IRB Manual
      4.3 Additional Elements - When Applicable
   

 
(1)   
A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus if the subject is, or may become pregnant) which are currently unforeseeable.

 
(2)   
Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
 
(3)   
Any additional costs to the subject that may result from participation in the research.

 
(4)   
A statement that subjects will be notified of significant new findings that may relate to the subject's willingness to continue to participate.

 
(5)   
The consequences of a subject's decision to withdraw from the research and proceduresfor orderly termination of participation by the subject.

 
(6)   

Notification of a friend or relative: Involvement of family members or a friend is encouraged.
Suggested language:

You are entitled to keep you research participation confidential, but you might like to notify
a friend of relative about it. If so, please provide us with the information needed and we

will do our best to notify that person.

I want someone notified      Yes         No    

____________________________                          _____________________
   Name of person to be notified                                   Telephone number

________________________________________________________________
 Address

 
(7)   
See Section 7.7 for special requirements for research involving genetic testing.
     
   


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