Attachment VII - Page 1 
NATIONAL INSTITUTES OF HEALTH 
POINTS TO CONSIDER IN THE DESIGN AND SUBMISSION OF 
HUMAN SOMATIC -CELL GENE THERAPY PROTOCOLS 
WORKING GROUP ON HUMAN GENE THERAPY 
NIH RECOMBINANT DMA ADVISORY COMMITTEE 
OUTLINE 
Applicability 
Introduction 
I. Description of Proposal 
A. Objectives and rationale of the proposed research 
B. Research design, anticipated risks and benefits 
1. Structure and characteristics of the biological system 
2. Preclinical studies, including risk assessment studies 
3. Clinical procedures, including patient monitoring 
4. Public-health considerations 
5. CXialifications of investigators, adequacy of laboratory and clinical 
facilities 
C. Selection of patients 
D. Informed consent 
E. Privacy and confidentiality 
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