STUDY NUMBER: 
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 
CONTINUATION: page _14_ of 1L pages. 
of the cells, and the fluid lining the air passages), examination and recovery 
of the cells lining the nostrils, and measurement of the electrical potential 
difference between the nose or airways and the skin. The tests in the vehicle 
control period (part 2) and the AdCFTR treatment period (part 3) are similar, 
except a few tests (sterility tests, HIV blood test) do not have to be repeat- 
ed. For timing and detail of these tests, see sections 5.6.2, 5.6.3, and 
5.6.4. The following discussion relates to details of the risks of these 
tests. All are routine tests in clinical medicine. Each is an accepted, safe 
medical test. Like most medical tests however, there are some associated 
discomforts and risks. 
1. Blood tests. Drawing blood can cause pain where the needle is put in the 
vein or artery and can cause a bruise or very rarely, damage to the 
blood vessel. Rarely, patients faint after blood drawing. The total 
amount of blood to be drawn during any single part of the study will not 
exceed 200 ml (less than half a pint) . This amount is within the 
acceptable limits for research with human according to NIH guidelines. 
2. Arterial blood gas. Unlike routine blood tests, which uses blood 
drawn from veins, blood gas testing requires the use of arterial blood. 
A small needle will be placed into the artery of your forearm to obtain 
blood needed for testing. Because arteries are more sensitive than 
veins and cannot be seen when inserting the needle, arterial blood gas 
examination is somewhat more painful than simple blood testing. As with 
routine blood tests, there may be damage to the wall of the blood ves- 
sel, a bruise may result or the patient may faint. 
3. Within the first year of the protocol the maximum total radiation expo- 
sure from the chest X-ray, chest computed tomography scan (a specialized 
chest X ray) and ventilation perfusion scans will be 4 rads. This amount 
is judged safe by NIH institutional guidelines (less than 5 rads per 
year allowable) . 
4. Breathing tests. These tests are harmless but may occasionally cause 
slight soreness in the respiratory muscles and chest due to effort. 
5. Collection of urine samples or sputum samples will not require any 
extra discomfort to the patient. All that is required is that when 
total daily urine (i.e. over a 24 hr period) or daily sputum (over a 
17 hr period) is to be collected the patient makes as complete a 
collection as possible. Occasionally the patient will be asked to give 
a single urine or sputum specimen for analysis. 
6. Examination, testing and sampling of the nasal passages. This is per- 
formed under direct observation. A nasal speculum is placed into the 
PATIENT IDENTIFICATION 
CONTINUATION SHEET for either: 
Recombinant DNA Research, Volume 16 
[785] 
