following your patients? How will patients be monitored to 
assess specific effects of the treatment on the disease? Vfriat 
is the sensitivity of the analyses? How frequently will follow-up 
studies be done? How long will patient follow-up continue? 
e. Wvat are the major potential beneficial and adverse effects of 
treatment that you anticipate? What measures will be taken in 
an attempt bo control or reverse these adverse effects if they 
occur? Can pa re the probability and magnitude of potential 
adverse effects on patients with the probability and magnitude 
of deleterious consequences frcm the disease if gene therapy 
is not performed. 
f. If a treated patient dies, what special studies will be performed 
as part of the autopsy? 
4 . Public-health considerations 
Describe any potential benefits and hazards of the proposed 
therapy to persons other than the patients being treated. 
Specifically: 
a. On what basis are potential public health benefits or hazards 
postulated? 
b. Is there a significant likelihood that the added ENA 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 roan, health-care workers, or family members)? 
Recombinant DNA Research, Volume 1 1 
[ 61 ] 
