1. How many patients do you plan to involve in the proposed study? 
2. How many eligible patients do you anticipate being able bo identify 
each year? 
3. vhat recruitment procedures do you plan bo use? 
4. What selection criteria do you plan to employ? Vhat are the exclusion 
and inclusion criteria for the study? 
5. Hew will patients be selected if it is not possible bo include 
all who desire to participate? 
D. Informed consent 
Indicate how patients will be informed about the proposed study and 
how their consent will be solicited. The consent procedure should adhere 
to the requirements of CHHS regulations for the protection of human 
subjects (45 Code of Federal Regulations, Part 46). If the study 
involves pediatric or mentally handicapped patients, describe procedures 
for seeking the permission of parents or guardians and, v^iere applicable, 
the assent of each patient. Areas of special concern highlighted 
below include potential adverse effects, financial costs, privacy, and 
long-term follcw-up. 
1. How will the major points covered in Sections I -A through I-C of 
this document be disclosed to potential participants in this study 
and/or parents or guardians in language that is understandable to 
them? 
Recombinant DNA Research, Volume 1 1 
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