NOT VALID WITHOUT INSTITUTIONAL REVIEW BOARD APPROVAL 
Page 3 of 5 ST. ELIZABETH S MEDICAL CENTER 
INFORMED CONSENT 
FOR 
EXPERIMENTAL PROCEDURES IRB Approval 
Stamp 
before receiving gene therapy, and that if this exam or any blood tests suggest that I have 
diabetes, I will not be considered for this protocol. I understand, however, that even if my 
diabetes is currently under good control, with or without insulin, and that even if my eye exam 
shows no evidence of disease, there is still a possibility that VEGF could cause worsening of 
my eyesight. 
4. A general description of the potential benefits include: 
Participation in this study may not result in any direct benefit to me. It is hoped that VEGF 
gene therapy will heal my ulcer and/or relieve the pain in my leg. It is not possible to predict 
or guarantee a positive response to this treatment 
I will be watched very closely for signs or symptoms of any side effects. In addition, my 
physician and/or his/her associates will provide wound care for my ulcers at each visit. I 
understand that I may be taken off of the study without my consent if it is in the best interest of 
my health and welfare, or if the sponsor or investigator wishes to do so. 
5. A fair disclosure of appropriate alternative procedures of courses of treatment, if any, that 
would be advantageous. These alternative procedures include the following: 
Vascular surgery and/or percutaneous peripheral angioplasty are generally potential 
alternative modes of therapy for patients with my vascular problem (blocked leg arteries); 
however, I understand that I am being considered a candidate for this highly investigational and 
unproven therapy (VEGF gene therapy) because the extent of blockages in my leg arteries 
makes angioplasty and surgery unlikely to be successful. I further understand that the protein 
itself (VEGF) is not currently approved or available for human therapy. It is possible, though 
not certain, that some form of amputation might be required in my case as an "alternative 
procedure"; my vascular doctors, however, have emphasized to me that even gene therapy does 
not guarantee that I will avoid an amputation. 
6. I understand that I may contact the Principal Investigator, Dr. Jeffrey M. Isner, at 
(617)789-2392 in regard to any pertinent questions about the project. 
Additional considerations: in light of the highly investigational nature of this protocol, 
my vascular doctors have discussed with me several additional issues indicated below: 
a. Consent for autopsy : In the event of my death, permission for an autopsy 
examination will be requested in order for my doctors to gain a fuller understanding of the 
consequences of gene therapy. I have been told that in the event of my death, they will seek 
permission to perform the autopsy from my relatives, and I have been asked to discuss this with 
my closest relatives upon entering into this study. 
b. Confidentiality: I understand that despite the attention from the media that may result 
from my participation in this protocol, my doctors will make every attempt to keep my 
participation private unless explicitly approved by me otherwise. I understand, however, that 
inadvertent disclosure of my name may occur despite the best efforts of my physicians. In this 
regard, I further understand that my medical records must be made available, upon request, to the 
[340] 
Recombinant DNA Research, Volume 20 
