Molecule Program Advisory Committee (to go down in history as the RAC) was chartered at the request of the Berg letter (Berg et al.1974). The RAC was "to evaluate hazards of recombinant DNA, develop procedures to minimize those risks, and devise guidelines for research with recombinant DNA." My predecessor, Robert S. Stone, had appointed DeWitt (Hans) Stetten to be chair. The NIH Director's chair was vacant, however, when the original dozen RAC members showed up at Asilomar, not exactly certain what they were to do.

The RAC was formed like any other NIH study section, beginning with the solicitation of recommendations from veteran executive secretaries. The selectors [End Page 170] had no hint that several years later a prominent senator would move legislation to do away with the RAC, replacing it with a "commission," each member of which was to be appointed by the President, and the chair confirmed by the Senate. The commission, furthermore, would have a minority of members who "have been professionally engaged in biological research" (Subcommittee on Health and Scientific Research 1977). The part-time body envisioned was to be responsible for both the writing and the policing of the guidelines, and in its spare time, to undertake a study of the basic ethical and scientific principles that should underlie the conduct of recombinant DNA research.

The RAC completed its initial assignment in December 1975. On the evening of the last meeting, Hans Stetten went to the phone to tell the new NIH Director that they had finished. Legend persists about how Hans returned to the table, shoulders sunken, blood gone from his face. "He wants to have a public hearing on them," he said (Stetten et al. 1984).

The NIH as Trustee of the Recombinant DNA Guidelines: How to Proceed?

In the fall of 1975, I had been given to understand that the NIH RAC would very soon complete the NIH Guidelines for Recombinant DNA, and that I would become responsible for implementing their recommendations. As I now begin to recount decisions made and actions taken in those hectic first months, I am reminded of Stephen Toulmin's remarks at the Academy Forum in 1977: "I think a disinterested outsider is justified in saying that Paul Berg, Don Fredrickson, and the high command at NIH did a very respectable and conscientious job of working on those safeguards in the absence of any proper institutional set-up for dealing with the societal aspects of science policy" (p. 105, emphasis added). He was condemning, as did many others after Asilomar, the "lack of more representative and responsible institutional machinery to assure that the interests of science and the larger community are served."

We had had no time to supply this missing societal machinery. First, I had to discern who were the experts and what was their story. Fortunately, the NIH was located at the center of the science: several NIH scientists had participated in Asilomar and events leading to it. As I listened to the opinions that this novel class of experiments might produce new pathogens causing human disease or organisms that would find niches in the environment and perhaps alter it irrevocably, I realized that within the technology probably lay the route to a revolutionary understanding of human genetics and development. It seemed obvious that only careful further experimentation could determine whether the assumed hazards of recombinant DNA (rDNA) were real. The molecular biologists made me aware of their impatience to resume the...


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