Attachment VI - Page 15 
17 
A. What steps will he taken to ensure that accurate in format ion is made 
available to the public with respect to such public concerns as may 
arise from the proposed study? 
B. Do you or your finding sources intend to protect under patent or trade 
secret laws either the products or the procedures developed in the pro- 
posed study? If so, vhat steps will he taken to permit as full oanmuii- 
cation as possible among investigators and clinicians concerning research 
methods and results? 
Ill . Requested Pocuinentation 
In addition to responses to the questions raised in these "Points to 
Consider," please submit the followinq materials: 
A. Your protocol ( including consent form) as approved by your local IRB 
and rBC. 
B. Local DRB and IBC minutes and recommendations that pertain to your 
protocol. 
C. A one-page abstract of the gene therapy protocol. 
D. Curricula vitae for professional personnel. 
E. An indication of other federal agencies to which the protocol is 
being submitted for review. 
F. Any other material which you believe will aid in the review. 
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