M.J. Welsh and A.E. Smith, RAC Application 
investigator. This consent form was prepared in language that is easy to read and 
understand. The patient has the right to ask questions at any time. The study does not 
involve minors or handicapped individuals. The consent form is attached. 
D.2. How will the innovative character and the theoretically possible adverse effects of the 
experiment be discussed with patients and/or parents or guardians? How will the 
potential adverse effects be compared with the consequences of the disease? 
See the Consent Form (Appendix 2). 
D.3. What explanation of the financial costs of the experiment, follow-up care, and any 
available alternatives will be provided to patients and/or parents or guardians? 
The attached Consent Form contains this information. Patients will not be responsible for 
the costs of this study. Patients will be compensated for the time and inconvenience 
involved in participating in the research in the amount of $75 for each day that they spend 
in the hospital. In addition, the patient will be reimbursed for travel expenses to and from 
the hospital for each day the patient comes to the clinic for an outpatient visit. The rate of 
reimbursement will be $0.25 per mile and will include parking expenses. 
D.4. How will patients and/or their parents or guardians be informed that the innovative 
character of the experiment may lead to great interest bv the media in the research 
and in treated patients? 
The investigator will discuss this with the patients. 
D.5. How will patients and/or their parents or guardians be informed : 
D.5.a. About the irreversible consequences of some of the procedures performed? 
See attached Consent Form (Appendix 2). 
D.5.b. About any adverse medical consequences that mav occur if a subject withdraws 
from the study once it has beg un? 
See attached Consent Form (Appendix 2). 
D.5.c. About a willingness to cooperate in long-term follow-up will be expected ? 
D.5.d. About expectations that permission to perform an autopsy will be granted in the 
event of a patient's death following transfer as a precondition for a patient's 
participation in the study? This stipulation is included because an accurate 
determination of the precise cause of a patient's death would be of vital importance to 
all future patients. 
This expectation is contained in the Information Summary For Informed Consent 
(Appendix 2). 
[922] 
Recombinant DNA Research, Volume 16 
