INVESTIGATOR'S STATEMENT 
I have fully explained to (patient) the nature and 
purpose of the above described procedure and the risk involved in its performance. I 
have answered and will answer all questions to the best of my ability. I will inform the 
participant of any changes in the procedure, or risk or benefits if any should occur during 
or after the course of this study. 
Signature of Investigator Date 
BASIC ELEMENTS OF INFORMED CONSENT 
The DHS and FDA Policies on Protection of Human Subjects list the basic elements of 
informed consent as follows: 
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 experimental procedures. 
2. A description of reasonably foreseeable risks and discomforts. 
3. A description of any benefits to the subject or others that can reasonably be 
expected from the research. 
4. A disclosure of appropriate alternative procedures or courses that might be 
advantageous to the subject. 
5. A statement describing the extent, if any, to which confidentiality of records 
identifying the subject will be maintained. 
6. An explanation as to whether any compensation and medical treatment is available 
if injury occurs. 
7. An explanation of whom to contact for answers to research-related questions and 
whom to contact in the event of a research-related injury. 
8. A statement that participation is voluntary, that refusal to participate will not involve 
loss of benefits, and that subjects may discontinue participation at any time without 
loss of benefits. 
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