Recombinant DNA Advisory Committee - 09/9-10/93 
the national health care reform effort and whether it might result in health 
insurance or other changes that will be relevant to this issue. As we continue to 
gather more information, the NIH would welcome any additional information or 
insights the RAC may have in this matter." 
Dr. Kirschstein's letter addressed the concerns of the RAC in the following statement: 
"Given NIH's peripheral role in the reform effort, I am transmitting the RACs 
recommendation to the Assistant Secretary for Health with a request that the 
specific issue of covering research injuries be brought to the attention of the 
National Task Force on Health Care Reform/ 
I-C. EXECUTIVE SECRETARY REPORT ON POSSIBLE ADVERSE EFFECTS/ 
DR WIVEL 
Dr. Wivel noted that a written report of possible adverse effect was submitted by Dr. 
Edward Oldfield, NIH, Bethesda, Maryland, in a patient enrolled in his human gene 
transfer protocol entitled: "Gene Therapy for the Treatment of Brain Tumors Using 
Intra-Tumoral Transduction with the Thymidine Kinase Gene and Intravenous 
Ganciclovir." Dr. Wivel summarized a verbal report by Dr. Crystal to the NIH 
Institutional Biosafety Committee (IBC) regarding a possible adverse effect in a patient 
enrolled in his human gene transfer protocol entitled: A Phase I Study, in Cystic Fibrosis 
Patients, of the Safety, Toxicity, and Biological Efficacy of a Single Administration of a 
Replication Deficient, Recombinant Adenovirus Carrying the cDNA of the Normal Human 
Cystic Fibrosis Transmembrane Conductance Regulator Gene in the Lung. 
I D. RECOGNITION FOR SERVICE ON THE RAC/DR WALTERS 
Dr. Walters recognized several members of the RAC whose term has expired. He 
expressed the gratitude of the committee for their years of service, dedication, and 
careful review of recombinant DNA research. The outgoing members of the RAC are: 
Drs. Carmen, Geiduschek, Hirano, Krogstad, and Post. Outgoing RAC members will 
continue to serve on the committee until future appointments have been finalized by the 
Department of Health and Human Services. 
II. MINUTES OF THE JUNE 7-8, 1993, RAC MEETING 
Dr. Walters called on Dr. DeLeon to review the minutes of the June 7-8, 1993, RAC 
meeting. Dr. DeLeon stated that the minutes were an accurate reflection of the June 
meeting. Minor corrections were submitted by Drs. DeLeon, Smith, and Parkman. 
Committee Motion 
The RAC approved a motion made by Dr. DeLeon and seconded by Dr. Parkman to 
accept the June 7-8, RAC minutes with the inclusion of minor grammatical changes by a 
vote of 18 in favor, 0 opposed, and no abstentions. 
Recombinant DNA Research, Volume 18 
[187] 
