Recombinant DMA Advisory Committee - 3/3-4/94 
I. CALL TO ORDER 
Dr. Walters (Chair) called the meeting to order and stated that the notice of the meeting 
was published in the Federal Register on February 11, 1994 (58 FR 6702), 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. 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 requested that the RAC observe a moment of silence in memory of Dr. 
Brigid Leventhal who died on February 6, 1994. During her service on the RAC, Dr. 
Leventhal was instrumental in establishing the current process of data management for 
all RAC approved human gene transfer protocols. Prior to her appointment to the 
RAC, Dr. Leventhal served on the RAC Human Gene Therapy Subcommittee on which 
she reviewed the first human gene transfer experiment approved in the United States. 
Apart from her inexhaustible dedication to the RAC, Dr. Leventhal is recognized for her 
major contribution to the development of treatments for pediatric leukemia. The RAC 
is honored to have had the opportunity to interact with a noted physician and patient 
advocate such as Dr. Leventhal. 
Dr. Walters noted several issues previously identified by the RAC, which were followed 
up by the Office of Recombinant DNA Activities (ORDA). On December 16, 1993, 
ORDA sent a memorandum to the NIH Office of Legislative Policy Analysis requesting 
that the language regarding provision of medical care to subjects injured in the course of 
their participation in clinical research be followed in the proposed health care reform 
benefits package. ORDA requested immediate notification of any changes to the 
proposed language by the Administration or Congress. 
In a letter dated January 27, 1994, the Institutional Review Board (IRB) of the 
University of Alabama, Birmingham, Alabama, responded to the RAC's 
recommendations regarding revisions to the Informed Consent document of Dr. Eric 
Sorscher (Protocol #9312-066). The IRB noted that in keeping with the institutional 
policy, the language regarding research related injury will not be modified. 
In a letter dated February 3, 1994, the Human Subjects Review Board of the University 
of California at San Diego, California, deferred to the RACs recommendation regarding 
azidothymidine (AZT) administration in human immunodeficiency virus (HIV) 
seropositive patients (Dr. Flossie Wong-Staal's Protocol #9309-057). AZT will no longer 
be required as a safeguard against the possible emergence of replication-competent 
retroviruses (RCR). However, the Board will maintain its requirement for animal 
toxicity testing for the first 3 lots of transduced cells produced by the investigators. 
In a letter dated February 11, 1994, Viagene, Inc., San Diego, California, notified the 
Recombinant DNA Research, Volume 19 
[17] 
