-4- 
Attachment III - Page 4 
Section D 
Points 1-5 are misleading and should be deleted. Add the 
following instead: "The consent form must adhere to the 
requi rements of 45 CFR 46 and 21 CFR 50. Special attention must 
be paid to the applicability of the additional elements of 
informed consent listed in these regulations. (Include a copy 
of the patient consent form as part of the documentation 
requested in Part III, below.)" 
Miller 
Section E 
Delete points 1 and 2 under "Privacy and Confidentiality." 
Mi Her 
Part II 
Section A 
Only this part should be kept. 
Mi ller 
Section C 
1. Not social but medical/scientific — improper. 
Singer 
Already answered previously. 
Juengst 
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