Recombinant DNA Advisory Committee - 09/9-10/93 
their parents. Mr. Capron and Ms. Buc questioned this practice. Dr. Secundy stated 
that she is not satisfied with the consent process for minors. Dr. Miller suggested that 
the forms should be separated for patients under or over 18 years of age. Dr. Kun 
agreed in principle to change the Informed Consent document stipulated by the RAC; 
however, such a change would be subject to local IRB approval. This issue of complexity 
and conformity of Informed Consents evolved into a lengthy discussion to be summarized 
below (see VII-B: RAC Recommendation Regarding the Establishment of a Working 
Group to Develop Guidelines for Informed Consent Document). 
Responding to Dr. Chase's comment. Dr. Kun noted that all the pertinent changes have 
been made in the protocol and consent documents. Regarding Dr. Parkman's question 
about inclusion criteria, Dr. Kun clarified that patients with nonresectable single foci > 
1.5 cm and < 5 cm will be included in the study. As to the question of quality control in 
this multicenter trial. Dr. Kun said that the same standards will apply as for Dr. 
Oldfield's protocol at NIH. Dr. Kun agreed to include a request for autopsy into the 
revised Informed Consent document. 
Dr. Kun responded to Dr. Smith's inquiry about the changes observed on an MRI 
obtained on a patient enrolled on Dr. Oldfield's study. Dr. Miller stated that these 
preliminary results have been overinterpreted in the media, raising false expectations for 
prospective patients. Dr. Krogstad said the RAC may have to deal with the issue of how 
preliminary results of gene therapy trials are reported by the media. Dr. Chase shared 
the same sentiment and urged that the Informed Consent document should properly 
convey the experimental nature of this kind of therapy to the patients. Dr. Kun said that 
the present protocol is a very limited Phase I toxicity trial; it is not designed to assess 
efficacy, which would require a statistically meaningful cohort of samples. The scientific 
results will be evaluated in concert with the NIH investigators and will avoid conflict of 
interest with the sponsoring company. Dr. McGarrity of Genetic Therapy, Inc., agreed 
that independent evaluation of the scientific results is essential. 
Committee Motion 
A motion was made by Dr. Post and seconded by Dr. Motulsky to approve the protocol. 
The motion passed by a vote of 17 in favor, 0 opposed and no abstentions. A friendly 
amendment was proposed by Dr. Miller and accepted by Drs. Post and Motulsky. This 
amendment stipulates that the RAC strongly recommends that the Informed Consent 
document should be divided into separate documents: (1) a guardian assent form for 
patients < 18 years of age, (2) a patient assent form for patients < 18 years of age, and 
(3) a patient consent form for patients ^ 18 years of age. 
VII-B. RAC RECOMMENDATION REGARDING THE ESTABLISHMENT OF A WORKING 
GROUP TO DEVELOP GUIDELINES FOR INFORMED CONSENT DOCUMENTS 
Discussion 
During the review of Dr. Kun's brain tumor protocol, several questions regarding 
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