Attachment III - Page 1 
DRAFT 
POINTS TO CONSIDER IN THE DESIGN AND SUBMISSION 
OF HUMAN GENE THERAPY PROTOCOLS 
WORKING GROUP ON HUMAN GENE THERAPY 
RECOMBINANT DNA ADVISORY COMMITTEE 
OUTLINE 
Preamble 
A. Focus on somatic-cell gene therapy 
B. Guidance provided by general rules for research involving 
human subjects and President's Commission report on 
Splicing Life 
C. Review procedures 
D. Procedure for periodic revision of "Points to Consider" 
I. Issues Covered by the Department of Health and Human Services (DHHS) 
Regulations for Research Involving Human Subjects 
A. Research design, anticipated risks and benefits 
1. Objectives and rationale 
a. Disease to be treated 
b. Natural history of disease 
c. Alternative treatments 
2. Research Methods 
a. Structure of genetic material to be inserted 
b. Tissue culture and animal studies 
3. Clinical and public-health considerations in the 
treatment of patients 
. Qualifications of investigators, adequacy of 
laboratory and clinical facilities 
B. Selection of subjects 
C. Informed consent process 
D. The protection of privacy and confidentiality 
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