Attachment II - Page 8 
8 
c. From what geographical area will patients be recruited? Hew 
many patient -candidates will be available per year frem this 
area? 
C. Informed Consent 
The IRB shall determine that: 
"(4) Informed consent will be sought frem each prospective subject 
or the subject's legally authorized representative, in accordance 
with, and to the extent required by §46.116. 
"(5) Informed consent will be appropriately documented...." 
The general DHHS requirements for informed consent, as outlined in 
§46,116, cure the following: 
" ...[N]o investigator may involve a human being as a subject in 
research covered by these regulations unless the investigator has 
obtained the legally effective informed consent of the subject or 
the subject's legally authorized representative. An investigator 
shall seek such consent only under circumstances that provide the 
prospective subject or the representative sufficient opportunity 
to consider whether or not to participate and that minimize the 
possibility of coercion or undue influence. The information that 
is given to the subject or the representative shall be in language 
understandable to the subject or the representative. Mo informed 
consent, whether oral or written, may include any exculpatory 
language through which the subject or the representative is made 
[ 116 ] 
