I 
MEDICAL record 

CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 

STUDY NUMBER: 
i 
CONTINUATION: page _LZ_ of JLL pages. 
To first consider the problems associated with the various tests and proce- 
dures in the protocol it should be noted that all the tests used are widely 
accepted tests in clinical medicine and in most instances would form an 
important part of the study subject's ongoing care. All these tests are regu- 
lated by National Institutes of Health regulatory bodies so that strict stan- 
dards are upheld. These include limitations on the amount of blood which can 
be drawn and the amount of radiation the subjects can be exposed to during the 
different parts of the protocol. Furthermore the invasive tests such as nasal 
instrumentation and bronchoscopy with its attendant procedures will all be 
performed by experts with much experience in these fields. 
The risks of giving AdCFTR to individuals with CF are at present mainly 
speculative. Potential risks are from any adenovirus itself, from the specific 
adenovirus to be used in this protocol and finally from the product of the 
genetically modified adenovirus to be used in this protocol. Adenoviruses are 
a common cause of respiratory problems in man, usually of a non- serious type, 
unless the infected individual has a compromised immune system (poor defense 
against germs). The fact that only individuals with antibodies against adeno- 
virus will be permitted into the study is a further safety precaution as any 
passage of AdCFTR or related adenovirus into the bloodstream will be met there 
by antibodies which are part of the body's defenses against adenoviruses. 
Therefore infection with an adenovirus per se is not felt to pose a major 
problem. 
It is possible that the AdCFTR virus will combine in some way with another 
adenovirus and thus acquire the ability to reproduce itself. This might lead 
to increased production of AdCFTR and an ongoing adenovirus infection. Another 
possibility is that the AdCFTR may acquire some genetic material from another 
adenovirus or other virus leading to the production of some form of mutant 
adenovirus. These potential problems would not only affect the individual 
receiving the AdCFTR but could also potentially affect individuals other than 
study participants. In order to prevent this occurring this protocol has built 
into it certain safeguards. These include the fact that no individual with 
evidence of adenovirus or other major respiratory viral infection will be 
included in the study. Therefore any possible combining of AdCFTR with other 
viruses will likely involve viruses acquired after starting the protocol. To 
minimize the chance of this occurring during the initial phase after adminis- 
tration of AdCFTR, the study individual will be isolated (as described above) 
for 10 days prior to being treated with AdCFTR. To protect others, the isola- 
tion will continue following administration of AdCFTR until tests taken on at 
least three separate occasions show no evidence of adenovirus in cultures 
taken from the pharynx, nose, rectum or urine. Study participants will be 
requested to stay in the NIH Clinical Center until these cultures are nega- 
tive. These problems while theoretically possible, have never been seen in 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
[788] 
Recombinant DNA Research, Volume 16 
