f. If a treated patient dies, what special studies will be 
performed as part of the autopsy? 
If a treated patient dies, a conventional autopsy would be done as well as 
the tests outlined in Appendix A. Of special significance at autopsy would be 
the testing of all organs. Including germ line, for retroviral sequences. 
4 . Public-health considerations 
Describe any potential benefits and hazards of the proposed therapy 
to persons other than the patients being treated. 
Speclcally: 
a. On what basis are potential public health benefits or hazards 
postulated? 
b. Is there a slgnflciant likelihood that the added DNA will spread 
from the patient to other persons or to the environment? 
c. What precautions will be taken against such spread (e.g.. to 
patients sharing a room, health-care workers, or family 
members)? 
d. What measures will be undertaken to mitigate the risks. If any. 
to public health? 
The potential public health risks from gene therapy can be divided into 
two categories: (1) formation of a replication-competent virus that can be 
spread, either vertically or horizontally, to the population, and (2) infection 
of the patient's germ line with the vector. The probability of occurrence have 
been discussed in Section (I.B.2.C.). The conclusions from the existing 
literature (and contingent on further testing outline in Section I.B.2.C.). is 
that human gene therapy with a replication-defective retroviral vector that is 
helper virus free could be done with little risk. Therefore, existing 
guidelines for recombinant DNA could be used for handling the materials used in 
human gene therapy. The effect of a contamination with 0.1% replication 
competent virus in the S3A RSV is unknown. In vivo primate studies are now 
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