requirements, paying particular attention to whether these procedures 
and requirements are fair and equitable. 
1. How many patients do you plan to involve in the proposed study? 
2. How marry eligible patients do you anticipate being able to identify 
each year? 
3. What recruitment procedures do you plan to use? 
4. fohat selection criteria do you plan to employ? What are the exclusion 
and inclusion criteria for the study? 
5. How will patients be selected if it is not possible to 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, where applicable, 
the assent of each patient. Areas of special concern highlighted 
below include potential adverse effects, financial costs, privacy, and 
long-term follow-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 
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