NOT VALID WITHOUT INSTITUTIONAL REVIEW BOARD APPROVAL 
Page 4 of 5 ST. ELIZABETH'S MEDICAL CENTER 
INFORMED CONSENT 
FOR 
EXPERIMENTAL PROCEDURES IRB Approval 
Stamp 
Food and Drug Administration under guidelines established by the Federal Privacy Act. 
Similarly, qualified representatives of the National Institutes of Health may also review my 
medical records. 
c. Compensation: I understand that I will not be paid to participate in this study. 
d. Patient Charges : I understand that clinic visits, laboratory tests, non-invasive 
vascular testing, x-rays, scans, angiograms, catheteterization procedures, professional charges 
and hospital room charges will not be free. I have been told, however, that items which relate to 
this research protocol and which are not covered by insurance will be covered by research grants. 
This includes the costs of long-term follow-up. The cost of tests and treatments unrelated to this 
study will be handled as usual and will depend upon my insurance coverage. It has been 
suggested to me that if I do not have insurance or if there are questions regarding my insurance 
coverage, these may be addressed in discussions with my vascular doctors and their assistants 
prior to embarking upon this study. In no case, however, will my participation in the study be 
refused because of my inability to pay. In the case of research-related injury, medical costs will 
be assumed by St. Elizabeth's Medical Center; the Medical Center, however, will not be 
responsible for compensation for time lost from work or similar types ofcompensatory 
reimbursement. 
e. Withdrawal from the study : I understand that I am free to withdraw from this study at 
any time and have been told that it will in no way affect the efforts of my vascular doctors to 
continue to apply their best efforts to treat me with conventional means. Medical consequences 
of withdrawal may - but do not necessarily include - persistence of rest pain and/or ischemic 
ulcers. 
f. Surgical or non-surgical (angioplasty) intervention: I understand that this consent 
form does not apply to any surgical or non-surgical (angioplasty) procedures unless explicity 
described in this protocol. 
g. Long-term follow-up : I understand that I am expected to cooperate in long-term 
(indefinite) follow-up that extends beyond the active phase of the study. During the follow-up 
period I may contact Dr. Isner (617-789-2392); Dr. Rosenfield (617-789-5027); Ms. Pieczek 
(617-789-3043); or the on-call Cardiology Attending Physician at St. Elizabeth's Medical Center 
(617-789-3000). I will continue to provide to the St. Elizabeth's vascular doctors my current 
address and telephone number. 
I understand clearly that I am free to withdraw my consent and to discontinue participation in the 
activity at any time without penalty or loss of benefits to which I am otherwise entitled. 
I have been told that any significant findings resulting from the study will be made known in a 
timely manner to me or my family. This includes new information about the experimental 
procedure, the harms and benefits experienced by other individuals involved in the study, and 
any long-term effects observed. 
Recombinant DNA Research, Volume 20 
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