Recombinant DNA Advisory Committee - 12/3-4/92 
limits the protocol to infertile individuals, (2) submit a revised informed consent 
document that incorporates the suggestions made by Drs. Zallen, DeLeon, and Walters, 
and (3) the production lots to be used in humans should be demonstrated to have less 
than 1 particle of replication-competent adenovirus per patient dose. The motion to 
approve the protocol passed by a vote of 16 in favor, 0 opposed and no abstentions. 
VIII. DISCUSSION REGARDING PROPOSED RAC REVIEW OF EUROPEAN HUMAN 
GENE THERAPY PROTOCOLS/DR. BLAESE 
Background-Dr. Wivel 
In Dr. Blaese's absence, Dr. Murray called on Dr. Wivel provided background 
information regarding the European request for assistance in the review of human gene 
therapy protocols. Dr. Wivel explained that Dr. Blaese was contacted by the European 
scientific and medical community with a request that the RAC provide review for a 
protocol that has been proposed by European investigators. 
The European community (EC) has not decided in a unified way how they plan to 
organize and legislate gene therapy. The EC is a multinational organization that has the 
responsibility for establishing policy on safety issues for biotechnology. The EC is 
requesting a one time review of a gene therapy protocol in order to assist them in the 
establishment of certain policies. 
Dr. Parkman said that the EC has complemented the RAC by their request for 
assistance in the review process. It is appropriate for the RAC to undertake this task 
and review the proposed protocol with the same standards that have been exercised for 
previous protocols. Dr. Post said that the EC has already initiated several human gene 
therapy protocols, e.g., France and the Netherlands. Why has this request come at this 
point in time? Dr. Wivel responded that there is some concern about the degree of 
stringency that is employed in the review process, and that there is a great deal of 
variation in the process among countries. The EC is interested in establishing a set of 
uniform standards for review. 
Dr. Anderson provided further background information on this issue. Approximately 
years ago a similar request was submitted to the Human Gene Therapy Subcommittee 
(HGTS). Given the political climate in Europe at the time, the Europeans decided that 
they did not want to rely on the advice of the Americans; therefore, they decided to 
establish their own review committee. Since that time, several European investigators 
have received approval to initiate human gene therapy protocols; however, the process 
was long and difficult. The EC has ascertained that a universal pattern of review is 
necessary. The EC has decided that if the RAC would be willing to provide review of a 
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