more effective. At some later time, should these alternatives be 
clinically indicated, they will be discussed with you because this study 
does not preclude their use. 
Other Pertinent Information 
1. Confidentiality. When results of a study such as this are reported in 
medical journals or at meetings, the identification of those taking 
part is withheld. Medical records are maintained according to current 
legal requirements, and are made available for review, as required by 
the Food and Drug Administration or other authorized users, only under 
the guidelines established by the Federal Privacy Act. A qualified 
representative of the National Institutes of Health may inspect 
patient and study records. This procedure may attract attention from 
the media. We will make every effort to protect your confidentiality. 
Because of media interest, however, there is a significant chance that 
information concerning you and your treatment will appear publicly 
without your consent. 
2. Policy regarding research-related injuries. In the unlikely event of 
physical injury resulting from research procedures, the University 
will provide first-aid medical treatment. Treatment of injuries or 
side effects directly related to this experimental treatment will be 
provided at no cost to you. Additional medical treatment will be 
provided in accordance with the determination by the University of its 
responsibility to provide such treatment. However, the University 
does not provide compensation to a person who is injured while 
participating as a subject in research. If you have questions 
regarding additional medical treatments, you may call the Patient 
Staff Relations Office (313/763-5456). 
3. You will not be paid to take part in this study. 
4. Outpatient and inpatient studies will be ordered to determine your 
eligibility for study and whether you have had a response to the 
treatment. Clinic visits, laboratory tests, x-rays, and scans will 
not be free. Items which are not covered by insurance which relate to 
this research protocol will be covered by research grants. The cost 
of tests and treatments unrelated to this study will be handled as 
usual and will depend on whether or not you have insurance and what 
costs your insurance covers. Unfortunately, insurance coverage cannot 
be guaranteed for all tests and treatments; however, you may discuss 
this issue with the hospital financial office or your insurance 
company before you agree to participate. 
5. This consent form does not include consent relating to the risks of 
any surgical procedures. Any surgical procedures performed will 
require a separate consent form. 
Please understand that you are free to withdraw your consent to 
participate in this study at any time during treatment or follow-up and 
seek care from any physician with no loss of benefits or disruption in 
your care. 
Recombinant DNA Research, Volume 17 
[735] 
