Attachment II - Page 9 
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to waive or appear to waive any of the subject's legal rights, or 
releases or appears to release the investigator, the sponsor, the 
institution or its agents from liability for negligence." 
The eight basic elements of informed consent, to be included in the 
information provided to each subject or to each subject's legally authorized 
representative, are the following (§46.116): 
"(1) A statement that the study involves research, an explanation of 
the purposes of the research and the expected duration of the 
subject’s participation, a description of the procedures to be 
followed, and identification of any procedures which are 
experimental; 
"(2) A description of any reasonably foreseeable risks or discomforts 
to the subject: 
"(3) A description of any benefits to the subject or to others which 
may reasonably be expected from the research; 
"(4) A disclosure of appropriate alternative procedures or courses 
of treatment, if any, that might be advantageous to the subject; 
"(5) A statement describing the extent, if any, to which confidential- 
ity of records identifying the subject will be maintained; 
"(6) For research involving more than minimal risk, an explanation 
as to whether any compensation and an explanation as to whether 
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