Recombinant DNA Advisory Committee - 5/30-31/91 
Dr Wivel said that he felt this would be one issue which would have to be resolved before the 
protocol were forwarded to Dr. Healy for her signature. 
Dr. Leventhal questioned Dr. Lotze as to his techniques for obtaining skin and muscle 
biopsies. Dr. Lotze said that he intended to do a punch biopsy for skin and that he planned 
to do a needle biopsy for muscle since it is less invasive. However, he agreed that details 
regarding risk and a description of the procedures should be included in the document. Dr. 
Leventhal underlined the necessity for rewriting this portion of the informed consent 
document so that the patient was aware that by agreeing to take part in the study that they 
will have needles stuck in them that would not otherwise be stuck in them. Dr. Lotze agreed 
to rewrite this paragraph of the informed consent document and circulate it within the next 
hour if necessary. Dr. Leventhal said this would be fine. 
Dr. McGarrity asked if Dr. Lotze was clear as to what was being asked as far as the informed 
consent. Dr. Lotze said that all the issues were clear to him and that he would draft wording 
to encompass the points made in the discussion. Dr. R. Murray added that it should also be 
noted that the frequency of the biopsies increases the risk of infection as a complication and 
that this should also be highlighted in the document. 
Mr. Mannix then made a motion to table the agenda item until the new consent document 
was available. Dr. Mclvor seconded the motion. Dr. McGarrity then put the motion to a 
vote. The motion to table passed by a vote of 17 in favor, zero opposed and one abstention. 
Dr. McGarrity then adjourned the committee for the morning coffee break and asked the 
members to reassemble at 10:35 a.m. 
Dr. McGarrity reconvened the committee at 10:35 a.m., and called on Dr. Mclvor to present 
the next agenda item. 
PROPOSED AMENDMENT TO THE POINTS TO CONSIDER IN THE DESIGN AND 
SUBMISSION OF PROTOCOLS FOR THE TRANSFER OF RECOMBINANT DNA INTO 
THE GENOME OF HUMAN SUBJECTS REGARDING PRECLINICAL STUDIES: 
Dr. Mclvor said he had raised this issue at the last meeting of the RAC in response to the 
review of several protocols at the November meeting of the HGTS in which it appeared that 
there had been a dearth of preclinical animal and, in some cases, in vitro experiments 
provided in these protocols and that he felt the best way to address this was to propose 
additional wording in the Points to Consider. The RAC suggested this be taken up at the 
HGTS for design of the specific wording. He said this was done and that under Section Two, 
"Preclinical Studies Including Risk Assessment Studies," the following wording is to be 
substituted: 
"Preclinical Studies Including Risk Assessment Studies: Provide Results that 
demonstrate the safety, efficacy and feasibility of the proposed procedures using animal 
Recombinant DNA Research, Volume 14 
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