Attachment II - Page 1 
II. 
III. 
POINTS TO CONSIDER IN THE DESIGN AND SUBMISSION 
OF HUMAN GENE THERAPY PROTOCOLS 
DRAFT 
WORKING GROUP ON HUMAN GENE THERAPY 
RECOMBINANT DMA ADVISORY COMMITTEE 
OUTLINE OF CONTENTS 
Issues Covered by the Department of Health and Human Services (DHHS) Regula- 
tions for Research Involving Human Subjects 
A. Research Design, Risks and Benefits 
1. The Disease and Alternative Therapies 
2. Research Methods 
a. Characterization of vector and inserted DNA 
b. Prior laboratory resea ch 
c. Clinical and public-health considerations 
d. Statistical considerations 
3. Qualifications of Investigators, Adequacy of Laboratory and 
Clinical Facilities 
B. Selection of Subjects 
C. Informed Consent 
D. Data Monitoring 
E. Privacy and Confidentiality 
General Social Issues Not Covered by the DHHS Regulations for Reseach 
Involving Human Subjects 
A. Financial Support 
B. Patents 
C. Impact on Germ Line 
D. Implications 
Requested Documentation 
October 1, 1984 
[ 109 ] 
