Attachment II - Page 19 
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2. What provision will be rrade to maintain the confidentiality of 
research data, at least in cases vhere data could be linked to 
individual patients? 
II. Special Issues 
Although the following issues are beyond the normal purview of 
local IRBs, the RAC and its working group request that investigators 
respond to questions A and B below. 
A. What steps will be taken, consistent with point I-E above, to ensure 
that accurate information is rrade available to the public with respect 
to such public concerns as may arise frcm 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, vhat steps will be taken to permit as full ccnmini- 
cation as possible among investigators and clinicians concerning research 
methods and results? 
Ill . Requested Documentation 
In addition to responses to the questions raised in these "Points to" 
Consider," please submit the following materials: 
A. Ycur protocol as approved by your local IRB and IBC. The consent 
form, which mast 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. 
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