Attachment II - 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 CNA ADVISORY COMMITTEE 
OUTLINE 
Appl icabi 1 i ty 
Introduction 
I. Description of Proposal 
A. Objectives and rationale of the preposed 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. Cuali f ications of investigators, adequacy of laboratory and clinical 
facilities 
C. Selection of patients 
D. Informed consent 
E. Privacy and confidentiality 
September 23, 1985 
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