14 
Dr. Childress said the working group had rejected this canment at an earlier 
meetinq, and the subworking group should reject it this time as well. 
Dr. Walters then called the attention of the subworking group to Dr. Miller's 
eleventh canment. Dr. Miller had suggested the first sentence of Section 
I-B-3 is sufficient; the other sentences require extremely canplex speculation 
of the investigator and should be deleted. 
Mr. Mitchell said Section I-B-3 is not requesting speculation since in many 
cases the answer will be based on experience. 
Dr. Murray said the second question in Section I-B-3 does not require specula- 
tion. In sane cases, a great deal of clinical literature exists; this literature 
could suggest potential effects. 
Dr. Anderson said a oanplex risk/benefit analysis is exactly what a clinician 
performs when treating patients. This is not speculation. The suhworking 
group rejected Dr. Miller's eleventh canment. 
Dr. Walters then called the attention of the subworking group to Dr. Miller's 
twelfth c ament. Dr. Miller had stated that in Section I-D, the initial para- 
graph under informed consent would provide sufficient guidance if points 1 
through 5 were deleted and the following language were added to the paragraph: 
"The consent form must adhere to the requirements 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.)" 
The sukworkinq group agreed the working group had discussed this suggestion at 
the April 1985 meeting and had determined it washed to highlight specific 
points. The sukworking group agreed no change was indicated at this time. 
Dr. Vfeilters said Dr. Miller's thirteenth cament was that in Section I-E the 
initial p>aragraph under "Privacy and Confidentiality" would pra/ide sufficient 
information without points 1 and 2; points 1 and 2 should be deleted. 
Ms. Areen felt the working group document highlighted certain important issues. 
She felt this section of the document should not be altered. 
Dr. Anderson agreed the working group wished to consider these issues. He said 
the working group document is not meant to be an FDA review. The suhworking 
group rejected Dr. Miller's thirteenth canment. 
Dr. waiters said Dr. Miller in his fourteenth canment said Section II-B is 
irrelevant to judging the appropriateness of a clinical trial. 
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