Recombinant DNA Advisory Committee - 12/2-3/93 
I. CALL TO ORDER 
Dr. Walters (Chair) called the meeting to order and stated that notice of the meeting 
was published in the Federal Register on November 9, 1993 (58 FR 59612), as required by 
the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) . 
He noted that a quorum was present and outlined the order in which speakers would be 
recognized. The primary and secondary reviewers will present their comments regarding 
the proposal, followed by responses from the principal investigators (Pis). The Chair will 
then recognize other committee members, ad hoc consultants, other NIH and Federal 
employees, the public who have submitted written statements prior to the meeting, 
followed by the public at large. 
Dr. Walters stated that the number of human gene therapy protocols submitted for RAC 
review has rapidly increased over the last 3 years. He noted that 2 gene therapy trials 
were approved by the RAC in 1990, 3 trials in 1991, 10 trials in 1992, and 21 trials in the 
first 3 meetings of 1993. To date, the RAC has recommended approval of 36 human 
gene therapy trials to the NTH Director (does not include gene marking studies). (See 
Attachment II for complete protocol listing). 
Dr. Walters stated that a favorable response was received to the RAC's recommendation 
regarding provision of medical care for subjects injured during the course of their 
participation in research. On August 6, 1993, Dr. Ruth Kirschstein, Acting NIH 
Director, responded to the RAC stating that she would forward the recommendations to 
Dr. Philip Lee, Assistant Secretary for Health, Department of Health and Human 
Services. In a letter dated October 8, 1993, Dr. Cliff Gaus (health care reform 
coordinator for Dr. Lee), indicated that the benefits package now envisioned for health 
care reform would probably cover services to subjects injured in clinical research. A 
brief discussion ensued about the interim policy regarding this issue. 
Dr. Walters stated that the Office of Recombinant DNA Activities (ORDA) forwarded 
letters to two Institutional Review Boards (IRBs): (1) St. Jude's Children's Research 
Hospital to notify them of the RAC's recommendation to divide the Informed Consent 
document into two separate documents: a guardian consent form and a child's assent 
form (Dr. Kun's protocol). (2) University of California, San Diego (UCSD) to notify 
them of the RACs requirement that prophylactic azidothymidine (AZT) administration 
be deleted from the protocol and that rabbit pyrogen testing not be mandatory (Dr. 
Wong-Staal's protocol). As a point of clarification. Dr. Parkman requested that the issue 
of AZT administration be verified. 
II. MINUTES OF THE SEPTEMBER 9-10, 1993, RAC MEETING 
Dr. Walters called on Dr. Carmen to review the minutes of the September 9-10, 1993, 
RAC meeting. Dr. Carmen summarized Dr. Hirano's written comments on the minutes 
and concurred that the minutes were an accurate reflection of the September meeting 
and recommended their approval. Minor changes were submitted by Drs. Miller and 
Zallen. 
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Recombinant DNA Research, Volume 18 
