Recombinant DNA Advisory Committee - 12/2-3/93 
The Informed Consent document contains an awkward and misleading statement about 
injuries arising in the course of the study will be covered except when they are "a 
consequence of research procedures designed directly to benefit..." the subject. Since this 
study may offer the potential of benefit, this statement could be interpreted that no 
coverage would be forthcoming. The investigator has provided a thorough response and 
a summary of the clinical experience with the 12 patients treated. No serious adverse 
effects were observed at any dose. In his written response, Dr. Haubrich states that this 
Phase I/II trial will not be initiated until the 12 subjects enrolled in the existing Phase I 
study have completed a full course of HIV-IT(V) or placebo injections. Preliminary data 
indicate that this treatment is safe; therefore, the protocol should be approved. 
Review-Dr. Dronamraju (presented by Dr. Walters) 
Dr. Walters summarized Dr. Dronamraju's written review. Although the animal data 
justifies this protocol, data has not been provided from the ongoing human study. The 
total number of patients accrued onto each stratum of the study should be clarified. The 
Informed Consent document acronyms should be revised so that terms such as CTL and 
HIV-IT(V) are clearly defined and are comprehensible to laypersons. The Informed 
Consent document should include a request for autopsy. He inquired whether the 
"Experimental Subject's Bill of Rights" is a standard component of all protocols at the 
institution. 
Review-Dr. Secundy (presented by Dr. Walters) 
Dr. Walters summarized Dr. Secundy's written comments. The data from the previous 
human study is insufficient with regard to CTL activity, antibody response, viral burden, 
and possible adverse effects. How long were the murine and baboon experiments 
carried out? What mechanisms are in place to ensure access to this study by women and 
minorities? 
Other Comments 
Dr. Carmen said that the Informed Consent document is unacceptable in its present 
form and submitted specific changes in writing that would make the document more 
comprehensible to laypersons. He inquired whether the patient information brochure 
prepared for Dr. Galpin's study would be given to patients considering participation in 
this study. Dr. Parkman inquired about the length of time the vector sequences will 
persist at the injection sites. 
Ms. Meyers stated that the Informed Consent document is very poorly written. Approval 
of this protocol should be contingent on review and approval of a revised Informed 
Consent document. Ms. Meyers agreed with Dr. Straus' interpretation of the 
compensation for research-related injury clause. This statement should be deleted from 
the Informed Consent document. 
Discussion ensued about how the RAC could relay its concerns to Dr. Haubrich's IRB 
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Recombinant DNA Research, Volume 18 
