Recombinant DNA Advisory Committee - 12/2-3/93 
Genetics Corporation is developing improved assays to detect potential GALV 
recombinants. The human HeLa cell line, which is susceptible to GALV infection, will 
be used as a rescue cell line. Upon infection of the HeLa cells with RCR, the rescued 
vector is detectable by its hygromycin selectable marker. The sensitivity of this rescue 
assay is currently being determined. Dr. Miller explained that S + L‘ assays have been 
performed, and there is no evidence of RCR using the PG13 cell line. Dr. Post 
suggested that approval of this protocol might be contingent on the submission of RCR 
sensitivity assays. 
Ms. Meyers asked whether recommendations for long-term follow-up and contraception 
for men/women were included in the Informed Consent document. Dr. Schuening 
replied that these issues have been addressed in the document. Dr. Parkman inquired 
about the length of time necessary for contraception to be practiced. If the experiment 
is successful, the inserted gene will persist during the life of these patients. Dr. Zallen 
said that it is reasonable to require contraception during the active phase of the gene 
transfer protocol. 
Committee Motion 
A motion was made by Dr. Haselkom and seconded by Dr. Carmen to approve the 
protocol contingent on the submission of data demonstrating the level of sensitivity of 
assays for RCR and review and approval of this data by the primary reviewers. The 
motion to approve the protocol passed by a vote of 13 in favor, 0 opposed, and 3 
abstentions. 
XII. DISCUSSION ON INFORMED CONSENT ISSUES/DR. ELLIS 
Dr. Zallen, Chair of the RAC Working Group on Informed Consent, presented an 
overview of the written questions that were forwarded to Dr. Gary Ellis, Director of the 
Office for Protection from Research Risks (OPRR) of NIH, prior to this meeting. She 
thanked Dr. Ellis for his willingness to present an oral response to the working group's 
questions. 
Dr. Zallen explained that the working group focused its concerns in three areas: (1) the 
role of OPRR and its mechanism for oversight of local IRBs, (2) the relationship 
between IRBs and Pis (e.g., quality control for Informed Consent documents), and (3) 
the independent responsibilities and cooperative efforts of the RAC, OPRR, and IRBs, 
particularly in relation to human gene transfer. The RAC frequently encounters 
resistance from local IRBs concerning recommended changes to Informed Consent 
documents. Dr. Zallen inquired whether the RAC, as part of its advisory role, can 
condition its approval of a given protocol contingent on Informed Consent document 
changes. Dr. Zallen asked Dr. Ellis for recommendations on how to resolve issues in 
which there is disagreement between the RAC and the local IRB. 
Dr. Ellis explained that OPRR is an office within the Department of Health and Human 
Services, but housed at NIH. OPRR oversees implementation of the federal regulations 
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