Recombinant DNA Advisory Committee - 01/14/93 
I. CALL TO ORDER 
Dr. Wivel, Executive Secretary of the Recombinant DNA Advisory Committee (RAC), 
welcomed the new Chair, Dr. Leroy Walters, Director of the Center for Bioethics, 
Kennedy Institute of Ethics, Georgetown University, Washington, D.C. Dr. Wivel noted 
that Dr. Walters was a member of the working group that designed the Points to 
Consider in the Design and Submission of Protocols for the Transfer of Recombinant DNA 
into the Genome of Human Subjects ( Points to Consider) and served as Chair of the 
Human Gene Therapy Subcommittee (HGTS) throughout its existence. 
II. OPENING REMARKS-DR. WALTERS 
Dr. Walters presented a brief historical background on recombinant DNA research and 
gene therapy. In 1973, Maxine Singer wrote a letter to Science entitled, Guidelines for 
DNA Hybrid Molecules. In 1974, Paul Berg and 10 fellow committee members from the 
National Research Council wrote a letter to Science entitled, Potential Hazards of 
Recombinant DNA. In 1975, there was a meeting in Asilomar to discuss the hazards 
associated with recombinant DNA; the RAC was established following the Asilomar 
meeting. In 1976, the first version of the NIH Guidelines for Research Involving 
Recombinant DNA Molecules (NIH Guidelines) was published. In 1982, the Presidents 
Commission for the Study of Ethical Problems in Medicine and Biomedical Behavioral 
Research published a report entitled, Splicing Life. In 1984, the RAC established the 
Working Group on Human Gene Therapy to discuss issues relevant to the review and 
approval of human gene therapy protocols. In 1985, the first version of the Points to 
Consider was published in the Federal Register. In 1988, the RAC and NIH Director 
approved the first human gene transfer protocol. In 1990, the RAC and NIH Director 
approved the first two human gene therapy protocols. In December 1992, the 34th 
through the 37th human gene transfer/therapy protocols were recommended for 
approval by the RAC to the NIH Director. Also in December 1992, the RAC 
confronted the issue of compassionate use of gene therapy for the first time. 
Dr. Walters explained that the purpose of providing this historical review is to remind 
the RAC that revolutionary advances have been made possible by recombinant DNA 
techniques within the last 20 years. The RAC has a long tradition and distinguished 
history. The RAC has survived by adapting to new circumstances and demonstrating a 
willingness to change policies and adapt new procedures. Each of the events that have 
been described have occurred with vigorous debate. Although reasonable solutions were 
often met with great difficulty, research has proceeded in a socially responsible manner. 
He stated that it is his hope that, through a process of honest and respectful discussion 
and debate, difficult problems will continue to be resolved. 
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