Recombinant DNA Advisory Committee - 2/10-11/92 
investigators are experiencing a special or specific situation, they should inform ORDA to 
allow for special arrangements. The RAC needs to be flexible in reporting requirements, 
but the RAC needs certain information from all investigators. 
Dr. H. Miller agreed with Mr. Barton that the reporting form needs refining and 
consideration. Dr. H. Miller gave several specific examples where problems could be 
avoided. Dr. Leventhal asked if the RAC could designate one meeting per year as a 
workshop where the investigators could present their data. The rationale for this 
suggestion is that there is no requirement that working group meetings or workshops have 
to be announced in the Federal Register 30 days in advance, which would provide more 
flexibility when scheduling. Dr. Wivel said that this type of meeting would be possible. 
Dr. Anderson expressed his support for the implementation of the patient information 
network. He endorsed Ms. Buc's idea of being flexible in reporting. A workshop would 
be the best way to share information among the investigators. Dr. Kelley suggested a 
working group to address the reporting issues. Dr. R. Murray suggested that the proposed 
working group review the protocols with the highest concerns about safety. The working 
group could send out a survey form to ask the most critical questions regarding the 
protocol. Dr. Krogstad suggested that the working group look at issues of publicity and 
data collection, and be comprised of RAC members and investigators. 
Dr. Mclvor reminded the RAC that a motion was passed to support the concept of a 
patient information network at the RAC meeting of May 30-31, 1991. Dr. Ledley 
commented that the FDA annual report could be part of the function of the network. Dr. 
B. Murray advised an expansion of the current working group to cover the reporting issues. 
Dr. Leventhal asked permission to request FDA reports from the investigators. 
Ms. Buc proposed that Dr. Kelley's suggestion of finding a way to make the reports public 
without compromising the investigators' patents, corporations, and desire to publish be 
pursued. Dr. Post suggested that when the investigators make public presentations of their 
data, copies of their abstracts or papers should be provided to the RAC. 
XV. FUTURE MEETING DATE AND OTHER BUSINESS OF THE RECOMBINANT 
DNA ADVISORY COMMITTEE 
The RAC discussed several housekeeping issues. Dr. Anderson said he would provide the 
RAC with complimentary copies of Human Gene Therapy including back issues. Dr. B. 
Murray reminded the RAC of their next meeting on June 1-2. 
Dr. Leventhal inquired whether the March 30 meeting of the HGTS was canceled. Dr. 
Wivel replied affirmatively and said that an extra review would be conducted in March to 
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