A. What steps will be taken, consistent with point I-E above, to ensure 
that accurate information is made available to the public with respect 
to Such public concerns as may arise from the proposed study? 
B. Do you or your funding sources intend to protect under patent or trade 
secret laws either the products or the procedures developed in the pro- 
posed study? If so, what steps will be taken to permit as full communi- 
cation as possible among investigators and clinicians concerning research 
methods and results? 
III. Requested Documentation 
In addition to responses to the questions raised in these "Points to 
Consider," please submit the following materials: 
A. Your protocol as approved by your local IRB and IBC. The consent 
form, which must have IRB approval, should be submitted to the NIH only 
on request. 
B. Local IRB and IBC minutes and recommendations that pertain to your 
protocol. 
C. A one-page scientific abstract of the gene therapy protocol. 
D. A one-page description of the proposed experiment in nontechnical language. 
E. Curricula vitae for professional personnel. 
F. An indication of other federal agencies to which the protocol is 
being submitted for review. 
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