Recombinant DNA Advisory Committee - 09/9-10/93 
in Biosketch format. When a proposal has been submitted previously, 
there should be a short section 200 words) immediately following the 
abstracts that summarizes the major revisions since the last review. Data 
provided.... 
"...written responses (including critical data in response to the primary 
reviewers' comments) must be submitted by the Principal Investigators to 
ORDA * 2 weeks before the RAC meeting. 
"Oral Responses to the RAC. Principal Investigators must limit their oral 
responses to the RAC only to those questions that are raised during the 
meeting. Oral presentations of previously submitted material and/or 
critical data that was not submitted * 2 weeks prior to the RAC meeting is 
prohibited." 
Committee Motion 
A motion was made by Dr. Krogstad and seconded by Dr. Parkman to accept the 
amendments to the Guidelines for the Submission of Human Gene Transfer/Therapy 
Protocols for Review by the RAC. The motion passed by a vote of 16 in favor, 1 opposed, 
and no abstentions. 
IX. WORKING GROUP REPORT ON CATEGORIES OF HUMAN GENE TRANSFER 
EXPERIMENTS THAT ARE EXEMPT FROM RAC REVIEW/DR. PARKMAN 
Presentation-Dr. Parkman 
Dr. Parkman said that the RAC is currently realizing a proliferation in the number of 
gene transfer protocols submitted for review due to the evolution and maturation of the 
field of gene therapy. The RAC formed a working group to formulate categories of gene 
transfer protocols that may not require full RAC review or are considered exempt from 
RAC purview. Dr. Parkman reported on a tentative consensus that resulted from a 
working group telephone conference call that was held on July 8, 1993. The working 
group proposed two categories of protocols that may qualify for the accelerated review 
process: (1) multiple site protocols under the umbrella of the original RAC-approved 
protocol. Under such protocols, the "original" PI will have full responsibility for quality 
control and data reporting at satellite sites, and (2) protocols that are similar to other 
RAC-approved protocols; however, minor modifications have been introduced that do 
not involve gene transfer aspects of the studies. He stated that a check list is being 
developed for use in screening protocols that may qualify for the accelerated review 
process. 
One major issue that remained unresolved by the working group is the uncertainty about 
how to proceed with the issue of Informed Consent documents that are different from 
those that were previously approved by the RAC. Dr. Parkman noted that Dr. Bruce 
Merchant of Viagene, San Diego, California, submitted a letter dated August 12, 1993, 
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Recombinant DNA Research, Volume 18 
