Recombinant DNA Advisory Committee - 12/2-3/93 
about the Informed Consent statements concerning compensation for research-related 
injury. Dr. Krogstad suggested that the protocol should be deferred with the stipulation 
that university representatives and/or the IRB Chair be present at the RAC meeting 
when the protocol is resubmitted for review. Dr. Parkman remarked that the present 
proposal is a Phase I/II trial that by definition is not for the benefit of the patient 
because there is no demonstration of efficacy. The sentence regarding benefits in the 
Informed Consent is not operative in this trial. Dr. Leventhal added that even Phase III 
studies are considered experimental and may not necessarily benefit the patient. Dr. 
Leventhal suggested that the RAC send a letter to Dr. Haubrich's IRB requesting that 
the statement about research-related injury be deleted from the Informed Consent 
document. 
Mr. G'dali Braverman of ACT-UP applauded the investigators for modifying the 
inclusion criterion concerning lower CD4 counts thereby allowing more patients to be 
eligible for this study than the previously approved protocol. He commented on several 
other inclusion/exclusion criteria from a patient's point of view, such as cross 
participation in other studies, lowering the eligibility age from 18 to 13, accrual of 
women and minorities, use of antivirals, mentioning of other experimental protocols to 
patients and other minor points. Mr. Braverman recommended approval of the protocol 
if the RAC members' comments and questions are adequately addressed. 
Investigators' Responses--Drs. Merchant and Haubrich 
Dr. Bruce Merchant, Director of Clinical and Regulatory Affairs, Viagene, Inc., San 
Diego, California, responded to the RAC's questions regarding the retrovirus vector. 
Murine data indicates that the vector sequences are detectable out to 56 days at the site 
of the injection. No sequences were detectable in the ovaries, lungs, lymph nodes, 
spleen, or liver of either primates or mice during this period. No vector sequences were 
present in primate sperm; however, data is not yet available about viral sequences at the 
site of injection in this group of animals. Any patients considering participation in the 
proposed study will receive the patient information brochure (same as for Dr. Galpin's 
study) several days in advance of the study coordinator interview. The Informed Consent 
document will be signed by the patient only after the brochure has been read and 
discussed with the coordinator. In regard to compensation for research-related injury, 
Viagene would be responsible for any expenses involved in the event of research-related 
injury. This policy is clearly stated in the patient information brochure; however, the 
IRB requested that this statement be removed from the Informed Consent document. 
Dr. Merchant encouraged the RAC to send a recommendation about this issue to the 
IRB. He agreed to include the Informed Consent document changes suggested by the 
RAC and expressed his appreciation for Mr. Braverman's comments and suggestions. 
Discussion 
There was a brief discussion regarding whether the letter to the IRB should be a 
contingency for approval of the protocol. Dr. Straus said that a stronger message would 
be sent to the IRB if this letter was a contingency. He said that the letter can be sent 
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