Recombinant DNA Advisoiy Committee - 3/3^/94 
D. 
LOCAL COMMriTEB APPROVALS 
1. 
Has the oroposed study been uncx>nditionaUY approved by your Institutional Biosafety Committee? If so, 
provide a copy of the approval. 
2. 
Has the proposed study been unconditioRattr appto^od by vow lastitattonai Reinew Board? If so. provide a 
copy of the approval. 
E. 
INFORMED CONSENT DOCUMENT 
1. 
Provide a copy of the IRB-approvcd Informed Consent document, consistent with the Points to Consider, 
and underline the text addressing the following apecifc Its ms: 
NOTE: 
If any of these items are not addressed in the Informed Consent document, provide an explanation as to the 
reason for their omission. 
a. 
Any requirement for use of birth-eontiot by male Md female participants during the course of the 
experiment; 
b. 
Financial costs for which the individual raacaMh n^cct wifi be responsible; 
c. 
Need for long-term follow-«p and th« armagaments for such follow-up; 
d. 
Statement indicating that a request for permiarion to perform an autopsy will be made of the 
family, regardless of the immediate causa «f death; 
e. 
Arrangements in place at the rescafch mslitiitlon for sharing informatioo with the new media and 
the public. 
f. 
Provisions for protecting patient privacy and the confWentiathy of data obtained from individual 
participants in the research. 
F. 
ADDITIONAL INFORMATION 
1. 
Provide curricula vitae (2 page Biosketch format) for principal investigators and key personnel. 
1 
Provide relevant publications only. 
Recombinant DNA Research, Volume 19 
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