Dr. Anderson then sumnarized the contents of the following sections of the 
document : 
I. Description of Proposal 
A. Objectives and rationale of the proposed research 
B. Research design 
1. Structure and characteristics of the biological systan 
a. Structure of the cloned DNA 
b. Structure of the material that will be administered 
(1) Viral particle preparation 
(2) Producer cells 
2. Preclinical studies 
a. Delivery system 
b. Expression 
c. Safety 
3. Clinical procedures 
4. Public health considerations 
5. Qualifications of investigators 
C. Selection of patients 
D. Informed consent 
E. Privacy and confidentiality 
II. Special Issues 
III. Requested Documentation 
Appendix Contents 
References 
Dr. Anderson surmarized a monkey safety protocol in Appendix A in which a 
large quantity of a replication defective amphotrcpic vector will be injected 
intravenously into a primate. A high dose of wild-type amphotrcpic helper 
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