* * * TABLE OF CONTENTS * * * 
I. Call to Order 7 
II. Minutes of September 14-15, 1992, meeting 7 
HI. Proposed Addition to Appendix D of the NIH Guidelines Regarding a Human 
Gene Therapy Protocol Entitled: Retroviral Mediated Transfer of the Human 
Multi-Drug Resistance -1 Gene into Hematopoietic Stem Cells During Autologous 
Transplantation After Intensive Chemotherapy for Breast 
Cancer IDs. O'Shaughnessy 7 
IV. Discussion Regarding Cost Associated with Treatment for Non-Negligent 
Research-Related Injury/Dr. Zallen and Ms. Meyers 16 
V. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene 
Therapy Protocol Entitled: Gene Therapy of the Respiratory Manifestations 
of Cystic Fibrosis Using a Replication Deficient Recombinant Adenovirus to 
Transfer the Normal Human Cystic Fibrosis Transmembrane Conductance 
Regulator cDNA to the Airway Epithelium /Dr. Crystal 19 
VI. Minor Modification and Summary Presentation of the Protocol 
Entitled: Ex Vivo Gene Therapy of Familial Hyper- 
cholesterolemia /Dr. Wilson 32 
VII. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene 
Therapy Protocol Entitled: Gene Therapy of Cystic Fibrosis Lung Diseases 
Using El Deleted Adenoviruses: A Phase I Trial /Dr. Wilson 34 
VIII. Discussion Regarding Proposed RAC Review of European Human Gene 
Therapy Protocols/Dr. Blaese 40 
IX. Addition to Appendix D of the NIH Guidelines Regarding a Human Gene 
Therapy Protocol Entitled: Cystic Fibrosis Gene Therapy Using an 
Adenovirus Vector: In Vivo Safety and Efficacy in Nasal Epithelium 
/Dr. Welsh 42 
X. Amendment to the Points to Consider Regarding Reporting Requirements 
for Human Gene Transfer/Therapy Protocols 52 
XI. Amendment to the Points to Consider Regarding Safety of Delivery/ 
Expression Systems and Report of Murine Replication-Competent (RCR) 
Assays/Dr. Anderson 55 
Recombinant DNA Research, Volume 16 
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